无菌工艺培训培训课件

无菌工艺培训无菌工艺培训无菌工艺培训2 2CLEANING 清洁清洁 Cleaning within a Pharmaceutical processing plant is a Cleaning within a Pharmaceutical processing plant is a criticalcritical activityactivity 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 processThere must be dedicated equipment for the cleaning process 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。剂及其配制。无菌工艺培训无菌工艺培训3 3CLEANING清洁清洁 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 activityCleaning has to be documented the same as any other activity 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无菌工艺培训无菌工艺培训4 4CLEANING ITS PURPOSE清洁目的清洁目的 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 from To remove as many particles or contaminates as possible from the area.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 7 daysdays 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）为保持期）为7 7天天 （从清洁当天开始计算）（从清洁当天开始计算）无菌工艺培训无菌工艺培训5 5CLEANING THE OUTCOME清洁的作用清洁的作用 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染处于较低水平 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来监测来监测无菌工艺培训无菌工艺培训6 6CLEANING MODULE清洁模块清洁模块 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 所使用的清洁设备所使用的清洁设备 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无菌工艺培训无菌工艺培训7 7WHAT ARE DISINFECTANTS什么是消毒剂什么是消毒剂 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 article Disinfection may be defined as:Cleaning an article of some or all of the pathogenic organisms which of some or all of the pathogenic organisms which may cause infectionmay cause infection 消毒可被定义为：清洁那些可能会造成传染的部分或消毒可被定义为：清洁那些可能会造成传染的部分或全部的病原微生物全部的病原微生物无菌工艺培训无菌工艺培训8 8DISINFECTANTS WE USE我们使用的消毒剂我们使用的消毒剂 VesphenellstVesphenellst 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杀孢子剂杀孢子剂无菌工艺培训无菌工艺培训9 9Vesphenellst碱性苯酚消毒剂碱性苯酚消毒剂 Process Vesphenellst is used in the Grade C and Process Vesphenellst is used in the Grade C and A/B areasA/B areas Process VesphenellstProcess Vesphenellst用于用于用于用于C C级区和级区和级区和级区和A/BA/B级洁净区级洁净区级洁净区级洁净区 Vesphenellst is a one step Vesphenellst is a one step alkaline phenolicalkaline phenolic disinfectantdisinfectant VesphenellstVesphenellst是一步是一步是一步是一步碱性酚类碱性酚类碱性酚类碱性酚类消毒剂消毒剂消毒剂消毒剂 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 包装是经过消毒的，贴有批号，标示有有效期用于追包装是经过消毒的，贴有批号，标示有有效期用于追溯溯无菌工艺培训无菌工艺培训1010VesphenellstVesphene碱性苯酚消毒剂碱性苯酚消毒剂 Vesphene is packed in a ready-to-use sachet with a Vesphene is packed in a ready-to-use sachet with a specific dilution ratespecific dilution rate VespheneVesphene是按即用型消毒剂包装的，按特定的稀释比是按即用型消毒剂包装的，按特定的稀释比例配制例配制 Vesphene kills a broad spectrum of micro-organisms Vesphene kills a broad spectrum of micro-organisms without harming surfaceswithout 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 disinfectant has a 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 10.4-10.6-10.6 无菌工艺培训无菌工艺培训1111LpH stLpH酸性的苯酚消毒剂酸性的苯酚消毒剂 