Medical device manufacturers should perform appropriate validation studies in order to justify shelf life and transport stability of their devices. This includes also the validation of the packaging processes, like forming and sealing process of sterile barrier systems, pursuant to ISO 11607-2. In the course of a combined stability and packaging validation study, sterilized and final packed test devices are subjected to a thermal and regular ageing and to a transport simulation (pursuant ISTA or ASTM standards).
According to ISO 11607-1, the specific properties of medical devices and their packaging systems must remain stable during their shelf life. Afterwards, the products can be subjected to the various test systems in order to evaluate the performance of the packaging system (aseptic presentation and microbial barrier properties) as well as the performance of the containing medical device (functionality and biocompatibility).
The following test system may be applicable for the packaging system
- Dye test for seal integrity
- Peel test, Burst test, Bubble test
- Air permeability test and test for microbiological tightness
- Qualification of Packaging Materials
- Validation of the Forming, Sealing and Assembly Processes of Packaging for Terminally Sterilized Medical Devices
- Validation of Final Packaging Systems for Sterile Medical Devices
- Evaluation of the Shelf-Life of the Sterile Packed Medical Device
- Stressed medical devices are subjected to specific performance tests as well as to a biological evaluation test strategy
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