초록

A flexible, multi-product, multi-technology, expandable facility for manufacturing products, such as biologicals, pharmaceuticals, or chemicals, and manufacturing processes using elements of such a facility.

대표청구항 ▼

1. A manufacturing system comprising: a housing; at least one corridor extending within the housing; a core supplying two or more utilities, wherein at least two of the two or more utilities are selected from the group consisting of (a) clean air, (b) clean water, (c) electricity, (d) oxygen, and (e

1. A manufacturing system comprising: a housing; at least one corridor extending within the housing; a core supplying two or more utilities, wherein at least two of the two or more utilities are selected from the group consisting of (a) clean air, (b) clean water, (c) electricity, (d) oxygen, and (e) carbon dioxide;a first movable manufacturing bay disposed within the housing and positioned adjacent to the corridor and removably coupled to the core for receiving the utilities;a first workspace defined by the first movable manufacturing bay and accommodating a first facility for performing at least a part of a manufacturing process;a second movable manufacturing bay disposed within the housing and positioned adjacent to the corridor and removably coupled to the core for receiving the utilities;a second workspace defined by the second movable manufacturing bay and accommodating a second facility for performing at least a part of a manufacturing process;a first clean connect area disposed between the first workspace and the corridor when the first movable manufacturing bay is removably coupled to the core, the first clean connect area for controlling access to and from the first workspace; anda second clean connect area disposed between the second workspace and the corridor when the second movable manufacturing bay is removably coupled to the core, the second clean connect area for controlling access to and from the second workspace;wherein the first and second clean connect areas are connected by the corridor such that personnel can pass between the first and second clean connect areas via the corridor; andwherein each of the first and second clean connect areas comprises a bay entry portion and a bay exit portion separated and/or sealed from each other by a partition, wherein operating personnel can gown and degown within the bay entry and exit portions, respectively. 2. The system of claim 1, wherein the first movable manufacturing bay includes a first utility room sealed from the first workspace, the first utility room supplying one or more first utilities to the first workspace, and wherein the second movable manufacturing bay includes a second utility room sealed from the second workspace, the second utility room supplying one or more second utilities to the second workspace, the first and second utilities selected from the group consisting of (a) clean air, (b) clean water, (c) electricity, (d) oxygen, and (e) carbon dioxide. 3. The system of claim 2, further comprising a duplicate utility supply system disposed in the core, the first utility room, and/or the second utility room, the duplicate utility supply system for providing utilities to the first and second workspaces in case of a breakdown or to increase capacity. 4. The system of claim 1, wherein the first and second clean connect areas are fixedly coupled to the first and second movable manufacturing bays, respectively. 5. The system of claim 1, wherein the first and second clean connect areas are structures separate from the first and second movable manufacturing bays. 6. The system of claim 1, wherein the corridor is part of the core. 7. The system of claim 1, wherein the corridor extends away from the core. 8. The system of claim 1, wherein the corridor is spaced away from the core. 9. The system of claim 1, further comprising: a first entry point between the corridor and the first clean connect area and a first exit point between the first clean connect area and the first workspace, the first entry and exit points for controlling personnel access to the first workspace when the first movable manufacturing bay is removably coupled to the core; anda second entry point between the corridor and the second clean connect area and a second exit point between the second clean connect area and the second workspace, the second entry and exit points for controlling personnel access to the second workspace when the second movable manufacturing bay is removably coupled to the core. 10. The system of claim 1, wherein the housing comprises a holding area disposed away from the core where each of the first and second movable manufacturing bays can be positioned to undergo one or more of: (i) a cleaning operation, whereby the workspaces of the first and second movable manufacturing bays are cleaned, (ii) a change-over operation, whereby the facilities of the first and second movable manufacturing bays are altered, (iii) a qualifying, preparation and loading operation, whereby supplies and specific raw materials are loaded for the next manufacturing process, and (iv) a servicing operation on any of the facilities, utilities, or an HVAC unit associated with the bays. 11. The system of claim 1, wherein the core comprises one or more conduits removably coupled to each of the first and second movable manufacturing bays, the one or more conduits extending from the core and supplying the two or more utilities. 12. The system of claim 11, wherein each of the one or more conduits includes a line selected from the group consisting of: (a) an electrical line, (b) a data line, (c) an air duct, (d) a fluid line, and (e) a gas line. 13. The system of claim 12, wherein each of the one or more conduits includes a fitting removably coupling the first and second movable manufacturing bays to the conduits, each fitting being selected from a group consisting of: (a) threaded couplings, (b) quick connect couplings, (c) male/female connectors, (d) sanitary couplings, (e) sanitary fluid connectors, (f) steam-in-place connectors, and (g) air duct connectors. 14. The system of claim 1, wherein the first and second workspaces, the first and second clean connect areas, and the corridor is each maintained to satisfy one air classification in the following range of air classifications: Class 1 to Class 100,000. 