Process LpH st is used in the Grade C and A/B Process LpH st is used in the Grade C and A/B areasareas Process LpH st Process LpH st 用于用于C C级区和级区和级区和级区和A/BA/B级洁净区级洁净区级洁净区级洁净区 LpH st is a one step LpH st is a one step acidic phenolicacidic phenolic disinfectant disinfectant LpH stLpH st是一步是一步是一步是一步酸性酚类酸性酚类酸性酚类酸性酚类消毒剂消毒剂消毒剂消毒剂 The packs are sterile and have The packs are sterile and have lot numberslot numbers and and expiry datesexpiry dates for traceability for traceability 包装是经过消毒的，贴有包装是经过消毒的，贴有批号批号，标示有，标示有有效期有效期用于追用于追溯溯无菌工艺培训无菌工艺培训1212LpH stLpH酸性的苯酚消毒剂酸性的苯酚消毒剂 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是按即用型消毒剂包装的，按特定的稀释比例配是按即用型消毒剂包装的，按特定的稀释比例配制制 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 a disinfectant has 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 2.6 3.03.0 无菌工艺培训无菌工艺培训1313DISINFECTANT ROTATION消毒剂轮换消毒剂轮换 Vesphenellst is an Vesphenellst is an alkaline alkaline disinfectantdisinfectant Vesphenellst Vesphenellst 为为碱性碱性消毒剂消毒剂 LpH st is an LpH st is an acidic acidic disinfectantdisinfectant LpH st LpH st 为为酸性酸性消毒剂消毒剂 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 消毒剂的轮换使用应确保微生物不会对消毒剂产生抗消毒剂的轮换使用应确保微生物不会对消毒剂产生抗性性无菌工艺培训无菌工艺培训1414Klercide 70/30Klercide 杀孢子剂杀孢子剂 Klercide 70/30 is a 70%IPA sterile ready to use sprayKlercide 70/30 is a 70%IPA sterile ready to use spray Klercide 70/30 Klercide 70/30 为为 70%70%的无菌的无菌IPA IPA（异丙醇），可直接使用（异丙醇），可直接使用 70%IPA and 30%deionised water70%IPA and 30%deionised water 由为由为 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 盛装用的瓶子经伽马射线灭菌，有双重胶塞盛装用的瓶子经伽马射线灭菌，有双重胶塞 Bottles have a batch number and expiry date-once opened Bottles have a batch number and expiry date-once opened they will have a they will have a ONE ONE month shelf lifemonth shelf life 瓶身贴有批号，标示有有效期，开封后有效期为瓶身贴有批号，标示有有效期，开封后有效期为一个月一个月无菌工艺培训无菌工艺培训1515Klercide 70/30Klercide 杀孢子剂杀孢子剂 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 用于杀灭微生物，生效要求一定的接触时间用于杀灭微生物，生效要求一定的接触时间 Quick and easy to useQuick and easy to use 简单便于使用简单便于使用 Has a number of uses onsiteHas a number of uses onsite 广泛用于生产现场的消毒：广泛用于生产现场的消毒：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：用于设备清洁擦拭无菌工艺培训无菌工艺培训1616Spor-KlenzSpor-Klenz杀孢子剂杀孢子剂 Spor-Klenz is a ready to use sporcidal disinfectantSpor-Klenz is a ready to use sporcidal disinfectant Spor-Klenz Spor-Klenz 为配制好的杀孢子消毒剂，可直接使用为配制好的杀孢子消毒剂，可直接使用 Effective at microbial control of bacteria,fungi,viruses and Effective at microbial control of bacteria,fungi,viruses and bacterial sporesbacterial spores 对微生物控制（细菌，真菌，病毒和细菌孢子）有效对微生物控制（细菌，真菌，病毒和细菌孢子）有效 Used at Biotech Plant as a spray disinfectant for equipment Used at Biotech Plant as a spray disinfectant for equipment going into the Grade A/B area that cannot be autoclaved.Or going into the Grade A/B area that cannot be autoclaved.Or when tools are needed in a breakdown situationwhen