Packaging validation and stability studies for medical device transport and storage:

Ingenes Packaging validation and stability studies for medical device transport and storageinclude validation of the packaging processes, such as the 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 both thermal or accelerated and regular aging and to 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. Afterward, products can be subjected to 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 systems may be applicable for the packaging system:

• Dye test for seal integrity,
• Peel test, burst test and 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.