MaxQ& A - Validation and Qualification

In his five years at MaxQ, Tyler Rapp has been involved in engineering packaging product development and manages MaxQ’s thermal testing operations. Tyler has designed customized solutions for a wide variety of cold chain applications including the transport and storage of blood products, specialty medications, vaccines, temperature-sensitive biologics, clinical trial programs, and more. He supports business development efforts by working one on one with customers to define performance requirements for their specific use case or payload. This includes everything from refrigerated or controlled room temperature (CRT) blood products and specialty medications, to ultra-low temperature (ULT) vaccines, clinical trial programs and more. Essential to the development of these products is the performance qualification process of MaxQ’s thermal packaging systems in a controlled laboratory environment – a role Tyler has mastered along with supporting customers with their internal validations.

In this Max Q & A, Tyler shares his experiences and knowledge about validations – common mistakes, observations and tips as well as how MaxQ can help make the process easier.

Q. What is the most common challenge customers face with their internal validation processes – and what’s your advice on overcoming them?

One of the biggest issues we see when our customers are struggling with validating their transport packaging systems or storage coolers is not pre-conditioning data loggers in the same environment as the payloads prior to testing. We always recommend attaching data loggers to the intended test payloads the night before testing or a minimum of 12 hours. You can do this by using a rubber band or packaging tape to affix the logger(s) to the payload(s). Allowing the data logger to sit in the refrigerator/freezer with the payload will ensure that the starting temperatures of both the loggers and payloads are equal at the start of the validation procedure and help avoid false negative test data. Continue Reading >>