无菌工艺培训(默沙东).ppt

清洁模块清洁模块 CLEANING MODULECLEANING MODULE1 1ASEPTIC PROCESSING无菌工艺CLEANROOM CLEANING EQUIREMENT洁净室-清洁设备清洁模块清洁模块 CLEANING MODULECLEANING MODULE2 2OBJECTIVES 目的At the end of this module:At the end of this module:在完成此模块培训后应明白：在完成此模块培训后应明白：Understand the materials and disinfectants used.Understand the materials and disinfectants used.所使用的材料及消毒剂所使用的材料及消毒剂 Why we clean in a particular way Why we clean in a particular way 为什么我们用特殊的方式来清洁为什么我们用特殊的方式来清洁 How to clean in the correct way.How to clean in the correct way.如何正确的清洁如何正确的清洁清洁模块清洁模块 CLEANING MODULECLEANING MODULE3 3CLEANING 清洁 Cleaning within a Pharmaceutical processing plant is a Cleaning within a Pharmaceutical processing plant is a criticalcritical activity activity 清洁对一个制药厂来说是一个关键工序清洁对一个制药厂来说是一个关键工序 There must be dedicated equipment for the cleaning There must be dedicated equipment for the cleaning processprocess 必须明确清洁程序所使用的设备必须明确清洁程序所使用的设备 Detailed procedures on how to clean,which disinfectants to Detailed procedures on how to clean,which disinfectants to use and the dilutions to be used for the cleaning processuse and the dilutions to be used for the cleaning process 应有相应规程来详细说明：清洁方法，清洁程序所使用的消毒剂及其应有相应规程来详细说明：清洁方法，清洁程序所使用的消毒剂及其配制。配制。清洁模块清洁模块 CLEANING MODULECLEANING MODULE4 4CLEANING清洁 Cleaning has to be a validated processCleaning has to be a validated process 清洁应是一个已验证的程序清洁应是一个已验证的程序 Cleaning has to be documented the same as any other Cleaning has to be documented the same as any other activityactivity 清洁应和其它工序一样，有相关的记录清洁应和其它工序一样，有相关的记录为什么清洁如此重要为什么清洁如此重要清洁模块清洁模块 CLEANING MODULECLEANING MODULE5 5CLEANING ITS PURPOSE清洁目的 To kill any micro-organisms that are presentTo kill any micro-organisms that are present 杀灭任何存在的微生物杀灭任何存在的微生物 To remove as many particles or contaminates as possible To remove as many particles or contaminates as possible from the area.from the area.尽可能的将洁净区的尘埃粒子或污染清除尽可能的将洁净区的尘埃粒子或污染清除 Ensure the area is clean for its next use-This can be up to Ensure the area is clean for its next use-This can be up to 7 days7 days from the day it was cleaned(Hold Time)from the day it was cleaned(Hold Time)n n确保洁净区已清洁，为下次使用做好准备，清洁有效期（清洁保持期）确保洁净区已清洁，为下次使用做好准备，清洁有效期（清洁保持期）为为7 7天天 （从清洁当天开始计算）（从清洁当天开始计算）清洁模块清洁模块 CLEANING MODULECLEANING MODULE6 6CLEANING THE OUTCOME清洁的作用 Cleaning the Cleanroom correctly will help to maintain low Cleaning the Cleanroom correctly will help to maintain low levels of particulate and microbial contamination in the arealevels of particulate and microbial contamination in the area 正确的清洁洁净室有利于保持洁净室内的尘埃粒子和微生物污染处于正确的清洁洁净室有利于保持洁净室内的尘埃粒子和微生物污染处于较低水平较低水平 Ensure the area is clean for the Ensure the area is clean for the 7 day hold7 day hold period period 确保洁净室处于清洁有效期内（确保洁净室处于清洁有效期内（7 7天）天）The effectiveness of the cleaning process can be monitored The effectiveness of the cleaning process can be monitored through the environmental monitoring system and the PMSthrough the environmental monitoring system and the PMS 清洁程序的效果可通过环境监测和清洁程序的效果可通过环境监测和PMSPMS来监测来监测清洁模块清洁模块 