BAG ARRANGEMENT AS WELL AS THEIR USE

1. field of the invention

[0001] The present invention relates to feed bag and specific feed bag for dispensing components and method of use.

1a. Summary of the Invention

[0002] a first aspect, the invention can provide for a supply bag arrangement Under, comprising: a feed bag, comprising a main part, bounding a compartment and having a dry feed component disposed therein, wherein the body portion is first end with an outlet formed thereat and second opposite end thereof; and a container, removably coupled with the feed bag; characterized in that the feed bag further comprising: a venting port, which in at least selective fluid communication with the compartment of the body; and a fluid tube, having a first end in at least selective fluid communication with the compartment of the body and an opposite second end, which is coupled with a fluid source for delivering fluid to the body, has.

[0003] the invention relates to a method, in accordance with a second aspect can provide for, comprising: coupling an outlet of a feed bag to an inlet of a container, wherein the feed bag bounding a compartment, a dry feed material disposed therein; characterized in that the method further comprises: discharging the dry feed material from the feed bag into the container; and discharging a fluid to the compartment of a feed bag, to blow residues of the dry feed material within said compartment to flush into the container.

2. Relevant technology

[0004] culture media, buffer, reagents and other biological materials (hereinafter referred to as "base materials") are extensively used in research and development of biotech, wherein vaccines are generated, proteins are purified and other biological materials be developed and produced. To safely and to be effective for their intended use, they must be pure and sterile base materials. By specialised manufacturers or end-users typically made are As such base materials, which have made significant investment in sophisticated equipment and plant. Such equipment and plant are operated under highly controlled process, which "Fond and Drug Administration" (FDA) and by the other similar authorities are regulated.

[0005] For example, most of the base materials in large high-grade steel tank hydrated, where with an exact amount of a desired base material in its powder form as grown Nasser is combined. Some additives may also be added in liquid form. A special mixer is then used, to allow the components to mix to the desired final solution. Once the solution is prepared, the solution is filtered and can be directly used for shipping or storage and dispensed into sterile containers are sealed or. The entire system is typically operated in a type of clean room.

[0006] Between the production of different batches of materials must the mix tanks, mixer and all other reusable components, which are in contact with the solution, be thoroughly cleaned, to avoid cross-contamination. The cleaning the structural components is labour-intensive, time-consuming and expensive. For example, depending on the structural component and the use of chemical cleaners cleaning the material produced, and may also require a sterilization require such as sodium hydroxide. The use of chemical cleaning agents, the additional challenge on, relatively dangerous to be to use, and can be difficult and/or expensive to dispose of cleaning active substances, as soon as they have been used.

[0007] Due to the significant expense, in the manufacture, operation and maintenance of the hassle systems, which are used in the manufacture of base materials, often the base materials in their final solution form Biotech companies buy. However, there are some disadvantages of this strategy. For example, the base materials in the solution form mainly water. These materials can be difficult and expensive to transport As such.

[0008] Furthermore, it is necessary, although the powdery base materials can be stored for a prolonged period of time under relatively environment something similar conditions, the final liquid solutions typically have a significantly shorter shelf life under refrigerated conditions and be kept. A storage of substantial amounts of the base materials because of the necessary cooling can be expensive in its solution form.

[0009] CEPOL-Publication EP-A -0,113,280 disclosed a device for preparing and dispensing a solution, which a bottle, the substance contains a to be solved, and a tube for solvent, the is mixed with the substance, includes. The bottle has a plug, which contains a rigid hollow rod and a deformable head, and the tube has a piston having a passage therethrough. If the tube is positioned on the upper side of the bottle, biases the rod the piston, urges what the solvent through the rod and into the bottle. Escape of air from the bottle allows practice-ground deformable head is.

[0010] What is required, are therefore systems and components of such systems, which allow an end user it, its own base materials in solution form to hydrate on one immediate needs based, but not the highly regulated and labour-intensive cleaning and sterilization processes which require, from typical manufacturers are used. Such systems would allow it to the end user, the storage of large quantities of base material in solution form to minimize, while permitting, the use of powdery base materials, which are more efficient to transport and store, to maximise. Manufacturers could also use such systems, to simplify their manufacturing processes.

[0011] Miscellaneous embodiments of the present invention will now discussed with reference to the accompanying drawings and for guidance.

[0012] 1 is a front view of an embodiment of a fluid preparation systembreak-like Fla.;

[0013] a 2 is supervision of cross section the tank assembly Fla., along of cut lines 2-2 of the add, 1 is carried out;

[0014] in Fia. 2 is an enlarged sectional view the 2Ä Fla. represented tank assembly;

[0015] Fia. 3 is a partially cut side view of the side wall of the in Ra. 1 represented tank assembly, which illustrates fluid channels;

[0016] Fia. 4 is across section side view of the tank assembly, which is performed along 4-4 of Fia. 2 of cut lines;

[0017] Fia5A cross section side view the tank assembly is. a, which is performed along of cut lines 5-5 of the Fia. 2;

[0018] Fig.cross section side view 5B is the same, which in Fia. 5 A is represented, wherein the bottom is raised therein;

[0019] 6 is a front view of an alternate embodiment of a tank assembly. Rqbreak-like ;

[0020] Fia. 7 is. 6 represented in Fia model opinion motion from above, the tank assembly;

[0021] Fia. 8 is an, exploded perspective detail view of a mixing bag assembly;

[0022] Fia. 9 is a side view of an element of the. 8 shown in Fia break-like mixing bag;

[0023] Fia. 1QA cross section side viewdaraestelltenin Fia. 8 is a the upper end of the mixing bag;

[0024] Fiais 1QB cross section side view of an alternate embodiment of the upper end of the. in a. Fia 8 daraestellten mixing bag;

[0025] Fia. 11 is represented a cross section side view of the lower end of the mixing bag having a mixing device arranged therein in Fia. 8;

[0026] Fia. 12 . 11 as viewed from above is shown in Fia model opinion of the mixer a;

[0027] Fig.13A in Fia. 11 is a bottom perspective view of the mixer shown viewed;

[0028] Fig.13B viewed from below is a perspective view of the in Fia. 13 A represented mixer, wherein the flaps are bent downwardly;

[0029] Fia. 14A cross section side view of the lower end of the. 8 shown in Fia is a mixing bag, wherein an alternative embodiment of a mixer disposed therein;

[0030] Fig.cross section side view 14B 14A shown in Fia. a mixer is in a second position of the;

[0031] Fia. 15 is shown in Fia. 14A model opinion of the motion from above, mixer;

[0032] Fia. 16 is a bottom perspective view of the viewed in Fia. 14 A represented mixer, wherein the flaps are bent downwardly;

[0033] Fig. cross section side view 14A add. 17 is represented in an enlarged the hub of the mixer;

[0034] Fig.cross section side view 18A is shown in Fia. 8 a of the lower end of the mixing bag, wherein an alternative embodiment of a mixer disposed therein;

[0035] Fig.18B is in Fia cross section side view of the a. 18 A represented mixer in a second position;

[0036] Fia. 19 is 8 shown in Fia model opinion of the. motion from above, in a collapsed state mixing bag, which is limited by a belt;

[0037] Fiabreak-like. 26 is a side view of a feed bag, which is coupled to the upper end of the 8 represented in Fig. feed bag;

[0038] Fia. 21A model opinion of a regulator is in an open position a as viewed from above, which is operable with the feed bag shown in Fia. 20;

[0039] in Fia 21B Fig.model opinion of the motion from above is. 21 A represented regulator in a closed position;

[0040] 22 is a side view of an alternate embodiment of the in Fia Fig.break-likedaraestellten feed bag. 20;

[0041] in Fia. 23 is a perspective view of a connection of the Fig. 22 represented feed bag;

[0042] 24 is a side view of a spray nozzle Fig.break-like, which is disposed within a connector on the 8 represented in Fig. mixing bag;

[0043] 25 is a side view of the in Fia. 24 representedbreak-like Fig. spray nozzle;

[0044] 25 represented in Fia cross section side view 26 is a spray nozzle. Fig.;

[0045] Fia. 27 is a perspective view of a temperature probe;

[0046] Fiacross section scrap viewdaraestellten27 . 28 is a temperature probe in Fia.;

[0047] Fiamodel opinion of the sensor 29 is. motion from above, in Fia daraestellten temperatur rsonde. 28;

[0048] 27 shown in Fia cross section scrap view 30 is a temperature probe. Fig., which is mounted at the bottom of the tank assembly shown in Fia. 1;

[0049] Fia. 31 is a schematic representation of the filter arrangement 1 represented in Fia fluid preparation system. the;

[0050] 32 is an , exploded perspective view of a pressure sensor arrangement. Fia, which is used in connection with the filtering system shown in Fia. 31;

[0051] Fiacross section side view 32 shown in Fia. 33 is a pressure sensor arrangement in an assembled state. the;

[0052] 34 is a side view of an alternate embodiment a membrane of the Fig.break-like in Fia. 32 represented pressure sensor arrangement;

[0053] 35 is a side view of an alternate embodiment of the in. Fia. Fia break-likedaraestellten membrane 34;

[0054] Fiabreak-like. 36 is a side view of a dispensing assembly and a collecting arrangement, which can be operated with a sterilizer;

[0055] Fiacross section side view 36 . 37 is a dispensing assembly in one filling tube of the represented Fig.;

[0056] Fia37 . 38 is an end view of the fill tube shown in Fia.;

[0057] 39 is in Fia cross section side view a cap on the a. Fig. 37 shown filling tube;

[0058] Fiacross section side viewfiller connector in Fia. 36 . 40 is a collection array represented a;

[0059] Fia. 41 is a perspective view of a pair of adjacent sterilizers;

[0060] 42 is an enlarged perspective view of the internal components of the in Fig.. Fia 41 represented sterilizer;

[0061] Fig.43 is a partially cut perspective view of the sterilizer shown in Fia. 42;

[0062] Fig.Kappenentfernerscross section side view a 44 is a;

[0063] Fia. 45 is a perspective view of the sterilizer of Fia. 43. wherein the shuttle are moved into the housing;

[0064] Fies. 46 cross section side view of the stuffing tube of Fia. 37 is a. which is arranged in a vertical alignment with the with the sterilizer Kappenentferner ;

[0065] Fia cross section side view the arrangement shown in Fia. 46 . 47 is a, wherein the cap is connected with the of the stuffing tube Kappenentferner ;

[0066] 47 . 48 is a Fiacross section side view the arrangement shown in Fia., wherein the cap is removed from the stuffing tube;

[0067] Fia. 49 is a perspective view of the sterilizer shown in Fia. 42, wherein the fill port coupled thereto;

[0068] Fiacross section side view 48 shown in Fia. 50 is a filling tube. of the, which is aligned with the fill port; and

[0069] Fia. 51 is a 48 represented in Fia. cross section side view of the fill tube, which is coupled with the fill port.

[0070] InFia fluid preparation system. 1 is represented an embodiment of a 10, which includes features of the present invention. The fluid preparation system10 is used for mixing of two or more components, to produce a homogeneous solution, wherein at least one of the components is liquid. Although each of the components may be liquid, in a typical embodiment one component is a substantially dry material, such as a powder, grain, granules or other solid form, while the other component is a liquid, such as water. The fluid preparation system 10 may be used in the preparation of a solution of any shape, including those, which are sterile, and of those, which are not sterile. In fluid preparation system10 in the production of a typical embodiment, the culture media, buffers, reagents and other biological materials used, which may or may not be sterile.

[0071] In one design embodiment is 10 configured in such a way the fluid preparation means that structural components of the system, which are in direct contact with the solution, are disposable. Consequently, , between the manufacture of different batches or types fluid preparation system 10 when the is varied of solutions, the contaminated components simply replaced with new components. Depending on the component and the desired solution may not be sterile or sterile the new component. Several different solutions can relatively quickly and without the Downtime As a result of the additional expense of a sterilization or purification of the system are produced. For other embodiments may, however, selected or all of the components of the system be constructed for sterilization and reuse.

[0072] General, although not necessary or exclusively, a tank assembly 10 comprises the fluid preparation system20, which is mounted on a platform 12, a mixing assembly 200, which is disposed at least partially within the tank assembly 20, a filter system 500, which is in fluid communication with the mixing assembly 200, and a delivery system 700, which is in fluid communication with the filter system 500.

[0073] 10 fluid preparation system in Fia. 1 includes the embodiment shown the For a movable platform 12, on which are mounted all or some of the components of the 10 fluid preparation system. Falls desired, some or all of the system components in a production line prior to shipping and can final assembly 12 be mounted on the platform at an end user location. The fluid preparation system10 can thus be formed as a modular unit, which can be moved between different installations relatively simple. Alternatively, the various components on the 12 be mounted on the and/or around the platform final consumer place. It is understood that in another embodiment, the platform 12 is not required, and may be permanently or otherwise at a fluid preparation systemfinal consumer plant that the assembled.

I. tANK ARRANGEMENT

A. sIDE PANEL

[0074] 22 comprises a plurality of legs 20 The tank assembly, and an annular side wall 12 which protrude upwardly from the platform support 24. As in Fia. Fia. 1 and 2 represented, has an inner surface 26 and an outer surface 28 on the side wall 24, each extending between an upper end 30 and an opposite lower end 32 extend. The inner surface 26 delimited at least in part a chamber 60. The side wall 24 has a pipe-like character on, so that the upper end 30 and32 are open lower end.

[0075] 24 comprises a body section 23 with a substantially side wall The C-shaped cross-section. The body section 54 and56 at substantially opposite one another facing end plates 22 terminates, wherein an input 57 is formed therebetween. Although not required, extending between the end plates 54 and56 at the lower end a support strut 32 rigidly58, about the23 to increasemain part sectionring firmness of the.

