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发表于 2023-2-3 16:10:03
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PDA第72号技术报告(TR 72)全球分销的被动热防护系统:鉴定和操作指南讨论了药物和生物产品温度控制分销的被动热防护系统(TPS)的鉴定和操作处理。使用被动系统与主动系统的决定取决于许多因素,本报告的目的是帮助供应链中的利益相关者在分销过程中保持药品和生物产品的质量、安全性和有效性。本报告提供了被动系统类型的指南,包括制造过程中使用的材料、这些系统的特性和能力、鉴定方法、操作使用和再利用,以及系统寿命结束时的回收选项。
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. |
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