When it comes to cold chain distribution, it is paramount that all involved facilities and units maintain a stable temperature during the storage and shipping of products. Cold chain validation is a necessary part of the entire quality control process, making sure that each and every link in the chain is tested to comply with official requirements.
Pharmaceutical and biochemical products are usually sensitive items that have to be kept in strictly controlled conditions from the point of production and for the remainder of their existence. When these conditions are compromised, it could result in the products being rendered ineffective and, thus, worthless. When the cold chain fails, it could mean huge losses, not only in terms of money, but of reputation.
Because of the delicate nature of these temperature-sensitive products, specific guidelines regarding their storage and distribution have been developed over time. Cold chain validation has become an important practice for suppliers to ensure compliance with government standards. Of course, this measure of quality assurance is also necessary in holding on to the trust and confidence bestowed upon them by their clients.
The cold chain validation process involves rigorous testing on the different pertinent materials and equipment used in the storage and transport of the products involved to ensure that they meet specifications. The target temperature must be maintained even in the most difficult situations and adverse conditions that the different facilities and vehicles could possibly encounter. To become validated, temperature mapping and monitoring must definitely be carried out with utmost care and accuracy.
During validation, everything is subjected to worst case conditions, and then findings are painstakingly documented. Live field tests are also normally carried out to demonstrate that the cold chain will hold up well in the real world. Should issues surface, validation will not be granted. All problems must be resolved first before the cold chain is validated.
With the continuous innovation happening in the field of cold chain distribution, new solutions are constantly improving the stability and reliability of the process. Temperature data logging, wireless temperature monitoring and reporting can be conducted with more accuracy while insulation technology such as polyurethane foam boxes which are considered twice as insulating as polystyrene boxes are more effective than other types of cold chain packaging.
Still, there’s always room for improvement and no process is fool-proof, which is why validation is necessary. It also doesn’t stop at the first successful testing. It’s a continuing process of monitoring, analysis, and documentation. Where life-saving products are involved, it does not pay to be over-confident.