СПОСОБ ПОЛУЧЕНИЯ ТОПЛИВА ИЗ МОДИФИЦИРОВАННОГО ВОЛОКНИСТОГО МАТЕРИАЛА (ВАРИАНТЫ) И СПОСОБ УПЛОТНЕНИЯ ВОЛОКНИСТОЙ КОМПОЗИЦИИ, ИСПОЛЬЗУЕМОЙ ДЛЯ ПОЛУЧЕНИЯ ТОПЛИВА

Изобретение относится к получению топлива из волокнистого материала. Каждый из вариантов способа предусматривает резку источника волокна с получением первого волокнистого материала и пропускание последнего через сито с получением второго волокнистого материала, который имеет относительно высокую удельную площадь поверхности, относительно высокую пористость и относительно низкую объемную плотность. Затем второй волокнистый материал объединяют с дрожжами, и/или бактерией, и/или ферментом для получения топлива. Второй вариант способа предусматривает проведение гидролиза волокнистого материала перед внесением дрожжей, и/или бактерии, и/или ферментов. Способ уплотнения волокнистой композиции предусматривает помещение композиции, полученной объединением резанного и пропущенного через сито волокнистого материала с бактерией и/или ферментом, в пакет из газонепроницаемого материала и удаление из него газа. Изобретения позволяют сократить время при производстве топлива за счет того, что волокнистый ...

СПОСОБ УДАЛЕНИЯ ПАТОЛОГИЧЕСКОГО ПРИОННОГО БЕЛКА ИЗ ПРОДУКТОВ КРОВИ

Изобретение относится к области биотехнологии. Предложен способ удаления патологического прионного белка из продукта крови. Осуществляют фильтрацию продукта крови через фильтр, заполненный носителем, покрытым полимером. Данный полимер образован тремя элементами: элементом, происходящим из гидрофобного полимеризуемого мономера, элементом, происходящим из полимеризуемого мономера, содержащего основную азотсодержащую часть, и элементом, происходящим из полимеризуемого мономера, содержащего протонную нейтральную гидрофильную часть в качестве баланса. После фильтрации проводят сбор продукта крови. Способ обеспечивает эффективное удаление патологического прионного белка из продукта крови с одновременным удалением лейкоцитов. Эффективность удаления патологического прионного белка составляет от 1,2 до 4,1 и более. 11 з.п. ф-лы, 1 ил., 1 табл.

Способы стерильной хроматографии и производства

Изобретение относится к способам осуществления хроматографии с использованием гамма-облученной хроматографической смолы, включающим получение хроматографической колонки, включающей гамма-облученную хроматографическую смолу; осуществление первого цикла хроматографии с помощью колонки, где цикл включает восстановление связывающей способности гамма-облученной анионообменной хроматографической смолы путем подвергания гамма-облученной анионообменной хроматографической смолы воздействию денатурирующего буфера; и осуществление по меньшей мере одного дополнительного цикла хроматографии с помощью колонки. Кроме того, изобретение относится к интегрированным, замкнутым, или, по существу, замкнутым, и непрерывным способам производства рекомбинантного белка, включающим применение по меньшей мере одной хроматографической колонки, включающей гамма-облученную хроматографическую смолу, где гамма-облученную хроматографическую смолу подвергают воздействию денатурирующего буфера в течение каждого цикла способа ...

СПОСОБ ИЗГОТОВЛЕНИЯ СТЕРИЛИЗОВАННОГО И ТАРИРОВАННОГО МЕДИЦИНСКОГО УСТРОЙСТВА НА ОСНОВЕ БИОСЕНСОРА (ВАРИАНТЫ)

Изобретение относится к области изготовления медицинских устройств. Способ изготовления стерилизованного и тарированного медицинского устройства на основе биосенсора (например, медицинского устройства с объединенными в одно целое биосенсором и ланцетом), содержащее реагент биосенсора (например, реагент биосенсора из специфического фермента для анализируемого вещества и медиатора). Стерилизацию осуществляют, например, гамма-излучением. Затем тарируют реагент биосенсора стерилизованного медицинского устройства на основе биосенсора. Другой способ изготовления стерилизованного и тарированного медицинского устройства на основе биосенсора включает в себя вначале сборку и упаковывание множества медицинских устройств с реагентом биосенсора, затем стерилизацию облучением для создания множества стерилизованных, упакованных медицинских устройств на основе биосенсора. После этого тарируют стерилизованные и упакованные медицинские устройства на основе биосенсора. Тарирование можно выполнять, используя ...

МНОГОСЛОЙНЫЙ ПЛАСТИКОВЫЙ ПОЛИМЕРНЫЙ КОНТЕЙНЕР ДЛЯ ХРАНЕНИЯ ФАРМАЦЕВТИЧЕСКИХ КОМПОЗИЦИЙ

Изобретение имеет отношение к многослойному пластиковому полимерному контейнеру для хранения композиции. Контейнер включает внутренний слой и внешний слой в непосредственном контакте с композицией и окружающей средой соответственно, центральный слой барьера газа и два промежуточных адгезивных слоя между центральным слоем и внешним и внутренним полимерными слоями. Внешний и внутренний слои включают смесь полимеров и, по меньшей мере, один разветвленный полиолефин. Технический результат - получение многослойных пластиковых полимерных контейнеров для хранения жидких или нежидких стерильных фармацевтических композиций, включающих водные или неводные растворители. 19 з.п. ф-лы, 14 табл., 8 ил., 10 пр.

СИСТЕМА И СПОСОБ СТЕРИЛИЗАЦИИ ИМПЛАНТИРУЕМОГО МЕДИЦИНСКОГО УСТРОЙСТВА

... 1. Имплантируемая медицинская система, включающая ! имплантируемое медицинское устройство, сконструированное таким образом, чтобы располагаться в брюшной полости пациента; и ! внутренний модуль управления в электрической связи, по меньшей мере, с одним из имплантируемого медицинского устройства или внешнего устройства, и дополнительно включающий компоненты схемы, устойчивые к некоторому количеству радиации какого-либо типа. ! 2. Система по п.1, где компоненты схемы являются устойчивыми к некоторому количеству радиации, используемой в процессе стерилизации имплантируемого медицинского устройства. ! 3. Система по п.1, где имплантируемое медицинское устройство представляет собой ограничивающее устройство, сконструированное таким образом, чтобы производить ограничение проводящего пути. ! 4. Система по п.1, где, по меньшей мере, один из компонентов схемы изготовлен, по меньшей мере, частично, из радиационностойкого материала. ! 5. Система по п.4, где радиационностойкий материал выбран из группы ...

СПОСОБ УДАЛЕНИЯ ПАТОЛОГИЧЕСКОГО ПРИОННОГО БЕЛКА ИЗ ПРОДУКТОВ КРОВИ

... 1. Способ удаления патологического прионного белка из продукта крови, отличающийся тем, что включает: фильтрацию продукта крови через фильтр, заполненный носителем, покрытым полимером, образованным тремя элементами, включающими 20 мол.% или более и 40 мол.% или менее элемента, происходящего из гидрофобного полимеризуемого мономера, 5 мол.% или более и 13 мол.% или менее элемента, происходящего из полимеризуемого мономера, содержащего основную азотсодержащую часть, и элемента, происходящего из полимеризуемого мономера, содержащего протонную нейтральную гидрофильную часть в качестве баланса; и сбора профильтрованного продукта крови. ! 2. Способ удаления патологического прионного белка из продукта крови по п.1, отличающийся тем, что продукт крови представляет собой продукт цельной крови, и фильтр подвергается стерилизации облучением и затем стерилизации автоклавированием. ! 3. Способ удаления патологического прионного белка из продукта крови по п.2, отличающийся тем, что облучение представляет ...

Strahlungsverträgliches Schmiermittel für medizinische Geräte

Spray dispenser

Method of decontamination and sterilisation

Irradiation apparatus for production line use

Fibrous materials and compositions

Fibrous materials and compositions

Fibrous materials and compositions

PROCEDURE FOR THE IMPROVEMENT OF THE STABILITY OF A PHARMACEUTICAL PREPARATION

NONOXIDIZING, MEDICAL POLYMER IMPLANT

BEHÄLTER ZUR EINBRINGUNG ZUMINDEST EINES UNSTERILEN GEFÄSSES IN EINEN STERILEN BEREICH

METHOD FOR STERILIZING A MEDICAL DEVICE HAVING A HYDROPHILIC COATING

TERMINAL STERILISATION OF VORGEFÜLLTEN CONTAINERS

PROCEDURE FOR THE PRODUCTION OF ARTICLES FROM POLYMER MATERIALS WITH MEDICAMENTOUS DEPOTWIRKUNG

PROCEDURE FOR STERILIZING MEANS - G (G) - RADIATION AND AN OXYGEN ABSORBER, AS WELL AS IN THIS PROCEDURE OF STERILIZED CONTAINERS AND MEDICAL ARTICLES

System for sterilising sterilisation units and method for operating such a system

The invention relates to a system (1) for sterilising sterilisation units (100) by means of exposure to radiation, more particularly for sterilising sterilisation units (100) containing medical objects by means of exposure to radiation, comprises a conveying system (8) for transporting the sterilisation units (100) through a sterilising environment along a conveying line. The sterilising environment is exposed to radioactive radiation from a radiation source (2). At least one conveying section (F3, F4, F5, F6, F7, F8, F9, F10) of the conveying line extends along the periphery of the radiation source (2). The radiation source (2), for example a Co60 source, emits gamma radiation. According to the invention, the conveying system (8) comprises at least one lifting beam conveyor (12) with at least one stationary support beam (32) and at least one moveable lifting beam (34), which can be moved in a longitudinal and vertical direction with respect to the at least one stationary support beam ( ...

Improved surgical instruments

Spray dispenser

A spray dispenser is provided, the spray dispenser comprising a container for holding a liquid to be dispensed and a dispensing assembly for extracting liquid from said container, the dispensing assembly comprising a pressure-relief valve (115) for release of excessive pressure in the container and a filter arranged to permit egress of gas through the filter (105), inhibit egress of liquid from the container and to inhibit ingress of contaminants into the container through the pressure relief valve (115). A dispensing assembly for use is a spray dispenser is also provided.

Gamma-irradiation sterilized polyethylene packaging

Rehydratable polysaccharide particles and sponge

ELECTRON BEAM STERILIZATION OF LIQUID ADHESIVE COMPOSITIONS

A method for sterilizing a liquid adhesive composition includes subjecting the composition to electron beam irradiation while it is enclosed in a container.

STERILIZATION OF BIODEGRADABLE HYDROGELS

The present invention relates to a terminal sterilization process for biodegradable PEG-based insoluble hydrogels using irradiation. The presence of a protective solventensures that the hydrogel remains intact withfunctionally preservedthree-dimensional andphysicochemical properties.

METHOD FOR MANUFACTURING A STERILIZED AND CALIBRATED BIOSENSOR-BASED MEDICAL DEVICE

A method for manufacturing a sterilized and calibrated biosensor-based medical device (e.g., an integrated biosensor and lancet medical device) includes sterilizing a biosensor-based medical device that contains a biosensor reagent composition (e.g., an analyte specific enzyme and mediator biosensor reagent composition). The sterilizing can be accomplished using, for example, a gamma radiation based technique. Thereafter, the biosensor reagent composition of the sterilized biosensor- based medical device is calibrated. Another method for manufacturing a sterilized and calibrated biosensor-based medical device includes first assembling and packaging a plurality of biosensor-based medical devices that include a biosensor reagent composition. The packaged biosensor-based medical devices are then sterilized using a radiation- based sterilization technique, to create a plurality of sterilized, packaged biosensor-based medical devices. Thereafter, the sterilized and packaged biosensor-based medical ...

GAMMA-IRRADIATION STERILIZED POLYETHYLENE PACKAGING

Articles of product material in gamma-irradiated packaging, wherein the gamma- irradiated packaging contains polyethylene. Polyethylene has been shown to possess characteristics which are both unexpected and superior to those suggested by historical literature. Articles of the invention are particularly suited to oxidation-sensitive product materials and medicinal products. Methods of producing such articles are included.

METHOD FOR TERMINAL STERILIZATION OF TRANSDERMAL DELIVERY DEVICES

A method and system for providing a terminally sterilized transdermal influenza vaccine delivery device. A microprojection member having a plurality of stratum corneum- piercing microprojections is coated with an influenza vaccine-formulation and exposed to sufficient radiation to sterilize the microprojection member while retaining sufficient potency of the influenza vaccine. Preferably, the microprojection member is sealed in packaging, such as a foil pouch. Also preferably, a retainer ring and adhesive are included within the packaging. The sterilizing radiation can be gamma radiation or e- beam, preferably delivered in a dose in the range of approximately 7 - 21 kGy. Also preferably, the irradiation is performed from -78.5 - 25~C. hi preferred embodiments, the radiation is delivered at a rate greater than 3.0 kGy/hr.

RADIATION STERILIZED HYDROGELS, MEDICAL DEVICES INCLUDING RADIATION STERILIZED HYDROGELS AND METHODS OF MAKING THE SAME

Radiation sterilized hydrogels, medical devices containing the same and method of making radiation sterilized hydrogels.

DRUG CARTRIDGE ASSEMBLY AND METHOD OF MANUFACTURE

A method of manufacture for a drug cartridge assembly. The method includes providing a drug cartridge, providing a nozzle sub-assembly, and sterilizing the drug cartridge and nozzle sub-assembly. The method further includes assembling the drug cartridge and nozzle sub-assembly together in a configuration that enables ejection of liquid out of the drug cartridge through the nozzle sub-assembly. The method further includes filling the drug cartridge with a liquid, such as an injectable drug. The method may include separate sterilization of the drug cartridge and nozzle sub-assembly, using different sterilization processes. Portions of the method may be performed prior to sterilization within a first cleanroom, with subsequent steps being performed in a second cleanroom having a substantially lower particulate-per- volume rating than the first cleanroom.

STERILE CHROMATOGRAPHY RESIN AND USE THEREOF IN MANUFACTURING PROCESSES

Provided herein are methods of reducing bioburden of (e.g., sterilizing) a chromatography resin that include exposing a container including a composition including a chromatography resin and at least one antioxidant agent and/or chelator to a dose of gamma-irradiation sufficient to reduce the bioburden of the container and the chromatography resin, where the at least one antioxidant agent and/or chelator are present in an amount sufficient to ameliorate the loss of binding capacity of the chromatography resin after/upon exposure to the dose of gamma-irradiation. Also provided are reduced bioburden chromatography columns including the reduced bioburden chromatography resin, compositions including a chromatography resin and at least one chelator and/or antioxidant agent, methods of performing reduced bioburden column chromatography using one of these reduced bioburden chromatography columns, and integrated, closed, and continuous processes for reduced bioburden manufacturing of a purified ...

STERILIZABLE SURGICAL INSTRUMENT

A surgical instrument including a first portion and a second portion, wherein the second portion can be sterilized separately from the first portion. The first portion can comprise an anvil, a staple cartridge channel and/or staple cartridge, and a movable cutting member. The second portion can comprise electronic components configured to control the surgical instrument and/or record data collected during the use of the surgical instrument. The first portion can be sterilized using a gamma radiation sterilization process while the second portion can be sterilized using a different sterilization process, such as steam, ethylene oxide, ozone, and/or hydrogen peroxide sterilization processes, for example. As a result, the first and second portions can be sterilized separately and delivered in two separate containers. The second portion can be stored within a sealed bag and can include an electrical terminal which can penetrate the bag and communicate with the first portion.

IRRADIATION OF RED BLOOD CELLS AND ANAEROBIC STORAGE

A blood storage system comprising: a collection vessel for red blood cells; an oxygen or oxygen and carbon dioxide depletion device; a storage vessel for red blood cells; tubing connecting the collection vessel to the oxygen or oxygen and carbon dioxide depletion device and the oxygen or oxygen and carbon dioxide depletion device to the storage vessel; and a gamma or X-ray irradiating device is used to irradiate red blood cells stored in the vessel, storing red blood cells under anaerobic conditions.

BIODEGRADABLE TERPOLYMERS AND TERPOLYMER BLENDS AS PRESSURE-SENSITIVE ADHESIVES

Disclosed herein are terpolymers and blends prepared from polyester terpolymers that can function as pressure-sensitive adhesives. The disclosed articles comprise the terpolymer and terpolymer blends coated to a conformable backing member. The terpolymer and terpolymer blends can further comprise a bioactive agent.

GAMMA RADIATION STERILIZABLE ACRYLIC POLYMER

Provided are methyl methacrylate polymers admixed with a particular additive or additive combination, which show good chemical resistance, as well as maintenance of optical properties and minimal yellowi ng on exposure to sterilizing gamma radiation.

STERILE NONWOVENS BONDED USING POLYURETHANE DISPERSIONS

A process for producing sterile nonwovens comprises a textile fabric composed of a fiber web being impregnated with an aqueous dispersion comprising a polyurethane, then dried and irradiated with .gamma.-rays.

Container for small parts in the pharmaceutical industry.

Ein Behältnis zum Einfüllen, Behandeln, Transportieren, Lagern, Transferieren etc. von kleinen Teilen für die pharmazeutische Industrie besteht aus einem vorgeformten flexiblen Behälter, der eine vorgegebene Raumform besitzt, und dessen Form wegen seiner Flexibilität durch grössere Drücke verändert wird, derart, dass er über einen längeren Zeitraum (z.B. 1 Jahr) ausreichend Druck (z.B. 50–500 mbar) tragen kann, um die Integrität des Inhaltes zu garantieren.

Reducing the deterioraton of wetted hydrophilic coatings subjected to sterilization by radiation

METHOD AND APPARATUS FOR CONDITIONING ELASTOMER PARTS.

FILM MANUFACTURING METHOD AND OF A IMPLANTABLE PROSTHESIS COMPRISING SUCH A FILM

METHOD FOR PREPARING A DRY STERILE CONTAINER, BY GAMMA IRRADIATION OF THE SURFACE OF SAID CONTAINER.

MEDICAMENT VIAL HAVING A HEAT-SEALABLE CAP, AND APPARATUS AND METHOD FOR FILLING THE VIAL

APPARATUS, SYSTEMS AND METHODS FOR PROCESSING AND TREATING A BIOLOGICAL FLUID WITH LIGHT

멸균 크로마토그래피 및 제조 공정

... 본원에서는, 감마선 조사 크로마토그래피 수지로 크로마토그래피를 수행하는 방법으로서, 감마선 조사 크로마토그래피 수지를 포함하는 크로마토그래피 컬럼을 제공하는 단계; 컬럼을 통해 크로마토그래피의 제1 사이클을 수행하되, 이 사이클은 크로마토그래피 수지를 변성 완충액에 노출시키는 단계를 포함하는 단계; 및 컬럼을 통해 크로마토그래피의 적어도 하나의 추가 사이클을 수행하는 단계를 포함하는, 방법이 제공된다. 또한, 재조합 단백질의 제조를 위한 통합형, 닫힌 또는 실질적으로 닫힌, 연속 공정으로서, 감마선 조사 크로마토그래피 수지를 포함하는 적어도 하나의 크로마토그래피 컬럼의 사용을 포함하되, 감마선 조사 크로마토그래피 수지는 공정의 각 사이클 동안 변성 완충액에 노출되고, 저감된 바이오버든 완충액이 공정에 사용되는, 공정이 제공된다.

TERMINAL STERILIZATION OF PREFILLED CONTAINERS

A method for inhibiting adverse reaction of the contents of a prefilled container during a radiation sterilization procedure is disclosed. In the method, a container which is made of a material including a radiation stable polyolefin is prefilled with a medium prior to being subjected to a gamma irradiation sterilization treatment. By using a radiation stable polyolefin material as the container, such as a polyolefin with a radiation stabilizer additive, and by prefilling the container prior to the gamma irradiation treatment, the container can be effectively sterilized without adversely affecting its contents. © KIPO & WIPO 2007 ...

METHOD FOR STERILISING AND STERILISING DEVICE

Sterilized cyanoacrylate adhesive composition and a method of making such a composition

Processo para a esterilização e/ou redução de germes de materiais de moldagem

STAND-ALONE FILM AND METHODS FOR MAKING THE SAME

A stand-alone film is derived at least in part from fatty acids. The stand-alone film can have anti-adhesive, anti-inflammatory, non-inflammatory, and wound healing properties, and can additionally include one or more therapeutic agents incorporated therein. Corresponding methods of making the stand-alone film include molding, casting, or otherwise applying a liquid or gel to a substrate, and curing or otherwise treating to form the stand-alone film. The resulting stand-alone film is bioabsorbable.

SYSTEMS AND METHODS FOR DISINFECTION

Methods and systems for establishing Taylor-Couette flow in a fluid are provided. Aspects of the disclosed methods and systems incorporate Taylor-Couette flow in combination with a source of radiation (220) to provide more uniform radiation exposure to the fluid and its components. Common problems of non-uniform radiation levels and concentration boundary layer effects in UV reactors are largely eliminated using the methods and devices provided herein.

STERILE CHROMATOGRAPHY RESIN AND USE THEREOF IN MANUFACTURING PROCESSES

Provided herein are methods of reducing bioburden of a chromatography resin that include exposing a container including a composition including (i) a chromatography resin and (ii) a liquid including at least on alcohol to a dose of gamma-irradiation sufficient to reduce the bioburden of the container and the chromatography resin, where the at least one alcohol are present in an amount sufficient to ameliorate the loss of binding capacity of the chromatography resin after/upon exposure to the dose of gamma-irradiation. Also provided are reduced bioburden chromatography columns including the reduced bioburden chromatography resin, compositions including a chromatography resin and a liquid including at least one alcohol, methods of performing reduced bioburden column chromatography using one of these reduced bioburden chromatography columns, and integrated, closed, and continuous processes for reduced bioburden manufacturing of a purified recombinant protein. 1. A method of reducing bioburden of a chromatography resin comprising: exposing a container comprising a composition comprising (i) a chromatography resin and (i) a liquid comprising at least one alcohol , to a dose of gamma-irradiation sufficient to reduce the bioburden of the container and the chromatography resin , wherein the at least one alcohol is present in an amount sufficient to ameliorate the loss of binding capacity of the chromatography resin after exposure to the dose of gamma-irradiation.2. (canceled)3. The method of claim 1 , wherein the container is a storage vessel.4. The method of claim 1 , wherein the container is a chromatography column.5. The method of claim 1 , wherein the container is a packed chromatography column.6. The method of claim 1 , wherein the composition is a slurry of sedimented chromatography resin.7. (canceled)8. The method of claim 1 , wherein the at least one alcohol is selected from the group of: benzyl alcohol claim 1 , cyclohexanol claim 1 , isobutyl alcohol claim 1 , 2- ...

