Sterility testing established to USP <71>
Ergopharm has established sterility testing to USP <71>, using membrane filtration and demonstrating method suitability separately for each product rather than assuming a single approach fits all.
A sterility test is a limited instrument: it examines a sample of the batch, not the batch, and its statistical power to detect low-level contamination is modest. Its value comes from being one element of a sterility assurance system built on process design, environmental control and media fills — not from being treated as the thing that makes a batch sterile.
“The sterility test does not make a batch sterile. The process does; the test only looks.”
Method suitability testing is the step most easily skipped and the one that determines whether the test can work at all. Each product is challenged with specified organisms in the presence of the product to confirm that any antimicrobial property has been removed by the filtration and rinsing procedure; without that demonstration, a passing result could simply mean the product inhibited growth.
Testing is performed under unidirectional airflow in a dedicated area with its own environmental monitoring, so that a positive result can be investigated for laboratory origin with evidence rather than assumption.
Key facts
- Chapter
- USP <71> sterility tests
- Method
- Membrane filtration with product-specific suitability
- Confirms
- Antimicrobial properties removed by rinsing
- Context
- One element of sterility assurance, not a substitute for it
This notice describes Ergopharm’s own packaging and processes and how they follow published standards; it does not assert a specific national marketing approval.