MODULAR, SELF-CONTAINED, MOBILE CLEAN ROOM

• US 20110053486A1
• Filed: 08/16/2010
• Published: 03/03/2011
• Est. Priority Date: 08/16/2009
• Status: Active Grant

• Current Assignee: G-Con Manufacturing, Inc.
• Original Assignee: G-CON LLC (G-Con Manufacturing, Inc.)
• Inventors: Maples, Phillip B., Shanahan, David M., Arledge, Troy, Holtz, R. Barry
• Granted Patent: US 9,518,748 B2
• Time in Patent Office: Days
• US Class Current: 454/187
• CPC Class Codes: B01L 1/04 Dust-free rooms or enclosures
• CPC Class Codes: C12M 37/00 Means for sterilizing, maintaining sterile conditions or avoiding chemical or biological contamination C12M23/38 takes precedence; filtration in general and filters per se B01D24/00-B01D41/00; autoclaves B01J3/04; treatment of microorganisms with electrical or wave energy C12N13/00
• CPC Class Codes: F24F 3/16 by purification, e.g. by filtering; by sterilisation; by ozonisation
• CPC Class Codes: F24F 3/167 Clean rooms, i.e. enclosed spaces in which a uniform flow of filtered air is distributed air distribution by perforated walls F24F7/10
• CPC Class Codes: F24F 8/00 Treatment, e.g. purification, of air supplied to human living or working spaces otherwise than by heating, cooling, humidifying or drying
• CPC Class Codes: Y02A 50/20 Air quality improvement or preservation, e.g. vehicle emission control or emission reduction by using catalytic converters
• CPC Class Codes: Y10T 29/49826 Assembling or joining

Abstract

Biosafety units, methods of making, and sealing the same are disclosed herein. The units comprise at least one controlled air, sealable, sterilizable cleanroom; and a mechanical system room adjacent to the cleanroom comprising: at least two air handling units in a support room adjacent the cleanroom that provide redundant air to the cleanroom with at least Class 100,000 air purity, the air handling units connected to a one or more supply ducts to the cleanroom, and an exhaust duct in communication with the cleanroom and the air handling unit exhaust, wherein a pressure gradient is formed between the cleanroom and the exterior of the structure; and at least two power supplies that provide redundant power to electrical outlets in the cleanroom, wherein the at least two power supplies are connectable to one or more external power sources and the structure is pre-validatable or validated for pharmaceutical manufacturing.

Claims

1. An unitary structure comprising:

at least one controlled air, sealable, sterilizable cleanroom; and

a mechanical system room adjacent to the cleanroom comprising;

at least two air handling units in a support room adjacent the cleanroom that provide redundant air to the cleanroom with at least Class 100,000 air purity, the air handling units connected to a one or more supply ducts to the cleanroom, and an exhaust duct in communication with the cleanroom and the air handling unit exhaust, wherein a pressure gradient is formed between the cleanroom and the exterior of the structure; and

at least two power busses that provide power to electrical outlets in the cleanroom from two sources, wherein the at least two power supplies are connectable to one or more external electrical power sources and the structure is validatable for pharmaceutical manufacturing.

2. The structure of claim 1, further comprising an unitary, information technology system that connects to an intranet, an extranet or both, wherein the system connects to and controls one or more sensors.

3. The structure of claim 1, further comprising one or more external controls connected to one or more sensors that monitor, temperature, humidity, air pressure, equipment status, security, fire protection, chemical or biological contamination, hard wired internet connection or wireless connections.

4. The structure of claim 1, further comprising universal connectors including at least one of an electrical, water, wastewater, gas, HVAC, water or air filtration inputs/outputs.

5. The structure of claim 1, wherein one or more equipments are fixed to the structure prior to validation.

6. The structure of claim 1, wherein the air handling unit and power busses have instantaneous fail-over during operation of the cleanroom without loss of air or power to the cleanroom.

7. The structure of claim 1, wherein the structure comprises additional fail-over systems to provide services to the cleanroom selected from at least one of the water, gas, drain water, chilled water or wastewater systems.

8. The structure of claim 1, wherein the structure comprises water, gas, drain water, or wastewater systems and these systems are repairable in the mechanical system room without loss of service to the cleanroom.