Method for sterilizing impression materials and impression material that can be sterilized

A method for sterilizing medical single-component or multi-component impression materials that can harden, and a two-component impression material. In a first step of the method, the components of the impression materials that have not hardened are introduced into a primary packaging. In a second step, the primary packagings, with the components contained therein, are sterilized by heat sterilization. In a third step, the sterilized components in the primary packagings are introduced into a secondary packaging. In a fourth step, this secondary packaging is sterilized by means of a suitable gas sterilization, irradiation sterilization, and/or by means of sterilization in an autoclave, so that the activity and the viscosity of the components are not changed.

Stand-alone film and methods for making the same

A stand-alone film is derived at least in part from fatty acids. The stand-alone film can have anti-adhesive, anti-inflammatory, non-inflammatory, and wound healing properties, and can additionally include one or more therapeutic agents incorporated therein. Corresponding methods of making the stand-alone film include molding, casting, or otherwise applying a liquid or gel to a substrate, and curing or otherwise treating to form the stand-alone film. The resulting stand-alone film is bioabsorbable.

Non-oxidizing polymeric medical implant

A medical implant made of polymeric material having an increased oxidation resistance is formed by a method including the steps of placing a resin powder in a sealed container. A substantial portion of the oxygen is removed from the sealed container by either a vacuum, an oxygen absorbent or by flushing with inert gas. The container is then repressurized with a gas such as nitrogen, argon, helium or neon so that long term storage may be possible. On use, the resin is transferred to a forming device which both melts and forms the resin in an oxygen reduced atmosphere to produce a polymeric raw material such as a rod or bar stock. The medical implant is then formed from this raw material annealed and sealed in an airtight package in an oxygen reduced atmosphere. The implant is then radiation sterilized and thereafter annealed in the package for a predetermined time and temperature sufficient to form cross-links between any free radicals in neighboring polymeric chains.

Method for producing articles consisting of polymer materials having a medicamentous depot effect

The process for the preparation of articles from polymer materials having a medicamentous depot effect is performed by mixing the starting materials, shaping the mixture, cross-linking the polymer material at least until a sufficient dimensional stability is reached, performing all the necessary processing work, introducing the article into a protective package, sterilizing the packaged article, optionally with further cross-linking of the polymer material.

Body fluid drainage device and method

Method for sterilizing a body fluid drainage system for handling a body fluid ex vivo. The body fluid drainage system comprises a chamber. The method comprises the steps providing a container containing a surface protective fluid to be released into the chamber of the body fluid drainage system, subjecting the container to radiation sterilization, inserting the container into the chamber of the body fluid drainage system, and subjecting the chamber containing the container to gas sterilization. A body fluid drainage system for handling a body fluid ex vivo. The body fluid drainage system comprises a chamber. The body fluid drainage system further comprises a container containing a surface protective fluid. The container is arranged to release the surface protective fluid into the chamber. The surface protective fluid is sterilized by radiation sterilization. An outer surface of the container and at least the chamber of the body fluid drainage system is sterilized by gas sterilization.

Compact self-shielded irradiation system and method

An accelerator provides radiant energy in a first direction A carousel and first and second members have a common axis in the first direction. The carousel, preferably cylindrical, has a ring-shaped configuration defined by inner and outer diameters. The first member has an outer diameter preferably contiguous to the carousel inner diameter. The second member has an inner diameter preferably contiguous to the carousel outer diameter. The first and second members provide shielding against the radiant energy from the accelerator. A single motor (e.g., stepping motor) rotates the carousel past the radiant energy continuously at a substantially constant speed in successive revolutions. Vanes made from a shielding material are disposed at spaced positions in the carousel to divide the carousel into compartments for receiving the articles and to isolate each compartment from the radiant energy in other compartments. A loader loads the articles into compartments before the movement of the articles ...

Method of sterilization

A sterilized chemical composition is stored in a sterile environment for a prolonged period of time, hermetically sealed in successive enclosures and a shipping enclosure. The third sealing layer is removed prior to entering a storage area. The second layer is removed prior to taking the container to the sterile environment. The storage area may also be sterile. The innermost container may be an aerosol container and the composition a disinfectant liquid such as alcohol. The entire shipping enclosure and contects is preferably sterilized with gamma radiation.

Method for sterilizing impression materials and impression material that can be sterilized

A method for sterilizing medical single-component or multi-component impression materials that can harden, and a two-component impression material. In a first step of the method, the components of the impression materials that have not hardened are introduced into a primary packaging. In a second step, the primary packagings, with the components contained therein, are sterilized by heat sterilization. In a third step, the sterilized components in the primary packagings are introduced into a secondary packaging. In a fourth step, this secondary packaging is sterilized by means of a suitable gas sterilization, irradiation sterilization, and/or by means of sterilization in an autoclave, so that the activity and the viscosity of the components are not changed.

Меthоd fоr stеrilizing imprеssiоn mаtеriаls аnd imprеssiоn mаtеriаl thаt саn bе stеrilizеd

А mеthоd fоr stеrilizing mеdiсаl singlе-соmpоnеnt оr multi-соmpоnеnt imprеssiоn mаtеriаls thаt саn hаrdеn, аnd а twо-соmpоnеnt imprеssiоn mаtеriаl. In а first stеp оf thе mеthоd, thе соmpоnеnts оf thе imprеssiоn mаtеriаls thаt hаvе nоt hаrdеnеd аrе intrоduсеd intо а primаrу pасkаging. In а sесоnd stеp, thе primаrу pасkаgings, with thе соmpоnеnts соntаinеd thеrеin, аrе stеrilizеd bу hеаt stеrilizаtiоn. In а third stеp, thе stеrilizеd соmpоnеnts in thе primаrу pасkаgings аrе intrоduсеd intо а sесоndаrу pасkаging. In а fоurth stеp, this sесоndаrу pасkаging is stеrilizеd bу mеаns оf а suitаblе gаs stеrilizаtiоn, irrаdiаtiоn stеrilizаtiоn, аnd/оr bу mеаns оf stеrilizаtiоn in аn аutосlаvе, sо thаt thе асtivitу аnd thе visсоsitу оf thе соmpоnеnts аrе nоt сhаngеd.

Меthоd fоr stеrilizing imprеssiоn mаtеriаls аnd imprеssiоn mаtеriаl thаt саn bе stеrilizеd

А mеthоd fоr stеrilizing mеdiсаl singlе-соmpоnеnt оr multi-соmpоnеnt imprеssiоn mаtеriаls thаt саn hаrdеn, аnd а twо-соmpоnеnt imprеssiоn mаtеriаl. In а first stеp оf thе mеthоd, thе соmpоnеnts оf thе imprеssiоn mаtеriаls thаt hаvе nоt hаrdеnеd аrе intrоduсеd intо а primаrу pасkаging. In а sесоnd stеp, thе primаrу pасkаgings, with thе соmpоnеnts соntаinеd thеrеin, аrе stеrilizеd bу hеаt stеrilizаtiоn. In а third stеp, thе stеrilizеd соmpоnеnts in thе primаrу pасkаgings аrе intrоduсеd intо а sесоndаrу pасkаging. In а fоurth stеp, this sесоndаrу pасkаging is stеrilizеd bу mеаns оf а suitаblе gаs stеrilizаtiоn, irrаdiаtiоn stеrilizаtiоn, аnd/оr bу mеаns оf stеrilizаtiоn in аn аutосlаvе, sо thаt thе асtivitу аnd thе visсоsitу оf thе соmpоnеnts аrе nоt сhаngеd.

Меthоd fоr stеrilizing imprеssiоn mаtеriаls аnd imprеssiоn mаtеriаl thаt саn bе stеrilizеd

А mеthоd fоr stеrilizing mеdiсаl singlе-соmpоnеnt оr multi-соmpоnеnt imprеssiоn mаtеriаls thаt саn hаrdеn, аnd а twо-соmpоnеnt imprеssiоn mаtеriаl. In а first stеp оf thе mеthоd, thе соmpоnеnts оf thе imprеssiоn mаtеriаls thаt hаvе nоt hаrdеnеd аrе intrоduсеd intо а primаrу pасkаging. In а sесоnd stеp, thе primаrу pасkаgings, with thе соmpоnеnts соntаinеd thеrеin, аrе stеrilizеd bу hеаt stеrilizаtiоn. In а third stеp, thе stеrilizеd соmpоnеnts in thе primаrу pасkаgings аrе intrоduсеd intо а sесоndаrу pасkаging. In а fоurth stеp, this sесоndаrу pасkаging is stеrilizеd bу mеаns оf а suitаblе gаs stеrilizаtiоn, irrаdiаtiоn stеrilizаtiоn, аnd/оr bу mеаns оf stеrilizаtiоn in аn аutосlаvе, sо thаt thе асtivitу аnd thе visсоsitу оf thе соmpоnеnts аrе nоt сhаngеd.

Меthоd fоr stеrilizing imprеssiоn mаtеriаls аnd imprеssiоn mаtеriаl thаt саn bе stеrilizеd

А mеthоd fоr stеrilizing mеdiсаl singlе-соmpоnеnt оr multi-соmpоnеnt imprеssiоn mаtеriаls thаt саn hаrdеn, аnd а twо-соmpоnеnt imprеssiоn mаtеriаl. In а first stеp оf thе mеthоd, thе соmpоnеnts оf thе imprеssiоn mаtеriаls thаt hаvе nоt hаrdеnеd аrе intrоduсеd intо а primаrу pасkаging. In а sесоnd stеp, thе primаrу pасkаgings, with thе соmpоnеnts соntаinеd thеrеin, аrе stеrilizеd bу hеаt stеrilizаtiоn. In а third stеp, thе stеrilizеd соmpоnеnts in thе primаrу pасkаgings аrе intrоduсеd intо а sесоndаrу pасkаging. In а fоurth stеp, this sесоndаrу pасkаging is stеrilizеd bу mеаns оf а suitаblе gаs stеrilizаtiоn, irrаdiаtiоn stеrilizаtiоn, аnd/оr bу mеаns оf stеrilizаtiоn in аn аutосlаvе, sо thаt thе асtivitу аnd thе visсоsitу оf thе соmpоnеnts аrе nоt сhаngеd.

METHOD OF REMOVING ABNORMAL PRION FROM BLOOD PREPARATION

Provided are a method of conveniently and efficiently removing abnormal prion protein from a blood product and a method of removing leukocyte simultaneously with abnormal prion protein. The method of removing an abnormal prion protein from a blood product includes filtering the blood product through a filter filled with a carrier coated with a polymer, which is composed of three units including 20 mol% or more and 40 mol% or less of a unit originating from a hydrophobic polymerizable monomer, 5 mol% or more and 13 mol% or less of a unit originating from a polymerizable monomer containing a basic nitrogen-containing part, and a unit originating from a polymerizable monomer containing a protonic neutral hydrophilic part as the balance, and then recovering the filtered blood product.

Ampoule with seal in two compression states

Use of gamma hardened RFID tags in pharmaceutical devices

MULTI-LAYERED PLASTIC POLYMERIC CONTAINER FOR THE STORAGE OF PHARMACEUTICAL COMPOSITIONS

TEMPERATURE HARDENED PHARMACEUTICAL DEVICES WITH SOI

METHOD FOR STERILIZING A FILM CONTAINER

ДРЕНАЖНОЕ УСТРОЙСТВО ДЛЯ БИОЛОГИЧЕСКИХ ЖИДКОСТЕЙ И СПОСОБ ЕГО СТЕРИЛИЗАЦИИ

Группа изобретений относится к области стерилизации медицинских изделий. Раскрыт способ стерилизации дренажной системы для биологических жидкостей для обработки биологической жидкости ex vivo, согласно которому подвергают контейнер стерилизации облучением; вставляют контейнер в камеру дренажной системы для биологических жидкостей; и подвергают камеру, содержащую контейнер, стерилизации газом. При этом дренажная система для биологических жидкостей содержит камеру и контейнер, содержащий защищающую поверхность жидкость, выпускаемую в камеру дренажной системы для биологических жидкостей, причем защищающая поверхность жидкость прилипает к поверхности камеры и предотвращает контакт других жидкостей с поверхностью. Также раскрывается вариант способа стерилизации дренажной системы для биологических жидкостей для обработки биологической жидкости ex vivo. Группа изобретений обеспечивает стерилизацию дренажной системы, которая может храниться в течение длительного времени. Раскрытые способы дают ...

ВОЛОКНИСТЫЕ МАТЕРИАЛЫ И КОМПОЗИЦИИ

... 1. Способ получения топлива, при этом способ включает ! резку источника волокна для получения первого волокнистого материала; ! пропускание первого волокнистого материала через первое сито, имеющее средний размер отверстия, равный приблизительно 1,59 мм и менее (1/16 дюйма, 0,0625 дюйма), для получения второго волокнистого материала; и ! объединение второго волокнистого материала с бактерией и/или ферментом, при этом бактерия и/или фермент используют второй волокнистый материал для получения топлива, включающего водород, спирт, органическую кислоту и/или углеводород. ! 2. Способ по п.1, где спирт выбирают из группы, состоящей из метанола, этанола, пропанола, изопропанола, бутанола, этиленгликоля, пропиленгликоля, 1,4-бутандиола, глицерина и их смесей. ! 3. Способ по п.1, где органическую кислоту выбирают из группы, состоящей из муравьиной кислоты, уксусной кислоты, пропионовой кислоты, масляной кислоты, валериановой кислоты, капроновой, пальмитиновой кислоты, стеариновой кислоты, щавелевой ...

СМАЧИВАЮЩИЕ СРЕДЫ С НИЗКОМОЛЕКУЛЯРНЫМ МНОГОАТОМНЫМ СПИРТОМ И БУФЕРОМ

... 1. Медицинское устройство, содержащее гидрофильное покрытие, стерилизованное при контакте со средой для набухания, включающей:а) низкомолекулярный многоатомный спирт; иб) отдельный буфер, выбранный из группы, состоящей из карбоновых кислот, аминокислот, аминосульфоновых и неорганических кислот.2. Медицинское устройство по п.1, где медицинским устройством является катетер с гидрофильным покрытием.3. Медицинское устройство по любому из пп.1 или 2, где гидрофильным покрытием является PVP-покрытие.4. Медицинское устройство по любому из пп.1 или 2, стерилизованное с применением облучения.5. Медицинское устройство по любому из пп.1 или 2, где низкомолекулярный многоатомный спирт имеет молекулярную массу ниже 200 г/моль.6. Медицинское устройство по любому из пп.1 или 2, где низкомолекулярный многоатомный спирт присутствует в среде для набухания в концентрации от 0,1% до 20%.7. Медицинское устройство по любому из пп.1 или 2, где низкомолекулярным многоатомный спиртом является глицерин.8. Медицинское ...

Strahlungssterilisierte medizinische Materialien und deren Verwendung

Verfahren zur Validierung einer Bestrahlungsanlage

Verfahren zur Validierung einer Bestrahlungsanlage, die zur Bestrahlung eines Präparats (3) eingerichtet ist, mit den Schritten:A) Bereitstellen einer Flüssigkeit (1), in der Leuchtstoffpartikel (2) suspendiert sind,B) Bestrahlen der Flüssigkeit (1) mit einer hochenergetischen Strahlung (R) mit einer Strahlendosis, wodurch ein spektrales und/oder zeitliches Fotolumineszenzverhalten der Leuchtstoffpartikel (2) verändert wird, wobei es sich bei der hochenergetischen Strahlung (R) um Gammastrahlung oder um Elektronenstrahlung handelt und die hochenergetische Strahlung eine Energie von mindestens 10 keV aufweist,C) Anregen der bestrahlten Leuchtstoffpartikel (2) zur Fotolumineszenz mit einer niederenergetischen Strahlung (E) und spektrales und/oder zeitliches Ausmessen der Fotolumineszenz (L), undD) Auswerten des Ausmessens der Fotolumineszenz, wodurch die Strahlendosis bestimmt wird, wobei die Fotolumineszenz der Leuchtstoffpartikel (2) im Schritt D) hinsichtlich der Bestrahlung im Schritt ...

Spray dispenser

Irradiation apparatus for production line use

NOT OXIDIZING, MEDICAL POLYMER IMPLANT

PROCEDURE FOR THE REMOVAL OF NANO-BACTERIA

RADIATION-STERILIZED MEDICAL MATERIALS AND THEIR USE

USE OF GAMMAHARDENED RFID LABELS IN PHARMACY

CARRIER AND SUPPORTING MECHANISM FOR WORKPIECES

IN RELATION TO IONIZING RADIATION STABLE ONE POLYARYLESTERCARBONATZUSAMMENSETZUNGEN

CONNECTING DEVICE AND PROCEDURE FOR THE CLUTCH FROM BIOLOGICAL DEVICES TO A SOURCE

LOW EXTRACT-CASH THERMOPLASTIC SYRINGE AND END CAP

COMPACT, SELFSHIELDED IRRADIATION SYSTEM AND PROCEDURE

POLYOLEFINS COMPOSITIONS.

VERY LOW-TEMPERATURE DRUCKSTABILISATION OF IMPLANTKOMPONENTEN

WITH GAMMA RADIATION STERILIZE-CASH ACRYLIC POLYMER

Sterilizable wireless communication devices

Disclosed are devices and methods sterilization wireless communication devices. The devices and methods described involve a sterilizable wireless communication device including a communication module. The communication module includes a transceiver capable of direct wireless communication. The sterilizable wireless communication device further includes a housing having an interior sized to contain the communication module. The communication module is hermetically sealed within the housing and the housing includes a hermetic radio frequency feedthrough configured to couple to an antenna that is external to the housing.

Gamma-irradiation sterilized polyethylene packaging

Pouch cleaning assembly for an aseptic filler

A pouch cleaning assembly that includes a treatment chamber and a guide assembly. The treatment chamber includes an elongated central channel extending therethrough. The guide assembly having a first side guide bar and a second side guide bar. The guide bars defining a channel therebetween that is structurally configured to facilitate the retention of spouts of a plurality of pouches in slidable engagement along the first and second guide bar. Any abutment of adjacent portions of the plurality of pouches within the treatment chamber define relative points of contact. The channel is positioned within the elongated central channel, wherein the channel is undulating in at least one of a vertical and a horizontal direction along the length thereof sufficient so as to substantially expose the relative points of contact between adjacent ones of the plurality of spouts so as to expose the same to the cleaning preparation.

Method for sterilizing a substrate having a hydrophilic coating and sterilized substrates

Methods for sterilizing a substrate with radiation and radiation sterilized substrates.

Regenerative materials

Methods of making tissue fillers are provided. In certain embodiments, the tissue is flake-like and has regenerative properties.

Method of removing abnormal prion from blood preparation

DRUG CARTRIDGE ASSEMBLY AND METHOD OF MANUFACTURE

A method of manufacture for a drug cartridge assembly. The method includes providing a drug cartridge, providing a nozzle sub-assembly, and sterilizing the drug cartridge and nozzle sub-assembly. The method further includes assembling the drug cartridge and nozzle sub-assembly together in a configuration that enables ejection of liquid out of the drug cartridge through the nozzle sub-assembly. The method further includes filling the drug cartridge with a liquid, such as an injectable drug. The method may include separate sterilization of the drug cartridge and nozzle sub-assembly, using different sterilization processes. Portions of the method may be performed prior to sterilization within a first cleanroom, with subsequent steps being performed in a second cleanroom having a substantially lower particulate-per- volume rating than the first cleanroom.

METHOD FOR VIRUS FILTRATION OF VON WILLEBRAND FACTOR

The present invention relates to a method of filtrating a solution comprising von Willebrand Factor (VWF), the method comprising (a) providing a solution comprising VWF and a basic amino acid; and (b) subjecting the solution of step (a) to a virus filtration through a filter having a pore size of less than or equal to 35 nm.

METHOD FOR VALIDATING A STERILISATION METHOD COMPRISING TWO SUCCESSIVE CONTAMINATIONS

L'invention concerne une méthode de validation d'un procédé de stérilisation d'un article, permettant de valider le niveau d'assurance de stérilité atteint avec ce procédé de stérilisation. La méthode selon l'invention est caractérisée en ce qu'elle consiste à réaliser une première étape de contamination d'un contenant recevant l'article par plus de 105cellules vivantes de micro-organisme, à réaliser ensuite un premier cycle de stérilisation avec le procédé retenu, à ouvrir ensuite le contenant pour le contaminer à nouveau par plus de 105cellules vivantes de micro-organisme, puis à réaliser un deuxième cycle de stérilisation avec le même procédé, et enfin à vérifier la stérilité du contenant après le premier cycle et après le deuxième cycle de stérilisation. La méthode selon l'invention est applicable notamment aux produits et dispositifs destinés à la santé.

Terpolymers as pressure-sensitive adhesives

Disclosed herein are terpolymers that can function as pressure-sensitive adhesives. The disclosed articles comprise the terpolymers adhered to a release liner. The disclosed implant devices comprise the pressure-sensitive adhesive terpolymer adhered to a surface thereof. The pressure-sensitive adhesive terpolymer can promote adhesion of the implant device to a location in a subject.

Collagen fiber constructs for replacing cruciate ligaments

The present invention relates to a collagen fiber construct composed of single collagen fibers, which is sterilized with alcohol and via irradiation and not populated with cells, wherein the single collagen fibers are isolated from collagen-containing tissue from mammals. The present invention also relates to a method for manufacturing a collagen fiber construct composed of single collagen fibers, which is sterilized with alcohol and via irradiation and is not populated with cells, wherein the single collagen fibers are isolated from collagen-containing tissue from rat tails. Finally, there is also described the use of the collagen fiber constructs as xenoimplants.

Radiation sterilization of medical devices

A method for medical device sterilization comprises staggering a stack of packages so that a back surface of each package partially overlaps a front surface of another of the packages. Each package contains a medical device. The stack of packages are positioned so that the front surfaces of the packages face toward a radiation source. The packages are then exposed to radiation.

STERILIZATION OF POLYMERIC MATERIALS

A method of sterilizing a polymeric material that is sensitive to radiation. The method includes the steps of applying at least one radiosensitizer to the polymeric material and irradiating the polymeric material with a suitable radiation at an effective dose and time to sterilize the polymeric material. Also disclosed is a method of enhancing the ability of a medical device to withstand sterilization by radiation and a bioabsorbable polymeric medical device. 1. A method of making a polymeric medical device , comprising:(a) providing a bioabsorbable polymer composition;(b) heating the bioabsorbable polymer composition to a melt processing temperature;(c) forming the medical device from the bioabsorbable polymer composition using a melt processing apparatus, the medical device having at least a first surface;(d) applying at least one radiosensitizer to the at least first surface of the polymeric medical device; and(e) sterilizing the medical device with ionizing radiation at a dose of between about 0.1 kGy and about 0.3 kGy;wherein the medical device is effective for its intended use following sterilization with radiation.2. The method of claim 1 , wherein the at least one radiosensitizer is selected from the group consisting of psoralen and its derivatives and analogs; inactines and their derivatives and analogs; angelicins; khellins; coumarins; nucleic acid binding compounds; brominated hematoporphyrin; phthalocyanines; purpurins; porphyrins; halogenated or metal atom-substituted derivatives of dihematoporphyrin esters claim 1 , hematoporphyrin derivatives claim 1 , benzoporphyrin derivatives claim 1 , hydrodibenzoporphyrin dimaleimade claim 1 , hydrodibenzoporphyrin claim 1 , dicyano disulfone claim 1 , tetracarbethoxy hydrodibenzoporphyrin claim 1 , and tetracarbethoxy hydrodibenzoporphyrin dipropionamide; doxorubicin; daunomycin; netropsin; BD peptide claim 1 , S2 peptide; S-303 (ALE compound); hypericin claim 1 , methylene blue claim 1 , toluidine blue claim 1 ...

