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Join Our Complimentary Webinar on
Wednesday, November 15, 2017 at 11:00 AM EST |
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Celsis® for Sterility:
Validating a 7-Day
Membrane Filtration
Sterility Test |
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Membrane filtration sterility tests remain one of the most crucial assays in the pharma production 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.
Join us as 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
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Have a scheduling conflict?
Sign up even if you can't make it, we'll share the recording after. |
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| Presenter Information |
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Stefan Gärtner, BSc
Head of Sterility Testing
Labor L+S AG |
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| Stefan Gärtner leads the Rapid and Alternative Microbial method validation group for Labor L+S AG. He has been involved in the development and validation of two rapid sterility test methods, and an alternative low endotoxin recovery assay. In March 2017, he was involved in the successful validation of Celsis AMPiScreen® technology to be used in routine analysis for batch release on sterile products at Labor L+S AG. |
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| Webinar Details |
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Time: 11:00 AM EST
Date: November 15, 2017
Duration: 1 Hour
Host: Charles River |
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