Modular parts that supply utilities to cleanroom, isolation or containment cubicles, pods, or modules
The present invention includes a removable utility unit and/or removable utility room for providing one or more utilities to at least one of a controlled air, a sealable, a sterilizable, a sanitizable cleanroom comprising: at least one of a utility connection selected from air, water, gas, or electricity; and a substantially hermetic connector between the removable unit and the cleanroom, wherein the at least one of air, water, gas, or electricity are connectable to matching utility inputs in the cleanroom.
1. A removable portable utility unit for providing one or more utilities to at least one of a controlled air, a sealable, a sterilizable, a sanitizable portable cleanroom wherein the portable cleanroom is validatable for manufacturing pharmaceuticals or products that require high levels of cleanliness during manufacture, wherein the removable portable utility unit and the portable cleanroom comprises:
a hermetic seal along a perimeter of a wall of the removable portable utility unit and along a perimeter of a wall of the portable cleanroom that is validatable for manufacturing pharmaceuticals or products that require high levels of cleanliness during manufacture when the wall of the removable portable utility unit is adjacent to and in direct contact with the wall of the portable cleanroom;
at least one of a utility connection within the removable portable utility unit for a utility selected from air, water, gas, or electricity; and
a hermetic connector within the removable portable utility unit that connects the removable portable utility unit and the portable cleanroom, wherein the at least one of a utility connection for a utility selected from air, water, gas, or electricity are connectable to matching utility inputs in the portable cleanroom.
2. The removable portable utility unit of claim 1 , wherein the removable portable utility unit is at least one of sterilizable or sanitizable separate from the portable cleanroom.
3. The removable portable utility unit of claim 1 , wherein the utility connection is an air utility connection that is provided by first and second air inputs connectable to two separate heating, ventilation, and air conditioning (HVAC) systems wherein the first and second air inputs are connected into one or more air distribution ventilation shafts, wherein the air distribution ventilation shafts have one or more outlets that direct air into the portable cleanroom.
4. The removable portable utility unit of claim 1 , wherein the utility connection is an air utility connection that includes one or more HVAC systems that further comprise one or more air filtration units that provide at least the air changes necessary to achieve Class A, B, C, D or CNC air purity.
5. The removable portable utility unit of claim 1 , wherein the utility connection is an air utility connection that further comprises at least one of one or more sterilizing, sanitizing or both, units selected from a UV unit, an ozonation unit, a hydrogen peroxide, a nitric oxide, chlorine dioxide, a steam or fog unit; or a control panel connected to one or more sensors that detect at least one or biological, radiological, at least one of particle size or count, or chemical contamination.
6. The removable portable utility unit of claim 1 , wherein the utility connection is a water utility connection that provides at least one or more of potable water, cold water, hot water, pharmaceutical water, water-for-injection or deionized water.
7. The removable portable utility unit of claim 1 , wherein the hermetic connector has a mechanical strength sufficient to permit positive air pressure within the portable cleanroom without dislodging the removable portable utility unit.
8. The removable portable utility unit of claim 1 , wherein when the removable portable utility unit and the portable cleanroom are connected the hermetic connector provides a containment or isolation system sufficient to isolate biosafety level 1, 2, 3, or 4 pathogens.
9. The removable portable utility unit of claim 1 , wherein the removable portable utility unit can be further adapted to connect to at least one of an isolation or containment cubicles, pods, modules and units like corridors, hallways, other cleanrooms or access structures.
10. A method of providing one or more utilities to at least one of a controlled air, a sealable, a sterilizable, or a sanitizable portable cleanroom wherein the portable cleanroom is validatable for manufacturing pharmaceuticals or products that require high levels of cleanliness during manufacture, wherein the method comprises:
obtaining the portable cleanroom that is validatable for manufacturing pharmaceuticals or products that require high levels of cleanliness during manufacture, the portable cleanroom having air, water, gas, or electricity requirements;
placing a removable portable utility unit adjacent to and in direct contact with the portable cleanroom;
placing a hermetic seal along a perimeter of a wall of the removable portable utility unit and along a perimeter of a wall of the portable cleanroom; and
attaching at least one of a utility connection for a utility selected from air, water, gas, or electricity from within the removable portable utility unit to a hermetic connector between the removable portable utility unit and the portable cleanroom, wherein the at least one of a utility connection for a utility selected from air, water, gas, or electricity are connectable to matching utility inputs in the portable cleanroom.
11. The method of claim 10 , wherein the removable portable utility unit is at least one of sterilizable, or sanitizable separate from the portable cleanroom.
