In order to test the suitability of sterile packaging for medical components, it is possible to complete the physical with microbiological tests. This is done after accelerated and real aging. This allows the sterility of the product to be proven over time.
The tasks of packaging a medical component that is sterilized are physical protection but also the preservation of sterility until use and the aseptic delivery of the product. Once the sterile barrier has been sealed, it is necessary to carry out physical tests on the packaging to check its effectiveness and the quality of the seal. The requirements and methods are described in EN ISO 11607-1 &-2.
It is easy to understand that the physical tests carried out only on the seal (tensile test, leak test, size of seal, etc.) cannot necessarily guarantee sterility up to the defined shelf life date.
A systematic approach to validation
In order to guarantee the integrity and stability of the sterile barrier over time, it is essential to consider the entire packaging, including the medical component and the environmental conditions.
Therefore, it is recommended to test the physical ones with microbiological tests after real and accelerated ageing. The effectiveness of the sterile barrier can be evaluated using two microbiological test methods.
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