奥星研讨会-讲义

1、2014/6/251Copyright 2014 STERIS Corporation. All Rights Reserved. CONFIDENTIAL and PROPRIETARY to STERIS Corporation.Global Best Practices in Cleanroom Disinfection 全球洁净室杀菌剂的最佳操作全球洁净室杀菌剂的最佳操作Jim Polarine Technical Services Manager Formulated ChemistriesShenzhen 深圳 June 2014Copyright 2014 STERIS Corporations. All Rights Reserved. CONFIDENTIAL and PROPRIETARY to STERIS CorporationBest Practices in Cleanroom Disinfection 洁净室杀菌剂的最佳操作洁净室杀菌剂的最佳操作- Why is this an important subject? - 为什么这是一个重要课题？Copyri

2、ght 2014 STERIS Corporations. All Rights Reserved. CONFIDENTIAL and PROPRIETARY to STERIS CorporationPatient Safety 病人安全Copyright 2014 STERIS Corporations. All Rights Reserved. CONFIDENTIAL and PROPRIETARY to STERIS CorporationDomestic Regulatory Compliance 国内执行标准Copyright 2014 STERIS Corporations. All Rights Reserved. CONFIDENTIAL and PROPRIETARY to STERIS CorporationForeign Regulatory Compliance 国外执行标准Copyright 2014 STERIS Corporations. All Rights Reserved. CONFIDENTIAL and PROPRIETARY to STER

3、IS CorporationAgenda议程议程 Disinfectant Validation Requirements 杀菌剂验证要求 Microbial Contamination Issues Carrier & Suspension Tests载体&悬浮液测试) TGA (Australia澳大利亚)More In Vitro Options for Testing 实验室测试更多选项Copyright 2014 STERIS Corporations. All Rights Reserved. CONFIDENTIAL and PROPRIETARY to STERIS CorporationUse-dilution稀释法 Temperature (hot WFI drops, use in cold room?)温度（热的WFI 水滴，在冷室中使用？） Technique技巧 Suspension vs. carrier悬浮液对比载体 Substrates基底 Neutralization/dilution中和/稀释液 Subculture techniques传代培养技

4、术 Microorganisms微生物 Efficacy requirements功效要求Further Considerations for In Vitro Testing实验室测试的进一步考虑事项Copyright 2014 STERIS Corporations. All Rights Reserved. CONFIDENTIAL and PROPRIETARY to STERIS CorporationElimination of inhibitory residual disinfectant activity消除残留杀菌 剂抑制活性 Chemical neutralization of the active化学剂中和活性 Dilution - generally not effective alone (alcohols)稀释-通常不会单独起 作用（醇类） Filtration + Rinsing separating the active from the organism过滤+漂 洗- 从微生物中分离活性Issues问题 Antimicrobial activity

5、of neutralizer (toxicity)中和剂的抗菌活性（毒性） Thioglycollate and sodium sulfite can be toxic硫胶质以及亚硫酸钠 可能会有毒 Mechanical separation causing damage to cells机械分离导致细胞伤 害Validation of neutralization is required要求验证中和剂Neutralization Methods中和方法Copyright 2014 STERIS Corporations. All Rights Reserved. CONFIDENTIAL and PROPRIETARY to STERIS CorporationUSP Common Neutralizers USP 常见中和剂*Tween 20 or 80, & Lubrol (Brij 58) are nonionic detergents Catalase for H2O2土温20或者80， &非离子型表面活性剂（Brij58）是非离子型清 过氧化氢酶Neutralizer 中和

6、剂中和剂Biocide Class抗微生物剂级别抗微生物剂级别Bisulfate硫酸氢盐Glutaraldehyde, Mercurials戊二醛，汞制剂Dilution稀释Phenolics, Alcohol, Aldehydes, Sorbate酚类，醇类，醛类， 山梨酸Glycine甘氨酸Aldehydes醛类Lecithin 卵磷脂Quaternary Ammonium Compounds (QACs), Parabens, Bis-biguanides季铵盐化合物（QACs）,对羟苯甲酸酯，双 胍类 Mg+2or Ca+2ions 镁离子 及钙离子EDTAPolysorbate (Tween)*聚三 梨醇酯（吐温）QACS, Iodine, Parabens季铵盐化合物（QACs）,碘，对羟 苯甲酸酯Thioglycollate硫胶质Mercurials汞抑制剂 Sodium thiosulfate硫代硫 酸钢Mercurials, Halogens, Aldehydes汞抑制剂，卤族，醛类Copyright 2014 STERIS Corporations. All Rig

7、hts Reserved. CONFIDENTIAL and PROPRIETARY to STERIS CorporationChemical Neutralizers化学中和剂Russell, Hugo, & Ayliffe 2004Chemical Neutralizers化学中和剂化学中和剂Active活性活性Polysorbate (Tween)聚三梨醇酯（土温）Phenolics酚类Lecithin + Tween卵磷脂+土温Phenolics酚类Letheen Broth卵磷脂肉汤Quaternary Ammoniums季铵盐Lubrol + Lecithin非离子型表面活性剂+卵磷脂Quaternary Ammoniums季铵盐Sodium Thiosulfate硫代硫酸钠Sodium Hypochlorite & Iodine次 氯酸钠&碘Catalase过氧化氢酶Hydrogen Peroxide过氧化氢Sodium sulphite亚硫酸钠Glutaraldehyde戊二醛Glycine甘氨酸Glutaraldehyde戌二醛D/E Neutralizer D/E

8、中和剂Phenolics & Quats酚类&醛类2014/6/256Copyright 2014 STERIS Corporations. All Rights Reserved. CONFIDENTIAL and PROPRIETARY to STERIS CorporationMicroorganism Selection微生物选择From McDonnell, “Antisepsis, Disinfection, and Sterilization: Types, Action, and Resistance” 2007, ASM PressB. cereus / B. sphaericusB. subtilis / G. stearothermophilusClostridium spp.蜡状芽孢杆菌/球形 芽孢杆菌枯草芽孢杆菌/嗜热 脂肪芽孢杆菌梭状芽孢杆菌Copyright 2014 STERIS Corporations. All Rights Reserved. CONFIDENTIAL and PROPRIETARY to STERIS CorporationIn

9、Vitro Testing Considerations Contributors to Test Failures 实验室测试中导致测试失败的因素Recovery issues post-drying (P. aeruginosa)干燥后恢复问题（铜 绿假单孢菌） Inoculum prep (e.g. fungal spores)培养液准备（真菌孢子） Coupon prep (autoclaving peeling Saniflex)取样片准备（高压蒸 汽灭菌- 剥落saniflex ） Improper dilution of Concentrate浓缩液不适当的稀释 Inappropriate biocide for spores孢子不适当的抗微生物剂 Insufficient contact time should match SOP不足的接触时间应 当符合SOP US vs. EU requirements 美国对比欧洲要求Copyright 2014 STERIS Corporations. All Rights Reserved. CONFIDENTIAL and PROPRIETARY to STERIS CorporationInoculum Preparation Viability 培养液准备 可行性Prepare inoculum suspensions from 18-24 hr cultures 准备从18-24小 时的培养基悬浮液Titer (cfu/mL) and viability must be verified at the end of every test day滴定 量（cfu/mL）和可行性必 须在每个测试日结束后都 要证实Copyright 2014 STERIS Corporations. All Rights Reserved. CONFIDENTIAL and PROPRIETARY to STERIS CorporationInoculum Preparation - Fungal Spores Spores 培养

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