CCIT for Cryogenically-Stored Products
Some drug products must be stored at cryogenic temperatures, which means temperatures below -150 degrees Celsius. These are typically biologics, such as stem cells and vaccines, which are extremely sensitive to temperature fluctuations. Cryogenic storage is the most effective way to maintain the stability and efficacy of these products. Cryogenic storage involves using liquid nitrogen or other cryogenic gases to support the extremely low temperatures required for these products. Specialized containers and equipment ensure that the products remain at the appropriate temperature during storage and transport. Proper storage and handling of these products are critical to maintaining their potency and ensuring patient safety.
CCIT Study: Cryogenically-Stored Products
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 cryogenically stored products. We recognize that CCIT at cryogenic temperatures demands unparalleled precision, considering the potential for package deformation and seal failure due to extreme cold. 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.
Deep Cold, Deeper Expertise.
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. Contact us today to discover how we can support your cryogenic CCIT needs with our validated and trusted methods.
