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The use of procedural or chronological controls to minimize potential interactions or contamination. It is usually applied in instances where supporting components, equipment, or product are closed and adequately protected from the surrounding environment. Such secondary separation mechanisms can vary widely and include storage of raw materials in different stages of quarantine; clean/dirty equipment areas; and general access paths/process areas. Whereas primary segregation controls the immediate quality of the process, secondary segregation measures are traditionally implemented to minimize the potential for human error. 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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