[0076] The body section 23 comprises an outer wall 34, 36 and a middle wall 38 a concentrically disposed inner wall, which is arranged concentrically between the outer wall 34 and the inner wall 36. Each of the walls 34,36 and38 is connected with each of the end plates 54 and 36. 40 38 of the middle wall 34 and between the outer wall is arranged an insulation layer. A chloride-free ceramic fiber comprises In one design embodiment the insulation layer 40, which is capable of, to withstand temperatures up to 1300 °C. Other conventional insulation types may also be used. Self between the middle wall 38 and the inner wall42 are a plurality of spaced apart spacers 36 extending there. The Spacer from the middle wall 38 and/or 42 can individual parts or protruding structures comprise the inner wall 36. The spacer 38 and 42 ensure a structural stability for both the middle wall the inner wall 36, 44 are formed during fluid channels, which allow it a fluid, between the middle wall 36 and 38 and the inner wall42 to flow around the spacers.

[0077] Specialadd. 3 is represented in a cut view, which shows the outside of the inner wall 36 with the thereof projecting spacers 42. The inner wall 36, the middle wall 28 and the outer wall are rigidly connected to a top plate 34 extend between and 70 and an opposing bottom plate 72. The previously discussed support strut 58 In one design embodiment can be formed integrally with the base plate 72. As is subsequently more closely discussed, extending throughout said body section 68 of a plurality of vertically aligned spaced slots 23 in the direction of the bottom plate in the direction of the top plate 72 of70. The slots 74 68 23 generally share the body section into a plurality of sections. The inner wall 36, the middle wall 38 and the outer wall 76 and78 connected with side plates 34 are each also, 68 limit which each side of each slot. main part section44 in each section74 of the As a result, the fluid channels 23 sealed closed.

[0078] To44 of the respective sections to facilitate fluid communication between fluid channels 74, extends at the upper end a transition tube 30 74 80 between the respective sections. Each transition pipe80 is in fluid communication with a corresponding fluid channel opposite end of the 44. As also represented in Fla. 3, extends a plurality of spaced vertically oriented channel ribs36 and38 of the middle wall between the inner wall 82. The channel ribs82 are positioned in such a manner that when fluid flows radially around the body section 23, the fluid is also forced to do so, on a sinusoidal like main part section23 to flow along the height of the path.

[0079] As inFla. 1 and 2 represented add., a fluid inlet pipe at the lower end 62 is designed specifically adjacent the end plate 23 connected with the body section 32 54, while a 32 64 56 fluid discharge opening pipe at the lower end adjacent the end plate23 is connected with the body section. 62 and the discharging pipe 64 is in fluid communication from said inlet pipe Each with fluid channels 44. If fluid is pumped into the fluid inlet pipe 62, enters the fluid through an inlet port 44 a 66 add. 3 in a fluid channel in. Due to its that it is confined between the side plate 76 and the end plate 54, moves vertically upwardly and around the spacers 42 around the fluid.

[0080] If the fluid reaches the upper end 30, passes into the next adjacent section 74 the fluid through the transition tube 80. If the fluid moves around the body section 23 aroundfluid discharge opening pipe 64 in the direction of the further, moves vertically up and down the fluid further, so that it comes to circulate around channel ribs 82. Once the fluid from the body section 23 and by it the 64 reachesfluid discharge opening pipe is released is heated or cooled depending on the desired operating parameters then the fluid and then through the fluid inlet pipe 61 re-established. In one design embodiment is the fluid passing through the fluid channels 44 a mixture of water and propylene glycol. For other embodiments can be any material, in the fluid, which can be used for heating and/or cooling.

[0081] In one design embodiment of the present invention are provided means, about a 60 of tank assembly 20 contained within the chamber selectively to heat or to cool solution. An example of such agents comprises fluid channels 44 and the associated structure as above discussed. As is discussed subsequently more precisely is situated during operation a solution within the chamber 60. By 44 is being run a fluid through the fluid channels, wherein the fluid is at a desired temperature, either as a heat sink the fluid acts is pulled by the inner wall 36 from the solution by energy, or as a heat source, by energy by the inner wall 36 is introduced into the solution, whereby the solution is heated or cooled.

[0082] Partiallychannel ribs82 to the serve, to distribute the fluid uniformly over the outer surface of the inner wall 36, uniformly supplying 60 to control the temperature of the solution within the chamber. Whereas, in this regard, the focus 44 channel ribs82 and fluid channels, so as to flow in a plurality of different paths. channel ribs82 may also be constructed without the body section 32.

[0083] In yet a further alternative embodiment of the means for selectively heating and cooling can be replaced through a pipe string 44 open fluid channels, which on the inside, on the outside and/or inside the inner wall 36 is running. The Pipework is arranged that the heating or cooling fluid flowing therethrough. Electrical heating elements may also on the inside, on the outside and/or inside the inner wall 36 be positioned, so as to facilitate a heating of solutions within the chamber 60. In yet an additional embodiment, the solution can be pumped out from the chamber 60 within the chamber 60, where it then is selectively heated or cooled by conventional systems, and then back into the chamber 60 are guided.

[0084] As inFla. 1.Fia. 2 and comprises the side wall 24 also a door daraestellt. 2A Fla. 25, which is arranged between the end plates 54 and 57 within the entrance 56. As the body section comprises an outer wall and an inner wall23 25 34 36 the door. In this embodiment includes no middle wall 25, however, the door 38. Instead, 34 and36 arranged between the walls is an insulating layer 40. In an alternative embodiment can include the door 24 25 also fluid channels, which are in communication with the body section 23 via flexible hose connections.

[0085] A vertically oriented elongated viewing slot 46 extends through a portion of the door 25. A Window view slot48 is disposed within the 46, to seal closed around the viewing slot 46, 60, however, to ensure an unobstructed view of the chamber. The door 23 mounted by hinges on the body section 25 is 50. A handle 25 is formed on the door 52, about an articulation of the door (not shown) 25 between an open position, in which free access is provided to the chamber 60 through the open input 57, and a closed position, in which the door closes 25 the input 57, to facilitate.

[0086] In one design embodiment of the present invention are means provided, selectively to lock the door in the closed position 25. Exemplary and nonrestrictive 2A and Fia. 4 is represented as in a vertically oriented tubular housing Fig. 90 movable along the end plate 56 of the53 mountedmain part section. Cabinet 90 has a front face having a plurality of vertically spaced lugs 102 formed thereon. Each stop 102 has a engagement surface 104 on, extending in the direction of the chamber slopes 60.

[0087] A actuator rod 92 extends through the housing 90 in parallel alignment therewith. The actuating rod 90 92 94 or the like is fixed rigidly to the housing by bolts and extends between a first end 96 and an opposed second end 98. The first end 92 is above the tubular housing 96 of the actuating rod 90 upwardly out. 98 100 comprising a hydraulic piston 92 is the actuator rod end The second coupled, which is arranged below the support strut 58. By 100 selectively the hydraulic piston is actuated is selectively raised and lowered the actuating bar 92, which in turn selectively raises and lowers the housing 90.

[0088] From a side surface 105 of the door are a plurality of vertically aligned and spaced latch flanges 25, projecting106 present. The locking flanges 108 separated by a gap 106 are in each case. To 25 to facilitate a locking of the door is moved to a lowered position said actuating rod 92, and the door 25 is moved to the closed position. In this configuration are the locking flanges 106 102 arranged between the stops. The hydraulic piston 100 is then used, around the actuator rod 92 raise. If this is done, lift 90 and the stops on the housing 102, so that the engagement surface is biased against a corresponding locking flange 102 106 104 each stop. The interference surfaces104 are inclined, so that the locking flanges 106 are biased radially inwardly, whereby the door is locked closed 25. In order to secure this locking further, 108 is a plate with a hole extending therethrough from the top of the door 25 out. If the door 25 is in the closed position, the hole in the plate 92 is aligned with the actuating rod 108. If the actuator rod 92 lifts itself, moves the first end 96 of said operating stick108 92 through the hole in the plate.

[0089] It is understood that the means for selectively locking the door 25 may have a plurality of alternative embodiments. Exemplary and nonrestrictive 100 by a pneumatic piston can the hydraulic piston, a Getriebeoder belt drive, a crank, a winch or other drive mechanism be replaced. Also it is clear that the locking flanges 106 and stops 102 can be swapped or can be replaced by a plurality of other conventional locking parts. For other embodiments a plurality of shafts can be positioned in such a manner that it selectively from one of the door and the body section 25 in or against the other thereof drive 23. Pedestrian pin holder or other conventional locking structures may also be used.

B. FLOOR

[0090] 1.2. and returning addadd To, the tank assembly 20 also includes a base 110, which is arranged within or in alignment with the inner side of the side wall 24. Soil basic ground112 110 comprises a substantially flat. In the illustrated embodiment is circular and extends to a peripheral edge 112 114 the basic ground. As is subsequently more closely discussed, extend a plurality of open boss holes 112 116 through thebasic ground. A central port hole 117 applies alsobasic ground112 by the. Although not required, are also a plurality of shielded overflow holesbasic ground118 112 formed on the.

[0091] A peripheral wall 120 inclines upwardly and outwardly from the peripheral edge 112 to a trailing edge 114 of thebasic ground122. Outwardly 122 124 projecting from the end edge is present a lip. The lip 24 is biased against the inner surface of the side wall 124 terminates either directly or directly adjacent thereto. Except of the lip 110 and the walls of the side wall 124 are the remainder of the base 24 typically made of a metal, such as stainless steel. The lip 124 is typically made of polypropylene, on the other hand, , however, can also be made of flexible materials, such as rubber, silicone, Viton, Teflon and other moldable plastics.

[0092] in the illustrated embodiment has a substantially frusto-conical configuration the bottom 112. In alternative embodiments the bottom 112 can completely flat, curved, pyramidal-, with a conical configuration or of any other desired configuration be, which can hold a bag as discussed below. Moreover, needs to be non-circular the bottom 112, but can polygonal, elliptical, irregular or of any other desired configuration be.

[0093] In one design embodiment of the present invention are means provided, around the bottom 24 selectively raising and lowering relative to the side wall 112. Exemplary and 24 is not limited to the outside of an exterior wall 68 thereof rotatably mounted in vertical alignment with each slot 130 provided a threaded shaft. In one design embodiment is mounted on the underside of each shaft 132 a drive 130, 130 to selectively rotate around each shaft. A collar surrounding each shaft 134 130, and thus is in threaded engagement, such that rotation of each shaft 130 effected that each respective collar 134 snail impulse configuration dependent of the direction of rotation in a 130 moved upwards or downwards in the length of the shaft. A strut 134 120 136 extending between the bottom and each collar, so that it runs through a corresponding slot 68. A simultaneous rotation of each shaft 130 facilitates a uniform As a result of raising and lowering the bottom 224 112 relative to the side wall. By the level of the bottom 112 is adjusted is the size of the chamber defined by the side wall 24 and the bottom 60 60 selectively adjusted, i.e. the size of the chamber 60 is smaller, when said deck raises 112.

[0094] It is understood that the means for selectively raising and lowering of the bottom 112 may comprise a plurality of modified and alternative embodiments. For example, instead of having a separate drive for each threaded shaft 132 130, 132 are used a single drive, by power transmissions with each separate threaded shaft 140 (represented in Fia. 2) 130 is connected. In still further modifications can be replaced by a and the collar 130 134 the shaft or more conventional chain drives, belt drives, gear drive, hydraulic lifting devices, pneumatic jacks, lifter, cranks, winches, roller systems and/or combinations thereof and the like, from the outside of the side wall 24 from around the struts selectively raise 136. Moreover, the above discussed can be positioned directly below the floor jacks and lifter 112 different, selectively raise and lower 112 around the bottom. On these embodiments are the struts 136 and slots 68 not necessary, may, however, be used for stabilization.

C. sLOT COVER ARRANGEMENT

[0095] In one design embodiment of the present invention are provided means, portions of the slots 60 and release selectively cover 68 within the chamber. As is discussed subsequently more precisely, it is at a desired embodiment, because a bag or other form of insert 60 of tank assembly 20 is disposed within the chamber typically that a cover over that portion of the slots 68 is arranged, which is exposed above the base 110, so that the bag or the insert is not from the slots 68 is increasingly redundant out-become baggy or thereto and possibly fail. As in Fia. SA andFia. SB represented, an example of such means comprises a 149 slot cover arrangement, which includes an elongated flexible Slit cover 150, 152 154 which has a first end and an opposite second end. The Slit cover 150 has a slightly greater width than the slot 68 ( as in Fia. 2 to see) and a thickness, which is typically in a range between about 2 mm to about 10 mm. Other desired thicknesses may also be used.

[0096] The first end 124 150 152 the Slit cover 110 is at or adjacent to the gap 26 of the side wall at or adjacent the inner surface of the bottom24 positioned. In one design embodiment is at least a portion of a first end 124 150 152 24 disposed between the lip and the side wall of the vent cover. 156 150 152 the Slit cover is by a holder end The first held in position, which is mounted on the strut 136. 110 or directly to the bottom 150 Slit cover Alternatively, the 136 of the strut be mounted. Starting from the first end 150 152 runs freely upwardly the vent cover, and substantially matches that movably cover 68 above the bottom portion of the slot 110. A main part section158 is mounted on the top plate 70 of the rounded bracket 23. The Slit cover 158 150 relies on the rounded along the outside of the side wall 24 downwardly and runs holder to the second end 154.

[0097] 159 160 149 also includes a tension spring and a conduitslot cover arrangement The. A end of said tension spring 150 is connected to the second end 154 of the vent cover 159. A first end 158 160 162 of the conduit is connected to said opposite end of the tension spring. The line 164 160 extends downwardly through a wrist strap, which is attached to the base plate 72 of the 23 main part section. A second end 166 of the conduit136 connected with the strut 160 is then again, for example by screwing, welding, a holder or the like. 149 forms a continuous loop slot cover arrangement Since the, opposite ends are connected with the strut 136, causes a raising or lowering of the bottom 110, the the vent cover 150 along the slot124 of the bottom 68 and these covers 110 moves continuously above the lip. This configuration enables also possible, however, that the slot 124 of the bottom110 is open below the lip 68, therein to allow a free movement of the strut 136.

