Environmental containment systems

• US 7,819,934 B2
• Filed: 07/13/2007
• Issued: 10/26/2010
• Est. Priority Date: 07/14/2006
• Status: Active Grant

• Current Assignee: Global Life Sciences Solutions USA LLC (Danaher Corporation)
• Original Assignee: Xcellerex, Inc. (General Electric Company)
• Inventors: Fisher, Michael, Hodge, Geoffrey L., Galliher, Parrish M.
• Primary Examiner(s): Smith; Duane
• Assistant Examiner(s): PHAM, MINH CHAU THI
• Application Number:
  US11/879,033
• Publication Number:
  US 20080139865A1
• Time in Patent Office: 1,201 Days
• Field of Search: 553/851, 553/852, 554/18, 554/71, 55D/IG.18, 55D/IG.46, 454/187, 454/192, 128/205.11, 128/205.26, 600/21, 135/116, 135/119, 135/127, 312/1
• US Class Current: 55/385.2
• CPC Class Codes: B08B 15/02 using chambers or hoods covering the area B08B15/002 takes precedence
• CPC Class Codes: C12M 23/52 Mobile; Means for transporting the apparatus transportable laboratories B01L1/52
• CPC Class Codes: C12M 37/02 Filters
• CPC Class Codes: C12M 41/00 Means for regulation, monitoring, measurement or control, e.g. flow regulation controlling or regulating chemical, physical or physicochemical processes B01J19/0006; heating or cooling apparatus for laboratory use B01L7/00; electro optical investigation of individual particles, flow cytometers G01N15/14; automatic analysis G01N35/00; controlling or regulating in general G06N
• CPC Class Codes: C12M 41/14 Incubators; Climatic chambers per se B01L1/00
• CPC Class Codes: C12M 41/40 of pressure
• CPC Class Codes: Y10S 55/18 Work bench

Abstract

Environmental containment systems, and in certain embodiments, systems and methods involving vessels and unit operations or components of cell culture, cell containment, bioreactor, chemical manufacturing, or pharmaceutical manufacturing systems provided with environmental containment are provided. Certain vessels, unit operations, devices, and components may be used to perform all or part of biological, chemical, and/or pharmaceutical manufacturing processes therein. In some embodiments, an environmental containment system includes a multi-level containment apparatus. For instance, a first substantially closed environmental containment enclosure may be contained within a second substantially closed environmental containment enclosure; the first and second enclosures may be contained in a third substantially closed environmental containment enclosure, etc. Each of the environments within the substantially closed environmental containment enclosures may be controlled independently, and leakage of any materials from an inner system may be contained by an outer system.

Claims

1. An apparatus comprising:

a vessel or a processing device having an interior comprising a container adapted for containing a liquid;

an environmental containment enclosure having an inner surface and configured for surrounding at least a portion of the vessel or the processing device, the environmental containment enclosure being configured so that at least a portion of the environmental containment enclosure has a shape and/or contour that is complementary to a shape and/or contour of an outer surface of the vessel or an outer surface of the processing device to which the at least a portion of the environmental containment enclosure is adjacent;

the inner surface of the environmental containment enclosure and the outer surface of the vessel or the processing device defining an enclosed space therebetween, at least a portion of said enclosed space not in continuous fluid communication with an interior portion of the container, and wherein said enclosed space is maintained during use of the vessel or the processing device at a pressure chosen from greater than atmospheric pressure, less than atmospheric pressure, and equal to atmospheric pressure;

an environmental treatment system in communication with the enclosed space, the environmental treatment system comprising a ventilation system in fluid communication with the enclosed space, the ventilation system comprising an inlet port dimensioned for connection to a source of gas unit for introducing gas into the apparatus and an outlet port for connection to an exhaust unit for removing a gas from the apparatus; and

a damper control configured for connection to at least one of the source of gas unit and the exhaust unit, the damper control capable of regulating pressurization within the apparatus; and

wherein the environmental treatment system and environmental containment enclosure are configured to maintain an aseptic and/or substantially particle-free environment within the enclosed space.

2. An apparatus as in claim 1, wherein the interior of the vessel or the processing devive is operated at a pressure greater than atmospheric pressure.

3. An apparatus as in claim 2, wherein the ventilation system comprises a particulate measurement system.

4. An apparatus as in claim 1, wherein the vessel defines a rigid container adapted for containing a liquid, wherein inner walls of the vessel are in direct contact with the liquid.

