Points to Consider for Sensitivity to Oxidation by Peroxide (single user digital version)

PDA's Points to Consider for Sensitivity to Oxidation by Peroxide addresses aspects to consider in the design, development, processing, instrumentation, materials, and equipment specific to issues with products sensitive to oxidation when exposed to H₂O₂. This document primarily applies to isolator systems, where vapor phase hydrogen peroxide (VPHP) or vaporized hydrogen peroxide (VHP) is used to decontaminate the system. Current issues and approaches to consider for an oxidation-sensitive product are summarized, and industry experts outline best practices for developing a manufacturing process for drug product.

General topics related to sterility assurance and development of the VHP decontamination process are not included, nor is cycle development from a sterility standpoint. General isolator considerations are addressed in PDA Points to Consider on Aseptic Processing of Sterile Pharmaceutical Products in Isolators.

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Format: PDF (1 file 1.99 MB)

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