Media
Press Release 10-02-09
PTI Micro Leak Testing Featured in PDA Journal
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 325/LV 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.
Please use the links below to read the abstracts of each article and the link to view and download the complete articles.
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 325/LV 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 325/LV is capable of detecting the slightest amount of vapor and gas release and 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).
For more information about PTI's VeriPac 325/LV Micro Leak Tester, contact Jesse Sklar, PTI Sales Manager: 914.337.2005; j.sklar@ptiusa.com. For media inquiries, please contact Michelle Wolf: 973.252.6039; m.wolf@ptiusa.com.