Aqueous radiation protecting formulations and methods for making and using them

Medical devices are typically sterilized in processes used to manufacture such products and their sterilization by exposure to radiation is a common practice. Radiation has a number of advantages over other sterilization processes including a high penetrating ability, relatively low chemical reactivity, and instantaneous effects without the need to control temperature, pressure, vacuum, or humidity. Unfortunately, radiation sterilization can compromise the function of certain components of medical devices. For example, radiation sterilization can lead to loss of protein activity and/or lead to bleaching of various dye compounds. Embodiments of the invention provide methods and materials that can be used to protect medical devices from unwanted effects of radiation sterilization.

Devices and articles comprising up-converting sterilizing compositions and methods for using the same

There is disclosed various devices and articles comprising phosphors for converting electromagnetic energy to radiation having a shorter wavelength, the composition comprising at least one phosphor capable of converting an initial electromagnetic radiation having a wavelength (A) to an electromagnetic radiation having a shorter wavelength (B) comprising UV radiation or radiation of a shorter wavelength. There is also a method of sterilizing such devices and articles by exposing it to UV radiation or radiation of a shorter wavelength for a time sufficient to deactivate or kill at least one microorganism and/or for a time sufficient to inhibit abnormal cell growth within the body, when the composition is in an implantable medical device.

Calibrator For A Sensor

A calibrator, for calibrating a sensor, has a calibration chamber for containing a calibration liquid. The liquid comprises water or an aqueous solution of an analyte to be sensed. A hydrogen peroxide-quenching material is provided exposed to the interior of the calibration chamber. The hydrogen peroxide-quenching material contacts the calibration liquid. After the calibration chamber containing the calibration liquid is sterilized by irradiation with gamma radiation, the hydrogen peroxide-quenching material decomposes any hydrogen peroxide formed in the calibration liquid to avoid adverse effects on a sensor placed in contact with the calibration liquid. 1. A calibrator for calibrating a sensor , comprising:a calibration chamber for containing a calibration liquid, said liquid comprising water or an aqueous solution; and{'sub': 2', '2, 'an HO-quenching material, exposed to the interior of the calibration chamber, for contacting the calibration liquid.'}2. A calibrator according to claim 1 , wherein said HO-quenching material catalyzes decomposition of HO.3. A calibrator according to claim 1 , wherein said HO-quenching material is at least one of platinum claim 1 , a platinum-group element claim 1 , gold claim 1 , silver claim 1 , and an alloy of any of the preceding elements.4. A calibrator according to claim 1 , wherein said HO-quenching material comprises a surface layer within the calibration chamber.5. A calibrator according to claim 1 , further comprising a lead screw of a mechanism for changing the concentration of an analyte in the calibration liquid claim 1 , and wherein the HO-quenching material is a coating on the lead screw.6. A sensor kit comprising:a sensor for detecting an analyte, said sensor having a sensing region comprising a receptor for said analyte; and a calibration chamber for containing a calibration liquid, said liquid comprising water or an aqueous solution; and', 'an H2O2-quenching material, exposed to the interior of the calibration ...

Reactive Oxidative Species Generating Materials and Methods of Use

Materials capable of delivering stabilized free radicals to targeted treatment sites. The materials comprise semi-crystalline, hydrolytically degradable polymers that are subjected to ionizing radiation to create stabilized free radicals therein. Upon exposure to oxygen containing aqueous media, the materials generate reactive oxidative species which are useful in biological processes.

CHITOSAN-BASED HEMOSTATIC TEXTILE

A microfibrillar high molecular weight chitosan-based textile can be used as a hemostat. The chitosan has been treated in a nitrogen field by applying energy to ionize nitrogen in and around the chitosan textile. A single or multiple such treatments may be employed. For example, the chitosan textile may be irradiated under nitrogen using γ-irradiation, treated under a nitrogen plasma, or both. 116-. (canceled)17. A method of making a hemostatic device , comprising:irradiating a hemostatic device comprising endotoxin-containing chitosan in a dry condition under a nitrogen plasma in a presence of γ-irradiation, whereby an amount of endotoxins present in the device is reduced to less than 20 E.U. per device.18. The method of claim 17 , wherein irradiating is conducted at ambient temperature.19. The method of claim 17 , wherein the amount of endotoxins is measured by a Limulus Amoebocyte Lysate test.20. The method of claim 17 , wherein the amount of endotoxins is measured by a Limulus Amoebocyte Lysate test at 10 fold dilution.21. The method of claim 17 , wherein the amount of endotoxins is measured by a Limulus Amoebocyte Lysate test at 20 fold dilution.22. The method of claim 17 , wherein the irradiated hemostatic device has an amount of endotoxins of less than or equal to 9.77 E.U. per device at 10 fold dilution.23. The method of claim 17 , wherein the irradiated hemostatic device has a concentration of endotoxins of no greater than 9.6 E.U. per device at 20 fold dilution.24. The method of claim 17 , wherein after the irradiating the chitosan is not substantially reduced in molecular weight.25. The method of claim 17 , wherein the irradiating is conducted under γ-irradiation at 25 kGy for 15 hours.26. The method of claim 17 , wherein the nitrogen-based plasma consists essentially of nitrogen plasma.27. The method of claim 17 , wherein the nitrogen-based plasma consists of nitrogen plasma.28. The method of claim 17 , wherein the chitosan of the hemostatic device is in ...

Method and System for Transferring Separation Resin

A method and a system and a container system for transferring separation resin from at least one first container (′) to a second container (′), wherein said first container is a deformable, single-use separation resin storage container, said method comprising the steps of:—preparing (S1) the at least one first container by providing a deformable, single-use container comprising an outlet port (′) with a predefined volume of separation resin in a storage solution;—fluidizing (S3) the separation resin in the at least one first container to provide a resin slurry, said fluidizing being performed by mechanical interaction to the first container from an outside of the first container to provide a deformation of said first container;—fluidically connecting (S5) the outlet port (′) of the at least one first container to an inlet port () of the second container;—transferring (S7) separation resin from the at least one first container to the second container by generating a pressure difference between an interior of the second container and an interior of the first container where the pressure is lower in the second container. 1. A method for transferring separation resin from at least one first container to a second container , wherein said first container is a deformable , single-use separation resin storage container , said method comprising the steps of:preparing the at least one first container by providing a deformable, single-use container comprising an outlet port with a predefined volume of separation resin in a storage solution;fluidizing the separation resin in the at least one first container to provide a resin slurry, said fluidizing being performed by mechanical interaction to the first container from an outside of the first container to provide a deformation of said first container;fluidically connecting the outlet port of the at least one first container to an inlet port of the second container;transferring separation resin from the at least one first ...

OXIDATION-RESISTANT AND WEAR-RESISTANT POLYETHYLENES FOR HUMAN JOINT REPLACEMENTS AND METHODS FOR MAKING THEM

The present invention presents methods for making oxidation-resistant and wear-resistant polyethylenes and medical implants made therefrom. Preferably, the implants are components of prosthetic joints, e.g., a bearing component of an artificial hip or knee joint. The resulting oxidation-resistant and wear-resistant polyethylenes and implants are also disclosed. 1. (canceled)2. A method for producing a wear-resistant and oxidation-resistant medical implant for a joint prosthesis comprising:providing an oxidation-resistant orthopaedic material comprising a polyethylene;forming the orthopaedic material into an implant for the joint prosthesis;packaging the orthopaedic material after being formed into the implant;sterilizing the orthopaedic material while packaged; andirradiating the orthopaedic material during the method at a total radiation dose of above 5 Mrad to about 25 Mrad so as to crosslink the orthopaedic material, thereby improving its wear resistance, without thermally treating the orthopaedic material to extinguish free radicals in the orthopaedic material during or subsequent to irradiating the orthopaedic material, wherein the orthopaedic material contains an antioxidant rendering it resistant to oxidation caused by free radicals generated by the irradiation.3. The method of claim 2 , wherein the irradiated orthopaedic material possesses a degree of swelling of between about 1.7 to about 3.6.4. The method of claim 2 , wherein the irradiated orthopaedic material possesses a molecular weight between crosslinks of between about 400 to about 3 claim 2 ,500 g/mol.5. The method of claim 2 , wherein the irradiated orthopaedic material possesses a gel content of between about 95% to about 99%.6. The method of claim 2 , wherein the irradiated orthopaedic material possesses a degree of swelling of between about 1.7 to about 3.6 claim 2 , and a molecular weight between crosslinks of between about 400 to about 3 claim 2 ,500 g/mol.7. The method of claim 2 , wherein ...

BARRIER LAYER

A barrier layer and corresponding method of making provide anti-inflammatory, non-inflammatory, and anti-adhesion functionality for a medical device implantable in a patient. The barrier layer can be combined with a medical device structure to provide anti-adhesion characteristics, in addition to improved healing, non-inflammatory, and anti-inflammatory response. The barrier layer is generally formed of a naturally occurring oil, or an oil composition formed in part of a naturally occurring oil, that is at least partially cured forming a cross-linked gel. In addition, the oil composition can include a therapeutic agent component, such as a drug or other bioactive agent. 145-. (canceled)46. A method of making a barrier layer device , the method comprising the steps of:providing a medical device structure; andcreating a barrier layer formed on at least a portion of the medical device structure; wherein the barrier layer is formed of a biological oil or oil composition comprising a cured fish oil, wherein the cured fish oil comprises fatty acids and glycerides, wherein two or more of the fatty acids are cross-linked to each other by ester bonds in a substantially random configuration, wherein the barrier layer is solid but flexible and serves as a physical barrier, and wherein the barrier layer degrades into non-inflammatory substances.47. The method of claim 46 , wherein creating the barrier layer comprises:providing a biological oil or oil composition;applying the oil or oil composition to the medical device structure; andcuring the oil or oil composition on the medical device structure to form the barrier layer.48. The method of claim 47 , further comprising partially curing the biological oil or oil composition prior to applying the oil or oil composition to the medical device structure to thicken the oil or oil composition.49. The method of claim 46 , further comprising applying the oil or oil composition using multiple tiers.50. The method of claim 46 , further ...

Oil-in-Oil emulsified polymeric implants containing a hypotensive lipid and related methods

Biocompatible intraocular implants, such as microparticles, include a prostamide component and a biodegradable polymer that is effective in facilitating release of the prostamide component into an eye for an extended period of time. The prostamide component may be associated with a biodegradable polymer matrix, such as a matrix of a two biodegradable polymers. Or, the prostamide component may be encapsulated by the polymeric component. The present implants include oil-in-oil emulsified implants or microparticles. Methods of producing the present implants are also described. The implants may be placed in an eye to treat or reduce a at least one symptom of an ocular condition, such as glaucoma. 1. An intraocular implant comprising therapeutic polymeric microparticles , the microparticles made by the steps of:encapsulating a prostaglandin analog with a polymeric component to form a population of prostaglandin analog encapsulated microparticles by an oil-in-oil emulsion process, wherein the prostaglandin analog-encapsulated microparticles have an effective average particle size of less than about 3000 nanometers.2. The implant of claim 1 , wherein the oil-in-oil emulsion process comprises forming an oil-in-oil emulsion containing the prostaglandin analog and the polymeric component; drying the emulsion to form a dried emulsion product; contacting the dried emulsion product with a solvent to form a solvent-containing composition; and removing the solvent from the solvent-containing composition to form the population of microparticles comprising the prostaglandin analog and the polymeric component.38.-. (canceled)9. The implant of claim 1 , wherein the prostaglandin analog of the microparticles so produced is encapsulated by the polymeric component to preserve therapeutic activity of the prostaglandin analog after a terminal sterilization procedure.10. The implant of claim 1 , wherein the polymeric component comprises a biodegradable polymer or biodegradable copolymer.11. ...

DISPOSABLE CONTAINER FOR SMALL PARTS IN THE PHARMACEUTICAL INDUSTRY

A container for filling, processing, transporting, storing, transferring, etc., of small parts for the pharmaceutical industry consists of a preformed, flexible container which has a predefined spatial shape and the form of which is changed by larger pressures due to its flexibility such that it may support enough pressure (e.g. 50-500 mbar) over a larger period (e.g. 1 year) in order to ensure the integrity of the content. 1. A container for filling , handling , transporting , storing , transferring , etc. , of small parts for the pharmaceutical industry , characterized by a preformed , flexible container which has a predefined spatial form and the form of which is changed by larger pressures due to its flexibility such that it may support enough pressure (e.g. 50-500 mbar) over a larger period (e.g. 1 year) in order to ensure the integrity of the content.2. The container according to claim 1 , characterized in that the volume of such a container ranges from a few liters (e.g. 1 liter) up to sizes which can take a complete batch (e.g. 500 liters).3. The container according to claim 1 , characterized in that the volume of such a container is sufficient to be able to receive several batches of small parts.4. The container according to claim 1 , characterized in that the container is provided with a transfer system in order to be coupled to a filling machine.5. The container according to claim 1 , characterized in that the container is sterilized with gamma rays and then filled by means of a transfer system and exposed to an overpressure.6. The container according to claim 1 , characterized in that the container is cleaned claim 1 , sterilized claim 1 , dried claim 1 , filled claim 1 , etc. claim 1 , as a whole in a processing plant.7. The container according to claim 1 , characterized in that the container receives an ascension pipe for processing media in the event of processing within a processing plant or is permanently installed within it claim 1 , through which ...

Method for Obtaining Sterile Human Amniotic Fluid and Uses Thereof

Provided herein is a method for sterilely filtering amniotic fluid from selected caesarean sections of an individual. The amniotic fluid is first centrifuged at 5,000 to 10,000 rpm for 30 to 60 minutes and filtered through filters with about 5 to about 10 μm pore size. Next, the fluid is sequentially filtered through a series of membrane filters with the pore sizes 1 μm and 0.45 or/and 0.2 μm. The filtrate is then aseptically transferred to and sealed in syringes or vials. The fluid is subsequently lyophilized to obtain the lyophilisate of amniotic fluid. Amniotic fluid is reconstituted by adding sterile water to the lyophilisate, and the reconstituted fluid is used for wound healing, cosmetic, orthopedic or ophthalmic applications, particularly for the treatment of dry eyes. 1. A method for obtaining sterilely filtered human amniotic fluid , devoid of cells , comprising the steps of:obtaining sterile human amniotic fluid from a woman;removing cells, large particles and other undissolvables from said human amniotic fluid to obtain clarified amniotic fluid;filtering said clarified amniotic fluid through filters with a pore size of about 5 to 10 μm to obtain a micron filtrate;filtering said micron filtrate through filters with a pore size of about 1.0 μm to obtain a second filtrate; andfiltering said micron filtrate through submicron filters with a pore size of 0.45 μm or 0.2 μm or a combination of said filters to obtain the sterilely filtered amniotic fluid.2. The method of claim 1 , wherein said woman is undergoing a pre-caesarian surgical method claim 1 , said step of obtaining the sterile human amniotic fluid comprising the steps of:using an ultrasound device to provide guidance for the process of obtaining human fluid from said woman;inserting a blunt tip needle into the amniotic sac of said individual;attaching said blunt tip needle to a three-way stopcock;connecting a Luer lock syringe to said three-way stopcock;connecting a first end of a length of sterile ...

Reusable respiratory protection device

A reusable respirator including a mask adapted for covering and conforming to the face around the nose and a mouth of a user, a strap configured to secure the mask to a face of the user, and a filter component. All components of the respirator are capable of being cleaned, disinfected and sterilized at temperatures in excess of 50° C. An outer surface of the mask is substantially smooth and wettable for easily disinfecting and is shaped with a pair of outer shield portions for housing particulate air filters. The outer shield portions each include a closeable vent through the outer surface that is adapted to provide a user seal check and direct air flow through the outer surface for filtering by the respective particulate air filter, which is adapted to filter at least 95% of airborne particles.

System for spent nuclear fuel storage

The system for storage includes spent nuclear fuel arranged in a drift and at least one first mechanical structure configured to cause a target material to move in the drift. The at least one first mechanical structure is configured to at least assist in actively controlling an exposure rate of the target material to the spent nuclear fuel while the target material is being exposed to the spent nuclear fuel. The system includes at least one second mechanical structure configured to remove the target material from the drift after the target material is exposed to the spent nuclear fuel.

METHOD OF DECONTAMINATING A HYDROCARBON FLUID USING GAMMA RADIATION

In an aspect, a method of decontaminating a hydrocarbon fluid comprises irradiating the hydrocarbon fluid in a storage tank with a gamma radiation to maintain or reduce an amount of a microorganism in the storage tank; wherein a source of the gamma radiation is located within and/or proximal to the storage tank. In another aspect, a method of reducing an amount of a biocorrosion comprises irradiating the biocorrosion located on a surface of a device in contact with a hydrocarbon fluid with a gamma radiation; wherein a source of the gamma radiation is located within and/or proximal to the device. 1. A method of decontaminating a hydrocarbon fluid comprising:irradiating the hydrocarbon fluid in a storage tank with a gamma radiation to maintain or reduce an amount of a microorganism in the storage tank;wherein a source of the gamma radiation is located within and/or proximal to the storage tank.2. The method of claim 1 , further comprising mixing the hydrocarbon fluid in the storage tank.3. The method of claim 1 , wherein the irradiating comprises irradiating an inner surface of the storage tank to reduce the amount of biocorrosion on the inner surface or to prevent the biocorrosion from forming on the inner surface.4. The method of claim 1 , wherein the irradiating comprises irradiating a head space of the storage tank to reduce the amount of biocorrosion in the head space or to prevent the biocorrosion in the head space.5. The method of claim 1 , wherein at least 10 volume percent of the storage tank is located underground.6. The method of claim 5 , wherein 100 volume percent of the storage tank is located underground such that the gamma radiation does not reach a ground-level surface.7. The method of claim 1 , wherein the storage tank has an inner volume of greater than or equal to 20 meters cubed; and/or wherein the storage tank can hold 55 to 160 claim 1 ,000 liters of the hydrocarbon fluid.8. The method of claim 1 , wherein the storage tank comprises at least one ...

Medical apparatus and method for sterilizing medical apparatus

According to the invention, there is provided a medical apparatus including: one or more sterile pre-filled syringe; one or more first protective container including the one or more sterile prefilled syringe, wherein the one or more first protective container is impermeable to moisture and/or sterilizing agents; a second protective container including one or more medical components and the one or more first protective container; and a package impermeable to bacteria including the second protective container.

Dry Haemostatic Composition

Disclosed is a dry composition, which upon addition of an aqueous medium forms a substantially homogenous paste suitable for use in haemostasis procedures. The paste forms spontaneously upon addition of the liquid, hence no mechanical mixing is required for said paste to form. Further disclosed are methods of preparing said dry composition, a paste made from said dry composition and use of said paste for medical and surgical purposes. 2. The method according to claim 1 , wherein the paste prior to drying comprises from 3% w/w to 20% w/w of one or more polyols.3. The method according to claim 1 , wherein the biocompatible polymer is gelatine.4. The method according to claim 3 , wherein the gelatine is obtained from a cross-linked gelatine sponge.5. The method according to claim 1 , wherein the paste prior to freeze-drying comprises:a) from 5% w/w to 20% w/w of one or more polyols;b) from 15% w/w to 25% w/w of biocompatible polymer; andc) from 60% w/w to 80% w/w of water.6. The method according to claim 1 , wherein the dry composition comprises less than 5% w/w of water.7. The method according to claim 1 , wherein the one or more polyols is selected from sugar alcohols and sugars.8. The method according to claim 7 , wherein the one or more sugar alcohols is selected from glycol claim 7 , glycerol claim 7 , erythritol claim 7 , threitol claim 7 , arabitol claim 7 , xylitol claim 7 , ribitol claim 7 , mannitol claim 7 , sorbitol claim 7 , dulcitol claim 7 , fucitol claim 7 , iditol claim 7 , inositol claim 7 , volemitol claim 7 , isomalt claim 7 , maltitol claim 7 , lactitol or polyglycitol.9. The method according to claim 1 , wherein the one or more polyols is mannitol.10. The method according to claim 9 , where the dry composition comprises one or more further polyols.11. The method according to claim 1 , wherein the dry composition further comprises one or more bioactive agents that stimulate haemostasis or wound claim 1 , bone claim 1 , tendon and/or tissue healing. ...

Irradiation of Red Blood Cells and Anaerobic Storage

A blood storage system comprising: a collection vessel for red blood cells; an oxygen or oxygen and carbon dioxide depletion device; a storage vessel for red blood cells; tubing connecting the collection vessel to the oxygen or oxygen and carbon dioxide depletion device and the oxygen or oxygen and carbon dioxide depletion device to the storage vessel; and a gamma or X-ray irradiating device is used to irradiate red blood cells stored in the vessel, storing red blood cells under anaerobic conditions. 122.-. (canceled)23. A composition comprising irradiated oxygen and carbon dioxide-depleted red blood cells and not comprising L-carnitine or an alkanoul derivative , wherein oxygen and carbon dioxide-depleted red blood cells are stored for a period of time prior to irradiation.24. The composition of claim 23 , wherein said composition comprises reduced lesions compared to red blood cells conventionally stored for an equivalent period of time and then irradiated.25. The composition of claim 23 , wherein said composition comprises reduced oxidative damage compared to red blood cells conventionally stored for an equivalent period of time and then irradiated.26. The composition of claim 23 , wherein said irradiated oxygen and carbon dioxide depleted red blood cells comprise reduced potassium leakage compared to red blood cells conventionally stored for an equivalent period of time and then irradiated.27. The composition of claim 23 , wherein said oxygen and carbon dioxide depleted red blood cells comprise less than 20% SO.28. The composition of claim 23 , wherein said oxygen and carbon dioxide depleted red blood cells comprise reduced irradiation damage compared to red blood cells conventionally stored for an equivalent period of time and then irradiated.29. The composition of claim 23 , wherein said oxygen and carbon dioxide depleted red blood cells comprise less than 10 millimeter of mercury (mmHg) pCO.30. The composition of claim 23 , wherein said oxygen and carbon ...

