СПОСОБ ПОЛУЧЕНИЯ ПОРОШКООБРАЗНЫХ МАТЕРИАЛОВ ИЗ ФТОРСОДЕРЖАЩИХ ПОЛИМЕРОВ

Изобретение относится к способу получения порошкообразных материалов из фторсодержащих полимеров. Суспензию твердых частиц фторсодержащего полимера в жидком носителе, предпочтительно воде, замораживают, а затем замороженный носитель удаляют сублимацией при субатмосферном давлении для получения сухого порошка частиц фторсодержащего полимера. Способ позволяет получать порошкообразные материалы из жидкой суспензии твердых частиц фторсодержащего полимера, который при нормальных условиях не поддается перекачке насосом из-за способности к фибриллированию. 12 з.п. ф-лы.

СПОСОБ РАЗЛОЖЕНИЯ

Изобретение касается способа обработки органического материала перед разложением или сублимационной сушкой. В данном способе органический материал, предпочтительно в охлажденном или замороженном состоянии, подвергают обработке расщеплением. После этого материал подвергают сублимационной сушке. Затем материал размещают для разложения. Изобретение также относится к устройству для осуществления данного способа. Устройство представляет собой закрытый резервуар с наличием соединения с источником вакуума, жидкого азота, водяных струй высокого давления, или пара высокого давления, или лазера с высокой энергией излучения, или растительного масла под высоким давлением. Устройство содержит ультразвуковой зонд, является туннельным резервуаром, дополнительно имеет вибрационное устройство. Изобретение обеспечивает разложение органического материала с возможностью усвоения его растительностью. 2 н. и 10 з.п. ф-лы, 1 табл., 1 ил.

СПОСОБ ПОЛУЧЕНИЯ ЛИОФИЛИЗИРОВАННЫХ ПЕЛЛЕТ, СОДЕРЖАЩИХ ФАКТОР VIII

Изобретение относится к области медицины и фармацевтики, а именно к способу получения лиофилизированных пеллет, содержащих фактор VIII, причем способ включает стадии: a) образования капель раствора, содержащего фактор VIII, и их замораживания с образованием пеллет, причем капли образуются посредством образования капель раствора, содержащего фактор VIII, в башне для охлаждения, которая имеет внутреннюю поверхность стенок с контролируемой температурой и внутреннюю температуру ниже температуры замерзания раствора; b) лиофилизации пеллет во вращающемся приемнике, который находится внутри вакуумной камеры. Способ дополнительно включает стадии c) хранения и гомогенизации лиофилизированных пеллет; d) анализа лиофилизированных пеллет при их хранении и гомогенизации; e) загрузки лиофилизированных пеллет в контейнеры. Технический результат заключается в более высокой удельной площади поверхности пеллет, что улучшает восстановление лиофилизированного твердого вещества в жидкость для введения, и более ...

ЛИОФИЛИЗАТ С УЛУЧШЕННОЙ ВОССТАНАВЛИВАЕМОСТЬЮ В ИСХОДНОЕ СОСТОЯНИЕ (ВАРИАНТЫ), СПОСОБ ЕГО ПОЛУЧЕНИЯ И ФАРМАЦЕВТИЧЕСКИЙ ПРЕПАРАТ

Изобретение относится к лиофилизатам с повышенной скоростью растворения, которые могут быть восстановлены без образования частиц, что достигается путем повторного нагревания отобранных растворов во флаконах до температуры от 30 до 95°С непосредственно в сублимационной сушилке, в течение от 10 мин до 4 ч. Предложены лиофилизаты веществ, выбранные из группы: метансульфонат 2-метил-5-метилсульфонил-4-(1-пирролил)бензоилгуанидина, гидрохлорид N-[2-метил-4,5-бис(метилсульфонил)бензоил]гуанидина или метансульфонат 4-изопропил-3-метилсульфонилбензоилгуанидина, а также фармацевтический препарат, содержащий эти лиофилизаты. Изобретение позволяет получать продукты без образования частиц с повышенной скоростью растворения. 6 с. и 3 з.п. ф-лы.

РАСТВОР ТРОМБИНА И СПОСОБЫ ЕГО ПРИМЕНЕНИЯ

Группа изобретений относится к области фармацевтических растворов, в частности к способам лиофилизации водного раствора тромбина, растворам для применения в таких способах лиофилизации и к твердым композициям тромбина. Способ лиофилизации водного раствора тромбина включает получение водного раствора тромбина, содержащего от 1 до менее чем 4,6% (вес/об) сахарида или сахарного спирта; от по меньшей мере 0,7 до менее чем 1,75% (вес/об) хлорида натрия; от 0,2 до 3% (вес/об) альбумина; 0,3 до 1,5% (вес/об) хлорида кальция; и от 0,14 до 1% (вес/об) ацетата натрия; и не содержащего полиэтиленгликоля, и лиофилизацию водного раствора тромбина, причем высота водного раствора тромбина в сосуде для лиофилизации находится в диапазоне от 6 мм до 10 мм, а общее время лиофилизации не превышает 35 часов. Также раскрыта твердая композиция для остановки кровотечений, получаемая указанным способом. Группа изобретений обеспечивает получение стабильных твердых композиций с низким содержанием воды и высокой активностью ...

Способ сублимационной сушки банана

Изобретение относится к пищевой промышленности, а именно к производству сублимированного банана. В предлагаемом способе банан перед сушкой замораживается, нарезается пластинами толщиной 10-20 мм и сушится сублимационным способом в две стадии: на первой стадии продолжительностью 3 ч используются инфракрасные нагреватели с длиной волны 2 мкм, а на второй стадии используются инфракрасные нагреватели с длиной волны 0,8 мкм. Остаточное давление в камере при этом должно составлять 50 Па, а температура нагрева продукта - не более 40 °С. Изобретение позволяет получить продукт высокого качества с ярко выраженным характерным вкусом, сохраняющий первоначальную форму, с содержанием влаги не более 5 %.

Устройство сублимационной сушки

Полезная модель относится к области холодильной обработки и сушки продуктов, а именно к устройствам, приспособленным для охлаждения и сушки продуктов, и может быть использована в пищевой промышленности. Устройство сублимационной сушки содержит герметично закрывающуюся люком теплоизолированную сушильную камеру с расположенными в ней полками, соединенную с вакуумным насосом, испаритель. Испаритель выполнен в виде окружающей полки обечайки с рубашкой, между которыми образованы щелевые каналы. Техническим результатом является повышение энергоэффективности устройства за счет повышения скорости теплообмена с продуктом. 9 з.п. ф-лы, 6 ил.

СПОСОБ ПОЛУЧЕНИЯ ФТОРПОЛИМЕРНЫХ ПОРОШКОВЫХ МАТЕРИАЛОВ

Изобретение относится к получению фторполимерных порошковых материалов. Получают модифицированный фторполимерный порошковый материал. Получают суспензию твердых частиц фторполимера из группы, включающей полимер фторэтиленпропилена и полимер перфоралкокси-соединений совместно с частицами ПТФЭ в водном жидком носителе. Замораживают водную суспензию. Замороженный носитель удаляют посредством сублимации при давлении ниже атмосферного с получением сухих частиц фторполимера, модифицированного наличием модификатора ПТФЭ в виде порошка. 13 з.п. ф-лы, 3 ил., 1 пр.

УСТРОЙСТВО ДЛЯ СУБЛИМАЦИОННОЙ СУШКИ

Изобретение относится к устройствам для сублимационной сушки. Сублимация термолабильного материала осуществляется с помощью устройства, включающего камеру сушки и камеру конденсации, между которыми установлен многоступенчатый (двухступенчатый) турбокомпрессор, оборудованный промежуточным охладителем пара между ступенями. Устройство также оборудовано блоком управления, датчиками давления и температуры, вентилями и насосами. При этом в камере сушки обеспечивают условия ниже тройной точки воды, а камере конденсации обеспечивают условия выше тройной точки воды. Результат – повышение энергетической эффективности и ускорение процесса сушки. 4 з.п. ф-лы, 2 ил., 1 табл.

СПОСОБ ВОССТАНОВЛЕНИЯ ПОВРЕЖДЕННЫХ ВЛАГОЙ ВОЛОКНИСТЫХ МАТЕРИАЛОВ ОРГАНИЧЕСКОГО ПРОИСХОЖДЕНИЯ И ИЗДЕЛИЙ ИЗ НИХ

Изобретение относится к восстановлению библиотечных фондов и музейных экспонатов из капиллярно-пористых материалов, поврежденных при затоплениях, в частности книг. Предварительно замороженный объект размещают в рабочей камере и циклично проводят сублимационную сушку. В каждом цикле создают разрежение в камере и нагревают ее стенки до заданной температуры, подают в камеру поток сухого воздуха с повышением давления в камере, дополнительно проводят высокочастотный нагрев восстанавливаемого объекта, затем отключают нагрев, прекращают подачу потока воздуха и вновь создают разрежение в камере. В процессе сушки осуществляют контроль температуры с помощью термопар и веса с помощью пружинных весов. Нагрев стенок камеры могут осуществлять инфракрасными излучателями до температуры +25 - +30°С. При восстановлении книги термопары размещают по высоте книги внутри нее и нагрев в каждом цикле производят до получения внутри нее температуры не более 0°С. При восстановлении книг с многослойными обложками ...

СПОСОБ ПОЛУЧЕНИЯ ПОРИСТЫХ ПОЛИМЕРНЫХ МИКРОЧАСТИЦ С ПРИМЕНЕНИЕМ ЛИОФИЛЬНОЙ СУШКИ

Изобретение относится к области биотехнологии и медицины, а именно к созданию высокопористых полимерных частиц, используемых в регенеративной медицине, тканевой инженерии и хирургии, а также в качестве назальных или трансдермальных форм доставки лекарств, или в качестве кровоостанавливающих средств. Для получения пористых полимерных микрочастиц используют лиофильную сушку. Способ включает несколько стадий: на первой готовят полимерный раствор, используя в качестве растворителей воду и разбавленные растворы кислот и щелочей, или буферные водные растворы или 1,4-диоксан, диметилсульфоксид. При этом к навеске полимерного материала с содержанием от 0,5 до 2 масс. % сухого вещества от конечного количества раствора приливают от 98 до 99,5 масс. % растворителя, перемешивают на магнитной мешалке не менее 48 ч при комнатной температуре и скорости от 100 до 300 об/мин. Затем проводят стадию формирования аэрозоля с последующей шоковой заморозкой, включающей залив полимерного раствора или суспензии ...

СИСТЕМА И СПОСОБ ЛИОФИЛИЗАЦИИ КЛЕТОК

Группа изобретений относится к области биотехнологии. Предложены система и способ лиофилизации клеток. Система содержит устройство подачи азота с повышенной температурой, рабочую камеру лиофилизации и газоотводящее устройство. Причем устройство подачи выполнено с возможностью подачи газообразного азота при температуре -196°C в рабочую камеру лиофилизации, рабочая камера лиофилизации выполнена с возможностью работы при подходящей для помещения замороженного жидким азотом образца клетки температуре, и газоотводящее устройство выполнено с возможностью отведения газообразного азота и газообразной воды. Способ включает помещение образца клетки в рабочую камеру лиофилизации, подогрев рабочей камеры лиофилизации и непрерывную подачу в нее газообразного азота при температуре -196°C, непрерывный отвод газообразного азота и газообразной воды и завершение процесса лиофилизации. Изобретения обеспечивают отсутствие повреждения клеток при одновременной безопасности и высокой эффективности процесса. 2 ...

СПОСОБ ПОЛУЧЕНИЯ ЛИОФИЛИЗИРОВАННЫХ ПЕЛЛЕТ, СОДЕРЖАЩИХ ФАКТОР VIII

ЛИОФИЛИЗИРОВАННЫЕ ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ

Anlage zur Gefriertrocknung von Stoffen

Freezing unit for centrifuged liquids

An arrangement for freezing a centrifuged liq. in a container, comprises a cooling unit (10) and an inlet unit (2). At least one container (60) is located outside the cooling unit. The supply unit (20) has a holding element (40) which is used to hold at least one container during the container movement, and a drive (30) is used to centrifuge the container. At least one holding element and drive element move laterally w.r.t. each other.The holding element pref. has a supporting stamper with a cut-out and PTFE surface.

Freeze-drying facility

The invention relates to a freeze-drying facility comprising the receiver (1) for the material to be freeze-dried, a molecular pump (3), the condenser (4) for removing the water vapour, and a rotary vane pump (5), all connected in series. Thus the condenser receives already compressed condensate, and can be operated at temperatures that are not so low as for a condenser connected directly to the receiver. This arrangement prevents in particular back-diffusion of hydrocarbons from the rotary vane pump (5) into the receiver (1), which is especially important for freeze-drying of foods. ...

Improved air curtain for slit door has the door dropping from the slit and with an angled edge of the curtain to ensure clean slit edges

An improved air curtain for a slit door, e.g. for access to an ultra clean sterile space, has the wall (2) over the slit angled towards the slit to guide the edge of the curtain to wash over the edges (4) of the slit and prevent accumulation of dust and small particulates. The access door (1) drops vertically, or is hinged to fold away from the slit to either side thereby ensuring that the air curtain is not impeded.

Verfahren zum Abtauen der Kühlrohre der Eiskondensatoren einer Vakuum-Gefriertrocknungskammer und Dampfführung dazu

IMPROVEMENTS IN OR RELATING TO FREEZE DRYING

... 1286018 Freeze-drying FMC CORP 1 Oct 1970 [3 Oct 1969] 46639/70 Heading F4G Frozen granules of coffee extract are admitted in batches through an air lock assembly 16, 18, 22 to a vacuum chamber 10 containing a cascade 12 through which granules flow in zig-zag columns while being heated, the dried granules being passed intermittently through gates 34 at the lower end of the cascade 12 into a hopper 36 and being removed in batches through an air lock assembly 38, 40, 42. A mechanism 24 spreads granules over a slotted feed plate 26 to keep the cascade 12 filled and to prevent clumping of the granules. The cascade 12 (Figs. 1-4) comprises a rectangular box having apertures in its sides 80 for the passage of vapour, and containing horizontal baffles 90 having inclined surfaces 92, 94 defining the columns. Electrical resistance heaters 110 are embedded in elements 100 which radiate heat at the exposed upper faces 98 of the zig-zag columns of granules. The heat supply to the various vertical zones ...

CONTINUOUS FREEZE DRYER

... 1328027 Freeze drying H GOTTFRIED 29 Sept 1971 [25 Feb 1971] 45315/71 Heading F4G A liquid slurry of food (e.g. fruit juice, meat, vegetables, or biological materials) is supplied from a constant-level device 44 to a cooled pipe 50 connected to a freezing chamber 16 (-40‹ C.) containing a conveying and crushing screw 58 rotated by a motor 62 (alternatively, the material may be frozen by dropping it into liquid nitrogen, and then pulverized); after freezing, the material is passed through a valve 62a into a first lyophilizing chamber 66 which contains a conveyer to circulate continuously the material along the chamber 66, which is heated or cooled by coils connected to a reversible refrigeration system, and which is evacuated by a vacuum pump 90 associated with a pair of vapour traps 86, 86a (at -40‹ to -80‹ C.); it passes to a second lyophilizing chamber 66a and thence to one of three similar finishing chambers 24, 26 or 28 from which it is discharged after prolonged circulation while maintaining ...

Freeze drying apparatus

... 1,039,591. Freeze drying. PENNSALT CHEMICALS CORPORATION. Feb. 6, 1964, No. 5146/64. Heading F4G. Apparatus for carrying out the sublimation portion of a freeze drying process comprises a chamber 12 connected to a pair of condensers for removing moisture therefrom and reducing the pressure therein, wherein frozen articles are contained in black pans 76 supported over and spaced from fluid heated shelves 24, 26 by black trays 74. The inner surfaces of the chamber and its door are white, and the shelves are each supported in notches at spaced points on vertical supports 16, 18, 22 disposed along the chamber walls to allow for thermal expansion of the shelves. The Specification states that by black is meant having a surface which, thermodynamically, is an absorptive surface of high emissivity and by white is meant surfaces which reflect all wavelengths of radiation with equal high efficiency and with considerable diffusion.

Improvements in or relating to a process and device for the freezing of a product to be lyophilized and other products

... 968,018. Freezing liquids. SOC. D'UTILISATION SCIENTIFIQUE ET INDUSTRIELLE DU FROID USIFROID. July 24, 1963 [Oct. 23, 1962], No. 29396/63. Heading F4H. A bottle 1 containing a liquid to be frozen, e.g. blood plasma, is supported in and driven by a rotatable cylindrical sleeve 2 which is partially immersed in a refrigerant bath L. The bottom of the sleeve has a central aperture 10 and disposed around this aperture are impeller blades 9 which, when the sleeve is rotated, force refrigerant upwardly through the annular gap 3 between the bottle and sleeve. The bottle stands on a transverse rod 8 and is centred by a polygonal spring (not shown) disposed in the space 3. A spindle 4 drives the sleeve 2 via a universal joint 5 and supporting strips 6, a flange 12 being provided on the lower part of the sleeve to damp any oscillations which may occur.

Freeze drying of target substances

Process

Improvements relating to drying

... 1,032,587. Drying; milk products. LEYBOLD - HOCHVAKUUM - ANLAGEN G.m.b.H. April 16, 1964 [April 20, 1963], No. 15909/64. Headings A2B and A2D. A dry product is prepared from substances which are separable into an aqueous phase and a coagulated residue, for example milk products such a cream or yoghourt, by mechanically separating the coagulated residue and subjecting the residue to freeze drying, subjecting the aqueous phase to any convenient drying process, and mixing the dry materials so obtained to provide the desired final dry product. For example the aqueous phase may be concentrated and subjected to. freeze drying, vacuum drying, or spray drying. The separation may be effected by decanting, centrifuging, or any other suitable method. In examples, (1) yoghourt is centrifuged, the residue is freeze-dried, the aqueous phase is concentrated under a vacuum and spray dried, and the resultant powders mixed to give a powder which is reconstitutable with water to a product equal to the original ...

LOADING EQUIPMENT FOR LYOPHILIZATION APPARATUS

Improvements in or relating to freeze-drying

... 1,131,082. Containers. EDWARDS HIGH VACUUM INTERNATIONAL Ltd. 11 Feb., 1966 [20 Feb., 1965], No. 6219/66. Heading B8P. [Also in Divisions A2 and F4] A container suitable for use in a freezedrying process (see Division F4), comprises a base-plate 1 on which is mounted a frame having four side-walls 4, and a lid 8, which may carry dowel pins 9 to engage in hollow cylinders 10 on the base-plate 1. Vertical walls 2 on the baseplate 1 engage within the side walls 4 of the frame, and an air inlet valve 6, operable from outside the container, is provided on one wall 4 of the frame. Rubber gaskets 5 produce sealing engagement of the frame with the base-plate and lid when the container is closed. A window 12 may be provided to allow the contents to be inspected, and the walls 2 of the base-plate 1 may be at least partially transparent to the same end. The walls 4 of the frame may carry a strengthening rib 7. Springs may be provided in the bores of the cylinders 10 to abut the free ends of the dowel ...

Lyophilizing Method and Equipment.

PROCESS FOR THE PREPARATION OF A CLOSED CONTAINER CONTAINING LYOPHILIZED MATERIAL

... 1520014 Lyophilized material BEHRING- WERKE AG 4 Aug 1975 [6 Aug 1974] 32449/75 Heading A2D A process for the preparation of a closed container containing lyophilized material comprises (1) filling the material to be lyophilized into a container, (2) putting a rubber stopper and an over cap loosely on the container, (3) introducing the container with its contents into a lyophilization apparatus, (4) lyophilizing the contents (5) within the lyophilization apparatus and in a single operation pressing the rubber stopper deep into the container, at the same time pressing the over cap onto the same and (6) removing the container closed under sterile conditions from the lyophilization apparatus. An over cap suitable for use in the above process is described in British Patent Application 32450/75 (Division B8).

Installation of freeze-drying of particles on vibrating bed.

CHAMBER FOR A FREEZING DRYING MECHANISM

DEVICE AND PROCEDURE FOR THE CONTROLLING OF THE DRAINAGE PROCEDURE DURING A FREEZING DRYING TREATMENT.

FREEZING SKIRT DEVICE

PROCEDURE FOR THE PRODUCTION OF STABLE BLOOD PLASMA

CHAMBER FOR FREEZING DRYING PROCESS THROUGH KRYOSORPTION

Plant for the processing of freezingdried products

THERAPEUTIC MEANS WITH GALACTITOL AS CARRIERS.

FIRM ONE OF FORM ARTICLES.

FREEZING DRYING UNIT

MICROWAVE FREEZE-DRIER AND MICROWAVE FREEZING DRYING PROCEDURE

Procedure for the determination of the procedural conditions for freezing skirt plants and device for the execution of the procedure

IN RELATION TO THE ATMOSPHERE OF FINAL CONTAINERS FOR THE TREATMENT OF PRODUCTS.

CHARGING SYSTEMS FOR TREATMENT PLANTS OF IN CONTAINERS OR CONTAINERS MATERIALS PRESENT

Freezing drying device

LYOPHILISATE WITH MORE IMPROVE REKONSTITUIERBARKEIT

HEAT EXCHANGE SYSTEMS

PROCEDURE AND MECHANISM FOR THE LYOPHILISIEREN AS WELL AS FILLING PLANT

OWNER FOR THE FREEZING DRYING PROCESS OF MEDICINE SOLUTIONS

Production method for freeze-dried products

Concentrated protein lyophilates, methods, and uses

Method for lyophilizing an active agent

... 5 A process for lyophilizing a solution (50) of an active agent in a container (19) is provided. Solution of active agent is deposited into a container, the container is covered with a covering plate (60) and placed inside a lyophilizing apparatus. Lyophilization can be conducted to dryness by radiation, convection or both. Also provided is a device made by this process, an active agent-plastic administration device 10 (e.g., a syringe (20)), containing an active agent in the form of lyophilized cake, and an array of such administration devices.

Rotary drum for use in a vacuum freeze-dryer

A rotary drum (302) for use within a vacuum chamber (212) in a vacuum freeze-dryer (204) for the bulkware production of freeze-dried particles is provided. The drum (302) is in open communication with the vacuum chamber (212) and comprises a main section (304) terminated by a front plate (306) and a rear plate (308), the rear plate (308) is adapted for connection with a rotary supporting shaft (312) for rotary support of the drum (302), and the rear plate (308) is permeable for sublimation vapor from freeze-drying the particles.

