A Midwestern pharmaceutical company planned to upgrade their in-process checks for blister card integrity from a destructive blue dye leak test to a non-destructive, vision system-based leak test. The existing blue dye leak test required that all tested blister cards be discarded even if they passed. This caused the customer to lose money on good product. This production cost could be eliminated by switching to a non-destructive leak test. The new non-destructive leak testers that were purchased function by taking still images of blister cards under various amounts of vacuum. The non-destructive leak testers then analyze the changes in pixels between images at different vacuum levels to identify both gross holes and micron-sized holes in individual blister cavities.
Validation Planning – Performance Validation (PV) developed User Requirements that applied to several different blister card orientations. A risk assessment (FMEA) was performed to evaluate the impact and determine the testing requirements for the new non-destructive leak testers.
Commissioning and Qualification – Site Acceptance Testing was utilized to troubleshoot and establish a baseline for qualification testing of the non-destructive leak testers. Product nests were created for each type of blister card that would be tested in the non-destructive leak testers to establish that every blister is tested with the same positioning. PV was able to assist the customer in choosing the correct material and layout for the final product nest designs. Qualification was successfully performed for each different type of blister card using the product nest unique to that type of blister card. A Traceability Matrix was created to ensure all User Requirements were successfully tested.
The new non-destructive leak testers were successfully implemented as the blister card integrity in-process check. Performance Validation completed the project on time and within budget for the customer.
The new non-destructive leak testers save the customer’s money. The blister cards that successfully pass the leak test are able to be reintegrated to the line and packaged for consumer use. The existing blue dye leak test required the tested blister card be discarded even if it passed the leak test, meaning good product would go to waste. The new non-destructive leak testers provide the customer significant savings on packaging expensive medicines.
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Vice President, Division Director, Indiana
Performance Validation, Inc.