12. The method of claim 10 , wherein the utility connection is an air utility connection that is provided by first and second air inputs connectable to two separate heating, ventilation, and air conditioning (HVAC) systems wherein the first and second air inputs are connected into one or more air distribution ventilation shafts, wherein the air distribution ventilation shafts have one or more outlets that direct air into the portable cleanroom.
13. The method of claim 10 , wherein the utility connection is an air utility connection that includes one or more HVAC systems that further comprise one or more air filtration units that provide the air changes required to achieve at least Class A, B, C, D and CNC air purity.
14. The method of claim 10 , wherein the utility connection is an air utility connection that further comprises at least one of one or more sterilizing units selected from a UV unit, an ozonation unit, a hydrogen peroxide, nitric oxide, chlorine dioxide, a steam or fog unit; or a control panel connected to one or more sensors that detect at least one or biological, radiological, at least one of particle size or count, or chemical contamination.
15. The method of claim 10 , wherein the utility connection is a water utility connection that provides at least one or more of potable water, cold water, hot water, pharmaceutical water, water-for-injection or deionized water.
16. The method of claim 10 , wherein the hermetic connector has a mechanical strength sufficient to permit positive air pressure within the portable cleanroom without dislodging the removable portable utility unit.
17. The method of claim 10 , wherein when the removable portable utility unit and the portable cleanroom are connected the hermetic connector is adapted to provide a containment or isolation system sufficient to isolate biosafety level 1, 2, 3, or 4 pathogens.
18. The method of claim 10 , wherein the removable portable utility unit can be further adapted to connect to at least one of an isolation or containment cubicles, pods, modules and units like corridors, hallways, other cleanrooms or access structures.
19. A biological processing plant comprising:
two or more portable cleanrooms connected to each other, wherein each of the portable cleanrooms is validatable for manufacturing pharmaceuticals or products that require high levels of cleanliness during manufacture, wherein each of the portable cleanrooms further comprises a removable portable utility unit for providing one or more utilities to the controlled air, sealable, sterilizable portable cleanroom comprising:
a hermetic seal between a perimeter of a wall of the removable portable utility unit and a perimeter of a wall of the portable cleanroom wherein the wall of the removable portable utility unit is adjacent to and in direct contact with the wall of the portable cleanroom;
at least one of a utility connection within the removable portable utility unit for a utility selected from air, water, gas, or electricity; and
a hermetic connector between the removable portable utility unit and the portable cleanroom, wherein the at least one of air, water, gas, or electricity are connectable to matching utility inputs in the portable cleanroom.
20. A removable portable utility room for providing one or more utilities to at least one of a controlled air, a sealable, a sterilizable, a sanitizable portable cleanroom, wherein the portable cleanroom is validatable for manufacturing pharmaceuticals or products that require high levels of cleanliness during manufacture, wherein the one or more utilities are provided through a removable portable utility unit comprising:
a hermetic seal along a perimeter of a wall of the removable portable utility unit and along a perimeter of a wall of the portable cleanroom that is validatable for manufacturing pharmaceuticals or products that require high levels of cleanliness during manufacture;
at least one of a utility connection within the removable portable utility unit selected from air, water, gas, or electricity; and
a hermetic connector between the removable portable utility room, the removable portable utility unit and the portable cleanroom, wherein the at least one of air, water, gas, or electricity are connectable to matching utility inputs in the portable cleanroom from the removable portable utility room.
21. The removable portable utility unit of claim 20 , wherein the removable portable utility room is at least one of sterilizable or sanitizable separate from the portable cleanroom.
22. The removable portable utility unit of claim 20 , wherein the removable portable utility room includes at least two separate heating, ventilation, and air conditioning (HVAC) systems and first and second inputs into one or more air distribution ventilation shafts, wherein the air distribution ventilation shaft has one or more outlets that direct air into the portable cleanroom.
23. The removable portable utility unit of claim 20 , wherein the removable portable utility room includes one or more HVAC systems that further comprise one or more air filtration units that provide at least the air changes necessary to achieve Class A, B, C, D or CNC air purity.
24. The removable portable utility unit of claim 20 , wherein the removable portable utility room further comprises at least one of one or more sterilizing, sanitizing or both, units selected from a UV unit, an ozonation unit, a hydrogen peroxide, a nitric oxide, chlorine dioxide, a steam or a fog unit; or one or more sensors that detect at least one or biological, radiological, particle size or chemical contamination.