Despite the clear advantages rapid microbiological methods (RMMs) provide over traditional ones, the pharmaceutical industry’s acceptance of them has been slow due in part to challenges encountered during validation coupled with a lack of global regulatory acceptance. These obstacles, along with potential bottlenecks and differences in regional health authority requirements, are valid concerns that need to be carefully assessed when considering an RMM.
It can be done, though. In this webinar we discuss the global implementation of the Celsis® ATP-bioluminescence system for non-sterile material testing using the validation approach according to USP <1223>, Ph. Eur. 5.1.6, and PDA TR33. Inge Van der Schoot, Senior Scientist at Janssen, presents information for decision-makers and technical scientific personnel seeking to learn more about:
Inge Van der Schoot
Janssen, Pharmaceutical Companies of Johnson & Johnson
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