Helium leak rate measurements were quantitatively correlated to the probability of microbial
ingress for rubber-stoppered glass vials subjected to immersion challenge. Standard 10-mL …

Validation of a helium leak rate method for pharmaceutical container/closure integrity quality
assurance required the demonstration that this physical testing method was as good or …

The rational development of a physical test method to evaluate the microbial barrier
properties of sterile containers necessitates its correlation to microbiological exclusion. This …

A direct test method using helium leak detection was developed to determine microbial
ingress in parenteral vial/rubber closure systems. The purpose of this study was to establish …

The parenteral vial/closure seal interface is tested for leakage of gas, liquids, and
microorganisms. Gas leakage is determined using a bubble test, liquid leakage is detected …

The development of mass spectrometry-based leak detection for pharmaceutical container
integrity was undertaken to provide an alternative to microbial challenge testing. Standard …

To demonstrate maintenance of parenteral product sterility, container-closure integrity over
the shelf life of the product is critical. In the past, sterility testing has been used to ensure …

Sometimes, drug product for parenteral administration is stored in a frozen state (eg,–20° C
or–80° C), particularly during early stages of development of some biotech molecules in …

The sterility of drug products intended for parenteral administration is a critical quality
attribute (CQA) because it serves to ensure patient safety and is thus a key requirement by …

This article presents an overview on what helium leak testing is and how it can be
implemented as a test method to determine the tightness of packages for oral drug products …