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 …

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 …

The relationship between a liquid tracer package leak test (Mg ion ingress) and microbial
immersion challenge test was demonstrated by direct and indirect correlation techniques …

Utilization of prefilled syringes as a preferred container closure system for biologics has
been increasing [1]. As a primary container closure system, prefilled syringes must provide …

The assurance of sterility of a parenteral drug product, prior to any human use, is a
regulatory requirement. Hence, all strategies related to container closure integrity (CCI) must …

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 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 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 …

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

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 …