Thermal qualification is a fundamental element of developing a resilient thermal packaging system and minimizes risks to product quality during transit. CCT’s experience, expertise, and execution make us the smart choice for your temperature-sensitive packaging qualification project. Life sciences 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.Our 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 turnaround on physical testing in our chambers and rapid design of our accurate predictive modeling software.
Our team develops 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.
Subscribe for CCT communications.
Get content related to cold chain best practices, solutions, and services.