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 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.
Why Cold Chain Distribution Strategy?
If your company is in the medical device, pharmaceutical, or life science sectors, then it is imperative to make sure you have a cold chain distribution strategy for each of the product lines offered by your company. Each product will have a different temperature sensitivity as well as shelf life. Both of these factors come in to play, as mentioned above, when trying to figure out your cold chain distribution plan of attach. Storage is a great opportunity and provides a reliable resource for your company’s data, especially because most of the equipment used can harbor and analyze data over an extended period of time, short or long. Not only is the gathering data part helpful, but so is keeping the integrity of your medicinal substances. The cold chain storage and distribution routes are studied and determined ahead of time to refrain from cost risk, product loss, and more. Consider working with Purple Diamond for your cold chain storage and distribution needs. Even if you only have questions and are just starting out, we are here to help. We’re also here for the companies who just want third party input to boost their already made strategy.
Once you invest in a distribution strategy, so many new opportunities will open for your company. With new advancements and capabilities in your drug products, you will be able to refrigerate medications that then can travel across the globe to countries in need. Cold chain is currently in high demand, because it is expensive to have in-house, so it is low in supply, however; that does not change the fact that higher developed countries are counted on to get the proper vaccines, medicines, and other items across the world to those who really need the product.
According to directrelief.org, “Direct Relief in all, the organization delivered 37.9 million defined daily doses of refrigerated or frozen medicine to 55 countries worldwide during its 2021 fiscal year, including Covid-19 antibody treatments, insulin for children with Type 1 diabetes, and advanced chemotherapy medicine to treat pediatric cancer patients.
Cold chain is an increasingly important part of medical logistics. Global cold chain pharmaceutical production is forecasted to grow 48% between 2018 and 2024, vs. 27% growth in room-temperature pharmaceutical production, according to Pharmaceutical Commerce. In 2019, 45% of new drugs approved by the FDA required refrigeration or freezing.”
We are here if you are interested in learning more. Please schedule a consultation with us, or if you are close to the Lehigh Valley in Pennsylvania, schedule a facility tour or phone call via the contact page. It can be found at www.purple-diamond.com/contact-us. One of our pharmaceutical and life science experts will touch base with you about the storage, distribution, and strategy process.