9. The structure of claim 1, wherein the redundant systems that support the clean room can be swapped without specialized electrical, water, waste-water personnel or permits.

10. The structure of claim 1, wherein the structure can be moved without disconnecting from the electrical, water, drain water, waste-water, gas, chilled water or hot water supplies connected to the structure.

11. The structure of claim 1, wherein the structure comprises at least one or more reinforced floors, comprised of I-beams below the floor, vibration dampeners, and other reinforcing members to support one or more specific equipments.

12. The structure of claim 1, further comprising a first and a second passage into the cleanroom for ingress and egress from the sealable cleanroom.

13. The structure of claim 1, wherein the structure is aluminum.

14. The structure of claim 1, wherein the mechanical system room may be serviced without entering the cleanroom.

15. The structure of claim 1, wherein the one or more supply ducts comprises one or more dampers adapted to vary the internal pressure in one or more areas within the cleanroom thereby creating a pressure gradient between the internal pressure and atmospheric pressure external to the structure.

16. The structure of claim 15, wherein the internal pressure can be varied to be greater than, less than or equal to the atmospheric pressure.

17. The structure of claim 1, wherein the cleanroom is provided with at least Class 10,000, 1,000, 100 or 10 air purity.

18. The structure of claim 1, wherein the cleanroom comprises at least one pre-validatable, centrifuge, tissue culture hood, chemical handling unit, stirrer tank, chromatography column, cell sorter, bioreactor, refrigerator, freezer, incubator, biosafety cabinet, temperature cycler, vacuum, or freeze drier, culture media, water, solvents, disposables, pipettes, disposable containers, and other bioprocess equipment that can be part of a validated process.

19. The structure of claim 1, wherein the clean room comprises at least one work table, work surface, sink, cabinet, surveillance equipment, bags, office items, and chairs.

20. The structure of claim 1, wherein at least a portion of the structure is thermally insulated.

21. The structure of claim 1, further comprising one or more sealable passages for pipes, electrical wiring, pneumatic or hydraulic lines, gas lines, communications wiring, and wireless connectivity.

22. The structure of claim 1, wherein the cleanroom further comprises one or more sealable conduits to transfer materials to and from the cleanroom.

23. The structure of claim 1, further comprising sufficient air-bearings under the structure to permit movement of the structure.

24. The structure of claim 1, wherein the structure is adapted for transport via land, sea or air.

25. The structure of claim 1, wherein the structure further comprises one or more of an air conditioner;

a water cooling unit;

a steam boiler;

a water softener;

a reverse osmosis unit;

a still;

a heat exchanger;

a hot water production system; and

an air compressor.

26. The structure of claim 1, wherein the structure further comprises a sealed envelope following validation for cGMP manufacturing.

27. The structure of claim 1, wherein the structure is portable.

28. A rapid deployment patient care facility comprising:

at least one controlled air, sealable, sterilizable cleanroom;

at least two air handling units in a support room adjacent the cleanroom that provide redundant air to the cleanroom with at least Class 100,000 air purity, the air handling units connected to a one or more supply ducts to the cleanroom, and an exhaust duct in communication with the cleanroom and the air handling unit exhaust, wherein a pressure gradient is formed between the cleanroom and the exterior of the structure; and

at least two power supplies that provide redundant power to electrical outlets in the cleanroom, wherein the at least two power supplies are connectable to one or more external power sources and the structure is validatable for patient care.

29. The facility of claim 28, wherein the cleanroom comprises at least one pre-validatable centrifuge, tissue culture hood, chemical handling unit, stirrer tank, chromatography column, cell sorter, bioreactor, refrigerator, freezer, incubator, biosafety cabinet, temperature cycler, vacuum, or freeze drier, culture media, water, solvents, disposables, pipettes, disposable containers, and other bioprocess equipment that can be part of a validated process.

30. The facility of claim 28, wherein the clean room comprises at least one work table, work surface, sink, cabinet, surveillance equipment, bags, office items, and chairs.

31. The facility of claim 28, wherein at least a portion of the structure is thermally insulated.

32. The facility of claim 28, further comprising one or more sealable passages for pipes, electrical wirings, pneumatic or hydraulic lines, gas lines, communications wiring, and wireless connectivity.

