name
packaging-validation-planner
description
Sterile barrier system validation planning skill per ISO 11607
allowed-tools
["Read","Write","Glob","Grep","Edit","Bash"]
metadata
{"specialization":"biomedical-engineering","domain":"science","category":"Sterilization and Manufacturing","skill-id":"BME-SK-027"}
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 chambers
Configuration
packaging-validation-planner:
package-types: