METHOD AND APPARATUS FOR LINING A CHAMBER

Abstract

The present invention provides a method and kit which can be used to prevent or reduce contaminants in a clean production environment. The method involves providing a processing apparatus having a chamber, and providing a liner within the chamber, wherein a negative pressure is applied to the interior of the chamber to retain the liner against the interior wall of the chamber.

Claims

1.-21. (canceled)

22. A method comprising: (a) providing a chamber with a flexible liner displaced therein, wherein the chamber comprises a wall with an air permeable opening, wherein the flexible liner comprises an outer surface and an inner surface, wherein the flexible liner has a thickness of from 0.1 m to 500 m, and wherein the flexible liner has an air permeable opening; (b) applying a negative pressure through the air permeable opening of the chamber and maintaining the negative pressure within the chamber for a period of time, thereby retaining the flexible liner against the wall of the chamber; and (c) applying a positive pressure to an interior of the flexible liner via the air permeable opening in the flexible liner to inflate the flexible liner while applying the negative pressure into the interior of the chamber.

23. The method of claim 22, wherein the flexible liner has an oxygen transmission rate of less than 5000 cm.sup.3.Math.m.sup.2.Math.d.sup.1.

24. The method of claim 22, wherein the flexible liner has a water vapor transmission rate of less than 200 g.Math.m.sup.2.Math.d.sup.3.

25. The method of claim 22, wherein the flexible liner is of a material selected from the group consisting of: polyvinylchloride, latex, polyethylene, polypropylene, polyetheretherketone, polyester, nylon, polytetrafluoroethylene, silicone rubber, cellulose, polylactic acid, and perfluoroalkoxy alkane.

26. The method of claim 22, wherein the flexible liner further comprises an access opening.

27. The method of claim 26, further comprising disposing a bacterial composition for pharmaceutical use into the interior of the flexible liner through the access opening.

28. The method of claim 27, further comprising performing a process on the bacterial composition in the interior of the flexible liner.

29. The method of claim 28, wherein the process comprises mixing the bacterial composition disposed in the interior of the chamber.

30. The method of claim 29, further comprising inserting a mixing apparatus into the access opening of the flexible liner.

31. The method of claim 26, wherein the flexible liner comprises a lid to close the access opening.

32. The method of claim 31, wherein the lid comprises an adhesive.

33. The method of claim 26, wherein the access opening comprises a frangible seal.

34. The method of claim 26, wherein the access opening comprises a collar around a perimeter of the access opening.

35. The method of claim 22, wherein the chamber is a mixer or a blender.

36. A method of lining a chamber comprising: (a) providing a clean room, an isolator, or a fume cupboard having an interior defined by a wall of the clean room, the isolator, or the fume cupboard, wherein the wall has an air permeable opening; (b) introducing a flexible liner into the clean room, the isolator, or the fume cupboard, wherein the flexible liner comprises an outer surface and an inner surface; (c) applying a negative pressure into the interior of the clean room, the isolator, or the fume cupboard via the air permeable opening and maintaining the negative pressure for a period of time to retain the flexible liner against the wall of the clean room, the isolator, or the fume cupboard; and (d) reducing or stopping the negative pressure applied to the interior of the clean room, the isolator, or the fume cupboard to enable removal of the flexible liner.

37. The method of claim 36, wherein the flexible liner is of a material selected from the group consisting of: polyvinylchloride, latex, polyethylene, polypropylene, polyetheretherketone, polyester, nylon, polytetrafluoroethylene, silicone rubber, cellulose, polylactic acid, and perfluoroalkoxy alkane.

38. The method of claim 36, wherein the flexible liner is inserted into a fume cupboard.

39. The method of claim 38, wherein the flexible liner further comprises gloves attached to a wall of the flexible liner.

40. The method of claim 36, wherein the flexible liner has an oxygen transmission rate of less than 5000 cm.sup.3.Math.m.sup.2.Math.d.sup.1.

41. The method of claim 36, wherein the flexible liner has a water vapor transmission rate of less than 200 g.Math.m.sup.2.Math.d.sup.3.

42. The method of claim 36, wherein the flexible liner comprises a window formed of a transparent material.

43. A method of reducing cross contamination of a bacterial composition in a chamber, comprising culturing a bacterial composition for pharmaceutical use disposed in an interior of a flexible liner, wherein the flexible liner is disposed within the chamber on a wall of the chamber by negative pressure applied through an air permeable opening on the wall of the chamber, wherein the air permeable opening of the chamber has an area of from 0.01 cm.sup.2 to 2 cm.sup.2, and wherein the bacterial composition does not contact the wall of the chamber.

44. The method of claim 43, wherein the flexible liner is not permeable to material in the chamber outside of the flexible liner.

45. The method of claim 44, wherein the material in the chamber outside of the flexible liner does not contact the bacterial composition disposed in the interior of the flexible liner.

