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Cold Chain Relies on Validation to Maintain High Standards
In a general sense, “validate” means to give official sanction to, approve or confirm. Therefore, “validation” can be applied to a very wide range of procedures, products or circumstances.
In the area of cold chain distribution – where it is critical to maintain a stable environment when shipping temperature-sensitive cargo – validation is an essential part of the quality control process; ensuring that active or passive isolation dispatchers are thoroughly tested and able to meet specific timing requirements.
Vaccines and pharmaceuticals are particularly sensitive materials that, if not manufactured and shipped under strict controls, can become ineffective or even dangerous for the consumer. To this end, in the 1970s the Food and Drug Administration (FDA) began to develop specific guidelines for testing and evaluating biological and pharmaceutical products before they could be released to the public.
Validation procedures began to develop and were applied to the pharmaceutical and vaccine approval process. Later, validation methods and guidelines were developed for the cold chain delivery system as well, with the aim 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.
The Cold Chain Validation Process
With some exceptions, the temperature standard during the manufacture, storage and shipping of pharmaceuticals and vaccines is between 2 to 8 degrees Celsius. Due to the critical nature of this cargo, rigorous testing must be performed on the equipment and materials responsible for its efficient delivery to ensure that it meets established standards. The target temperature must be maintained under the adverse conditions to which insulated shipping containers might be exposed. These conditions are initially simulated and then tested “in the field”. Results of these tests are documented in great detail.
With new cold chain solutions in place, the pharmaceutical supply chain is more stable and reliable than ever before. Data recording and reporting technology has taken a step forward and is more meticulous. The technology around isolated shippers is also more advanced.
Of course with this progression comes an increased number of qualifications for cold chain equipment to meet and exceed as part of the validation process.
Although they vary slightly according to each unique situation, some of the fundamental procedures within a cold chain validation testing process are:
• All test equipment, from thermal test chambers to vibration tables, is subject to a full validation process. This ensures that equipment is installed correctly and works as intended. Temperature monitoring devices are calibrated to ensure that data is accurately documented.
• All elements of the valid cold chain packaging system are inspected to ensure they meet specification. This ranges from insulated shipping containers and refrigerated packages to active heating and cooling systems.
• In a laboratory environment, the cold chain packaging system is subjected to worst-case simulation of transit conditions. This includes thermal testing against hot and cold ambient temperatures and physical hazards such as drops, vibration and compression. Equipment and data are carefully monitored and all observations and findings are well documented.
• The cold chain packaging system is then monitored in a live field test to demonstrate that performance seen in the laboratory environment translates to “real world” conditions.
If there are any inconsistencies or problems with the process or equipment during testing, there will be no validation. Validation will not occur until issues are resolved and the hold time capability has demonstrated stability under further rigorous testing.
Cold chain validation does not stop after successful testing. The monitoring, analysis and documentation of the system will continue even after initial validation testing is done. The importance of consistent and reliable temperature control in situations where life-saving products are involved cannot be emphasized enough. And to those who manage cold chain distribution operations, the validation process offers insurance.
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