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首页> 外文期刊>European journal of pharmaceutics and biopharmaceutics: official journal of Arbeitsgemeinschaft fuer Pharmazeutische Verfahrenstechnik e.V >A proposed rationale and test methodology for establishment of acceptance criteria for vacuum integrity testing of pharmaceutical freeze dryers
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A proposed rationale and test methodology for establishment of acceptance criteria for vacuum integrity testing of pharmaceutical freeze dryers

机译：建立药品冷冻干燥机真空完整性测试的验收标准的拟议理由和测试方法

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摘要

A scientific rationale is proposed for the establishment of acceptance criteria for leak rates in pharmaceutical freeze dryers. A method was developed to determine the quantity of air that could leak into any lyophilizer from the outside while still maintaining Class 100/Grade A microbial conditions. A lyophilizing product is assumed most vulnerable to microbial contamination during secondary drying, when mass transfer of water vapor from product to condenser is minimal. Using the void volume of the dryer, calculated from change in internal pressure when a known volume of air is introduced, and the potential maximum bioburden of the leaked air (based on measured values), calculations can determine the allowable leaked volume of air, the flow rate required to admit that volume in a given time frame, and the pressure rise that would result from the leak over a given testing period. For the dryers in this study, using worst-case air quality conditions, it was determined that a leak resulting in a pressure rise of 0.027 mbar over a 30 min period would allow the dryers to remain in secondary drying conditions for 62 h before the established action level of one colony forming unit for each cubic meter of air space would be reached.
机译：为建立药物冷冻干燥机泄漏率的接受标准，提出了科学依据。开发了一种方法来确定可从外部泄漏到任何冻干机中的空气量，同时仍保持100级/ A级微生物条件。当水蒸气从产品到冷凝器的传质极少时，冻干产品被认为最容易在二次干燥过程中受到微生物污染。使用干燥机的空隙体积，该空隙体积是根据引入已知体积的空气时内部压力的变化以及泄漏空气的潜在最大生物负荷（基于测量值）计算得出的，这些计算可以确定允许的泄漏空气量，在给定的时间范围内允许进入该体积所需的流速，以及在给定的测试期间内由泄漏引起的压力升高。对于本研究中的干燥机，使用最坏的空气质量条件，可以确定泄漏导致30分钟内的压力升高0.027 mbar，这将使干燥机在建立之前在二级干燥条件下保持62 h每立方米空气空间将达到一个菌落形成单位的作用水平。

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