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 …

Vial “fogging” is a common observation in lyophilized biological products and has been
reported in the pharmaceutical industry. In addition to unappealing appearance, severe …

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 …

USP< 1207.1> Section 3.5 states that “A deterministic leak test method having the ability to
detect leaks at the product's maximum allowable leakage limit is preferred when …

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 …

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 …

Aseptic packaging is employed by food and beverage industries to maintain sterility for
prolonging product shelf life without refrigeration. In a fully integrated fast-moving consumer …

Container closure integrity (CCI) testing is required by different regulatory authorities in
order to provide assurance of tightness of the container closure system against possible …

The application of a head space analyzer for oxygen concentration was examined to
develop a novel ampoule leak test method. Studies using ampoules filled with ethanol …

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 …