4 common failure points of sterile barrier packaging validations

1. oversealing. applying too much heat will melt tyvek and fuse it to the film layer, causing a clarification of the materials. as sealing temperatures increase, the amount of overseal and clarification damage also increases, becoming more visible, in turn.&nbsp 2.&nbsptearspinholes. &nbsptears and pinholes are frequently a result of the product&rsquos natural movement in relation to the package during shipping and distribution. packaging should be designed to keep all parts of the device from moving and shifting within the package.&nbsp 3 packaging configuration. an initial investment in finding suitable packaging from the onset is fundamental to the success of a validation. during the product&rsquos design phase, it is important to confirm that the product and packaging are compatible.&nbsp 4. compatibility with sterilization. you may be tempted to use a onesizefitsall approach to packaging for your portfolio of products. but you need to consider the expected sterilization method for the product as part of the packaging design. sourcehttpwww.mddionline.comblogdevicetalk4commonfailurepointssterilebarrierpackagingvalidations091214