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If media fills are incubated for an extended period is that sufficient to extend the BUD?

April 26, 2017bud EXTEND extended fills incubated media period sufficient

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If media fills are incubated for an extended period is that sufficient to extend the BUD?

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No. BUD applies to chemical and physical stability. Extended incubation of media fill test specimens is irrelevant to extending BUD and sterility storage times for a particular CSP microbial contamination risk level. Extended BUDs require evidence from stability-indicating chemical assays, and extended sterility storage times require sterility testing evidence.