Sterility testing | USP 795 & 797 revisions

The quality attribute “sterile” attribute describes a condition that “cannot be applied to actual items labeled as sterile because of irresolvable limitations in testing” (USP <1211> Sterility Assurance). These irresolvable limitations are statistical and biological.  While the attribute “sterile” applies to a complete absence of living organisms (an absolute condition), there is no test that can detect all living organisms, and the complete absence of living organisms could only be tested if the entire production of the preparation were tested (and thus destroyed).

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