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2022 ISPE Annual Meeting & Expo

SES108 - Concurrent Session: Quality and Regulatory Challenges


Oct 31, 2022 1:45pm ‐ Oct 31, 2022 3:15pm


Description

The use of Hydrogen Peroxide (H2O2) for decontamination of equipment and/or medical devices has traditionally relied on initial validation and periodic revalidation to check the efficacy of the process with biological indicators (BIs). Enzyme Indicators (EIs) are an innovative rapid tool for providing instant and quantitative feedback, of H2O2 efficacy by providing real time quantifiable data when applied to cycle optimization, qualification, continuous process monitoring and trouble-shooting.

This session will provide an overview of the technology and how it can be used throughout the validation phases whilst showcasing data from various pharmaceutical companies and their collective suggestions on applications and future usage of EIs. Presentations will demonstrate the EIs ability to aid, clarify and provide additional confidence of H2O2 cycles and also share details of how a working group has been established to provide a consistent approach to industry application of H2O2 decontamination including the use of EIs.

Speaker(s):

  • Peter G. Millili, PhD, Senior Director, Manufacturing Science and Technology, Bristol-Myers Squibb

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