GB2344651A

GB2344651A - Reaction pouch

Info

Publication number: GB2344651A
Application number: GB9827319A
Authority: GB
Inventors: Jonathan Mortimer
Original assignee: BIOFENCE Ltd
Current assignee: BIOFENCE Ltd
Priority date: 1998-12-11
Filing date: 1998-12-11
Publication date: 2000-06-14
Also published as: GB9827319D0

Abstract

A sealed pouch for containing reaction material is formed of a tubular flexible membrane or plastics material having opposed ends sealed at respective sealing lines and includes at least one access port providing access to the interior of the pouch. The container pouch is formed by cutting a continuous, substantially flexible, plastics tubular membrane to length, sealing the ends of the cut length and forming the access port. The pouch can be fabricated from polyethylene and may be disposed within a rigid support.

Description

Reaction Container The present invention is concerned with a reaction container and particularly a reaction container for biological/chemical materials.

Laboratory reactions involving biological/chemical materials may be carried out in reaction vessels which are typically open to the outside environment. This may prove dangerous in situations where materials of a hazardous nature are being dealt with. In certain cases, it may be necessary to avoid the contents of reaction vessels becoming contaminated (for example, contamination by exposure of the reaction material to external factors). In these situations, it is therefore necessary to have a container or the like which provides a sterile, sealed environment. Furthermore, due to limited shapes and sizes of traditional reaction vessels, certain constraints are imposed on the extent to which the scale of a particular reaction may be increased.

Sealed reaction vessels which generally comprise two superimposed plastics sheets sealed at the edges to form a sealed envelope are known. Reaction envelopes of this type are typically only suitable for reaction volumes of up to 100 litres.

Furthermore, the manufacture of these envelopes may prove costly and lengthy if a variety of envelopes of differing sizes are to be produced.

An improved reaction container and method of making the same have now been devised.

According to a first aspect of the present invention, there is provided a process for manufacturing a reaction pouch, which process comprises: (a) providing a continuous, substantially flexible, plastics tubular member; (b) cutting the tubular member to length; (c) sealing the tubular member to provide substantially closed opposed ends; and, at any stage in the process, (d) forming at least one access port in the tubular member.

According to the present invention, it is preferred that the cutting step comprises cutting of the tubular member in a substantially transverse direction. The cutting of the tubular member may be carried out using methods known in the art.

According to a further preferred feature of the present invention, the cutting of the tubular member can be such as to effect simultaneous sealing of the newly cut end of the tubular member. Alternatively, the cutting and sealing of the tubular member may be two distinct and separate steps.

In a process according to the present invention, a continuous, substantially flexible, plastics tubular member is provided. The tubular member may, according to one embodiment of the present invention, be provided with pre-formed access ports at spaced intervals along its length. Alternatively, the tubular member may be provided without access ports; the access ports may subsequently be introduced, either before or after the cutting and/or sealing step.

Advantageously, the cutting of the tubular member effects the simultaneous sealing of the freshly cut end of the tubular member. Following sealing (or alternatively prior to sealing), the cut tubular member may: (i) have at least one access port introduced thereto; or (ii) if a preformed access port is present, the now formed reaction pouch may be collected ready for use. The continuous tubular member may then progress in a forwards direction (either manually or automatically) along a conveyor system or the like ready for manufacture of the next reaction pouch.

Advantageously, the tubular member may be cut to a required length to enable production of several reaction pouches with different capacities all along the same production line.

It is a preferred feature of the present invention that the cut tubular member is sealed at one or both ends thereof by heat sealing; alternatively, one or both open ends of the cut tubular member may be sealed ultrasonically or by other bonding techniques including gluing.

It is preferred that the pouch of the present invention is in a flattened condition prior to sealing and/or cutting to length, preferably so as to be substantially rectangular in shape.

In a preferred embodiment, the sealing step comprises forming sealing lines on the flattened tubular member extending at converging inclined angles relative to one another. Desirably the access port is positioned substantially between converging sealing lines. The reaction pouch according to the present invention may therefore be substantially effectively diamondshaped (in flattened condition) for use in reactors where directional flow of the reaction material is necessary.