Heating device for rotary drum freeze-dryer

A heating device (124) for heating particles to be freeze-dried in a rotary drum (102) of a freeze-dryer (100) is provided, the device comprising at least one radiation emitter (202) for applying radiation heat to the particles, and a tube-shaped separator (204) for separating the particles from the at least one emitter (202). The separator (202) being integrally closed at one end and separating an emitter volume (206) encompassing the at least one emitter (202) from a drum process volume (126) inside the drum (102), wherein the heating device (124) protrudes into the drum process volume (126) such that said integrally closed end of the separator (204) is arranged inside the drum (102) as a free end.

Multi chamber flexible bag and methods of using same

A method of preparing a pharmaceutical product in a single multiple chamber flexible bag. A pharmaceutical product is introduced in a liquid state into a first chamber of the flexible bag through a first port. The pharmaceutical product is lyophilized within the first chamber of the flexible bag to provide a lyophilized pharmaceutical product. The flexible bag has a second chamber and the first chamber and the second chamber are separated by a breakable seal. The second chamber further includes a reconstituting solution for reconstituting the lyophilized pharmaceutical product in the first chamber. A user may apply pressure to the flexible bag to break the seal and mix the lyophilized pharmaceutical product and the reconstituting solution to order to administer the pharmaceutical product to a patient. T 7- +----2 126------- +----24 702 +----112 ...

Transfer port system

Lyophilisates with improved reconstitutibility

CONTINUOUS FREEZE DRYING PROCESS

APPARATUS FOR CONDITIONING LYOPHILISED PRODUCTS

FREEZE-DRYING DEVICE

The invention relates to drying equipment for removing solvent from humid material and to a method for operating the drying equipment. The equipment comprises at least one drying chamber (23) comprising at least one support plate (2) for receiving containers (3) filled with humid material or planar layers of humid material. The drying chamber (23) is connected to the capacitor (22) by a vapour channel (15) in which the sublimated solvent can be separated; the support plates (2) are connected to a temperature regulated heating/cooling circuit; the chamber (23) comprises heating/cooling plates (4) or (4') which are connected to a second heat transfer medium circuit. The invention is characterised in that the heating/cooling plates (4) or (4') are configured in such a manner that they can be substantially thermally decoupled from the chamber wall (6).

METHOD OF PRODUCING MULTICOMPONENT LYOPHILIZED PRODUCT

METHOD FOR THE PREPARATION OF FLUOROPOLYMER POWDERED MATERIALS

A method for the preparation of a modified fluoropolymer powdered material is disclosed. A suspension of solid fluoropolymer particles together with PTFE particles in an aqueous carrier, is frozen and the frozen carrier is then removed by sublimation at sub-atmospheric pressure to produce a dry powder of modified fluoropolymer particles.

DISPOSABLE MEMBRANE

The invention relates mainly to an apparatus comprising a chamber for physically and/or chemically treating one or more samples or products, said apparatus comprising a door for introducing samples inside the apparatus chamber or bringing samples outside the apparatus, said apparatus comprising a membrane or film defining a chamber wall inside said apparatus when the door is closed.

FREEZE-DRYING PROCESS

Application for Letters Patent on an Invention Entitled: "FREEZE-DRYING PROCESS" A process is provided for freeze-drying an aqueous liquid product which comprises distributing the liquid product in containers closely fitted in cavities of a tray-shaped heat-conducting solid metal block having relatively high heat transfer, subjecting the block to accelerated cooling such that the liquid in each container is frozen thereby freezing the liquid in each container at. substantially the same rate, and drying the frozen product under vacuum while in the block so that the frozen product in each container is dried at substantially the same rate.

CONTINUOUS FREEZE DRYING SYSTEM

PROCESS FOR LYOPHILISING A PRODUCT

The present invention relates to a process for lyophilising a product (3), comprising the steps of providing a bulk product (3) loading system in the form of a bag (1), the bag (1) having an interior and an exterior defined by a flexible wall, the bag (1) further comprising a filling port (5) providing access to the interior of the bag (1), filling a product (3) having a first moisture content into the interior of the bag (1) via the filling port (5), and exposing the product (3) in the interior of the bag (1) to a lyophilisation cycle such that the moisture content of the product (3) is reduced from the first moisture content to a second, lower, moisture content.

METHOD AND APPARATUS AND CONTAINER FOR FREEZE-DRYING

A method of drying (sublimation or desorption) a frozen product stored in a container (703), comprising: a) capturing (1401) a thermal IR image of the container wall using a thermal IR camera (701); b) processing (1402) the thermal IR image by calculating temperature values of points located on the outer surface of the container wall; c) calculating (1403) a maximum temperature of the product in the container using a mathematical model that models heat flow and that models progress of the drying process; d) controlling an amount of power supplied to the container based on the calculated maximum product temperature (Tprod_max) and on a temperature safety_margin (Tsm). A freeze drying apparatus for performing said method. A container having a specific shape for use in such a process.

METHOD OF INDUCING NUCLEATION OF A MATERIAL

CRYOGENIC REFRIGERATION SYSTEM FOR LYOPHILIZATION

The cryogenic refrigeration system (2) includes a cryogenic heat exchange r system (105) adapted for vaporizing a liquid cryogen and using the gaseous cryogen to cool heat transfer fluid and a heat transfer cooling circuit (10 2) that cools the lyophilization chamber (110) as well as the condenser (115 ). The disclosed heat transfer cooling circuit (102) includes a primary reci rculation loop (104) adapted for cooling the lyophilization chamber (110) wi th the heat transfer fluid, a secondary recirculation loop (106) adapted for cooling a condenser (115) with the heat transfer fluid, and one or more val ves (70, 80) operatively coupling the cryogenic heat exchanger system (105), the primary recirculation loop (104), and the secondary recirculation loop (106).

APPARATUS AND METHODS FOR SEALING A MEDICAMENT WITHIN A MEDICAL DELIVERY DEVICE

Apparatus and methods for lyophilizing and sealing a medicament within a medical delivery device having an opening. The apparatus may include a stopper for sealing the opening. The stopper may have one or more elongated members extending from a base, in a direction that is parallel to a central axis of the base. One or more of the members may be set radially away from the axis and define a coaxial central well. The member or members may define a void. The elongated member or members may engage a device inner wall and support the base away from the opening. The void may provide gas exchange between a device interior and a device exterior. The gas may be a lyophilization byproduct that escapes from the device interior between the inner wall, the base and the member or members. The stopper may be advanced into the device to seal the opening.

MULTI CHAMBER FLEXIBLE BAG AND METHODS OF USING SAME

A method of preparing a pharmaceutical product in a single multiple chamber flexible bag. A pharmaceutical product is introduced in a liquid state into a first chamber of the flexible bag through a first port. The pharmaceutical product is lyophilized within the first chamber of the flexible bag to provide a lyophilized pharmaceutical product. The flexible bag has a second chamber and the first chamber and the second chamber are separated by a breakable seal. The second chamber further includes a reconstituting solution for reconstituting the lyophilized pharmaceutical product in the first chamber. A user may apply pressure to the flexible bag to break the seal and mix the lyophilized pharmaceutical product and the reconstituting solution to order to administer the pharmaceutical product to a patient.

METHOD FOR PROVIDING A DRIED REAGENT IN A MICROFLUIDIC SYSTEM AND MICROFLUIDIC SYSTEM

The invention relates to a method for providing a dried reagent in a microfluidic system, comprising the following steps: providing a microfluidic system having a microfluidic struc-ture, introduction of a flowable carrier medium containing a reagent in the microfluidic struc-ture, and drying the reagent in the microfluidic structure by lyophilization.

VACUUM-ASSISTED PRESERVATION OF BIOLOGICAL PRODUCTS, IN PARTICULAR OF VACCINES

The present invention relates generally to the fields of immunology and vaccine technology. More specifically, the present invention relates to methods for vitrifying biological preparations, including peptides, antigens, antibodies, cells, and the like.

A PROCESS LINE FOR THE PRODUCTION OF FREEZE-DRIED PARTICLES

A process line for the production of freeze-dried particles under closed conditions is provided, the process line comprising a freeze-dryer (100) for the bulkware production of freeze-dried particles under closed conditions, the freeze-dryer (100) comprising a rotary drum (104, 302) for receiving the frozen particles, and a stationary vacuum chamber (102) housing the rotary drum (104, 302), wherein for the production of the particles under closed conditions the vacuum chamber (102) is adapted for closed operation during processing of the particles. The drum (104, 302) is in open communication with the vacuum chamber (102) and at least one transfer section (106, 108) is provided for a product transfer between a separate device of the process line and the freeze-dryer (100), the freeze-dryer (100) and the transfer section (106, 108) being separately adapted for closed operation, wherein the transfer section (106, 108) comprises a temperature-controllable inner wall surface ...

CRYOGENIC APPARATUS

... 2134224 9322598 PCTABS00027 The present invention provides methods and devices for freezing drops of liquid reagent solutions in a cryogenic liquid. In one embodiment, the apparatus of the present invention comprises means for dispensing (22) uniform, precisely measured drops of a liquid reagent (4) and a rotatable carousel (36) positioned below the dispensing means (22). The upper surface of the carousel has a plurality of trays (58) each containing a cryogenic liquid, typically liquid nitrogen, for receiving the drops of liquid reagent. An alternative embodiment of the present invention comprises a tank (66) comprising a cryogenic liquid for receiving the drops of liquid reagent. The tank has a heat source (70) for slightly heating a portion of the cryogenic liquid such that a convection current in the cryogenic liquid provide mild agitation of the liquid and prevent aggregation of the frozen drops.

LYOPHILIZATION SYSTEM

... 11 Abrégé descriptif INSTALLATION DE LYOPHILISATION Installation de lyophilisation du type comportant: - deux enceintes contiguës communiquant l'une avec l'autre, l'une (1) de dessiccation munie d'étagères (5) destinées à porter le produit à lyophiliser. l'autre (2) contenant le piège (6) destiné à recevoir l'eau contenue dans le produit, - un ensemble de conduites de circulation de fluide caloporteur reliées entre elles et contenant un seul et même fluide caloporteur, caractérisée en ce qu'elle comporte : - un circuit principal (7) fermé comportant en série au moins un groupe frigorifique (16) et une pompe de circulation (14) de telle sorte que le fluide caloporteur circule en continu dans ce circuit, - en parallèle au moins un groupe de lyophilisation comprenant chacun une boucle de circuit primaire (9) traversant le piège (6), et en parallèle une boucle de circuit secondaire (8) traversant les étagères (5), la boucle secondaire étant reliée en parallèle à un circuit secondaire (80) muni ...

Procédé pour obtenir des poudres déshydratées à partir de corps d'origine végétale ou animale.

Verfahren und Vorrichtung zur Trocknung von in zu evakuierenden Behältern untergebrachten biologisch aktiven oder andern Substanzen.

Verfahren und Einrichtung zum kontinuierlichen Konzentrieren von Lösungen durch Gefrieren eines Lösungsmittels und Trennung des flüssigen vom erstarrten Anteil

Gefriertrocknungsapparat

Verfahren zur Herstellung leicht löslicher Trockenpräparate quellbarer Substanzen.

Procédé et installation pour la régulation des opérations de congélation-dessiccation ou lyophilisation

Installation de séchage d'une denrée alimentaire

Procédé de préparation d'un produit déshydraté et appareil pour sa mise en oeuvre

Verfahren zur Gefriertrocknung einer Stoffprobe

Procédé de lyophilisation continu et appareil pour la mise en oeuvre du procédé

Vorrichtung zur Gefriertrocknung von Partikeln

Procédé de conservation de produits multicellulaires d'origine biologique

Verfahren und Vorrichtung zum Trocknen eines mit Wasser beladenen, wärmeempfindlichen Materials und gemäss diesem Verfahren getrocknetes Produkt

Procédé de cryo-séchage de matières

Procédé de fabrication d'une friandise au lait glacé, déshydratée par congélation

Verfahren und Einrichtung zur Gefriertrocknung

Verfahren zum Einfrieren von einem Gefriertrocknungsprozess zu unterwerfendem, flüssigem oder pastösem Gut

Vorrichtung zur Gefriertrocknung von pulverförmigen Materialien

Procédé pour la déshydratation de substances alimentaires par séchage à l'état congelé

Procédé pour l'obtention de nouveaux produits alimentaires

Using thermal imaging for control of a manufacturing process

A thermal imaging camera monitors the temperature different zones in a pharmaceutical process such as ribbon compaction, coating, spray drying, fluid bed drying, high shear wet granulation, crystallization, lyophilization, precipitation, fermentation, and low dosage dispensing of a pharmaceutically active liquid. The thermal imaging camera can be used to produce a visual display of a temperature profile, or a spray pattern. In addition, feedback from the thermal imaging camera is used to control one or more processing parameters.

Monitoring Freeze Drying With Gas Measurement On Vacuum Pump Exhaust

Parameters of a freeze drying process are monitored by measuring trace materials in the vacuum pump exhaust. The measurements are made using techniques such as acousto-optic spectrometry, multipass cavity-enhanced absorption spectrometry (CEAS) and cavity ring-down spectrometry (CRDS). The technique may be used to diagnose problems such as leakage in the freeze drying shelves, leakage in the condensation coils, leaks from atmosphere in the chambers and the presence of residual cleaning materials. The technique may also be used to monitor the presence of water vapor in the exhaust of a secondary drying process.

Controlled nucleation during freezing step of freeze drying cycle using pressure differential ice fog distribution

A method of controlling and enhancing the nucleation of product in a freeze dryer, wherein the product is maintained at a predetermined temperature and pressure in a chamber of the freeze dryer, and a predetermined volume of ice fog is created in a condenser chamber separate from the product chamber and connected thereto by a vapor port. The ice fog has a predetermined pressure that is greater than that of the product chamber, and is rapidly conveyed through the vapor port into the product chamber for even distribution therein to create uniform and rapid nucleation of the product in different areas of the product chamber.

LYOPHILISATION TARGETING DEFINED RESIDUAL MOISTURE BY LIMITED DESORPTION ENERGY LEVELS

A process of freeze drying of an essentially aqueous solution comprising at least one first step having a first temperature and pressure level (i.e. primary drying phase) and at least one second step having a second temperature and pressure level (i.e. secondary drying phase) following the first step, wherein in the secondary drying phase limited desorption energy input is applied. 1. A process of freeze drying an essentially aqueous solution comprising the sequential steps ofa) subjecting the solution to a primary drying phase at a first temperature and pressure level to obtain a product; andb) subjecting the product to a secondary drying phase at a second temperature and pressure level;wherein a limited desorption energy input is applied in the secondary drying phase at predefined pressure and temperature levels;to obtain a lyophilized product having a predefined target rest moisture in steady-state conditions.2. The process of wherein the limited desorption energy input applied results in a desorption rate at the target rest moisture of the product approaching zero.3. The process of having a first shelf temperature level and a first chamber pressure level (i.e. primary or sublimation drying phase) and at least one second step having a second shelf temperature level and a second chamber pressure level (i.e. secondary or desorption drying phase) following the first step claim 1 , characterized in that in the secondary or desorption drying phase at which the desorption rate at the target at rest moisture of the product approaches zero.4. The process of claim 1 , wherein the aqueous solution contains biopolymers such as proteins claim 1 , polysaccharides claim 1 , nucleic acids.5. The process of claim 1 , wherein the biopolymers are pharmaceutically active substances.6. The process of claim 1 , wherein the aqueous solution contains proteins selected from the group consisting of plasma proteins such as blood plasma claim 1 , coagulation factors claim 1 , proteases or ...

Bulk freeze drying using spray freezing and stirred drying

A freeze dryer processes bulk powder products. The freeze dryer freezes the product by mixing an atomized spray of product with sterile liquid nitrogen. The resultant powder is freeze dried in a vessel, and the vessel contents is agitated to maintain product contact with heated vessel wall and to prevent agglomeration.

Thermal Shielding to Optimize Lyophilization Process for Pre-Filled Syringes or Vials

A device for supporting at least one vessel containing a target material to be lyophilized generally includes a support panel, a central region, a perimeter region, a thermal shield, and at least one shielding cavity. The support panel has a support surface. The central region is defined by the support panel for supporting the at least one vessel. The perimeter region is also defined by the support panel and surrounding the central region. The thermal shield is positioned about the perimeter region and extends transverse to the support surface of the support panel such that the thermal shield and the support panel define a storage space for accommodating the at least one vessel. The at least one shielding cavity is defined by the thermal shield and contains a shielding material during a lyophilization process. The shielding material is distinct from the target material.

Loading and/or unloading device for a freeze drying system

A [lacuna] principally for loading and unloading the utility surface ( 3 ′) of the drying chamber ( 2 ) of a freeze drying system, which utility surface is located at a defined height position, the unloading position, is characterized by a carriage ( 8 ), which is disposed slightly above said utility surface and extends, during loading or unloading, transversely with respect to a movement direction ( 8 ′) and in parallel with the utility surface and which forms a movable guiding edge for the drying vessels ( 5 ), and by guides ( 7 ), which are disposed on both sides of the utility surface ( 3 ), extend in parallel with the said movement direction and form fixed guiding edges for the drying vessels ( 5 ). The carriage ( 8 ) is driven by two linear motors, the respective secondary parts ( 18 ) of which are fixedly connected to the ends of the carriage ( 8 ) on both sides and are supported on the guides ( 7 ) which at the same time accommodate the primary parts. All of the components of the device thus defined are located inside the drying chamber ( 1 ), wherein a mechanically extraordinarily simple and low-wear design is achieved. The structural design of this type of device renders it possible inside the drying chamber ( 2 ) to provide lateral guides ( 7 ), which are independent of the utility surface, and is suitable for the upgrading existing freeze drying systems in stages with a view to using a plurality of carriages, a lateral displaceability of the guides ( 7 ), i.e. which is to be arranged transversely with respect to the movement direction ( 8 ′), etc. By virtue of the fact that the essential components of this device can be formed in a hermetically encapsulated construction, and are thus accessible for sterilization, reliable handling capability is also provided in terms of hygiene.

FREEZE DRIED PULP AND METHOD OF MAKING

A method for making a dry pulp comprising the steps of 1. A method for making a dry pulp comprising the steps of(i) forming a dispersion in water of a pulp comprising polymeric fibers having a tenacity of at least 20 g/dtex,(ii) filtering the dispersion to form a mass of wet pulp having a solids content of from 5 to 60%,(iii) freezing the wet pulp until the mass is at least 95% frozen,(iv) subliming the water from the frozen mass by subjecting the frozen mass to vacuum of less than 4.5 Torr until the final moisture content of the pulp is no greater than 5%, and(v) warming the pulp to ambient temperature under vacuum.2. The method of wherein the dispersion is filtered to form a mass of wet pulp having a solids content of from 10 to 30%.3. The method of wherein the mass is at least 98% frozen.4. The method of wherein the vacuum is less than 0.5 Torr.5. The method of wherein the final moisture content is no greater than 3%.6. The method of wherein the fibers are para-aramid claim 1 , aromatic copolyamide claim 1 , polyazole claim 1 , or ultra-high molecular weight polyethylene.7. The method of wherein the fiber length is from 0.5 to 1.1 mm.8. A pulp made by the method of wherein the specific surface area is no less than 11 m/g.9. A pulp made by the method of wherein the specific surface area is no less than 15 m/g. 1. Field of the InventionThis invention pertains to a method of making a pulp comprising para-aramid fibers.2. Description of Related ArtU.S. Pat. No. 8,110,129 to Kurino at al describes a method for obtaining para-type wholly aromatic polyamide particles comprising the steps of (a) introducing an aramid polymer solution into a water-based coagulating liquid to obtain a hydrous shaped product and (b) subjecting the never-dried or partly-dried shaped product having a water content of 10 to 99% by weight to freeze-grinding. These aramid polymer particles can be used as a filler material.Chinese patent application number 1952226A to Song relates to a para- ...

Calculation Method and Calculation Device for Sublimation Interface Temperature, Bottom Part Temperature, and Sublimation Rate of Material to be Dried in Freeze-Drying Device

[Object] 1. A calculation method for a sublimation interface temperature and a sublimation rate of a material to be dried in a freeze-drying device ,in the calculation method for the sublimation interface temperature, a bottom part temperature, and the sublimation rate of a material to be dried in the freeze-drying device comprising: a drying chamber (DC) into which the to-be-dried material is introduced; a cold trap (CT) for condensing and trapping water vapor generated from the to-be-dried material introduced into the drying chamber (DC); a main pipe (a) for providing communication between the drying chamber (DC) and the cold trap (CT); a main valve (MV) for opening and closing the main pipe (a); vacuum adjustment means for adjusting the degree of vacuum in the drying chamber (DC); vacuum detection means for detecting an absolute pressure in the drying chamber (DC) and an absolute pressure in the cold trap (CT); and a control device (CR) for automatically controlling the operations of the drying chamber (DC), of the cold trap (CT), and of the opening adjustment means,wherein the control device (CR) stores a required relational expression and a calculation program, drives the vacuum adjustment means during a primary drying period of the to-be-dried material to temporarily change the degree of vacuum (Pdc) in the drying chamber (DC) in an increasing direction, and calculates an average sublimation interface temperature, an average bottom part temperature, and the sublimation rate of the to-be-dried material that prevail during the primary drying period in accordance with the relational expression and with measured data including at least the degree of vacuum (Pdc) in the drying chamber (DC) and the degree of vacuum (Pdt) in the cold trap (CT), which are obtained before and after the temporary change.2. The calculation method for a sublimation interface temperature claim 1 , and a sublimation rate of a material to be dried in a freeze-drying device according to claim ...

LYOPHILIZED PHARMACEUTICAL COMPOSITIONS

The invention provides a method of preparing a lyophilized pharmaceutical composition containing a compound described herein or a pharmaceutically-acceptable salt thereof. The process comprises dissolving the compound in a solvent comprising dimethylsulfoxide and optionally one or more co-solvents to form a solution, and then removing the solvent and any co-solvents by a freeze-drying process. Also provided by the invention are lyophilized pharmaceutical compositions and their use in medicine and in particular in the treatment of cancer. 2. The method of claim 1 , wherein the compound of formula (1) is in the form of a sodium salt.3. The method of claim 1 , wherein the solvent is non-aqueous.4. The method of claim 1 , wherein the lyophilized pharmaceutical composition has a dissolution time claim 1 , at ambient temperature claim 1 , and without the aid of mechanised stirring claim 1 , in a non-aqueous solvent containing 65% (v/v) propylene glycol; 25% (v/v) glycerine; and 10% (v/v) ethanol claim 1 , of no greater than about 20 minutes.5. The method of claim 1 , wherein in an amount of the lyophilized pharmaceutical composition obtained from 1 gram of the solution claim 1 , there is a residual DMSO content of no greater than about 20 mg.6. The method of claim 1 , wherein any residual DMSO present in the lyophilized pharmaceutical composition is in an amount corresponding to no more than 35 mg per 100 mg equivalent of a free base of the compound of formula (1).7. The method of claim 1 , further comprising packing the lyophilized pharmaceutical in a sealed pharmaceutical container.8. The method of claim 1 , further comprising dissolving the lyophilized pharmaceutical composition in a solvent to form an injectable liquid composition.9. The method of claim 8 , wherein the solvent is a non-aqueous solvent.10. The method of claim 1 , wherein the solution further comprises a co-solvent.11. The method of claim 1 , further comprising reconstituting the lyophilized ...

