Thermal Packaging Qualification

Thermal packaging qualification is a fundamental element of Good Distribution Practices
(GDPs) and minimizes risks to product quality during transit when done properly.  Cold Chain Technologies’ experience, expertise and execution make us the smart choice for your
temperature-sensitive packaging qualification project. Hundreds of companies have relied on
CCT to develop and qualify thermal packaging for every step of the distribution process.

CCT adheres to industry best practices regarding the principles of qualification as defined in the Parenteral Drug Association’s (PDA) Technical Report 39 (TR39) which closely aligns with the Center for Drug Evaluation and Research (CDER) Guideline on General Principals of Process Validation. The qualification process consists of the following steps.

  • Design Qualification – Laboratory testing that creates confidence that the thermal packaging system is capable of consistently operating within established limits and tolerances.
  • Operational Qualification – Laboratory testing that provides documented verification that the thermal packaging system’s performance is effective and reproducible throughout the anticipated operating ranges
  • Performance Qualification – Live field testing that provides documented verification that the thermal packaging system meets all release requirements for functionality
Working on a fast track, our multi-disciplinary design team focuses on understanding and defining your opportunities. We offer flexible turn around on physical testing in our chambers, and rapid design using KoolDesigns®, our accurate predictive modeling software. We develop user-driven, well-documented designs that meet your thermal, physical, pack out, and cost requirements. At CCT, we recognize that our ongoing value lies in our ability to continually generate new ways to solve your problems.