[0098] The line149 slot cover arrangement can 160 of a wire, a cable, a rope or the like be. In an alternative embodiment may be replaced by the same material as the vent cover 150 160 the conduit. The line 160 is simply used, by less hindrance to be. In yet other embodiments the agent may a spring-loaded spool, an electric winch 23 be arranged at the top or outer side of the side wall or the like, around the vent cover 150 selectively gripping and releasing, when the bottom 110 is selectively raised and lowered.

D. mIXER DRIVES

[0099] As inFla. 1 represented is extends through the central port hole 117 of the base110 (a mixing shaft 208 present 2t Fla. extending. As subsequently discussed and represented more precisely is within the chamber 60 a mixer208 mounted at the first end of the mixing shaft positioned. In one design embodiment of the present invention are provided means, to selectively raise and lower the mixing shaft 208. Exemplary and nonrestrictive extends below the floor 168 110 and is attached to one frame. A hydraulic piston 168 170 is mounted on the frame, which acts on an actuating rod 172. The actuator rod 172 in turn removably connectable to the mixing shaft 176 A clutch 208 connects. Flexible hydraulic hoses 170 174 provide said hydraulic piston a hydraulic fluid, around the actuator rod 172 and thus raise and lower the mixing shaft 208. Due to its that the hydraulic piston 168 170 110 is attached at the bottom by means of the frame, will be cancelled out and descends the hydraulic piston 110 170 with the ground.

[0100] It is understood that numerous alternative embodiments of the means for selectively raising and lowering of the mixing shaft positioned 208 exist. Exemplary and nonrestrictive can be mounted on the platform 12 or a bottom surface 170 of the hydraulic piston. This embodiment is practical, when the bottom 110 is stationary. Many other forms of drives can also be replaced by the hydraulic piston 170, such as a pneumatic piston, a turning crank, various forms of belt drives, chain drives or gear drives or other well-known mechanisms, which allow a repeated raising and lowering of a shaft. It is understood also that such drives may be connected directly to the mixing shaft 208 by the actuating rod may be connected or associated with, 172.

[0101] In alternative embodiments of the tank assembly 20 it is clear that neither the bottom 110 must be adjustable, nor the tank assembly must be capable of 20, to heat or cool the solution disposed therein. Zum consider Fki. 6 andFia is in. 7 a tank assembly 178 represented. The tank assembly 178 comprises a substantially frustoconical bottom with a plurality of support legs 180 182, extending downwardly therefrom. Starr 180 connected with the periphery of the base and extending upwardly therefrom is an annular side wall 184 present. 183 184 180 and the side wall define a chamber Soil.

[0102] Soil185 180 comprises a central boss holes 116 and a central port hole 117 withbasic ground, which extend therethrough. 185 has a hexagonal configuration basic ground The, which terminates at a plurality of peripheral edges 186. A 187 extends at an angle of each peripheral edge area is trapezoidal shaped bottom plate 186 185 upwardlybasic ground of the. Any of the bottom plates is 187, for example by welding, screwing or the like, attached to the adjacent floor panels 187. The resulting 185 has a generally truncated cone design with an inner surface bottom thus, an outer surface and a peripheral edge, each having a substantially hexagonal in cross-section.

[0103] The side wall 188 184 comprises a plurality of side plates, each having a substantially rectangular configuration. Any side plate 187 188 is connected rigidly to an outer peripheral edge of a corresponding bottom plate and extends upwardly therefrom. 188 187 connected adjacent side plates to each other and to the bottom plates are Once, for example by welding, screwing or the like. The side wall 184 has thus an inner surface and an outer surface, each having a substantially hexagonal in cross-section along the length of the side wall 184.

[0104] Unlike the tank assembly 178 180 184 of the tank assembly 20 are the bottom and the side wall made of metal or another material made from solid sheets thus neither fluid channels 44 and limit, nor are they all slots extending therethrough on 68. Moreover, no door and no window includes the side wall 184. Finally, 180 184 connected rigidly to the side wall and the bottom is raised or lowered relative to the side wall 184 not, therefore, considered.

[0105] Both in the tank assembly 20 and in the tank assembly 178 can be of any desired configuration the side wall and the bottom, such as elliptical, polygonal, irregular or of any other desired configuration. The soil typically has a design, which is complementary to the side wall. In alternative embodiments it is clear that the different features can be mixed and matched tank arrangements20 and the 178, so as to generate a diversity of tank arrangement arrangements with different properties. For example, a tank assembly can be constructed, to heat or cool a solution, however, have a fixed base, raises or lowers which is not. Moreover, with many different sizes are produced tank arrangements can. For example can be produced with a chamber tank arrangements, having a volume of 20 liter, 250 liter, 500 liter, 750 litre, 1500 litre 1000 liter, 3000 litre, 5000 litre, 10000 litre or other size. Furthermore, the two or more 10 fluid preparation systemtank arrangements at the same or a different size, shape and/or comprise properties, which are mounted on or off the platform 12.

II. mIXTURE ARRANGEMENT

[0106] InFia. 8 is represented an embodiment of a mixing assembly 200. General, although not necessary or exclusively, the mixing arrangement comprises a mixing bag 202 200, a mixer204, which is adapted to be located within the mixing bag 202, and an extensible tubular seal 206, which is arranged, a fluid-tight connection between the mixing bag 202 and204 provide the mixer. As previously discussed the mixing shaft 208 can either In alternative embodiments a part of or be separate from the mixing arrangement 200.

A. mIXTURE BAG

[0107] As inFia. 8 represented, comprises an elongated bag-like main part 203 210 202 the mixing bag with an inner surface and an outer surface 212. Defines a compartment 220 210 The Inside. Special comprises the main part 203 a side wall213, which, when the main part 203 blow up will, has a substantially circular or rounded polygonal cross-section, and which extends between an upper end and an opposite lower end 214 216 extends. 214 terminates at a top end wall 215 The upper end, while the lower end terminates on a lower end wall 217 216.

[0108] The main part203 consists of a flexible water-impermeable material, such as polyethylene, polyurethane or other polymer films, having a thickness in a range between about 0.1 mm to about 5 mm, wherein about 0.2 mm to about 2 mm are customary. Other thicknesses may also be used. In one design embodiment is the material for a direct contact with living cells tested and is in a position, a solution to keep sterile. The material should also be sterilizable With this embodiment, such as by ionizing radiation. Examples of materials, which can be used, are disclosed in the US-patent No 6, 083, 587, which was granted on 4 July 2000, and the US patent application publication 2003-0077466, on 19 October 2001.

[0109] The main part203 can comprise two or more layers of a single layer of material or can, which are either sealed together or separately, to form a double-walled vessel. In one design embodiment comprises the main part 203 a two-dimensional bag, wherein two sheets of material are positioned in an overlapping relationship and the two layers are connected to each other at their peripheries, to form an internal compartment 220. In the illustrated embodiment, however, a three dimensional bag comprises the main part 203, which not only has an annular side wall 213, but also a two-dimensional top end wall 215 and217 a two-dimensional bottom end wall.

[0110] Theadd. 9 203 comprises a plurality in represented as three-dimensional body, i.e. typically three or more, individual elements 228. Each element comprises a portion of the side wall 228 is substantially identical and 213a, 217a 215a and said bottom end wall of the top end wall. Corresponding peripheral edges of each element 228 are missed with each other, to form seams add. 8 230 as represented in. The seams are formed using methods known in the art; 230, such as thermal energies, RF-energies, sealing energiesscarf-blaze other.

[0111] In alternative embodiments can be constructed in a plurality of different patterns 228 the elements. Another disclosure with regard to a process for the preparation of three-dimensional bags is disclosed in the US- patent application publication Nr.

2002-0131654, on 19 March 2001.

[0112] By individual elements 228 are used, it is clear that the main part 203 and thus the mixing bag 202 can be made so that it practically any desired size, shape and configuration. For example 220 are formed with the compartment 202 can the mixing bag, which is sized, 20 liter, 250 liter, 500 liter, 750 litre, 1000 liter, 1500 litre, 3000 litre, 5000 litre, 10000 litre or other desired quantities to contain. The main part 203 is often made from four or six elements 228, depending on the desired volume of the mixing bag 202. The mixing bag 202 fits to simply the configuration of the tank assembly 20, when it is filled with solution. In one design embodiment can be adapted to the mixing bag 202, however, specifically to be complementary to the inner surface of the tank assembly 20, which defines the chamber 60. If e.g. the inner surface of the side wall 24 has a hexagonal configuration, can be made from six elements 202 the mixing bag, so that it has a substantially hexagonal cross section.

[0113] In each case they will, when the mixing bag 202 within the chamber60 is received, the main part 203 110 and the side wall24 of tank assembly 20 uniformly supported from the bottom. This substantially uniform support of the main part 203 by the tank assembly 20 it does is, failure of mixing bag 202 by hydraulic forces exerted on the main part 203 to prevent, when the mixing bag 202 is filled with a solution.

[0114] InFies. 1QA represented, comprises the mixing bag 202 further comprises a supplying port 222, 224 and a barbed pressure port a barbed fluid connection 226, which are mounted in each case on the top end wall 215 of the main part 203, so as to protrude outwardly therefrom. 222 and 223 surrounds the free end of the feeding terminal annular flange A is apparent outwardly therefrom. A channel 227 extends through each of said terminals 222,224 and226, 220 provide provide a fluid communication between the compartment and the outside.

[0115] A flexible and is thus received is above the supply port 239 extension seal 222 241 connected by a strap. 239 243 is at the opposite end of the sleeve coupling piece tubular A and 241 secured thereto by a strap is also mounted. A 245 239 extension seal removable clip is closed around the, 220 to close the fluid communication between the compartment and the outside. 249 and251 are coupled to the terminals 226 224 or extension tubes. A belt 241 can also be used, to secure around each of these compounds. 249 and 251 is also about each tube 224 removable clip A closed, to close the fluid communication between the compartment 220 and the outside.

[0116] In 10B is represented an alternative embodiment.add, wherein similar elements are characterized by the same reference symbols. In this embodiment have been replaced by a cover plate 244 232 239 and the clamp the extension seal. The cover plate 232 234 220 is disposed within the compartment by means of a button and is rotatably mounted at or adjacent the supply port 222. The cover plate can be rotated 232,227 232 extending passageway around which selectively cover or expose by said supply port.

[0117] In Fla 11 represented, attached to said bottom end wall 203 217 of the main part, so that it protrudes outwardly therefrom is a barbed blowing up connection 236,238 and a barbed inlet port a barbed outlet port 240 242 is centrally located on the lower barbed attachment connection. A 217 and is arranged in the compartment 220 clear from end wall. A channel 236 227 also extends through each of the terminals, 238,240 and 242,220 provide provide a fluid communication between the compartment and the outside. Falls desired extension tubes with terminals 236 at the terminals thereto can, 238 and 240 are mounted, as with the terminals 224 and 226 discussed, the connection to the chamber 220 to close prior to use of the mixing bag 202.

[0118] in the above-discussed embodiments the mixing bag 202 a flexible pouch-like although construction, it is clear that in alternative embodiments the mixing bag 202 can comprise any kind of a collapsible container or rigid container.

B. A MIXING DEVICE

[0119] In one design embodiment of the present invention are provided means, to form a liquid solution 220 of the mixing bag 202 mechanically to mix within the compartment. Exemplary and nonrestrictive is a mixer 204 220 of the mixing bag 202 arranged within the compartment. As in Fia. 11 represented, comprises the mixer 264 204 a base 205 with flaps, which are attached thereto. Special 247 205 comprises a central hub with an outer surface the base 246,248 extending between a first end and an opposite end which extends 250. The second end terminates with a 250 254 252. barbs on an end face formed thereon threaded hollow at the second end 250 and 246 are surrounded the hub out radially outwardly therefrom.

[0120] As in add. 12 represented, the base 205 further comprises a plurality of spaced struts 256, to the first end 246 248 from the outside of the hub to an annular rim 258 protrude radially outwardly. A retaining screen 260, which is kept at or by the struts 256,258 246 extends between the hub and the rim defines a plurality of fluid openings 260 259. The retaining screen, which are formed between the hub 258 246 and the edge. In the illustrated embodiment the retaining screen is made of wire or other cord 260, which is tensioned between the struts 256. In alternative embodiments different types of meshes can the retaining screen 260, Vermattung, conventional screen, plates with slots, holes or other openings or similar types of structures comprise types characterized extending, which can keep flaps 264 as discussed below, which, however, allow the passage of a fluid therethrough.

[0121] As in Fig. 11 andFig. 13 A represented, extend a plurality of spaced spokes 258 246 262 also between the hub and the rim is aligned with a corresponding strut 262 256. Any Spoke, on whose side, which is closer to the second end 250 of hub 246. 260 262 and the retaining screen is positioned between each spoke 264 264 a flexible wedge-shaped flap 266 has a pointed front end. Any flap, which is positioned at or adjacent the hub 246, and a flared rear end 268,258 which is disposed adjacent to the edge. 270 and 272 264 also includes opposed diverging sides each flap, extending from the front end to the rear end 268 266 extend. Any flap 264 is so positioned that a corresponding spoke 262 266 268 extending between the front end and rear end 270 and 272 extends centrally between the sides. The flaps 264 are arranged, between the hub and the rim 246 258 formed completely or at least substantially covering fluid ports, when the flaps 264 260 rest on the retaining screen. In one design embodiment are made from a sheet of silicone having a thickness the flaps 264 in a range between about 1 mm to about 10 mm. Other flexible layers of a material such as polyethylene or polyurethane with a variety of different thicknesses may also be used.

