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The use of physical facility design elements to define the basic organization of the biopharmaceutical plant design and establish environmentally controlled work areas around specific steps of the process, e.g., the establishment of classified areas. It provides distinct environmental protection for the process/product from contamination, and is traditionally accomplished by the designation of dedicated areas, staff, and supporting mechanical systems. FDA CBER suggests discussion of segregation concepts more specifically, addressing physical segregation or procedural segregation.
Publication Source: ISPE Baseline® Guide, Vol. 6: Biopharmaceutical Manufacturing Facilities
Publication Date: 2004
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