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A recent issue of the PDA Journal of Pharmaceutical Science and Technology featured two articles about PTI's VeriPac vacuum decay micro leak tester. Although vacuum decay leak testing has been widely used in many industries, the articles discuss significant case studies and provide statistical data that further demonstrates vacuum decay's usefulness as a non-destructive leak test method for pharmaceutical packaging.

The results of these studies are of tremendous value to the pharmaceutical industry, especially in the field of container closure integrity for syringes, vials, and ampoules. The VeriPac vacuum decay method was found to be more sensitive, more reliable and provides quantitative results that are not subject to human interpretation. Vacuum decay detected all defects = 5.0 µm with no false positives and no false negative results. The VeriPac leak tester can be incorporated into protocols at any point in the handling process since it is non-destructive, non-invasive and requires no sample preparation. Applications for this technology include stability studies, clinical studies, quality assurance testing and production statistical process control (SPC).

Part 1 of the article details the ASTM F2338-09 (Standard Test Method for Non-destructive Detection of Leaks in Packages by Vacuum Decay Method) Precision and Bias Studies performed in 2008 to expand this method's scope to include rigid, nonporous packages completely or partially filled with liquid. Tests were performed using pre-filled syringes and included both a gas leak test and liquid leak test.

Vacuum Decay Container/Closure Integrity Testing Technology. Part 1. ASTM F2338-09 Precision and Bias Studies
Heinz Wolf, Tony Stauffer, Shu-Chen Y. Chen, Yoojin Lee, Ronald Forster, Miron Ludzinski, Madhav Kamat, Phillip Godorov, and Dana Morton Guazzo PDA J Pharm Sci Technol 2009;63 472-488

Part 2 of the article details a case study comparing the ISO & USP dye ingress integrity test methods to PTI's vacuum decay technology for leak detection of glass prefilled syringes.

Vacuum Decay Container/Closure Integrity Testing Technology.
Part 2. Comparison to Dye Ingress Tests Heinz Wolf, Tony Stauffer, Shu-Chen Y. Chen, Yoojin Lee, Ronald Forster, Miron Ludzinski,
Madhav Kamat, Brian Mulhall, and Dana Morton Guazzo PDA J Pharm Sci Technol 2009;63 489-498

SOURCE: PTI Inspection Systems