[0122] As inFia. 11 represented, 220 of the mixing bag202 204 within the compartment is the mixer 208 held by the mixing shaft. Specially, the mixing shaft 208 a threaded first end and an opposite second end 278 280 on. The first end 278 227 242 208 runs slidably through the channel of the mixing shaft positioned and then into the threaded hollow attachment connection252 of the hub is of the screwed 246. 202 208 280 of the mixing shaft positioned outside of the mixing bag is end The second disposed.

[0123] In one design embodiment of the present invention are means provided, around the mixer 204 220 of the mixing bag202 raise and lower within the compartment, to mix the solution within the compartment 220. One embodiment of such means comprises a mixing shaft 208 as above discussed. Alternative embodiments of such means as herein disclosed include alternative mixture shanks.

[0124] The present invention also includes means, for allowing the mixing shaft 208 to enable, the mixer 204 202 220 of the bag raise and lower within the compartment, while preventing, 220 of the mixing bag202 escapes that liquid from the compartment. A tube-like seal has a first end 206 and nonrestrictive Exemplary 284, an opposing second end288 286 and a extending therebetween expandable bellows portion. The first end 284 of the seal246 206 surrounds the second end 250 of the hub. A circulating belt 290 is used, to secure the connection to a liquid-tight manner. Similarly 242 206 the mounting aperture surrounds the second end 286 of the seal. A belt 292 is also used, to secure a liquid-tight manner on these compound.

[0125] In the in Fia. 11 208 can freely within the channel 227 shown assembled configuration the mixing shaft 242 attachment connection of the slide, so that by selectively raising and lowering of the mixing shaft positioned from the mixer 208 from the outside of the mixing bag 202 202 202 204 appropriately within the compartment is raised and lowered relative to the mixing bag. The 206 is stretched and contracted bellows portion 288 of the seal selectively, relative to the mixing bag when the mixing shaft 208 202 is raised and lowered, whereby the sealed connection is maintained between the mixer 242 204 and theattachment connection.

[0126] As is discussed in more detail below is within the compartment 220 of the mixing bag202 accomplished a mixing a solution, by the mixer 220 is repeatedly raised and lowered within the compartment 204. As in Fig. 13B represented, runs, when the mixer 204 is raised, by the retaining screen 220 260 and presses fluid within of the compartment against the flaps 264, causing, 270 and272 of the flaps that the sides on opposite sides of the spokes 264 262 downwardly bend, thereby allowing the mixer 204 is enabled is to move without substantial interference from the fluid. If the mixer 204 begins, to move down, as in Fia. 13 A represented, presses the flaps 260 264 against the retaining screen the fluid, so that the passage of fluid through the fluid openings 259 of the mixer204 is prevented. The movement of the mixer 204 downwardly causes As such that the fluid within the compartment 220 downwardly, outside, at the top and flows, as represented by the arrow 294 in Fia. 11. Since the act of lifting and lowering of the mixer 204 is repeated, a vortical motion of the solution caused by the mixer 204 mixes the solution.

[0127] mixture parameter can be varied based on the amount and the type of the prepared solution. For example can the stroke length, i.e. the vertical distance, about which the mixer 204 moves, and the frequency, i.e. the number of times, how often the mixer 204 moves per unit time for the stroke length, and the acceleration and deceleration, i.e. the speed, with which the mixer 204 starts and stops, selectively be regulated. The stroke length and frequency can be changed not only between different batches, but may also be changed at different times during the mixing a single batch. Falls desired, may, in addition, one or more of the variables during mixing are continuously changed.

[0128] In one design embodiment are the parameters set so, and yet allow a quick and thorough mixing of the components that they are gently enough, for an extended period of time to obtain about suspensions, without excessive foaming bring about a. Exemplary and nonrestrictive the stroke length is in a range between 0.1 cm to about at a 30 cm embodiment, wherein about 5 cm to about 20 cm are conventional, while the frequency is in a range between 0.1 Hz to about 4 Hz, wherein about 0.5 Hz to about 2 Hz is conventional. Other parameter settings may, however, also based on the design of the mixer and the amount and type of the prepared solution are used.

[0129] It is understood that the means for mechanically mixing a liquid solution within the compartment 220 of the mixing bag202 204 may comprise a plurality of modifications or alternative embodiments of the mixer. For example, can make a big difference in the embodiment of the mixer 204 be reversed, so that a swirl is generated in a reverse direction. Moreover, the flaps 264 simply as a one-way valve. It is understood that there is a plurality of alternate paths, one-way valves to said mixer form 204. For example can, instead to take flexible flaps 264, rigid flaps hinged to the mixer 204 be mounted. Moreover, pneumatic, hydraulic or electrical switch 204 be coupled to the mixer, which one-way valves selectively open and close at the mixer 204. In this embodiment can comprise simple flaps said one-way valves, which are selectively Move is one or more holes 204 extending to selectively open or close through the mixer.

[0130] In a further alternative embodiment, it is clear that the mixer 204 can be formed without one-way valves. A rigid or flexible plate 204 can, for example, comprise the mixer without openings. In this embodiment swirled mixes it in a different way the solution or the plate, when said plate is moved in both directions. In still further embodiments, the plate can have holes or slots therein fixed, to direct the movement of the fluid. Similarly 204 may simply comprise a plurality of fixed blades or vanes the mixer, which may be adapted, either located within the mixing bag 202 to rotate and/or to move up and down, to mix the solution. In still further embodiments may be mounted on the mixing shaft, two or more mixer 208 204. For example 208 204 may be spaced apart longitudinally along the shaft the mixer.

[0131] For other embodiments of the means for mixing can mixers are employed, which do not work, by be raised and lowered. For example oh-driven sheets and magnetically operated agitating rods can, which is within the mixing bag 202 rotate, are used.

[0132] InFia. 14 an alternative embodiment of a mixer 310 is represented A. 310 comprises a base 312 with associated flaps The mixer 314. The 312 has a substantially circular plate-like design with an upper base 316 and an opposite lower surface 318 surface. As in Fla. 15 represented, includes the base 322 324 312 an integrally formed central hub and integrally formed struts, which from the hub322 326 protrude outwardly toward an outer edge. The struts 328 324 312 into a plurality of wedge-shaped sections share the base. Within 328 formed each section, to collect between the upper surface and the lower surface 316 318 to extend, are a plurality of fluid openings 330.

[0133] The base 312 is typically made of a polymer material, such as high density polyurethane or polyethylene, may, however, also of metal, a composite material or other desired materials be made. The base 330 312 may be formed with fluid openings formed thereon. Alternatively, the base 330 312 and/or the fluid orifices are cut out. In one design embodiment has a thickness 312 316 318 the base between the surfaces in a range between about 1 cm to about 6 cm and, wherein about 2 cm to about 4 cm are conventional. Other use parameters can also be used depending on size and dimensions.

[0134] As inFia daraestellt. 16 312 314 318. are mounted on the lower surface of the base flaps. The flaps 264 314 have substantially the same design as the flaps. In this embodiment, flaps 314 polyethylene situations having a thickness in a range from 0.1 mm to about 5 mm between, wherein about 0.2 mm to about 2 mm are customary. Other materials and thicknesses are used can Once again. Unlike the mixer 204, wherein the flaps are retained in position 262 264 of spokes, are the flaps 312 welded directly to the base 314. In other words each flap 314 is, such as by heat, sound, chemical welding or the like along a central axis 324 332 welded to a corresponding strut. Any flap 314 is arranged, the half 328 to be overlaid from each adjacent section, wherein the side edges of each flap 314 for bending are free. 314 can thus operate in the same manner as previously Flaps with respect to the flaps 264 discussed.

[0135] As inFia. 17 represented, 322 318 336 is a blind hole 312 formed on the lower surface of the base of the hub. The blind hole 336 has a frustoconical configuration, which tapers outwardly in the direction of the upper surface 316. The taper is typically 10° in a range between about 1a, although other angles may also be used. A tubular connector 340 has a first end 318 disposed on the lower surface, so as to surround the blind hole 336, and has a second end barbed annular provided, which projects downwardly therefrom. The tubular connector 340 can be integrally or connected to the base 312 be constructed.

[0136] ToFig. 14A returning, has a tubular terminal 346 344 a flanged first end, which is welded or otherwise fastened thereto on the mixing bag 202, and has second end provided with barbs 348, which projects outwardly from the mixing bag 202. 352 350 has a first end and an opposite seal A tubular second end 354. The first end 352 is received over the second end of the tubular connector 340, to thereby form a sealed connection. The second end 344 350 354 of the seal and then guided by the tubular connector is turned from the inside to the outside, around the barbed second end 344 348 of the tubular terminal and thus form a sealed connection to enclose. The 350 is typically formed from a polymeric material tubular seal, such as polyethylene, having a thickness in a range between about 0.5 mm to about 10 mm, about 0.75 mm to about 3 mm are wherein conventional. Other flexible materials and thicknesses may also be used.

[0137] A mixing shaft 358 310 connected releasably to the mixer is represented. Mixing shaft 358 360 has a first end and an opposite second The end 362. To Fla. returning 17 is a tubular clamping sleeve 358 363 360 of the shaft out from the first end. 364 363 has an outer surface with threads formed thereon and clamping sleeve The an inner surface 365, 366 which surrounds a socket. A plurality of radially spaced slots 364 and365 376 extending between surfaces along the length thereof. 366 368 a truncated cone-shaped wedge is disposed within the base with a first end and an opposing second end 369 370.

[0138] Before the mixing shaft is coupled with the mixer 310 358, 363 has a substantially cylindrical configuration the clamping sleeve, wherein the base is sized 366, 368 receive only the smaller second end 370 of the wedge. The first end 360 358 of the mixing shaft positioned during the assembly is with the partially within the base 368 350 366 received in the blind hole by the tubular seal 336 and wedge the base 312 guided. If 363 336 is pressed further into the blind hole the clamping sleeve, the first end 368 369 of the wedge is against the bottom of the blind hole 336 biased. Gradually, 368 366 pressed further into the socket the wedge, causing, 363 radially outwardly expands that the clamping sleeve, so that the threaded exterior surface on the inner surface of the blind hole 336 363 364 of the clamping sleeve is engaged. 368 363 is pressed further into the clamping sleeve By the wedge is attached to the base 360 358 of the mixing shaft positioned the first end 312 connected. Once, however, the use of the mixing bag 202 is complete, the mixing shaft 358 can be rotated, so that the clamping sleeve is unscrewed from the base 312 363, thereby enabling reuse of the mixing shaft positioned 358 is made possible.

[0139] The above embodiment allows a relatively simple attachment of the mixing shaft positioned on the inside of the mixing bag 202 310 358 positioned mixer, without an oblique screwing into the thread is to be feared. In alternative embodiments, however, it is clear that the mixing shaft 358 using conventional compounds, such as, for example, of screw engagement, with the mixer 310 310 may be attached to the mixer can be connected or permanently.

[0140] TorA. 14A returning, can, as soon as the mixing shaft 358 310 is attached to the mixer, the mixing shaft 358 are used, the mixer for mixing the solution to raise and lower within the compartment 202 310 selectively. Unlike the expanding and contracting of the 288 of the tubular seal bellows section206 (as in 1, the tubular seal 9 add Fla. 350. 14 A 14B represented progressively from the inside to the outside and turns and Fla. then back from the outside to the inside, when the shaft 358 is raised and lowered. The 350 is thus a further example of an agent tubular seal, to allow for enabling a mixing shaft, a mixer 202 raise and lower within the compartment 220 of the bag, while an escape of liquid from the compartment 220 of the mixing bag202 is prevented.

[0141] a further alternative embodiment of a mixer 374 is represented 18A Fla. In having attached a shaft 376. In the mixer 310 374 and the mixer are similar elements by identical reference symbols characterized. The mixer 374 is substantially identical to the mixer 310, except that the base 340 336 374 378 of the mixer contains no blind hole and no tubular connector. 380 378 a through hole has Instead the base, which is formed by the hub 322. A 378 381 is on the upper surface 316 of the base bolts arranged in such a way that a threaded shaft is received within the through hole 380 382 thereof. The mixing shaft 376 384 383 has a first end and an opposite second end. A Screwed 383 376 is recessed within the first end of the mixing shaft positioned. 383 380 376 is within the through-hole of the mixing shaft positioned end The first positioned and in threaded engagement with the bolts 381. A annular flange 376 385 is from the mixing shaft 378, and is biased outwardly against the bottom face of the base, thereby preventing that the mixing shaft 376 378 is carried out by the base. In this embodiment is the mixing shaft 376 adapted to be mounted permanently on the mixer 374. Can the mixing shaft 376 by using any one conventional mounting mechanism Once, such as welding, integral formations, screws, clamps and the like, with the mixer 374 be connected.

[0142] 384 376 of the mixing shaft positioned on or in the direction of the second end is mounted a flexible diaphragm 388. In one design embodiment 388 made of polyurethane is the membrane. Other flexible materials may also be used. The 388 has a hollow hemispherical configuration membrane, forming an outer annular base 389 390 includes outwardly projecting annular flange with a thereof. The flange 390 is, e.g. by welding or other conventional techniques, with the mixing bag 202 sealed, so that the membrane is in communication with the compartment 202 220 of the mixing bag 388. 391 388 also includes a central portion with a thereof The membrane protruding tubular sleeve 392. A plurality of ribs in the direction of its second end 376 393 surrounded the mixing shaft 384 and are at or out radially outwardly thereto. 393 388 392 of the diaphragm is guided over the fins sleeve The, so that a sealed connection is formed between the mixing shaft 388 376 and the membrane. 394 can be secured around the sleeve 392 A belt, to ensure a sealed connection.

[0143] In this configuration is another example of the means 388 the membrane, to allow for enabling a mixing shaft, a mixer 220 of the mixing bag202 raise and lower within the compartment, while an escape of liquid from the compartment 220 of the mixing bag202 is prevented. Specially, as in add. 18 A 18B represented and Fla., 388 freely inward and outward bends the membrane, when the mixing shaft 376 is selectively raised and lowered, to raise and lower the mixer 374, 376 is made possible so that a free movement of the mixing shaft positioned.

