In general “validation” can be described as the official sanction to confirm or approve. Hence, thermal validation service can be applied to various products, procedures as well as circumstances.
For the cold chain companies – it is very crucial to maintain a steady environmental condition during the shipment process of temperature sensitive products or goods. As the thermal validation is the significant part of quality control procedure, that ensures passive or active insulate shipments are thoroughly checked and capable of meeting specific requirements of hold time.
Pharmaceuticals and vaccines are basically such sensitive products that if not produced and transported under strict controls, can become hazardous or ineffective to use for the consumers. Hence, since 1970 FDA started to develop specific guidelines for testing and transporting pharmaceutical and biologic goods under thermal validation services before it get released to the public.
The procedures of thermal validation began to take shapes that were applied to various vaccine and pharmaceutical approval process. Gradually, guidelines and methods of validation were developed also for the cold chain transit system with a goal of offering temperature assurance at the time of production, storage, transit and delivery of the goods.
Cold Chain Thermal Validation Procedure –
With few exceptions, the standard temperature during production, storage and transit of the vaccines and pharmaceuticals is in between two to eight degree Celsius that can be achieved with the help of the thermal validation service providers. As the critical nature of such products or goods, strict testing must be conducted on the material and equipments responsible for the efficient delivery for assuring the standard level of establishment. The set temperature should be maintained under unfavorable conditions that lined shipping containers might get exposed. Such conditions are very first stirred and then checked in the area. These results or reports of the tests are recorded in detail for further access.