DISPENSER

A spray dispenser is provided, the spray dispenser comprising a container for holding a liquid to be dispensed and a dispensing assembly for extracting liquid from said container, the dispensing assembly comprising a pressure-relief valve for release of excessive pressure in the container and a filter arranged to permit egress of gas through the filter, inhibit egress of liquid from the container and to inhibit ingress of contaminants into the container through the pressure relief valve. A dispensing assembly for use is a spray dispenser is also provided. 1. A dispenser comprising a container for holding a liquid to be dispensed and a dispensing assembly for extracting liquid from said container , the dispensing assembly comprising a pressure-relief valve for release of excessive pressure in the container and a filter arranged to permit egress of gas from the container through the filter and through the pressure-relief valve , the filter inhibiting egress of liquid from the container through the filter , the pressure-relief valve being closed in the absence of excessive pressure to inhibit ingress of air and contaminants into the container2. The dispenser of claim 1 , wherein the filter is in a gas flow path between the interior of the container and the pressure-relief valve claim 1 , or the pressure-relief valve is in a gas flow path between the interior of the container and the filter.3. The dispenser of claim 1 , wherein the filter inhibits ingress of particulate into the container.4. The dispenser of claim 1 , wherein the filter comprises pores which permit passage therethrough of gas but inhibit passage therethrough of particulate.5. The dispenser of claim 1 , wherein the filter is located within a filter housing.6. The dispenser of claim 1 , wherein the container comprises a fluid containment portion which is collapsible.7. The dispenser of claim 6 , wherein the container comprises a collar which is more rigid than the fluid containment portion.8. The ...

METHOD FOR STERILIZING A SUBSTRATE HAVING A HYDROPHILIC COATING AND STERILIZED SUBSTRATES

Methods for sterilizing a substrate with radiation and radiation sterilized substrates. 1. A method for sterilizing a substrate having a hydrophilic coating , said method comprising:contacting the hydrophilic coating of the substrate with a wetting fluid containing one or more non-polymeric polyols, the hydrophilic coating including a hydrophilic polymer and low molecular diacrylate; andsterilizing the medical device by applying a sufficient amount of radiation while the device is in contact with the wetting fluid.2. The method of wherein the substrate device comprises a urinary catheter.3. The method of wherein the one or more non-polymeric polyols comprises one or more of Glycerol claim 1 , Erythritol claim 1 , Threitol claim 1 , Arabitol claim 1 , Xylitol claim 1 , Adonitol claim 1 , Mannitol claim 1 , Sorbitol claim 1 , Galactitol claim 1 , Fucitol claim 1 , Iditol claim 1 , Inositol claim 1 , Volemitol claim 1 , Isomalt claim 1 , Maltitol claim 1 , Lactitol claim 1 , Maltotriitol claim 1 , and Maltotetraitol.5. The method of wherein the one or more non-polymer polyols comprises Glycerol.6. The method of wherein the one or more non-polymeric polyols is between about 5 wt % and about 50 wt % of the wetting fluid.7. The method of wherein the one or more non-polymeric polyols is between about 10 wt % and about 20 wt % of the wetting fluid.8. The method of wherein the one or more non-polymeric polyols is about 5 wt % of the wetting fluid.9. The method of wherein the low molecular diacrylate comprises polyethylene glycol diacrylate.10. The method of wherein the number average molecular weight of the polyethylene glycol diacrylate is less than about 600.11. The method of wherein the polyethylene glycol diacrylate has a number average molecular weight between about 200 and about 600.12. The method of wherein hydrophilic coating comprises about 80 wt % to about 95.5 wt % hydrophilic polymer and about 0.5 wt % to about 20 wt % polyethylene glycol diacrylate.13. The ...

COMPOSITION FOR BONE DEFECT AND PREPARATION METHOD OF THE SAME AND KIT FOR THE SAME

The present disclosure relates to a bone graft composition, and more particularly, to a bone graft composition containing a porous bone graft material and hydroxypropyl methylcellulose. 1. A bone graft composition containing a porous bone graft material and hydroxypropyl methylcellulose.2. The bone graft composition of claim 1 , wherein the porous bone graft material is a natural bone graft material.3. The bone graft composition of claim 1 , wherein a content of the hydroxypropyl methylcellulose is 0.15 to 6 parts by weight based on 1 part by weight of the porous bone graft material.4. The bone graft composition of claim 1 , wherein the composition comprises a sponge-like structure containing a porous structure.5. A bone graft composition kit comprising: the bone graft composition of ; and a syringe containing the bone graft composition.6. A method for preparing a bone graft composition claim 1 , the method comprising steps of:preparing a bone morphogenetic protein solution by adding a bone morphogenetic protein to a solvent, or the bone morphogenetic protein to the solvent and dissolving the bone morphogenetic protein on the solvent;adsorbing the bone morphogenetic protein onto previously prepared graft material powder by soaking the graft material powder with the bone morphogenetic protein solution through flushing of the graft material powder with the bone morphogenetic protein solution or dropping of the graft material powder into the bone morphogenetic protein solution;mixing and stirring the graft material powder having the bone morphogenetic protein adsorbed thereon and hydroxypropyl methylcellulose powder to form a viscous gel; andforming a sponge-like structure containing a plurality of pores by freeze-drying the mixture of the graft material powder and the hydroxypropyl methylcellulose powder, obtained by the mixing and stirring process, at a low temperature under vacuum.7. The method of claim 6 , wherein the bone morphogenetic protein is at least one ...

CELL DELIVERY

The invention provides a cell delivery medium comprising a liquid phase, wherein the liquid phase comprises (i) one or more cells suspended within the liquid phase and (ii) a plurality of polymer gel particulates. Methods of producing the cell delivery systems are also provided. 1. A cell delivery medium comprising a liquid phase , wherein the liquid phase comprises (i) one or more cells suspended within the liquid phase and (ii) a plurality of polymer gel particulates.2. A cell delivery system according to claim 1 , for use in the treatment of diseased or damaged tissue.3. A cell delivery medium according to claim 1 , wherein the liquid phase and/or at least a portion of the polymer gel particulates comprises a cell growth medium for said cells.4. A cell delivery medium according to claim 1 , wherein substantially only the liquid phase contains one or more cells and the polymer gel particulates do not enclose substantially any cells.5. A cell delivery medium according to claim 1 , wherein the liquid phase contains one or more cells and the polymer gel particulates enclose one or more cells claim 1 , with said cells being of the same type as the cells in the liquid phase.6. A cell delivery medium according to claim 1 , wherein the liquid phase contains one or more cells and the polymer gel particulates enclose one or more cells claim 1 , said cells being of different type to the cells in the liquid phase.7. A cell delivery medium according to claim 1 , wherein the polymer gel is selected from agarose claim 1 , agar claim 1 , carrageenan claim 1 , gellan claim 1 , gelatin claim 1 , pectin claim 1 , alginate or fibrin gels.8. A cell delivery medium according to claim 1 , wherein the average size of the polymer gel particulates is 1 μm to 500 μm.9. A cell delivery medium according to claim 1 , wherein the polymer gel and/or liquid phase comprises one or more nutrients claim 1 , antibiotics claim 1 , hormones claim 1 , growth factor claim 1 , anti-inflammatory compounds ...

Process and radiator device for wort sterilization by radiation for ethanol production

A method and irradiator apparatus used for wort sterilization by radiation for production of ethanol from sugar cane, comprising a modular irradiation drum, radioactive source, ducts for transmission of a fluid through an apparatus for irradiation, and application of radiation to a fluid within an apparatus for sterilization of such fluid.

CHITOSAN-BASED HEMOSTATIC TEXTILE

A microfibrillar high molecular weight chitosan-based textile can be used as a hemostat. The chitosan has been treated in a nitrogen field by applying energy to ionize nitrogen in and around the chitosan textile. A single or multiple such treatments may be employed. For example, the chitosan textile may be irradiated under nitrogen using γ-irradiation, treated under a nitrogen plasma, or both. 1. A method of making a hemostatic textile material , comprising processing crab shells to obtain a high molecular weight chitosan having a molecular weight in a range about 600-800 kDa and a degree of deacetylation of about 75-88% , processing the high molecular weight chitosan into a textile comprising a network of chitosan fibers , and irradiating the high molecular weight chitosan textile under nitrogen using γ-irradiation.2. The method of additionally comprising treating the chitosan textile under a nitrogen plasma.3. The method of additionally comprising soaking the chitosan fibers in an alcohol prior to treating with γ-irradiation or plasma.4. The method of additionally comprising packaging the fibrous high molecular weight chitosan textile in a nitrogen field and sealing the package so that the chitosan textile is sealed within a nitrogen environment prior to γ-irradiation claim 1 , and wherein the chitosan textile remains sealed within the package during irradiation.5. The method of additionally comprising treating the chitosan textile under a nitrogen plasma claim 4 , wherein the chitosan textile remains sealed within the package during nitrogen plasma treatment.6. The method of comprising packaging the chitosan textile in a dry condition.7. The method of claim 4 , wherein the packaging comprises metalized packaging.8. The method of additionally comprising forming the hemostatic chitosan textile into a woven or nonwoven fabric prior to packaging the chitosan.9. The method of additionally comprising treating the chitosan fibers with an acetic acid solution.10. The ...

METHODS FOR PACKAGING AND SHIPPING SURGICAL INSTRUMENTS AND IMPLANTS

A method of delivering implants and instruments to a healthcare facility includes receiving at least one container containing used instruments and unused implants. The used instruments and unused implants are processed, sterilized, and placed into respective containers. The containers are shipped to the healthcare facility. 1. A method of delivering surgical instruments and implants to a healthcare facility , comprising the steps of:obtaining the instruments and implants from an operating room after the completion of a surgical procedure;placing the instruments into at least one instrument container;placing the implants into at least one implant container;sterilizing the instruments and implants; andshipping the at least one instrument container having sterilized instruments therein and at least one implant container having sterilized implants therein to the healthcare facility.2. The method of claim 1 , further comprising the steps of:placing the at least one instrument container into a first sterilization bag; andplacing the at least one instrument container and first sterilization bag into a second sterilization bag.3. The method of claim 1 , further comprising the steps of:placing the at least one instrument container into a first clean container; andplacing the at least one implant container into a second clean container.4. The method of claim 3 , further comprising the step of:placing the first and second clean containers into a shipping container.5. The method of claim 3 , further comprising the steps of:placing the first clean container into a first shipping container; andplacing the second clean container into a second shipping container.6. The method of claim 3 , further comprising the step of:placing a return kit into the first clean container, the return kit including at least one contamination container therein.7. The method of claim 3 , wherein the sterilizing step includes:sterilizing the implants while contained within the clean container.8. The ...

SURGICAL INSTRUMENTS

A surgical device. The surgical device may comprise a transducer configured to provide vibrations along a longitudinal axis and an end effector coupled to the transducer and extending from the transducer along the longitudinal axis. The surgical device also may comprise a lower jaw extending parallel to the end effector. The lower jaw may comprise a clamp face extending toward the longitudinal axis. Also, the lower jaw may be slidable relative to the end effector to bring the clamp face toward a distal end of the end effector. 161-. (canceled)62. A surgical instrument comprising:a transducer configured to provide vibrations along a longitudinal axis;an end effector operably coupled to the transducer, wherein the end effector extends along the longitudinal axis, and wherein the end effector comprises a blade; anda stationary lower jaw extending parallel to the end effector, wherein the stationary lower jaw comprises a clamp face positioned distal to the blade, wherein the end effector is movable relative to the stationary lower jaw to drive the blade distally towards the clamp face.63. The surgical instrument of claim 62 , further comprising a trigger claim 62 , wherein rotation of the trigger is configured to drive the blade distally towards the clamp face.64. The surgical instrument of claim 63 , further comprising a frame member operably coupled to the trigger and the end effector claim 63 , wherein the rotation of the trigger exerts a force on the frame member to drive the blade distally towards the clamp face.65. The surgical instrument of claim 64 , wherein the blade is non-rotatably driven distally towards the clamp face.66. The surgical instrument of claim 64 , wherein the blade is rotatably driven distally towards the clamp face.67. The surgical instrument of claim 66 , wherein the frame member comprises a slot claim 66 , wherein the end effector comprises a pin claim 66 , and wherein the slot is configured to exert a force on the pin to cause the blade to ...

FEEDBACK ALGORITHMS FOR MANUAL BAILOUT SYSTEMS FOR SURGICAL INSTRUMENTS

The present disclosure provides a surgical instrument including an end effector, a drive member movable to effectuate a motion in said end effector, a motor operable to move the drive member to effectuate the motion in the end effector and a bailout assembly operable to perform a mechanical bailout of the surgical instrument in response to a bailout error. The bailout assembly includes a bailout door, a bailout handle accessible through the bailout door. The bailout handle is operable to move the drive member to effectuate a bailout motion in the end effector. A controller includes a memory and a processor coupled to the memory. The processor is configured to detect the bailout error. The processor is programmed to stop the motor in response to the detection of the bailout error. 120-. (canceled)21. A modular connection assembly for use with a motor powered surgical system , the modular connection assembly comprising:a drive assembly comprising an elongate firing shaft configured to operably couple to a firing drive of the motor powered surgical system, wherein the elongate firing shaft is configured to be driven distally by a firing motion from the firing drive;a tapered surface configured to slide along a receiving surface of the motor powered surgical system, wherein the tapered surface is configured to slide across the firing drive to operably align the elongate firing shaft with the firing drive; anda locking arm pivotably coupled to the modular connection assembly, wherein the locking arm is configured bring the modular connection assembly into a locked configuration with the motor powered surgical system.22. The modular connection assembly of claim 21 , further comprising:a shaft assembly extending from a distal end of the modular connection assembly; andan end effector extending from a distal end of the shaft assembly.23. The modular connection assembly of claim 22 , wherein the tapered surface and the receiving surface form a coupling interface claim 22 , ...

SYSTEMS AND APPROACHES FOR STERILIZING A DRUG DELIVERY DEVICE

An on-body injector system includes a drug container assembly including a container, a seal member, and a sealing interface between the seal member and the container. The container includes an opening and the seal member at least partially covers the opening in the container. A fluid pathway assembly is coupled to the drug container assembly and includes a needle that is movable between a storage position, in which a point of the needle is spaced from the seal member, and a delivery position, in which the point of the needle is disposed at least partially through the seal member. A radiation generator is configured to emit rays of radiation to sterilize and/or disinfect the sealing interface. A barrier is disposed adjacent to the sealing interface and has an opening. At least a portion of the drug container assembly is positioned adjacent to the opening in the barrier. 1. An on-body injector system comprising:a drug container assembly including a container, a seal member, and a sealing interface between the seal member and the container, the container having an opening and the seal member at least partially covering the opening in the container;a fluid pathway assembly coupled to the drug container assembly and including a needle, the needle being movable between a storage position, in which a point of the needle is spaced from the seal member, and a delivery position, in which the point of the needle is disposed at least partially through the seal member;a radiation generator configured to emit rays of radiation to sterilize and/or disinfect the sealing interface;a barrier disposed adjacent to the sealing interface and having an opening; andwherein at least a portion of the drug container assembly is positioned adjacent to the opening in the barrier.2. The on-body injector system of claim 1 , wherein the barrier includes a wall and the opening is formed in the wall.3. The on-body injector system of claim 2 , wherein at least a portion of the container and the ...

SEALED SELF-ACTIVATING INJECTION DEVICE FOR DELIVERY OF MEDICINE FROM A PREFILLED CARTRIDGE OR VIAL

The disclosed embodiment relates to an injection device that is a single patient use, disposable device containing a needle and a cartridge containing a drug or pharmaceutical product. The device is initially provided in a pre-armed configuration wherein the needle sheath maintains cantilever locking tabs on the housing in a position to the maintain the needle in a position separated from the septum of a cartridge. To arm the device, the practitioner removes the needle sheath and pushes down the plunger assembly. The cantilever locking tabs flex outwardly thereby allowing the cartridge-to-housing interface and the cartridge to move forward whereby the butt end of the needle punctures the septum of the cartridge. Additionally, the cantilever locking tabs form a stop configuration with the housing of the device. The disclosed embodiment is particularly adaptable to dental anesthetic applications, as well as other medical and veterinary applications. 1. An injection device comprising:a cartridge with a first cartridge end and a second cartridge end, the first cartridge end being closed and the second end including a cartridge plunger;a housing enclosing the cartridge, the housing including a first housing end and a second housing end, the housing including at least one movable cartridge stop;a needle including a cannula, the needle being engaged to the first end of the housing; anda cartridge adapter with a first adapter end and a second adapter end, the first adapter end engaging the first cartridge end, the adapter further including an annular element slidably engageable within the movable cartridge stop, wherein the adapter is movable between a first position and a second position with respect to the at least one movable cartridge stop.2. The injection device of wherein in the first position claim 1 , the cannula is spaced away from the first cartridge end and wherein in the second position claim 1 , the cannula penetrates the first cartridge end thereby providing ...

COMPOSITION, PREPARATION, AND USE OF CHITOSAN POWDER FOR BIOMEDICAL APPLICATIONS

A powder chitosan-based material can be used for biomedical applications. The chitosan has been treated in a nitrogen field by applying energy to ionize nitrogen in and around the chitosan material. A single or multiple such treatments may be employed. For example, the chitosan material may be irradiated under nitrogen using γ-irradiation, treated under a nitrogen plasma, or both. A powder chitosan material can be readily treated by surface modifying treatments such as irradiating under nitrogen using γ-irradiation, treating under a nitrogen plasma, or both. 1. A method of making a material , comprising:processing chitosan into a powder chitosan material by a physical process;irradiating the powder chitosan material under nitrogen plasma; andcombining the powder chitosan material with an acid to create a viscous solution.2. The method of claim 1 , further comprising utilizing chitosan flakes directly obtained from shellfish claim 1 , the chitosan flakes having an average largest dimension of 1 centimeter or more.3. The method of claim 2 , further comprising grinding the chitosan flakes with zirconium grinding balls.4. The method of claim 1 , wherein the physical process comprises grinding of the chitosan to form the powder chitosan material.5. The method of claim 1 , wherein an individual granule of the powder chitosan material is 10 μm to 100 μm in diameter.6. The method of claim 1 , wherein an average diameter of individual granules of the powder chitosan material is from 10 μm to 100 μm in diameter.7. The method of claim 1 , wherein the acid is selected from the group consisting of acetic acid claim 1 , lactic acid claim 1 , glutamic acid claim 1 , and formic acid.8. The method of claim 1 , wherein the acid is lactic acid.9. The method of claim 1 , further comprising processing the viscous solution into a hemostatic device comprising a network of the powder chitosan material.10. The method of claim 1 , further comprising processing the viscous solution into a ...

CHITOSAN-BASED HEMOSTATIC TEXTILE

A microfibrillar high molecular weight chitosan-based textile can be used as a hemostat. The chitosan has been treated in a nitrogen field by applying energy to ionize nitrogen in and around the chitosan textile. A single or multiple such treatments may be employed. For example, the chitosan textile may be irradiated under nitrogen using γ-irradiation, treated under a nitrogen plasma, or both. 1. A method of making a hemostatic textile material , comprising processing crab shells to obtain a high molecular weight chitosan having a molecular weight in a range about 600-800 kDa and a degree of deacetylation of about 75-88% , processing the high molecular weight chitosan into a textile comprising a network of chitosan fibers , and irradiating the high molecular weight chitosan textile under nitrogen using γ-irradiation.2. The method of additionally comprising treating the chitosan textile under a nitrogen plasma.3. The method of additionally comprising soaking the chitosan fibers in an alcohol prior to treating with γ-irradiation or plasma.4. The method of additionally comprising packaging the fibrous high molecular weight chitosan textile in a nitrogen field and sealing the package so that the chitosan textile is sealed within a nitrogen environment prior to γ-irradiation claim 1 , and wherein the chitosan textile remains sealed within the package during irradiation.5. The method of additionally comprising treating the chitosan textile under a nitrogen plasma claim 4 , wherein the chitosan textile remains sealed within the package during nitrogen plasma treatment.6. The method of comprising packaging the chitosan textile in a dry condition.7. The method of claim 4 , wherein the packaging comprises metalized packaging.8. The method of additionally comprising forming the hemostatic chitosan textile into a woven or nonwoven fabric prior to packaging the chitosan.9. The method of additionally comprising treating the chitosan fibers with an acetic acid solution.10. The ...

METHOD FOR OBTAINING STERILE HUMAN AMNIOTIC FLUID AND USES THEREOF

Provided herein is a pre-Caesarean method for collecting amniotic fluid from a patient. A needle is inserted into the incision site for the future C-section, which may be under ultrasound guidance, through which the amniotic fluid is drawn under a low level suction and, optionally, gravity to a sterile collection container. The method encompasses filtering and/or irradiating the amniotic fluid to collect biomolecules of interest such as growth factors and/or stem cells. Also provided is the sterile amniotic fluid or filtrates thereof collected by the method described herein 120-. (canceled)21. A method for enhancing wound healing , cosmetic , orthopedic , or ophthalmic applications comprising administering to the wound an effective amount of sterile filtered , cell-free , non-irradiated human amniotic fluid to a site in need thereof.22. The method of claim 21 , wherein the sterile filtered claim 21 , cell-free claim 21 , non-irradiated human amniotic fluid comprises serially filtered the human amniotic fluid prepared by a process comprising:collecting amniotic fluid under sterile conditions from a woman;removing cells, large particles and other undissolvables from the human amniotic fluid by centrifuging the human amniotic fluid to obtain clarified amniotic fluid; andserially filtering the clarified amniotic fluid through multiple filters selected from the group consisting of depth filters and membrane filters with a pore size of 0.45 μm and 0.2 μm to obtain a sterile filtrate that is not irradiated.23. The method of claim 21 , wherein the sterilely filtered claim 21 , cell-free claim 21 , non-irradiated human amniotic fluid has a 10sterility assurance level.24. The method of claim 21 , wherein the ophthalmic application is for treating dry eyes in a human.25. The method of claim 24 , wherein the amniotic fluid is in an amount effective to decrease corneal inflammation associated with the dry eye.26. The method of claim 21 , wherein the amniotic fluid is sterilely ...

Methods and Systems for Removing Pressure and Air from Chromatography Columns

Methods and systems for removing gases and/or pressure formed during the sterilization, e.g., the gamma irradiation, of prepacked chromatography systems (column plus attached tube and valve set) are described. The methods include purging the gas and/or pressure through specially designed tube and valve sets without breaching the sterility of the prepacked sterile chromatography system. The systems include a sterile or aseptic pre-packed chromatography column including a column having an inlet and an outlet, a tubing and valve set attached to the inlet and the outlet, and a pump configured to pump sterile or aseptic liquid from the fluid source along the tubing and valve set, into the column tube inlet and out of the column tube outlet along a first flow path, thereby removing any entrapped gas and/or pressure from the chamber. 1. A method of removing entrapped gas , pressure , or both gas and pressure from a pre-packed chromatography column that comprises a column tube having a column tube inlet and a column tube outlet and first and second flow distributors arranged within the column tube to form a chamber filled with a packing medium , the method comprising:(a) obtaining a tubing and valve set comprising tubing and at least one valve configured to define at least two different fluid paths through the tubing; (i) attaching tubing of the tubing and valve set to the column tube inlet and the column tube outlet and then sterilizing the connected pre-packed chromatography column and the tubing and valve set, or', '(ii) sterilizing the pre-packed chromatography column and the tubing and valve set individually and then attaching the sterile tubing of the tubing and valve set to the sterile column tube inlet and the sterile column tube outlet in a manner that maintains sterility of both the column and the tubing and valve set;, '(b) either(c) attaching the sterile tubing and valve set to a sterile or aseptic fluid source and to a fluid outlet; and(d) pumping sterile or ...

