Recently PCL had a client reach out after experiencing failures in their Tyvek/ Film pouch. The failures were all consistent pinholes in the corner of the pouch. The client had reached an impasse with their packaging and did not want to waste any more time or money. In one week our team was able to identify the problem and fix it completely for the client. It is times like these where our team can come to the rescue!
Our team determined the failure was caused by the hazards associated with the parcel shipping environment. From there we developed a plan to run a two-part study comparing 5 new shipping alternatives to the current control group. We were able to source the needed materials for the study in only two days and begin the study right away.
The first part of the study was a DOE comparing the shipping alternatives and the control group. We put the samples through 1.5x ASTM D4169 Assurance Level 1 Schedules A, F, A. After running the samples through a transit simulation the packages were opened and each pouch was then subjected to a bubble leak test checking for sterile barrier integrity. If any failures were seen then the shipping alternatives were eliminated from consideration.
The second part was a confirmation study with the optimal shipping configuration found in part 1 using a sample size of N = 30. The packages were sent through normal transit testing sequences of ASTM D4169 Assurance Level 1 DC13 Schedules A,F,E,A. After the transit simulation, the packages were opened up and the pouches were again subjected to a bubble leak test. No failures were found thus confirming the new packaging alternative as the optimal choice. Finally the material numbers, supplier information and box drawings were sent to the client.
This entire process was able to be done in an efficient time of one week, saving our client the stress of packaging failure. PCL is here to be a resource to you and your company! To ask us a question or request a quote please click here. We promise to deliver results fast and work hand-in-hand with your team!