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The Case for Qualification and Validation of Biological Material Storage and Transit Systems

Posted by Praveen Bezawada-Joseph on Mar 25, 2014 10:20:00 AM

qualification and validation shipperHow much is your lack of temperature control costing you? Too often vaccines and bio-therapeutics are destroyed because of improper storage and distribution. And lost inventory is only the beginning of the true cost of not maintaining cold chain. Meeting ever more stringent regulatory requirements will become more difficult without taking the steps needed to qualify or validate your storage and transit systems. If you get 99 percent of your cold chain right but miss on the final 1 percent, you still fail, especially where cell-based products are involved. And the reason is most likely excess complexity, which is especially true for managing newer biologics such as an autologous cell therapy that requires the patient's sample to formulate the final therapeutic agent. 

The proliferation of pack-outs and procedures, quality agreements, storage conditions, and training requirements lead to reductions in efficiency and increased opportunity for error.  Qualifying/validating your storage and shipping equipment will allow you to reduce complexity by defining your most robust, common, and efficient solution.

There are four situations in which validating your cold storage equipment is necessary: when purchasing and installing a new unit; after resuming operation of a unit that has been shut down; after transfer to a different location; and after mechanical failure. In many of these situations, a limited validated is acceptable, especially if the unit was previously validated.

Temperature maintenance is just as critical and even more challenging when biological specimens are in transit. Validation/qualification of your shipping system can ultimately save you many headaches, as well as cost.  A transit study can reduce cost by identifying when a more expensive shipper combined with less expensive transport is more cost effective. A shipper qualification can also determine the sufficient amount of dry ice and save cost by reducing weight.   

Maintaining cold chain is a primary issue in preserving the integrity of biological materials, and is thus a focus of regulatory requirements. Validating your storage equipment and your shipping systems will allow you to simplify your processes, make your operations more robust, and avoid tripping over that final 1 percent.

Do you know what temperature you should be shipping that biological material at? For some of us in the cold chain industry it may be hard (at least I did) to quickly gauge why and what are some of temperature requirements for managing and transporting biological materials. Here is a nice infographic that I and my team uses everyday. Click here to download the Biobank Storage Temperatures:An Illustrative Guide. 

If you are interested in more information about cold chain qualification, please click below to download my eBook on Cold Chain Qualification: 5 Question You Must Ask When Shipping Biologics.  

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