Cold Chain Relies on Validation to Maintain High Standards

In a general sense, to validate means to give official sanction to, approve or confirm. Accordingly, validation can be applied to a very wide range of procedures, products or circumstances.  In the area of cold chain distribution – where it is basic to maintain a stable environment during the shipping of temperature-sensitive freight – validation is a crucial piece of the quality control process; assuring that active or passive insulate shippers are thoroughly tested and able to meet specific hold time requirements.

Vaccines and pharmaceuticals are particularly sensitive materials which, if not manufactured and shipped under stringent controls, can become ineffective or even hazardous to the consumer. Keeping that in mind, in the 1970s the Food and Drug Administration (FDA) began to develop specific guidelines to test and evaluate biologic and pharmaceutical products before they could be released to the public.

Validation procedures started to take shape and were applied to the pharmaceutical and vaccine approval process. Eventually, validation methods and guidelines were developed for the cold chain delivery system too, with the objective of providing temperature assurance during the manufacturing, storage, shipping and delivery of medicines. Specifically, the Parenteral Drug Administration’s (PDA) Technical Report #39 outlines validation strategies for the cold chain and click               .

The Cold Chain Validation Process

With some exceptions, the temperature standard during the manufacturing, storage and shipping of pharmaceuticals and vaccines is between 2 to 8 degrees Celsius. Because of the basic nature of this freight, rigorous testing must be performed on the equipment and materials responsible for its effective delivery to ensure that it meets established standards. The target temperature must be maintained under the adverse conditions that insulated shipping containers may be exposed to. These conditions are at first simulated and afterward tested in the field. Results from these tests are documented in great detail.

With new cold chain solutions in place, the pharmaceutical supply chain is more stable and reliable than at any other time. Data logging and reporting technology has taken a step forward and is more meticulous. The technology surrounding insulated shippers is more advanced also.