Sterility
A test (for example USP <71>) for whether viable microorganisms grow from the units tested. It is different from a PCR or microbial-count screen.
What a sterility test is
A compendial sterility test, such as USP <71>, places the sample (directly or after membrane filtration) in growth media and incubates it for at least 14 days to see whether any living bacteria or fungi grow. "Pass" or "no growth" means none grew from the units tested, under those conditions.
Only a small number of units from a lot are tested, so a pass shows that contamination wasn't detected in that sample. It can't rule out contamination elsewhere in the lot.
Sterility vs microbial screening
Microbial screens answer different questions. PCR panels look for DNA from specific organisms, and can also pick up DNA from organisms that are no longer alive. Total aerobic microbial and yeast/mould counts (TAMC/TYMC) count colonies against a limit. Both are useful, but neither establishes sterility.
Sterility is also separate from endotoxin: a sterile sample can still contain endotoxin left by bacteria that are no longer alive.
How PeptideAudits reads this
- We show sterility only when the certificate prints a sterility result. Microbial screens appear as their own line and are never counted as a sterility pass.
- A certificate that doesn't mention sterility is "not reported", which is not a pass or a fail.
PeptideAudits doesn't test products; values come from certificates sellers publish. See the scoring methodology.
For research use only. Not medical advice.