Optimization of a bio-decontamination process: atomized hydrogen peroxide new cycle development method
Risk-based cycle development, considering not only the required decontamination level but the type of load and cycle total time
Atomized hydrogen peroxide requires a methodical positioning of the load to achieve a correct decontamination. According to GMP regulations, it is recommended to develop a recipe for each load and register every load pattern used.
Changes on load pattern can reduce efficacy or efficiency in the cycle. To ensure effectiveness in bio-decontamination cycles, a specific cycle development for the target load is required.
This article details how a cycle development is performed in a case when a change of production procedure takes place introducing non-validated loads inside an isolator.
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