33. The facility of claim 28, wherein the facility further comprises one or more sealable conduits to transfer materials to and from the facility.

34. The facility of claim 28, further comprising sufficient air-bearings under the facility to permit movement of the facility.

35. The facility of claim 28, wherein the facility is adapted for transport via land, sea or air.

36. The facility of claim 28, wherein the facility further comprises one or more of an air conditioner;

a water cooling unit;

a steam boiler;

a water softener;

a reverse osmosis unit;

a still;

a heat exchanger;

a hot water production system; and

an air compressor.

37. The facility of claim 28, wherein the facility further comprises a sealed envelope following validation for cGMP manufacturing.

38. A biosafety unit comprising:

at least one controlled air, sealable, sterilizable cleanroom; and

a mechanical system room adjacent to the cleanroom comprising two or more redundant systems, the redundant systems comprising;

at least two air handling units in a support room adjacent the cleanroom that provide redundant air to the cleanroom with at least Class 100,000 air purity, the air handling units connected to a one or more supply ducts to the cleanroom, and an exhaust duct in communication with the cleanroom and the air handling unit exhaust, wherein a pressure gradient is formed between the cleanroom and the exterior of the unit; and

at least two power supplies that provide redundant power to electrical outlets in the cleanroom, wherein the at least two power inputs are connectable to one or more external power sources and the unit is validatable for pharmaceutical manufacturing.

39. The unit of claim 38, wherein the unit is pre-validated or validated for compliance with the requirements of an applicable regulatory agency.

40. The unit of claim 38, wherein the unit is validated and further comprises a sealed envelope following validation for cGMP manufacturing.

41. The unit of claim 38, further comprising an unitary, information technology system that connects to an intranet, an extranet or both, wherein the system connects to and controls one or more sensors.

42. The unit of claim 38, further comprising one or more external controls connected to one or more sensor that monitor, temperature, humidity, air pressure, equipment status, security, chemical or biological contamination, hard wired internet connection or wireless connection.

43. The unit of claim 38, further comprising universal connectors including at least one of an electrical, water, wastewater, gas, HVAC, water or air filtration inputs/outputs.

44. The unit of claim 38, wherein one or more equipments are fixed to the unit prior to validation.

45. The unit of claim 38, wherein the air handling unit and power busses have instantaneous fail-over during operation of the cleanroom without loss of air or power to the cleanroom.

46. The unit of claim 38, wherein the unit comprises additional fail-over systems to provide service to the cleanroom selected from at least one of the water, gas, drain water, chilled water or wastewater systems.

47. The unit of claim 38, wherein the unit comprises one or more water, gas, drain water, or wastewater systems and these systems are repairable in the mechanical system room without entrance into the cleanroom.

48. The unit of claim 38, wherein the redundant systems that support the clean room can be connected without specialized electrical or mechanical contractors.

49. The unit of claim 38, wherein the unit can be moved without disconnecting from the electrical, water, drain water, waste-water, gas, chilled water or hot water supplies connected to the unit.

50. The unit of claim 38, further comprising a first and a second passage into the cleanroom for ingress and egress from the sealable cleanroom.

51. The unit of claim 38, wherein the mechanical system room may be serviced without entering the cleanroom.

52. The unit of claim 38, wherein the cleanroom is provided with at least Class 10,000, 1,000, 100 or 10 air purity.

53. The unit of claim 38, wherein the cleanroom comprises at least one pre-validatable centrifuge, tissue culture hood, chemical handling unit, stirrer tank, chromatography column, cell sorter, bioreactor, refrigerator, freezer, incubator, biosafety cabinet, temperature cycler, vacuum, or freeze drier, culture media, water, solvents, disposables, pipettes, disposable containers, and other bioprocess equipment that can be part of a validated process.

54. The unit of claim 38, wherein the clean room comprises at least one work table, work surface, sink, cabinet, surveillance equipment, bags, office items, and chairs.

55. The unit of claim 38, further comprising one or more sealable passages for pipes, electrical wirings, pneumatic or hydraulic lines, gas lines, communications wiring, and wireless connectivity.

56. The unit of claim 38, further comprising sufficient air-bearings under the unit to permit movement of the unit.

57. The unit of claim 38, wherein the unit is adapted for transport via land, sea or air.

58. The unit of claim 38, wherein the unit further comprises one or more of an air conditioner;

a water cooling unit;

a steam boiler;

a water softener;

a reverse osmosis unit;

a still;

a heat exchanger;

a hot water production system; and

an air compressor.