According to a further embodiment of the present invention, the sealing step comprises forming sealing lines on the flattened tubular member so as to form a parallelogram-shaped pouch. According to-this embodiment, the tubular member is sealed along a first (inclined) sealing line extend from a nonopen edge of the tubular member to the corner of the pouch diagonally opposite the non-open edge. The pouch may then be further sealed along a second (declining) sealing line which extends from the other non-open edge of the pouch to the diagonally opposing corner of the pouch.

Providing one or more sealing lines at an inclined attitude to the longitudinal direction of the pouch (when in flattened condition) permits directional flow to be conveniently accommodated when the pouch is in use.

It is a preferred feature of the present invention, that the reaction pouch (when fully expanded) is substantially elliptical or more preferably circular in cross section. The cross section transverse to the sealed opposed ends is preferably substantially elliptical or tubular. The cross section from one closed end to the opposing closed end preferably tapers towards the opposed closed ends, desirably comprising a median portion of maximum width and respective narrowing portions extending towards respective opposed ends.

According to a further aspect of the invention, there is provided a substantially water-resistant, sealed pouch for containing reaction material, the pouch comprising a tubular flexible membrane having opposed ends sealed at respective sealing lines and at least one access port providing access to the interior of the pouch.

The pouch is expandable from a collapsed condition (typically substantially flattened) to an expanded condition in which the pouch may assume the tubular configuration of the tubular membrane (when fully expanded) or any expanded configuration between collapsed and fully expanded.

In a fully expanded condition, the flexible pouch preferably tapers toward one or both ends from a cylindrical tubular portion spaced from the ends.

It is a preferred feature of the present invention that the pouch comprises polyethylene or other suitable plastics material. In one embodiment of the present invention, it is preferred that at least part of the pouch comprises a substantially opaque material. However, in certain reactions, for example, phototrophic reactions, a substantially translucent material is preferred.

According to a preferred feature of the present invention, the pouch comprises two access ports. The access port (s) may be provided either on an upper or under surface of the pouch and/or along an edge of the pouch of the present invention. The access port (s) provided on the pouch according to the present invention are preferably such that standard laboratory equipment may be connected thereto thereby enabling addition/removal of materials (as and when necessary) from the pouch. Advantageously, the access port (s) may be connected to sterile laboratory equipment to enable a sterile environment to be retained within the pouch for the duration of the reaction.

Further advantageously, the access port (s) may be connected to connector equipment enabling a plurality of reaction pouches to be connected via their respective access ports.

Furthermore, it is preferred that the pouch according to the present invention is susceptible to sterilisation, for example, by irradiation, ultaviolet techniques or, more preferably by use of an autoclave. It is preferred that the pouch is sterilised prior to use. Further advantageously, the pouch according to the present invention is disposable.

The reaction pouch according to the present invention is suitable for use as a bioreactor, for example, as a phototrophic reactor. The pouch according to the present invention may be used to contain toxic or hazardous materials (for example, during vaccine production or for containment of virulent or pathogenic matter). The pouch may also be suitable for fermentation reactions or cell culture. Due to the disposable nature of the pouch of the invention, it is particularly suitable for reactions that would otherwise damage non-disposable reactors.

It is a preferred feature of the present invention that the pouch is contained within a substantially rigid support (for example, a support in the form of a chamber or, more preferably, a cage). It is preferred that the support allows light to access the reaction pouch. It is preferred that the shape and/or size of the rigid support may be chosen according to the nature of the reaction. For example, for a phototrophic reaction, a cage which is substantially flat in nature, that is one which provides an increased surface area for maximised contact with light, would be preferable. The shape of the support defines the shape to which the pouch may be expanded.

It is preferred that the contents of the pouch may be temperature controllable. The temperature of the reacting material, according to one embodiment of the present invention, may be controlled by placing the pouch into at least one outer envelope (which envelope is advantageously a further pouch according to the invention) within which a temperature control medium may be present. The temperature control medium (which may for example comprise water or other fluid/gel material, at a desired temperature) may be passed through the envelope.

Alternatively, the reaction pouch may simply be placed in a temperature-controlled water bath.

