USP <71> Testing — Laboratories & Overview
USP <71> is the compendial chapter for sterility testing of pharmaceutical articles, describing culture-based procedures and method suitability expectations.
When is it used?
- Sterile product release testing
- Sterilisation validation programmes
- Investigating suspected sterility failures
Sample considerations
- Sample quantity relates to batch size and container volume as set out in the chapter.
- Method suitability (bacteriostasis/fungistasis) work is normally required first.