ASTM F2338-09 Standard Test Method for Nondestructive Detection of Leaks in Packages
by Vacuum Decay Method is applicable for leak-testing rigid and semi-rigid non-lidded trays; …

Part 1 of this series demonstrated that a container closure integrity test performed according
to ASTM F2338-09 Standard Test Method for Nondestructive Detection of Leaks in …

A leak test performed according to ASTM F2338-09 Standard Test Method for
Nondestructive Detection of Leaks in Packages by Vacuum Decay Method was developed …

The sensitivity, reliability, reproducibility and ease of use of the WILCO LFC package
integrity test method was evaluated by preparing and testing a series of rubber-stoppered …

In reaction to the limitations of the traditional sterility test methods, in 2008, the US Food and
Drug Administration issued the guidance “Container and Closure System Integrity Testing in …

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

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 …

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 …

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 …

Container closure integrity (CCI) is a critical factor to ensure that product sterility is
maintained over its entire shelf life. Assuring the CCI during container closure (C/C) system …