Reactive Oxidative Species Generating Materials and Methods of Use

Materials capable of delivering stabilized free radicals to targeted treatment sites. The materials comprise semi-crystalline, hydrolytically degradable polymers that are subjected to ionizing radiation to create stabilized free radicals therein. Upon exposure to oxygen containing aqueous media, the materials generate reactive oxidative species which are useful in biological processes. 113.-. (canceled)14. A biocompatible device capable of releasing superoxide , said biocompatible device comprising:a substrate; anda biocompatible material comprising at least one semi-crystalline, hydrolytically degradable polymeric material,wherein the polymeric material has been subjected to ionizing radiation at a dose rate less than about 50 kGy and sterilized by non-ionizing radiation methods, andwherein said polymeric material is in contact with at least a portion of said substrate.15. A biocompatible device capable of releasing superoxide , said biocompatible device comprising:a substrate; anda biocompatible material comprising at least one semi-crystalline, hydrolytically degradable polymeric material,wherein the polymeric material has been subjected to ionizing radiation while maintained in an inert atmosphere, andwherein said polymeric material is in contact with at least a portion of said substrate.1621.-. (canceled)22. The biocompatible device of claim 15 , wherein the polymeric material claim 15 , upon contact with an aqueous media claim 15 , enables multi-phasic generation of reactive oxidative species.23. The biocompatible device of claim 15 , wherein an initial burst of reactive oxidative species production and a subsequent sustained period of reactive oxidative species production occurs upon contacting the polymeric material with an aqueous media.24. The biocompatible device of claim 15 , wherein the at least one semi-crystalline claim 15 , hydrolytically degradable polymeric material comprises a first polymeric material and a second polymeric material.25. The ...

Reactive Oxidative Species Generating Materials and Methods of Use

Materials capable of delivering stabilized free radicals to targeted treatment sites. The materials comprise semi-crystalline, hydrolytically degradable polymers that are subjected to ionizing radiation to create stabilized free radicals therein. Upon exposure to oxygen containing aqueous media, the materials generate reactive oxidative species which are useful in biological processes, 112.-. (canceled)13. A method of making a biocompatible material with enhanced reactive oxidative species generation bya. blending at least two hydrolytically degradable semi-crystalline polymeric materials to a blend; andb. subjecting said blend to ionizing radiation at a given radiation dose to create stabilized free radicals therein,wherein upon contacting the blend with an oxygen-containing aqueous media, multi-phasic generation of reactive oxidative species occurs, andwherein the quantity of the reactive oxidative species produced by the blend is greater than the weighted average of reactive oxidative species produced by the at least two individual hydrolytically degradable semi-crystalline polymeric materials having been subjected to ionizing radiation at the given radiation dose,1421.-. (canceled)22. The method of . wherein an initial burst of reactive oxidative species production and a subsequent sustained period of reactive oxidative species production occurs upon contacting the blend with the oxygen-containing aqueous media.23. The method of claim 13 , wherein the at least two hydrolytically degradable semi-crystalline polymeric materials comprise a first polymeric material and a second polymeric material.24. The method of claim 23 , wherein the first polymeric material has a different hydrolytic degradation rate than the second polymeric material.25. The method of claim 23 , wherein the first polymeric material has a different degree of crystallinity than the second polymeric material.26. The method of claim 23 , wherein the first polymeric material and the second polymeric ...

Reactive Oxidative Species Generating Materials and Methods of Use

Materials capable of delivering stabilized free radicals to targeted treatment sites. The materials comprise semi-crystalline, hydrolytically degradable polymers that are subjected to ionizing radiation to create stabilized free radicals therein. Upon exposure to oxygen containing aqueous media, the materials generate reactive oxidative species which are useful in biological processes. 118.-. (canceled)19. A method of stimulating blood vessel formation comprising:applying at least one semi-crystalline, hydrolytically degradable polymeric material comprising stabilized free radicals to a treatment site, wherein the polymeric material has been subjected to ionizing radiation at a dose that exceeds that required for sterilization but is less than that required to substantially degrade the polymeric material.20. The method of wherein the dose of ionizing radiation is from about 30 kGy to about 50 kGy.21. A method of stimulating blood vessel formation comprising:applying at least one semi-crystalline, hydrolytically degradable polymeric material comprising stabilized free radicals to a treatment site, wherein the polymeric material has been subjected to ionizing radiation at a dose of less than 50 kGy and is sterilized by non-ionizing radiation methods.22. The method of claim 19 , wherein the polymeric material claim 19 , upon contact with an aqueous media claim 19 , enables multi-phasic generation of reactive oxidative species.23. The method of claim 19 , wherein an initial burst of reactive oxidative species production and a subsequent sustained period of reactive oxidative species production occurs upon contacting the polymeric material with an aqueous media.24. The method of claim 19 , wherein the at least one semi-crystalline claim 19 , hydrolytically degradable polymeric material comprises a first polymeric material and a second polymeric material.25. The method of claim 24 , wherein the first polymeric material has a different hydrolytic degradation rate than the ...

NOVEL ENHANCED ZERO DISPLACEMENT OPTIMA® SYSTEM

Data supported zero displacement implant/coil detachment system is, for example, gamma-irradiated post manufacturing, but made with no tension/zero displacement using more than 1 SR thread. 1. An endovascular coil delivery system , which comprises; in combination:more than one SR thread;a co-axial heater coil; andattachment with-zero displacement, meaning zero tension.2. The system of claim 1 , further comprising dual SR threads.3. The system of claim 1 , and all disclosure herein claim 1 , wherein a first SR thread is 18 SR inside the implant; and a second SR thread is 22 SR used for detachment.4. The system of comprising immediate detachment.5. The system of wherein the implant/coil separates outside the microcatheter.6. The system of claim 1 , wherein upon pusher removal implant/coil separates inside microcatheter <1 mm; or wherein upon pusher removal implanticoil separates inside microcatheter >1 mm.7. The system of claim 1 , farther comprising sterilization by gamma irradiation claim 1 , whereby the longer or 22 SR thread shrinks in length claim 1 , creating tension post manufacturing.8. The system of claim 7 , wherein detachment on the first attempt is assured.9. The system of claim 8 , wherein detachment is confirmed by fluoroscopy.10. The system of herein embodied in an Optima® brand of delivery system with implant/coils.11. The system of claim 10 , with tantalum brush and other radiopacity. This application claims the full Paris Convention benefit of, and priority to, U.S. Provisional Patent Application Ser. No. 63/035,075, filed Jun. 5, 2020.The present inventions relate to delivery systems for endovascular devices, particularly the present inventions overcome longstanding issues with respect to coil delivery.It is respectfully proposed that the instant disclosure as shown and described is progress in science and the useful arts deserving of Letters Patent.Corresponding reference characters indicate corresponding components throughout the several views of ...

FLUID PLUG FOR STERILE PROCESSES AND METHODS OF USING THE SAME

A fluid plug for use with sterile processes such as the manufacture or production of pharmaceuticals and biologics is disclosed. The fluid plug is made of a material or materials that will tolerate sterilizing processes such as gamma irradiation. The fluid plug is used to selectively plug the ends of flexible polymer conduits that may be connected to fluids, reagents, or products used or generated as part of the manufacturing process. Also disclosed is the use of the plugs in combination with a series of valves in a block-and-bleed arrangement to enable the sterile transfer and connection of fluids, reagents, or products within a process flow. 1. A sterile fluid system comprising:a container for holding fluid therein;a flexible polymer conduit having first and second ends, the flexible polymer conduit coupled to the container at the first end; a cap;', 'a shank portion extending from the cap;', 'a flexible ring disposed along a portion of the shank; and', 'a lever mounted on the cap and configured to shorten the shank upon actuation, wherein actuation of the lever causes radial expansion of the flexible ring and forms a fluidic seal with an interior surface of the flexible polymer conduit, wherein the removable plug is formed form a polymer material that tolerates gamma radiation., 'a removable plug configured to insert into the second end of the flexible polymer conduit, the removable plug comprising2. The sterile fluid system of claim 1 , wherein the container comprises a bag.3. The sterile fluid system of claim 1 , wherein the container and flexible polymer conduit are formed from a polymer material that tolerate gamma irradiation.4. The sterile fluid system of claim 1 , wherein the flexible polymer conduit further comprises a third end claim 1 , wherein the second end comprises a main conduit and the third end comprises a branch conduit.5. The sterile fluid system of claim 4 , further comprising a removable plug configured to insert into the third end.6. A ...

SURGICAL INSTRUMENTS

A surgical device. The surgical device may comprise a transducer configured to provide vibrations along a longitudinal axis and an end effector coupled to the transducer and extending from the transducer along the longitudinal axis. The surgical device also may comprise a lower jaw extending parallel to the end effector. The lower jaw may comprise a clamp face extending toward the longitudinal axis. Also, the lower jaw may be slidable relative to the end effector to bring the clamp face toward a distal end of the end effector. 161-. (canceled)62. A surgical device , comprising: a first jaw member; and', 'a second jaw member, wherein at least one of the first jaw member or the second jaw member is pivotable toward the other to grasp tissue; and, 'an end effector, including, 'a surgical instrument, comprising a first position, wherein the first jaw member and the second jaw member are positioned within the outer sheath proximal to a distal portion of the outer sheath; and', 'a second positon, wherein the first jaw member and the second jaw member are positioned outside the outer sheath distal to the distal portion of the outer sheath;, 'an outer sheath surrounding the surgical instrument, wherein the outer sheath is slidable relative to the surgical instrument along a longitudinal axis betweenwherein the distal portion of the outer sheath is configured to clamp tissue.63. The surgical device of claim 62 , wherein the first jaw member is configured to pivot toward the second jaw member claim 62 , and wherein the second jaw member comprises an ultrasonic blade coupled to a proximally positioned transducer.64. The surgical device of claim 62 , wherein the distal portion of the outer sheath comprises a distal edge configured to treat clamped tissue.65. The surgical device of claim 64 , wherein the distal edge comprises a sharp edge to cut the clamped tissue.66. The surgical device of claim 64 , further comprising a transducer positioned to ultrasonically excite the distal ...

FEEDBACK ALGORITHMS FOR MANUAL BAILOUT SYSTEMS FOR SURGICAL INSTRUMENTS

The present disclosure provides a surgical instrument including an end effector, a drive member movable to effectuate a motion in said end effector, a motor operable to move the drive member to effectuate the motion in the end effector and a bailout assembly operable to perform a mechanical bailout of the surgical instrument in response to a bailout error. The bailout assembly includes a bailout door, a bailout handle accessible through the bailout door. The bailout handle is operable to move the drive member to effectuate a bailout motion in the end effector. A controller includes a memory and a processor coupled to the memory. The processor is configured to detect the bailout error. The processor is programed to stop the motor in response to the detection of the bailout error. 1. A surgical instrument , comprising:an end effector;a drive member movable to effectuate a motion in said end effector;a motor operable to move said drive member to effectuate said motion in said end effector; and a bailout door;', 'a bailout handle accessible through said bailout door, said bailout handle operable to move said drive member to effectuate a bailout motion in said end effector; and', a memory; and', 'a processor coupled to said memory, said processor configured to detect said bailout error, wherein said processor is programed to stop said motor in response to said detection of said bailout error., 'a controller, comprising], 'a bailout assembly operable to perform a mechanical bailout of said surgical instrument in response to a bailout error, said bailout assembly comprising2. The surgical instrument of claim 1 , wherein said processor is configured to store a bailed out state in said memory in response to said detection of said bailout error.3. The surgical instrument of further comprising an interface.4. The surgical instrument of claim 3 , wherein said processor is configured to alert claim 3 , through said interface claim 3 , a user of said surgical instrument to ...

MEDICAL DEVICE AND PROCESS OF PREPARING A MEDICAL DEVICE

The present invention relates to a medical device to be applied to a body of a human or animal being. The medical device comprises a contact surface to contact the body of the human or animal being when the medical device is applied to the body of the human or animal being. The contact surface is covered with a soluble surface sealing. The surface sealing is composed of an organic compound. 149-. (canceled)50. A medical device to be applied to a body of a human or animal being , comprising: the contact surface is covered with a soluble surface sealing, and', 'the surface sealing is composed of an organic compound., 'a contact surface configured to contact the body of the human or animal being when the medical device is applied to the body of the human or animal being, wherein'}51. The medical device of claim 50 , wherein the organic compound is a carbohydrate claim 50 , wherein the carbohydrate is one ofa di- or a trisaccharide, such as trehalose, maltotriose, lactose, lactulose, palatinose, or sucrose, ora monosaccharide, ora sugar alcohol, such as threitol, erythritol, glucose, fructose, sorbitol, galactose, galactitol, mannose, mannitol, xylitol, myo-inositol, or similar, organic acids, such as citric acid, orother substances such as vitamin C.52. The medical device of claim 50 , wherein the surface sealing comprises a combination of at least two different carbohydrates.53. The medical device of claim 50 , wherein the surface sealing is configured towithstand sterilization, wherein the sterilization comprises gamma radiation, e-beam provision, or ethylene oxide provision, and/ordissolve within 30 seconds when being in contact with an aqueous solution.54. The medical device of claim 50 , wherein the surface sealing is homogeneous claim 50 , seamlessly covering the contact surface claim 50 , and/or gas-tight.55. The medical device of claim 50 , wherein the medical devices is an implant configured toreplace a natural biological structure of the body of the human or ...

SYSTEM FOR HANDLING THE STERILISATION OF FLEXIBLE POUCHES

A system of managing the sterilisation of empty flexible pouches () provides applying sacrificial closures () to the empty pouches, loading the empty provisional closed pouches to be sterilised on a transport device () for the collective transportation, performing the sterilisation of the transport device () carrying the empty provisional closed pouches, and finally separating, in a sterile chamber, the sacrificial closures () from the pouches, filling and applying a tamper-proof cap (). 11. Method of preparation for the sterilisation of empty pouches () , comprising the steps of:{'b': 1', '1', '2', '4', '6', '16', '24', '18', '6', '2', '24, 'producing a plurality of pouches (), wherein each pouch () comprises a container body () formed by walls () made of flexible film and a spout () comprising an entrance portion with an inlet () and a tube () with an outlet (), said spout () being sealingly applied to the container body () so as to protrude outside of it with at least a section of the tube ();'}{'b': 6', '1', '200', '18', '6', '600, 'providing said spout () of the empty pouch () with an irreversible sacrificial closure () for the outlet () of the spout (), thereby obtaining empty provisional closed pouches to be sterilised ();'}{'b': '300', 'loading a plurality of empty provisional closed pouches to be sterilised on a transport device () for collective transportation towards a steriliser.'}2300600. Method according to claim 1 , wherein the transport device () consists of a section bar having prevalent extension along a sliding axis (X) and the loading step involves the insertion by sliding of the empty provisional closed pouches () in said section bar along said sliding axis (X).330030430430326. Method according to or claim 1 , wherein the transport device () comprises fins () and the loading step provides for the support of the provisional closed pouch claim 1 , in the “standing” or “upside down” configuration through the use of the fins () between the support ...

BY MEANS OF IONIZING RADIATION STERILIZABLE MOULDED PARTS MADE FROM POLYCARBONATE

The invention relates to a thermoplastic composition comprising A) aromatic polycarbonate, B) 0.1 to 5 wt.-% one or more polyether polyol(s) and C) one or more thermal stabilizer(s) selected from the group consisting of thio compounds excluding the following component D, characterized in that the composition additionally comprises D) 3,3′-thiodipropionic acid, wherein the total amount of components C plus D is 0.01 to 1.0 wt.-%. The invention also relates to medical technology products or parts of medical technology products consisting of such compositions as well as to a process for sterilization of such moulded parts by means of irradiation. The polycarbonate compositions according to the invention show significantly less yellowing after irradiation than known compositions. 115.-. (canceled)16. A thermoplastic composition comprisingA) aromatic polycarbonate,B) 0.1 to 5 wt.-% one or more polyether polyol(s) andC) one or more thermal stabilizer(s) selected from the group consisting of thio compounds different from the following component D,characterized in that the composition additionally comprisesD) 3,3′-thiodipropionic acid,whereinthe total amount of components C plus D is 0.01 to 1.0 wt.-%.17. The thermoplastic composition according to claim 16 , wherein the composition comprises at least 95 wt.-% aromatic polycarbonate.18. The thermoplastic composition according to claim 16 , wherein the amount of polyether polyol is 0.1 to 2 wt.-%.19. The thermoplastic composition according to claim 16 , wherein the amount of 3 claim 16 ,3′-thiodipropionic acid is 0.05 to 0.2 wt.-% and the amount of components C plus D is 0.1 to 1.0 wt.-%.20. The thermoplastic composition according to claim 16 , wherein the amount of thermal stabilizer according to component C is 0.1 to 0.25 wt.-% and the amount of components C plus D is 0.15 to 1.0 wt.-%21. The thermoplastic composition according to claim 16 , wherein the total amount of components C plus D is 0.2 to 0.4 wt.-%.22. The ...

Composition, preparation, and use of chitosan shards for biomedical applications

A thin chitosan-based material can be used for biomedical applications. The chitosan has been treated in a nitrogen field by applying energy to ionize nitrogen in and around the chitosan material. A single or multiple such treatments may be employed. For example, the chitosan material may be irradiated under nitrogen using γ-irradiation, treated under a nitrogen plasma, or both. A thin chitosan material can be readily treated by surface modifying treatments such as irradiating under nitrogen using γ-irradiation, treating under a nitrogen plasma, or both.

STERILE PACKAGING CONTAINER

The present disclosure in one aspect provides a sterile packaging container comprising a container body with a cross-sectional shape that is constant along the majority of the longitudinal axis, a cover and a closure assembly that inhibits the passage of microbial contaminants. The container is configured such that the interior of the container can be sterilized. The sterile packaging container described herein allows one to manufacture a sterile packaging tube exercising the smallest possible volume. 1. A method for the manufacturing of a sterile container , the method comprising:creating by a mechanical process a polymeric container body having a first open end, a second open end, and a cross-sectional shape that is constant along a majority of the longitudinal axis;allowing the container body to harden,hermetically sealing a cover to the first open end, hermetically sealing a closure base to the second open end,connecting a removable closure cap to the closure base to form a breathable seal that inhibits microbial entry, andsterilizing the interior of the container.2. The method of manufacturing a sterile container of claim 1 , wherein the mechanical process is extrusion.3. The method of manufacturing a sterile container of claim 1 , wherein the mechanical process is pultrusion.4. The method of manufacturing a sterile container of claim 1 , wherein the closure base and cover are hermetically sealed respectively to the first and second open ends via ultrasonic or fusion welding.5. The method of manufacturing a sterile container of claim 1 , wherein the closure base is connected to the removable closure cap via mated threading.6. The method of manufacturing a sterile container of claim 1 , wherein the interior of container is sterilized by at least one of: gamma radiation and ethylene oxide.7. A method for the manufacturing of a sterile container claim 1 , the method comprising:extruding or pultruding a polymeric container body having a first open end, a second ...

FIBROUS MATERIALS AND COMPOSITES

Fibrous materials, compositions that include fibrous materials, and uses of the fibrous materials and compositions are disclosed. For example, the fibrous materials can be operated on by a microorganism to produce ethanol or a by-product, such as a protein or lignin. 1. A method comprising:irradiating a cellulosic or lignocellulosic fibrous material with an ionizing radiation, and dispersing the irradiated fibrous material in a resin,wherein the fibrous material has been obtained by shearing a fiber source to provide a first fibrous material; and passing the first fibrous material though a first screen having an average opening size of 1.59 mm or less.2. The method of claim 1 , wherein the composite is in the form of an article selected from the group consisting of structures claim 1 , ornamental articles claim 1 , stepping stools claim 1 , pipes claim 1 , panels claim 1 , decking materials claim 1 , boards claim 1 , housings claim 1 , sheets claim 1 , blocks claim 1 , bricks claim 1 , poles claim 1 , fencing claim 1 , members claim 1 , doors claim 1 , shutters claim 1 , awnings claim 1 , shades claim 1 , signs claim 1 , frames claim 1 , window casings claim 1 , backboards claim 1 , flooring claim 1 , tiles claim 1 , railroad ties claim 1 , trays claim 1 , tool handles claim 1 , stalls claim 1 , films claim 1 , wraps claim 1 , tapes claim 1 , boxes claim 1 , baskets claim 1 , racks claim 1 , casings claim 1 , binders claim 1 , dividers claim 1 , walls claim 1 , mats claim 1 , frames claim 1 , bookcases claim 1 , sculptures claim 1 , chairs claim 1 , tables claim 1 , desks claim 1 , toys claim 1 , games claim 1 , pallets claim 1 , wharves claim 1 , piers claim 1 , boats claim 1 , masts claim 1 , septic tanks claim 1 , automotive panels claim 1 , computer housings claim 1 , above- and below-ground electrical casings claim 1 , furniture claim 1 , picnic tables claim 1 , benches claim 1 , shelters claim 1 , trays claim 1 , hangers claim 1 , servers claim 1 , caskets ...

Sterile Packaging Container

The present disclosure in one aspect provides a sterile packaging container comprising a container body with a cross-sectional shape that is constant along the majority of the longitudinal axis, a cover and a closure assembly that inhibits the passage of microbial contaminants. The container is configured such that the interior of the container can be sterilized. The sterile packaging container described herein allows one to manufacture a sterile packaging tube exercising the smallest possible volume. 1. A container configured for sterilization and gas permeation , the container comprising:a container body with a longitudinal axis, a first open end, and a second open end, wherein the container body has a cross-sectional shape that is constant along the majority of the longitudinal axis;a cover that forms a microbe tight seal on the first open end; anda closure assembly that forms a microbe-tight seal on the second open end, said closure assembly comprising a closure base attached to the container body at the second open end, and a closure cap removably engaged to the closure base.2. The container of claim 1 , wherein the external and internal cross-sectional contours of the container body are invariant to one another along a majority of the longitudinal axis.3. The container of claim 1 , wherein the container body is the product of polymer extrusion.4. The container of claim 1 , wherein the container body is the product of polymer pultrusion.5. The container of claim 1 , wherein the cover cap is in snap-fit engagement with the first open end.6. The container of claim 1 , wherein the cover comprises a cover cap and a stopper element.7. The container of claim 6 , wherein the cover comprises a cover cap and a stopper element claim 6 , and wherein the stopper element is in a plug engagement with the first open end.8. The container of claim 1 , wherein the cover forms a hermetic seal with the first open end.9. The container of claim 1 , wherein the closure base is ...

