sterilization-validation-planner

# 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 design - Dose audit planning ## Usage Guidelines ### When to Use - Selecting sterilization methods - Planning validation activities - Developing validation protocols - Establishing revalidation programs ### Prerequisites - Product materials characterized - Packaging system defined - Bioburden data available - Sterilization facility identified ### Best Practices - Select method based on material compatibility - Validate worst-case configurations - Plan for ongoing process monitoring - Document all parameters thoroughly ## Process Integration This skill integrates with the following processes: - Sterilization Validation - Sterile Barrier System Validation - Design for Manufacturing and Assembly (DFMA) - Design Control Process Implementation ## Dependencies - ISO 11135 (EO) - ISO 11137 (radiation) - ISO 17665 (steam) - AAMI standards - Sterilization service providers ## Con...