59. The unit of claim 38, wherein the unit further comprises a sealed envelope following validation for cGMP manufacturing.

60. The unit of claim 38, wherein the unit is portable.

61. A method of making a unitary pre-validatable unit comprising:

building at least one controlled air, sealable, sterilizable cleanroom; and

connecting to the building a mechanical system room adjacent to the cleanroom comprising;

at least two air handling units in a support room adjacent the cleanroom that provide redundant air to the cleanroom with at least Class 100,000 air purity, the air handling units connected to a one or more supply ducts to the cleanroom, and an exhaust duct in communication with the cleanroom and the air handling unit exhaust, wherein a pressure gradient is formed between the cleanroom and the exterior of the unit; and

at least two power busses that provide power to electrical outlets in the cleanroom from two sources, wherein the at least two power supplies are connectable to one or more external electrical power sources and the unit is validatable for pharmaceutical manufacturing.

62. The method of claim 61, further comprising the step of pre-validating the unit by an applicable regulatory agency.

63. The method of claim 61, further comprising the step of validating the unit and surrounding the unit with a sealed envelope following validation for cGMP manufacturing.

64. The method of claim 61, further comprising the step of connecting a unitary, information technology system that connects to an intranet, an extranet or both, wherein the system connects to and controls one or more sensors.

65. The method of claim 61, further comprising the step of connecting one or more external controls connected to one or more sensor that monitor, temperature, humidity, air pressure, equipment status, security, chemical or biological contamination, hard wired internet connection or wireless connection to the unit.

66. The method of claim 61, further comprising the step of selecting universal connectors including at least one of an electrical, water, wastewater, gas, HVAC, water or air filtration inputs/outputs to standardize the unit.

67. The method of claim 61, further comprising the step of fixing equipment in the cleanroom prior to validation.

68. The method of claim 61, further comprising the step of adapting the air handling unit and power busses to have instantaneous fail-over during operation of the cleanroom without loss of air or power to the cleanroom.

69. The method of claim 61, further comprising the step of adding one or more fail-over systems to provide service to the cleanroom selected from at least one of the water, gas, drain water, chilled water or wastewater systems.

70. The method of claim 61, further comprising the step of locating the water, gas, drain water, or wastewater systems and these systems are repairable in the mechanical system room and the repairs occur without entrance into the cleanroom.

71. The method of claim 61, further comprising the step of connecting the redundant systems that support the clean room to be swapped without specialized electrical or mechanical contractors.

72. The method of claim 61, further comprising the step of connecting flexible connector that allow the unit to be moved without disconnecting from the electrical, water, drain water, waste-water, gas, chilled water or hot water supplies connected to the unit.

73. The method of claim 61, further comprising the step of connecting to the cleanroom a first and a second passage into the cleanroom for ingress and egress to the cleanroom.

74. The method of claim 61, further comprising the step of servicing the mechanical system room without entering the cleanroom.

75. The method of claim 61, further comprising the step of providing the cleanroom with at least Class 10,000, 1,000, 100 or 10 air purity that can be serviced without entering the cleanroom.

76. The method of claim 61, further comprising the step of including within the cleanroom comprises at least one pre-validatable centrifuge, tissue culture hood, chemical handling unit, stirrer tank, chromatography column, cell sorter, bioreactor, refrigerator, freezer, incubator, biosafety cabinet, temperature cycler, vacuum, or freeze drier, culture media, water, solvents, disposables, pipettes, disposable containers, and other bioprocess equipment that can be part of a validated process.

77. The method of claim 61, wherein the clean room comprises at least one work table, work surface, sink, cabinet, surveillance equipment, bags, office items, and chairs.

78. The method of claim 61, further comprising the step of connecting one or more sealable passages for pipes, electrical wirings, pneumatic or hydraulic lines, gas lines, communications wiring, and wireless connectivity to the unit.

79. The method of claim 61, further comprising the step of positioning sufficient air-bearings under the unit to permit movement of the unit.

80. The method of claim 61, further comprising the step of adapting the unit for transport via land, sea or air.