tools are needed in a breakdown situation 在生物技术工厂当做喷洒消毒剂来对那些进入在生物技术工厂当做喷洒消毒剂来对那些进入A/BA/B级洁净区而不级洁净区而不能通过灭菌柜灭菌的设备的消毒，或在设备故障时，用于对维能通过灭菌柜灭菌的设备的消毒，或在设备故障时，用于对维修工具的消毒修工具的消毒无菌工艺培训无菌工艺培训1717DISINFECTANTS WE USE我们所使用的消毒剂我们所使用的消毒剂EFFICENCY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无菌工艺培训无菌工艺培训1818DIFFERENT DISINFECTANTS各种消毒剂各种消毒剂 Alcohols 醇类 Oxidizing Agents氧化剂 Phenolics 酚类 Quaternary Ammonium季铵无菌工艺培训无菌工艺培训1919DIFFERENT DISINFECTANTS各种消毒剂各种消毒剂 Alcohols(IPA)Alcohols(IPA)have wide microbicidal activity,are have wide microbicidal activity,are non corrosive to surfacesnon corrosive to surfaces 醇类醇类(IPA)(IPA)对广泛的微生物有效，对各种表面不会有对广泛的微生物有效，对各种表面不会有腐蚀效果腐蚀效果 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无菌工艺培训无菌工艺培训2020DIFFERENT DISINFECTANTS各种消毒剂各种消毒剂 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的死亡 Sodium HypochloriteSodium Hypochlorite and and ChlorineChlorine are oxidizing are oxidizing agentsagents 次氯酸钠次氯酸钠和和氯氯为氧化剂为氧化剂 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：漂白剂漂白剂无菌工艺培训无菌工艺培训2121DIFFERENT DISINFECTANTS各种消毒剂各种消毒剂 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 对各种表面没有危害，但是存在残留对各种表面没有危害，但是存在残留无菌工艺培训无菌工艺培训2222DIFFERENT DISINFECTANTS各种消毒剂各种消毒剂 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 存在残留无菌工艺培训无菌工艺培训2323EFFECTIVENESS OF DISINFECTANTSEFFECTIVENESS OF DISINFECTANTS消毒剂消毒效果消毒剂消毒效果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 a The test disinfectant is compared with Phenol on a standard microbestandard microbe 消毒剂的消毒效果测试是通过对标准微生物进行消毒，消毒剂的消毒效果测试是通过对标准微生物进行消毒，与苯酚对比来确认与苯酚对比来确认无菌工艺培训无菌工艺培训2424EQUIPMENT 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，用于过滤从洁净室排除的空气于过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 6 every 6 monthsmonths 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无菌工艺培训无菌工艺培训2525EQUIPMENT 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所使用的清洁设备所使用的清洁设备-拖把头拖把头拖把头拖把头/抹布抹布抹布抹布/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 foam The mop head is covered with wipes to ensure pieces of foam are not detached during the cleaning processare 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开来 The wipes are lint free to ensure no particles are shed during The wipes are lint free to ensure no particles are shed during cleaningcleaning 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无菌工艺培训无菌工艺培训2626EQUIPMENT 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所使用的清洁设备所使用的清洁设备-拖把桶拖把桶拖把桶拖把桶/拖把杆拖把杆拖把杆拖把杆 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设备应进行定期检查，如塑料存在深的刮痕或有老化变脆的现象，应进行更换变脆的现象，应进行更换无菌工艺培训无菌工艺培训2727HOW DO WE PREPARE TO CLEAN THE AREA?HOW DO WE PREPARE TO CLEAN THE AREA?