[0144] It is understood that the various mixer, shanks and/or seals and their components can be mixed and matched, to generate a plurality of other alternative embodiments. There will also be noted that the first end of the seals 206 and208 ormixture shanks350 in sealed communication directly to the. 358 can be coupled, in contrast to the corresponding mixers.

[0145] 200 as a disposable unit which is In one design embodiment manufactured and sold the mixture and order. During the preparation is, as previously discussed, a part of the elements 228 missed with each other. Against the complete sealing of the elements, however, the mixer 220 228 204 is positioned within the compartment. As previously discussed is then between the mixer 206 The seal 204 and the mounting aperture 242 coupled. Once the seal 206 is correctly installed, the rest of the elements 228 missed with each other, to complete the production.

[0146] As inFla. 19 represented is the mixing bag 202 296 enclosed by a belt is folded and then accordion shape. Once it is complete, the mixing arrangement 200 can be sterilized, such as by ionizing radiation or other conventional methods. Depending on the desired solution, however, it may not be necessary and the production process, the mixing arrangement 200 sterilize.

[0147] The mixing shaft 208 can be mounted to the mixer 204, either before the mixer 204 202 220 of the mixing bag is placed within the compartment or at any time after the mixer 204 is sealed within the compartment 220. As in Fies. 11 represented, these later attachment accomplished is, by simply the first end 202 to 208 278 of the mixing shaft positioned from the outside of the mixing bag 206 242 and is guided by the tubular seal and then the mixture opening208 the mixing shaft is screwed into the mixer 204. In this embodiment can either be disposed of after use or removed the mixing shaft 208 and be re-used.

[0148] In the embodiments, in which the mixing shaft 208 is viewed as disposable, can the mixing shaft 208 to any desired conventional manner, such as by adhering, welding, press fit, 204 be connected to the mixer, or may be formed integrally as a portion of the hub 246. If the first end of the seal is coupled to the mixing shaft 208 204 206 instead to the mixer, the mixing shaft 208 204 coupled with the mixer is, before it is sealed within the compartment 220. The second end 206 is then downwardly through the seal 208 of the mixing shaft positioned to the outside of the mixing bag 202 guided.

[0149] The mixer 374 are also prior to the complete sealing of the elements 310 and228 220 of the mixing bag202 positioned within the compartment. Similarly may also be coupled with corresponding mixers mixture shanks 376 358 and the, either before or after the mixer 220 are sealed within the compartment.

[0150] As previously discussed, can be made so the mixing bag 202 that it contains any desired volume of fluid. During the use a manufacturer determined first, how much solution is to be produced. Based on 200 corresponding to the desired volume of that article, a mixing arrangement selected. Based on the size of the selected mixing arrangement 20 110 200 is either raised or lowered the bottom of the tank assembly, so that, when the mixing bag 202 within the chamber60 of tank assembly 20 is fully inflated or filled, the upper end wall 30 of the tank assembly 215 of the mixing bag202 is positioned within the upper end 20.

[0151] Where110 has been moved into the desired position the bottom, 57 into the chamber 200 through the open input is the mixing arrangement 20 used 60 of the tank assembly. Special fluid preparation system comprises the 10 at a embodiment, as in Fia. 1 400 daraestellt. further comprises a lifting device, which is mounted on the platform 12. The 402 404 400 comprises a tower with an attached arm lifting device. The tower 406 402 having a longitudinal axis and is arranged on, to rotate around such a axis. Similarly 404 adapted is the arm, selectively along the length of the tower 402 raise and lower. In the arm is mounted a winch 408 404, 410 is operable with a rope. 412 410 is a connector mounted on the end of the rope.

[0152] To200 within the chamber60 to position the mixing arrangement, the arm 408 404 and/or the cable be lowered, so that the connector 202 is mounted on the mixing arrangement 412 296 to the belt. The Hoisting device 400 is then used, the mixing arrangement 60 to guide 57 into the chamber 200 through the doorway. The mixing arrangement 200 is lowered within the chamber 60, so that, when the lower end wall 112 of the bottom 217 of the mixing bag202 basic ground110 is caused to rest on the, the terminals 236,238 and240 are aligned with the paired 116. Similarly is aligned with the central port hole 117 and the mixing shaft 208 guided therethrough, as previously discussed with the actuator rod 176 172 so as to be coupled by the clutch. Once the mixing arrangement 60 is inserted within the chamber 200, 296 is removed and the door is closed and locked the belt 25.

[0153] extending through said port holes 116 extending terminals Next will coupled with different tubes. For example 420 238 coupled with the exhaust port is a discharge tube. On passing through a first valve 422 420 emissions stack The, a pump424, 426 or is coupled to a second valve is coupled to a filtration system and then 500, which is discussed in detail below. A sample tube 422 428 is coupled with the first valve. A 426 430 extending between said second valve and said inlet port feedback pipe 240.

[0154] the expression "pipe" for, as in the description and accompanying claims used, however, the intention is that it comprises conventional flexible hose and tubing, which is relatively inexpensive and, if desired, between the manufacture of different batches or types of solution simply can be replaced. The expression "pipe" intends, it is also possible for that solid pipelines and other forms of conduits, which may be invariable and a sterilization between the production batches or types of solution require between different.

[0155] Furthermore, it is for the expression "valve", as used in the description and the appended claims, intends, any type or combination of mechanisms that it includes wide, which allows a selective closing a gas path leading fluid. For example can comprise a T -connection the first valve 422, which is coupled with two sections of the of the delivery tube 428 420 andsample pipe, which act in combination with an external clamp, such as a conventional hose clamp, which can be operated manually or otherwise selectively about either the delivery tube 428 420 or sample tube can be closed around. Alternatively, there are a plurality of other conventional types of electric or manual valves, which can be used. The use of external clamps or other forms of valves, which do not touch the solution, have the advantage that it can be reused without sterilization. However, valves, which are in contact with the solution, and then disposed of or are sterilized also be used. The pump can comprise a peristaltic pump 424 this respect, wherein the delivery tube 420 is passed through them, without ever that the solution contacts the pump. Conventional pumps may also be used, but where the solution directly contacts the pump.

[0156] blowing up connection236 is coupled with the an air tube 432. The air tube 432 is coupled to a source of air. In one design embodiment the air source comprises a compressor or some form of tank, in which already compressed air is stored. In the illustrated embodiment is hollow and forms a portion of the platform a large holding tank for compressed air. A advantage of the use of a large holding tank for receiving compressed air is, there is a fast inflation of the mixing bag 202 allows. By the platform 12 than the holding tank is used, the space utilization is optimized. 434 with the platform 12 is by means of a valve 432 air tube The coupled.

[0157] Once the air tube 432 is coupled is air or another form of gas through the tube into the compartment 220 guided 432, to completely or substantially inflate the mixing bag 202 within the chamber 60. As previously discussed, are clamps 244 in connection with the terminals 222,224 and226 used, so as to reverse the connections to seal, whereby an inflation of the mixing bag 202 is made possible. Alternatively, different types of caps, gaskets or other types of obturators are used, so as to reverse the connections to seal temporarily. As in add. 20 represented is a supporting frame 24 of the tank assembly 20 436 at the upper end30 of the side wall mounted or positioned, so that it is at least partially over the side wall 24 extends. A removable clamp 438 is used, around said supply port 222 (Fig. 10 A 436 to secure 1 to said support column.

[0158] Once the mixing bag 202 inflated and 436 is fixed to said support column, either directly or by an extension pipe 440 is a fluid conduit 249 242 coupled with the fluid connection. The fluid conduit 440 is for the selective supply of a fluid, such as various forms of water, in the mixing bag 202 designed. A pressure regulator 442 is coupled with the pressure port 226, such as by the extension tube 251, to selectively to control the air pressure within the mixing bag 202 within a desired range. 442 444 operates with an air-intake duct of this the pressure regulator, which is coupled to a pump or compressed gas source, air or other gases in the mixing bag 202 to guide, and an exit air duct 446, around it to allow air, to escape from the mixing bag 202. 446 447 is coupled with the outlet line A filter, to prevent about a particulate feed component within the mixing bag 202, with the exiting air to escape.

[0159] The aforementioned process is typical for a positioning a relatively large mixing bag within a tank assembly with a movable floor. 6 and 7 represented in Fig. Fig. for the 178 tank assembly, in which the bottom is attached to the sidewall, typically sized 202 is the mixing bag that it has a volume, which corresponds to the volume of the chamber of the tank assembly. In general, such systems to 1/5 of the volume of the mixing bag efficiently mix fluid volumes to down. For example, a tank assembly 178 with a chamber having a volume of 100 liters typically a mixing bag with a compartment having a volume of 100 liters to receive. Such an arrangement, however, could be used, in the range of about 20 liters to about a 100 liter solution volume to mix efficiently.

[0160] The mixing bag 202 is inserted into the chamber of the tank assembly 178 is lowered by forcing it through the upper opening. This can be accomplished either manually or by use of the lifting device 400. Falls desired, can said supplying port 222 (Fig. 10Ä1 to said support column436 (Fig. 201 be fixed, which is mounted on the top of the tank assembly 178. For small mixing bag needs not to be supported within the tank assembly, however, the mixing bag.

[0161] The inflation of the mixing bag 202 is partly helpful for the correct positioning of the mixing bag 202 within the tank assembly, for access and for connecting various structures at the top of the mixing bag 202 and, as is subsequently discussed more precisely, for generating a gas positive pressure, which helps, the dry material component 202 to supply in the mixing bag. In particular, however, it is not necessary for smaller mixing bag, the mixing bag inflate. Bids for smaller mixing bag the air tube 432 (1 be eliminated and the mixing bag add. 1 solely by the intake conduit 444 (Fia. 201 are inflated.

IV. sUPPLY BAG

[0162] 20 is a feed bag 450 represented. Fia In, which is coupled with the mixing bag 202. Feed bag 450 452 comprises a main part The, 451 453 extending from an upper end to a lower end extends. 484 has an inner surface 452 The main part, which defines a compartment 449. The compartment is filled at least partially with the feed component 449, which typically in the form of a powder material, grain or other substantially dry material is present, which is flowable. The feed component can also in liquid form. Although the feed component may be any desired material, the feed component comprises culture media at a embodiment, buffers, or reagents in a powder form.

[0163] 452 453 The bottom end tapers downwardly to a tubular spout 454 of the main part. 455 454 limited an outlet tubular spout The, which selectively and removably coupled with a tubular coupling 243. (243 was previously with respect to Fig tubular coupling The. 10 discussed. A) This link enables the feed component, of the feed bag 450 to the mixing bag 202 to run, and can by the use of a tape, a belt, a clamp or the like are secured. 456 454 clamped over the spout is removable clip A, to prevent an undesirable passage 454 that supply component through the spout.

[0164] The feed bag 450 456 comprises further a handle, which is positioned at the upper end 452 451 of the main part, around the feed bag 450 to hold. 452 451 of the main part on the upper end, so that it communicates with the compartment 449, 459 457 and a spaced venting port a fluid connection is present. 457 and459 In one design embodiment comprise conventional barbed connections the connections, which protrude outwardly from the main part 452. Other conventional access types may also be used. 457 and458 459 is coupled with the terminals or a vent tube 462 a fluid tube. Moreover, 461 is a clamp, such as a conventional hose clamp, 458 and462 positioned at each of the tubes.

[0165] 460 458 is selectively and removably coupled to a discharge line fluid tube The, with a fluid source for supplying a cleaning fluid, such as water, into the compartment communicates 449. Vent tube 462 is coupled with a filter 464 The. 459 464 The filter can at any point along the directly to the venting port 462 ventilation pipe be mounted or. The filter 464 enables air and/or other gases, to escape therefrom into the compartment 449 to enter and/or, while the escape of the feed component is prevented. In alternative embodiments it is clear that the feed bag 450 may be formed with a single port, which can be used for one of the two or both of the above functions.

[0166] 452 of the feed bag450 can be made from the same materials The main part, such as polyethylene, and layers as previously discussed with respect to the main part 203 of the mixing bag 202. 452 and thus the feed bag 450 the main part Tours can be in any desired form or configuration and may be either a three-dimensional bag be dior. It is understood also that the feed bag 450 is any type of collapsible container or may be a rigid reusable container.

[0167] ToFig. returning 1, an L-shaped bracket 400 further includes the lifting device at the end of connector mounted with a 466 468. The mount 404 466 is selectively rotatable about the longitudinal axis of the arm, for connecting the connector 468 456 of the feed bag450 to facilitate to the handle. The feed bag 450 468 is attached to the connector, so that it is suspended therefrom. 466 can also be arranged The mount, the feed bag 450 to weigh, when it is connected thereto.

[0168] Although not necessary, a regulator 404 470 is mounted on the arm at a embodiment, from the feed bag 450 selectively deliver the feed component. As in Fies. 21A represented, comprises a base frame 472 470 the regulator 474 with a central channel formed thereon. 454 of the feed bag450 is positioned tubular spout The, 474 that it runs through the channel. 472 476 and is slidably mounted on the base frame is control plate A by a push-rod 475 controlled, to selectively 474 to slide within the channel. A vibrator 478 476 is mounted on the control plate. During operation is the control plate 476, operable under electrical control of the push rod 475, 474 advanced within the channel, around the tubular spout 454 472 compress against the base frame, whereby the unwanted passage of the feed component is prevented.

[0169] to an increasing extent the control plate 476 is controllably delivering the feed component Zur withdrawn, thereby enabling the feed component is made possible, through the now only partially contracted tubular spout 454 to flow. To to help, by the tubular spout 454 to facilitate the passage of the feed component, 478 are activated can the vibrator, which the feed component can be in transit through said tubular spout 454 and they vibrate, the clutch243, the supports 220 239 and into the compartment extension seal. The levy the feed component can be determined by the change in weight of the feed bag 450, 466 as it is measured by the holder. It is understood that the regulator 470 required may or may not be necessary, when all of the contents of the feed bag 450 in the mixing bag 202 are to be supplied.

