Cold Chain Validation is a critical step in meeting regulatory requirements, ensuring that your product’s temperature is maintained, as labeled, for the duration of the shipping process. Failing to maintain the correct holding temperature for consumer products can lead to a slew of product safety and integrity issues including textural degradation, changes in physical appearance, or microbial growth. An unbroken cold chain is especially imperative in elongating the shelf life and ensuring the efficacy of products such as pharmaceutical drugs, medical devices, and biologics. Non-compliance and a broken cold chain can result in irreconcilable consequences in quality, safety, and public health.
What Is Cold Chain Validation?
Cold Chain Validation is achieved under thoroughly controlled conditions and ultimately confirms that a process delivers results that meet a predetermined set of acceptance criteria. There are two key critical variables involved in heat transfer that should be considered when designing cold chain packaging: time and temperature differential. In any particular distribution process, if there is exercised control over both the length of transit and the external temperature of the distribution environment, cold chain validation would be dependent upon the specific product requirements and the thermal technology used.
How We Validate Cold Chain Packaging
Cold Chain Package Testing
Cold chain related packaging is a critical variable in validation. Thermal transport packaging, for instance, must be capable of holding a product temperature through the entire length of the distribution cycle. For example, refrigerated pharmaceuticals and biologics that require temperature control, shipped in an insulated shipping kit, may be monitored using temperature indicators and trackers to collect data during transit and then assessed accordingly.
An extension of the Good Manufacturing Practice (GMP) environment, thermal mapping evaluates the packaging system used to distribute and ship temperature sensitive products. This type of testing assesses the packaging’s ability to maintain the stability of its contained product within the required conditions. Thermal mapping may be used in conjunction with additional cold chain testing and distribution simulation tests.
Why Purple Diamond?
At Purple Diamond, the integrity of your packaged product is our number one priority in the Cold Chain Validation process. The engineers at Purple Diamond simulate, track, and monitor for the specific conditions and hazards your temperature controlled packaged products will face during distribution. Evaluating your isothermal packaging allows our team to address cold chain stressors that would otherwise prevent your packaged product from arriving safely to its destination, while maintaining its required temperature.
Purple Diamond follows the distribution testing standards and protocols set forth by organizations such as ASTM and ISTA. Our team is committed to delivering high-quality results as we develop a comprehensive solution to your specific cold chain packaging needs.