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The PDA report discusses qualification and operational handling of passive thermal protection systems.
The Parenteral Drug Association (PDA) has released Technical Report No. 72, Passive Thermal Protection Systems for Global Distribution: Qualification and Operational Guidance (TR 72). The report discusses the qualification and operational handling of passive thermal protection systems (TPS) for temperature-controlled distribution of pharmaceutical and biological products. The report provides guidance regarding the materials used in the manufacture of TPS, as well as their characteristics and capabilities. It also gives guidance on the qualification approach, operational use and reuse, and options for recycling at the end of the systems’ life.
According to PDA, many factors play into the decision to use a passive system versus an active system. TR 72 assists “stakeholders in the supply chain to preserve the quality, safety, and efficacy of pharmaceutical and biological products during distribution,” said PDA in a press release.