METHOD FOR OBTAINING FREEZE-DRIED ANIMAL SKIN, FREEZE-DRIED ANIMAL SKIN, USE THEREOF AND KIT

The present invention describes a method for obtaining freeze-dried tilapia skin, comprising the steps of cleaning by scraping, washing with physiological saline solution and trimming the edges of the skin; incubation with biocompatible detergent in a sterile recipient and rinsing, incubation with bactericidal agent in sterile recipient and rinsing, incubating with detoxifying solution and rinsing, incubation with antibiotics, rinsing and freezing, cold freeze-drying, vacuum sealing and sterilization, and more specifically the present invention includes the use of tilapia skin to prepare a remedy for treating lesions in humans and animals. The present invention relates to the fields of pharmacy, medicine, dentistry, veterinary medicine, chemistry, biotechnology and tissue engineering. 1. Method for obtaining freeze-dried animal skin characterized by comprising freeze-drying at a temperature in the range from −30° C. to −80° C. , with inner pressure lower than 50 μmHg and time from 2 to 24 h.2. Method claim 1 , according to claim 1 , characterized by the animal skin being obtained preferably from fishes.3Oreochromis niloticus.. Method claim 2 , according to claim 2 , characterized by the fish being optionally tilapia4. Method claim 2 , according to any one of to claim 2 , characterized by comprising the steps of:i) cleaning and trimming the skin of the tilapia;ii) incubation and rinse;iii) freezing;iv) freeze-drying;v) vacuum sealing; andvi) sterilization.5. Method claim 4 , according to characterized by further comprising a step vii) of rehydration of the freeze-dried animal skin.6. Method claim 4 , according to claim 4 , characterized in that step (ii) comprises incubation with biocompatible detergent and rinsing; followed by incubation with bactericidal agent and rinsing; followed by incubation with a detoxifying solution and rinsing.7. Method claim 6 , according to claim 6 , characterized in that it occurs in a sterile environment containing biocompatible ...

METHOD AND SYSTEM FOR FREEZE-DRYING INJECTABLE COMPOSITIONS, IN PARTICULAR PHARMACEUTICAL COMPOSITIONS

Methods and systems for freeze-drying injectable compositions, in particular pharmaceutical compositions, are provided whereby a freeze-dried composition may thus obtained by the method and systems. The systems for freeze-drying injectable compositions, in particular pharmaceutical compositions, make use of the method as described by storing a quantity of a dispersion of an injectable composition in an aqueous dispersion medium in at least one ready-to-use vial, cooling the vial to form ice crystals, applying a vacuum, and applying thermal heat to the dispersion while rotating the vial to homogeneously supply heat to the vial. The condition of the drying dispersion in the rotating vial is measured using an optical sensor using electromagnetic detection and adaptively controlling the amount of thermal heat. 1. A method for freeze-drying injectable compositions , comprising:a. storing a quantity of a dispersion of an injectable composition in an aqueous dispersion medium in at least one ready-to-use vial,b. cooling the vial to form ice crystalsc. applying a vacuumd. applying a thermal heat to the dispersion while rotating the vial to homogeneously supply heat to the vial, whereinstep d. comprises measuring the condition of the drying dispersion in the rotating vial using an optical sensor using electromagnetic detection and adaptively controlling the amount of thermal heat.2. The method according to wherein the thermal heat is generated using microwave electromagnetic radiation.3. The method according to wherein the rotating vial also is translated.4. The method according to claim 1 , wherein the sensor is configured to determine a moisture content and/or a temperature of the composition in the dispersion layer.5. The method according to wherein the amount of thermal heat reaching the vial is determined by supply of power claim 1 , residence time before a source and vacuum pressure level.6. A system for freeze-drying compositions claim 1 , comprising:a. at least one ...

HEATING DEVICE FOR ROTARY DRUM FREEZE-DRYER

A heating device () for heating particles to be freeze-dried in a rotary drum () of a freeze-dryer () is provided, the device comprising at least one radiation emitter () for applying radiation heat to the particles, and a tube-shaped separator () for separating the particles from the at least one emitter (). The separator () being integrally closed at one end and separating an emitter volume () encompassing the at least one emitter () from a drum process volume () inside the drum (), wherein the heating device () protrudes into the drum process volume () such that said integrally closed end of the separator () is arranged inside the drum () as a free end. 1. A heating device for heating particles to be freeze-dried in a rotary drum of a freeze-dryer , the device comprisingat least one radiation emitter for applying radiation heat to the particles; anda tube-shaped separator for separating the particles from the at least one emitter, the separator being integrally closed at one end and separating an emitter volume encompassing the at least one emitter from a drum process volume inside the drum,wherein the heating device is adapted to protrude into the drum process volume such that said integrally closed end of the separator is arranged inside the drum as a free end.2. The heating device according to claim 1 , wherein the heating device is adapted to be held rotatable inside the drum process volume.3. The heating device according to or claim 1 , wherein the separator is at least in part transmissive for the emitter radiation to enter the drum process volume.4. The heating device according to claim 3 , wherein the separator is made at least in part of glass material claim 3 , preferably wherein the separator comprises a glass tube.5. The heating device according to any one of the preceding claims claim 3 , wherein the other end of the separator is closed by a flange hermetically sealing the emitter volume defined inside the tube against the drum process volume claim 3 ...

Vacuum arrangement and method

According to various embodiments, a vacuum arrangement may comprise the following: a first dehydration chamber and a second dehydration chamber, which are gas-separated from one another; a substrate transfer chamber for changing clocked substrate transport into continuous substrate transport towards the second dehydration chamber; a first high-vacuum pump of gas-transfer type for evacuating the first dehydration chamber; and a second high-vacuum pump of gas-binding type for evacuating the second dehydration chamber; wherein the first dehydration chamber is, with respect to the substrate transport, arranged between the second dehydration chamber and the substrate transfer chamber. 1. Vacuum arrangement , comprising:a first dehydration chamber and a second dehydration chamber, which are gas-separated from one another;a substrate transfer chamber for changing clocked substrate transport into continuous substrate transport towards the second dehydration chamber;a first high-vacuum pump of gas-transfer type for evacuating the first dehydration chamber; anda second high-vacuum pump of gas-binding type for evacuating the second dehydration chamber;wherein the first dehydration chamber is, with respect to the substrate transport, arranged between the second dehydration chamber and the substrate transfer chamber.2. Vacuum arrangement according to claim 1 ,wherein the first dehydration chamber and a second dehydration chamber are gas-separated from one another by means of a substrate transfer gap.3. Vacuum arrangement according to claim 2 ,wherein the substrate transfer gap has a smallest extent of less than 10 cm.4. Vacuum arrangement according to claim 1 ,wherein the first high-vacuum pump has a turbomolecular pump; and/orwherein the second high-vacuum pump has a cold trap.5. Vacuum arrangement according to claim 1 , furthermore comprising:a shield which is arranged in the second dehydration chamber between the second high-vacuum pump and a substrate transport region of the ...

LYOPHILIZED PHARMACEUTICAL COMPOSITIONS

The invention provides a method of preparing a lyophilized pharmaceutical composition containing a compound described herein or a pharmaceutically-acceptable salt thereof. The process comprises dissolving the compound in a solvent comprising dimethylsulfoxide and optionally one or more co-solvents to form a solution, and then removing the solvent and any co-solvents by a freeze-drying process. Also provided by the invention are lyophilized pharmaceutical compositions and their use in medicine and in particular in the treatment of cancer. 128.-. (canceled)30. The method of claim 29 , wherein the substantially anhydrous solvent comprises about 65% (v/v) propylene glycol claim 29 , about 25% (v/v) glycerin claim 29 , and about 10% (v/v) ethanol.31. The method of claim 29 , wherein the reconstituting occurs without mechanized stirring.32. The method of claim 29 , wherein the pharmaceutical composition is an injectable liquid composition.33. The method of claim 29 , wherein the compound of formula (1) is in the form of a sodium salt.34. The method of claim 29 , wherein the T-cell activating agent is an anti-CTLA4 antibody.35. The method of claim 29 , wherein the condition is a leukemia.36. The method of claim 35 , wherein the leukemia is acute myelogenous leukemia claim 35 , acute promyelocyte leukemia claim 35 , acute lymphoblastic leukemia claim 35 , or chronic myelogenous leukemia.38. The method of claim 37 , wherein the compound of formula (1) is in the form of a sodium salt.39. The method of claim 37 , wherein the substantially anhydrous solvent comprises about 65% (v/v) propylene glycol claim 37 , about 25% (v/v) glycerin claim 37 , and about 10% (v/v) ethanol.40. The method of claim 37 , wherein any residual DMSO present in the lyophilized product is in an amount corresponding to no more than 35 mg per 100 mg equivalent of a free base of the compound of formula (1).41. The method of claim 37 , the method further comprising packing the lyophilized product in a ...

LYOPHILIZED PREPARATION OF CYTOTOXIC DIPEPTIDES

The present invention is directed to novel lyophilized pharmaceutical preparations comprising a cytotoxic dipeptides such as melphalan flufenamide and one or more excipient(s) selected from the group comprising a polysorbate; a polyethylene glycol; β-cyclodextrin; ocyclodextrin; hydroxypropyl-β-cyclodextrin; sulfobutylether-β-cyclodextrin; lactose; benzyl alcohol; disodium succinate; propylene glycol; Cremophor EL; Dimethyl sulfoxide; D-mannitol; Trehalose; Sucrose and an amino acid. This preparation may be further formulated and is useful in cancer therapy. 140-. (canceled)41. A lyophilized pharmaceutical preparation which is directly soluble in a physiologically acceptable aqueous solution , comprising (i) melphalan flufenamide or a pharmaceutically acceptable salt thereof and (ii) one or more of β-cyclodextrin , α-cyclodextrin , hydroxypropyl-β-cyclodextrin , and sulfobutylether-β-cyclodextrin.42. The lyophilized pharmaceutical preparation according to claim 41 , wherein said melphalan flufenamide is melphalan flufenamide hydrochloride (J1).43. The lyophilized pharmaceutical preparation according to claim 41 , wherein the amount of β-cyclodextrin claim 41 , α-cyclodextrin claim 41 , hydroxypropyl-β-cyclodextrin claim 41 , or sulfobutylether-β-cyclodextrin is 10-100% by weight of said melphalan flufenamide.44. The lyophilized pharmaceutical preparation according to claim 41 , which contains less than 0.5% by weight organic solvents.45. The lyophilized pharmaceutical preparation according to claim 42 , which contains less than 0.5% by weight organic solvents.46. The lyophilized pharmaceutical preparation according to claim 43 , which contains less than 0.5% by weight organic solvents.47. The lyophilized pharmaceutical preparation according to claim 41 , which comprises β-cyclodextrin claim 41 , α-cyclodextrin claim 41 , hydroxypropyl-β-cyclodextrin claim 41 , or sulfobutylether-β-cyclodextrin as the sole excipient.48. The lyophilized pharmaceutical preparation ...

PROCESS MONITORING AND CONTROL USING BATTERY-FREE MULTIPOINT WIRELESS PRODUCT CONDITION SENSING

An arrangement for monitoring an aseptic manufacturing process includes product condition sensors capable of making closely spaced measurements of a product condition such as temperature or humidity. The measurements are made using closely spaced sensors arranged in a linear array on a single probe, which may be used to take measurements at multiple levels within the product. Data from the sensors is transmitted to a data collection point via short range wireless digital communications. The sensors may be used to measure temperature and humidity at a single point. For example, when the sensors are used in pharmaceutical freeze drying, the location of a sublimation front may be calculated for each vial, and the freeze drying process may be controlled using the data. 1. A product condition measurement unit for measuring a condition profile of a product contained in a product vial being processed in an aseptic pharmaceutical processing chamber , comprising:a support structure for positioning in an opening of the product vial;a single elongate probe supported by the support structure and having a plurality of sensors spaced longitudinally in a linear array along the single elongate probe at incremental distances from the support structure, the plurality of sensors comprising surface mount sensors mounted on a printed circuit board;a processor supported by the support structure and connected for receiving measurements from the plurality of sensors.2. The product condition measurement unit of claim 1 , further comprising:a radio frequency energy harvesting board connected for powering the processor using a received wireless powering signal.3. The product condition measurement unit of claim 1 , wherein the condition profile comprises a temperature profile.4. The product condition measurement unit of claim 1 , wherein the condition profile comprises a humidity profile.5. The product condition measurement unit of claim 1 , further comprising a measurement processing module ...

PROCESS FOR LYOPHILISING A PRODUCT

The present invention relates to a process for lyophilising a product (), comprising the steps of providing a bulk product () loading system in the form of a bag (), the bag () having an interior and an exterior defined by a flexible wall, the bag () further comprising a filling port () providing access to the interior of the bag (), filling a product () having a first moisture content into the interior of the bag () via the filling port (), and exposing the product () in the interior of the bag () to a lyophilisation cycle such that the moisture content of the product () is reduced from the first moisture content to a second, lower, moisture content. 120.-. (canceled)21. A method of lyophilizing a product comprising:a. filling a product into an interior of a bag, wherein the product comprises pharmaceutical-grade live anaerobic bacterial cells having a first moisture content; andb. exposing the product to a lyophilization cycle in a lyophilizer via a portion of the bag which is open, wherein the first moisture content of the product is reduced to a second moisture content,wherein the bag has an evaporative capacity of:{'sup': −4', '2, '(i) at least about 0.8×10kg/s/mwhen measured at −10° C. and at 150 μbars;'}{'sup': −4', '2, '(ii) at least about 0.7×10kg/s/mwhen measured at −10° C. and at 60 μbars;'}{'sup': −4', '2, '(iii) at least about 1.5×10kg/s/mwhen measured at 0° C. and at 150 μbars; or'}{'sup': −4', '2, '(iv) at least about 1.0×10kg/s/mwhen measured at 0° C. and at 60 μbars.'}22. The method of claim 21 , wherein the bag has an evaporative capacity of about 0.9×10kg/s/mwhen measured at −10° C. and at 150 μbars.23. The method of claim 21 , wherein the bag has an evaporative capacity of about 0.8×10kg/s/mwhen measured at −10° C. and at 60 μbars.24. The method of claim 21 , wherein the bag has an evaporative capacity of about 1.7×10kg/s/mwhen measured at 0° C. and at 150 μbars.25. The method of claim 21 , wherein the bag has an evaporative capacity of about 1.2 ...

Dry Chemistry Container

A microfluidic system is presented that includes a cartridge and a container. The cartridge includes a plurality of microfluidic channels coupled to one or more chambers. The container holds dry chemicals and includes a housing with a first opening and a second opening smaller than the first opening. The container is designed to be inserted into an opening of the cartridge, such that the container is independently secured within the opening. The insertion of the container allows for the container to be fluidically coupled with a microfluidic channel of the plurality of microfluidic channels via the second opening.

Method and Device for Freeze-Drying Drug Liposomes Powder Assisted by Variable-Frequency Alternating-Current Electric Field

The present invention discloses a method for freeze-drying drug liposomes powder assisted by a variable-frequency alternating-current electric field, which includes the following steps: (1) preparing a drug-liposome suspension sample; (2) dehydrating the sample under a 1-10 kHz, 3-10 kV high-voltage alternating current; (3) freezing and drying the sample treated in step (2) at −20° C. to −40° C., under a 10-25 kHz, 0.2-1 kV high-voltage alternating current, until completion of the freezing process; and (4) heating and drying the sample in a vacuum until completion of sublimation and desorption, and obtaining the drug liposomes freeze-dried powder. The present invention not only greatly shortens a freezing and drying time, but also controls a size of nuclei and ice crystals, further ensuring a quality of the freeze-dried powder. 1. A method for freeze-drying drug liposomes powder assisted by variable-frequency alternating-current electric field is provided , wherein the method comprises the following steps:(1) preparing a drug-liposome suspension sample;(2) dehydrating the sample under a 1-10 kHz, 3-10 kV high-voltage alternating current;(3) freezing and drying the sample treated in step (2) at −20° C. to −40° C., under a 10-25 kHz, 0.2-1 kV high-voltage alternating current, until completion of the freezing process; and(4) heating and drying the sample in a vacuum until completion of sublimation and desorption, and obtaining the drug liposomes freeze-dried powder.2. The method for freeze-drying drug liposomes powder assisted by variable-frequency alternating-current electric field according to claim 1 ,wherein the water content of the drug-liposome suspension in step (1) is 40% to 80%.3. The method for freeze-drying drug liposomes powder assisted by variable-frequency alternating-current electric field according to claim 1 , wherein the dehydrating in step (2) is specifically as follows: dehydrating until the water content of the sample is 18% to 35%.4. The method ...

Lyophilization Container And Method Of Using Same

Provided is a multi-part lyophilization container for lyophilizing a fluid, storing the lyophilizate, reconstituting the lyophilizate, and infusing the reconstituted lyophilizate into a patient, including a method of using same. The container includes a front surface, a back surface, a non-breathable section including a port region, a breathable section including a breathable membrane, and an occlusion zone encompassing a boundary between the non-breathable section and the breathable section. The non-breathable section is configured to accommodate any of a liquid, a solid, a gas or combination thereof. The breathable section is configured to accommodate only a gas. The method includes creating a temporary seal between the non-breathable section of the container and the breathable section, inputting a liquid into the non-breathable section, freezing the liquid, removing the temporary seal to allow vapor transport between the non-breathable section and the breathable section, and adding heat energy the frozen liquid under vacuum. 128-. (canceled)29. A multi-part lyophilization container , the container comprising:a front surface;a back surface;a non-breathable section;a breathable section including a breathable membrane; anda smooth region forming a boundary bridging the non-breathable section and the breathable section, the smooth region including a texture that is smooth relative to the texture of an adjacent material.30. The container of claim 29 , wherein the smooth region comprises front surface material and back surface material which are the same as one another.31. The container of claim 29 , wherein the smooth region comprises material which is dissimilar to material of the non-breathable section and the breathable section.32. The container of claim 29 , wherein the smooth region comprises material having an appearance which is dissimilar to an appearance of material of the non-breathable section and of the breathable section.33. The container of claim 32 , ...

Cannabis Freeze Drying Machine

The present invention is a freeze dryer that contains attachments, accessories, and equipment to assist cannabis cultivators in the drying and curing process of their cannabis produce. The present invention comprises a flexible filter assembly surrounding a vacuum release valve, that helps filter out any pollutants or harmful substances from reaching the cannabis produce. Further, the present invention eliminates the need to periodically remove the cannabis produce for inspection, by attaching moisture probes, temperature sensors, weight scales, and cannabis analyzer within the freeze dryer, and integrating the values obtained from these equipment into a display panel on the freeze dryer. Furthermore, the present invention includes a blackout panel for maintaining darkness inside the specimen chamber, as well as a collapsible worktable for additional utility. Additionally, the present invention eliminates the problem of involving too many separate components, by combining these components and equipment into a single freeze dryer. 1. A machine for freeze drying cannabis , the machine comprising:a freeze dryer chamber;a vacuum release valve;a front door;a glass window;a blackout panel;the freeze dryer chamber comprising an inner cavity, a specimen chamber and a condensation chamber;the inner cavity traversing through a front surface of the freeze dryer chamber;the specimen chamber and the condensation chamber being mounted within the inner cavity of the freeze dry chamber;the condensation chamber being laterally mounted onto the specimen chamber;the vacuum release valve being integrated onto an external surface of the freeze dryer chamber, and being operably coupled to the inner cavity, wherein the vacuum release valve can be opened or closed to adjust the pressure within the inner cavity;the front door being hingedly mounted over an opening of the inner cavity;the glass window being laterally integrated onto the front door and positioned adjacent to the inner cavity; ...

FREEZE DRYING PROCESS AND EQUIPMENT HEALTH MONITORING

In a system and method for controlling a freeze drying process, a diagnostics server () is connected for receiving time series data from a freeze drying system (). The diagnostics server uses a tuned freeze drying system mathematical model to analyze the time series data to predict a system event, and alter the freeze drying process. An analytics server () is connected for secure communication with the diagnostics server, and creates and tunes the freeze drying system mathematical model. An equipment provider service and diagnostic cloud () may apply learning algorithms to the time series data to enhance diagnostic tools and provide predictive maintenance and diagnostic services to the operator of the first production sites using the diagnostic tools. 1. A method for controlling a target freeze drying system , comprising:receiving time series data from a plurality of sensors arranged on the target freeze drying system;tuning a general freeze drying system mathematical model using the time series data to adjust parameters of the general freeze drying system mathematical model to create a tuned freeze drying system mathematical model representing the target freeze drying system;receiving monitoring data from the plurality of sensors;predicting a system event of the target freeze drying system using the tuned freeze drying system mathematical model to analyze the monitoring data; andbased on the predicting the system event of the target freeze drying system, altering a freeze drying process being performed by the target freeze drying system.2. The method according to claim 1 ,wherein predicting a system event of the target freeze drying system comprises predicting a process deviation within a chamber of the target freeze drying system.3. The method according to claim 2 ,wherein the time series data and the monitoring data each comprise pressure measurements within at least a condenser of the target freeze drying system; andwherein predicting a system event of the ...