Several reaction pouches may be linked via their respective access ports.

According to a further aspect, the invention provides a method of setting up a reactor, which method comprises: (a) obtaining a substantially water-resistant pouch comprising a collapsible tubular flexible membrane having opposed ends sealed at respective sealing lines and at least one access port providing access to the interior of the pouch; (b) disposing the pouch, in an at least partially collapsed configuration, into a shaped support; (c) introducing material into the interior the pouch via the port, such that the flexible pouch expands to take up a shape determined by the support.

Desirably, reaction material is introduced into the pouch to cause the pouch to adopt the expanded configuration.

The present invention will now be described with reference to the accompanying figures which are by way of example only.

Figure 1 is a diagrammatic representation of a pouch according to the present invention.

Figures 2a and 2b are diagrammatic representations of reaction pouches according to further embodiments of the present invention.

Figure 3 is a representation of an access port of a reaction pouch according to the present invention.

Figures 4a, 4b, 4c, and 4d are representations of exemplary supports for a pouch according to the present invention.

Figure 5 is a schematic representation of the reaction pouch of the present invention as used in a fermentation reaction.

Figures 6a and 6b are schematic representations of reaction pouches according to the present invention used as phototrophic reactors.

Figures 7 is a schematic representation of a reaction pouch according to the present invention used a chemical reactor.

Referring to Figure 1, there is shown a pouch 1 formed from a substantially flexible plastics tubular member 2, which tubular member is cut transversely to provide two opposing open ends 3. The tubular member 2 is drawn from a store (such as a reel or roll-not shown) of indefinite length and comprises a collapsible membrane of circular transverse cross section in flattened condition in readiness for cutting to length and sealing. The tubular membrane may, for example, comprise a blown/extended plastics film and desirably substantially seamless in its longitudinal direction. The cutting of the tubular member may be such as to effect the simultaneous sealing of the open ends 3. The cutting and/or sealing takes place when the tubular member is preferably in a substantially collapsed and flattened state. Also illustrated are two access ports 4 providing access to the interior of the pouch. The access ports 4 are provided along an edge of the pouch 1. The access ports may be introduced to the pouch either before or after the sealing of the open ends 3. The access ports may be introduced as a semi-circular recess 4 formed by (thermal) cutting of the tubular member along lines X-X. (This may be effected simultaneously with cutting and/or sealing of the ends 3.) Referring to Figure 2a, there is shown a pouch 1 according to a further embodiment of the present invention. This pouch is also formed from a substantially flexible plastics tubular member. However, the pouch according to this further embodiment of the present invention is (heat or ultrasonically) sealed along lines A-A (alternatively or in addition to sealing of the open ends 3) to provide a substantially diamond-shaped pouch. The substantially diamond-shaped pouch is particularly suitable for use in reactions where directional flow of reaction material is required. The pouch according to this further embodiment of the invention comprises access ports 4 on an upper surface 5 of the pouch 1. The access ports 4 are such that standard laboratory equipment may be attached thereto allowing several reaction pouches to be linked (or pouches to be linked to standard laboratory apparatus).

Figure 2b is a representation of a pouch according to a further embodiment of the present invention. Again, the pouch is formed from a substantially flexible plastics tubular member.

The pouch according to this embodiment is sealed along lines Y-Y to form a substantially parallelogram-shaped reaction pouch. The pouch according to this embodiment is particularly suitable for reactions where directional flow of reaction material is required. The pouch comprises two access ports 4 on an upper surface of the pouch 1. Alternatively, sealing along the lines Y-Y will leave access ports at opposed ends of the pouch. The sealing step and access port defining dtep can thereby be incorporated in a single procedure. The positioning of the access ports in opposing corners of the pouch aids in the directional flow of reaction material when the pouch is in use.

Figure 3 illustrates an access port 4 in position on a reaction pouch 1. The access port comprises a substantially rigid tubular plastics material which may be inserted into a recess (formed by thermal cutting) of a section of the pouch.

The access port may be held in place with the aid of washers 7.

Furthermore, a cap 6 (which is preferably a screw cap) is provided for sealing the access port when the pouch 1 is not in use. The arrangement shown permits connection, by standard laboratory fittings, to application specific laboratory apparats, as required.

