奥星研讨会-讲义
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?Copyright © 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 STERIS 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 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 Rights 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 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