Formulations and Methods for Contemporaneous Stabilization of Active Proteins During Spray Drying and Storage

A method of treatment of plasma with a physiologically compatible spray dry stable acidic substance (SDSAS) prior to or contemporaneously with spray drying of the plasma that results in greater recovery and greater long-term stabilization of the dried plasma proteins as compared to spray dried plasma that has not be subject to the formulation method of the present invention, as well as compostions related to plasma dried by the methods of the present invention. 1) A method of producing a formulated plasma for drying , the method comprising:a) combining one or more stable acidic substances with plasma, wherein the concentration of the stable acidic substance is in a range between about 0.001 mmol/ml and about 0.050 mmol/ml, wherein said one or more stable acidic substances is an acid or acidic salt that effectuates a pH, to thereby create a formulated plasma.2) The method of claim 1 , wherein the method further comprises drying said formulated plasma in a plasma drying system to thereby obtain a dried formulated plasma.3) The method of claim 1 , wherein said formulated plasma has a pH of about 5.5 to about 7.2.4) The method of claim 1 , wherein the pH of the plasma is known prior to addition of said one or more stable acidic substances and the amount of said one or more stable acidic substances to be added plasma is determined based on the known pH of said plasma.5) The method of claim 1 , wherein said one or more stable acidic substances is physiologically suitable for addition to plasma being dried or physiologically suitable for subjects into which reconstituted plasma is transfused.6) The method of claim 1 , wherein the one or more stable acidic substances is selected from the group consisting of ascorbic acid claim 1 , citric acid claim 1 , gluconic acid claim 1 , lactic acid claim 1 , glycine hydrochloride claim 1 , monosodium citrate claim 1 , oxalic acid claim 1 , halogenated acetic acids claim 1 , arene sulfonic acids claim 1 , molybdic acid claim 1 , ...

METHOD AND DEVICE FOR OPTIMIZED FREEZE-DRYING OF A PHARMACEUTICAL PRODUCT

A method for lyophilizing a substance is provided which may include placing at least one vial containing the substance in a lyophilization chamber, the at least one vial having an opening in which a stopper is inserted in a closed state not allowing gas exchange between the interior and exterior of the vial; providing mechanical means external to the stopper and arranged at the opening for restricting an upward movement of the stopper; lowering the temperature within the lyophilization chamber to a predefined value below the freezing temperature of the substance and reducing the pressure within the lyophilization chamber to a predefined pressure at a predefined temperature, the predefined pressure being chosen such that the force exerted by it on the stopper lifts the stopper from the closed state to an exchange state in which the stopper is only partly inserted in the opening of the vial allowing gas exchange between the interior and exterior of the vial, wherein the lowering of the temperature within the lyophilization chamber to the predefined value is performed before reducing the pressure within the lyophilization chamber to the predefined pressure and wherein lifting the stopper from the closed state abruptly lowers the pressure within the at least one vial which initiates nucleation in the substance within that vial. In addition, mechanical means is provided which may be used in order to perform the method for lyophilizing a substance. 1. A method for lyophilizing a substance comprising the steps of:placing at least one vial containing the substance in a lyophilization chamber, the at least one vial having an opening in which a stopper is inserted in a closed state in which the stopper does not allow gas exchange between the interior and exterior of the vial;providing mechanical means external to the stopper and arranged at the opening for restricting an upward movement of the stopper;lowering the temperature within the lyophilization chamber to a predefined ...

METHOD FOR MANUFACTURING FREEZE-DRIED BODY AND MANUFACTURING DEVICE FOR SAME

The present invention aims to provide a method and an apparatus for producing a lyophilized body, each of which can achieve energy saving, low cost, and a reduction in processing time and can provide a lyophilized body less damaged by a freezing process and a drying process. The present invention relates to a method for lyophilizing a substance using an electromagnetic wave, and the lyophilization method includes freezing the substance under irradiation of at least an electromagnetic wave and reduced-pressure drying the frozen substance under irradiation of at least an electromagnetic wave. 1. A method for producing a lyophilized body , comprising:freezing a substance that is a raw material of the lyophilized body under irradiation of at least an electromagnetic wave; andreduced-pressure drying the frozen substance under irradiation of at least an electromagnetic wave.2. The method for producing a lyophilized body according to claim 1 ,wherein the freezing is performed under irradiation of an electromagnetic wave and a magnetic field, and the reduced-pressure drying is performed under irradiation of an electromagnetic wave and a magnetic field.3. The method for producing a lyophilized body according to claim 1 ,wherein the reduced-pressure drying includes primary reduced-pressure drying and secondary reduced-pressure drying.4. The method for producing a lyophilized body according to claim 1 ,wherein the magnetic field is a static magnetic field.5. The method for producing a lyophilized body according to claim 1 ,wherein the substance is a drug-containing material containing water and at least one drug.6. The method for producing a lyophilized body according to claim 5 ,wherein the at least one drug includes a protein.7. The method for producing a lyophilized body according to claim 6 ,wherein the protein is a physiologically active protein.8. The method for producing a lyophilized body according to claim 7 ,wherein the physiologically active protein is at least one ...

Apparatus and methods for sealing a medicament within a medical delivery device

Apparatus and methods for lyophilizing and sealing a medicament within a medical delivery device having an opening. The apparatus may include a stopper for sealing the opening. The stopper may have one or more elongated members extending from a base, in a direction that is parallel to a central axis of the base. One or more of the members may be set radially away from the axis and define a coaxial central well. The member or members may define a void. The elongated member or members may engage a device inner wall and support the base away from the opening. The void may provide gas exchange between a device interior and a device exterior. The gas may be a lyophilization byproduct that escapes from the device interior between the inner wall, the base and the member or members. The stopper may be advanced into the device to seal the opening.

METHOD OF FREEZE-DRYING

A method of freeze-drying comprising rapidly freezing either liquid or supercritical carbon dioxide in and around a material having pores at a rate of at least 0.2° C./min to limit the size of crystals formed from the carbon dioxide so as to avoid the formation of gas bubbles and damage to the pores and exposure of the material to gas-liquid interfaces. During freezing a solid layer primarily of solid carbon dioxide is formed on and surrounding the material by transferring heat with a cryogenic liquid circulating about the material. This solid layer protects the material from gas-liquid interfaces and surface tension before decreasing pressure about the material by venting carbon dioxide. 1. A method of preserving a material in contact with a first fluid comprising the steps of;replacing the first fluid with a first non-gaseous fluid,cooling the first non-gaseous fluid to cause the first non-gaseous fluid to freeze to form a solid, andcharacterized by:forming a solid layer of the solid on and surrounding the material,then decreasing pressure about the material by expanding the first non-gaseous fluid to form a gas.2. The method of wherein the decreasing pressure is at a rate of at least 0.001 Mpa/min and less than or equal to 2.0 Mpa/min.3. The method of wherein the forming a solid layer of the solid on and surrounding the material comprises transferring heat with a liquid circulating about the material.4. The method of wherein the first fluid is non-gaseous.5. The method of wherein the replacing the first fluid with the first non-gaseous fluid comprises flushing the first fluid from the material with the first non-gaseous fluid.6. The method of comprising subliming the solid from the material.7. The method of including;preserving a material containing at least one pore,subjecting the material to an impregnating agent with the impregnating agent being non-gaseous at the temperature and pressure conditions at which the first non-gaseous fluid is sublimed and with the ...

ENERGY RECOVERY IN A FREEZE-DRYING SYSTEM

Disclosed herein are embodiments of an energy recovery system for a freeze-drying system. In some embodiments, the freeze-drying system includes a freeze dryer chamber having one or more shelves disposed therein; a refrigeration system comprising a refrigerant condenser; a heat exchanger; a first fluid line to thermally couple the refrigerant condenser to the heat exchanger; and a second fluid line to thermally couple the one or more shelves to the heat exchanger. 120-. (canceled)21. A freeze-drying system comprising:a freeze dryer chamber having one or more shelves disposed therein;a refrigerant condenser;a heat exchanger;a first fluid line that passes through the heat exchanger and the one or more shelves; anda second fluid line, separate from the first fluid line, that passes through the heat exchanger and the refrigerant condenser.22. The freeze-drying system of claim 21 , wherein the first fluid line is arranged to thermally couple the refrigerant condenser to the heat exchanger.23. The freeze-drying system of claim 22 , wherein the second fluid line defines a first fluid flow path through the heat exchanger and the one or more shelves.24. The freeze-drying system of claim 23 , wherein the second fluid line further defines a second fluid flow path through the one or more shelves that bypasses the heat exchanger.25. The freeze-drying system of claim 24 , wherein the second fluid line comprises a first valve and a second valve claim 24 , and wherein a heat transfer fluid claim 24 , when present in the second fluid line claim 24 , is confined to the first fluid flow path when the first valve is open and when the second valve is closed.26. The freeze-drying system of claim 25 , wherein the first fluid line and the second fluid line facilitate heat transfer from the refrigerant condenser to the one or more shelves when the heat transfer fluid flows through the first fluid flow path.27. The freeze-drying system of claim 25 , wherein the heat transfer fluid claim 25 , ...

CONTROLLED NUCLEATION DURING FREEZING STEP OF FREEZE DRYING CYCLE USING PRESSURE DIFFERENTIAL WATER VAPOR CO2 ICE CRYSTALS

A method of controlling and enhancing the nucleation of product in a freeze dryer wherein a product is maintained at a predetermined temperature and pressure. A mixture of water vapor and COgas is introduced into a condenser chamber separate from the product chamber to create a predetermined volume of condensed frost, ice and dry ice crystals on an inner surface of the condenser chamber. The condenser chamber is connected to the product chamber and has a predetermined pressure that is greater than that of the product chamber. Upon the opening of the condenser chamber into the product chamber, gas turbulence is created that causes the condensed frost in the form of an ice fog and accompanying ice and dry ice crystals to rapidly enter the product chamber for even distribution therein to create uniform and rapid nucleation of the product in different areas of the product chamber. 1. A method of controlling and enhancing the nucleation of product in a freeze dryer , comprising:maintaining the product at a predetermined temperature and pressure in a chamber of the freeze dryer;{'sub': '2', 'introducing a mixture of water vapor and COgas into a condenser chamber separate from the product chamber to create a predetermined volume of condensed frost, ice and dry ice crystals on an inner surface of the condenser chamber, the condenser chamber being connected to the product chamber by a vapor port and having a predetermined pressure that is greater than that of the product chamber; and'}opening the vapor port into the product chamber to create gas turbulence that causes the condensed frost in the form of an ice fog and accompanying ice and dry ice crystals to rapidly enter the product chamber for even distribution therein to create uniform and rapid nucleation of the product in different areas of the product chamber.2. The method of claim 1 , wherein COgas is introduced into the condenser chamber prior to the introduction of the water vapor and COgas mixture to create a dry ...

ULTRAHIGH EFFICIENCY SPRAY DRYING APPARATUS AND PROCESS

The disclosure relates to ultrahigh efficiency spray drying systems and processes, utilizing induction of localized turbulence in a drying fluid flow stream to produce spray dried product, having particular utility for low temperature spray drying operations. In a specific implementation, a method of processing a spray dryable liquid composition to form a spray dried product includes the steps of: generating a spray of the spray dryable liquid composition; contacting the spray of spray dryable liquid composition in a spray drying contact zone with a stream of primary drying fluid; injecting pressurized secondary drying fluid into the stream of primary drying fluid in the spray drying contact zone at multiple loci thereof to provide localized turbulence at said multiple loci; and recovering the spray dried product from the spray drying contact zone. Systems of the present disclosure are effective in achieving high-rate production of dry powder spray dried products, with substantially reduced capital equipment costs, energy requirements, and operating expenditures. 1. A spray drying system , comprising: (i) an interior volume arranged to receive an atomized spray-dryable material and drying fluid for contacting of the atomized spray-dryable material with the drying fluid in the interior volume;', '(ii) at least one drying fluid inlet by which the drying fluid is introduced into the interior volume for said contacting; and', '(iii) a spray-dried material outlet communicating with the interior volume, arranged to discharge spray-dried material and effluent drying fluid from the vessel;, '(a) a spray drying vessel comprising(b) an atomizer adapted to receive a spray-dryable material and discharge the atomized spray-dryable material into the interior volume of the vessel for said contacting;(c) at least one turbulator adapted to generate turbulence in the drying fluid in the interior volume of the vessel;(d) a process control unit adapted to regulate flow rate of drying ...

VENTED COVER PLATE FOR AN ARRAY OF SYRINGES

A cover plate for use in lyophilization processes is provided. The cover plate includes a base portion and a plurality of protuberances which project from the base portion. The protuberances are adapted to fit in one or more delivery containers, such as syringe barrels. The cover plate permits the escape of vapor from the one or more delivery containers during a lyophilization process. In addition, the cover plate prevents the escape of lyophilizate from the one or more delivery containers during a lyophilization process. Vent features provided to provide enhanced and preferred venting operations during lyophilization processes. 1. A cover plate adapted for communication with a plurality of delivery containers during a lyophilization process , the cover plate comprising:a base portion comprising a length and a width;a plurality of protuberances extending from the base portion and distributed along at least one of the length and the width of the base portion;each of the plurality of protuberances adapted to extend at least partially into a delivery container;each of the plurality of protuberances comprising a plurality of extensions distributed about a circumference of the protuberance;at least one vent provided between the extensions, the at least one vent provided to allow at least one of a gas, a vapor, and a fluid to flow therethrough;and wherein the cover plate substantially prevents the escape of a lyophilizate from the one or more delivery containers during a lyophilization process.2. The cover plate of claim 1 , wherein each of the plurality of protuberances comprises a frustoconical member.3. The cover plate of claim 1 , wherein the protuberances comprise a first portion and a second portion claim 1 , and wherein the extensions are provided proximal to an intersection of the first portion and the second portion.4. The cover plate of claim 1 , wherein the extensions comprise a plurality of rectangular extensions.5. The cover plate of claim 1 , wherein the ...

LYOPHILIZATION SYSTEMS AND METHODS

System and methods related to lyophilization of pharmaceutical products are disclosed. In some embodiments, vials of product are moved through a system using one or more movers which are electromagnetically levitated and moved through the system without making mechanical contact with each other or the system. Load lock chambers may allow a mover to enter from one process region's environment and then be brought to an environment condition of the next process region to allow materials to be passed through conditioning, nucleation, and/or vacuum drying regions prior to finally exit the system to an unloading zone. The movers may then be cleaned or reloaded with vials to begin the process again with a new load of vials.

Lyophilized preparation of cytotoxic dipeptides

The present invention is directed to novel lyophilized pharmaceutical preparations comprising a cytotoxic dipeptides such as melphalan flufenamide and one or more excipient(s) selected from the group comprising a polysorbate; a polyethylene glycol; β-cyclodextrin; ocyclodextrin; hydroxypropyl-β-cyclodextrin; sulfobutylether-β-cyclodextrin; lactose; benzyl alcohol; disodium succinate; propylene glycol; Cremophor EL; Dimethyl sulfoxide; D-mannitol; Trehalose; Sucrose and an amino acid. This preparation may be further formulated and is useful in cancer therapy.

APPARATUS FOR LOADING AND UNLOADING A FREEZE-DRYER

A movement apparatus for loading/unloading containers () into/from a freeze-dryer () provided with a freeze drying chamber () that has at least one shelf () for receiving and supporting containers (), comprising a push bar () to push the containers () and a movement arrangement () for moving the push bar () through the freeze drying chamber () along a direction of movement (A); the movement arrangement () comprises at least one rigid interlocking chain linear actuator () that has a first movement rigid interlocking chain () mobile along the direction of movement (A) and provided with a first operating end () connected to the push bar (). 110-. (canceled)11. A movement apparatus for loading/unloading containers into/from a freeze dryer provided with a freeze drying chamber that has at least one shelf for receiving and supporting said containers , comprising a push bar to engage and push said containers and a movement arrangement for moving said push bar through said freeze drying chamber along a direction of movement , wherein said movement arrangement comprises at least a first rigid interlocking chain linear actuator that has a first movement rigid interlocking chain mobile along said direction of movement and provided with a first operating end connected to said push bar , wherein said movement arrangement further comprises at least a second rigid interlocking chain linear actuator that is arranged to rotate said push bar about a rotation axis at least between a lowered position wherein said push bar is arranged to engage and push said containers , and a raised position wherein said push bar does not interact with said containers , and wherein said rotation axis is transverse to said direction of movement.12. The movement apparatus according to claim 11 , wherein said movement arrangement comprises a pair of first rigid interlocking chain linear actuators that are connected to opposite ends of said push bar.13. The movement apparatus according to claim 11 , ...

SOLID COLORANT FOR TINTING PAINT

A solid colorant including a. 30-97 wt % of a pigment, b. less than 5 wt % of a solvent c. 3-40 wt % surfactants and wherein: the ratio S/A [Std dev of the particle size distribution/average particle size] of the solid colorant is <25%, preferably <22% and more preferably <20%, wherein wt % is relative to the total weight of the solid colorant, and wherein the particle size distribution is determined with light scattering with fully automated image analysis according to ISO 13322-1 Static image analysis First edition 2004-12-01 by the use of the OCCHIO ZEPHYR ESR analyzer. A process for making the solid colorant, and the use of the solid colorant for tinting base paints by volumetric dosing of the solid colorant to the base paint. 1. A solid colorant comprising:a. 30-97 wt % of a pigment;b. less than 5 wt % of a solvent;c. 3-40 wt % surfactants;and wherein a ratio S/A of the [Standard dev of the particle size distribution/average particle size] of the solid colorant is <25%, wherein wt % is relative to the total weight of the solid colorant and wherein the particle size distribution is determined with light scattering with fully automated image analysis according to ISO 13322-1 Static image analysis First edition 2004-12-01 by the use of an OCCHIO ZEPHYR ESR analyzer.2. The solid colorant according to claim 1 , wherein the average particle size ranges between 400 and 1400 μm.3. The solid colorant according to claim 1 , wherein the colorant comprisesa. 50-90 wt % of a pigment;b. less than 3 wt % of a solvent;c. 5-30 wt % surfactants;d. 0.1-5 wt % additives;e. 0-20 wt % colorless filler;f. 0-10 wt % binder;wherein the solid colorant has an average particle size between 400 and 1400 μm.4. The solid colorant according to claim 1 , wherein the colorant comprises 0.1 wt % to 5 wt % of an antioxidant based on the total weight of the solid colorant.5. The solid colorant according to claim 1 , wherein the colorant comprises 0.1 wt % to 2 wt % amount of defoaming agent.6. A ...

Apparatus, System, and Method for Quinoa Food Products

A method for producing powdered quinoa. The method includes dehulling quinoa in a dehuller in some embodiments. The quinoa is dried in a dryer in some embodiments. The quinoa is soaked in a soaker and freeze dried in a freeze dryer. In certain embodiments, the quinoa is extruded on an extruder. In one embodiment, the quinoa is ground in a grinder. 1. A method for producing powdered quinoa comprising:dehulling quinoa in a dehuller;drying the quinoa in a dryer;soaking the quinoa in a soaker;extruding the quinoa in an extruder; andgrinding the quinoa in a grinder.2. The method of claim 1 , wherein dehulling comprises wet dehulling and dry dehulling;3. The method of claim 1 , wherein soaking comprises soaking the quinoa for over eight hours.4. The method of claim 1 , wherein soaking comprises soaking the quinoa for between twenty two and twenty six hours.5. The method of claim 1 , wherein soaking comprises soaking the quinoa for a period of time sufficient to initiate germination of the quinoa.6. The method of claim 1 , further comprising cooking the quinoa in the extruder.7. The method of claim 6 , wherein cooking comprises three stages wherein the first stage is within 5° C. of 80° C. and the third stage is within 5° C. of 140° C.8. The method of claim 7 , wherein the second stage is within 5° C. of 100° C.9. The method of claim 1 , wherein the extruder comprises a twin-screw extruder.10. The method of claim 9 , wherein the extruder has a rotation speed between 1000 RPM and 1800 RPM.11. The method of claim 9 , wherein the extruder has a rotation speed between 1300 RPM and 1500 RPM.12. The method of claim 9 , wherein the extruder comprises a die comprising two 4 mm apertures.13. The method of claim 1 , further comprising micronizing extruded quinoa such that between 11% and 13% is retained on sieve #200 and that between 9% and 11% is retained on sieve #325.14. A system for a quinoa processor claim 1 , the system comprising:a dehuller configured to remove hull from ...

FREEZE DRYING WITH CONSTANT-PRESSURE AND CONSTANT-TEMPERATURE PHASES

Freeze-drying methods and systems include performing a constant-pressure drying phase in a chamber, where a temperature of a heating tray increases. A constant-temperature drying phase is performed in the chamber, where a pressure in the chamber decreases. Additional phases alternate between constant-pressure drying phases and constant-temperature drying phases. The alternating drying phases are halted, responsive to a determination that the temperature of the heating tray has reached a maximum temperature. 1. A method , comprising:performing a constant-pressure drying phase in a chamber, where a temperature of a heating tray increases;performing a constant-temperature drying phase in the chamber, where a pressure in the chamber decreases;alternating between additional constant-pressure drying phases and additional constant-temperature drying phases; andhalting the alternating drying phases responsive to a determination that the temperature of the heating tray has reached a maximum temperature.2. The method of claim 1 , further comprising measuring the temperature of the heating tray using a temperature sensor.3. The method of claim 1 , wherein alternating between constant-pressure drying phases and constant-temperature drying phases is triggered in a fixed-period mode.4. The method of claim 1 , wherein alternating between constant-pressure drying phases and constant-temperature drying phases is triggered in a threshold-triggered mode.5. The method of claim 1 , wherein performing the constant-pressure drying phase comprises activating a heater that causes a sample sublimation rate to match a combined evacuation rate and condensation rate.6. The method of claim 1 , wherein performing the constant-temperature drying phase comprises activating a heater that compensates for heat loss due to sample sublimation.7. The method of claim 1 , further comprising performing an initial constant-pressure phase claim 1 , before the constant-pressure drying phase.8. The method of ...

CONTINUOUS ROLL-TO-ROLL FREEZE-DRYING SYSTEM AND PROCESS

Roll-to-roll freeze-drying (lyophilization) system and process for facilitating freeze-drying processes and enabling the collection of data by which a freeze-drying process can be monitored and evaluated. Such a system includes a roll-to-roll freeze-drying apparatus adapted to continuously freeze and dry a liquid to form a freeze-dried and encapsulate freeze-dried sheet portions of the freeze-dried sheet to create premeasured pouches containing the freeze-dried sheet portions. The system further includes a metrology section that monitors any of the freeze-dried sheet and the freeze-dried sheet portions during the freezing and drying of the liquid to generate data for controlling the freezing and drying of the liquid. 1. A continuous roll-to-roll freeze-drying process comprising:dispensing and continuously freezing and drying a liquid to form a freeze-dried sheet;encapsulating freeze-dried sheet portions of the freeze-dried sheet to create premeasured pouches containing the freeze-dried sheet portions; andmonitoring any of the freeze-dried sheets and the freeze-dried sheet portions during the freezing and drying of the liquid to generate data for controlling the freezing and drying of the liquid.2. The continuous roll-to-roll freeze-drying process of claim 1 , further comprising:continuously conveying a substrate through a roll-to-roll freeze-drying apparatus;continuously depositing the liquid as a liquid film on the substrate; andimmediately and continuously freezing the liquid film to form a frozen film.3. The continuous roll-to-roll freeze-drying process of claim 2 , further comprising monitoring chemical compositions of vapors sublimated during the drying of the liquid to generate further data for controlling the freezing and drying of the liquid.4. The continuous roll-to-roll freeze-drying process of claim 3 , wherein the roll-to-roll freeze-drying apparatus comprises a vacuum chamber in which the dispensing and continuous freezing and drying claim 3 , the ...

