Membrane filtration sterility tests remain one of the most crucial assays in the pharma product cycle. With lengthy incubation periods, the risk of false negatives, and additional regulatory scrutiny revolving around the assay, many QC labs can clearly see the need for an alternative rapid method.
In this webinar, Stefan Gärtner discusses how Labor L+S AG successfully validated a 7-day membrane filtration sterility test using existing protocols and Celsis AMPiScreen® technology.
Learn more about:
- Requirements for validating alternative microbial test methods
- Statistical analyses used
- Product-specific method suitability tests
- Regulatory acceptance processes
- Stefan Gärtner, BSc, Head of Sterility Testing, Labor L+S AG