Figure 4a is a support for a reaction pouch. The support shown is ovoidal in cross section and in the form of a cage. A reaction pouch substantially as shown in figure 1 is inserted into the cage represented. The pouch may be introduced to the interior of the cage either in a fully-collapsed or partly-collapsed state. Reaction material (or further reaction material) may then be introduced to the interior of the pouch via the access port. Similarly, if required, reaction material may be removed from the interior of the pouch via the access port.

The reaction pouch will expand on introduction of reaction material thereto. Furthermore, the reaction pouch will generally take the shape of the cage when the pouch is in an expanded state (in this instance, the pouch will expand to an ovoidal shape).

Figure 4b is a further support (also in cage form) which is substantially flat in nature providing a large surface area for maximised light absorption and is therefore particularly suitable for phototrophic reactions. Again, a substantially collapsed reaction pouch may be introduced to the interior of the cage before reaction material is introduced to the interior of the pouch via the access port. The reaction pouch will again expand (when filled with reaction material) to substantially conform to the shape of the cage. The pouch will therefore also be substantially flat in nature and will have two relatively large, flat surfaces to maximise absorption of light.

Figures 4c and 4d illustrate further supports of various shapes. Supports of various shapes and sizes may be provided according to reaction volume and/or according to the reaction to be carried out. The supports shown in figures 4c and 4d are not in cage-form, however, as long as a substantially rigid support is provided, the pouch may be supported quite adequately. The supports provided may comprise a substantially translucent/transparent material or even a substantially opaque material.

Figure 5 is a representation of a pouch 1 as used in a fermentation reaction. A first access port 4a allows reaction material 9 to be introduced to the interior of the pouch 1. Also provided is an air vent 10 allowing gasses formed during the fermentation reaction to escape. A gauge 11 is provided to monitor different parameters such as temperature, pH etc. of the contents of the reaction pouch. A second access port 4b allows the entry or removal of gasses such as air or carbon dioxide into or out of the pouch. On completion of the fermentation reaction, the contents of the pouch 1 may be poured out of access port 4a or 4b and the pouch subsequently disposed of.

Figure 6a is a representation of a plurality of pouches according to the present invention as used in a phototrophic reactor system. The reactor system comprises three pouches 1 linked to each other via their respective access ports 4 with the aid of connector equipment 12. Two of the reaction pouches la and lb are substantially diamond-shaped with tapering ends to aid directional flow of reaction material through the system.

Pouches la and lb are also substantially flat in nature to provide maximised surface area for absorption of light. Also provided is a pump 13 to aid the circulation of reaction material throughout the reactor system.

Figure 6b is a phototrophic reactor system as shown in figure 6a except that two of the reaction pouches lc and ld are pouches according to the embodiment represented in figure 2b.

Figure 7 is a representation of a reaction pouch 1 when used as a chemical reactor. The pouch 1 is enveloped in a further pouch 14, which further pouch is temperature regulated by the flow of water 15 (at a desired temperature) through the further pouch 14. The flow of water 15 through the further pouch 14 in turn controls the temperature of the contents of the reaction pouch 1 (the contents of the reaction pouch 1 being of a substantially similar temperature to that of the water 15 passing through the further pouch 14). The flow of water 15 through the further pouch 14 is facilitated by an inlet 16 and an outlet 17 which allows circulation of the water.