5. An apparatus as in claim 1, wherein the vessel comprises a collapsible bag adapted for containing a liquid and defines a support structure adapted for surrounding and supporting the collapsible bag.

6. An apparatus as in claim 1, wherein the environmental containment enclosure comprises at least one access port selected independently from the group consisting of an iris port, a glove port, a septum, and a valve, said access port arranged to allow access to a liquid in the container or to the processing device without the liquid or the processing device being subjected to an atmosphere surrounding the environmental containment enclosure.

7. An apparatus as in claim 1, wherein only a portion, but not all, of the vessel is enclosed by the environmental containment enclosure.

8. The apparatus of claim 1, wherein the enclosed space is maintained at a pressure greater than atmospheric pressure during use of the vessel.

9. The apparatus of claim 2, wherein the enclosed space is maintained at a pressure less than atmospheric pressure during use of the vessel.

10. An apparatus comprising:

at least one device comprising a vessel or a processing device having an outer surface and an interior portion configured for containing a fluid or biological cells;

a first environmental containment enclosure having an inner surface and configured for surrounding at least a portion of the vessel or the processing device,

the inner surface of the environmental containment enclosure and the outer surface of the vessel or the processing device defining a first enclosed space therebetween, said first enclosed space not in continuous fluid communication with the interior portion of the vessel or the processing device;

a second environmental containment enclosure surrounding at least a portion of the first environmental containment enclosure, the second environmental containment enclosure having an inner surface, the inner surface of the second environmental containment enclosure and the outer surface of the first environmental containment enclosure defining a second enclosed space therebetween,

said second enclosed space not in continuous fluid communication with the interior portion of the vessel or the processing device, and wherein said first and said second enclosed spaces are each maintained during use of the vessel or the processing device at a pressure chosen independently from greater than atmospheric pressure, less than atmospheric pressure, and equal to atmospheric pressure;

an environmental treatment system in communication with at least one of the first and second enclosed spaces, the environmental treatment system comprising a ventilation system in fluid communication with at least one of the first and second enclosed spaces the ventilation system comprising an inlet port dimensioned for connection to a source of gas unit for introducing gas into the apparatus and an outlet port for connection to an exhaust unit for removing a gas from the apparatus; and

a damper control configured for connection to at least one of the source of gas unit and the exhaust unit, the damper control operably connected to the apparatus and capable of regulating pressurization within the first and the second enclosed space of the apparatus; and

wherein the environmental treatment system and the first and second environmental containment enclosures are configured to maintain an aseptic and/or substantially particle-free environment within the at least one of the first and second enclosed spaces.

11. An apparatus as in claim 10, comprising a third, substantially closed environmental containment enclosure configured to contain the first and the second environmental containment enclosures and to contain a leakage of any materials from an inner system.

12. An apparatus as in claim 10, wherein the interior portion of the vessel or the processing device is maintained at a pressure greater than atmospheric pressure during use of the vessel.

13. An apparatus as in claim 10, wherein at least one of the first enclosed space, the second enclosed space, and the vessel is maintained at a pressure less than atmospheric pressure during use of the vessel.

14. An apparatus as in claim 10, wherein the vessel comprises a collapsible bag adapted for containing a liquid and includes a support structure adapted for surrounding and supporting the collapsible bag.

15. An apparatus as in claim 10, wherein the vessel or the processing device is in the form of a unit operation component adapted for performing a biological, chemical, and/or pharmaceutical manufacturing process.

16. The apparatus of claim 10, wherein at least one of the first and the second environmental containment enclosures comprises at least one access port selected independently from the group consisting of an iris port, a glove port, a septum, and a valve, said access port arranged to allow access to the interior portion of the vessel or the processing device without the interior portion of the vessel or the processing device being subjected to an atmosphere surrounding the second environmental containment enclosure.

17. The apparatus of claim 10, wherein the ventilation system is in fluid communication with the first enclosed space, the apparatus having a configuration wherein the interior portion of the vessel or the processing device is at a first pressure greater than atmospheric pressure;

the first enclosed space is at a second pressure less than the first pressure; and

the second enclosed space is at a third pressure greater than the second pressure in the first enclosed space;

the configuration thereby allowing a material that enters the first enclosed space from the second enclosed space to be removed by the ventilation system.