AAPS PharmSciTech ( IF 3.4 ) Pub Date : 2023-01-26 , DOI: 10.1208/s12249-023-02506-x Arnab Ganguly 1 , Lisa Hardwick 2 , Serguei Tchessalov 3 , Steven L Nail 2 , Dan Dixon 3 , Frank Kanka 4 , Anthony Guidinas 3 , T N Thompson 5 , Cindy Reiter 5 , Zakaria Yusoff 6 , Ted Tharp 7 , Joseph Azzarella 8 , Prerona Sharma 9 , Petr Kazarin 10 , Alina Alexeenko 10 , Michael J Pikal 11
|
Best practices for performing freeze dryer equipment qualification are recommended, focusing on identifying methods to quantify shelf thermal uniformity (also known as “shelf surface uniformity”), equipment capability, and performance metrics of the freeze dryer essential to the pharmaceutical Quality by Design paradigm. Specific guidelines for performing shelf temperature mapping, freeze dryer equipment limit testing (the capability curve), and condenser performance metrics have been provided. Concerning shelf temperature mapping and equipment capability measurements, the importance of paying attention to the test setup and the use of appropriate testing tools are stressed. In all the guidelines provided, much attention has been paid to identifying the balance between obtaining useful process knowledge, logistical challenges associated with testing in the production environment vs that at laboratory scale, and the frequency of the testing necessary to obtain such useful information. Furthermore, merits and demerits of thermal conditions maintained on the cooled surfaces of the freeze dryer condenser have been discussed identifying the specific influence of the condenser surface temperature on the process conditions using experimental data to support the guidelines. Finally, guidelines for systematic leak rate testing criteria for a freeze dryer are presented. These specific procedural recommendations are based on calculations, measurements, and experience to provide useful process and equipment knowledge.
Graphical Abstract
中文翻译：
冷冻干燥机设备性能鉴定的推荐最佳实践：2022 年
建议执行冻干机设备鉴定的最佳实践，重点是确定量化货架热均匀性（也称为“货架表面均匀性”）的方法、设备能力和冷冻干燥机的性能指标，这对于药物质量源于设计范式至关重要。提供了执行货架温度映射、冷冻干燥机设备极限测试（能力曲线）和冷凝器性能指标的具体指南。关于货架温度映射和设备能力测量，强调了注意测试设置和使用适当测试工具的重要性。在提供的所有指南中，都非常注意确定获取有用的过程知识、与实验室规模相比，以及获得此类有用信息所需的测试频率。此外，还讨论了冷冻干燥机冷凝器冷却表面上保持的热条件的优点和缺点，使用实验数据来支持指南，以确定冷凝器表面温度对过程条件的具体影响。最后，介绍了冷冻干燥机的系统泄漏率测试标准指南。这些特定的程序建议基于计算、测量和经验，以提供有用的过程和设备知识。
京公网安备 11010802027423号