SPEAKER: Aseptic Processing Summit 2022 Pharma ED Resources | San Diego, CA
October 25, 2022 @ 8:00 am - October 26, 2022 @ 5:00 pm
Novatek is delighted to be part of the 2022 speaker line up at this year’s Aseptic Processing Summit in San Diego.
Hosted by Pharma ED Resources, we are proud to contribute to this year’s program with our presentation on: Future Trends in Total Contamination Control Strategies
The recent revision of Annex 1 encourages companies to develop a total contamination control strategy (CCS). A comprehensive strategy includes data from cleaning, environmental monitoring (EM), cleanroom qualification, media fills, and utility monitoring (UM). This enables expediting product development, improving quality, and reducing costs. Companies automating their trending often automate the elements of contamination control in hybrid systems, in isolation, or in data silos and this approach does not effectively facilitate root cause analysis or a comprehensive strategy for contamination control. As such, by the time the data from the various systems are correlated, and a trend is discovered, the underlying condition is likely to have changed.
Based on Annex 1, a total contamination control strategy is achievable through both automation tools and a centralized program. It starts with proper cleaning, proper determination of Maximum Safe Carryover (MSC), a routine cleaning program, EM, UM, and personnel monitoring, which completes the contamination control cycle. For this presentation, we discuss elements of a sound CCS, routine trends and data analysis that support a total CCS, and trending for investigational purposes including root cause determination. Furthermore, how to correlate or centralize trending of disinfectant qualification, effectiveness of cleaning, EM, UM, and personnel qualification
Presenter: Sheba Zaman
Mention Novatek with your registration and secure 10% off!
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