Sterilization is, of course, a fundamental requirement in the medical field.
Here are four common reasons for failing a sterile barrier packaging validation test, presented by MDDI Online.
1. Oversealing packages: Applying extra heat in attempts to ensure a package is sealed can actually have adverse effects on the packaging. Too much heat can cause the materials to clarify, which can create small holes along the seal. Oversealing can be identified by curling or peeling seals and spotty patches.
2. Tears and pinholes on the package: Product packaging may tear and or puncture due to product movement in the package during shipping and distribution. To prevent this from potentially happening, packaging should be designed to keep all the parts within the package from moving, utilizing tools such as inner pouches, foam or trays, suggests the report. Package design should also account for the weight and shape of a device and the possibility for tears when devices are stacked in boxes, as well as how the product is placed within the shipping container.
3. Incompatible packaging for the product: The report indicates finding proper packaging for the device should be one of the first tasks during the product's design phase. Packaging pouches that are too big for a product and folding the pouch to fit dispenser boxes is not advised because it may potentially cause layer separation of the pouch, so it is important to make sure the sterile barrier system is of a proper size for the device.
4. Choosing packaging that are incompatible with sterilization: There is no "one-size-fits-all" approach when it comes to packaging products, as some packaging materials are not compatible with certain sterilization methods, according to the report. "It is important to verify that all materials in the package — both the SBS and protective packaging — are compatible with the sterilization method," according to the report.
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