The purpose of the package strength testing procedures is baseline both pouch vendor and customer seals and later repeated to screen for undesirable changes negatively affecting the Sterile Barrier Systems (SBS) ability to maintain stability and the packaging system's ability to adequately protect the product. Note also that these are both quantitative tests.
The strength tests consist of the seal peel test according to ASTM F88 / F88M, and the burst test conducted according to ASTM F1140 / F1140M or ASTM F2054 / F2054M. Both are attempting to measure the strength and consistency of the seals on a pouch or tray containing a medical device, but have very different approaches. For the peel test, a 1 inch width section of the seal is pulled apart and the force of the seal strength is measured and plotted. In the burst test, the primary package is inflated with air pressure at a constant rate until the package fails or bursts. The fundamental purpose of both approaches is to prove the SBS hasn't changed after sterilization, transit and storage.
Typical Sample Size
Typical sample sizes range from 30 to 60 samples.
10 free Test Samples
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