Sterilization Validation Planner Skill Purpose The Sterilization Validation Planner Skill supports sterilization process development and validation for medical devices, ensuring sterility assurance levels per ISO standards and FDA guidance. Capabilities - Sterilization method selection guidance - Bioburden determination protocol - Dose setting (ISO 11137) or half-cycle development - IQ/OQ/PQ protocol templates - Sterility test requirements - Parametric release guidance - Revalidation scheduling - Material compatibility assessment - Biological indicator selection - Process challenge device des…