PDA TR21_生物负荷复原验证_Bioburden Recovery Validation_1990.pdfVIP

TechnicalReport:BioburdenRecovery Validation 技术报告：生物负荷复原验证 PDA BioburdenRecovery ValidationTaskForce ParenteralDrugAssoiiation TaskForceMembers 小组成员 CarmenAmador Bristol-MyersSquibb Company Barceloneta,PuertoRico PamelaDeschenes Wyeth-Ayerst West Chester,PA Mary SueDorminy Bristol-MyersSquibb Company East Syracuse,NY BethDudley BaxterHealthcareCorporation RoundLake,IL BobbiGordon Bristol-MyersSquibb Company NewBrunswick,NJ CarolLampe,Chairman BaxterHealthcareCorporation RoundLake,IL RosemaryMcGarrah Bristol-MyersSquibb Company Evansville,IN JosephPrulello LederleLaboratories PearleRiver,NY RaymondWild Lyphomed,Inc. MelrosePark,IL OutlineofTechnicalReport 技术报告大纲 Ⅰ.Introduction-TheImportanceofBioburdenRecoveryValidation 介绍-生物负荷复原验证的重要性 Ⅱ.BioburdenRecoveryMethods 生物负荷复原方法 A.HandlingofBioburden Test Samples 生物负荷测试样本的处理 1.Collection ofBioburden Samples 生物负荷样本的收集 2.SampleFrequency and Size 样本频率和尺寸 3. SampleTransport and Storage 样本运输和储存 4.TestingEnvironment 测试环境 B.Recovery Methods 复原方法 1.SolutionsandRawMaterials-TotalCount 解决方法和原材料数量 a.QuantitativeRecovery-Filtration 定量复原--过滤 b.QuantitativeRecovery-Pour Plate — 定量复原 倾倒平板法 c.QuantitativeRecovery-SpreadPlate — 定量复原 涂布平板法 d.QuantitativeRecovery-AutomatedProcedures — 定量复原 自动化程序 e.QualitativeRecovery-MostProbableNumber (MPN) — 定性复原 最近似数 2.Product Contact Surfaces 产品接触表面 a.RodacContactPlates(ReplicateOrganismDetection andCounting) 接触型平板 b.Cotton Swabs 棉签 c.CalciumAlginate Swabs 海藻酸钠海绵 d.Container/Componentry 容器元件部分/ C.Bioburden Characterization/ScreeningMethods 生物负荷鉴定筛选方法/ ⅢBioburdenRecoveryValidation