Modular, self-contained, mobile clean room
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.
1. A unitary structure cleanroom system for pharmaceutical manufacturing comprising:
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; and
one or more power busses that provide power to electrical outlets in the cleanroom from two sources, wherein one or more power busses are connectable to one or more external electrical power sources; and
a hallway unit with one side connected to the cleanroom entry points of the rectangular unitary structures 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 system of claim 1 , further comprising:
an information technology system that connects to an intranet, an extranet, or both, wherein the information technology system connects to and controls one or more sensors in the at least one cleanroom of the plurality of unitary structures.
3. The system of claim 1 , further comprising:
one or more external controls connected to one or more sensors in at least one of the cleanrooms of the unitary structures that monitor, temperature, humidity, air pressure, equipment status, security, fire protection, chemical or biological contamination, hard wired internet connection, or wireless connections connected to an information technology system.
4. The system of claim 1 , further comprising:
universal connectors on the unitary structures including at least one of an electrical, water, wastewater, gas, HVAC (heating, ventilation, and air conditioning), water, air filtration inputs/outputs, or a fire suppression system.
5. The system of claim 4 , wherein the fire suppression system comprises a gas fire suppression system.
6. The system of claim 1 , wherein the cleanroom further comprises at least one of an integral autoclave, a robot capable of cleaning the cleanroom, or a vapor hydrogen peroxide cleaning system.