15. The system of claim 1, further comprising a pressure differential between the first workspace and the first clean connect area and between the second workspace and the second clean connect area. 16. A method of manufacturing, comprising: providing a housing;providing a corridor extending within the housing;providing a core adapted to supply two or more utilities, wherein at least two of the two or more utilities are selected from the group consisting of (a) clean air, (b) clean water, (c) electricity, (d) oxygen, and (e) carbon dioxide;providing a first movable manufacturing bay including a first workspace accommodating a first facility;providing a second movable manufacturing bay including a second workspace accommodating a second facility;moving the first and second movable manufacturing bays to locations adjacent to a corridor within the housing;removably coupling the first and second movable manufacturing bays to the core;controlling personnel access to the first and second workspaces via first and second clean connect areas disposed between the corridor and the first and second workspaces, respectively, the first and second clean connect areas connected by the corridor;delivering the two or more utilities from the core to the first and second movable manufacturing bays;performing at least a part of a manufacturing process with the first facility of the first movable manufacturing bay; and performing at least a part of a manufacturing process with the second facility of the second movable manufacturing bay; and wherein controlling access to each of the first and second workspaces comprises:opening an entry point between the corridor and the respective clean connect area,closing the entry point after personnel has passed from the corridor into the respective clean connect area,opening an exit point between the respective clean connect area and the respective workspace after closing the entry point, andclosing the exit point after personnel has passed from the respective clean connect area into the respective workspace. 17. The method of claim 16, further comprising: providing a first utility room on the first movable manufacturing bay, the first utility room being sealed from the first workspace;providing a second utility room on the second movable manufacturing bay, the second utility room being sealed from the second workspace;delivering one or more first utilities to the first workspace from the first utility room; anddelivering one or more second utilities to the second workspace from the second utility room, whereinthe first and second utilities are selected from the group consisting of (a) clean air, (b) clean water, (c) electricity, (d) oxygen, and (e) carbon dioxide. 18. The method of claim 16, further comprising: providing a duplicate utility supply system in the core, the first utility room, and/or the second utility room; anddelivering utilities to at least one of the first and second workspaces with the duplicate utility supply system in the event of a breakdown or to increase capacity. 19. The method of claim 16, wherein performing at least a part of a manufacturing process with the first facility comprises bringing a first product to a first stage of manufacture; andperforming at least a part of a manufacturing process with the second facility comprises bringing the first product to a second stage of manufacture. 20. The method of claim 19, further comprising moving the first product from the first workspace to the second workspace after bringing the first product to the first stage of manufacture. 21. The method of claim 16, further comprising: selecting the first and second movable manufacturing bays from a plurality of available manufacturing bays prior to moving the first and second movable manufacturing bays adjacent to the corridor. 22. The method of claim 21, further comprising: decoupling the first movable manufacturing bay from the core;moving the first movable manufacturing bay away from the corridor;selecting a third movable manufacturing bay from the plurality of available movable manufacturing bays, the third movable manufacturing bay having a third workspace accommodating a third facility;moving the third movable manufacturing bay to the first location adjacent to the corridor that was previously occupied by the first movable manufacturing bay;removably coupling the third movable manufacturing bay to the core;controlling access to the third workspace via a third clean connect area disposed between the third workspace and the corridor;delivering the two or more utilities from the core to the third movable manufacturing bay; andperforming at least a part of a manufacturing process with the third facility of the third movable manufacturing bay. 23. The method of claim 16, wherein removably coupling the first and second movable manufacturing bays to the core comprises removably coupling each of the first and second movable manufacturing bays to one or more conduits extending from the core and supplying the two or more utilities, each of the one or more conduits including one or more lines selected from the group consisting of: (a) an electrical line, (b) a data line, (c) an air duct, (d) a fluid line, and (e) a gas line. 24. The method of claim 23, wherein removably coupling each of the first and second movable manufacturing bays to the conduits comprises removably coupling a fitting of each conduit to one of the first and second movable manufacturing bays, each fitting selected from the group consisting of: (a) a threaded coupling, (b) a quick connect coupling, (c) a male/female connector, (d) a sanitary coupling, (e) a sanitary fluid connector, (f) a steam-in-place connector, and (g) an air duct connector. 25. The method of claim 16, further comprising maintaining the first and second workspaces, the first and second clean connect areas, and the corridor to satisfy one air classification in the following range of air classifications: Class 1 to Class 100,000. 26. The method of claim 16, further comprising maintaining a pressure differential between the first workspace and the first clean connect area and between the second workspace and the second clean connect area. 27. The method of claim 16, further comprising: moving the first and second movable manufacturing bays to a holding area disposed within the housing away from the core; andperforming one or more of the following: (i) a cleaning operation, whereby the workspaces of the first and second movable manufacturing bays are cleaned, (ii) a change-over operation, whereby the facilities of the first and second movable manufacturing bays are altered, (iii) a qualifying, preparation, and loading operation, whereby supplies and specific raw materials are loaded into the workspaces for the next manufacturing process, and (iv) a servicing operation on any of the facilities, utilities, or an HVAC unit associated with the bays. 28. The method of claim 27, further comprising: sealing access points of the first and second movable manufacturing bays after performing the one or more operations and prior to returning the first and second movable manufacturing bays to other locations adjacent to the corridor within the housing.