我们如何准备洁净室的清洁我们如何准备洁净室的清洁我们如何准备洁净室的清洁我们如何准备洁净室的清洁 Components have been autoclaved mop heads,handles,Components have been autoclaved mop heads,handles,buckets and wringers are assembledbuckets and wringers are assembled 相关清洁工具配件应通过灭菌柜传入洁净室，例如：拖把头，相关清洁工具配件应通过灭菌柜传入洁净室，例如：拖把头，拖把杆，拖把桶，不锈钢提手等拖把杆，拖把桶，不锈钢提手等 The disinfectants are ready to use in a sterile pouchThe disinfectants are ready to use in a sterile pouch 消毒剂已装入无菌袋备用消毒剂已装入无菌袋备用 Wipes and IPA are sterile and ready to useWipes and IPA are sterile and ready to use 抹布和抹布和IPAIPA已灭菌备用已灭菌备用下一步是什么？下一步是什么？无菌工艺培训无菌工艺培训2828HOW DO WE PREPARE TO CLEAN THE AREA?HOW DO WE PREPARE TO CLEAN THE AREA?我们如何准备洁净室的清洁我们如何准备洁净室的清洁我们如何准备洁净室的清洁我们如何准备洁净室的清洁 Then filter the WFI into the bucketsThen filter the WFI into the buckets 过滤过滤WFIWFI到拖把桶中到拖把桶中 Add the disinfectant and mix the solutionAdd the disinfectant and mix the solution 加入消毒剂，混合加入消毒剂，混合 Start to cleanStart to clean 开始清洁开始清洁是上面这么回事么？是上面这么回事么？无菌工艺培训无菌工艺培训2929CLEANING清洁清洁 为什么？为什么？The accurate dispense of WFI is criticalThe accurate dispense of WFI is critical WFIWFI的放入量是非常关键的的放入量是非常关键的 The disinfectant sachet must be emptied completely The disinfectant sachet must be emptied completely and rinsed in WFIand rinsed in WFI 消毒剂小包装袋内的消毒剂必须完全倒出，并用消毒剂小包装袋内的消毒剂必须完全倒出，并用WFIWFI对包装袋进行冲洗对包装袋进行冲洗 WFI should not be added to the disinfectantWFI should not be added to the disinfectant 应避免应避免WFIWFI被倒入消毒剂盛装容器中被倒入消毒剂盛装容器中 The solution must be mixed before proceedingThe solution must be mixed before proceeding 在执行清洁前，配制的消毒液应混合均匀在执行清洁前，配制的消毒液应混合均匀无菌工艺培训无菌工艺培训3030CLEANING清洁清洁 原因原因 WFI dilution factors of 1:128 or 1:256 are accurate process WFI dilution factors of 1:128 or 1:256 are accurate process measurements of the solution:measurements of the solution:WFIWFI稀释系数为稀释系数为1:128 1:128 或或1:2561:256为准确的消毒液配置比例为准确的消毒液配置比例 If its too weak it will not be as effective at killing the micro-If its too weak it will not be as effective at killing the micro-organisms organisms 消毒剂浓度太低会降低灭微生物效果消毒剂浓度太低会降低灭微生物效果 If its too strong it could damage the equipment ie cause rust,If its too strong it could damage the equipment ie cause rust,leave residues that could affect the equipment or it may not leave residues that could affect the equipment or it may not be effective be effective 浓度太高会破坏设备，例如：造成生锈，残留的消毒剂会影响浓度太高会破坏设备，例如：造成生锈，残留的消毒剂会影响设备，影响灭微生物效果设备，影响灭微生物效果无菌工艺培训无菌工艺培训3131CLEANING清洁清洁 原因原因 The disinfectant sachets are an exact volume to be a 1:128 or The disinfectant sachets are an exact volume to be a 1:128 or 1:256 dilution1:256 dilution 小包装的消毒剂的装量应适用小包装的消毒剂的装量应适用1 1：128128或或1 1：256256的比例稀释的比例稀释 If volume of sachets are not used the solution will be again If volume of sachets are not used the solution will be again either too weak or too strongeither too weak or too strong 如果小包装的装量不符合此比例系数，所配置的溶液就可能会如果小包装的装量不符合此比例系数，所配置的溶液就可能会浓度太低或太高浓度太低或太高 Rinsing the sachets ensure all the contents have been Rinsing the sachets ensure all the contents have been emptied from sachetemptied from sachet 用用WFIWFI冲洗小包装袋，应确保所有的内容物都被冲洗出袋子冲洗小包装袋，应确保所有的内容物都被冲洗出袋子无菌工艺培训无菌工艺培训3232CLEANING清洁清洁 