Freeze-Drying Apparatus with a Loading and Unloading Device

A freeze-drying apparatus () includes an arrangement of individual product platforms () that are supported vertically in a frame () in a drying chamber, in which each platform is able to be moved to a shift level, in which lateral guides () designed to support a carriage () are arranged with a fixed height position, and which cooperate with the guides () of a loading and unloading device. All product platforms () in the drying chamber can be loaded by repeating this operation cyclically. The freeze-drying apparatus () comprises an electrical drive unit powered by a battery (). 1. A freeze-drying apparatus , comprising:a drying chamber accommodated inside a housing;an arrangement of product platforms disposed so as to be displaceable vertically in a frame and designed to support drying receptacles containing a substance to be dried, located inside the drying chamber, wherein the housing has at least one opening that is closable by a door;a loading and unloading device for the drying receptacles outside of the drying chamber, which has at least one carriage that is supported in guides, and is configured to push the drying receptacles into the drying chamber;wherein the freeze-drying apparatus comprises an electrical drive unit powered by a battery.2. The freeze-drying apparatus according to claim 1 , comprising a charging station for the battery set up outside the drying chamber.3. The freeze-drying apparatus according to claim 1 , comprising a charging station for the battery which is located at a limit position of the carriage.4. The freeze-drying apparatus according to claim 3 , wherein the limit position of the carriage is one of a parking position during the drying operation which is a position set up on the opposite side of the conveyor belt from the point of view of the drying chamber and a position set up on a loading stage.5. The freeze-drying apparatus according to claim 2 , wherein the charging unit for the battery is located at a limit position of the ...

Freeze Drying and Tumble Drying of Flake Powder

Provided is a process for providing a flake powder characterized by a particle size of −40 mesh to +200 mesh; a Scott density of at least 1.458 g/cm; and a flow of at least 1 g/s. The process includes introducing a milled flake powder in a solvent to a first dryer; removing the solvent at a temperature below a melting point of the solvent under a reduced atmosphere to obtain a partially dry flake powder; and introducing the partially dry flake powder to a second dryer to form flake powder wherein particles of partially dry flake powder are heated and simultaneously subjected to an uncorrelated motion relative to adjacent particles. 1. A flake powder characterized by:a particle size of −40 mesh to +200 mesh;{'sup': '3', 'a Scott density of at least 1.458 g/cm; and'}a flow of at least 1 g/s.2. The flake powder of wherein said flow is at least 2 g/s.3. The flake powder of wherein said flow is at least 3 g/s.4. The flake powder of wherein said flow is at least 4 g/s.5. The flake powder of wherein said flow is no more than 8 g/s.6. The flake powder of wherein said Scott density is at least 1.464 g/cm.7. The flake powder of wherein said charge density is between 110 claim 1 ,000 and 180 claim 1 ,000 μFV/g.8. The flake powder of wherein said charge density of said flake powder is at least 200 claim 1 ,000 μFV/g.9. The flake powder of wherein said charge density is at least 250 claim 8 ,000 μFV/g.10. The flake powder of wherein said particle size is −40 mesh to +100 mesh.11. The flake powder of having less than 30 ppm of iron claim 1 , nickel claim 1 , chromium claim 1 , silicon and zirconium combined.12. The flake powder of having a carbon content of less than 23 μg/Mof particle surface.13. The flake powder of wherein said carbon content is less than 18 μg/Mof particle surface.14. The flake powder of comprising a valve metal.15. The flake powder of wherein said valve metal is selected from the group consisting of tantalum claim 14 , niobium claim 14 , tungsten claim 14 , ...

METHOD AND APPARATUS FOR TREATING HUMAN REMAINS BY CHILLING

A method of treating human remains prior to burial or other means of disposal comprises the steps of freezing the remains and size reducing the remains to particulate matter. The freezing step includes the steps of placing the remains in a freezing chamber, charging the chamber with a gas, and circulating the gas in a loop between the freezing chamber and a cooling device. The gas cooling device is adapted to cool the gas to a temperature below −100° C. while maintaining the gas in a gaseous form. The gas cooling device may include a heatsink and a means for cooling the heatsink, wherein the circulating gas is cooled by being brought into contact with the heatsink. 155-. (canceled)57. A method as claimed in in which the gas cooling device includes a heatsink and a means for cooling the heatsink claim 56 , wherein the circulating cryogas is cooled by being brought into contact with the heatsink.58. A method as claimed in in which the heatsink is a body of ice.59. A method as claimed in in which the body of the heatsink comprises at least one conduit for the passage of the gas therethrough.60. A method as claimed in in which the means for cooling the heatsink comprises cooled cryogenic fluid supplied by a cryocooler.61. A method as claimed in in which heat generated by the cryogenic cooling device is re-cycled.62. A method as claimed in in which the heatsink is adapted to cool the gas to below −150° C. claim 57 , optionally below −180° C. claim 57 , optionally below −200° C.63. A method as claimed in in which the gas is capable of remaining in gaseous form at a temperature of −100° C. or lower claim 56 , −150° C. or lower claim 56 , or −200° C. or lower claim 56 , at atmospheric pressure.64. A method as claimed in in which the step of charging the freezing chamber with gas removes all air from the freezing chamber.65. A method as claimed in in which the step of circulating the gas is continued for a period of time sufficient to reduce the core temperature of the ...

Conveyance system

A conveyance system includes a chamber 1, a plate 7A disposed in the chamber 1, the plate 7A being used for disposing an article thereon, an in-chamber bridge 19 disposed in the chamber 1 and capable of coming into contact with the plate 7A, a moving member 3A that moves along the in-chamber bridge 19 and the plate 7A to move the article on the in-chamber bridge 19 and the plate 7A, and a sterilization device 100 that sterilizes an interior of the chamber 1, in which the chamber 1 is allowed to be tightly sealed, with the moving member 3A disposed on the in-chamber bridge 19.

LYOPHILIZED FACTOR IX FORMULATIONS

The present invention provides, among other things, pre-lyophilization formulations, reconstituted formulations, and lyophilate powder compositions comprising a Factor IX (FIX) polypeptide. The present invention also provides lyophilization methods for producing lyophilate powder comprising a FIX polypeptide. 1. A pre-lyophilization formulation comprising:(a) a chimeric Factor IX (FIX) polypeptide, comprising FIX and a heterologous moiety that extends the half-life of the FIX;(b) L-histidine;(c) sucrose;(d) mannitol; and(e) polysorbate 20,wherein the formulation has a fill volume of less than about 5 mL, less than about 4 mL, or less than about 3 mL and wherein each of (a)-(e) are at an amount per vial (mg/vial) sufficient to allow(1) improved stability of the chimeric FIX polypeptide when lyophilized;(2) reduced reconstitution time when lyophilized;(3) reduced splashing onto a stopper comprising the formulation;(4) reduced lyophilization cycle time;(5) increased shelf-life of a lyophilate prepared from the pre-lyophilization formulation at room temperature; or(6) any combinations thereof,compared to a reference pre-lyophilization formulation,wherein the reference formulation comprises (a)-(e) at the amount per vial identical to the pre-lyophilization formulation, but has a 5 mL fill volume.2. The pre-lyophilization formulation of claim 1 , wherein the fill volume is about 4 mL claim 1 , about 3.5 mL claim 1 , about 3.0 mL claim 1 , about 2.9 mL claim 1 , about 2.8 mL claim 1 , about 2.7 mL claim 1 , about 2.65 mL claim 1 , about 2.6 mL claim 1 , about 2.5 mL claim 1 , about 2.4 mL claim 1 , about 2.3 mL claim 1 , about 2.2 mL claim 1 , about 2.1 mL claim 1 , or about 2.0 mL.3. (canceled)4. The pre-lyophilization formulation of claim 1 , wherein the reduced reconstitution time is less than 1.5 minute claim 1 , less than 1 minute claim 1 , less than 50 seconds claim 1 , less than 40 seconds claim 1 , less than 30 seconds claim 1 , less than 20 seconds claim 1 , or ...

Drug Particles From Freezing Onto A Surface

The present invention is a method for preparing micron-sized or submicron-sized drug particles comprising contacting a solution comprising a poorly water soluble drug substance and at least one freezable organic solvent with a cold surface so as to freeze the solution; and removing the organic solvent. The resulting particles are also disclosed, as are several embodiments of an apparatus that can be used in performing the method of the present invention.

Repeated sterile use of a gauge in a steam sterilizable freeze-drying system

An assembly is described, including a filter disposed downstream from a freeze dryer chamber, a first valve and a second valve disposed downstream from the filter, and a gauge disposed downstream from the first valve. A method is described, including maintaining a first valve of a circuit in a closed position during a steam sterilization cycle, maintaining the second valve in an open position during the steam sterilization cycle, receiving, from the gauge, a plurality of pressure measurements, and determining, by a processing device, an endpoint of a primary drying stage. The circuit includes the filter, the first valve, the second valve, and the gauge. A freeze-drying system is described, including a freeze dryer chamber including one or more orifices in fluid communication with the freeze dryer chamber and a circuit coupled to the freeze dryer chamber via a first orifice.

Novel Method for Vacuum-Assisted Preservation of Biologics Including Vaccines

The present invention relates generally to the fields of immunology and vaccine technology. More specifically, the present invention relates to methods for vitrifying biological preparations, including peptides, antigens, antibodies, cells, and the like.

Method of Providing Inline Sterile Freeze Drying of a Product in Trays Accommodated in a Trolley, System for Carrying Out the Method, and Use of the Method

For providing inline sterile freeze drying of a product containing solid matter and a solvent, such as water, in a plurality of trays accommodated in at least one trolley, a system comprises a filling station having an inlet end and an outlet end, or a docking station, a freeze storage, a freeze dryer unit, an emptying station having an inlet end and an outlet end, or a docking station, a plurality of trays adapted to be accommodated in at least one trolley. A cleaning and sterilizing unit is provided between the outlet end of the emptying station and the inlet end of the filling station. 1. A method of providing inline sterile freeze drying of a product containing solid matter and a solvent , which comprises:i. filling the product into a plurality of trays accommodated in at least one trolley in a filling station;ii. reducing the temperature of the product;iii. bringing the product to a pressure and a temperature below the triple point of the solvent in a freeze dryer unit;iv. maintaining the lowered pressure and thereby provide a freeze dried product by removing the solvent as vapor in the freeze dryer unit;v. bringing the freeze dried product to a temperature and pressure above the triple point;vi. emptying the product from the plurality of trays;vii. sterilizing the at least one trolley with the plurality of trays; andviii. bringing the at least one trolley with the plurality of trays to the filling station.2. The method according to claim 1 , which further comprises cooling the at least one trolley with the plurality of trays before step i.3. The method according to claim 1 , which further comprises bringing the at least one trolley with the plurality of trays to a freeze storage after step i.4. The method according to claim 2 , which further comprises cooling the at least one trolley with the plurality of trays in a freeze storage before step i.5. The method according to claim 3 , which further comprises bringing the at least one trolley with the plurality of ...

ENERGY RECOVERY IN A FREEZE-DRYING SYSTEM

Disclosed herein are embodiments of an energy recovery system for a freeze-drying system. In some embodiments, the freeze-drying system includes a freeze dryer chamber having one or more shelves disposed therein; a refrigeration system comprising a refrigerant condenser; a heat exchanger; a first fluid line to thermally couple the refrigerant condenser to the heat exchanger; and a second fluid line to thermally couple the one or more shelves to the heat exchanger. 1. A freeze-drying system comprising:a freeze dryer chamber having one or more shelves disposed therein;a refrigeration system comprising a refrigerant condenser;a heat exchanger;a first fluid line arranged to thermally couple the refrigerant condenser to the heat exchanger; anda second fluid line arranged to thermally couple the one or more shelves to the heat exchanger to facilitate transfer of refrigerant condenser-produced heat to the one or more shelves.2. The freeze-drying system of claim 1 , wherein the first fluid line defines a first fluid flow path between the refrigerant condenser and the heat exchanger.3. The freeze-drying system of claim 2 , wherein the second fluid line comprises a first valve and a second valve.4. The freeze-drying system of claim 3 , wherein the second fluid line defines a second fluid flow path from the one or more shelves to the heat exchanger when the first valve is open and when the second valve is closed.5. The freeze-drying system of claim 4 , wherein the first fluid line and the second fluid line facilitate heat transfer between a heat exchanger of the refrigerant condenser and the one or more shelves when fluid flows through the first fluid flow path and through second fluid flow path.6. The freeze-drying system of claim 4 , wherein the first fluid line defines a second fluid flow path that bypasses the heat exchanger when the first valve is closed and when the second valve is open.7. The freeze-drying system of claim 4 , further comprising:a flow controller, ...

DOUBLE-SEALING TYPE APPARATUS FOR COLLECTING SPRAY FREEZE ICE BALL PARTICLES AND COLLECTING METHOD THEREOF

A double-sealing type apparatus for collecting spray freeze ice ball particles and a collecting method for the double-sealing type apparatus are provided. The double-sealing type apparatus includes a collector, a collecting trolley, a vacuum pumping device, a heating device, a first sealing pad and a second sealing pad. The collector is arranged on the collecting trolley, and is provided with a collecting port. The collecting port corresponds to a discharging port at the bottom of a freezing tower. A water inlet is further provided at the collecting port, and the water inlet is in communication with a space formed by the aligning of the collecting port and the discharging port. Good sealing performance is achieved in a double-sealing manner including the sealing pads and the ice sealing, so as to smoothly transfer ice balls in the freezing tower. 1. A double-sealing type apparatus for collecting spray freeze ice ball particles , comprising:a collector,a collecting trolley,a vacuum pumping device,a heating device,a first sealing pad, anda second sealing pad,wherein the collector is arranged on the collecting trolley and is provided with a collecting port, the collecting port corresponding to a discharging port at the bottom of a freezing tower and is configured to be aligned with the discharging port, and the discharging port and the collecting port are opened or closed by a first baffle and a second baffle, respectively;a water inlet is further arranged at the collecting port, and the water inlet is in communication with a space which is formed by the aligning of the collecting port and the discharging port, and ice sealing is formed between the collecting port and the discharging port in the case that water is injected into the water inlet; andthe vacuum pumping device is in communication with an internal space of the collector, the heating device and the first sealing pad are arranged at the collecting port, sealing between the collecting port and the discharging ...

FREEZE VACUUM DRYING APPARATUS AND FREEZE VACUUM DRYING METHOD

A freeze vacuum drying apparatus includes: a spraying unit; a pipe unit; a heating unit; and a collection unit. The spraying unit sprays a raw material liquid into a vacuum chamber. The pipe unit has a non-linear shape, includes a first opening end and a second opening end, and traps frozen particles via the first opening end, the frozen particles being formed by self-freezing of liquid droplets formed by spraying the raw material liquid into the vacuum chamber. The heating unit heats the frozen particles in the pipe unit for sublimation drying, the frozen particles moving in the pipe unit from the first opening end toward the second opening end by kinetic energy produced during spraying. The collection unit collects dried particles that are formed by sublimation drying of the frozen particles in the pipe unit and released from the second opening end of the pipe unit. 1. A freeze vacuum drying apparatus , comprising:a spraying unit spraying a raw material liquid into a vacuum chamber;a pipe unit having a non-linear shape, including a first opening end and a second opening end, trapping frozen particles formed by self-freezing of liquid droplets via the first opening end, and the liquid droplets being formed by spraying the raw material liquid into the vacuum chamber;a heating unit sublimating and drying the frozen particles in the pipe unit by heating, the frozen particles moving in the pipe unit from the first opening end toward the second opening end by kinetic energy produced during spraying; anda collection unit collecting dried particles formed by sublimation drying of the frozen particles in the pipe unit and released from the second opening end of the pipe unit,the pipe unit having a turning axis in a direction from the spraying unit toward the collection unit and turning spirally between the spraying unit and the collection unit.2. A freeze vacuum drying apparatus , comprising:a spraying unit spraying a raw material liquid into a vacuum chamber;a pipe unit ...

TRANSFER APPARATUS

A transfer apparatus comprises a first rod-shaped member comprising a magnetic material; a first terminal member configured to allow insertion of a first end portion of the first rod-shaped member; a second terminal member configured to allow insertion of a second end portion of the first rod-shaped member; a second rod-shaped member comprising a magnetic material; a third terminal member configured to allow insertion of a first end portion of the second rod-shaped member; a fourth terminal member configured to allow insertion of a second end portion of the second rod-shaped member; a coupling member coupling the second terminal member and the third terminal member; and an opposite member facing a part of side surfaces of the first and second rod-shaped members, wherein the first rod-shaped member and the first terminal member are not fixed, the first rod-shaped member and the second terminal member are fixed to each other. 1. A transfer apparatus comprising:a first rod-shaped member comprising a magnetic material;a first terminal member configured to allow insertion of a first end portion of the first rod-shaped member;a second terminal member configured to allow insertion of a second end portion of the first rod-shaped member;a second rod-shaped member comprising a magnetic material;a third terminal member configured to allow insertion of a first end portion of the second rod-shaped member;a fourth terminal member configured to allow insertion of a second end portion of the second rod-shaped member;a coupling member configured to couple the second terminal member and the third terminal member; andan opposite member facing a part of side surfaces of the first and second rod-shaped members and comprising a magnetic material,wherein the first rod-shaped member and the first terminal member are not fixed, the first rod-shaped member and the second terminal member are fixed to each other, and when the first and second rod-shaped members rotate, the opposite member ...

APPARATUS AND METHOD FOR DEVELOPING FREEZE DRYING PROTOCOLS USING SMALL BATCHES OF PRODUCT

A method and apparatus for eliminating or minimizing the non-uniformity of edge vials compared to center vials during freezing or primary drying of product therein in a freeze dryer. A temperature controlled surface is positioned in close proximity to or in contact with the edge vials to control the temperature thereof. The method and apparatus may be used to simulate in a development freeze dryer the conditions of the center and edge vials in a larger batch target freeze dryer. 1. An apparatus to simulate in a development freeze dryer containing a small sample of product in center and outer edge vials freezing and sublimation conditions of product in center and outer edge vials in a larger batch target freeze dryer , comprising:a temperature controlled surface in close proximity or connected to the outer edge vials in the development freeze dryer to simulate by varying the temperature of the temperature controlled surface the conditions of the center vials and/or the outer edge vials of the target freeze dryer.2. The apparatus of wherein the temperature controlled surface is connected to the outer edge vials by a thermal conductor or is in close proximity to the outer edge vials.3. The apparatus of wherein the thermal conductor is formed of a thermally conductive material.4. The apparatus of wherein the thermal conductor is formed of copper claim 3 , stainless steel claim 3 , aluminum claim 3 , ceramic claim 3 , paste claim 3 , borosilicate glass and/or conductive rubber.5. The apparatus of herein the thermal conductor is a flexible membrane that can expand and contract for intimate contact with the edge vials or center vials.6. The apparatus of wherein the flexible membrane is filled with a thermally conductive fluid that is temperature controlled.7. The apparatus of wherein the thermal conductor is adjustable to provide adequate contact with the vials.8. The apparatus of wherein the temperature controlled surface is controlled by a circulating fluid claim 1 , ...

COMPOSITIONS AND METHODS FOR ATMOSPHERIC SPRAY FREEZE DRYING

Methods of preparing dried powders of biologically active compositions are disclosed. They are designed to provide dried material that maintains biological activity at low economic cost. Compositions made by the above methods are also described. 120-. (canceled)21. A method of preparing a dried powder of a pharmacologically active composition , comprising the steps of:a. spraying a carrier liquid into a chamber to form a flow of liquid droplets, wherein the carrier liquid contains a powder-forming ingredient;b. freezing the liquid droplets into frozen particles;c. entraining the flow of frozen particles within a net flow of gas, wherein the net flow of gas prevents the frozen particles from accumulating on the walls of the chamber;d. collecting the frozen particles on a filter;e. drying the frozen particles; andf. forming a dry powder.221. The method of claim , wherein the drying of frozen particles is by passing a flow of gas downward through the frozen particles to remove the carrier liquid.231. The method of claim , wherein the drying of frozen particles is by lyophilization.241. The method of claim , wherein the liquid droplets are snap frozen.251. The method of claim , wherein the gas has an initial temperature range below the freezing temperature of the liquid particles and subsequent temperatures during drying of the frozen particles above the freezing temperature of the liquid particles.261. The method of claim , wherein the method is per d in the presence of vibration , internals , mechanical stirring , and/or agitation.271. The method of claim , wherein the carrier liquid comprises at least one powder-forming ingredient.286. The method of claim , wherein the at least one powder-forming ingredient is chosen from the list of the following: a bulking agent , a surfactant , a cryoprotectant , a lyoprotectant , an excipient , or a stabilizer.291. The method of claim , wherein the frozen particles will have a median diameter of up to 200 μM.30. The method of ...

PROCESS AND APPARATUS FOR TREATING CONTAINERS FOR STORING SUBSTANCES FOR MEDICAL, PHARMACEUTICAL OR COSMETIC APPLICATIONS

In a process and apparatus for treating or processing containers () that are used for storing substances for medical, pharmaceutical or cosmetic applications or contain the same, cylindrical containers open at least at one end are automatically led past or pass through processing stations for treatment or processing by means of a conveying device, while said containers are jointly held by a carrier () in a regular two-dimensional arrangement. The carrier comprises a plurality of openings or receptacles (), which determine the regular arrangement. 132-. (canceled)33. A process for the treatment or processing of containers , which serve for storing substances for medical , pharmaceutical or cosmetic applications or contain such substances , wherein the containers are open at one end and are conveyed automatically , by a conveyor , to processing stations or pass them for the treatment or processing , in which processa plurality of containers are conveyed by the conveyor while the containers supported by a supporting structure in a regular two-dimensional array, wherein the supporting structure comprises a plurality of openings or receptacles, which define the regular array, and wherein the bottoms of the containers are freely accessible at their closed ends from a first side of said supporting structure,wherein one processing station is a freeze-dryer having at least one cooling plane, in which a freeze-drying process is carried out, wherein the bottoms are in direct contact with the respective cooling plane during the freeze-drying process in said freeze-dryer while the containers are supported by the supporting structure or are accommodated in the openings or receptacles of the supporting structure.34. The process according to claim 33 , wherein the supporting structures are accommodated in transport or packaging containers and are removed from the respective transport or packaging container and supported on the respective cooling plane for carrying out said freeze- ...

