Medical & Pharmaceutical Package Validation
Ensuring the safety, sterility, and integrity of medical and pharmaceutical packaging is critical to protecting patient health and meeting global regulatory requirements. Our validation services are designed to support manufacturers of sterile medical devices, pharmaceuticals, and biologics through every stage of the packaging lifecycle.
We validate packaging systems in accordance with ISO 11607-1 and ISO 11607-2, the globally recognized standards for terminally sterilized medical devices. This includes:
- Material qualification and compatibility
- Seal strength and integrity testing (ASTM F88, F1140)
- Microbial barrier verification
- Visual inspection and dye penetration testing (ASTM F1929)
To ensure packaging maintains sterility over time, we conduct:
- Accelerated aging using ASTM F1980 to simulate long-term storage conditions
- Real-time aging for shelf-life confirmation
- Post-aging performance evaluations to verify continued barrier integrity
Packaging is exposed to a range of environmental stresses during distribution. We simulate these conditions to ensure durability and sterility:
- Temperature and humidity cycling
- Vacuum and altitude testing (ASTM D6653)
- Rough handling and vibration simulation (ASTM D4169, D7386)
We replicate real-world shipping and handling scenarios to validate packaging performance:
- Drop testing (ASTM D5276)
- Compression and vibration testing (ASTM D642, D999)
- Bubble emission leak detection (ASTM F2096)
Our testing protocols align with FDA regulations (21 CFR 820.130) and labeling requirements (21 CFR 801), helping you meet compliance for:
- Class I, II, and III medical devices
- Unique Device Identifier (UDI) labeling
- Sterilization method indicators