Medical device packaging must protect product integrity and prevent damage throughout the entire supply chain. Strict health and safety regulations make compliance with packaging validation standards essential. CTL Biotec’s packaging validation process complies with ISO 13485 and ISO 11607 sterilized medical devices Packaging standards:
- ISO 11607-1:2019 (Part 1: Requirements for materials, sterile barrier systems, and packaging systems)
- ISO 11607-2:2019 (Part 2: Validation requirements for forming, sealing, and assembly processes)
All sterile barrier system packaging processes must be validated, demonstrating barrier integrity over the product’s intended shelf life and during transportation. CTL Biotec follows a standardized validation approach that meets global quality requirements (ISO, ASTM, and ISTA compliance). Our validation experts provide all necessary tests, standards advice, and complete validation reports ready for submission.
Tests for terminally sterilized medical device packaging include:
- Package integrity test
- Sealing strength test (ASTM F88/F88M:2023)
- Dye penetration test (ASTM F3039:2023)
- Accelerated aging test
- Shipping Validation (ISTA 3A etc).
- Customized testing for specific customer needs