PCL CASE STUDY: Root Cause Analysis of Post Transit Integrity Failures

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PCL was contracted by a client for root cause analysis of post-transit integrity failures.  To determine the cause of the failures, a transit feasibility study was run with visual inspection after each schedule of transit conditioning.  Based on the results of the inspections, it was determined that drops (rather than compression or vibration) were causing seals to rupture.

PCL came up with three different design concepts intended to protect the trays during drop testing.  These concepts included corrugated end caps, a corrugated “nest” surrounding the tray, and lining the shipper box with open cell foam.  PCL worked with local vendors on the designs to quickly acquire prototypes for testing.

Each concept was tested at 1.5 times drop height, with visual inspections being performed after a full set of 10 drops on various faces, edges and corners.  Samples were tested to failure, meaning that the drops and visual inspections were repeated until a failure was observed.  The nest and foam concepts performed the best, surviving three full rounds of drops from the increased height.  The endcap prototype experienced a failure after the second round of drops.

The final design concepts, pricing and test results were then shared with the client, who opted for the nest concept.  The new design was subjected to full transit conditioning, with all samples passing visual inspection and package integrity testing.  The nest design affected the shipping configuration only, meaning that previous validation work (IQ, OQ, and PQ) were unaffected by the change.

Our Engineering team features a strong medical device background focused manufacturing and testing.  We can ensure the testing our clients require is appropriate for the type of device and meets the required regulatory standards.  If a failure occurs in the lab, our engineering team can analyze the failure and recommend a path forward.

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