[0170] In a method of use, as it is represented in Fia. 20 is, as soon as the mixing bag 202 is inflated, the vent tube 232 (Fig. 1t closed from the junction with the sealed and the clamps 224 226 244 are removed and pressure port fluid connection. The compartment 220 of the mixing bag is filled at least partly with a liquid component 202 now, by the fluid conduit 224 enters 440 and the fluid connector. In one design embodiment is the mixing bag 202 initially with the liquid component up to a volume fraction of about 50% to 80% filled. If 220 enters the liquid component in the compartment, the air within the compartment 226 220 escapes through the pressure port, so that the pressure range is maintained within the compartment 220. Either before, during or after the initial fluid filling of the compartment 202 as above discussed is the feed bag 450 220 coupled with the mixing bag.

[0171] Once the mixing bag 202 is filled with the liquid component to the initial capacity, be removed so the terminals 245 and 456 that the feed component is free to be guided from the feed bag 450 in the compartment 202. As previously discussed, a particular charge are supplied or feed component The by the use of the regulator 470 be regulated. In alternative embodiments can at any time during the process the feed component 202 are fed into the compartment.

[0172] It has been found that the free and continuous flow of the powdered feed component 454 452 of the feed bag450 from the main part by the tubular spout extension seal239 is improved and, when the feed bag 450 is operated under a positive air pressure. For example, the powdered feed component improved river characteristics, when the feed bag 450 is at least partially inflated by air, from the mixing bag 202 239 and the tubular spout 454 extension seal flowing upwardly through the. The pressure regulator 220 maintains the air pressure within the compartment As such 442 202 of the mixing bag, so that, when the clamps are removed and 456 245, the feed bag 450 is exposed to a positive air pressure. In other words, air or other gases through the intake conduit 444 or can. Air exhaust duct 446, 442 are controlled by the pressure regulator, in the mixing bag 202 supplied or are removed therefrom.

[0173] A holding the mixing bag 202 at an excess gas pressure also helps here, ensure that undesirable gases or particles is not unintentionally enter and contaminate the solution into the mixing bag 202. In one design embodiment holds the pressure regulator 442 an overpressure within said compartment in a range between about 0 220,5kPa to about 14kPa, wherein about 3,5kPa to about 10kPa are conventional. Other pressures can also be used depending on the system parameters.

[0174] Once the feed bag 450 is empty, 458 461 on the fluid pipe is the clamp opened, and a cleaning fluid, such as water or other compatible liquids to the solution is 450 460 458 in the feed bag through the conduit and the fluid pipe guided. The cleaning fluid is used, to help it, suspended particles and other residues within the feed component of the feed bag 450, 239 in the compartment 243 of the clutch220 to flush and theextension seal. Once the feed bag 450 is empty and rinsed is closed and the conduit 461 460 uncoupled the clamp. Moreover, 239 245 and456 on theextension seal or the clamps. Spout 454 closed. In this configuration remains the feed bag 450 202 inflated by air supplied from the mixing bag.

[0175] In order to empty the feed bag 450, 463 462 the clamp is opened to the vent tube. The bled air passes through the filter 464, to detect about a remaining feed component. Vent tube 462 is also used The, around feed bag 450 to empty, which are only partially emptied of the feed component. The feed bag 450 is243 decoupled either before or after the emptying of the coupling. If necessary, a new feed bag 450 can then be connected with the clutch 243. It is understood that it may be necessary in some embodiments, a plurality of feed bag 450 for the preparation of the solution in the mixing bag 202 to empty, whilst other embodiments may be necessary, only a part of a single feed bag 450 to empty.

[0176] the vent tube 462 during dispensing of the feed component For some method of use can be left open, so that air continuously thereby emerges. Bids in embodiments, in which the mixing bag 202 not is under positive pressure, the vent tube 462 are opened, to allow filtered air around it, to run freely in the mixing bag 202, to increase the flow of the feed component. Air or other gases through the vent tube 462 in the feed bag 450 can also be driven.

[0177] 22 is an alternative embodiment of a feed bag 562 representedadd. In. Similar elements of the feed bag 562 and of the feed bag 450 are characterized by identical reference symbols. Unlike the feed bag 450, wherein the spout is removably connected with the clutch 243 454, 454 of the feed bag562 561 is the spout to an outlet port welded or otherwise fastened. As in Fia. 23 represented, has a diamond-shaped base 561 563 the exhaust port 564 with a plurality of ribs, extending along the length thereof. 565 563 is integrally formed with the base and tubular shaft A extends thereby. 565 566 and terminates a port bounded The shaft at an outwardly projecting flange 567.

[0178] 561 563 455 within the outlet of the exhaust port, is The base452 received of the main part, so that the sides of the spout cover 454 the ribs 564. A conventional welding technique, such as heat-welding or acoustic welding is then used, around the sides of the spout on the ribs 564 to weld 454, form a sealed connection therebetween. As requested, then a clamp 568 used is, around the exhaust port 561 of the feed bag562 removably and222 of the mixing bag202 to connect directly with the supply port.

[0179] The feed bag 450 also sends out of the feed bag 562 different, 570 that a single terminal 451 is formed at the upper end. 570 572 extends between the terminal and a three-way valve transition tube A 574. Vent tube 462 458 and fluid tube The, as previously discussed, are coupled respectively to the valve 574. A operation of the valve and the vent tube 462 458 574 thus can make the fluid tube, 449 of the feed bag562 to communicate selectively with the compartment.

V. sPRAY NOZZLE

[0180] Either after and/or simultaneously with the discharge of the feed component in the mixing bag 202 is the remainder of the required fluid component through the fluid port 224 (Fia. 20t in the mixing bag 202 guided. Although not required is at a embodiment, as shown in Fia. 24, a spray nozzle 413 224 mounted removably attached to the fluid connector. As represented by arrows 415, 413 a radially outwardly directed spray nozzle facilitates the spraying of the by the fluid connector 220 224 202 entering liquid component into the compartment of the mixing bag. The sprayed liquid component it does is, the feed component to down-wash, located at the side walls of the mixing bag 202 may have accumulated, and also helps in the process, to remove particles of the feed component, are suspended or floating within the mixing bag 202.

[0181] As inFia. 25 and 26 represented . Fia, 413 414 415 comprises the spray nozzle with an outer surface and an inner surface416 a tubular main portion, each extending between a first end and an opposite second end 418 417 extend. 417 415 The outer surface outwardly protruded at the first end is a stepped flange surrounding and409 present radially therefrom. The inner surface 416 419 a channel limited, 421 at the second end 418 to an end wall which extends radially inward. Self 416 419 extending between the inner surface and the outer surface, at least a portion of the second end 418 to surround, a spiral slot 411 is present.

[0182] ToFia. 24 returning, the second end 418 of the spray nozzle is in use by the fluid connector 224 led 413, so that the stepped flange 409 224 engages with the leading edge of the fluid connection. In this configuration is the second end 220 411 418 with the formed thereon spiral slot 202 arranged within the compartment of the mixing bag. The fluid component, which flows down the extension tube 249, enters into the channel 413 417 419 of the spray nozzle at the first end a. The fluid component moves the channel 411 419 down and is sprayed radially outwardly by the spiral slot. The sprayed fluid component serves in turn this, as previously discussed the feed component to down-wash. In alternative embodiments it is clear that the spray nozzle can be replaced by numerous different spray heads or the end thereof, such as those, which are used in conventional sprinkler systems.

[0183] During of feeding the components in the compartment 202 and/or thereafter the mixer 220 of the mixing bag204 or one of the alternatives to activate, to mix the components into a homogeneous solution. Specially is, as previously discussed, the mixer 204 under various operating parameters, which are specific for the volume and the type of the solution prepared, 220 repeatedly raised and lowered within the compartment. One of the advantages of the mixer 204,310 and374 is that they are able, Both large and relatively small levels with minimal shear forces and to mix efficiently while minimizing the formation of foam. High shear forces and the formation of foam can be harmful for some biological solutions.

[0184] Although the side wall 24 of tank assembly 20 may be of any configuration, such as circular as represented in Fla. 2, has been found that improved mixture characteristics are obtained, when the inner configuration of the side wall has a polygonal configuration, such as the hexagonal configuration shown in Fia. 7. The polygonal configuration seems to propagate the turbulent flow, which improves the mixing.

[0185] If the feed component 220 are mixed and the liquid component within the compartment, can by the sample tube 428, which as shown is in communication with the delivery tube 420add. 1 in, samples are tested and pulled out. Similarly can be added 428 selected adjuncts through the sample tube, wherein the additives then through the pump and then through the return tube 430 424 220 run back into the compartment. Examples of additives include serum, acids, bases, lipids, trace element components buffer. Once the feed component are mixed at a desired rate and liquid component, typically into a homogeneous solution, the solution can be dispensed directly by the delivery tube 420, 500 ( as discussed below) are guided by the filtration system with a different type of system are guided or prior to the discharge.

[0186] For the embodiment, in which the upper end 214 of the mixing bag202 as represented by the clamp 20 436 438 to said support column in Fig. is attached, remains suspended 60 within the chamber 202 the mixing bag, the mixing bag is removed when the solution of 202. In one design embodiment begins the mixing bag 202, when the solution is removed, from the upper end to the lower end 214 216 radially coincide. Consequently, , when the entire solution is removed, the mixing bag 436 202 approximately completely supported by the supporting frame. In an alternative embodiment is, when the solution is removed, air or another gas into the compartment 444 220 pumped continuously through the intake conduit, so as to maintain a positive pressure within the mixing bag 202. The mixing bag 202 thus remains partially supported from the side wall of the tank assembly. A inflation of the mixing bag 202 also helps here, the entire solution to remove therefrom.

[0187] Once the entire solution is removed, 202 for a new batch of being recharged can the mixing bag. Alternatively is decoupled by the various tubes 202 the mixing bag, and the mixing shaft 208 is decoupled from the actuator rod 172. By use of the lifting device 200 is then400 The entire mixing arrangement 60 removed from the chamber, where they then either disposed of or is passed to the re-use. A new mixing arrangement for the production of a new batch of solution can then be used in the chamber 60, without the need for, the tank assembly 20 to sterilize or clean.

VII. tHERMOMETRIC BULB

[0188] As previously discussed, 44 in the side wall24 of tank assembly 20 used are the fluid channels, so as to control the temperature of the solution inside of the mixing bag 202. Although fluid channels 44 of regulating the temperature, the temperature of the solution they didn't really measure. In one design embodiment can be used by terminals on the mixing bag 202 temperature probes into the solution. One downside of this embodiment, however is that the probes then prior to use with a different batch or another type of solution must be sterilized.

[0189] embodiment of the present invention means provided at a Consequently,, the temperature of the solution inside of the compartment continuously to detect 200 220 of the mixing bag, without directly to contact the solution. Exemplary and nonrestrictive add. 27 a temperature probe480 is represented in, which has an outer surface 481, 482 extending between a first end and an opposing second end483 extends. 481 482 Outwardly, 483, projecting from the outer surface and between the opposite ends is a mounting flange 484 present. 485 483 terminates at a substantially flat end The first end side. From the second end 468 443 is present a projectingsignal wiring, to transmit the signal generated by the temperature probe 480.

[0190] As in the temperature probe 28 is further defined as a 480 daraestellt Fig.. 488 comprising cylindrical housing, having a surrounding peripheral wall 489 and490 482 thereof positioned at the first end comprises an end wall. Cabinet 488 is typically made of metal, such as stainless steel, and typically has a thickness in a range between about 0.3 mm to about 3 mm. Other materials and thicknesses may also be used. Cabinet 488 has an inner surface 491, 492 which defines a cavity. Within of the cavity 492 arranged, so that it is biased against the inner surface 490 491 of the end wall is a thermal sensor 494. The thermal sensor 494 comprises In one design embodiment a thermal impedance or other formations of heat-sensitive material, such as in the form of an electrical line, wherein the electrical resistance of the material changes, when the temperature of the material changes. It can, therefore, by passing an electrical current through the thermal resistance or the other material is fed and the resistance is measured, the temperature at the thermal sensor 494 are measured.

[0191] in the illustrated embodiment comprises the thermal sensor 494 the electrical line from a conventional linear RTD-probe (RTD: "Resistance Thermal device"). As in Fia, 29 represented, the linear electrical lead to a substantially flat circular configuration has been wound. In one design embodiment, the engaging member 494 of platinum, may, however, also of nickel, copper, nickel iron or other thermal resistance materials are made. 492 extending from the thermal sensor 494 within the cavity is the To signal wiring486 present. The signal wiring486 is used, so as to guide a current through the thermal sensor 494. 496 492 is filled with an insulating plug The rest of the cavity, which surrounds the signal wiring 486. In one design embodiment is made of a ceramic of insulating plug 496, such as aluminum oxide (alumina). Other insulation types may also be used. The above configuration of the thermal sensor 494 and496 494 the positioning of the insulating plug 490 temperature collection way of the thermal sensor in the direction of the end wall the focused.

[0192] In one design embodiment is, as shown in Fia. 30, to facilitate the use of the temperature probe 480, a hole 112 of the base110 formed by the basic ground 497. A tubular collar 498 is, such as by welding, to the underside surface of the 112 mountedbasic ground, so that it surrounds the hole 497. 498 499 is available between the free end of the collar flange A emerges outwardly. 480 482 the temperature probe is through the tubular collar end The first advanced 498, 499 480 484 the temperature probe so that the attachment flange is biased against the flange. 493 A clamp, such as a hinge-tri-clamp type of clamp or any other is then used, removably for securing together said flanges 484 and 499. In this firm but removable configuration is at least a portion of a first end 482 of the temperature probe 480 basic ground60 and into the chamber 112 behind the inner surface of the out.

