Critical Factors to Consider when Choosing a Helium Leak Detection System for Cryogenic Storage Applications?
In the pharmaceutical and biotech industries, products such as vaccines, biologics, and cell therapies often require storage at ultra-low temperatures. Cryogenic conditions are essential to maintain the stability, efficacy, and shelf life of these sensitive products. However, extreme cold poses significant challenges to the integrity of packaging. Even the smallest micro-leak in a vial, prefilled syringe, or combination product can compromise sterility, reduce product effectiveness, or lead to regulatory non-compliance. Helium leak detection has emerged as the gold standard for evaluating container closure integrity (CCI) in cryogenic storage applications. Its ability to detect minute leaks makes it an indispensable tool for manufacturers striving to ensure product safety in ultra-cold conditions. Container Closure Integrity in Cryogenic Conditions Cryogenic storage subjects packaging materials to extreme thermal stress. Plastics, glass, and elastomers can shrink,...