Case Study

Comparison Of Helium vs. Microcurrent HVLD Leak Testing Technologies

By Oliver Stauffer

Comparison Of Helium vs. Microcurrent HVLD Leak Testing Technologies

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.


Get unlimited access to:

Trend and Thought Leadership Articles
Case Studies & White Papers
Extensive Product Database
Members-Only Premium Content
Welcome Back! Please Log In to Continue. X

Enter your credentials below to log in. Not yet a member of Med Device Online? Subscribe today.

Subscribe to Med Device Online X

Please enter your email address and create a password to access the full content, Or log in to your account to continue.


Subscribe to Med Device Online

PTI Packaging and Inspection Systems