What is typically involved in validating equipment such as shipping containers?

Validation documents that equipment will consistently meet pre-established quality and performance specifications. For blood shipping containers specifications would include the ability of the container to maintain required temperatures for blood components and products in ambient temperatures (including extremes) experienced in the shipping region.

Shipping containers are typically validated using different

  • types of blood components and products
  • numbers of components
  • configurations of ice packs, gel, and dry ice
  • ambient temperatures
  • transportation times