PDA TR3 干热灭菌除热原_Dry Heat Sterilization_Depyrogenation_1981.pdf

TechnicalReportNo.3 VALIDATION OF DRY HEAT PROCESSESUSED FOR STERILIZATIONANDDEPYROGENATION PARENTERALDRUGASSOCIATION,Inc. PREFACE (1,2) THIS IS THE THIRD Technical Report dealing with sterilization validation . Specifically, this report presents a review of validation for processes that use dryheattoachievesterilization and/or depyrogenation. Task Group 16, under the co-chairmanship of William Frieben and Thomas Lypka, has developed a discussion of various biological and engineering parameterswhichmaybeconsideredinvalidation. SolMotola—1980 R.MichaelEnzinger—1981 Chairman Research Committee (1) Validation of Steam Sterilization Cycles,ParenteralDrugAssociation Inc., TechnicalMonographNo. 1. (2) Validation ofAseptic Filling For Solution Drug Products,Parenteral Drug Association Inc.,TechnicalMonographNo.2. CONTENTS 1.0Introduction介绍 1 2.0 Scope范围 3 3.0ConvectionHeating 对流加热4 3.1Batch 批次6 3.2Continuous 连续 10 4.0ConductionHeating 传导加热 15 4.1Batch 批次15 4.2Continuous 连续15 5.0RadiantHeat 辐射加热19 5.1ProcessFactors 工艺因素 19 5.2Batch 批次20 5.3Continuous 连续 20 6.0BiologicalValidation 生物验证 24 6.1BiologicalIntent 生物意图 24 6.2Laboratory Studies 实验室研究27 6.3Plant Studies 工厂研究 44 7.0References 参考文献 50 8.0AppendixA 附表A 52 9.0AppendixB 附表B 54 1.0INTRODUCTION介绍 Dry heat is often the agent of choice for sterilizing items which will tolerate relatively high temperatures, yet which might not be adequately penetrated by steam or are damaged by moist heat. Dry heat is often employed for sterilizing such items as powders, oils, petrolatum jellies, glassware, and stainless steel equip