Julian Stauffer, COO of PTI, recently gave a presentation on The New Evolution in Vacuum Decay Leak Testing Technology at the PharmaEd Prefilled Syringe Conference in Philadelphia, PA.
The presentation reviewed vacuum decay technology, how it works and what has made it a lasting solution for the pharmaceutical industry for package leak detection and container closure integrity testing. Recent technology advances of the new evolution in vacuum decay were discussed and how these new advancements will serve and benefit the pharmaceutical industry moving forward.
Vacuum decay is a test method that has been proven over decades and improved with new technology innovations. Vacuum decay has been verified that it is the most practical and sensitive vacuum-based leak test method. The test measurement creates a reliable and accurate quantitative result and a pass or fail determination. The standard vacuum decay leak test method (ASTM F2338), developed using PTI's VeriPac instruments, is recognized by the FDA as a consensus standard for container closure integrity (CCI) testing. The test method is listed in ISO 11607 and referenced in the United States Pharmacopeia Chapter on CCI (USP Chapter 1207).
Vacuum decay's acceptance as a regulatory tool is evident, and continued development optimizes the technology so that it can do more, do it better and perform it faster. PTI’s next generation of improvements are not an incremental improvement, but rather foundational shifts in how the technology will serve the pharmaceutical industry. The PERMA-VAC technology is geared towards detecting leaks in the MALL range for parenteral packaging and can also be applied to flexible and semi flexible package formats.
Click below to view the presentation slides.