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A new issue of the PDA Journal of Pharmaceutical Science and Technology is now available online. This issue features two articles about PTI's VeriPac vacuum decay micro leak tester.

• 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.
• Part 2 of the article includes 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 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
http://journal.pda.org/cgi/content/abstract/63/5/472

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
http://journal.pda.org/cgi/content/abstract/63/5/489

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 micro 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).

SOURCE: PTI Inspection Systems