Helium Technology
Helium leak testing is defined as the act of finding leaks in different types of enclosed or sealed systems using helium as a “tracer” gas and its concentration is measured as it escapes due to leakage. A vial, consisting of a container and elastomeric closure, is a good example of a package system. A vial is helium-filled & is subjected to vacuum. The amount of helium escaping that package is quantitatively measured and stated as a leak rate. Other examples include a prefilled syringe, a foil pouch or a cold form blister card. Each of these package types is designed and intended to keep the drug product contained while keeping out any detrimental environmental contaminants, such as debris, microorganisms, or even gases. The helium leak detection method has the sensitivity to evaluate each of them.
Low Temperature/Cold Storage Package Test Systems
Complex drug and biologic formulations have resulted in a continuous drive toward deeper cold storage in an effort to maintain product quality attributes, requiring life science companies to drive toward deeper cold storage. Since these products are often cell or gene or proteinaceous in nature, they are required to be stored at below -20°C, and also needs storage and distribution environment that include dry ice (~-78.5°C), or even liquid nitrogen (~-200°C).
