Important note for clients submitting injectable samples:
Microarray and PCR-based screens are not USP <71> sterility tests, and they are not recognized as compendial sterility methods under USP <71>, <72>, or <73>.
USP <71>, <72>, and <73> remain the official compendial sterility tests for injectable products.
Rapid or molecular methods may have research or screening value, but they should not be represented as USP sterility testing unless they fully meet the applicable USP compendial requirements and validation expectations.
Always ask the lab: “Is this a true USP compendial sterility test (<71/72/73>), or a non-compendial rapid method?”
Your compliance depends on clear answers.
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