In a general sense, to "validate" means to give official sanction to, approve or confirm

In a general sense, to "validate" means to give official sanction to, approve or confirm. Accordingly, "validation" can be applied to a extremely wide range of procedures, items or circumstances.

Inside the area of cold chain distribution - where it really is crucial to maintain a stable environment in the course of the shipping of temperature-sensitive cargo - validation is really a vital part of the top quality control method; assuring that active or passive insulate shippers are thoroughly tested and able to meet distinct hold time requirements.

Vaccines and pharmaceuticals are particularly sensitive materials which, if not manufactured and shipped under stringent controls, can turn out to be ineffective or even hazardous to the consumer. To that end, in the 1970s the Food and Drug Administration (FDA) began to develop certain guidelines to test and evaluate biologic and pharmaceutical items prior to they could possibly be released to the public.

Validation procedures began to take shape and were applied to the pharmaceutical and vaccine approval procedure. Eventually, validation approaches and guidelines were developed for the cold chain delivery system also, with the objective of providing temperature assurance throughout the manufacturing, storage, shipping and delivery of medicines. Particularly, the Parenteral Drug Administration's (PDA) Technical Report #39 outlines validation methods for the cold chain.

The Cold Chain Validation Process

With some exceptions, the temperature regular during the manufacturing, storage and shipping of pharmaceuticals and vaccines is between 2 to 8 degrees Celsius. Since of the critical nature of this cargo, rigorous testing should be performed on the equipment and materials responsible for its successful delivery to make certain that it meets established standards. The target temperature should be maintained under the adverse conditions that insulated shipping containers might be exposed to. These conditions are at initial simulated and then tested "in the field." Outcomes from these tests are documented in excellent detail.

With new cold chain solutions in place, the pharmaceutical supply chain is a lot more stable and reliable than ever prior to. Information logging and reporting technologies has taken a step forward and is more meticulous. The technologies surrounding insulated shippers is much more advanced also.

Of course with this progression comes an increased number of qualifications for cold chain equipment to meet and surpass as component of the validation process.

Although they vary slightly based on each and every unique situation, some of the fundamental procedures within a cold chain validation testing process are:

? All testing equipment, from thermal test chambers to vibration tables, is subjected to a full validation process. This ensures that equipment is installed properly and functions as intended. Temperature monitoring devices are calibrated to guarantee that data is accurately documented.

? All elements of the cold chain packaging method to be validated are inspected to make sure that they meet specification. This ranges from insulated shipping containers and refrigerant packs to active heating and cooling systems.

? In a lab environment, the cold chain packaging program is subjected to a simulation of worst case transit conditions. This includes thermal testing against hot and cold ambient temperature profiles and physical hazards like 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 within the lab environment translates to "real world" conditions.

If there are any inconsistencies or complications with the method or equipment during testing, there will probably be no validation. Validation won't happen until problems are resolved as well as the hold time capability has demonstrated stability under further rigorous testing.

Cold chain validation does not stop upon productive testing. The monitoring, analysis and documentation of the program will continue even right after initial validation testing is done. The significance of consistent and dependable temperature control in scenarios where life-saving products are involved cannot be emphasized enough. And to those that manage cold chain distribution operations, the validation procedure offers insurance.

S. Mills is Product Development / Thermal and Structural Analysis Engineer for AcuTemp Thermal Systems. Mr. Mills is responsible for the development and testing of cold chain shipping systems to meet distinct customer profile requirements. Mr. Mills earned a Bachelor of Science in Packaging from Michigan State University. Scott has 5 years of experience inside the cold chain distribution field and inside the design of insulated storage containers utilizing thermal and structural study.