Vacuum Decay Technology
Quality is assured with PTI testing solutions – the most sensitive, the most reliable.
Referenced in the new USP <1207> Chapter Guidance as a deterministic test method for container closure integrity testing and is an ASTM Test Method F2338 also recognized by the FDA as a Consensus Standard for Package integrity testing.
Vacuum decay is a test method that has been proven over decades and improved with new technology innovations. The test method is simple in principle and challenges container integrity based on fundamental physical properties. It involves drawing a vacuum on a package within a test chamber and monitoring the vacuum level for any decay, which would indicate a leak. The method established itself as a non-destructive replacement to the water bath leak test. It provides significant savings by not wasting products for a leak test and generates a fast return on investment for many products.
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).
VeriPac Vacuum Decay Technology
PTI’s VeriPac technology is the ideal non-destructive solution for container closure integrity determination for many package formats. The VeriPac Series will evaluate a wide variety of high-risk package applications and verify that the product meets regulatory and consumer integrity expectations.
The VeriPac product line systems inspect the package in a manner that is fast, repeatable and reproducible – providing reliable test results that are quantitative and deterministic. PTI’s Vacuum Decay technologies can detect package leaks and invisible defects using a method that is non-invasive, non-subjective and requires no sample preparation.
The criteria for selecting the appropriate VeriPac model is based on the type of package and leak test sensitivity desired. Configurations can be optimized and customized according to each application.
New Advances in Vacuum Decay Technology
PTI's advances in high vacuum testing and has redefined what is achievable with a vacuum-based leak detection technology. The next generation PERMA-VAC technology addresses vacuum decay leak detection at the very core of the physical test measurement, controlling the test system volume and maximizing the SNR between good and defective samples. The technology provides the VeriPac Series with the most stable test measurement ever achieved through vacuum decay. The technology reduces the baseline measurement for good samples and amplifies the test result for defective samples. 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. The PERMA-VAC technology improvements make the VeriPac line of test systems the most sensitive
vacuum-based leak tests available on the market.
We, at CCIT, always ensure that we continuously improve our process and always use cutting edge technology for our systems. Our latest VeriPac 400 series can be used in various applications like stability studies, clinical trials, quality assurance testing and production statistical process control.