[0193] In one design embodiment is the end face 485 basic ground112 by a distance from the inside surface of the 1 mm to about 5 mm spaced in a range between about. Other distances may also be used. In this configuration is directly against the end face 485 480 biased the temperature probe 202 the mixing bag. This biasing force increases, when the mixing bag 202 is filled with the solution.

[0194] the temperature probe measures the surface temperature of the mixing bag 202 480 During operation and thus the temperature of the solution therein, without the mixing bag 202 to pierce or to be in direct contact with the solution. In this way is no demand, the temperature probe 480 sterilize or cleaning, between the manufacture of different batches or types when the 10 fluid preparation system changes of solution. To the temperature of the solution to be accurately detected, the detected temperature is calibrated, temperature wake of the mixing bag 202 to compensate for the. The accuracy depends in part on the measured temperature, the temperature probe 480 485 that the end face is in close contact with the mixing bag 202 and is clean. In the illustrated embodiment is the temperature probe 480 basic ground112 mounted on the, the weight of the solution at the holding a close contact between the temperature probe 480 and the mixing bag 202 to use over the entire process.

[0195] In alternative embodiments it is clear that the end face 480 485 of temperature probe 112 may be positioned flush with or below the inner surface of the basic ground. The temperature probe 480 at other portions of the base 102 may also or be mounted on the side wall 24. It is understood also that the temperature probe 480 on a considerable number of firm or removable Wise Men 20 may be mounted on the tank assembly.

VIII. fILTRATION SYSTEM

[0196] As inFia. 31 represented, the filtration system 500 comprises a valve502, 504 which the delivery tube 420 506 divides into a first branch and a separate second branch. As previously discussed, may comprise simply a T-connection the valve 502, 504 and506 420 and the branches which is coupled with the discharge tube, which acts in combination with external clamps, which selectively is either the first branch 504 506 Close and/or the second branch. A plurality of other conventional types of electrical and manual exist Alternatively, valves, which can be used.

[0197] 504 and506 and 508 are a pressure sensor This, together with each branch 510 one or more filters. The type and the number of filter 510 is quite dependant on the processed material and the desired properties of the final product. The filter 510 may comprise conventional bacterial filter In one design embodiment, to facilitate sterilization of the solution about a. Once the solution through the filter runs 510, 511 504 and506 connect the branches to each other again as a valve, to restore the delivery tube 420.

[0198] The solution then flows again by a pressure sensor and then by a final filter 514 512 or therepast.

[0199] During operation511 502 and the valves are so adjusted that the solution 506 504 or runs by only one of the branches. 511 502 and initially be adjusted so the valves can, for example that the incoming solution through the first branch from the delivery tube 504 runs 420. While the filter are clogged part by filtered material 510a, 508a detectedfluid rope printing from the pressure sensor is the. If the filters are clogged 510a sufficient, as determined by a given back pressure, the valves 502 and511 are switched over, so that the fluid passes through the branch 506. The filter 510a are then replaced by clean filter. If the filters are clogged 510b, the process is repeated. Consequently, by using this configuration of the filtration system 500 the filtration of the solution be continuous.

[0200] The pressure sensor 512 is coupled either directly or indirectly to the pump 424 (FjslI ), so as to control the flow rate of the solution through the delivery tube 420. In other words, when the pressure at the pressure sensor 512 510a or510b decreases due to the increased clogging of the filter, the speed of the pump 424 can be increased, so that the flow rate of the solution is relatively constant. Similarly can, when the filtration system 500 switches to new filter, causing that the pressure rises, the pump 424 are decelerated. If it is not desired, to have a constant flow rate is the pressure sensor 512 not necessary.

[0201] As700 is discussed subsequently with respect to the dispensing assembly, the solution used is the filter 514 for either as a part of the filtration system and can final sterilization500 or700 be seen the dispensing assembly.

[0202] In alternative embodiments it is clear that the filtration system 500 may comprise three or more separate branches. Alternatively, not two or more separate branches comprise the filtration system 500, but can simply comprise a pressure sensor and one or more filters, 420 runs through which the delivery tube. In this embodiment, however, it is necessary, stop the filtration procedure, to replace the filter. In still further embodiments, the pressure sensor 508 508 or are not necessary the pressure sensors. These embodiments 510 can be replaced simply according to predetermined use periods the filters.

IX. pRESSURE SENSOR ARRANGEMENT

[0203] The various pressure sensors 508 and512, which are represented inadd. 31, may comprise any conventional pressure sensor, which is positioned in direct connection with the solution, so as to measure the fluid pressure. In an alternative embodiment, however, the pressure sensors can be positioned that they are not in direct fluid communication with the solution. As a result it is not necessary, the pressure sensors to sterilize or clean, when the 10 different batches or types of solution fluid preparation system changes between the manufacture.

[0204] Exemplary and nonrestrictive add. 32 516 is represented in an embodiment a pressure sensor arrangement.

[0205] 517 516 comprises a pressure sensor arrangement The, a membrane518, 519 and521 a clamp acollection connection. 519 520 comprises a tubular shaft collection connection The, which protrudes from the delivery tube 420. A passage 523 520 bounded The shaft, which is in communication with the delivery tube 420. The free end of the shaft is a flange 520 524 present surrounding and radially outwardly projecting therefrom respectively. 524 526 terminates at a engagement surface bringing the flange. 526 528 is recessed at the engagement surface sealing groove continuous A, so that it surrounds the passage 523.

[0206] 32 and 33 represented in Fia.add. As, has a first side and an opposite second side 518 the membrane 532 530. 534 and536 is in a continuous loop from the sealing edge A first side 530 532 outwardly apparent or second side. In the second side 532 538 536 sealing edge a pocket is recessed within the from the confined area. 519 518 is removably mounted on the engagement surface 526 of thecollection connection The membrane set, 536 528 sealing edgesealing groove is received within the so that the. In this configuration the membrane covers the opening into the passageway 518 523, wherein the pocket 538 in line therewith.

[0207] The pressure sensor 517 is a standard part "by the rod", such as a conventional digital or analog pressure transducer. An example 517 comprises the "mini Pressure transducer" of the pressure sensor, manufactured by Anderson Instrument Co from Fultonville, New York. As represented comprises a main part with a 540 517 the pressure sensor 542 tubular shaft projecting therefrom. The free end projecting outwardly therefrom is a flange surrounding and 542 Of shaft 544 present. 544 546 is formed on one side of the flange engagement surface A. 548 surrounds an opening 546 engagement surface The, in which a sensor 550 is arranged to be movable. 546 552 is recessed on the engagement surface sealing groove continuous A, so that it surrounds the opening 548.

[0208] 546 518 530 of the membrane on the first side is the engagement surface received, so that the is received within the 534 552 sealing edgesealing groove. 530 550 against the first side is the sensor in this configuration the membrane 518 538 biased from the pocket.

[0209] The clamp 521 is then used, 524 and544 for securing together said flanges, so that the membrane 550 519 518 against the sealscollection connection518 against the membrane is maintained and so that the sensor. The seal prevents that by the delivery tube 420 running and in the passage 523 524 518 emerges between the flange and the membrane solution entering. In one design embodiment comprises the clamp 521 a conventional hinge-tri- Ölamp, such as, e.g. from tri-Clover of Kenosha, Wisconsin available. Alternatively, any type of removable clamp or mounting structure are used, which generates the desired coupling.

[0210] During operation by the delivery tube enters into the passageway 523 519 collection connection420 running solution a and presses against the membrane of the518. The 550 518 presses against the sensor membrane in turn. The pocket 538 is formed, by the thickness of the membrane to reduce 518 at this point, whereby there is increased the pressure sensitivity. Measurement values or signals from the sensor 550 are used, to determine the actual or relative fluid pressure of the solution.

[0211] Because the solution does not directly contact the clamp 521 or the pressure sensor 517, must be sterilized or otherwise cleaned not these components, when the 10 fluid preparation systemöhargen or types of solution between the manufacture of various changes. The rest of the pressure sensor arrangement 516, 518 and519 collection connection in other words the membrane the, are relatively inexpensive and can easily be replaced during the production of different solutions.

[0212] The membrane518 is typically formed of a soft flexible material, such as by press or injection moulding. Examples of materials, which can be used, include neoprene, silicone, EPDM, Viton, Kalrez, Teflon, polypropylene, polyethylene, polyolefin, as well as other moldable Plastics buna and nitrile rubber. The above materials can also with glass, carbon or other types of fibres be enhanced. The portion of the diaphragm 51 8, which presses against the sensor 550, typically has a thickness in a range between 2 mm to about 20 mm, wherein about 3 mm to about 10 mm are customary.

[0213] 34 and 35 are represented alternative embodiments of the membranerA. In Fla. 518, wherein similar elements are characterized by the same reference symbols. In Fies. 34 is represented a membrane 554, 556 in which pivotal detection portion, i.e. the region defined by the seal edges 534 and 536, has a substantially uniform thickness. The thickness can have an arbitrary desired amount, eliciting the desired sensitivity. In daraestelltadd. 35 is a membrane 558, 560 located on each side in which pivotal534 and536 detecting section by the seal edges 562 tapers to a central flat portion. In still further embodiments may be flat as in the membrane a side of the central seal portion 560 554 represented, while the other side is tapered as in the membrane 558 represented. Other combinations and alternative configurations may also be used.

X. dELIVERY SYSTEM

[0214] Once the solution through the filtration system 500 runs, either directly into their final use environment or the solution is delivered into a container. If it is not necessary that the solution is sterile, the solution can be delivered to any desired conventional manner from the delivery tube 420 simply. If the solution must remain sterile after passing through the filter, it is necessary that a sterile fluid coupling between the delivery tube 420 and the final storage case is formed.

[0215] Exemplary and nonrestrictive add. 36 700 is represented in an embodiment of a sterile fluid delivery system. The delivery system 700 includes a dispensing assembly 702, 704 and706 a sterilizer a collection array. The dispensing assembly 514 comprises the filter 702, 712 and714 a flexible extension tube a rigid filling pipe. The final sterilization filter514 is a filter, which is designed such that the entire thereby completely or at least to the desired parameters of the current solution is filtered final product solution is sterile. In this way needs the solution prior to filter 514 not be sterile. 708 710 has an inlet port and an outlet port 514 The filter. The inlet port 708 is arranged, selectively and removably 420 to be coupled with the discharge tube, while the exhaust port 712 711 710 in sealed fluid communication with a first end of the extension tube is coupled.

[0216] 713 714 The filling pipe is coupled in a sealed fluid communication with a second end of the extension tube 712. In Fla. 37 represented, comprises a tubular cylindrical main body part 715 716 714 the filling tube with an inner surface and an outer surface 718, each extending between a first end and an opposite second end 720 722 extend. The inner surface 724 716 limited a channel, which extends longitudinally through the filling tube 714. 715 720 of the main part and extending radially thereof surrounding end The first extendedly 728 present is a flange. From the first end 720 of the main part in a longitudinal alignment therewith, projecting 715, 717 present is a barbed connection. Barbed port 717 713 is within said second end The of the extension tube712 received, so as to effect a sealed fluid communication therewith. In alternative embodiments can be any conventional form of compound used, produce about a fluid coupling of the fill tube with the extension tube 712 714.

[0217] 722 715 is formed on the second end of the main part730 a tapered substantially truncated cone-shaped projection. 730 732 in fluid communication with the channel an outlet bounded Be Measured 724. 730 734 718 of the projection surrounding the outer surface and is locking groove A recessed therein. 37 and 38. Fia As in represented Fla., 716 are mounted on the inner surface of the projection 730 within the outlet 70 and 736 cross parting bladefasten in pair of there. 738 736 has a sharpened outer edge blade Any, which stands out over that end of the projection 730.

[0218] 37 and 39 represented in Fia. Fia. As, 740 722 of the stuffing tube is a cap mounted removably at the second end 714, around the outlet 732 shut off. The cap 740 has an annular, substantially frusto-conical side wall 742, 744 which terminates to an end plate. 746 748 742 has an inner surface and an outer surface side wall The, each extending between a first end and an opposite second end 752 750 extend. At the first end projecting radially inwardly from the inner surface 746 750 754 present is an annular locking edge. At the second end 752 748 The outer surface surrounding and radially outwardly projecting therefrom respectively is a barb 756 present. As in Fia. 37 represented is received over the projection 730 740 the cap, so that the locking edge is received within the locking groove 734 740 754 of the cap, whereby a sealed connection is formed between the cap and the filling tube 740 714. In one design embodiment is the filling tube 714 made of metal, such as stainless steel, while the cap is formed from molded plastic material 740. For other embodiments also can the filling tube of rigid plastics 714, composites or other materials be made.

[0219] In its fully assembled condition, as represented in Fia. 36 is sterilized as a unit the delivery system 702, such as by ionizing radiation or other conventional sterilizing techniques.

[0220] The collection array 36 comprises a flexible extension tube 760 704 as shown in Fia. 762 764 with a first end and an opposing second end. 760 764 of the extension tube is in sealed fluid communication end The second with a container 765 coupled. 765 can comprise any rigid or flexible container The bin, which is used for receiving of sterile fluids. The container 765 can be re-used once or disposable. For example 765 comprises a bag at a embodiment of the container, which is made with the same materials and methods, as it has been discussed previously with respect to the mixing bag 202.

[0221] 760 762 766 on the first end of the extension tube is mounted a fill port. As in Fia. 40 represented, the fill port 766 comprises a tubular, substantially cylindrical main part 768 770 767 having an inner surface and an outer surface, each extending between a first end and an opposite second end 772 774 extend. 768 The Inside 776 a channel limited, which extends longitudinally through the fill port 766. 772 770 The outer surface at the first end an annular flange surrounding and projecting outwardly therefrom is 778 present. 774 770 The outer surface is outwardly protruded at the second end an annular barb 780 present surrounding and thereof. 766 774 filler connector is in sealed fluid communication within the end The second of the first end of the extension tube 760 762 received. For other embodiments can other conventional compounds are used, the fill port 766 760 to couple with the extension tube. For example, to use instead the barb 780, the fill port 766 by heat sealing, welding or otherwise be secured to the extension tube 760.