Claims

CLAIMS: 1. A process for manufacturing a reaction pouch, which process comprises: (a) providing a continuous, substantially flexible, plastics tubular member; (b) cutting the tubular member to length; (c) sealing the tubular member to provide substantially closed opposed ends; and, at any stage in the process, (d) forming at least one access port in the tubular member.
2. A process according to claim 1, wherein the cutting step (b) comprises cutting of the tubular member in a substantially transverse direction.
3. A process according to claim 1 or 2, wherein the cutting of the tubular member and sealing of the cut end of the tubular member is effected concurrently.
4. A process according to any preceding claim, wherein at least one end of the cut tubular member is sealed by heat sealing.
5. A process according to any preceding claim, wherein the tubular member is provided in a substantially flattened condition prior to sealing and/or cutting to length.
6. A process according to claim 5, wherein the substantially flattened tubular member is substantially rectangular in shape.
7. A process according to claim 5 or 6, wherein the sealing step comprises forming sealing lines on the substantially flattened tubular member extending at converging inclined angles relative to one another.
8. A process according to claim 5 or 6, wherein the substantially flattened tubular member is sealed along a first (inclined) sealing line extending from a non-open edge of the tubular member to the corner of the pouch diagonally opposite the non-open edge.
9. A process according to claim 8, wherein the substantially flattened tubular member is further sealed along a second (declining) sealing line which extends from the other non open edge of the pouch to the diagonally opposing corner of the pouch.
10. A sealed pouch for containing reaction material, the pouch comprising a tubular flexible membrane having opposed ends sealed at respective sealing lines and at least one access port providing access to the interior of the pouch.
11. A pouch according to claim 10, wherein the tubular member is substantially flattened.
12. A pouch according to claim 11, wherein the substantially flattened tubular member is substantially rectangular in shape.
13. A pouch according to claim 11 or 12, wherein the sealing lines on the substantially flattened tubular member extend at converging inclined angles relative to one another.
14. A pouch according to claim 11 or 12, wherein a first (inclined) sealing line on the substantially flattened tubular member, extends from a non-open edge of the tubular member to the corner of the pouch diagonally opposite the non-open edge.
15. A pouch according to claim 14, wherein a second (declining) sealing line on the substantially flattened tubular member, extends from the other non-open edge of the pouch to the diagonally opposing corner of the pouch.
16. A process according to claim 7 or a pouch according to claim 13, wherein the at least one access port is positioned substantially between the converging sealing lines.
17. A process or pouch according to any preceding claim, wherein the reaction pouch is substantially elliptical or circular in cross section when the pouch is fully expanded.
18. A process or pouch according to any preceding claim, wherein the cross section transverse to the sealed opposed ends of the reaction pouch is substantially elliptical or tubular when the pouch is fully expanded.
19. A process or pouch according to any preceding claim, wherein the cross section from one closed end to the opposing closed end of the reaction pouch substantially tapers in the direction of the opposed closed ends.
20. A process or pouch according to any preceding claim, wherein the pouch is substantially water resistant.
21. A pouch according to any of claims 10 to 20, wherein the pouch contains reaction material.
22. A process or pouch according to any preceding claim, wherein the pouch comprises polyethylene.
23. A process or pouch according to any preceding claim, wherein at least part of the pouch comprises a substantially opaque material.
24. A process or pouch according to any of claims 1 to 22, wherein the pouch comprises a substantially translucent material.
25. A process or pouch according to any preceding claim, wherein the pouch comprises two access ports.
26. A process or pouch according to any preceding claim, wherein the pouch is susceptible to sterilisation.
27. A pouch according to any of claims 10 to 26, wherein the pouch is disposable.
28. A pouch according to any of claims 10 to 27, in combination with a substantially rigid support, arranged to contain the pouch.
29. A combination according to claim 28, wherein the substantially rigid support comprises a cage.
30. A combination according to claim 28 or 29, wherein the support allows light to access the pouch.
31. A combination according to any of claims 28 to 30, wherein the shape and/or size of the rigid support is chosen according to the nature of the reaction.
32. A pouch according to any of claims 10 to 31, in combination with at least one outer envelope within which the pouch is placed, the outer envelope including a temperature control medium permitting temperature control of the contents of the pouch.
33. A combination according to claim 32, wherein the temperature control medium is passed through the envelope.
34. A method of setting up a reactor, which method comprises: (a) obtaining a substantially water-resistant pouch comprising a collapsible tubular flexible membrane having opposed ends sealed at respective sealing lines and at least one access port providing access to the interior of the pouch; (b) disposing the pouch, in an at least partially collapsed configuration, into a shaped support; (c) introducing material into the interior of the pouch via the port, such that the flexible pouch expands to take up a shape determined by the support.
35. A method according to claim 34, wherein reaction material is introduced into the pouch to cause the pouch to adopt the expanded configuration.