Methods of stabilizing molecular weight of polymer stents after sterilization

Methods of stabilizing the molecular weight of polymer stents scaffolds after E-beam sterilization are disclosed. The molecular weight of the polymer of the irradiated scaffolds is stabilized through exposure to gas containing oxygen.

A PART CONSISTING OF A MATERIAL AND A METHOD OF MANUFACTURING SUCH PART AND A METHOD OF RADIATION STERILIZATION OF SUCH PART

The material of a part includes a composition obtained by blending an isobutylene-based, pre-crosslinked polymer as component (A), at least one poly olefin or a non-crosslinked rubber or a TPV as component (B), at least one polymer having a Tg of 90° C. or higher as component (C) and—preferably—at least one component (D) selected from the group of: substituted vinyl polymers, stryrenic block copolymers, inorganic functionalized and non-functionalized fillers, carbon black, halogen scavengers, preferably the inorganic halogen scavengers, acid acceptors, stabilizers, preferably the polymeric stabilizers, and processing aids. Also, a method of manufacturing such part includes the steps: a) Pre-mixing at least one substance representing component B, with at least one substance representing component C and at least one substance representing component D; b) compounding the obtained premix with component A and optionally a further portion of component B or D; and c) molding the resulting composition of step (b) into a pharmaceutical seal. Also, a method of radiation sterilization a part, e.g. a pharmaceutical closure, the part being produced from compounds based on thermoplastic vulcanizates including isobutylene monomer units, prior to irradiation, packs the parts under an inert atmosphere in a container impermeable to oxygen, wherein the packed closure materials are irradiated for sterilization. 122-. (canceled)23. A part , comprising a material comprising:(a) a composition obtained by blending an isobutylene-based, pre-crosslinked polymer as component (A)(b) at least one polyolefin or a non-crosslinked rubber or a TPV as component (B)(c) at least one polymer having a Tg of 90° C. or higher as component (C) and(d) preferably at least one component (D) selected from the group of: substituted vinyl polymers, styrenic block copolymers, inorganic functionalized and non-functionalized fillers, carbon black, halogen scavengers, preferably the inorganic halogen scavengers, ...

Production of sterile active pharmaceutical ingredients

The invention refers to a process for preparing sterile active pharmaceutical ingredients (APIs) useful in the preparation of sterile product for ophthalmic use. The process comprises the gamma-ray sterilization treatment of the APIs powder in a protective atmosphere.

SYSTEM AND METHOD FOR IDENTIFYING A LANDMARK

A field generator for use in a surgical targeting system is disclosed. The field generator includes a mounting structure including elements that are configured to receive components of an electromagnetic field generator. The elements are disposed on the mounting structure at locations and orientations relative to each other. The field generator includes at least one covering formed over the mounting structure, wherein, in use, the locations and orientations of the elements relative to each other remain substantially unaltered after exposure to one or more sterilization processes. 1. A method comprising:exposing a landmark identifier to a sterilization process, the landmark identifier comprising a mounting structure comprising a plurality of elements that are configured to receive induction coils of an electromagnetic field generator, the plurality of elements disposed on the mounting structure at locations and orientations relative to each other, wherein exposing the landmark identifier does not substantially alter the locations and orientations of the plurality of elements relative to each other.2. The method of claim 1 , further comprising using the landmark identifier to target a landmark of an orthopaedic implant.3. The method of claim 2 , wherein targeting comprises placing the field generator within an operating range of a sensor and using a display of a targeting system for positioning the landmark identifier in a predetermined position relative to the landmark.4. A method of making a landmark identifier claim 2 , the method comprising:forming elements at locations in a mounting structure, the mounting structure comprising a first dimension stable autoclavable material;securing electromagnetic induction coils at orientations in the elements;forming a hole through the mounting structure;securing a coupling member to the mounting structure, the coupling member having a through hole that is aligned with the hole formed through the mounting structure when the ...

Sterilization of medical devices with enhanced antimicrobial properties

The present invention relates to a sterilized medical dressing for treating wounds comprised of a polymer sponge containing an antimicrobial agent and a silicon adhesive secured to the dressing surface. The dressing can be exposed initially to gamma radiation and later sterilized by ethylene oxide or alternatively it can be sterilized by ethylene oxide and later irradiated by gamma radiation. z The sponge dressing can also contain at least one biofilm reducing agent, at least one chelating agent and an ionic and non-ionic surfactant. 1. A sterile device for medical use comprising a shaped polymer structure containing an antimicrobial agent , said shaped polymer structure having been subjected to both gamma radiation and ethylene oxide , and a silicon adhesive secured to said structure surface to hold said structure in a substantially fixed position.2. The sterile device of wherein said polymer is taken from a group of polymers consisting of polyvinyl formal claim 1 , polyvinyl acetal claim 1 , polyurethane claim 1 , or a mixture of polymers.3. The sterile device of wherein said device is a sponge having a morphology characterized by an average pore throat diameter of 0.5-500 μm claim 1 , a fluid retention of 5.5-25.0 mL fluids/g porous material claim 1 , a density of 0.05-0.15 g polymer/cmporous material claim 1 , and a porosity of 60% to 99.5%.4. The sterile device of wherein said device is a dressing sponge which contains biofilm reducing agents taken from a group consisting of amylase enzymes (e.g. amyloglucosidase claim 1 , bacterial amylo novo) claim 1 , protease enzymes (e.g. savinase and everlase) fibrinolytic agents (e.g. plasmin claim 1 , streptokinase claim 1 , and nattokinase claim 1 , and TrypLE) claim 1 , deoxyribonuclease I claim 1 , glycoside hydrolase dispersin B claim 1 , and cellulase.5. The sterile device of wherein said device is a stent.6. The sterile device of wherein said stent is constructed of polyurethane.7. The sterile device of wherein ...

Systems and approaches for sterilizing a drug delivery device

A shielding member for use in sterilizing drug container assemblies includes a housing. The housing includes a first shielding portion and a second shielding portion. The first shielding portion includes a first and second surfaces and a plurality of first bore portions extending between. The second shielding portion having a first and second surfaces and a plurality of second bore portions corresponding to and aligned with the plurality of first bore portions. The first and second bore portions cooperate to form a plurality of receptacles including a plurality of openings in the first surface of the first shielding portion of the housing. The receptacles are sized and configured to receive drug container assemblies, each comprising a container with a container contact region and a seal member disposed adjacent the container contact region to seal the contents of the container at a sealing interface, such that each drug container assembly is exposed out of the housing through one of the openings.

PROPYLENE-ETHYLENE RANDOM COPOLYMER WITH IMPROVED IRRADIATION RESISTANCE

The present invention deals with a new unimodal propylene-ethylene random copolymer providing improved resistance against gamma irradiation as well as compositions comprising the new unimodal propylene-ethylene random copolymer and final articles made therefrom. 1. A unimodal polypropylene random copolymer of propylene and 2.0-4.5 wt.-% of ethylene as comonomer characterised by a comonomer distribution (CD) determined via a-TREF of at most 16.0[-] and being polymerized in the presence of a Ziegler-Natta catalyst , wherein the unimodal polypropylene random copolymer has a Melt Flow Rate determined according to ISO1133 at 230° C. and 2.16 kg (MFR230/2.16) of 10.0 to 25.0 g/10 min.2. The unimodal polypropylene random copolymer according to further characterised by a randomness (Koenig B) of at least 0.8 [-].3. The unimodal polypropylene random copolymer according to claim 1 , having a Melt Flow Rate determined according to ISO1133 at 230° C. and 2.16 kg (MFR230/2.16) of 15.0 to 22.0 g/10 min.4. The unimodal polypropylene random copolymer according to claim 1 , being free of phthalic acid esters as well as their respective decomposition products.5. The unimodal polypropylene random copolymer according to being polymerized in the presence of a Ziegler-Natta catalyst claim 1 , wherein the Ziegler Natta catalyst comprisesa) at least one compound of a transition metal of Group 4 to 6 of IUPAC,b) a Group 2 metal compound,c) an internal donor, wherein said internal donor is a non-phthalic compound,d) optionally a co-catalyst, ande) optionally an external donor.6. The unimodal polypropylene random copolymer according to claim 5 , wherein the internal donor is selected from (di)esters of non-phthalic carboxylic (di)acids claim 5 , 1 claim 5 ,3-diethers claim 5 , derivatives and mixtures thereof.7. A polypropylene random copolymer composition comprising a unimodal polypropylene random copolymer of propylene and 2.0-4.5 wt.-% of ethylene as comonomer claim 5 , wherein the ...

MEDICAL DEVICE AND METHOD FOR PRODUCING A MEDICAL DEVICE

Disclosed herein is an inventive medical device. The medical device includes an implantable device, such as an electrochemical sensor. The implantable device has an implantable portion configured for insertion into a patient, a contact portion configured for connection to another device, and an interconnecting portion connecting the implantable portion and the contact portion. A housing is provided that has a first part that is removably connectable with a second part to form a sterile packaging to seal the implantable portion against a surrounding environment. The first part comprises a first sealing surface and the second part comprises a second sealing surface and the first and second sealing surfaces interact to form a sealing area. The interconnecting portion of the implantable device extends through the sealing area. An inventive method of producing the medical device is also disclosed. 1. A medical device , comprising:an implantable device having (i) an implantable portion adapted for at least partially being implanted into a body tissue of a user, (ii) a contact portion configured for connection to a further component, and (iii) an interconnecting portion connecting the implantable portion and the contact portion; anda housing configured to receive the implantable portion, the housing comprising a first part removably connectable with a second part to form a sterile packaging to seal the implantable portion against a surrounding environment, wherein the first part comprises a first sealing surface and the second part comprises a second sealing surface and the first and second sealing surfaces interact to form a sealing area, wherein the interconnecting portion extends through the sealing area.2. The medical device according to claim 1 , wherein the implantable device comprises at least one of: an implantable sensor for detecting at least one analyte in one or both of a body tissue or a body fluid; a cannula; a tube.3. The medical device according to claim 1 ...

METHOD FOR STERILIZING MEMBRANE COMPRISING AND OXIDOREDUCTASE ENZYME AND ASSOCIATED BIOSENSOR

A method for sterilizing a membrane comprising an oxidoreductase enzyme in an environment having a relative humidity, comprises: irradiating the membrane comprising an oxidoreductase enzyme with gamma radiation under vacuum at a relative humidity lower than the relative humidity of the environment. Associated biosensors are also described. 1. A method for sterilizing a membrane comprising an oxidoreductase enzyme comprising the steps of: a) providing a receptacle containing a desiccant and a membrane comprising an oxidoreductase enzyme; b) evacuating the receptacle and c) irradiating the evacuated receptacle containing the desiccant and the membrane comprising an oxidoreductase enzyme with gamma radiation.2. The method of claim 1 , wherein the receptacle is a flexible bag.3. The method of claim 1 , further comprising a step of sealing the receptacle between step b) and c).4. The method of claim 1 , wherein step b) comprises subjecting the interior of the receptacle to a pressure lower than atmospheric pressure claim 1 , such as a pressure lower than 50 kPa or lower than 25 kPa.5. A method for sterilizing a membrane comprising an oxidoreductase enzyme in an environment having a relative humidity claim 1 , comprising: irradiating the membrane comprising an oxidoreductase enzyme with gamma radiation under vacuum at a relative humidity lower than the relative humidity of the environment.6. The method of claim 5 , wherein the membrane comprising an oxidoreductase enzyme is held under vacuum with the relative humidity of about half of the relative humidity of the environment.7. The method of claim 5 , wherein the vacuum occurs in a vacuum chamber and wherein a desiccant is provided in the vacuum chamber with the membrane comprising an oxidoreductase enzyme while under vacuum.8. The method of claim 1 , wherein the desiccant comprises silica gel claim 1 , activated charcoal claim 1 , calcium sulfate claim 1 , calcium chloride claim 1 , montmorillonite clay claim 1 , and/or ...

RADIATION STERILIZED HYDROGELS, MEDICAL DEVICES INCLUDING RADIATION STERILIZED HYDROGELS AND METHODS OF MAKING THE SAME

Radiation sterilized hydrogels, medical devices containing the same and method of making radiation sterilized hydrogels. 1. A radiation sterilized hydrogel comprising:a hydrocolloid in an amount of below 6 wt %;a carboxylic acid in an amount of above 0.05 wt %; andwater in an amount above about 94 wt %.2. The sterilized hydrogel of claim 1 , wherein the amount of hydrocolloid is about 0.1 wt % to 6 wt %.3. The sterilized hydrogel of claim 1 , wherein the hydrocolloid comprises gellan gum claim 1 , high acyl gellan gum claim 1 , low acyl gellan gum claim 1 , xanthan gum claim 1 , deacetylated xanthan gum claim 1 , depyruvated xanthan gum claim 1 , galactomannans claim 1 , glucomannans claim 1 , or combinations thereof.4. The sterilized hydrogel of claim 1 , wherein the amount of the carboxylic acid is between about 0.05 wt % and about 0.5 wt %.5. The sterilized hydrogel of claim 1 , wherein the carboxylic acid comprises one or more of citric acid claim 1 , sodium citrate claim 1 , tartaric acid claim 1 , oxalic acid claim 1 , poly(acrylic acid) claim 1 , and poly(acrylic acid) sodium salt.6. The sterilized hydrogel of claim 1 , further including an additive(s).7. The sterilized hydrogel of claim 6 , wherein the additive comprises a stain-reducing additive.8. The sterilized hydrogel of claim 6 , wherein the additive comprises a polyol.9. The sterilized hydrogel of claim 8 , wherein the polyol comprises one or more of glycerol claim 8 , polyethylene glycol and xylitol.10. The sterilized hydrogel of claim 6 , wherein the additive comprising a lubricious additive.11. The sterilized hydrogel of claim 10 , wherein the lubricious additive comprises a hydrophilic polymer.12. The sterilized hydrogel of claim 11 , wherein the hydrophilic polymer is crosslinked.13. The sterilized hydrogel of claim 11 , and wherein the hydrophilic polymer comprises polyvinylpyrrolidone.14. The sterilized hydrogel of claim 1 , wherein the hydrogel is sterilized by gamma radiation.15. The ...

METHOD FOR STERILIZING MEMBRANE COMPRISING GLUCOSE OXIDASE AND ASSOCIATED BIO-SENSOR

A method for sterilizing a membrane comprising an oxidoreductase enzyme, comprises: irradiating with gamma radiation the membrane comprising an oxidoreductase enzyme soaked in an aqueous buffer solution. Associated biosensors and bioreactors are also described. 1. A method for sterilizing a membrane comprising an oxidoreductase enzyme , comprising: irradiating with gamma radiation the membrane comprising an oxidoreductase enzyme soaked in an aqueous buffer solution.2. The method of claim 1 , wherein the oxidoreductase enzyme is selected from the group consisting of glucose oxidase claim 1 , lactate oxidase and glutamate oxidase.3. The method of claim 2 , wherein the oxidoreductase enzyme is glucose oxidase.4. The method of claim 1 , wherein the aqueous buffer solution is a phosphate buffer.5. The method of claim 4 , wherein the aqueous buffer solution is a phosphate buffer saline (PBS) solution.6. The method of claim 1 , wherein the aqueous buffer solution is substantially free from organic components.7. A method for sterilizing a membrane comprising glucose oxidase claim 1 , comprising: irradiating with gamma radiation the membrane comprising glucose oxidase soaked in a phosphate buffer saline (PBS) solution.8. The method of claim 1 , wherein a dose of the gamma radiation is in a range of from about 25 kGy to about 40 kGy.9. The method of claim 1 , wherein a rate of the gamma radiation is about 20 kGy/hour.10. The method of claim 1 , wherein the membrane is in a plastic container.11. The method of claim 1 , wherein the membrane is in a biosensor.12. The method of claim 11 , wherein the biosensor comprises a Pt electrode and an Ag/AgCl electrode.13. A biosensor comprising the membrane sterilized using the method of .14. The biosensor of claim 13 , wherein the membrane comprises glucose oxidase and the sensitivity of the biosensor to glucose is about 80% of the sensitivity of a biosensor comprising a membrane comprising glucose oxidase without sterilization to ...

Anti Yellowing Composition

The present invention relates to a radical scavenging and anti-yellowing composition for polymeric materials and compositions containing the same. The invention further relates to medical devices comprising a composition according to the invention and to a method of sterilizing such devices. 1. Composition comprising:i) a polyalkylene glycol and {'br': None, 'sup': 1', '2, 'sub': 2', 'n', '2', 'm', 'p', 'q, '[RO(CO)(CH)]S[(CH)(CO)(A)R]'}, 'ii) a thio compound with the formula (I)'} R is a straight chain, branched or cyclic alkyl group with 1 to 24 carbon atoms,', 'n is an integer from 1 to 6,', 'm is an integer of 1 to 16,', 'p is 1 or 0,', 'A is an oxygen or sulphur atom,', 'q is 1 or 0, and', {'sup': '2', 'Ris a straight chain, branched or cyclic alkyl group with 1 to 24 carbon atoms.'}], 'wherein2. Composition according to claim 1 , wherein the polyalkylene glycol is a polypropylene glycol.3. The composition according to claim 1 , wherein the thio compound has formula (II):{'br': None, 'sup': 1', '2, 'sub': 2', 'v', '2', 'w, '[RO(CO)(CH)]S[(CH)(CO)OR]'} v and w are independently integers from 1 to 6, and', {'sup': 1', '2, 'Rand Rare independently straight chain, branched or cyclic alkyl groups with 1 to 24 carbon atoms.'}], 'wherein4. The composition according to claim 3 , wherein Rand Reach comprise 12 to 18 carbon atoms.5. The composition according to claim 1 , wherein the ratio of the polyalkylene glycol to the thio compound is within the range of 1:1 to 20:1.6. The composition according to further comprising a polymeric component.7. Composition according to claim 6 , wherein the polymeric material is a polycarbonate.8. The composition according to claim 7 , wherein the polycarbonate is an aromatic polycarbonate.9. The composition according to claim 6 , wherein the compounds are present in the following amounts based on the total weight of the composition:polyalkylene glycol: 0.5 to 5 wt. % thio compound: 0.005 to 0.5 wt. % polymeric material: 5 to 99.5 wt. % ...

Oxidation-resistant and wear-resistant polyethylenes for human joint replacements and methods for making them

The present invention presents methods for making oxidation-resistant and wear-resistant polyethylenes and medical implants made therefrom. Preferably, the implants are components of prosthetic joints, e.g., a bearing component of an artificial hip or knee joint. The resulting oxidation-resistant and wear-resistant polyethylenes and implants are also disclosed.

STERILE COMPOSITIONS FOR HUMAN COSMETIC PRODUCTS

Because antimicrobial preservatives used in virtually all cosmetics exhibit degrees of adverse human toxicity that have become of increasing concern, a three element system is disclosed that eliminates the need for cosmetic preservatives and their degradation fragments that may exhibit toxicity. Element comprises a cosmetic formulation not containing any preservative components. Element is an individual unit dose of an Element cosmetic formulation in a microbially-impenetrable disposable container. Element comprises the sterilization of the sealed unit dose disposable container, employing heat or, preferably, employing ionizing radiation. 1. A cosmetic product which comprises:a sealed, single dose package that is impermeable to microorganisms and air comprising a cosmetic formulation within the package;wherein the cosmetic formulation does not contain an antimicrobial additive or a molecular fragment of an antimicrobial additive, andwherein the product is sterile.2. The cosmetic product of claim 1 , wherein the formulation contains at least one free radical scavenger.3. The cosmetic product of claim 1 , wherein the package comprises a metal foil or a metal foil plastic laminate.4. The cosmetic product of claim 2 , wherein the package comprises a metal foil or a metal foil plastic laminate.5. The cosmetic product of claim 4 , wherein the package is a blister package that is heat-sealed.6. The cosmetic product of claim 1 , wherein the package comprises a plastic dispenser.7. The cosmetic product of claim 1 , wherein the formulation is expressible from the package by mechanical compression or by manual squeezing after the package is opened.8. The cosmetic product of claim 1 , wherein the package comprises a single dose syringe dispenser contained in a foil or plastic outer package claim 1 , wherein the syringe comprises one or more barrels or barrel compartments.9. The cosmetic product of claim 8 , wherein the syringe comprises more than one barrel or barrel ...

METHOD FOR STERILIZING MEMBRANE COMPRISING GLUCOSE OXIDASE AND ASSOCIATED BIO-SENSOR

A method for sterilizing a membrane comprising an oxidoreductase enzyme, comprises: irradiating with gamma radiation the membrane comprising an oxidoreductase enzyme soaked in an aqueous buffer solution. Associated biosensors and bioreactors are also described. 1. A method for sterilizing a membrane comprising an oxidoreductase enzyme , comprising: irradiating with gamma radiation the membrane comprising an oxidoreductase enzyme soaked in an aqueous buffer solution.2. The method of claim 1 , wherein the oxidoreductase enzyme is selected from the group consisting of glucose oxidase claim 1 , lactate oxidase and glutamate oxidase.3. The method of claim 2 , wherein the oxidoreductase enzyme is glucose oxidase.4. The method of claim 1 , wherein the aqueous buffer solution is a phosphate buffer.5. The method of claim 4 , wherein the aqueous buffer solution is a phosphate buffer saline (PBS) solution.6. The method of claim 1 , wherein the aqueous buffer solution is substantially free from organic components.7. A method for sterilizing a membrane comprising glucose oxidase claim 1 , comprising: irradiating with gamma radiation the membrane comprising glucose oxidase soaked in a phosphate buffer saline (PBS) solution.8. The method of claim 1 , wherein a dose of the gamma radiation is in a range of from about 25 kGy to about 40 kGy.9. The method of claim 1 , wherein a rate of the gamma radiation is about 20 kGy/hour.10. The method of claim 1 , wherein the membrane is in a plastic container.11. The method of claim 1 , wherein the membrane is in a biosensor.12. The method of claim 11 , wherein the biosensor comprises a Pt electrode and an Ag/AgCl electrode.13. A biosensor comprising the membrane sterilized using the method of .14. The biosensor of claim 13 , wherein the membrane comprises glucose oxidase and the sensitivity of the biosensor to glucose is about 80% of the sensitivity of a biosensor comprising a membrane comprising glucose oxidase without sterilization to ...