[0222] 781 766 terminates at the first end on an end face fill port The772. 768 766 includes an inclined The Inside filler connector of the, substantially frustoconical seat 782, which extends from the end face 781. 776 782 784 into the channel an opening limited The seat. 781 mounted at the end face, to extend as to extend beyond the opening 784, 768 is a membrane. 786 784 from the membrane is the opening in this configuration sealed shut. The membrane 786 is typically made from a sheet of a polymer material, which can be selectively pierced.

[0223] In its fully assembled condition, as in Fies. 36 represented is the collection array 704 entirely sealed. In this configuration is the collection array 704 sterilized, such as by ionizing radiation or other conventional sterilizing techniques.

[0224] Inadd. 41 is an embodiment of two adjoining sterilizers 706 represented, in a partially disassembled state wherein one of these sterilizers is represented. Every sterilizer 706 is an automated hose clamp 757 mounted. 758 757 hose clamp comprises a frame The, to which a flexible hose or a tube is selectively positioned. 759 761 selectively lifts and lowers a thereof projecting arm A plunger. If the arm is in the lowered position 759, 759 is biased against the hose the arm, crimp closed around the hose. If the arm 759 is raised, it will allow a fluid, to flow through the hose.

[0225] As inFia. 42 represented, 706 792 790 comprises a housing with a front side of the sterilizer, 794 and796 extends extending between opposite side faces. 794 and796 extending between the side faces also Self, 798 present is a top surface. As in Fia. 43 represented is a cavity 808 790 formed within the housing. 794 and796, projecting from each side surface, so that it is in alignment with the cavity 808, 800 present is a electron beam generator. Each generator 790 800 is by a corresponding channel formed on the housing in communication with the cavity 808. Although not required, in the represented embodiment example, the generators 800 are at an angle α in a range between about 15° to about 45° relative to the horizontal. An example an electron beam generator is the e-Beam Modulus, from from GyprusUSHIO America, California is available.

[0226] Each electron beam generator 808 800 generates an electron field within the cavity, around the cavity808 and sterilize all structures positioned therein. During the operation of the generators 800 808 continuously with a non-oxidizing gas is the cavity, such as nitrogen, flooded. The displaces any oxygen from the cavity 808 non-oxidizing gas. A exposing Convert of oxygen over the electron field could be the oxygen to ozone, which could generate a corrosion effect. To prevent that the surrounding environment is exposed to the electron field is made of stainless steel or other shielding materials with sufficient thickness 79 the housing formed, to release any harmful emission of the to block electron field.

[0227] 790 798 of the housing is a plunger 802 mounted on the upper side, which operates a tubular piston 804. A passage 806 804 limited The tubular piston (Fia. 421. which communicates with the cavity 808. As in Fia. 43 represented is arranged the piston 804, 806 714 receive the fill pipe within the passageway, so that the flange rests on the piston 714 804 728 of the stuffing tube. In this configuration is the second end 714 722 of the stuffing tube808 received within the cavity. As is subsequently more closely discussed, 802 and804 arranged are the plunger piston, the filling tube 714 securely hold, when it is disposed therein, and said fill tube 714 selectively raise and lower.

[0228] ToFia. 42 returning, 816 boat arrangement is a slidably mounted, so as to be selectively in and out of the housing 792 790 extends through the front side. 818 816 comprises a female and a male shuttle shuttles boat arrangement The 820. 818 824 822 and has opposed side surfaces with a boat Women 826 828 and a top front side, extending therebetween. 826 has an inclined stepped configuration Alternatively, the front side. A substantially vertical upper portion 826 830 has Specially the front face, a substantially vertical lower portion and an outwardly inclined central portion 832 834, extending therebetween. In the front side and extending along the length extending 826 recessed, so that it has substantially the same configuration as the front side inclined 826, 836 present is an open channel.

[0229] Flush on the top side 828 826 is mounted at the interface with the front side a substantially U-shaped retaining collar 840 present. 842 840 has an inner surface with a thereto The collar substantially U-shaped groove 844 recessed.

[0230] The male shuttle 820 848 has a front side. As subsequently discussed and represented more precisely, 848 820 adapted is the front side of the male shuttle, 826 818 in close tolerance complementary mate with the front side of the female shuttle, 836 is left open during the channel. 818 and820 between a boat Usually of three positions operable the. In a first position, as represented in.add 42, 848 826 820 from the front side is the front side of the female shuttle 818 the male shuttle separately, wherein both front sides 848 826 and790 are arranged outside of the housing. In a second position the male shuttle 820 is shifted, so that it mates with the female shuttle 818. In the third position, as in Fies. 45 represented, 818 and820 790 in the casing in such a way the mating shuttles are moved that the retaining collar 840 808 is disposed in alignment with the cavity.

[0231] During the use is, as previously discussed and in 43 represented add., 714 806 of the tubular piston slidably within the opening the filling tube 804 received. Once the fill tube 714 is positioned, the 800 electron-beam generators be activated, so that the electron field is generated within the cavity 808, whereby the second end 722 of the fill tube714 is sterilized. The extension tube 712 the dispensing assembly 702 (757 758 add 36t is the hose clamp on the frame. (. 41 t positioned add. The 749 is then lowered arm, to temporarily to close the extension tube 712.

[0232] 860 840 844 in the fixing ring is in the groove removably Kappenentferner A pushed. As add. 44 represented in, 862 864 860 Kappenentferner has an inner surface and an opposite outer surface of, each extending between an upper end surface and a lower end surface 866 868 extend. 866 864 The outer surface on the upper end surface is an annular flange projecting radially outwardly therefrom surrounding and870 present. 872 862 The Inside a channel limited, and extending through said slit extends Kappenentferner 860. 876 862 The Inside comprises a cylindrical portion, which extends from the lower end face 868, and an inwardly inclined frustoconical tapered portion 878, from the top end face 866 876 extends to the cylindrical portion. In this configuration has the cylindrical portion 876 a diameter, which is slightly smaller than the diameter of the cap on the barb 756 740.

[0233] 840 860 is positioned within the retaining collar manually Kappenentferner The, 870 844 is pushed into the groove by the flange. Once positioned, 818 820 is mated with the female shuttle shuttles said male, Kappenentferner860 in position to lock the. The mated shuttle 790 are then moved into the housing, as in add, 45 and 46 illustrates add., so that the is aligned vertically and being exposed to the cavity 808 Kappenentferner 860.

[0234] 46 and 47 represented add Fig. As in., next the piston 714 804 drives the filling pipe downwardly, causing that the second end 752 740 Kappenentferner860 is guided by the said cap. The annular barb 756 is elastically compressed, when it is guided by the cylindrical section 860 876 Kappenentferners the inner surface of the, stretches, however, then radially outwardly, when it passes the lower end face 868. The annular barb 756 rests on the lower end face 868 As result, whereby said cap is locked 860 Kappenentferner740 in engagement with the.

[0235] Asadd 48 represented in., 714 804 then moves the piston back to the raised position the filling tube. As Kappenentferner740 a result of engagement between the and the cap is removed and the cap 714 740 from the stuffing tube860 held on the Kappenentferner. In this position is the second end 722 of the fill tube714 790 uncovered 808 of the housing open within the cavity. Due to the within the cavity 808, however, the second end 722 of the fill tube714 sterilizedelectron field remains maintained.

[0236] Once the cap 740 is removed, the shuttle 790 818 and820 slide out from the housing and move apart. Next is, as represented in.add 49, with the fill port 766 704 860 againKappenentferner of the collection array840 positioned in the retaining collar (36 Fig. t. The extension tube 760 is836 positioned within the channel. 818 and820 are closed again boat The, what the fill port 766 760 locked therebetween and the extension tube. As in Fig. daroestellt790 into the housing 50 then. be pushed the mated shuttle, so that the fill port 766 808 is positioned vertically below and in communication with the cavity. The by being exposed to the electron field 766 is thus sterilized filler connector outside of the.

[0237] Once the fill port 766 is positioned is the filling tube 714 lowered again. As in Fia. 51 represented, the blades 786 714 736 of the stuffing tube pierce the membrane. Once the membrane is pierced 786, comes the projection 714 782 730 of the stuffing tube into engagement on the seat, whereby a fluid coupling is formed between the fill tube 714 and the fill port 766. Again, it is clear that over the entire process the electron field is maintained within the cavity 808, so that all parts therein are sterilized.

[0238] Once the filling tube is coupled with the fill port 766 714 is the clamp 757 (41t opened. Fiq, what the flow of solution through the dispensing assembly 702 and704 allows into the collection array, whereby the container is filled 765. As Fsa. 1 represented in, 765 882 below the container is disposed at a embodiment a scale. Once the container up to a desired weight or other type of 765 Füllmarke has been filled is closed again the clamp 757, whereby the flow of solution is blocked. A Rohrheißversiegler880, which comprises two opposed heated elements as represented in Fia. 43, on opposite sides of the extension tube 760 is then closed, whereby the extension tube 760 is heat sealed closed and clamped shut. The extension tube 760 is then either removed or cut off by the shuttle above the seal, to allow removal of the container containing the sterile solution 765.

[0239] Once765 a first container is filled, the process can be repeated for a new collection array 704. In other words, the filling tube 714 818 820 808 into the cavity and is raised and the boats are withdrawn. A new fill port 766, which is coupled with a new container 765 is then pushed back into the cavity to the boats and 808, 714 to be filled through the filling tube.

[0240] 818 and820 are arranged and the shuttle 790 Cabinet, the radiation of the shield 808 electron field outside the cavity. The channel 836 may, however, be shielded not closed, since the extension tube 760 is disposed therein. The move along straight trajectories and 808 into the cavity absorbs electrons entering be, as soon as they take on the shield. Consequently, , order to prevent the emission of electrons through the channel 836, the channel in a stepwise manner as previously discussed curved 836. This curvature of the channel 836 ensures that the electrons entering into the channel 836 836 contact the channel defining wall, before they emerge thereby. In alternative embodiments the channel in a plurality of different configurations can 836 curved, bent or otherwise be shielded, so as to prevent a straight path from the cavity 808 to the outside.

[0241] In the above-described embodiment the sterilizer 706 electron-beam generators used are, around parts sterilize, 808 are located in said cavity or related. In alternative embodiments it is clear that other types of radiation, such as ultraviolet light, also can be used for sterilization. In still further embodiments can be used a heat sterilizing, such as by the use of steam. Finally, can be used a vapor phase sterilization, such as by the use of hydrogen peroxide or chlorine dioxide. All the above-described options are examples of means for generating a sterilization field808 in the cavity.

[0242] be In one design embodiment, as soon as the solution from the mixing bag 202 is emptied, all the components, which were in direct contact with the solution, simply removed and disposed of or put to reuse. For example, each of the structural components, such as the mixing bag, the feed bag, the mixer, the tubes, the pressure-sensor diaphragm, the connectors, the terminals, the filter and the dispensing assembly, constructed and prepared to be viewed as Dermabrasion. Once the old components are removed, they are replaced by clean components. The fluid preparation process can then be repeated for a new solution, without the need for a purification, sterilization or the risk of cross-contamination. Of course, where alternative embodiments, in which the solution must be or strictly not sterile, some or all of the components are used several times and then have to be disposed of, if they are worn or if an incompatible solution is to be produced.

[0243] In one design embodiment it is desirable that each of the structural components, which contacts the solution, resin family is made from the same. Each of the above-mentioned structural components and can, for example, any other, which contact directly the solution or feed component, be made of polyethylene. By all of the structural components are made from the same resin family, it is easier to control and monitor the effects, which from a leaching, a adsorption and absorption between the solution and the structural components a result. Depending on the it can also be desirable solution prepared that the structural components, which are in contact with the solution, a test according to USP Class 6 for biological products that they do not satisfy and/or effects have cytotoxic. For other embodiments the various components can be made of different materials and need not to ge-XI the above test. RESULT

[0244] It is understood from the foregoing that the manual actuated components 10 according to the invention in various embodiments fluid preparation system, electrically operated components may contain and combinations thereof. In embodiments, in which electrically operated components are used is a processor provided 890, as shown in Fia. 1, to control the components. 890 are loaded with selected programmes Secondly, it allows the processor, to automate fluid preparation system around selected operations of the 10.

[0245] The offer many unique advantages over conventional fluid preparation system10 and its structural components fluid preparation systems. Exemplary and nonrestrictive allows the system a manufacturer or an end user, efficiently predefined amounts of a solutioe, around a desired needs that will, whereby an underprovision or the necessary supporting a glut is avoided. By Dermabrasion are used, the system may be used, different batches or types of solutions to quickly produce, without the costly delay or the burden, structural parts having to clean or sterilize. The Mixer allow an efficient mixing the solution, while a high shear stress, a foam formation or a spraying are minimized, which potentially could be harmful for some solutions. The feed bag enables an efficient storage and dispensing of powder components, while the possibility is minimized that potentially harmful components are discharged into the surrounding environment. Similarly offers the final delivery system an efficient way, and to quickly to fill a number of different containers to change between different solution loads, whilst ensuring that the solution is sterile and is sealed in a closed container.

[0246] Thefluid preparation system10 includes many individual components, some of which are designated by section headings. It is understood that each of the disclosed new features include components and alternatives thereof and that each component independently, in different arrangements can be used in systems other than 10 orfluid preparation systemsfluid preparation system of the. For example it is clear that each of the various components to be produced depending on the type of solution and thereof, whether or not the solution must be sterile, can be mixed and matched.

This allows different systems have a number of advantages and are used at a site remote from.