原因原因 WFI is added first as the disinfectant sachets are WFI is added first as the disinfectant sachets are concentrated.As one or two drops splashed could:concentrated.As one or two drops splashed could:因为消毒剂的浓度很高，应先加入因为消毒剂的浓度很高，应先加入WFIWFI，如果有一两，如果有一两滴消毒剂洒落可能会造成：滴消毒剂洒落可能会造成：Alter the dilution factorAlter the dilution factor 稀释因数的改变稀释因数的改变 Erode the equipment or surfaces that it has Erode the equipment or surfaces that it has splashed onto because it is so concentratedsplashed onto because it is so concentrated 因为浓度高，腐蚀掉落在的设备或表面因为浓度高，腐蚀掉落在的设备或表面无菌工艺培训无菌工艺培训3333CLEANING-NOTES清洁清洁 注意事项注意事项 Mixing the solution before proceeding ensures a Mixing the solution before proceeding ensures a homogeneous mixhomogeneous mix 在执行清洁前，确保消毒液混合均匀在执行清洁前，确保消毒液混合均匀 Ensures the dilution factor is correct before applying to Ensures the dilution factor is correct before applying to equipment and surfacesequipment and surfaces 在使用消毒液清洁设备和各种表面，确保稀释因数正确在使用消毒液清洁设备和各种表面，确保稀释因数正确 Weak solution doesnt kill the micro-organsimsWeak solution doesnt kill the micro-organsims 消毒液浓度太低的话，不能灭杀微生物消毒液浓度太低的话，不能灭杀微生物 Strong solutions harms the surfacesStrong solutions harms the surfaces 消毒液浓度太高，会损坏表面消毒液浓度太高，会损坏表面无菌工艺培训无菌工艺培训3434CLEANING PROCESS清洁程序清洁程序-洁净区清洁洁净区清洁无菌工艺培训无菌工艺培训3535VACUUM PROCESS真空吸尘器清洁真空吸尘器清洁 Vacuuming is done at the end of a batch runVacuuming is done at the end of a batch run 在批次运行结束时使用真空吸尘器清洁在批次运行结束时使用真空吸尘器清洁 It collects larger items from the floor ie stoppers,pieces of It collects larger items from the floor ie stoppers,pieces of autoclave tape autoclave tape 在这个过程中会收集地上较大体积的物体，例如：胶塞，灭菌在这个过程中会收集地上较大体积的物体，例如：胶塞，灭菌指示带指示带 Effective at large particle removal the HEPA filter in the Effective at large particle removal the HEPA filter in the vacuum prevents the redeposit of particlesvacuum prevents the redeposit of particles 有效清除大颗粒，在真空吸尘器清洁时移除有效清除大颗粒，在真空吸尘器清洁时移除HEPAHEPA过滤器，以避过滤器，以避免尘埃粒子的再沉积免尘埃粒子的再沉积无菌工艺培训无菌工艺培训3636MOPPING PROCESS拖把擦拭拖把擦拭 Wet mopping is the Wet mopping is the most effectivemost effective method for method for removing particleremoving particle contaminantscontaminants from the area.from the area.用湿拖把拖地，是移除洁净区的用湿拖把拖地，是移除洁净区的尘埃粒子污染尘埃粒子污染是是最有最有效的方法效的方法 The The two buckettwo bucket method ensures that the method ensures that the redeposit of contaminates is controlled.redeposit of contaminates is controlled.采用两拖把桶的方式，来确保污染物再沉积的控制采用两拖把桶的方式，来确保污染物再沉积的控制无菌工艺培训无菌工艺培训3737TWO BUCKET SYSTEM两拖把桶系统两拖把桶系统 Bucket One(1)is used to apply the fresh disinfectant solutionBucket One(1)is used to apply the fresh disinfectant solution 桶一桶一(1)(1)用于更新消毒液用于更新消毒液 Bucket Two(2)is used to rinse the mop,and to hold the used Bucket Two(2)is used to rinse the mop,and to hold the used disinfectant solutiondisinfectant solution 桶二桶二(2)(2)用于清洗抹布和盛装使用过的消毒液用于清洗抹布和盛装使用过的消毒液12无菌工艺培训无菌工艺培训3838SURFACE