46. An apparatus comprising: (a) a chamber having a capacity of at least 1 liter, wherein the chamber comprises a wall with an air permeable opening, wherein the air permeable opening has an area of from 0.01 cm.sup.2 to 2 cm.sup.2; (b) a vacuum pump operatively coupled to the air permeable opening configured to generate a pressure of less than 100 Pa; (c) a flexible liner disposed on the wall of the chamber, wherein the flexible liner comprises a water vapor transmission rate of less than 200 g.Math.m.sup.2.Math.d.sup.3 and a thickness of from 0.1 m to 500 m; and (d) a bacterial composition for pharmaceutical use disposed in the interior of the flexible liner.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0058] By way of example, one or more embodiments of the present invention will now be described with reference to the accompanying drawings in which:

[0059] FIG. 1a is a cross-sectional view of a chamber and liner for use in accordance with a first embodiment of the present invention;

[0060] FIG. 1b is a cross-sectional view of the apparatus of FIG. 1a when a negative pressure has been applied to the interior of the chamber;

[0061] FIG. 1c is a cross-sectional view of the apparatus of FIGS. 1a and 1b when component parts of a product being mixed in the chamber have been placed inside the liner;

[0062] FIG. 1d is a cross-sectional view of the apparatus of FIGS. 1a to 1c when a mixing apparatus has been inserted into the interior of the liner;

[0063] FIG. 1e is a cross-sectional view of the apparatus of FIGS. 1a to 1d when the negative pressure has been removed from the interior of the chamber;

[0064] FIG. 1f is a cross-sectional view of the apparatus of FIGS. 1a to 1e when the liner is being removed from the interior of the chamber; and

[0065] FIG. 2 is a view of a liner for use in accordance with a second embodiment of the present invention.

DETAILED DESCRIPTION OF THE DRAWINGS

Example 1Cone Mixer

[0066] FIGS. 1a to 1f show an arrangement of component parts of a cone mixer which can be used in a method according to a first aspect of the present invention. The component parts include a liner and chamber for use in the method according to the first aspect of the present invention, and also comprise a kit according to a further aspect of the present invention.

[0067] As shown in FIG. 1a, the method comprises providing a chamber 11 which has an interior defined by a chamber wall 3. The chamber wall 3 is provided with a plurality of air permeable openings 2. The chamber 11 is part of a cone mixer 1. Outer walls of the cone mixer 1 include vacuum channels 5 which can be connected to a vacuum pump (not shown) that can be used to apply a negative pressure to the interior of the chamber 11 through the air permeable openings 2. The method further comprises providing a flexible liner 7, comprising a bag, the flexible liner 7 having an outer surface and an inner surface. The flexible liner 7 is located within the chamber 11, and includes an access opening 9 comprising a collar.

[0068] As shown in FIG. 1b, air is pumped into the liner 7 via the access opening defined by collar 9 using a pump (not shown). Simultaneously, negative pressure is applied into the interior of the chamber 11 via vacuum channels 5 and the plurality of air permeable openings 2 in the interior chamber wall 3. The liner 7 is shaped such that its exterior surface corresponds to the shape of the interior wall 3 of the cone mixer 1. The negative pressure is applied and maintained within the chamber 11 for a period of time which causes the liner 7 to be drawn to and retained against the interior wall 3 of the cone mixer 1.

[0069] As shown in FIG. 1c, the flow of air into the liner 7 is stopped. Material 13 which is to be mixed in the chamber is then placed inside the liner 7 via the access opening 9. Negative pressure continues to be applied to the interior of the chamber 11 to retain the liner 7 against the interior wall 3 of the chamber of the cone mixer 1.

[0070] As shown in FIG. 1d, mixing apparatus 15 (which may be disposable or reusable) is then inserted into the interior of the liner 7 via access opening 9. The mixing apparatus 15 is then operated until mixing of the material 13 is complete.

[0071] As shown in FIG. 1e, the mixing apparatus 15 is then removed from the liner 7, and the liner 7 is closed with rigid closure 17. The application of negative pressure into the interior of the chamber 11 is then stopped such that the liner 7 is no longer retained against the inner wall 3 of the chamber 11 of the cone mixer 1. This allows the liner 7 to be removed from the chamber 11 of the cone mixer 1 as shown in FIG. 1f.

[0072] Following extraction of the liner 7 from the chamber 11, the cone mixer 1 is immediately ready for use in another mixing operation without the need to clean or sterilise the interior of the mixing chamber 11.

[0073] A replacement liner 7 can then be inserted into the interior of the chamber, and the process outlined above can be repeated. Alternatively, in the event that the same material is to be processed, the liner 7 used in the process described above can be re-used.

Example 2Fume Cupboard

[0074] An alternative arrangement is shown in FIG. 2. In that arrangement a flexible liner 101 is constructed to have an outer profile which corresponds to the shape of a fume cupboard (not shown). The walls of the fume cupboard are provided with openings (not shown) through which air can pass. The liner is positioned within the fume cupboard, and a negative pressure is applied to the interior of the fume cupboard through those openings to retain the liner 101 against the walls of the cupboard.

[0075] The liner 101 is additionally provided with inlet 103, outlet 105 and gloves 107. A window formed of transparent material 109 is also provided to enable observers to view the interior of the liner 101. The regions of the fume cupboard walls (not shown) adjacent to the window 109, inlet 103 and outlet 105 are cut away and not provided with openings.

[0076] The negative pressure that has been applied to the interior of the fume cupboard is then reduced or stopped to allow the liner 101 to be removed from the fume cupboard.

[0077] It will be appreciated that the embodiments shown in the figures are by way of example only, and that alterations or modifications may be made within the scope of the invention as defined in the following claims.