CLEANING MODULECLEANING MODULE7 7CLEANING MODULE清洁模块 n n我们将要学习的内容：Review the disinfectants used in the areaReview the disinfectants used in the area 回顾我们在洁净区使用的消毒剂回顾我们在洁净区使用的消毒剂 Equipment used to clean the areaEquipment used to clean the area 所所使用的清洁设备使用的清洁设备 Techniques used to cleanTechniques used to clean 清洁技术清洁技术 Why they are so importantWhy they are so important 为什么上述项目很重要为什么上述项目很重要清洁模块清洁模块 CLEANING MODULECLEANING MODULE8 8WHAT ARE DISINFECTANTS什么是消毒剂 Disinfectants are antimicrobial agents that are Disinfectants are antimicrobial agents that are applied to objects to destroy the micro-organismsapplied to objects to destroy the micro-organisms 消毒剂是由抗菌药物配制而成，用于消灭微生物消毒剂是由抗菌药物配制而成，用于消灭微生物 Disinfection may be defined as:Cleaning an Disinfection may be defined as:Cleaning an article of some or all of the pathogenic organisms article of some or all of the pathogenic organisms which may cause infectionwhich may cause infection 消毒可被定义为：清洁那些可能会造成传染的部分或全部消毒可被定义为：清洁那些可能会造成传染的部分或全部的的病原微生物清洁模块清洁模块 CLEANING MODULECLEANING MODULE9 9DISINFECTANTS WE USE我们使用的消毒剂 VespheneVesphenellstllst VespheneVesphene碱性苯酚消毒剂碱性苯酚消毒剂碱性苯酚消毒剂碱性苯酚消毒剂 LpH stLpH st LpHLpH酸性的苯酚消毒剂 Klercide 70/30Klercide 70/30 KlercideKlercide杀孢子剂杀孢子剂杀孢子剂杀孢子剂 Spor-KlenzSpor-Klenz Spor-KlenzSpor-Klenz杀孢子剂清洁模块清洁模块 CLEANING MODULECLEANING MODULE1010Vesphenellst碱性苯酚消毒剂 Process VespheneProcess Vesphenellst is used in the Grade C and llst is used in the Grade C and A/B areasA/B areas Process VespheneProcess Vesphenellstllst用于用于用于用于C C级级区和区和区和区和A/BA/B级洁净级洁净区区区区 VespheneVesphenellst is a one step llst is a one step alkaline phenolicalkaline phenolic disinfectantdisinfectant VespheneVesphenellstllst是一步是一步是一步是一步碱性酚碱性酚碱性酚碱性酚类类消毒消毒消毒消毒剂剂 The packs are sterile and have lot numbers and The packs are sterile and have lot numbers and expiry dates for traceability expiry dates for traceability 包装是包装是经过经过消毒的，消毒的，贴贴有批号，有批号，标标示有有效期用于追溯示有有效期用于追溯清洁模块清洁模块 CLEANING MODULECLEANING MODULE1111VesphenellstVesphene碱性苯酚消毒剂 Vesphene is packed in a ready-to-use sachet Vesphene is packed in a ready-to-use sachet with a specific dilution ratewith a specific dilution rate VespheneVesphene是按即用型消毒是按即用型消毒剂剂包装的，按特定的稀包装的，按特定的稀释释比例配制比例配制 Vesphene kills a broad spectrum of micro-Vesphene kills a broad spectrum of micro-organisms without harming surfacesorganisms without harming surfaces VespheneVesphene可杀灭广谱微生物，不会损害各种表面可杀灭广谱微生物，不会损害各种表面 When Vesphene is diluted,this When Vesphene is diluted,this alkalinealkaline disinfectant has a disinfectant has a pH range of 10.4-10.6pH range of 10.4-10.6 当当VespheneVesphene被稀释时，其被稀释时，其碱性碱性消毒剂的消毒剂的pHpH范围为范围为10.4-10.610.4-10.6 清洁模块清洁模块 CLEANING MODULECLEANING MODULE1212LpH stLpH酸性的苯酚消毒剂 Process LpH stProcess LpH st is used in the Grade C and A/B is used in the Grade C and A/B areasareas Process LpH stProcess LpH st 用于用于C C级级区和区和区和区和A/BA/B级洁净级洁净区区区区 LpH st is a one step LpH st is a one step acidic phenolicacidic phenolic disinfectantdisinfectant LpH stLpH st是一步是一步是一步是一步酸性酚酸性酚酸性酚酸性酚类类消毒消毒消毒消毒剂剂 The packs are sterile