USP General Chapter 71 (revision 1)
Old revision·09:00, 30 Oct 2024·TechnicianTeal
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| USP General Chapter 71 | |
|---|---|
| Title | Sterility Tests |
| Status | Mandatory where referenced |
| Methods | Membrane filtration; direct inoculation |
| Topic infobox · conventions | |
USP General Chapter 71, titled Sterility Tests, prescribes the media, incubation conditions, sample quantities and method-suitability procedures for demonstrating that a sample yields no microbial growth. It is a mandatory chapter where a monograph or regulatory requirement invokes it.[1]
The chapter is explicit that a passing result is not proof of sterility of a batch. Sterility assurance derives from process design and validation; the compendial test is a final check with limited statistical power, and the chapter's companion informational chapter on sterility assurance says so at length.[2]
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