packaging-validation-planner

# Packaging Validation Planner Skill ## Purpose The Packaging Validation Planner Skill supports sterile barrier system development and validation per ISO 11607, ensuring package integrity and shelf life determination for medical devices. ## Capabilities - Packaging material qualification guidance - Seal strength optimization protocols - Package integrity test selection - Accelerated aging study design (ASTM F1980) - Distribution simulation planning (ISTA protocols) - Shelf life determination - Packaging validation protocol templates - Peel testing methodology - Visual inspection criteria - Worst-case condition identification - Stability protocol development ## Usage Guidelines ### When to Use - Developing packaging systems - Planning validation activities - Designing aging studies - Establishing shelf life claims ### Prerequisites - Package design finalized - Sterilization method selected - Distribution conditions defined - Shelf life targets established ### Best Practices - Validate worst-case configurations - Use appropriate aging factors - Include distribution simulation - Plan for real-time aging correlation ## Process Integration This skill integrates with the following processes: - Sterile Barrier System Validation - Sterilization Validation - Design Control Process Implementation - Design for Manufacturing and Assembly (DFMA) ## Dependencies - ISO 11607 standard - ASTM F1980 guidance - ISTA test protocols - Packaging test laboratories - Environmental chambe...