HERB ESSENTIAL OIL PROCESSING EQUIPMENT

A plant oil extractor includes a food grade tray with a removable lid that together define an evaporation chamber. A gaseous fluid pump has an inlet fluidly connected to the evaporation chamber and an outlet fluidly connected to an area outside of the evaporation chamber, which may be positioned in a freezer to recover condensed solvent leaving previously dissolved plant essential oil on the food grade tray. A vacuum sublimation freeze drying apparatus includes a container, which defines a drying chamber, is positioned in a freezer. A gaseous fluid pump has an inlet fluidly connected to the drying chamber and an outlet that opens outside the container. Water in fresh herbs positioned in the drying chamber initially freezes and then sublimates leaving behind freeze dried herbs. 1. A plant oil extractor comprising:a food grade tray with a perimeter wall separating a base surface from a rim;a removable lid with a rim contact surface shaped and sized to mate with the rim;wherein the tray and the lid define an evaporation chamber when the lid is mated to the tray, and at least one of the tray and the lid including a transparent window positioned to allow the base surface to be seen from outside of the evaporation chamber;an electric gaseous fluid pump with an inlet fluidly connected to the evaporation chamber and an outlet fluidly connected to an area outside of the evaporation chamber; andwherein the extractor has a first configuration in which the pump is off and the lid is out of contact with the tray, and a second configuration in which the rim contact surface of the lid is mated to the rim of the tray, the pump is on, and a pressure inside the evaporation chamber is lower than a pressure outside the evaporation chamber, and a third configuration in which the lid is mated to the tray, and both the tray and lid are tilted together.2. The plant oil extractor of including a lid support compressed between the base surface and an inside surface of the lid when the ...

A surface tension mediated lyo-processing technique for preservation of biologics

Methods and devices for lyo-processing biological materials are provided. The methods include submerging the biological molecules or cells in a buffer solution comprising trehalose, withdrawing the biological molecules or cells from the buffer solution in an environment that does not include oxygen to generate lyo-stabilized biological molecules or cells, and storing the lyo-stabilized biological molecules or cells. The devices include a motor that lowers a horizontal member having a clamp for receiving a substrate toward a solvent reservoir and raises the horizontal member having the clamp up and away from the solvent reservoir.

POROUS CELLULOSE BODY AND METHOD FOR PRODUCING SAME

A porous body that contains cellulose nanofibers having very thin fiber diameters and high hydrophilicity, and has a large specific surface area, and to provide a method of producing the porous body simply with low cost. A method of producing a porous cellulose comprises a process of lyophilizing a mixed liquid containing cellulose nanofibers and a dispersion medium, wherein the dispersion medium is a mixed dispersion medium of water and an organic solvent dissolving in water, a concentration of the organic solvent in the mixed dispersion medium is 2 to 40 mass %, and a solid content concentration of the cellulose nanofibers in the mixed liquid is 0.001 to 5 mass %. 1. A method of producing a porous cellulose body , the method comprising a process of lyophilizing a mixed liquid containing cellulose nanofibers and a dispersion medium , whereinthe dispersion medium is a mixed dispersion medium of water and an organic solvent dissolving in water,the concentration of the organic solvent in the mixed dispersion medium is 2 to 40 mass %, andthe solid content concentration of the cellulose nanofibers in the mixed liquid is 0.001 to 5 mass %.2. The method of producing a porous cellulose body according to claim 1 , wherein preparation of the mixed liquid is performed by preparing an aqueous dispersion of the cellulose nanofibers in which the cellulose nanofibers are dispersed in water claim 1 , and then adding the organic solvent to the aqueous dispersion of the cellulose nanofibers.3. The method of producing a porous cellulose body according to claim 1 , wherein the number average fiber diameter of the cellulose nanofibers is 1 to 100 nm.4. The method of producing a porous cellulose body according to claim 1 , wherein the organic solvent comprises at least one product selected from the group consisting of: alcohols claim 1 , carboxylic acids and carbonyl compounds.5. The method of producing a porous cellulose body according to claim 4 , wherein the organic solvent comprises ...

METHOD AND APPARATUS FOR LOADING A LYOPHILIZATION SYSTEM

Disclosed are systems and methods for aseptically filling pharmaceutical containers with a pharmaceutical substance and then lyophilizing it. In one general aspect, the system and method can employ a lyophilizer loader subsystem having an interior chamber in communication with an interior chamber of a lyophilizer subsystem via a portal with a sealable door, with the collective interior being aseptically sealable. An articulated robotic arm can be employed to batch transfer to the lyophilizer subsystem container nests bearing the pharmaceutical containers. In one embodiment, the nests may be transferred serially to the loader subsystem, with the articulated robotic arm being configured to transfer the nests of containers in batches to the lyophilizer subsystem. The articulated robotic arm can also be configured to be used to move batches of nests within the lyophilizer subsystem. One implementation includes two articulated arms and a joint rotary wrist driven by two rotary shoulders. 1. An integrated pharmaceutical processing system comprising:a lyophilizing subsystem configured to lyophilize a pharmaceutical substance and having a lyophilizer interior chamber sealable from an ambient environment and a supply portal with a sealable door; and a multi-nest support mechanism that includes a plurality of support structures that are each constructed to support one of a plurality of multi-container nests, and having a range of motion that extends between a nest loading station and a first location in the lyophilizer interior chamber, and', 'a drive mechanism operatively connected to the multi-nest support mechanism and operative to drive the multi-nest support mechanism between the loading station and the first location in the lyophilizer interior chamber., 'a lyophilizer loading subsystem having a loader interior chamber sealable from the ambient environment and in communication with the lyophilizer interior via the supply portal, the loading subsystem comprising within ...

DRYER WITH MONITORING DEVICE

The invention provides a monitoring device () for a dryer () includes a means for sensing a physical parameter, such as temperature or strain, at a sensing locus within the dryer (), for example at a vial (). The sensing means comprises an optical sensing fiber () having at least one fiber Bragg grating (). Moreover, the invention provides a dryer, in particular a freeze dryer (), which is equipped with such monitoring device (). 1. A dryer comprising a monitoring device , wherein the monitoring device includes a means for sensing a physical parameter at a sensing locus within the dryer , the means comprising an optical sensing fiber having at least one fiber Bragg grating.2. The dryer of claim 1 , wherein the physical parameter is a temperature or a force.3. The dryer of claim 1 , wherein the at least one fiber Bragg grating is in a medially located longitudinal section of the sensing fiber.4. The dryer of claim 1 , wherein at least a portion of the sensing fiber is located in a tubular holder claim 1 , which portion preferably includes the at least one fiber Bragg grating.5. The dryer of claim 1 , wherein the section in which the at least one fiber Bragg grating is located is a curved section claim 1 , the curved section preferably being curved over an angular range of at least 180°.6. The dryer of claim 5 , wherein the curved section forms a loop claim 5 , a spiral claim 5 , a circle claim 5 , an ellipse claim 5 , or a helix.7. The dryer of claim 5 , wherein the curved section is insertable into a container holding a material which is to be dried.8. The dryer of claim 5 , wherein the curved section extends from a sensing rod through which the sensing fiber is guided.9. The dryer of claim 1 , wherein the sensing fiber is affixed to claim 1 , or incorporated in claim 1 , a support unit adapted to support a material which is to be dried claim 1 , the material preferably being contained in at least one container resting on the support unit.10. The dryer of claim 1 , ...

METHOD FOR DEHYDRATING SEMICONDUCTOR STRUCTURE AND DEHYDRATING METHOD OF THE SAME

The present disclosure provides a method for dehydrating a semiconductor structure, including providing a semiconductive substrate, forming a trench on the semiconductive substrate, dispensing an agent in liquid form into the trench, solidifying the agent, and dehydrating a surface in the trench by transforming the agent from solid form to vapor form. 1. A method for dehydrating a semiconductor structure , comprising:providing a substrate;forming a trench on the substrate;dispensing diluted hydrogen fluoride into the trench;dispensing isopropanol into the trench subsequent to dispensing diluted hydrogen fluoride;dispensing an agent in liquid form into the trench subsequent to dispensing isopropanol;solidifying the agent; andtransforming the agent from solid form to vapor form.2. The method of claim 1 , wherein solidifying the agent includes cooling the substrate.3. The method of claim 1 , wherein solidifying the agent is through lowering a temperature of the agent to at least 5 degrees below a melting point of the agent.4. The method of claim 2 , wherein cooling the substrate is performed by purging a coolant on a surface of the substrate.5. The method of claim 4 , wherein the surface is at an opposite side to the trench.6. The method of claim 1 , further comprising dispensing deionized water into the trench prior to dispensing isopropanol.7. The method of claim 1 , wherein a melting point of the agent is ranging from 0° C. to 25° C. under pressure 1 atm.8. The method of claim 1 , wherein a saturated vapor pressure of the agent under pressure 1 atm and 5 degrees below the melting point is at least 1 kPa.9. A method for fabricating a semiconductor structure claim 1 , comprising: providing a substrate;', 'forming a plurality of fins over the substrate;', 'flowing an agent in spaces between the plurality of fins;', 'solidifying the agent in the spaces;', 'transforming the solidified agent into vapor in a chamber; and', {'sub': '2', 'providing superheated HO steam in ...

LYOPHILIZED PHARMACEUTICAL COMPOSITIONS

The invention provides a method of preparing a lyophilized pharmaceutical composition containing a compound described herein or a pharmaceutically-acceptable salt thereof. The process comprises dissolving the compound in a solvent comprising dimethylsulfoxide and optionally one or more co-solvents to form a solution, and then removing the solvent and any co-solvents by a freeze-drying process. Also provided by the invention are lyophilized pharmaceutical compositions and their use in medicine and in particular in the treatment of cancer. 114-. (canceled)16. The method of claim 15 , wherein the reconstitution time of the reconstituting of the lyophilization product is less than 15 minutes.17. The method of claim 15 , wherein the reconstitution time of the reconstituting of the lyophilization product is less than 10 minutes.18. The method of claim 15 , wherein the substantially anhydrous solvent comprises 45% to 85% (v/v) propylene glycol claim 15 , 5% to 45% (v/v) glycerin claim 15 , and 0% to 30% (v/v) ethanol.19. The method of claim 15 , wherein the substantially anhydrous solvent comprises about 45% to about 85% (v/v) propylene glycol claim 15 , about 5% to about 45% (v/v) glycerin claim 15 , and about 0% to about 30% (v/v) ethanol.20. The method of claim 15 , wherein the substantially anhydrous solvent comprises about 65% (v/v) propylene glycol claim 15 , about 25% (v/v) glycerin claim 15 , and about 10% (v/v) ethanol.21. The method of claim 15 , wherein the compound of formula (1) is in the form of a sodium salt.22. The method of claim 15 , wherein in an amount of the lyophilized pharmaceutical composition obtained from 1 gram of the solution claim 15 , there is a residual DMSO content of no greater than about 20 mg.23. The method of claim 15 , wherein any residual DMSO present in the lyophilized pharmaceutical composition is in an amount corresponding to no more than 35 mg per 100 mg equivalent of a free base of the compound of formula (1).24. The method of ...

HEATED SHELF APPARATUS AND FREEZE DRY CART USING SAME

A freeze-drying system is disclosed which includes a vented cart configured for operation in a pressure-controlled chamber, and a plurality of heated shelves disposed in the vented cart. At least one heated shelf of the plurality of heated shelves is provided. The heated shelf includes a first planar sheet formed from a thermally conductive material having a top configured to conduct heat to a tray resting on the top, a second planar sheet disposed opposite the first planar sheet, and a heating element secured between the first and second planar sheets. The heating element has a surface disposed in thermally conductive contact with the first planar sheet. 1. A freeze-drying system comprising:a vented cart configured for operation in a pressure controlled chamber; and a first planar sheet formed from a thermally conductive material and having a top configured to conduct heat to a tray when the tray is resting on the first planar sheet;', 'a second planar sheet disposed opposite the first planar sheet; and', 'a heating element secured between the first planar sheet and the second planar sheet, the heating element having a surface disposed in thermally conductive contact with the first planar sheet., 'a plurality of heated shelves disposed in the vented cart, at least one heated shelf of the plurality of heated shelves including2. The freeze-drying system of claim 1 , wherein the heating element is secured to the second planar sheet of the at least one heated shelf.3. The freeze-drying system of claim 2 , wherein the heating element is secured to the second planar sheet of the at least one heated shelf by a thermally conductive adhesive.4. The freeze-drying system of claim 1 , wherein the second planar sheet of the at least one heated shelf is formed from a thermally conductive material claim 1 , and wherein the heating element is disposed in thermally conductive contact with the second planar sheet.5. The freeze-drying system of claim 1 , wherein the vented cart ...

HOUSING DEVICE

An enclosure includes a furnace and plates A to D arranged in the furnace and used for placement of articles Each of the plates A to D is movable vertically in the furnace The enclosure further includes guide members A and B, each of which is disposed adjacent to a side of one plate of the plates A to D that is disposed at a loading/unloading position where the articles are allowed to be loaded into or unloaded from the furnace The guide members A and B guide the articles and are rotatable with vertical movement of the plate. 1. An enclosure comprising:a furnace;a plurality of plates arranged in the furnace, the plates being used for placement of an article, each of the plates being movable vertically in the furnace; anda guide member disposed adjacent to a side of one plate of the plates that is disposed at a loading/unloading position where the article is allowed to be loaded into or unloaded from the furnace, the guide member guiding the article and being rotatable with vertical movement of the plate.2. The enclosure according to claim 1 ,wherein the guide member includes a contact portion capable of contacting the plate, andwherein as the plate moves vertically, the plate contacts the contact portion and the guide member rotates.3. The enclosure according to claim 1 , wherein the guide member rotates about an axis located outside the side of the plate.4. The enclosure according to claim 3 , wherein the guide member has a center of gravity located below the axis of rotation.5. The enclosure according to claim 1 , wherein the plate disposed at the loading/unloading position contacts the guide member to prevent the guide member from rotating claim 1 , thereby stabilizing the posture of the guide member.6. The enclosure according to claim 1 , further comprising:an external bridge disposed outside a door of the furnace; andan article transfer device configured to move the article on the external bridge and the plate,wherein the article transfer device includes a ...

APPARATUS AND METHOD FOR CONTINUOUS LYOPHILIZATION

A method and apparatus for the continuous sublimation of a substance includes cascading a material containing a substance capable of sublimation, such as water, between a plurality of trays vertically stacked within a processing zone provided within a processing chamber. A substantially atmospheric environment is maintained within the processing zone at a temperature whereby the substance sublimes forming a sublimate within the environment. The environment containing the sublimate is contacted with a drying agent such as a desiccant to maintain the environment whereby the substance sublimes at substantially atmospheric pressure and at the controlled temperature. 1. An apparatus for continuous sublimation of a substance , the apparatus comprising:a processing chamber containing a substantially atmospheric environment, the processing chamber having a plurality of trays vertically stacked therein for cascading therethrough a material containing a substance capable of sublimation to form a sublimate at a predetermined temperature;a heater for supplying heated gas to the processing chamber; anda desiccant in fluid communication with the processing chamber for maintaining the partial pressure of the substance within the environment within the processing chamber less than the vapor pressure of the substance.2. The apparatus of claim 1 , wherein the trays are rotatable.3. The apparatus of claim 2 , further including a plurality of fans within the processing chamber for circulating the environment therein.4. The apparatus of claim 3 , wherein the desiccant is selected from the group consisting of lithium chloride claim 3 , calcium chloride claim 3 , calcium sulfate claim 3 , phosphorous pentoxide claim 3 , triethylene glycol claim 3 , diethylene glycol claim 3 , ethylene glycol claim 3 , tetrathylene glycol claim 3 , silica gel claim 3 , and molecular sieves.5. The apparatus of claim 4 , further including a cooling apparatus for cooling an exhaust gas discharged from the ...

MULTI CHAMBER FLEXIBLE BAG AND METHODS OF USING SAME

A method of preparing a pharmaceutical product in a single multiple chamber flexible bag. A pharmaceutical product is introduced in a liquid state into a first chamber of the flexible bag through a first port. The pharmaceutical product is lyophilized within the first chamber of the flexible bag to provide a lyophilized pharmaceutical product. The flexible bag has a second chamber and the first chamber and the second chamber are separated by a breakable seal. The second chamber further includes a reconstituting solution for reconstituting the lyophilized pharmaceutical product in the first chamber. A user may apply pressure to the flexible bag to break the seal and mix the lyophilized pharmaceutical product and the reconstituting solution to order to administer the pharmaceutical product to a patient. 1. A method of preparing a pharmaceutical product in a multiple chamber flexible bag , the method comprising:introducing the pharmaceutical product in a liquid state into a first chamber of the flexible bag through a first port; andlyophilizing the pharmaceutical product within the first chamber of the flexible bag to provide a lyophilized pharmaceutical product,wherein the flexible bag has a second chamber and the first chamber and the second chamber are separated by a breakable seal.2. The method according to claim 1 , further comprising introducing a reconstituting solution into a second chamber of the flexible bag.3. The method according to claim 1 , further comprising introducing a gas into the first chamber and sealing the first port after the pharmaceutical product in the first chamber has been lyophilized.4. The method according to claim 1 , further comprising applying a predetermined amount of pressure to the flexible bag to break the breakable seal between the first chamber and the second chamber; andmixing a reconstituting solution with the lyophilized pharmaceutical product in the first chamber to create a reconstituted pharmaceutical product.5. The method ...

FREEZE-DRIED POWDER OF HIGH MOLECULAR WEIGHT SILK FIBROIN, PREPARATION METHOD THEREFOR AND USE THEREOF

The invention discloses a freeze-dried powder of high molecular weight silk fibroin, preparation process and use thereof. The freeze-dried powder is obtained from silk by degumming, dissolution, dialysis, centrifugation, high temperature and high pressure treatment and freeze-drying. A method of preparing silk fibroin microspheres with polyethylene glycol comprises mixing a silk fibroin solution of 1-30 wt % with a PEG solution of 10-60 w % and incubating the resulting solution. A controlled-release or sustained-release silk fibroin gel formulation includes a gel-state carrier and a drug dispersed/adsorbed therein, the carrier is a silk fibroin gel formed by blending with LMW-PEG. The freeze-dried powder will not change the native molecular weight and random coil structure of silk fibroin, and can be rapidly dissolved into a solution, and can be stored and transported for a long time, and this reduces waste of silk fibroin materials and promotes R & D and biomedical applications of silk fibroin biomaterials. 1. A preparation process of a freeze-dried powder of high molecular weight silk fibroin , comprising the steps of:(1) boiling silk in an amount of a sodium carbonate solution for a period of time, and then soaking and washing with clear water to get degummed silk;(2) after air drying of the degummed silk, dissolving a suitable amount of the degummed silk in a lithium bromide solution;(3) after complete dissolution, dialyzing the degummed silk in a dialysis tube for two days;(4) after dialysis, centrifuging the silk fibroin solution, and taking the supernatant as a silk fibroin solution; and(5) after determining the concentration of the solution, mixing it with a phosphate buffer solution to prepare a silk fibroin solution, treating the solution with high temperature and high pressure, transferring a volume of the solution into a glass bottle and freezing overnight, and then freeze-drying for a period of time to obtain the freeze-dried powder of high molecular ...

OPTIMIZATION OF NUCLEATION AND CRYSTALLIZATION FOR LYOPHILIZATION USING GAP FREEZING

This application discloses devices, articles, and methods useful for producing lyophilized cakes of solutes. The devices and articles provide for a method of freezing liquid solutions of the solute by the top and the bottom of the solution simultaneously. The as frozen solution then provides a lyophilized cake of the solutes with large and uniform pores. 1. (canceled)2. (canceled)3. (canceled)4. (canceled)5. (canceled)6. (canceled)7. (canceled)8. In a method of freezing a liquid solution for subsequent lyophilization , the liquid comprising top and bottom surfaces and disposed in a container , and the container disposed in a lyophilization chamber comprising a heat sink , the improvement comprising separating the container from direct contact with the heat sink to thereby freeze the solution from the top and bottom surfaces at approximately the same rate.9. (canceled)10. (canceled)11. An article adapted for use in a lyophilization chamber comprising:a heat sink comprising a heat sink surface in thermal communication with a refrigerant;a tray surface; anda thermal insulator disposed between the heat sink surface and the tray surface.12. The article of claim 11 , wherein the heat sink comprises a refrigerant conduit in thermal communication with the heat sink surface.13. The article of claim 12 , wherein the heat sink further comprises a heat sink medium disposed between the refrigerant conduit and the heat sink surface.14. The article of claim 11 , wherein the heat sink surface and tray surface are separated by a fixed distance of greater than about 0.5 mm.15. The article of further comprising a spacer disposed between the heat sink surface and the tray surface.16. The article of claim 15 , wherein the spacer has a thickness of greater than about 0.5 mm.17. The article of claim 15 , wherein the spacer supports a tray carrying the tray surface.18. The article of claim 11 , wherein the thermal insulator carries the tray surface.19. A lyophilization device comprising:a ...

Lyophilization Container And Method Of Using Same

Provided is a multi-part lyophilization container for lyophilizing a fluid, storing the lyophilizate, reconstituting the lyophilizate, and infusing the reconstituted lyophilizate into a patient, including a method of using same. The container includes a front surface, a back surface, a non-breathable section including a port region, a breathable section including a breathable membrane, and an occlusion zone encompassing a boundary between the non-breathable section and the breathable section. The non-breathable section is configured to accommodate any of a liquid, a solid, a gas or combination thereof. The breathable section is configured to accommodate only a gas. The method includes creating a temporary seal between the non-breathable section of the container and the breathable section, inputting a liquid into the non-breathable section, freezing the liquid, removing the temporary seal to allow vapor transport between the non-breathable section and the breathable section, and adding heat energy the frozen liquid under vacuum. 1. A multi-part lyophilization container , the container comprising:a front surface;a back surface;a non-breathable section including a port region, the non-breathable section configured to accommodate a liquid, a solid, a gas, or any combination thereof;a breathable section including a breathable membrane, the breathable section configured to accommodate only a gas; andan occlusion zone encompassing a boundary bridging the non-breathable section and the breathable section.2. The container of claim 1 , wherein the front surface and the back surface each comprise a portion of breathable section including a breathable membrane.3. The container of claim 1 , wherein the breathable membrane comprises a continuous sheet including an isoclinal fold allowing the breathable membrane to bridge a portion of the front surface and a portion of the back surface.4. The container of claim 1 , wherein the occlusion zone comprises material that is the same as ...

