By Oliver Stauffer
This study shows that PTI’s HVLDmc can in fact detect 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, dictates that there is still a potential for microbial ingress at the 1 micron level. Many clients may be concerned with that high a level of sensitivity, potentially detecting defects that were otherwise not detectable before. 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.