Rapid sterility test systems in the pharmaceutical industry

Описание: Download the paper here: https://eu1.hubs.ly/H0nnQht0

The current compendial sterility test has a 14-day incubation time and is often the time-limiting step in the assessment and release process of pharmaceutical products.

Regulators have been encouraging the pharmaceutical industry to adopt innovative systems that are available on the market; however, it has taken considerable time before receiving the first approvals from various health authorities (including both EMA and FDA) for the use of an alternative and rapid sterility test for the release of sterile drug product lots.

This webinar describes a systematic 9-step approach to the evaluation, equipment qualification, validation, and deployment of alternative sterility tests which can be applied by pharmaceutical companies wanting to take advantage of the numerous benefits of alternative sterility tests.

Our speakers:
Sven Deutschmann, Head of gASAT, ‪@roche‬
Jonas van den Berg, Global Quality Manager, ‪@roche‬
Marja Claassen, Senior Microbiological Specialist, ‪@Merck‬

Chapters:
0:00 Webinar and BioPhorum introduction
4:15 9 step approach to implement rapid sterility test systems
21:15 Case study 1 - Respiration-based test
36:49 Case study 2 - ATP-bioluminescence-based test
50:12 Summary

#BioPhorum #FillFinish #Biopharma #RapidStertility