and have The packs are sterile and have lot numberslot numbers and and expiry datesexpiry dates for traceability for traceability 包装是包装是经过经过消毒的，消毒的，贴贴有有批号批号，标标示有示有有效期有效期用于追溯用于追溯清洁模块清洁模块 CLEANING MODULECLEANING MODULE1313LpH stLpH酸性的苯酚消毒剂 LpH is packed in a ready-to-use sachet with a LpH is packed in a ready-to-use sachet with a specific dilution ratespecific dilution rate LpHLpH是按即用型消毒是按即用型消毒剂剂包装的，按特定的稀包装的，按特定的稀释释比例配制比例配制 LpH st kills a broad spectrum of micro-organisms LpH st kills a broad spectrum of micro-organisms without harming surfaceswithout harming surfaces LpHLpH可杀灭广谱微生物，不会损害各种表面可杀灭广谱微生物，不会损害各种表面 When LpH is diluted,this When LpH is diluted,this acidic acidic disinfectant has disinfectant has a a pH range of 2.6 to 3.0pH range of 2.6 to 3.0 当当LpHLpH被稀释时，其被稀释时，其酸性酸性消毒剂的消毒剂的pHpH范围为范围为2.6 3.02.6 3.0 清洁模块清洁模块 CLEANING MODULECLEANING MODULE1414DISINFECTANT ROTATION消毒剂轮换 VespheneVesphenellst is an llst is an alkaline alkaline disinfectantdisinfectant VespheneVesphenellst llst 为为碱性碱性消毒消毒剂剂 LpH st is an LpH st is an acidic acidic disinfectantdisinfectant LpH st LpH st 为为酸性酸性消毒消毒剂剂 Rotation of disinfectants ensures that that micro-Rotation of disinfectants ensures that that micro-organisms dont build up a tolerance to the organisms dont build up a tolerance to the disinfectantdisinfectant 消毒消毒剂剂的的轮换轮换使用使用应应确保微生物不会确保微生物不会对对消毒消毒剂产剂产生抗性生抗性清洁模块清洁模块 CLEANING MODULECLEANING MODULE1515Klercide 70/30Klercide 杀孢子剂 Klercide 70/30 is a 70%IPA sterile ready to use Klercide 70/30 is a 70%IPA sterile ready to use sprayspray Klercide 70/30 Klercide 70/30 为为 70%70%的无菌的无菌IPA IPA（异丙醇），可直接使（异丙醇），可直接使用用 70%IPA and 30%deionised water70%IPA and 30%deionised water 由由为为 70%70%的的IPA IPA（异丙醇）和（异丙醇）和30%30%的去离子水配制而成的去离子水配制而成 The bottles are gamma irradiated and double baggedThe bottles are gamma irradiated and double bagged 盛装用的瓶子盛装用的瓶子经经伽伽马马射射线灭线灭菌，有双重胶塞菌，有双重胶塞 Bottles have a batch number and expiry date-once Bottles have a batch number and expiry date-once opened they will have a opened they will have a ONE ONE month shelf lifemonth shelf life 瓶瓶身身贴贴有批号，有批号，标标示有有效期，开封后有效期示有有效期，开封后有效期为为一个月一个月清洁模块清洁模块 CLEANING MODULECLEANING MODULE1616Klercide 70/30Klercide 杀孢子剂 Works to kill micro-organisms but requires a contact time to Works to kill micro-organisms but requires a contact time to be effectivebe effective 用于用于杀灭杀灭微生物，生效要求一定的接触微生物，生效要求一定的接触时间时间 Quick and easy to useQuick and easy to use 简单简单便于使用便于使用 Has a number of uses onsiteHas a number of uses onsite 广泛用于生广泛用于生产现场产现场的消毒：的消毒：Eg.used in Grade A/B as gloved hands sanitiser Eg.used in Grade A/B as gloved hands sanitiser 例如：用于例如：用于A/BA/B级区手套的消毒级区手套的消毒 Eg.for cleaning or wiping down of equipmentEg.for cleaning or wiping down of equipment 例如：用于设备清洁擦拭例如：用于设备清洁擦拭清洁模块清洁模块 CLEANING MODULECLEANING MODULE1717Spor-KlenzSpor-Klenz杀孢子剂 Spor-Klenz is a ready to use sporcidal disinfectantSpor-Klenz is a ready to use sporcidal disinfectant Spor-Klenz Spor-Klenz 为为配制好的配制好的杀孢杀孢子消毒子消毒剂剂，可直接使用，可直接使用 Effective at microbial control of