Deep-Cold & Ultra-Cold Stored Products
Drug products that need to be stored at extremely low temperatures are often referred to as ultra-cold or deep-cold products. These products require specialized storage solutions that maintain temperatures as low as -80 degrees Celsius to ensure their stability and efficacy. Some products require storage as low as -196 degrees Celsius. This is particularly important for vaccines, gene therapies, and other biologics that require a specific temperature range to remain effective. Proper storage and handling of these products are critical to maintaining their potency and ensuring patient safety.
CCIT for Deep-Cold and Ultra-Cold Stored Products
It is generally known that CCIT at extremely low temperatures can be challenging due to the potential for package deformation and seal failure caused by thermal contraction of the packaging materials. Pharmaceutical and biotechnology companies must work closely with regulatory agencies and testing laboratories to develop and validate appropriate CCIT methods for their product-package configurations, including those stored at extremely low temperatures.
Gateway Analytical is your go-to laboratory for CCIT of drug products stored at extremely low temperatures. Several regulatory agencies have reviewed our validated methods, and will work for your needs. Contact Gateway Analytical today to learn more about our approach to CCIT for storing ultra-cold or deep-cold products.
CCIT for Deep-Cold and Ultra-Cold Stored Products
Ensuring the integrity of drug products stored at cryogenic temperatures presents unique challenges, such as potential package deformation and seal failures due to thermal contraction. At Gateway Analytical, we specialize in Container Closure Integrity Testing (CCIT) for these ultra-cold conditions, offering validated methods approved by regulatory bodies.
