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Concurrent Session: Decontamination and Single-use Systems

‐ Mar 7, 2023 12:30pm

This session will explore the advancements and innovations in decontamination and single-use technology to comply with the newly revised EU GMP Annex 1. New gaseous hydrogen peroxide (H2O2) with lower percentages of peroxide have been shown to lessen downtime from off gassing following treatment and have improved material compatibilities. Furthermore, the development and validation of H2O2 cycles continue to see advancements with the use of enzyme indicators. The understanding of enzyme indicators and their possibilities continues to grow as more data about the influence of temperatures, storage conditions, timing of the reading, and degree of inactivation is gathered through experimental results. Lastly, the revised EU GMP Annex 1 maintains the importance of cross-contamination prevention and operator risk. Continued research and advancements in single-use technology show the advantages single-use presents for product loss and filling accuracy.

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