Packaging forms an integral and very important part of all sterile medical devices. CE technical files and FDA submissions both require testing to ISO 11607-1: Packaging for terminally sterilized medical devices. This is why medical device packaging testing is so important.
MET offers comprehensive medical device packaging testing to support engineers with the validation of pharmaceutical containers, medical pouches and blisters, including shelf-life claims for all classes of devices. Our facilities include an ISO/IEC 17025 accredited laboratory, dedicated accelerated ageing chambers, and sophisticated burst, leak and tensile testing equipment. We also undertake transit simulation studies to assess the suitability of shipping cartons or single boxes to protect the products within. Find out more about the kinds of medical device packaging testing we offer below...
Accelerated ageing is used to simulate real shelf-life ageing and is, therefore, conducted to validate shelf-life claims. It is carried out according to ASTM F1980 - Standard Guide for Accelerated Ageing of Sterile Medical Device Packages. Read more about Accelerated Ageing...
Seal Strength & Integrity
All sterile medical devices require validation of their packaging. The sterile barrier must be shown to be effective throughout the product's claimed shelf-life. Examination of materials, processes and stability all contribute to demonstrating that the sterilisation process is effective and that sterility is maintained. Read more about Seal Strength and Integrity...
Shipping validation is mandatory for CE marked medical devices. MET's testing protocols follow the philosophy of ISO 11607-1 - Packaging for terminally sterilized medical devices. Requirements for materials, sterile barrier systems and packaging systems. Read more about Transit Simulation…
- ISO 11607 Sterile Barrier Validation – A Reminder
- ISO 11607 Requirements change for 2019 - New Packaging Standards for Medical Devices
- ISO11607 Medical Device Packaging
- Air Transport Validation of PFSs and Auto-injectors
- Can Shelf Life Testing Be Dissociated From Transit Testing?
- Accelerated Ageing for Medical Device Packs What Temperature?