Device for Introducing Bottles into a Lyophilization Chamber

A device to introduce bottles into a lyophilization chamber of a lyophilization machine provided at least with an arrival plane of the bottles and with a deposit plane inside the lyophilization chamber comprises at least limited feed means cooperating with a thruster bar to move it along an approach travel in the direction from the arrival plane to said deposit plane. The introduction device also comprises pantograph means connected to the limited feed means and to the thruster bar and configured to extend with respect to the limited feed means and toward the deposit plane, at least by the defined amount necessary to introduce the bottles completely into the lyophilization chamber. 1. Device to introduce bottles into a lyophilization chamber of a lyophilization machine provided at least with an arrival plane of the bottles and with a deposit plane inside said lyophilization chamber , said introduction device comprising at least limited feed means cooperating with a thruster bar to move said thruster bar along an approach travel in the direction from said arrival plane to said deposit plane , further comprising pantograph means connected to said limited feed means and to said thruster bar and configured to extend with respect to said limited feed means and toward said deposit plane , at least by the defined amount necessary to introduce the bottles completely into the lyophilization chamber and in that said limited feed means comprise thrust means with an associated container mobile along said approach travel , said thruster bar being part of said mobile container.2. Device as in claim 1 , wherein said container contains said pantograph means.3. Device as in claim 2 , further including at least a motor member conditioning a temporal position of said pantograph means.4. Device as in claim 3 , wherein the motor member is associated to motion transmission members which comprise worm screws.5. Device as in claim 1 , wherein the device is further configured to make said ...

PROCESS LINE FOR THE PRODUCTION OF FREEZE-DRIED PARTICLES

A process line for the production of freeze-dried particles under closed conditions is provided, the process line comprising a freeze-dryer for the bulkware production of freeze-dried particles under closed conditions, the freeze-dryer comprising a rotary drum for receiving the frozen particles, and a stationary vacuum chamber housing the rotary drum, wherein for the production of the particles under closed conditions the vacuum chamber is adapted for closed operation during processing of the particles; the drum is in open communication with the vacuum chamber; and at least one transfer section is provided for a product transfer between a separate device of the process line and the freeze-dryer, the freeze-dryer and the transfer section being separately adapted for closed operation, wherein the transfer section comprises a temperature-controllable inner wall surface. 1. A process line for the production of freeze-dried particles under end-to-end closed conditions , the process line comprising:a particle generator for producing frozen particles under closed conditions;a freeze-dryer for producing freeze-dried particles under closed conditions, the freeze-dryer comprising a vacuum chamber housing a particle carrier for receiving the frozen particles; anda transfer section for product transfer between the particle generator and the freeze-dryer,wherein for the production of the freeze-dried particles under closed conditions:the particle generator is adapted for closed operation;the vacuum chamber is adapted for closed operation, andthe transfer section is adapted for protecting a sterile product flow, and to operatively separate the freeze-dryer and the particle generator from each other such that at least a first one of the freeze-dryer and the particle generator is operable under closed conditions separately from a second one of the freeze-dryer and the particle generator.2. The process line according to claim 1 , wherein the transfer section comprises a mechanical ...

WOUND-HEALING AND HEMOSTATIC SPONGE OF SQUID INK POLYSACCHARIDE/CHITOSAN, PREPARATION METHOD AND USE THEREOF

A wound-healing and hemostatic sponge of squid ink polysaccharide/chitosan, a preparation method and use thereof are provided. The sponge comprises squid ink polysaccharide and chitosan as carriers and calcium chloride as an initiator for blood coagulation, and the wound-healing and hemostatic sponge of squid ink polysaccharide/chitosan is achieved via a lyophilization technology. Particularly, the preparation method comprises slowly adding a squid ink polysaccharide solution to a chitosan solution to form a uniformly mixed solution, adding a calcium chloride solution to the uniformly mixed solution, forming a gel followed by the gel being frozen and then lyophilized, and achieving the product. The wound-healing and hemostatic sponge has a good absorbing-errhysis effect, a good pro-coagulant effect, fast hemostasis and a complete hemostatic effect, without secondary re-hemorrhage. Moreover, the wound-healing and hemostatic sponge can promote wound healing, re-epithelialization and repair of epidermis and dermis, with strong wound-healing ability, good biocompatibility, weak toxic side effects and irritation, belonging to a novel wound-healing and hemostatic material. Moreover, the preparation method is reliable, fast, and low cost. 1. A preparation method for a wound-healing and hemostatic sponge of squid ink polysaccharide/chitosan , characterized in that , it comprises squid ink polysaccharide and chitosan as carriers and calcium chloride as an initiator for blood coagulation , and the wound-healing and hemostatic sponge of squid ink polysaccharide/chitosan being achieved via a lyophilization technology.2. The preparation method according to claim 1 , wherein the preparation method comprises slowly adding a squid ink polysaccharide solution to a chitosan solution claim 1 , to form a uniformly mixed solution claim 1 , adding a calcium chloride solution to the uniformly mixed solution claim 1 , forming a gel follow by the gel being frozen and then lyophilized claim ...

CONTROLLED NUCLEATION DURING FREEZING STEP OF FREEZE DRYING CYCLE USING PRESSURE DIFFERENTIAL ICE CRYSTALS DISTRIBUTION FROM CONDENSED FROST

A method of controlling and enhancing the nucleation of product in a freeze dryer, wherein the product is maintained at a predetermined temperature and pressure in a chamber of the freeze dryer, and a predetermined volume of condensed frost is created on an inner surface of a condenser chamber separate from the product chamber and connected thereto by a vapor port. The opening of the vapor port into the product chamber when the condenser chamber has a pressure that is greater than that of the product chamber creates gas turbulence that breaks down the condensed frost into ice crystals that rapidly enter the product chamber for even distribution therein to create uniform and rapid nucleation of the product in different areas of the product chamber. 1. A method of controlling and enhancing the nucleation of product in a freeze dryer , comprising:maintaining the product at a predetermined temperature and pressure in a chamber of the freeze dryer;creating a predetermined volume of condensed frost on an inner surface of a condenser chamber separate from the product chamber and connected thereto by a vapor port; andopening the vapor port into the product chamber when the condenser chamber has a predetermined pressure that is greater than that of the product chamber to create gas turbulence that breaks down the condensed frost into ice crystals that rapidly enter the product chamber for even distribution therein to create uniform and rapid nucleation of the product in different areas of the product chamber.2. The method of wherein the vapor port has an isolation valve between the product chamber and the condenser chamber to open or close vapor flow therebetween.3. The method of wherein a vacuum pump is connected to the condenser chamber for selectively reducing the pressure within the product chamber and the condenser chamber when the isolation valve is opened.4. The method of wherein the pressure within the product chamber is about 50 Torr and the pressure within the ...

METHODS AND ASSEMBLIES FOR PREPARING AND DISPENSING LYOSPHERES OF PHARMACEUTICAL COMPOSITIONS

Disclosed herein are methods for preparing and/or dispensing lyospheres of pharmaceutical compositions of biologics (e.g., vaccines, therapeutic proteins such as monoclonal antibodies) or small molecules (e.g., chemical compounds). Also described are assemblies and systems for preparing and/or dispensing the lyospheres. 1. (canceled)2. A method for preparing lyospheres of a pharmaceutical composition , comprising:(a) providing an assembly comprising a generally planar base plate, wherein the base plate is placed on top of a heat sink and chilled to a low temperature, wherein the base plate is not physically attached to the heat sink;(b) dispensing droplets of the pharmaceutical composition on the base plate in an array format, wherein the droplets freeze on the base plate; and(c) placing the assembly in a lyophilizer to dry the frozen droplets and produce an array of lyospheres.3. The method of claim 2 , repeating steps (a) and (b) multiple times claim 2 , preparing a stack of assemblies with a thermally conductive path formed between the assemblies; and in step (c) drying the frozen droplets in the entire stack in a lyophilizer to produce arrays of lyospheres.4. The method of claim 3 , wherein the assembly further comprises an insert plate overlaying the base plate; wherein the insert plate has an array of apertures; and wherein each droplet is dispensed into an aperture to be supported by the base plate.5. The method of claim 4 , wherein the base plate has an array of openings and solid portions located between and surrounding the openings; wherein the apertures align with the solid portions of the base plate with no overlap with the openings; and wherein each droplet is dispensed into an aperture to be supported by the solid portions of the base plate.6. A method for preparing lyospheres of a pharmaceutical composition claim 4 , comprising:(a) providing an assembly comprising an insert plate overlaying a base plate; wherein the base plate has an array of openings ...

METHODS FOR MEASURING PRESSURE IN FREEZE DRYING SYSTEMS

An improved method for determining pressure in a lyophilisation system containing a lyophilisation chamber and a condenser chamber wherein a freeze drying operation is being performed is provided for. The improved method uses a temperature measuring device such as a thermocouple or a temperature resistance device to measure temperature and from this measurement the pressure of the components in the lyophilisation chamber can be calculated using a predetermined relationship between temperature and pressure. 1. An improved method for determining pressure in a lyophilisation system wherein a freeze drying operation is being performed , the improvement comprising measuring temperature in the lyophilisation system and calculating pressure of the lyophilisation system therefrom using a predetermined relationship between temperature and pressure.2. The method as claimed in wherein the lyophilisation system comprises a lyophilisation chamber and a condenser chamber.3. The method as claimed in wherein the temperature is measured with a device selected from the group consisting of a thermocouple and a resistance temperature device.4. The method as claimed in wherein the pressure is calculated from the temperature according to the formula:5. The method as claimed in wherein water claim 1 , nitrogen and air are present in the lyophilisation system.6. The method as claimed in wherein the condenser chamber contains a condenser coil.7. The method as claimed in wherein the condenser chamber is in fluid communication with a vacuum pump.8. An improved freeze drying method in a lyophilisation system claim 2 , the improvement comprising measuring temperature in the lyophilisation system and calculating pressure of the lyophilisation system therefrom.9. The method as claimed in wherein the lyophilisation system comprises a lyophilisation chamber and a condenser chamber.10. The method as claimed in wherein the temperature is measured with a device selected from the group consisting of a ...

BULK FREEZE DRYING USING SPRAY FREEZING AND AGITATED DRYING WITH DIELECTRIC HEATING

A freeze dryer processes aseptic bulk powder products. The freeze dryer freezes the product by mixing an atomized spray of product with sterile liquid nitrogen to produce a frozen powder. The frozen powder is freeze dried in a vessel by dielectrically heating the frozen powder using electromagnetic radiation such as microwave radiation or infrared radiation, and the frozen powder is continuously agitated using a sterilizable apparatus such as a series of vibrating shelves to maintain even heating and to prevent agglomeration. 1. A freeze drying system for freeze drying a bulk product , comprising:a freezing chamber;at least one spray nozzle directed to an interior of the freezing chamber, the at least one spray nozzle being connected for spraying the bulk product and a freezing agent to create a spray-frozen powder;a vacuum drying chamber;a connection between the freezing chamber and the vacuum drying chamber for transferring the spray-frozen powder and for pressure isolation of the freezing chamber from the vacuum drying chamber;an agitating mechanism for agitating the spray-frozen powder in the vacuum drying chamber by continuously moving particles of the spray-frozen powder relative to adjacent particles, the agitating mechanism including a plurality of inclined shelves arranged within the vacuum drying chamber in a series for conducting the spray-frozen powder from inclined shelf to inclined shelf, and a vibrating mechanism located outside the vacuum drying chamber and linked for transmitting vibrations to the inclined shelves to transport the spray-frozen powder relative to the inclined shelves, the vibrations being isolated from the vacuum drying chamber;a heat source for heating the spray-frozen powder;a sterilization system for sterilizing components of the agitating mechanism within the vacuum drying chamber; anda vacuum pump connected for evacuating the vacuum drying chamber.2. (canceled)3. The freeze drying system of claim 1 , wherein each inclined shelf ...

DIRECTIONAL FREEZING

The invention relates to an apparatus and a method of freezing a liquid substance contained in at least one receptacle, comprising the steps of: providing the liquid substance in at least one receptacle, providing a cooling chamber and a cooling device having a cooling surface; setting the temperature of the cooling surface, starting a freezing procedure by placing the receptacle with the liquid substance therein on the cooling surface to form a seed or initial zone of nucleation; and continuing the freezing procedure to completely freeze the substance. 1. A method of freezing a liquid substance contained in at least one receptacle comprising the steps of:providing the liquid substance in at least one receptacle,providing a cooling chamber and a cooling device having a cooling surface;setting the temperature of the cooling surface to less than −130° C. (143.15 K);starting a freezing procedure by placing the receptacle with the liquid substance therein on the cooling surface to make surface contact between the receptacle and the cooling surface to cool the receptacle and thereby to have a portion of the liquid substance, which is contained in the receptacle in proximity of the cooling surface, form a seed or initial zone of nucleation;continuing the freezing procedure to completely freeze the substance such that, starting from the seed or initial zone of nucleation, directional freezing of the liquid substance with a propagating crystallisation front occurs at or near melting point temperature of the substance at the crystallisation front;and transferring the receptacle from the cooling surface to a region of the cooling chamber, with the cooling temperature within said region of the cooling chamber being set to a value in the range between −60° C. and −5° C. (213.15 K and 268.15 K), wherein the step of transferring the receptacle from the cooling surface to a region of the cooling chamber is performed before the liquid substance contained in the receptacle has been ...

FREEZE DRYER COUNTER-FLOW SHELF CONSTRUCTION AND METHOD

A shelf for a freeze dryer and method for enhancing temperature uniformity across the shelf. In one embodiment, the shelf has a lower shelf plate and an upper shelf plate mounted on the lower shelf plate and channels in a serpentine pattern are positioned between the upper and lower shelf plates to circulate heating or cooling fluid in a counter-flow pattern therebetween for temperature uniformity. The upper-shelf plate is formed of a temperature conductive material. 1. A shelf for a freeze dryer that has channels therein constructed to produce a fluid counter-flow pattern resulting in significantly better temperature uniformity.2. The shelf of wherein the counter-flow pattern is a serpentine pattern.3. A shelf for a freeze dryer claim 1 , comprising:a lower shelf plate;an upper shelf plate mounted on said lower shelf plate; andchannels in a serpentine pattern positioned between said upper shelf plate and said lower shelf plate to circulate heating or cooling fluid in a counter-flow pattern therebetween for temperature uniformity;said upper shelf plate being formed of a temperature conductive material.4. The shelf of wherein piping is connected to said upper shelf plate to provide heating or cooling fluid to said channels.5. The shelf of wherein said upper shelf plate is formed of a material that is lighter in weight than the material of the lower shelf plate.6. The shelf of wherein said lower shelf plate is formed of stainless steel claim 5 , and said upper shelf plate is formed of aluminum claim 5 , stainless steel or plastic.7. The shelf of wherein said serpentine channels extend from a peripheral portion of said upper and lower shelf plates to a center portion thereof.8. The shelf of wherein said upper shelf plate is fixedly mounted on said lower shelf plate.9. The shelf of wherein said upper shelf plate is removably mounted on said lower shelf plate.10. The shelf of wherein said lower shelf plate has a plurality of pins extending upwardly therefrom through said ...

METHOD FOR A PRESSURE-BASED DETERMINING OF A PRODUCT PARAMETER IN A FREEZE DRYER, FREEZE DRYER AND SOFTWARE PRODUCT

The invention relates to a method for the pressure-based determining of a product parameter in a freeze dryer, in particular a product temperature. In a method of this type at a point in time ta closing element as an intermediate valve between an ice chamber and a drying chamber of the freeze dryer is closed. Then, during a pressure rise occurring due to the sublimation pressure values (P, P, . . . ) are measured in the drying chamber. At a point in time tthen the closing element is opened. From the measured pressure values (P, P, . . . ) an approximation of a product parameter, in particular a product temperature T, is determined. 1. Method for a pressure-based determination of a product parameter in a freeze dryer comprising an ice chamber , a drying chamber and a valve arranged between the ice chamber and the drying chamber , the valve comprising a closing element which in a closed position separates the drying chamber from the ice chamber whereas in an open position of the closing element the valve connects the drying chamber and the ice chamber , the method comprising the following method steps:{'sub': START', 'START', 'END, 'a) moving the closing element into the closed position at a point in time tand keeping the closing element in the closed position for a time span between the point in time tand a point in time t,'}{'sub': 1', '2', 'START', 'END, 'b) measuring of pressure values (P, P, . . . ) in the drying chamber during the time span between the point in time tand the point in time t,'}{'sub': 1', '2', 'START', 'END, 'c) determining an approximation of a product parameter from the measured pressure values (P, P, . . . ) measured during the time span between the point in time tand the point in time tand'}{'sub': 'END', 'd) moving the closing element into the open position at the point in time t,'}{'sub': 'END', 'e) wherein the determined approximation of the product parameter is considered for the determination of the point in time tand'}{'sub': END', 'END ...

HEATING DEVICE FOR ROTARY DRUM FREEZE-DRYER

A heating device () for heating particles to be freeze-dried in a rotary drum () of a freeze-dryer () is provided, the device comprising at least one radiation emitter () for applying radiation heat to the particles, and a tube-shaped separator () for separating the particles from the at least one emitter (), The separator () being integrally closed at one end and separating an emitter volume () encompassing the at least one emitter () from a drum process volume () inside the drum (), wherein the heating device () protrudes into the drum process volume () such that said integrally closed end of the separator () is arranged inside the drum () as a free end. 1. A rotary drum with a heating device for heating particles to be freeze-dried in a freeze-dryer , the heating device protruding into a drum process volume inside the drum and comprising:at least one radiation emitter for applying radiation heat to the particles;a tube-shaped separator for separating the particles from the at least one emitter, with an emitter volume encompassing the at least one emitter and being separated from the drum process volume, the separator comprising an inner tube and an outer tube and providing an inner sub-volume between the inner tube and the outer tube as part of the emitter volume, and wherein the separator is integrally closed at one end, with said integrally closed end of the separator protruding into the drum process volume inside the drum as a free end, and with the other end of the separator being closed by a flange hermetically sealing the emitter volume against the drum process volume and an exterior of the drum; andwherein a cooling medium is conveyed through the separator for cooling at least parts of the heating device.2. The rotary drum according to claim 1 , wherein the inner sub-volume between the inner tube and the outer tube is an annular space.3. The rotary drum according to claim 1 , wherein the radiation emitter is arranged inside the inner tube.4. The rotary ...

Process and apparatus for treating containers for storing substances for medical, pharmaceutical or cosmetic applications

A process and apparatus are provided for treating or processing containers that are used for storing substances for medical, pharmaceutical or cosmetic applications or contain the same. During the process, cylindrical containers open at least at one end are automatically led past or pass through processing stations for treatment or processing by means of a conveying device, while the containers are jointly held by a carrier in a regular two-dimensional arrangement. The carrier includes a plurality of openings or receptacles that determine the regular arrangement. The treatment or processing of the containers is performed on or in at least one of the processing stations while the containers are supported by the carrier.

Lyophilization

Embodiments of methods, systems, and apparatuses for lyophilizing, storing, and transfusing materials are described. In embodiments, the materials may include whole blood or a component of whole blood such as plasma. 18-. (canceled)9. A container for lyophilizing and storing a lyophilized blood component , the container comprising: a first wall made from a flexible polymeric material and comprising a first permeability to water vapor; and', 'a second wall attached to the first wall to define an interior volume of the first chamber, wherein at least a portion of the second wall comprises a region that has a second permeability to water vapor, the second permeability being higher than the first permeability;, 'a first chamber comprising a third wall made from a flexible polymeric material; and', 'a fourth wall attached to the third side wall to define an interior volume of the second chamber; and, 'a second chamber fluidly connectable to the first chamber through a pathway, the second chamber comprisinga seal in the pathway, the seal isolating the first chamber from the second chamber, wherein the seal may be opened to allow communication from the first chamber to the second chamber through the pathway.10. The container of claim 9 , wherein the seal comprises one or more of a clamp claim 9 , a weld claim 9 , a frangible claim 9 , or combinations thereof.11. The container of claim 10 , wherein the first chamber further comprises a first port for adding a blood component into the interior volume of the first chamber.12. The container of claim 11 , wherein the second chamber further comprises a second port for adding a rehydration fluid into the interior volume of the second chamber.13. The container of claim 12 , wherein the second chamber further comprises a third port for removing a rehydrated blood component from the interior volume of the first chamber.14. The container of claim 13 , wherein the at least a portion of the second wall comprises a nonwoven textile.1530 ...

LYOPHILIZED PREPARATION OF CYTOTOXIC DIPEPTIDES

The present invention is directed to novel lyophilized pharmaceutical preparations comprising a cytotoxic dipeptides such as melphalan flufenamide and one or more excipient(s) selected from the group comprising a polysorbate; a polyethylene glycol; β-cyclodextrin; ocyclodextrin; hydroxypropyl-β-cyclodextrin; sulfobutylether-β-cyclodextrin; lactose; benzyl alcohol; disodium succinate; propylene glycol; Cremophor EL; Dimethyl sulfoxide; D-mannitol; Trehalose; Sucrose and an amino acid. This preparation may be further formulated and is useful in cancer therapy. 1. A lyophilized pharmaceutical preparation comprising(i) melphalan flufenamide, or a pharmaceutically acceptable salt thereof; and(ii) at least one excipient selected from the group comprising a polysorbate; a polyethylene glycol; β-cyclodextrin; α-cyclodextrin; hydroxypropyl-β-cyclodextrin; sulfobutylether-β-cyclodextrin; lactose; benzyl alcohol; disodium succinate; propylene glycol; Cremophor EL; Dimethyl sulfoxide; D-mannitol; Trehalose; Sucrose and an amino acid.2. A lyophilized pharmaceutical preparation according to claim 1 , wherein the excipient is selected from the group comprising Polysorbate 80; PEG 400; lactose; benzyl alcohol; disodium succinate; propylene glycol; PEG 300; Cremophor EL; Dimethyl sulfoxide; D-mannitol; Trehalose; Sucrose; and histidine.3. A lyophilized pharmaceutical preparation according to or claim 1 , wherein said melphalan flufenamide is melphalan flufenamide hydrochloride (J1).4. A lyophilized pharmaceutical preparation according to any one of - claim 1 , wherein said at least one excipient has surfactant properties.5. A lyophilized pharmaceutical preparation according to any one of - claim 1 , wherein said at least one excipient is a polysorbate or polyethylene glycol.6. A lyophilized pharmaceutical preparation according to claim 5 , wherein said at least one excipient is Polysorbate 80.7. A lyophilized pharmaceutical preparation according to claim 5 , wherein said at least ...

