PDA TR 72

PDA Technical Report No. 72 (TR 72) Passive Thermal Protection Systems for Global Distribution: Qualification and Operational Guidance discusses the qualification and operational handling of passive thermal protection systems (TPS) for temperature-controlled distribution of pharmaceutical and biological products. The decision to use a passive system versus an active system is dictated by many factors and the intent of this report is to assist stakeholders in the supply chain to preserve the quality, safety, and efficacy of pharmaceutical and biological products during distribution. This report provides guidance on the types of passive systems, including the materials used in their manufacture, characteristics and capabilities of these systems, qualification approach, operational use and reuse, and options for recycling at the end of the systems' life.