bacteria,fungi,viruses Effective at microbial control of bacteria,fungi,viruses and bacterial sporesand bacterial spores 对对微生物控制（微生物控制（细细菌，真菌，病毒和菌，真菌，病毒和细细菌菌孢孢子）有效子）有效 Used at Biotech Plant as a spray disinfectant for Used at Biotech Plant as a spray disinfectant for equipment going into the Grade A/B area that cannot equipment going into the Grade A/B area that cannot be autoclaved.Or when tools are needed in a be autoclaved.Or when tools are needed in a breakdown situationbreakdown situation 在生物技在生物技术术工厂当做工厂当做喷喷洒消毒洒消毒剂剂来来对对那些那些进进入入A/BA/B级洁净级洁净区而不区而不能通能通过灭过灭菌柜菌柜灭灭菌的菌的设备设备的消毒，或在的消毒，或在设备设备故障故障时时，用于，用于对维对维修工具的消毒修工具的消毒清洁模块清洁模块 CLEANING MODULECLEANING MODULE1818DISINFECTANTS WE USE我们所使用的消毒剂SPOR-KLENZVESPHENE/LpH醇类醇类 ALCOHOLSEFFICENCY消毒效果消毒效果 Disinfectants cannot Disinfectants cannot sterilisesterilise the object or area the object or area 消毒剂不能灭菌物体或洁净区消毒剂不能灭菌物体或洁净区清洁模块清洁模块 CLEANING MODULECLEANING MODULE1919DIFFERENT DISINFECTANTS各种消毒剂 Alcohols 醇类 Oxidizing Agents氧化剂 Phenolics 酚类 Quaternary Ammonium季铵清洁模块清洁模块 CLEANING MODULECLEANING MODULE2020DIFFERENT DISINFECTANTS各种消毒剂 Alcohols(IPA)Alcohols(IPA)have wide microbicidal activity,have wide microbicidal activity,are non corrosive to surfacesare non corrosive to surfaces 醇类醇类(IPA)(IPA)对广泛的微生物有效，对各种表面不会有腐对广泛的微生物有效，对各种表面不会有腐蚀效果蚀效果 They leave little residue due to the evaporationThey leave little residue due to the evaporation 可挥发，残留量小可挥发，残留量小 Alcohols(IPA)are not effective against fungal or Alcohols(IPA)are not effective against fungal or bacterial sporesbacterial spores 醇类醇类(IPA)(IPA)对真菌或细菌孢子无效对真菌或细菌孢子无效清洁模块清洁模块 CLEANING MODULECLEANING MODULE2121DIFFERENT DISINFECTANTS各种消毒剂 Oxidizing disinfectants affect the cell membrane,Oxidizing disinfectants affect the cell membrane,this leads to the death of the micro-organismthis leads to the death of the micro-organism 氧化消毒剂可影响微生物的细胞膜，从而导致微生物的死氧化消毒剂可影响微生物的细胞膜，从而导致微生物的死亡亡 Sodium HypochloriteSodium Hypochlorite and and ChlorineChlorine are are oxidizing agentsoxidizing agents次氯酸钠和氯为氧化剂 Household example of these would be Household example of these would be BleachBleach 家用的消毒剂也有这类型的，例如：家用的消毒剂也有这类型的，例如：漂白剂漂白剂清洁模块清洁模块 CLEANING MODULECLEANING MODULE2222DIFFERENT DISINFECTANTS各种消毒剂 PhenolicsPhenolics are the active ingredient in some are the active ingredient in some disinfectants and mouthwashesdisinfectants and mouthwashes 酚类酚类是一些消毒剂和漱口水的活性组成部分是一些消毒剂和漱口水的活性组成部分 They are effective at killing a broad spectrum of They are effective at killing a broad spectrum of bacteriabacteria 对广谱细菌能够有效杀灭对广谱细菌能够有效杀灭 They do not harm surfaces but there is residual They do not harm surfaces but there is residual build upbuild up 对对各种表面没有危害，但是存在残留各种表面没有危害，但是存在残留清洁模块清洁模块 CLEANING MODULECLEANING MODULE2323DIFFERENT DISINFECTANTS各种消毒剂 Quaternary ammoniums are effective against bacteria but not against some pseudomonas(water)bacteria季铵对细菌有效，但对一些假单胞菌和水生细菌无效 They have residual build up 存在残留清洁模块清洁模块 CLEANING MODULECLEANING MODULE2424EFFECTIVENESS OF DISINFECTANTSEFFECTIVENESS OF DISINFECTANTS消毒剂消毒效果消毒剂消毒效果 The effectiveness of a disinfectants is done by The effectiveness of a disinfectants is done by comparing it against a known paring it against a known standard.