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Packaging Testing
Medical Device Packaging Testing
Packaging forms an integral and very important part of all sterile medical devices. CE technical files and FDA submissions both require testing to ISO 11607-1:2006 Packaging for terminally sterilized medical devices.
MET offer comprehensive support to assist engineers with the validation of medical pouches and blisters and shelf-life claims for all classes of devices. Our facilities include an ISO 9001-2008 accredited laboratory, dedicated accelerated ageing ovens and sophisticated burst, leak and tensile testing equipment. We also undertake transit simulation studies to assess the suitability of shipping cartons or single boxes in protecting products within.
Accelerated Ageing
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. Accelerated Ageing read more...
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. Seal Strength and Integrity read more...
Transit Simulation
Shipping validation is mandatory for CE marked medical devices. MET's testing protocols follow the philosophy of ISO 11607-1:2006 Packaging for terminally sterilized medical devices. Requirements for materials, sterile barrier systems and packaging systems. Transit Simulation read more...
Medical Device Testing Standards
MET has expertise in testing to a wide range of standards, here are just a few of them... Medical Device Testing Standards read more...