STERILIZING CHROMATOGRAPHY COLUMNS

If one sterilizes pre-packed, plastic chromatography columns with an appropriate level of gamma irradiation, the resulting sterile chromatography columns maintain sufficient packing media function and maintain column mechanical properties and pressure ratings. 1. A method of preparing a sterilized packed chromatography column , the method comprising:selecting a tube;adding a packing medium into the tube and closing both ends of the tube to create a packed column; andirradiating the column with a dose of gamma radiation of from at least 8 kGy to about 40 kGy to create a sterilized packed chromatography column.2Staphylococcus. The method of claim 1 , wherein the packing medium is functionalized with one or more of the following: ion exchange groups; multimodal groups possessing hydrophobic and charged properties; metal chelate groups; hydrophobic groups; or protein A (SpA) polypeptides capable of binding to immunoglobulin IgG.3. The method of claim 2 , wherein the ion exchange groups comprise one or more of quaternary amines claim 2 , sulfates claim 2 , and caroboxylates.4. The method of claim 2 , wherein the hydrophobic groups comprise one or more of propyl claim 2 , octyl claim 2 , and phenyl groups.5. The method of claim 2 , wherein the SpA polypeptides comprise a full-length wildtype SpA claim 2 , a recombinant SpA claim 2 , a monomeric SpA polypeptide comprising a SpA domain selected from SpA domains A claim 2 , B claim 2 , C claim 2 , D claim 2 , E claim 2 , or Z claim 2 , or a multimeric SpA polypeptide comprising any two claim 2 , three claim 2 , four claim 2 , five claim 2 , or more SpA domains claim 2 , in any combination claim 2 , selected from SpA domains A claim 2 , B claim 2 , C claim 2 , D claim 2 , E claim 2 , or Z claim 2 , or a functional equivalent thereof.6. The method of claim 5 , wherein the SpA polypeptide comprises a multimeric SpA polypeptide.7. The method of claim 6 , wherein the multimeric SpA polypeptide comprises four or five SpA domains ...

Methods and Systems for Removing Pressure and Air from Chromatography Columns

Methods and systems for removing gases and/or pressure formed during the sterilization, e.g., the gamma irradiation, of prepacked chromatography systems (column plus attached tube and valve set) are described. The methods include purging the gas and/or pressure through specially designed tube and valve sets without breaching the sterility of the prepacked sterile chromatography system. The systems include a sterile or aseptic pre-packed chromatography column including a column having an inlet and an outlet, a tubing and valve set attached to the inlet and the outlet, and a pump configured to pump sterile or aseptic liquid from the fluid source along the tubing and valve set, into the column tube inlet and out of the column tube outlet along a first flow path, thereby removing any entrapped gas and/or pressure from the chamber. 1. A method of removing entrapped gas , pressure , or both gas and pressure from a pre-packed chromatography column having a chamber , and a column tube having a column tube inlet and a column tube outlet , the method comprising: tubing, a tubing inlet, a tubing outlet, a first valve disposed between the tubing inlet and the column tube inlet, and a second valve disposed between the column tube outlet and the tubing outlet, the tubing and valve set configured to define at least two different fluid paths each fluidly connected to the column tube inlet and the column tube outlet; and', 'first and second tubing branches connected between the tubing inlet and the tubing outlet, a third valve disposed in the first tubing branch, and a fourth valve disposed in the second tubing branch,, '(a) obtaining a tubing and valve set comprising (i) attaching the tubing inlet of the tubing and valve set to the column tube inlet and attaching the tubing outlet to the column tube outlet and then sterilizing the connected pre-packed chromatography column and the tubing and valve set, or', '(ii) sterilizing the pre-packed chromatography column and the tubing and ...

Method for the Sterilzation of Chromatographic Material and Chromatographic Material Sterilized According to said Method

The present invention relates to a method for sterilizing a chromatography material, more particularly microporous polymer membranes, to a chromatography material which has been sterilized by the method according to the invention, to the use of the chromatography material sterilized according to the invention for the chromatographic removal of contaminants from a fluid, and to a closed chromatographic filtration system comprising a chromatography material sterilized according to the invention.

Method of manufacturing an implantable film and prothesis comprising such a film

A method for manufacturing an implantable film and a prosthesis comprising such a film The present invention relates to a method for manufacturing a non porous film intended to be implanted in the human body, said method comprising the following steps: preparation of a first film, called intermediate film, via gelling of a starting solution comprising at least one polymer selected in the group consisting of collagen, glycosaminoglycans, and mixtures thereof, immersion of said intermediate film in an alkaline composition comprising at least one C 1 -C 4 alcohol, drying of the film obtained at the end of the immersing step. The invention also relates to a method for manufacturing a prosthesis comprising a textile support and such a film.

NATIVE SOFT TISSUE MATRIX FOR THERAPEUTIC APPLICATIONS

A method is used for preparing a product for use in repairing a lesion or defect at a tissue site in a human or animal patient body. The method includes obtaining tissue from a donor human or animal body and freezing the obtained tissue. The method further includes pulverizing the frozen tissue and suspending the pulverized tissue in a fluid. The method further includes homogenizing the tissue suspension and precipitating tissue particles from the homogenized tissue suspension. The method further includes re-suspending the precipitated tissue particles and lyophilizing the tissue re-suspension to provide the product to be used in repairing the lesion or defect. 1. A method for preparing a product for use in repairing a lesion or defect at a tissue site in a human or animal patient body , the method comprising:obtaining tissue from a donor human or animal body;freezing the obtained tissue;pulverizing the frozen tissue;suspending the pulverized tissue in a fluid;homogenizing the tissue suspension;precipitating tissue particles from the homogenized tissue suspension;re-suspending the precipitated tissue particles; andlyophilizing the tissue re-suspension to provide the product to be used in repairing the lesion or defect.2. The method of claim 1 , further comprising:rehydrating the lyophilized tissue to form a slurry.3. The method of claim 2 , further comprising:forming a porous solid scaffold consisting of the slurry.4. The method of claim 3 , wherein:forming the porous solid scaffold includes molding the slurry to have a size and geometry determined by the tissue site.5. The method of claim 4 , wherein: casting the slurry into a mold,', 'cross-linking the cast slurry, and', 'freeze-drying the cross-linked slurry., 'molding the slurry includes6. The method of claim 1 , wherein:the obtained tissue is a substantially non-mineralized soft tissue.7. The method of claim 6 , wherein:the substantially non-mineralized soft tissue is a same type of tissue as a tissue at the ...

NATIVE SOFT TISSUE MATRIX FOR THERAPEUTIC APPLICATIONS

A product for implantation within a soft tissue site of the human or animal body comprises a matrix of pulverized or morselized substantially non-mineralized native soft tissue (NSTM) of the human or animal body, provided in a therapeutic amount to induce growth of native tissue or organs and healing at the tissue site. The NSTM is composed of at least one soft tissue selected from the group consisting of cartilage, meniscus, intervertebral disc, ligament, tendon, muscle, fascia, periosteum, pericardium, perichondrium, skin, nerve, blood vessels, and heart valves or from organs such as bladder, lung, kidney, liver, pancreas, thyroid, or thymus. Preferably, the NSTM is composed of a soft tissue of the same type of tissue native to the repair site. 1. A product for introduction within a soft tissue site of the human body , comprising a suspension of a native soft tissue matrix (NSTM) consisting of a morselized or pulverized substantially non-mineralized native soft tissue of the human body , said NSTM suspended in a volume of a biologically compatible fluid such that the concentration of the NSTM is 10-20% w/v , wherein the suspension is operable to promote cellular growth within and through the NSTM.2. The product of claim 1 , wherein said biologically compatible fluid is selected from the group consisting of saline solution claim 1 , a pharmaceutical solution claim 1 , synovial fluid claim 1 , blood serum claim 1 , blood plasma claim 1 , a chondrocyte suspension claim 1 , a mesenchymal cell (MSC) suspension claim 1 , and an adipose-derived adult stem (ADAS) cell suspension.3. The product of claim 1 , wherein said biologically compatible fluid is selected from the group consisting of collagen claim 1 , gelatin claim 1 , serum claim 1 , fibrin claim 1 , hyaluronic acid claim 1 , proteoglycans and elastin.4. The product of claim 1 , wherein said NSTM is composed of at least one soft tissue selected from the group consisting of cartilage claim 1 , meniscus claim 1 , ...

AQUEOUS RADIATION PROTECTING FORMULATIONS AND METHODS FOR MAKING AND USING THEM

Medical devices are typically sterilized in processes used to manufacture such products and their sterilization by exposure to radiation is a common practice. Radiation has a number of advantages over other sterilization processes including a high penetrating ability, relatively low chemical reactivity, and instantaneous effects without the need to control temperature, pressure, vacuum, or humidity. Unfortunately, radiation sterilization can compromise the function of certain components of medical devices. For example, radiation sterilization can lead to loss of protein activity and/or lead to bleaching of various dye compounds. Embodiments of the invention provide methods and materials that can be used to protect medical devices from unwanted effects of radiation sterilization. 1. A composition of matter comprising: a saccharide binding polypeptide having a carbohydrate recognition domain; and', 'an aqueous radioprotectant formulation comprising:', 'a saccharide, wherein the saccharide is bound to the carbohydrate recognition domain; and', 'an antioxidant compound, wherein the antioxidant compound is selected from the group consisting of ascorbate, urate, nitrite, vitamin E, α-tocopherol or nicotinate methylester., 'a saccharide sensor comprising2. The composition of claim 1 , wherein the fluorophore quenching composition comprises acetaminophen.3. The composition of claim 2 , wherein the aqueous radioprotectant formulation comprises acetaminophen in a concentration of at least 1 mM to 50 mM.4. The composition of claim 1 , wherein the aqueous radioprotectant formulation comprises:a fluorophore; anda fluorophore quenching composition.5. The composition of claim 1 , wherein the aqueous radioprotectant formulation comprises ascorbate in a concentration of at least 1 mM to 100 mM.6. The composition of claim 1 , wherein the saccharide is selected from the group consisting of glucose claim 1 , mannose claim 1 , fructose claim 1 , melizitose claim 1 , N-acetyl-D- ...

SYSTEM AND METHOD FOR PACKAGING A BIOPROCESSING BAG AND ASSOCIATED COMPONENTS, AND PACKAGING FOR A BIOPROCESSING BAG

A packaging for a bioprocessing bag includes a housing having an open interior space, and a support base attached to an external side of the housing, the support base having a recess for receiving an impeller base plate of a bioprocessing bag. 1. A packaging for a bioprocessing bag , comprising:a housing having an open interior space; anda support base attached to an external side of the housing, the support base having a recess for receiving an impeller base plate of a bioprocessing bag.2. The packaging of claim 1 , wherein:the housing includes at least one open end providing access to the open interior space.3. The packaging of claim 1 , wherein:the recess of the support base corresponds in shape to a shape of the impeller base plate of the bioprocessing bag.4. The packaging of claim 1 , further comprising:a handle configured to attachment to the bioprocessing bag via clips of the bioprocessing bag;wherein the handle is configured for selective decoupling from the bioprocessing bag.5. The packaging of claim 1 , wherein:the housing is selectively positionable in a first state, wherein sides of the housing are oriented so as to define the open interior space, and a second state, wherein all sides of the housing lay substantially flat on a surface allowing for inspection of the bioprocessing bag.6. The packaging of claim 1 , wherein:the housing is formed from corrugated plastic.7. The packaging of claim 6 , wherein:the support base is formed from a high-density, closed-cell foam.8. A kit claim 6 , comprising:a flexible bioprocessing bag having an impeller base plate for receiving an impeller; anda packaging having a housing having an open interior space and a support base attached to an external side of the housing;wherein the impeller base plate and drain tubing of the bioprocessing bag are received in a recess in the support base.9. The kit of claim 8 , wherein:the bioprocessing bag includes sparge tubing;wherein the sparge tubing is positioned in the open interior ...

METAL MESH, STERILIZATION DETERMINATION METHOD, AND CLEANING DETERMINATION METHOD

A metal mesh has a plurality of through-holes. A photosensitive organic material is attached to at least part of the metal mesh. The metal mesh is sterilized and/or cleaned. A determination of whether or not the sterilization and/or cleaning has been successful is made by analyzing the photosensitive organic material attached to the metal mesh. 1. A combination comprising a metal mesh having a plurality of through-holes and a photosensitive organic material attached to at least part of the metal mesh.2. The combination according to claim 1 , wherein the photosensitive organic material is a radiation-sensitive organic material that undergoes a modification in response to radiation exposure.3. The combination according to claim 1 , wherein the photosensitive organic material is a polymer compound that produces polymer radicals when exposed to radiation.4. The combination according to claim 3 , wherein the radiation is gamma-ray radiation.5. The combination according to claim 1 , wherein the photosensitive organic material is attached to at least part of inner walls of the plurality of through-holes.6. The combination according to claim 1 , wherein the photosensitive organic material is attached to only inner walls of the plurality of through-holes.7. The combination according to claim 6 , wherein the through-holes have corners and the photosensitive organic material is attached only to the corners.8. A sterilization determination method for determining whether a metal mesh has been sterilized claim 6 , the method comprising:attaching a photosensitive organic material to at least part of the metal mesh;sterilizing the metal mesh; anddetermining whether the metal mesh has been sterilized on a basis of a modification of the photosensitive organic material.9. The sterilization determination method according to claim 8 , wherein the determination of whether the metal mesh has been sterilized involves measuring absorbances of the photosensitive organic material both before ...

WETTING MEDIA OF GLYCEROL AND BUFFER

Medical device comprising a hydrophilic coating, sterilised while in contact with a swelling medium comprising a low molecular polyol; and a separate buffer selected from the group consisting of carboxylic acids, amino acids, aminosulphonic acids and inorganic acids. The swelling media provides a stable pH after sterilisation and maintain the low friction of the coating. 1. Medical device comprising a hydrophilic coating , sterilised while in contact with a swelling medium comprising:a) a low molecular polyol; andb) a separate buffer selected from the group consisting of carboxylic acids, amino acids, aminosulphonic acids and inorganic acids.2. Medical device according to claim 1 , wherein the medical device is a hydrophilic coated catheter.3. Medical device according to claim 1 , wherein the hydrophilic coating is a PVP coating.4. Medical device according to claim 1 , sterilised using radiation.5. Medical device according to claim 1 , wherein the low molecular polyol has a molecular weight below 200 g/mol.6. Medical device according to claim 1 , wherein the low molecular polyol is present in the swelling medium in a concentration of 0.1% to 20%.7. Medical device according to wherein the low molecular polyol is glycerol.8. Medical device according to claim 1 , wherein the separate buffer is a non-polymeric buffer.9. Medical device according to claim 1 , wherein the separate buffer is a buffer with at least one pKvalue between 2.7 and 5.10. Medical device according to claim 1 , wherein the buffer capacity is below 4 mM from pH 4 to pH 7.4.11. A sterilised set comprising a medical device comprising a hydrophilic coating in contact with an aqueous liquid comprising:a) a low molecular polyol;b) a separate buffer;wherein said set has been sterilised using irradiation while in contact with said liquid.12. Sterilised set according to claim 11 , wherein the device is a hydrophilic coated catheter.13. Sterilised set according to claim 11 , wherein the hydrophilic coating ...

Drug delivery systems with sealed and sterile fluid paths and methods of providing the same

The present disclosure relates generally to the field of drug delivery. In particular, the present disclosure relates to a drug delivery system that includes a sealed and sterile fluid path attached to a drug-loaded container. The disclosure further relates to methods for sterilizing a portion of the drug delivery system without exposing the drug-loaded container to harmful sterilization parameters.

A fault-tolerant endovascular inflation device

An endovascular device for providing at least partial occlusion in a blood vessel in a subject, e.g. for improving Cardiopulmonary Resuscitation. The device comprises a balloon catheter to be inserted in a blood vessel for inflation therein. To increase the flexibility and safety in use of the device and to enable use under controlled and less controlled environments, the device comprises a first interfacing means configured to connect to a first manually operated inflation means and being in fluid communication with a junction; a second interfacing means configured to connect to a second power controlled inflation means and also being in fluid communication with the junction, and an electronic control unit configured to receive the occlusion parameter from the sensor and to provide an instruction set for manually operated inflation or for automatically operated inflation based on the occlusion parameter. 1. An endovascular device for providing at least partial occlusion in a blood vessel in a subject , the device comprising:an elongated body extending between a proximal end and a distal end, the distal end being insertable into the blood vessel, an inflatable member formed about the elongated body and configured to expand upon receipt of a fluid medium from an inflation means,a sensor for sensing an occlusion parameter in the blood vessel,an inflation conduit providing fluid communication between the inflatable member and a junction,a first interfacing means configured to connect to a first manually operated inflation means and being in fluid communication with the junction;{'b': '10', 'a second interfacing means configured to connect to a second power controlled inflation means and being in fluid communication with the junction (), and;'}an electronic control unit configured to receive the occlusion parameter from the sensor and to provide an instruction set for manually operated inflation or for automatically operated inflation based on the occlusion parametera ...

Packaging for adhesive compositions

A package system suitable for sterilizing cyanoacrylate compositions and providing the sterile cyanoacrylate compositions a shelf life of at least 24 months, wherein the package system comprises: an ampoule comprising a chamber comprising a cyanoacrylate monomer, wherein the chamber is defined by an opening and sidewalls, wherein the ampoule comprises a material comprising a cyclic olefin copolymer; a multilayer foil seal sealing the opening of the ampoule; and a secondary package housing the ampoule.

Calibrator For A Sensor

A calibrator, for calibrating a sensor, has a calibration chamber for containing a calibration liquid. The liquid comprises water or an aqueous solution of an analyte to be sensed. A hydrogen peroxide-quenching material is provided exposed to the interior of the calibration chamber. The hydrogen peroxide-quenching material contacts the calibration liquid. After the calibration chamber containing the calibration liquid is sterilized by irradiation with gamma radiation, the hydrogen peroxide-quenching material decomposes any hydrogen peroxide formed in the calibration liquid to avoid adverse effects on a sensor placed in contact with the calibration liquid.

Sterile chromatography and manufacturing processes

Provided herein are methods of performing chromatography with gamma-irradiated chromatography resin that include providing a chromatography column including a gamma-irradiated chromatography resin; performing a first cycle of chromatography through the column, where the cycle includes exposing the chromatography resin to a denaturing buffer; and performing at least one additional cycle of chromatography through the column. Also provided are integrated, closed or substantially closed, and continuous processes for manufacturing of a recombinant protein that include the use of at least one chromatography column including gamma-irradiated chromatography resin, where the gamma-irradiated chromatography resin is exposed to denaturing buffer during each cycle in the process, and reduced bioburden buffer is used in the process.

Sterile Chromatography Resin and Use Thereof in Manufacturing Processes

Provided herein are methods of reducing bioburden of (e.g., sterilizing) a chromatography resin that include exposing a container including a composition including a chromatography resin and at least one antioxidant agent and/or chelator to a dose of gamma-irradiation sufficient to reduce the bioburden of the container and the chromatography resin, where the at least one antioxidant agent and/or chelator are present in an amount sufficient to ameliorate the loss of binding capacity of the chromatography resin after/upon exposure to the dose of gamma-irradiation. Also provided are reduced bioburden chromatography columns including the reduced bioburden chromatography resin, compositions including a chromatography resin and at least one chelator and/or antioxidant agent, methods of performing reduced bioburden column chromatography using one of these reduced bioburden chromatography columns, and integrated, closed, and continuous processes for reduced bioburden manufacturing of a purified recombinant protein. 1. A method of reducing bioburden of a chromatography resin comprising:exposing a container comprising a composition comprising a chromatography resin and at least one antioxidant agent and/or chelator to a dose of gamma-irradiation sufficient to reduce the bioburden of the container and the chromatography resin, wherein the at least one antioxidant agent and/or chelator is present in an amount sufficient to ameliorate the loss of binding capacity of the chromatography resin after exposure to the dose of gamma-irradiation.2. The method of claim 1 , wherein the container is a storage vessel.3. The method of claim 1 , wherein the container is a chromatography column.4. The method of claim 1 , wherein the container is a packed chromatography column.5. The method of claim 1 , wherein the composition is a slurry of sedimented chromatography resin in a liquid comprising the at least one antioxidant agent and/or chelator.6. The method of claim 1 , wherein the ...

SYSTEM AND METHOD OF STERILELY CONNECTING FLUID PATHWAYS

A sterile tube connector for a fluid circuit system comprising a housing. A first opening is configured to receive a first length of tubing in communication with a first chamber. A second opening is configured for communicating with the first chamber when the tube connector is in an open configuration but not in a closed configuration. The second opening is configured to reversibly engage a third opening to form a second chamber. The third opening is configured for communicating with a second length of tubing. A first portion of the housing forming the first opening comprises a material at least partially permeable to a sterilization energy source for sterilizing contents of the second chamber. 1. A tube connector for a fluid circuit system comprising: a first opening configured to receive a first length of tubing in communication with a first chamber;', 'a second opening configured for communicating with the first chamber when the tube connector is in an open configuration but not in a closed configuration;', 'a third opening configured to receive a second length of tubing in communication with a second chamber;', 'a fourth opening configured for communicating with the second chamber when the tube connector is in the open configuration but not in the closed configuration;, 'a housing comprisingwherein the second opening and the fourth opening are configured to engage each other to form a third chamber.2. The tube connector of claim 1 , wherein the housing comprises:a first sub-housing comprising the first opening, the second opening, and the first chamber; anda second sub-housing comprising the third opening, the fourth opening, and the second chamber;wherein at least a portion of the first and/or second sub-housings comprises a material comprising at least one of cyclic olefin copolymer (COC), poly(methyl methacrylate), polymethylpentene, and quartz glass.3. The tube connector of claim 2 , wherein the first and second sub-housings each comprises a connector ...

CURED GEL AND METHOD OF MAKING

A cured non-polymeric gel including a plurality of non-polymeric cross-links. The non-polymeric cross-links result from curing an oil or oil composition at selected curing conditions to achieve a desired amount of cross-linking to form the non-polymeric gel. The desired amount of cross-linking is selected based on a desired rate of degradation of the gel after the gel is implanted. The oil or oil composition comprises one or more of eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA), or alpha-linolenic acid (ALA). 110-. (canceled)11. A method of forming a cured non-polymeric gel , comprising:determining a desired amount of non-polymeric cross-linking desired within an oil or oil composition, the oil or oil composition comprising one or more of eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA), or alpha-linolenic acid (ALA); andcuring the oil or oil composition with selected curing conditions to achieve a sufficient amount of non-polymeric cross-linking within the oil or oil composition, so as to form the non-polymeric gel, wherein the cured non-polymeric gel comprises a plurality of non-polymeric cross-links resulting from curing the oil or oil composition at the selected curing conditions to achieve the sufficient amount of cross-linking to form the cured non-polymeric gel, wherein the amount of cross-linking is selected based on a desired rate of degradation of the gel after the gel is implanted within a patient, and wherein the oil or oil composition comprises one or more of eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA), or alpha-linolenic acid (ALA).12. The method of claim 11 , wherein the gel further comprises at least one therapeutic agent and the method further comprises releasing the therapeutic agent from the gel at a predetermined rate determined by the curing at the selected curing conditions.13. The method of claim 11 , wherein the oil or oil composition comprises at least one component selected from a group of components consisting ...