消毒剂的效果是通过与已知标准比较来确认的消毒剂的效果是通过与已知标准比较来确认的 PhenolPhenol is the standard and the rating system is is the standard and the rating system is called the called the“Phenol Coefficient”“Phenol Coefficient”已知标准为已知标准为已知标准为已知标准为苯酚苯酚苯酚苯酚，其评级系统被称为，其评级系统被称为，其评级系统被称为，其评级系统被称为“苯酚系数苯酚系数苯酚系数苯酚系数”The test disinfectant is compared with Phenol on The test disinfectant is compared with Phenol on a standard microbea standard microbe 消毒剂的消毒效果测试是通过对标准微生物进行消毒，与消毒剂的消毒效果测试是通过对标准微生物进行消毒，与苯酚对比来确认苯酚对比来确认清洁模块清洁模块 CLEANING MODULECLEANING MODULE2525EQUIPMENT USED TO CLEAN VACUUM EQUIPMENT USED TO CLEAN VACUUM CLEANERCLEANER所使用的清洁设备所使用的清洁设备-真空吸尘器真空吸尘器 The Vacuum cleaner used in the Clean room is The Vacuum cleaner used in the Clean room is different from a domestic vacuum cleanerdifferent from a domestic vacuum cleaner 洁净室所使用的真空吸尘器不同于家用真空吸尘器洁净室所使用的真空吸尘器不同于家用真空吸尘器 The vacuum is fitted with a The vacuum is fitted with a HEPA filterHEPA filter which which filters the exhaust air being discharged in the filters the exhaust air being discharged in the Cleanroom Cleanroom 洁净室所使用的真空吸尘器配备有洁净室所使用的真空吸尘器配备有HEPAHEPA过滤器过滤器，用于过，用于过滤从洁净室排除的空气滤从洁净室排除的空气 The HEPA filter on the vacuum is changed The HEPA filter on the vacuum is changed every every 6 months6 months 吸尘器中的吸尘器中的吸尘器中的吸尘器中的HEPAHEPA过滤器过滤器过滤器过滤器每每每每6 6个月个月个月个月更换一次更换一次更换一次更换一次清洁模块清洁模块 CLEANING MODULECLEANING MODULE2626EQUIPMENT USED TO CLEAN MOP EQUIPMENT USED TO CLEAN MOP HEADS/WIPES/IPAHEADS/WIPES/IPA所使用的清洁设备所使用的清洁设备-拖把头拖把头/抹布抹布/IPA/IPA The mop heads are foamThe mop heads are foam 拖把头材质为泡沫塑料拖把头材质为泡沫塑料 The mop head is covered with wipes to ensure pieces of The mop head is covered with wipes to ensure pieces of foam are not detached during the cleaning processfoam are not detached during the cleaning process 拖把头上覆盖有抹布，以确保在清洁过程中泡沫塑料不会分离开来拖把头上覆盖有抹布，以确保在清洁过程中泡沫塑料不会分离开来 The wipes are lint free to ensure no particles are shed The wipes are lint free to ensure no particles are shed during cleaningduring cleaning 抹布为无绒材质，以确保在清洁过程中不会有微粒脱落抹布为无绒材质，以确保在清洁过程中不会有微粒脱落 The wipes are gamma irradiated to ensure sterilityThe wipes are gamma irradiated to ensure sterility 抹布应通过伽马曲线灭菌来确保无菌性抹布应通过伽马曲线灭菌来确保无菌性清洁模块清洁模块 CLEANING MODULECLEANING MODULE2727EQUIPMENT USED TO CLEAN MOP EQUIPMENT USED TO CLEAN MOP BUCKETS/HANDLESBUCKETS/HANDLES所使用的清洁设备所使用的清洁设备-拖把桶拖把桶/拖把杆拖把杆 Plastic buckets with stainless steel wringersPlastic buckets with stainless steel wringers 拖把桶为塑料材质，提手为不锈钢材质拖把桶为塑料材质，提手为不锈钢材质 Mop handles are aluminum with plastic ends and Mop handles are aluminum with plastic ends and head fittingshead fittings 拖把杆为铝材质，杆末端为塑料材质的杆套拖把杆为铝材质，杆末端为塑料材质的杆套 Equipment should be checked regularly if the Equipment should be checked regularly if the plastic has deep scratches or appears brittle it plastic has deep scratches or appears brittle it should be replacedshould be replaced 设备应进行定期检查，如塑料存在深的刮痕或有老化变脆设备应进行定期检查，如塑料存在深的刮痕或有老化