The pharmaceutical industry is seeing increased use of biologics, vaccines, cell therapies, and gene therapies that require storage at extremely low temperatures. Many of these products are stored at temperatures as low as -80°C or below to preserve their effectiveness throughout their shelf life. While these storage conditions are necessary, they can create challenges for the packaging system.
A vial that performs well at room temperature may not behave the same way when exposed to ultra-cold environments. Materials used in stoppers and seals can respond differently to freezing conditions, which may affect their ability to maintain a tight seal. Because of this, evaluating package integrity under actual storage conditions has become an important part of package development and validation.
What Is Container Closure Integrity (CCI) Testing?
Container Closure Integrity testing is performed to confirm that a vial and closure system can maintain a secure barrier against contamination. The test helps determine whether the package can protect the product from outside gases, moisture, and microorganisms throughout storage and distribution.
For sterile pharmaceutical products, maintaining package integrity is critical because even a small leak can impact product quality and safety.
Why Can Ultra-Cold Temperatures Affect Vial Integrity?
Helium leak detection is widely used to evaluate package integrity because it can identify extremely small leaks. The method measures the amount of helium escaping from a package, providing a direct indication of package performance.
This level of sensitivity is particularly useful for products stored under ultra-cold conditions, where very small changes in seal performance can have a significant impact over time.
How Does SIMS 1915+ Support Ultra-Cold Testing?
The SIMS 1915+ Helium Leak Detection System is designed to evaluate pharmaceutical packaging using highly sensitive leak-rate measurements. When equipped with Low-Temperature (LT) add on unit capability, the system can test vials at temperatures approaching -80°C.
This allows manufacturers to study package performance while the vial remains in the same temperature range used during storage. Testing under these conditions can reveal issues that may not be detected during room-temperature evaluations.
The information gained from these studies can support package development, closure selection, and overall confidence in package performance.
Conclusion
Ultra-cold storage plays an important role in protecting many modern pharmaceutical products, but it can also place additional demands on vial packaging systems. Testing package integrity at the temperatures products experience provides a more complete understanding of package performance.
By combining ultra-cold testing with helium leak detection technologies such as the SIMS 1915+ system, manufacturers can identify potential integrity issues earlier, make better packaging decisions, and help ensure that products remain protected throughout storage and distribution.
