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EU24CEMAR1/SES310 - Hydrogen Peroxide Detection in Pharmaceutical Water

‐ Mar 13, 2024 12:15pm

• For clean room technologies decontamination using hydrogen peroxide (H2O2) is increasingly attractive to fulfill regulatory requirements. Several approaches are currently used, ranging from manual wipe disinfection to vapor phase hydrogen peroxide (VPHP) or automated nebulization sanitization (e. g. V-CRT®, Vetter Cleanroom Technology).
• To simulate the filling process in a specific cleanroom, technical runs with water for injection (WfI) are popular. Thus, the ability to detect traces of H2O2 in water is an important prerequisite to ensure a safe and reliable use of H2O2 for isolator or cleanroom decontamination.
• For this, we developed and validated a customized Amplex UltraRed assay, which is capable of quantifying H2O2 in WfI selectively, sensitively, accurately, precisely, and robustly. This assay is now used in process development and qualification using WfI in H2O2-decontaminated cleanrooms and isolators.
• Furthermore, we extended the use to developmental studies within process development by applying a platform design for multiple matrices including biological drug products.