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Case Studies

Helium Leak Detection vs. MicroCurrent HVLD

The study that follows concludes that PTI’s HVLD technology is capable of detecting leaks down to the Maximum Allowable Leakage Limit (MALL) and arguably makes it one of the most sensitive leak test methods in the market. The Kirsch et al study that is often cited in papers laying out what the critical leak size is for parenteral products, confesses that there is still a potential for microbial ingress at a 1 micron level. This just raises the bar for product stability considerably as now the products seek a test sensitive enough to attain that standard of stability. However, if a defect is not detected and the product is put up for stability, it will undoubtedly cause much greater trouble that can lead to stability failure and major recalls.

MicroCurrent HVLD test method has the caliber to detect the most sensitive of unwanted ingressions. From a client's perspective, as long as a method identifies good samples defective samples, the client should only have confidence in the methods impact on their testing regime. PTI’s MicroCurrent HVLD is also capable of testing a wide range of product conductivities. This study proves the sensitivity and reliability of the results HVLDmc making it the forefront in the field of parenteral CCIT.

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