In simple terms, Helium technology is the act of finding leaks in some type of enclosed or sealed system using helium as a “tracer” gas, and measuring its concentration as it escapes due to leakage. A package system such as a vial, consisting of a container and elastomeric closure, is a good example. A helium-filled vial is subjected to vacuum, and the amount of helium escaping that package is quantitatively measured and reported 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. Helium leak detection has the sensitivity to evaluate each of them.
Benefits of Using Helium Based Testing Methods:
- Helium is a highly sensitive leak test technology, specifically designed for the detection of extremely small leaks and tortuous pathways which is not possible with any other leak testing methods.
- Using a high vacuum technique, the leak test thresholds can be set down as low as 1×10-10 mbar L/sec, a sensitivity level allowing unique comparisons between package components, materials selection, and production controls, for example.
Over the past 20 years, regulatory agencies worldwide have increasingly focused on container closure integrity (CCI) issues. This shift has led to the adoption of advanced technologies that offer more effective test methods, replacing traditional sterility testing. The primary goal is to ensure that contaminants, such as gases (especially reactive ones), microorganisms, or any other foreign substances, cannot breach the protective barrier of a closed system. These contaminants could otherwise compromise the enclosed drug product or the sterility of the system.
The Packaging Technologies & Inspection (PTI) team possesses unparalleled expertise and knowledge in the Container Closure Integrity Testing (CCIT) market. We are dedicated to helping you understand and comply with stringent regulatory requirements for your container and package system testing needs.
PTI's team brings a level of experience and knowledge to the Container Closure Integrity testing market that is unmatched. They are committed to assisting and ensuring that you understand and meet the strict regulatory requirements when it comes to your container and package system testing needs.