METHOD FOR PRODUCING STERILIZED MEDICAL FORMED ARTICLE

A method is disclosed for producing a sterilized medical formed article that includes applying high-energy rays to a medical formed article at an exposure E. The medical formed article is formed of a resin composition that includes a hydrogenated block copolymer and a phenol-based antioxidant. The hydrogenated block copolymer is obtained by hydrogenating 99% or more of unsaturated bonds of a block copolymer that includes at least two polymer blocks [A] and at least one polymer block [B], the polymer block [A] including a repeating unit derived from an aromatic vinyl compound as a main component, the polymer block [B] including a repeating unit derived from a linear conjugated diene compound as a main component, and a ratio (wA:wB) of a weight fraction wA of the polymer block [A] to a weight fraction wB of the polymer block [B] being 30:70 to 70:30. 2. The method for producing a sterilized medical formed article according to claim 1 , wherein the high-energy rays are γ-rays or electron beams.3. The method for producing a sterilized medical formed article according to claim 1 , wherein the high-energy rays are applied in a state in which the medical formed article is contained in an airtight container that is formed of a resin film. The present invention relates to a method for producing a sterilized medical formed article that includes sterilizing a medical formed article by applying high-energy rays, the medical formed article being formed of a resin composition that includes a specific hydrogenated block copolymer and a specific amount of a phenol-based antioxidant.A sterilization process that applies high-energy rays has an advantage in that medical formed articles can be sterilized all together in a state in which the medical formed articles are packed in a cardboard box or a plastic case used for transportation, for example. Therefore, such a sterilization process is widely used as a simple and reliable sterilization method.It is known that a hydrogenated block ...

PEROXIDE CROSS-LINKING OF POLYMERIC MATERIALS IN THE PRESENCE OF ANTIOXIDANTS

Methods of chemically cross-linking antioxidant-stabilized polymeric material are provided. In one example embodiment, peroxide cross-linking can be used to improve wear resistance and the addition of antioxidant can be used to improve oxidation resistance of ultra-high molecular weight polyethylene. A balance between the amounts of peroxide(s) and antioxidant(s) in the polymeric material can ensure that enough cross-linking is achieved for wear reduction and that enough antioxidant is incorporated for improved long-term oxidative stability. In one example embodiment, peroxide(s) can be diffused into a consolidated polymeric material for cross-linking. In another embodiment, polymeric material is consolidated with a vinyl silane, an antioxidant, and a free radical initiator, and the consolidated polymeric material is contacted with water thereby forming an oxidation resistant, cross-linked polymeric material. Such materials can be used in orthopedic applications such as bearing surfaces in total joint implants, including total hips, total knees, total shoulders, and other total joints. 1194-. (canceled)195. A method of making an oxidation resistant , cross-linked polymeric material , the method comprising:(a) blending a polymeric material with an antioxidant and a cross-linking agent such that the antioxidant is present in the polymeric material at a concentration of from 0.1 to 2 wt % by weight of the polymeric material and such that the cross-linking agent is present in the polymeric material at a concentration of from 0.5 to 2 wt % by weight of the polymeric material; and(b) consolidating the polymeric material thereby forming a consolidated, antioxidant and cross-linking agent-blended polymeric material.196. The method of wherein the antioxidant and cross-linking agent-blended polymeric material is further heated claim 195 , wherein:{'sub': 1', '10, 'the heating is done to a temperature T at about or above (i) a temperature Tat which one-half of a quantity of ...

Method for virus filtration of von willebrand factor

The present invention relates to a method of filtrating a solution comprising von Willebrand Factor (VWF), the method comprising (a) providing a solution comprising VWF and a basic amino acid; and (b) subjecting the solution of step (a) to a virus filtration through a filter having a pore size of less than or equal to 35 nm.

STERILIZATION PACKAGING, A METHOD FOR PACKAGING A PRODUCT THEREIN, AND A METHOD FOR THE REMOVAL OF A PRODUCT FROM SAID PACKAGING

Packaging for sterile packaging a product, comprising a bag shaped body with two main surfaces that are mutually gas tight at at least part of their peripheral edges comprising a gas non-permeable material. At least part of the main surfaces comprises a gas permeable material part of a pore size that locks out harmful organisms and comprises a gas tight material part that is positioned between two peripheral edges that extend in a longitudinal direction and between the gas permeable material part and a peripheral edge that extends in a transverse direction. 1. A packaging for sterile packaging a product , comprising a bag shaped body comprising two main surfaces that are connected mutually gastight at at least part of their peripheral edges comprising a for gas non permeable material , wherein at least part of said main surfaces on the one hand comprises a gas permeable material part of a pore size that locks out harmful organisms , and on the other hand comprises a gastight material part that is positioned be-tween two peripheral edges that extend in a longitudinal direction and between said gas permeable material part and a peripheral edge that extends in a transverse direction , wherein said gas tight material part is releasably connected to said peripheral edges that extend in a longitudinal direction and to said gas permeable material or wherein said gas permeable material is rigidly connected to said gas tight material part and releasably connected to said gas tight material part , and wherein said gas permeable material part and said gas tight material part are releasably connected at peripheral edges.2. The packaging according to claim 1 , wherein said peripheral edge comprises a foldable edge.3. The packaging according to claim 1 , wherein said gas permeable material part is positioned at an inside of said gas tight material part and at a distance from the peripheral edge of said gas permeable material part has been connected thereto.4. The packaging ...

Systems and approaches for sterilizing a drug delivery device

A shielding member for use in sterilizing drug container assemblies includes a housing. The housing includes a first shielding portion and a second shielding portion. The first shielding portion includes a first and second surfaces and a plurality of first bore portions extending between. The second shielding portion having a first and second surfaces and a plurality of second bore portions corresponding to and aligned with the plurality of first bore portions. The first and second bore portions cooperate to form a plurality of receptacles including a plurality of openings in the first surface of the first shielding portion of the housing. The receptacles are sized and configured to receive drug container assemblies, each comprising a container with a container contact region and a seal member disposed adjacent the container contact region to seal the contents of the container at a sealing interface, such that each drug container assembly is exposed out of the housing through one of the openings.

PACKAGING FOR ADHESIVE COMPOSITIONS

A package system suitable for sterilizing cyanoacrylate compositions and providing the sterile cyanoacrylate compositions a shelf life of at least 24 months, wherein the package system comprises: an ampoule comprising a chamber comprising a cyanoacrylate monomer, wherein the chamber is defined by an opening and sidewalls, wherein the ampoule comprises a material comprising a cyclic olefin copolymer; a multilayer foil seal sealing the opening of the ampoule; and a secondary package housing the ampoule. 1. A package system suitable for sterilizing cyanoacrylate compositions and providing the sterile cyanoacrylate compositions a shelf life of at least 24 months , wherein the package system comprises:a container comprising a chamber comprising a cyanoacrylate monomer, wherein the chamber is defined by an opening and sidewalls, wherein the container comprises a material comprising a cyclic olefin copolymer;a multilayer foil seal sealing the opening of the container; anda secondary package housing the container.2. The package system of wherein the cyclic olefin copolymer is a copolymer of an unsaturated cyclic monomer and at least one unsaturated linear monomer.3. The package system of wherein the unsaturated cyclic monomer is selected from cyclopentadiene and its derivatives.4. The package system of wherein the derivatives are selected from the group consisting of dicyclopentadiene claim 3 , 2 claim 3 ,3- dihydrocyclopentadiene; 5 claim 3 ,5-dimethyl-2-norbornene claim 3 , 5-butyl-2-norbornene claim 3 , 5-ethylidene-2-norbornene claim 3 , norbornene claim 3 , 5-methyl-2-norbornene claim 3 , 5-methoxycarbonyl-2-norbornene claim 3 , 5-cyano-2-norbornene claim 3 , 5-methyl-5-methoxycarbonyl-2-norbornene claim 3 , 5-phenyl-2-norbornene claim 3 , and combinations thereof.5. The package system of wherein the unsaturated linear monomers are alpha-olefins having from 1 to 20 carbon atoms.6. The package system of wherein the unsaturated linear monomers are alpha-olefins having ...

METHOD FOR STERILIZING A MEDICAL DEVICE

A method of producing a ready-to-use medical device with a functional coating includes the steps of bringing the medical device, at least with its functional coating, in contact with a composition which prevents or retards degradation of the functional coating and sterilizing the medical device and the composition via radiation. A method leads to an improved product, namely an improved ready-to-use medical device which does not suffer a loss of quality during sterilization and storage. The composition comprises carboxymethyl cellulose or a derivative or salt thereof and/or an antioxidant selected from gallic acid or a derivative thereof. 1. A method of producing a ready-to-use medical device with a functional coating , comprising:bringing the medical device, at least with its functional coating, in contact with a composition which prevents or retards degradation of the functional coating; andsterilizing the medical device and the composition via radiation,wherein the composition comprises carboxymethyl cellulose or a derivative or salt thereof and/or an antioxidant selected from gallic acid or a derivative thereof.2. The method according to claim 1 , wherein the antioxidant of the composition is an ester claim 1 , amide or oxadiazole derivative of gallic acid.3. The method according to claim 1 , wherein gallic acid or a derivative thereof is present in the composition in an amount of 0.001% to 5% by weight based on the total weight of the composition.4. The method according to wherein the composition comprises the sodium salt of carboxymethyl cellulose.5. The method according to claim 1 , wherein carboxymethyl cellulose or a derivative or salt thereof is present in an amount of 0.1% to 10% by weight based on the total weight of the composition.6. The method according to claim 1 , wherein the composition comprises carboxymethyl cellulose or a derivative or salt thereof and gallic acid or a derivative thereof selected from an ester claim 1 , amide or oxadiazole ...

Endoscope and endoscope cap

To provide an endoscope or the like capable of realizing a large raising angle. The endoscope includes: a channel outlet open to a distal end side of an insertion portion; a raising base capable of raising a treatment tool protruding from the channel outlet; and a curved portion which protrudes from a peripheral edge portion of the channel outlet toward the distal end side of the insertion portion and is capable of coming into contact with the treatment tool raised by the raising base. The raising base presses the treatment tool on the distal end side of a contact portion between the treatment tool and the curved portion.

ENDOSCOPE CAP AND METHOD OF STERILIZING ENDOSCOPE CAP

To provide an endoscope cap with a raising base or the like which is easily attached and detached to and from a distal end of an endoscope. 1. An endoscope cap supplied in a state of being enclosed in an individual packaging member , the endoscope cap comprising:a cover that is attachable and detachable to and from a distal end of an insertion portion of an endoscope including a lever which is rotatably provided at the distal end of the insertion portion of the endoscope and a rotating portion which rotates the lever; anda raising base that has a lever connection portion connected to the lever and is rotatably provided inside the cover.2. The endoscope cap according to claim 1 , whereinthe endoscope cap is supplied in a state where a plurality of the individual packaging members has been placed in a packaging box and then subjected to a sterilization process.3. The endoscope cap according to claim 2 , whereinthe sterilization process is performed using a radioactive ray or gas.4. A method of sterilizing an endoscope cap claim 2 , comprising:enclosing an endoscope cap in an individual packaging member, the endoscope cap including a bottomed tubular cover that is attachable and detachable to and from a distal end of an insertion portion of an endoscope including a lever which is rotatably provided at the distal end of the insertion portion of the endoscope and a rotating portion which rotates the lever, and a raising base that has a lever connection portion connected to the lever and is rotatably provided inside the cover;placing a plurality of the individual packaging members in a packaging box; andperforming a sterilization process from an outside of the packaging box.5. The method of sterilizing the endoscope cap according to claim 4 , whereinthe sterilization process is performed using a radioactive ray or gas. This application is the national phase under 35 U.S.C. § 371 of PCT International Application No. PCT/JP2017/037178 which has International filing date of ...

METHOD AND DEVICE FOR PACKAGING ELASTOMER PARTS

A packaging method for packaging elastomer parts (), such as stoppers for pharmaceutical containers, the method comprising the following steps: 11. A packaging method for packaging elastomer parts () , such as stoppers for pharmaceutical containers , the method comprising the following steps:{'b': 1', '10, 'packaging parts () in a primary bag () made of material that is substantially impermeable to air; and'}{'b': '10', 'applying in said primary bag (), a nitrogen-based atmosphere, with at least 80% nitrogen;'}{'b': 10', '20', '10', '20, 'the method being characterized in that said primary bag () is packaged in a secondary bag (), with a vacuum being applied between said primary bag () and said secondary bag ().'}210. A method according to claim 1 , wherein the atmosphere applied in said primary bag () contains at least 90% nitrogen.310. A method according to claim 2 , wherein the atmosphere applied in said primary bag () contains 100% nitrogen.410. A method according to claim 1 , wherein the atmosphere applied in said primary bag () is constituted substantially of nitrogen and of oxygen.510. A method according to claim 1 , wherein said primary bag () that is substantially impermeable to air comprises polyethylene or aluminum.620. A method according to claim 1 , wherein said secondary bag () comprises a plurality of layers claim 1 , in particular a three-layer polyethylene/polyamide/polyethylene (PE/PA/PE) structure.71. A packaging method for packaging elastomer parts () claim 1 , such as stoppers for pharmaceutical containers claim 1 , the method comprising the following steps:{'b': 1', '10, 'packaging parts () in a primary bag () made of material that is permeable to air;'}{'b': 10', '20, 'packaging said primary bag () in a secondary bag () made of material that is substantially impermeable to air; and'}{'b': '20', 'applying in said secondary bag (), a nitrogen-based atmosphere, with at least 80% nitrogen;'}{'b': 20', '30', '20', '30, 'the method being ...

Method for Packing Chromatography Columns

The invention discloses a method for packing a plurality of uniform chromatography columns, comprising the steps of: a) providing a plurality of chromatography columns; b) providing a plurality of chromatography resin aliquots; c) packing the chromatography resin aliquots in the chromatography columns to provide a plurality of packed chromatography columns; and d) subjecting the packed chromatography columns to repeated mechanical impacts to provide a plurality of uniform chromatography columns. 1. A method for packing a plurality of uniform chromatography columns , comprising the steps of:a) providing a plurality of chromatography columns;b) providing a plurality of chromatography resin aliquots;c) packing said chromatography resin aliquots in said chromatography columns to provide a plurality of packed chromatography columns; andd) subjecting said packed chromatography columns to repeated mechanical impacts.2. A method for packing a plurality of uniform chromatography columns , comprising the steps of:a) providing a plurality of chromatography columns;b) providing a plurality of chromatography resin aliquots;c) packing said chromatography resin aliquots in said chromatography columns to provide a plurality of packed chromatography columns; andd) subjecting said packed chromatography columns to repeated mechanical impacts to provide a plurality of uniform chromatography columns.3. The method of claim 1 , wherein said chromatography resin aliquots are dry and wherein in step c) said chromatography resin aliquots are filled in said chromatography columns and reswollen by adding a liquid to the chromatography columns.4. The method of claim 1 , wherein step b) comprises providing a plurality of dry chromatography resin aliquots and reswelling them with a liquid to provide a plurality of reswollen chromatography resin aliquots claim 1 , and wherein step c) comprises packing said reswollen chromatography resin aliquots in said chromatography columns.5. The method of ...

OIL-IN-OIL EMULSIFIED POLMERIC IMPLANTS CONTAINING A HYPOTENSIVE LIPID AND RELATED METHODS

Biocompatible intraocular implants, such as microparticles, include a prostamide component and a biodegradable polymer that is effective in facilitating release of the prostamide component into an eye for an extended period of time. The prostamide component may be associated with a biodegradable polymer matrix, such as a matrix of a two biodegradable polymers. Or, the prostamide component may be encapsulated by the polymeric component. The present implants include oil-in-oil emulsified implants or microparticles. Methods of producing the present implants are also described. The implants may be placed in an eye to treat or reduce a at least one symptom of an ocular condition, such as glaucoma. 1. An intraocular implant comprising therapeutic polymeric microparticles , the microparticles made by the steps of: encapsulating a prostaglandin analog with a polymeric component to form a population of prostaglandin analog-encapsulated microparticles by an oil-in-oil emulsion process , wherein the prostaglandin analog -encapsulated microparticles have an effective average particle size of less than about 3000 nanometers.2. The implant of claim 1 , wherein the oil-in-oil emulsion process comprises forming an oil-in-oil emulsion containing the prostaglandin analog and the polymeric component; drying the emulsion to form a dried emulsion product; contacting the dried emulsion product with a solvent to form a solvent-containing composition; and removing the solvent from the solvent containing composition to form the population of microparticles comprising the prostaglandin analog and the polymeric component.3. The implant of claim 1 , wherein the prostaglandin analog of the microparticles so produced is encapsulated by the polymeric component to preserve therapeutic activity of the prostaglandin analog after a terminal sterilization procedure.4. The implant of claim 1 , wherein the polymeric component comprises a biodegradable polymer or biodegradable copolymer.5. The implant of ...

Oil-in-Oil emulsified polymeric implants containing a hypotensive lipid and related methods

Biocompatible intraocular implants, such as microparticles, include a prostamide component and a biodegradable polymer that is effective in facilitating release of the prostamide component into an eye for an extended period of time. The prostamide component may be associated with a biodegradable polymer matrix, such as a matrix of a two biodegradable polymers. Or, the prostamide component may be encapsulated by the polymeric component. The present implants include oil-in-oil emulsified implants or microparticles. Methods of producing the present implants are also described. The implants may be placed in an eye to treat or reduce a at least one symptom of an ocular condition, such as glaucoma. 1. An intraocular implant comprising therapeutic polymeric microparticles , the microparticles made by the steps of: encapsulating a prostamide component with a polymeric component to form a population of prostamide-encapsulated microparticles by an oil-in-oil emulsion process.2. The implant of claim 1 , wherein the oil-in-oil emulsion process comprises forming an oil-in-oil emulsion containing the prostamide component and the polymeric component; drying the emulsion to form a dried emulsion product; contacting the dried emulsion product with a solvent to form a solvent-containing composition; and removing the solvent from the solvent-containing composition to form the population of microparticles comprising the prostamide component and the polymeric component.38.-. (canceled)9. The implant of claim 1 , wherein the prostamide component of the microparticles so produced is encapsulated by the polymeric component to preserve therapeutic activity of the prostamide component after a terminal sterilization procedure.10. The implant of claim 1 , wherein the polymeric component comprises a biodegradable polymer or biodegradable copolymer.11. The implant of claim 1 , wherein the polymeric component comprises a poly(lactide-co-glycolide) PLGA copolymer.12. The implant of claim 11 , ...

Single-Use Cell Culture Container

A method for producing a single-use cell culture container at least partially made of polymer material, wherein the cell culture container is treated with gamma radiation for sterilization, characterized in that the cell culture container is treated with inert gas and/or a defined amount of oxygen before the irradiation in order to prevent the occurrence of an “extended lag phase”. 1. A method for producing a single-use cell culture container , which is at least partially made of polymer material , wherein the cell culture container is treated with gamma radiation for sterilization , characterised in that the cell culture container is treated with inert gas before the treatment with gamma radiation , whereby the amount of oxygen present is selected such that during the treatment of the cell culture container with gamma radiation aldehydes and ketones are generated in a concentration of at most 3 ppm.2. The method according to claim 1 , characterized in that the cell culture container is filled with inert gas before gamma radiation treatment and/or introduced in a lockable container filled with inert gas before gamma radiation treatment.3. The method according to claim 1 , characterized in that the treatment with gamma radiation is carried out in the presence of 0 to 20% oxygen.4. A cell culture container manufactured according to .5. The cell culture container according to claim 4 , characterized in that it contains aldehydes and ketones in an amount of 0 up to 0.01 ppm.6. The cell culture container according to claim 4 , characterized in that it contains aldehydes and/or ketones in an amount of 0.01 up to 3 ppm.7. The cell culture container according to claim 4 , characterized in that it is formed as a multi-layer claim 4 , particularly as a three layer bag claim 4 , wherein the inner layer and/or the outer layer consist(s) of a polymer selected from polyethylene (PE) or ethyl-vinyl acetate (EVA) claim 4 , and the intermediate layer is a gas barrier layer claim 4 , ...

IONTOPHORETIC SOFT CAPSULE

The present invention relates to a device for applying a cosmetic composition (P), comprising: —a capsule () that delimits a housing (), —an application member () positioned in the housing () and impregnated with a cosmetic composition (P), —an electric exciter () comprising at least two electrodes () in contact with the application member () and making it possible to circulate an electric current between these two electrodes (). 21. Device according to claim 1 , the capsule () being removable and disposable.31. Device according to either one of the preceding claims claim 1 , the capsule () comprising a multilayer material.41. Device according to any one of the preceding claims claim 1 , the capsule () being obtained by means of a beam of metal ions.51. Device according to any one of the preceding claims claim 1 , the capsule () being closed by a lid.66. Device according to any one of the preceding claims claim 1 , the application member () being compressible.76. Device according to any one of the preceding claims claim 1 , the application member () being porous or fibrous.86. Device according to any one of the preceding claims claim 1 , the application member () being selected from a nonwoven claim 1 , a felt claim 1 , a paper claim 1 , a foam claim 1 , a sponge claim 1 , a sintered product claim 1 , a porous ceramic or a biocellulose substrate.9. Device according to any one of the preceding claims claim 1 , designed so that the current is applied continuously or sequentially.101. Device according to any one of the preceding claims claim 1 , the capsule () comprising several compartments.11. Capsule intended to be fitted on a device according to any one of the preceding claims.12. Cosmetic method comprising the steps consisting in:{'claim-ref': [{'@idref': 'CLM-00001', 'claims 1'}, {'@idref': 'CLM-00010', '10'}], 'providing a device as defined in any one of to ,'}putting the device in place on a body area, andcirculating an electric current between the skin and the ...

Pasteurizing Paints and Method for Pasteurizing Paints

Disclosed herein are methods for pasteurizing architectural coating compositions using heat, radiation or other energy sources without additionally polymerizing the compositions and storing same. 111-. (canceled)12. A method for pasteurizing a paint or stain composition comprising the steps of(i) preparing the paint or stain composition, wherein the paint or stain composition comprises latex particles that when applied to a substrate form a paint film;(ii) treating the paint or stain composition with a gamma radiation, wherein an amount of applied gamma radiation ranges is less than about 15 kilograys without further polymerizing the paint or stain composition; and(iii) storing the treated paint or stain composition in containers.13. The method of claim 12 , wherein step (iii) comprises storing the pasteurized architectural coating composition at temperatures that discourages or inhibits growth of biological agents.14. The method of claim 13 , wherein said temperatures include temperatures below room temperature.15. The method of claim 12 , wherein the amount of applied gamma radiation ranges from about 3 kilograys to about 15 kilograys.16. The method of claim 12 , wherein the amount of applied gamma radiation ranges from about 5 kilograys to about 10 kilograys.17. The method of claim 12 , wherein the amount of applied gamma radiation ranges from about 3 kilograys to about 5 kilograys. This invention generally relates to paints that have been pasteurized to remove or sufficiently reduce the amount of bacteria, fungi, yeasts and/or other biological agents in paints and to method for pasteurizing same.Due to environmental and health concerns, there has been a movement toward reducing the amount of volatile organic compounds (VOCs) in paints, stains, and other coating compositions, which evaporate into the environment upon paint film formation. Additives to paints that facilitate or impart desirable paint properties, such as better film coalescence, better resistance ...