Testing method
Sterility testing
For laboratory research use only. Not for human consumption.
- What it measures
- Whether viable microorganisms grow from the sample.
- How it works
- The sample is filtered through a membrane, or added directly to growth media, and incubated for at least 14 days in media that support bacteria and fungi. Growth means the sample is not sterile.
- Sample
- Multiple units from a batch, as the standard specifies by batch size.
- Result reported as
- Pass (no growth) or fail (growth) for the units tested.
- Limits
- A pass applies to the units tested and the batch they were sampled from, at the sample size used.
- Standards
- USP General Chapter <71> Sterility Tests; Ph. Eur. 2.6.1 Sterility
- On our reports
- 0 of 23 None of our published reports include sterility testing.