Packaging Validation
MDR Reference: Annex II, Section 6.1.4; Annex I GSPR 11.5
BPG Rev.4 Reference: Section 6.1.4
Service Item ID: mdr_sec06_packaging
Applicability: Sterile devices, packaged devices requiring barrier integrity
Overview
Packaging validation demonstrates that the sterile barrier system (SBS) and protective packaging maintain device sterility and physical protection throughout the claimed shelf life and distribution cycle. The primary standard is the EN ISO 11607 series.
Current Standard: EN ISO 11607
EN ISO 11607-1:2020+A1:2023 (packaging requirements) and EN ISO 11607-2:2020 (validation requirements for forming, sealing, and assembly processes):
Harmonisation status: ISO 11607 is not listed as a harmonised standard under MDR as of 2026. Compliance must be independently demonstrated without presumption of conformity. However, it remains the universally accepted state-of-the-art standard.
Key Deliverables
| Document | Description |
|---|---|
| Packaging BOM | Materials, specifications, suppliers for all packaging components |
| Seal Strength Validation | Protocol and report for peel/burst testing |
| Package Integrity Testing | Dye penetration, bubble leak, or visual inspection |
| Distribution Simulation | ASTM D4169 or ISTA protocol testing |
| Accelerated and Real-time Aging | Shelf-life testing of the packaging system |
| Worst-case Configuration | Justification for test article selection |
Validation Scope
Forming, Sealing, and Assembly (ISO 11607-2)
- Process validation (IQ/OQ/PQ) for sealing equipment
- Seal parameter window determination (temperature, pressure, dwell time)
- Worst-case testing at process limits
Sterile Barrier System (ISO 11607-1)
- Microbial barrier properties
- Seal strength and integrity
- Material compatibility with sterilisation process
- Material compatibility with device (no adverse interaction)
Distribution Testing
- Drop, compression, vibration per ASTM D4169 or ISTA
- Climate conditioning if applicable
- Post-distribution sterile barrier integrity verification
GSPR Mapping
| GSPR | Requirement |
|---|---|
| 11.5 | Safe storage, transport, and conditions |
| 6.6 | Shelf life supported by appropriate testing |
Related Topics
- Sterilisation Validation -- Sterile barrier maintains post-sterilisation sterility
- Stability & Shelf-life -- Packaging aging is part of shelf-life validation