Automated Drying and Curing Chamber

Machines, systems and methods for curing materials, including organic and nonorganic materials, are described. In particular, machines, systems and methods for machines, systems and methods for materials, such as organic plant materials or inorganic materials, including cannabis materials. In particular, the present invention relates to machines, systems and methods for an automated drying and curing chamber machine for both personal and commercial applications, wherein the machine uses customized variable settings and laminar air flow dynamics via negative pressure to ensure the optimal curing and drying environment for plant materials are described.

METHOD AND SYSTEM FOR FREEZE-DRYING INJECTABLE COMPOSITIONS, IN PARTICULAR PHARMACEUTICAL COMPOSITIONS

The invention relates to a method for freeze-drying injectable compositions, in particular pharmaceutical compositions, comprising: A) storing a quantity of a dispersion of an injectable composition in an aqueous dispersion medium in at least one ready-to-use vial, B) rotating the vial at least for a period of time to form a dispersion layer at an inner surface of a circumferential wall of the vial, C) during rotating of the vial according to step B) cooling the vial to form ice crystals at the inner surface of the circumferential wall of the vial, and D) drying the cooled composition to sublime at least a portion of the ice crystals formed in the dispersion by substantially homogeneously heating the circumferential wall of the vial. The invention also relates to a freeze-dried composition obtained by the method according to the invention and a system for freeze-drying injectable compositions, in particular pharmaceutical compositions, in particular by making use of the method according to the invention. 145-. (canceled)46. Method for freeze-drying injectable compositions , in particular pharmaceutical compositions , comprising:A) storing a quantity of a dispersion of an injectable composition in an aqueous dispersion medium in at least one ready-to-use vial,B) rotating the vial at least for a period of time to form a dispersion layer at an inner surface of a circumferential wall of the vial,C) during rotating of the vial according to step B) cooling the vial to form ice crystals at the inner surface of the circumferential wall of the vial, andD) drying the cooled composition to sublime at least a portion of the ice crystals formed in the dispersion by substantially homogeneously heating the circumferential wall of the vial,wherein during step D) the dispersion layer formed onto the inner surface of the circumferential wall of the vial is monitored using a sensor.47. Method according to claim 46 , wherein a formation of ice crystals in the composition is monitored ...

Method for manufacturing a dispensing device for eye drops

The present invention relates to a process for the production of a device ( 1 ) for dispensing eye drops. The process comprises the steps of: —providing a first container ( 2 ) and a second container ( 3 ) configured to be engaged in a fluid-tight manner, —providing a spacer ( 4 ), —introducing a water-based solution ( 200 ) inside the first container ( 2 ), —introducing a solution or dispersion comprising a drug inside the second container ( 3 ), —arranging the spacer ( 4 ) between the first and second containers ( 2, 3 ), —engaging in a fluid-tight manner the second container ( 3 ) and the first container ( 2 ); and —freeze-drying the solution or dispersion comprising the drug.

HEATED SHELF FOR A FREEZE-DRYING SYSTEM HAVING A LEADING FOLDED EDGE THAT DOES NOT CATCH ON FOOD BEING REMOVED FROM THE SYSTEM

A freeze-drying system includes a vented cart for operation in a pressure-controlled chamber, and a plurality of heated shelves disposed in the vented cart. Each heated shelf includes a planar sheet made from a thermally conductive material. The planar sheet is folded to provide a top portion configured to conduct heat to a tray resting on the top portion, a bottom portion disposed opposite the top portion, and a folded leading edge. A heating element is secured between the top portion and the bottom portion so as to be disposed in thermally conductive contact with either the top portion or the bottom portion. The top portion is configured to conduct heat to a tray resting on the top portion. The leading folded edge permits food items to slide out of the freeze-drying system, even though pressing along the bottom portion of the heated shelf, without catching on the food. 1. A freeze-drying system comprising:a vented cart configured for operation in a pressure controlled chamber of the freeze-drying system; and a planar sheet formed from a thermally conductive material, and folded so as to form a top portion configured to conduct heat to a tray when the tray is resting on the top portion of the planar sheet, and a bottom portion disposed opposite the top portion;', 'a heating element secured between the top portion and the bottom portion, the heating element having a surface disposed in thermally conductive contact with the top portion; and, 'a plurality of heated shelves disposed in the vented cart, at least one heated shelf of the plurality of heated shelves includingwherein the plurality of heated shelves is configured for control by a temperature controller of the freeze-drying system.2. The freeze-drying system of claim 1 , wherein the heating element is secured to the top portion of the at least one heated shelf.3. The freeze-drying system of claim 1 , wherein the heating element is secured to the bottom portion of the at least one heated shelf.4. The freeze- ...

Preparation Method of Azacitidine for Injection

Disclosed is a preparation method for an azacitidine for injection, wherein each injection vial of azacitidine for injection contains 100 mg of azacitidine and 100 mg of mannitol. The preparation method comprises the steps of measuring 80% of the total volume of water for injection at a temperature of 2-6° C.; adding mannitol, and stirring to completely dissolved at a temperature of 2-6° C.; adding azacitidine, stirring to completely dissolved at a temperature of 2-6° C. to obtain an azacitidine solution for injection; filling each injection vial with 23 ml azacitidine solution for injection after filtration; freeze-drying at a preset temperature; and stoppering, capping and packaging after nitrogen filling. The preparation method has the advantages of a simple process, low energy consumption, high production efficiency and stable product quality. 1. A preparation method of azacitidine for injection , wherein each injection vial of azacitidine for injection contains 100 mg of azacitidine and 100 mg of mannitol , and the preparation method comprises following steps:a. measuring 80% of the total volume of water for injection at a temperature of 2-6° C.;b. adding mannitol, and stirring to completely dissolved at a temperature of 2-6° C.;c. adding azacitidine, stirring to completely dissolved at a temperature of 2-6° C. to obtain an azacitidine solution for injection;d. filling each injection vial with 23 ml azacitidine solution for injection after filtration;e. freeze-drying at a preset temperature; andf. stoppering, capping and packaging after nitrogen filling.2. The preparation method of azacitidine for injection according to claim 1 , wherein the preparation method does not comprise a step of adsorbing with an activated carbon.3. The preparation method of azacitidine for injection according to claim 1 , wherein the azacitidine has a content of ≤0.6 Eu/mg of bacterial endotoxin.4. The preparation method of azacitidine for injection according to claim 1 , wherein the ...

Article of manufacture containing lyophilized leuprolide acetate

A process for lyophilizing a solution of an active agent in a container is provided. Solution of active agent is deposited into a container, the container is covered with a covering plate and placed inside a lyophilizing apparatus. Lyophilization can be conducted to dryness by radiation, convection or both. Also provided is a device made by this process, an active agent-plastic administration device (e.g., a syringe), containing an active agent in the form of lyophilized cake, and an array of such administration devices.

FREEZE-DRYING SYSTEM AND METHOD THEREFOR

The invention relates to a freeze-drying system for drying products containing liquid and to a method for operating a freeze-drying system, said freeze-drying system having a vacuum chamber, in which at least one holding device for holding the products containing liquid is inserted, a coolable condenser being provided, on which liquid drawn from the product in a drying phase can be condensed from a vapor phase. According to the invention, at least one sound generator is arranged on the holding device, by means of which sound generator sound can be applied to the product during the drying phase. 1. A freeze-drying system for drying products containing liquid , having a vacuum chamber in which at least one reception device for receiving the products containing liquid is introduced and wherein a coolable condenser is present at which liquid withdrawn from the product in a drying phase can be precipitated from a vapor phase ,characterized in thatat least one sound generator by which the product can be treated with sound during the drying phase is arranged at the reception device.2. A freeze-drying system in accordance with claim 1 ,characterized in thatthe reception apparatus comprises one or more reception plates, with the at least one product being able to be placed on an upper side of the reception plate, and with the at least one sound generator being arranged at a lower side of the reception plate disposed opposite the upper side.3. A freeze-drying system in accordance with claim 1 ,characterized in thata reception space is formed in the vacuum chamber, with the condenser being introduced in the reception space together with the reception apparatus and the product.4. A freeze-drying system in accordance with claim 1 ,characterized in thatthe condenser is spatially formed such that is surrounds the reception apparatus at the outer side.5. A freeze-drying system in accordance with claim 1 ,characterized in thatthe reception apparatus comprises a reception plate that ...

Method of the Preparation of Fibrillar and Lamellar Porous Microstructures and Nanostructures by Means of Controlled Vacuum Freeze-Drying of Liquid Nanoparticles Dispersions

The invention relates to a method of preparation of lamellar porous microstructures and nanostructures of various density based on controlled vacuum freeze-drying of a liquid dispersion of nanoparticles. 1. The method of preparation of nanostructural materials by means of controlled freeze-drying of a liquid dispersion of nanoparticles or submicron particles , characterized by that the liquid dispersion of nanoparticles or submicron particles is frozen and in this form it is submitted to freeze-drying where the molecules of the dispersion medium are removed at requested rate of sublimation , until their entire disposal by sublimation , while the orientation of the normal vector of the predominant surface of sublimation interface is adjusted as required at arbitrary angle to the vertical line , and the rate of sublimation of frozen material is controlled by the combination of vacuum depth and external heating of sublimation surface of the frozen material.2. The method of preparation of nanostructural materials by means of controlled freeze-drying of a liquid dispersion of nanoparticles or submicron particles according to claim 1 , characterized by that in the preparation of fibrillar and lamellar micro- and nanostructures the total volume of nanoparticles or submicron particles in the dispersion is smaller than the initial total volume of the dispersion medium liquid.3. The method of preparation of nanostructural materials by means of controlled freeze-drying of a liquid dispersion of nanoparticles or submicron particles according to and claim 1 , characterized by that during the preparation of fibrillar and lamellar micro- and nanostructures claim 1 , the orientation of the normal vector of the dominant sublimation surface is set with regard to the required properties of the sublimate structure as follows:a) to form multi-bonded fibrillar and in particular lamellar aggregates, it is chosen between 0°-45° to upward vertical directionb) to form significantly simpler ...

FREEZE-DRYING APPARATUS WITH A LOADING AND UNLOADING DEVICE

A freeze-drying apparatus () includes an arrangement of individual product platforms () that are supported vertically in a frame () in a drying chamber, in which each platform is able to be moved to a shift level, in which lateral guides () designed to support a carriage () are arranged with a fixed height position, and which cooperate with the guides () of a loading and unloading device. All product platforms () in the drying chamber can be loaded by repeating this operation cyclically. In order to unload the drying chamber, the arrangement of the product platforms () are moved to such a position above the shift level in which the carriage () can be moved as far as its rear limit position inside the drying chamber, travelling underneath each loaded product platform (). 120-. (canceled)211. A freeze-drying apparatus () , comprising:{'b': 2', '3, 'a drying chamber () accommodated inside a housing ();'}{'b': 19', '20', '42', '2', '3', '13', '12, 'an arrangement of product platforms () disposed so as to be displaceable vertically in a frame () and designed to support drying receptacles () containing a substance to be dried, located inside the drying chamber (), wherein the housing () has at least one opening () that is closable by a door ();'}{'b': 42', '2', '15', '16', '18', '21', '22', '42', '2', '24', '24, 'a loading and unloading device for the drying receptacles () outside of the drying chamber (), which has at least one carriage () that is supported in guides (, , , ), and is configured to push the drying receptacles () into the drying chamber () by means of a back side (), wherein said back side () forms a first movable leading edge,'}{'b': 13', '13, 'wherein at least one horizontal shift level is defined by the height position of the opening (), wherein the guides extend into said opening () and assume a fixed height position,'}{'b': 19', '2', '15', '19', '19', '2, 'wherein the arrangement of product platforms () is displaceable vertically inside the drying ...

Process line for the production of freeze-dried particles

A process line ( 300 ) for the production of freeze-dried particles under closed conditions is provided, the process line comprising at least the following separate devices: a spray chamber ( 302 ) for droplet generation and freeze congealing of the liquid droplets to form particles, and a bulk freeze-dryer ( 304 ) for freeze drying the particles, wherein a transfer section ( 308 ) is provided for a product transfer from the spray chamber ( 302 ) to the freeze-dryer ( 304 ), for the production of the particles under end-to-end closed conditions each of the devices ( 302, 304 ) and of the transfer section ( 308 ) is separately adapted for closed operation, and the spray chamber ( 302 ) is adapted for separation of the liquid droplets from any cooling circuit.

FREEZE-DRYING SYSTEM AND FREEZE-DRYING METHOD

An object is to provide a freeze-drying system and a freeze-drying method which can improve cleanliness and productivity. The present invention relates to a freeze-drying system in which freeze-drying is performed by sublimating moisture frozen by cooling an object. The system includes a cooling device () which generates cold with an air cycle in which air is used as a refrigerant, a freeze-drying chamber () accommodating a heat exchange unit which causes heat exchange between the refrigerant and the object, and a control unit () which controls a cooling capacity of the cooling device. The control unit adjusts the temperature in the freeze-drying chamber to a predetermined target temperature by controlling an amount of the cold generated in the cooling device. 1. A freeze-drying system in which freeze-drying is performed by sublimating moisture frozen by cooling an object , and collecting the sublimated moisture with a cold trap , the freeze-drying system comprising:a cooling device which generates cold with an air cycle in which air is used as a refrigerant;a freeze-drying chamber accommodating a heat exchange unit which causes heat exchange between the refrigerant and the object;a cold air supplying mechanism which supplies precooled air into the freeze-drying chamber; anda control unit which controls a cooling capacity of the cooling device, wherein an outer air intake unit which takes in outer air;', 'a cooling unit which cools the outer air by performing the heat exchange between the taken outer air and the refrigerant; and', 'a blower unit which blows the cooled outer air into the freeze-drying chamber, and, 'the cold air supplying mechanism includesthe control unit adjusts the temperature in the freeze-drying chamber to a predetermined target temperature by controlling an amount of the cold generated in the cooling device.2. The freeze-drying system according to claim 1 , whereinthe control unit performs first cooling of cooling the freeze-drying chamber to a ...

LYOPHILIZATION

Embodiments of methods, systems, and apparatuses for lyophilizing, storing, and transfusing materials are described. In embodiments, the materials may include whole blood or a component of whole blood such as plasma. 119-. (canceled)20. A method of lyophilizing material , the method comprising:pooling liquid in a container to create pooled liquid;adding a photosensitizer to the pooled liquid;exposing the pooled liquid with the photosensitizer to a light source to create a pathogen reduced liquid; cooling the pathogen reduced liquid to freeze a liquid component to create a solid;', 'subjecting the solid to a first pressure, which is less than atmospheric pressure; and', 'sublimating a portion of the solid., 'lyophilizing the pathogen reduced liquid, wherein the lyophilizing comprises21. The method of claim 20 , wherein the photosensitizer comprises riboflavin.22. The method of claim 21 , wherein the light source generates light with a wavelength in the ultraviolet range.23. The method of claim 20 , wherein the liquid comprises human plasma.2430-. (canceled) This application claims priority to: U.S. Provisional Patent Application No. 62/009,629, filed Jun. 9, 2014, entitled LYOPHILIZATION; U.S. Provisional Patent Application No. 62/010,027, filed Jun. 10, 2014, entitled LYOPHILIZATION; and U.S. Provisional Patent Application No. 62/142,146 filed Apr. 2, 2015, entitled CONTAINER FOR LYOPHILIZATION. All three of the above-identified provisional patent applications are hereby incorporated by reference in their entirety as if set forth herein in full.Lyophilization is a process that is used to preserve materials and increase their shelf life, including biological materials, food, and pharmaceuticals. Lyophilization occurs by first freezing material to solidify it and then subjecting the material to a low pressure environment (below atmospheric pressure) to allow for sublimation of a component of the material. Typically the component is a liquid at standard temperature and ...

LYOPHILIZATION

Embodiments of methods, systems, and apparatuses for lyophilizing, storing, and transfusing materials are described. In embodiments, the materials may include whole blood or a component of whole blood such as plasma. 123-. (canceled)24. A system for use in lyophilizing a material , the system comprising:a first plate with a first surface;a second plate with a second surface opposed to the first surface, the second plate comprising channels for circulating a fluid; anda plate moving system operable to increase and decrease a space between the first surface and the second surface.25. The system of claim 24 , further comprising an IR radiating material on the first plate claim 24 , the IR radiating material comprising the first surface.26. The method of claim 24 , wherein the first surface comprises features for imparting a macro texture27. The method of claim 24 , wherein the first plate and the second plate comprise the same structure.2830-. (canceled) This application claims priority to: U.S. Provisional Patent Application No. 62/009,629, filed Jun. 9, 2014, entitled LYOPHILIZATION; U.S. Provisional Patent Application No. 62/010,027, filed Jun. 10, 2014, entitled LYOPHILIZATION; and U.S. Provisional Patent Application No. 62/142,146 filed Apr. 2, 2015, entitled CONTAINER FOR LYOPHILIZATION. All three of the above-identified provisional patent applications are hereby incorporated by reference in their entirety as if set forth herein in full.Lyophilization is a process that is used to preserve materials and increase their shelf life, including biological materials, food, and pharmaceuticals. Lyophilization occurs by first freezing material to solidify it and then subjecting the material to a low pressure environment (below atmospheric pressure) to allow for sublimation of a component of the material. Typically the component is a liquid at standard temperature and pressure, one example being water.Depending on the type of material and volume being lyophilized, the ...

LYOPHILIZATION

Embodiments of methods, systems, and apparatuses for lyophilizing, storing, and transfusing materials are described. In embodiments, the materials may include whole blood or a component of whole blood such as plasma. 127-. (canceled)28. A method of preparing a liquid comprising a blood component for lyophilization , the method comprising:pooling a plurality of volumes of liquid comprising a blood component to generate a pooled volume of liquid;removing a portion of liquid from the pooled volume of liquid to create a reduced volume of liquid; andfilling a plurality of containers with the reduced volume of liquid, wherein the plurality of containers comprise a wall that is permeable to water vapor.29. The method of claim 28 , further comprising reducing pathogens in the reduced volume of liquid.30. The method of claim 29 , wherein the reducing pathogens comprises:adding a photosensitizer to the reduced volume of liquid; andexposing the photosensitizer and the reduced volume of liquid to a light source. This application claims priority to: U.S. Provisional Patent Application No. 62/009,629, filed Jun. 9, 2014, entitled LYOPHILIZATION; U.S. Provisional Patent Application No. 62/010,027, filed Jun. 10, 2014, entitled LYOPHILIZATION; and U.S. Provisional Patent Application No. 62/142,146 filed Apr. 2, 2015, entitled CONTAINER FOR LYOPHILIZATION. All three of the above-identified provisional patent applications are hereby incorporated by reference in their entirety as if set forth herein in full.Lyophilization is a process that is used to preserve materials and increase their shelf life, including biological materials, food, and pharmaceuticals. Lyophilization occurs by first freezing material to solidify it and then subjecting the material to a low pressure environment (below atmospheric pressure) to allow for sublimation of a component of the material. Typically the component is a liquid at standard temperature and pressure, one example being water.Depending on the type ...

LIQUID FEEDING DEVICE FOR THE GENERATION OF DROPLETS

The present invention provides, inter alia, for a liquid feeding device for the generation of droplets, in particular for the use in a process line for the production of freeze-dried particles, with a droplet ejection section for ejecting liquid droplets in an ejection direction, the droplet ejection section comprising at least one inlet port for receiving a liquid to be ejected, a liquid chamber for retaining the liquid, and a nozzle for ejecting the liquid from the liquid chamber to form droplets, wherein the liquid chamber is restricted by a membrane on one side thereof, the membrane being vibratable by an excitation unit, wherein the longitudinal axis of the liquid chamber is tilted relative to the longitudinal axis of the nozzle, and/or the liquid feeding device further comprises a deflection section for separating the droplets from each other by means of at least one gas jet, wherein the deflection section gas jet intersects perpendicular with an ejection path of the liquid ejected from the liquid chamber. 1. Liquid feeding device for the generation of droplets , in particular for the use in a process line for the production of freeze-dried particles , witha droplet ejection section for ejecting liquid droplets in an ejection direction, the droplet ejection section comprising at least one inlet port for receiving a liquid to be ejected, a liquid chamber for retaining the liquid, and a nozzle for ejecting the liquid from the liquid chamber to form droplets, wherein the liquid chamber is restricted by a membrane on one side thereof, the membrane being vibratable by an excitation unit, wherein the liquid feeding device further comprises a deflection section for separating the droplets from each other by means of at least one gas jet, and wherein the deflection section gas jet intersects perpendicular with an ejection path of the liquid ejected from the liquid chamber.2. Liquid feeding device according to claim 1 , wherein the longitudinal axis of the liquid ...

FREEZE-DRYING METHODS AND RELATED PRODUCTS

The disclosure in some aspects relates to systems and related methods for the continuous freeze-drying of materials (e.g., pharmaceuticals) with high speed and control. 1. A method for processing a composition , the method comprising:continuously moving a vessel configured to contain a composition through a plurality of modules arranged to promote step-wise freezing and/or drying of the composition, wherein the vessel comprises a housing defining a boundary between an exterior surrounding of the vessel and an interior space configured to contain the composition, and wherein, during movement of the vessel through the plurality of modules, the vessel is arranged to promote heat transfer between the exterior surrounding and the interior space across a portion of the housing contactable with the composition in the interior space when the composition is present in the interior space.2. The method of claim 1 , comprising operating one or more control systems to control the temperature of the vessel as it moves through the plurality of modules.3. The method of claim 2 , wherein while the vessel contains the composition claim 2 , the method comprises inputting one or more measurements from a wireless thermocouple into a model-based control system so as to adjust the temperature of a heat transfer fluid in order to maintain the temperature of the composition at a controlled value during freezing and/or drying.4. The method of claim 1 , wherein the vessel is suspended from a conveyor configured to continuously move the vessel through the plurality of modules.5. The method of claim 1 , wherein a product claim 1 , comprising one or more components of the composition claim 1 , resulting from the processing method has an average pore size of between or equal to 20 microns and 1000 microns.6. The method of claim 1 , wherein a product claim 1 , comprising one or more components of the composition claim 1 , resulting from the processing method has an average pore size of between or ...

Vacuum insulation material

A vacuum insulation material includes a pair of gas barrier exterior materials, a core material including a cellulose structure having porosity of greater than or equal to about 80% under reduced pressure of about 1 Pa, where the cellulose structure has a unit length of greater than or equal to about 1 μm and less than or equal to about 5 mm in the heat-insulation direction, and the method of manufacturing the same, and a gas adsorption agent, where the core material and the gas adsorption agent are interposed between the pair of gas barrier exterior materials and sealed inside of the pair of gas barrier exterior materials under reduced pressure.