Modular, self-contained, mobile clean room

• US 9,795,957 B2
• Filed: 11/06/2012
• Issued: 10/24/2017
• Est. Priority Date: 08/16/2009
• Status: Active Grant

• Current Assignee: G-Con Manufacturing, Inc.
• Original Assignee: G-Con Manufacturing, Inc.
• Inventors: Holtz, R. Barry, Arledge, Troy, Maples, Phillip B., Shanahan, David M.
• Primary Examiner(s): Huson, Gregory
• Assistant Examiner(s): Becton, Martha
• Application Number:
  US13/669,785
• Publication Number:
  US 20130109291A1
• Time in Patent Office: 1,813 Days
• Field of Search: None
• CPC Class Codes: B01L 1/04 Dust-free rooms or enclosures
• CPC Class Codes: B23P 11/00 Connecting or disconnecting metal parts or objects by metal-working techniques not otherwise provided for connecting sheet metal or metal tubes, rods or profiles B21D39/00; riveting B21J; soldering, unsoldering, welding B23K; hand tools for connecting wire or strip B25B25/00; connecting metal parts by adhesives F16B11/00
• 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: E04H 3/08 Hospitals, infirmaries, or the like; Schools; Prisons
• CPC Class Codes: E04H 5/02 Buildings or groups of buildings for industrial purposes, e.g. for power-plants or factories buildings forming part of cooling plants E04H5/10
• 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: 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 present invention includes a unitary structure able to be validated for pharmaceutical manufacturing comprising: at least one controlled air, sealable, sterilizable cleanroom; a mechanical system room adjacent to and separate from the cleanroom comprising: one or more air handling units that provide conditioned air to the cleanroom; and one or more 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; an integrated fire suppression system integral to the cleanroom; and one or more corridor connectors, wherein a corridor can be attached at the corridor connector.

Claims

1. A method of assembling unitary pre-validatable cleanroom units, the method comprising:

building a plurality of rectangular unitary structures, each unitary structure comprising;

at least one controlled air, sealable, sterilizable cleanroom, the cleanroom having an entry point at a first end of the rectangular unitary structure;

a mechanical system room at a second end of the rectangular unitary structure, the second end being opposite the first end, the mechanical system room comprising;

one or more air handling units that provide air to the cleanroom;

one or more power busses that provide power to electrical outlets in the cleanroom from two sources, wherein the one or more power busses are connectable to one or more external electrical power sources; and

a mechanical system room doorway to an area outside of the unitary structure that is separate from the entry point to the cleanroom; and

an integrated fire suppression system integral to the cleanroom;

building a hallway unit; and

connecting the first end of each rectangular unitary structure with the cleanroom entry point to a common side of the hallway unit such that the rectangular unitary structures project in a same direction from the hallway unit and the mechanical system rooms are opposite the hallway unit.

2. The method of claim 1, wherein the hallway unit is pre-validated or validated for compliance with requirements of an applicable regulatory agency.

3. The method of claim 1, further comprising:

surrounding each unitary structure with a sealed envelope following validation for cGMP manufacturing by a regulatory agency; and

transporting the unitary structure.

4. The method of claim 1, further comprising:

connecting an information technology system of each cleanroom to an intranet, an extranet or both, wherein the information technology system connects to and controls one or more sensors in each cleanroom that monitor temperature, humidity, air pressure, equipment status, security, chemical or biological contamination, hard wired internet connection or wireless connection, and at least one of an electrical, water, wastewater, gas, HVAC, water or air filtration inputs/outputs, or fire suppression system.

5. The method of claim 1 further comprising:

moving at least one of the unitary structures from the hallway unit to a decontamination area of a gray space; and

decontaminating the unitary structure.

6. The method of claim 1 wherein each unitary structure includes multiple air handling units that are redundant with one another.

7. The method of claim 1 wherein each unitary structure includes multiple power busses that provide power to electrical outlets in the cleanroom from two sources.

8. The method of claim 1 wherein the fire suppression system comprises a gas fire suppression system.

9. The method of claim 1 wherein at least one of the cleanrooms includes at least one of an integral autoclave, a robot capable of cleaning the cleanroom, or a vapor hydrogen peroxide cleaning system.