1、清洁模块 CLEANING MODULE,1,ASEPTIC PROCESSING无菌工艺,CLEANROOM CLEANING EQUIREMENT洁净室-清洁设备,清洁模块 CLEANING MODULE,2,OBJECTIVES 目的,At the end of this module:在完成此模块培训后应明白：Understand the materials and disinfectants used.所使用的材料及消毒剂Why we clean in a particular way 为什么我们用特殊的方式来清洁 How to clean in the correct way.如何
2、正确的清洁,清洁模块 CLEANING MODULE,3,CLEANING 清洁,Cleaning within a Pharmaceutical processing plant is a critical activity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 process必须明确清洁程序所使用的设备Detailed procedures on how to clean,which disinfectants to use and the dilutions to be used for th
3、e 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配制。,WHY?,清洁模块 CLEANING MODULE,4,CLEANING清洁,Cleaning has to be a validated process清洁应是一个已验证的程序Cleaning has to be documented the same as any other activity清洁应和其它工序一样，有相关的记录为什么清洁如此重要,WHY,IS CLEANING SO IMPORTANT,?,清洁模块 CLEANING MODULE,5,CLEANING ITS PURPO
4、SE清洁目的,To kill any micro-organisms that are present杀灭任何存在的微生物To remove as many particles or contaminates as possible from the area.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 7 days from the day it was cleaned(Hold Time)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7天（从清洁当天开始计算）,
5、清洁模块 CLEANING MODULE,6,CLEANING THE OUTCOME清洁的作用,Cleaning the Cleanroom correctly will help to maintain low levels 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较低水平Ensure the area is clean for the 7 day hold period确保洁净室处于清洁有效期内（7天）The effectiveness of the clean
6、ing process can be monitored through the environmental monitoring system and the PMS清洁程序的效果可通过环境监测和PMS来监测,清洁模块 CLEANING MODULE,7,CLEANING MODULE清洁模块,我们将要学习的内容：Review the disinfectants used in the area回顾我们在洁净区使用的消毒剂Equipment used to clean the area所使用的清洁设备Techniques used to clean清洁技术Why they are so im
7、portant为什么上述项目很重要,WHAT WILL WE LEARN?,清洁模块 CLEANING MODULE,8,WHAT ARE DISINFECTANTS什么是消毒剂,Disinfectants are antimicrobial agents that are applied 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Disinfection may be defined as:Cleaning an article of some or all of the pathogenic organism
8、s which 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的病原微生物,清洁模块 CLEANING MODULE,9,DISINFECTANTS WE USE我们使用的消毒剂,VesphenellstVesphene碱性苯酚消毒剂LpH stLpH酸性的苯酚消毒剂Klercide 70/30Klercide杀孢子剂Spor-KlenzSpor-Klenz杀孢子剂,清洁模块 CLEANING MODULE,10,Vesphenellst碱性苯酚消毒剂,Process Vesphenellst is used in the Grade C and A/
9、B areasProcess Vesphenellst用于C级区和A/B级洁净区Vesphenellst is a one step alkaline phenolic disinfectantVesphenellst是一步碱性酚类消毒剂The packs are sterile and have lot numbers and 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溯,清洁模块 CLEANING MODULE,11,VesphenellstVesphene碱性苯酚消毒剂,Vesphene is packed in a rea
10、dy-to-use sachet with a specific dilution rateVesphene是按即用型消毒剂包装的，按特定的稀释比例配制Vesphene kills a broad spectrum of micro-organisms without harming surfacesVesphene可杀灭广谱微生物，不会损害各种表面When Vesphene is diluted,this alkaline disinfectant has a pH range of 10.4-10.6 当Vesphene被稀释时，其碱性消毒剂的pH范围为10.4-10.6,清洁模块 CLE
11、ANING MODULE,12,LpH stLpH酸性的苯酚消毒剂,Process LpH st is used in the Grade C and A/B areasProcess LpH st 用于C级区和A/B级洁净区LpH st is a one step acidic phenolic disinfectantLpH st是一步酸性酚类消毒剂The packs are sterile and have lot numbers and 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溯,清洁模块 CLEANING MODULE,
12、13,LpH stLpH酸性的苯酚消毒剂,LpH is packed in a ready-to-use sachet with a specific dilution rateLpH是按即用型消毒剂包装的，按特定的稀释比例配制LpH st kills a broad spectrum of micro-organisms without harming surfacesLpH可杀灭广谱微生物，不会损害各种表面When LpH is diluted,this acidic disinfectant has a pH range of 2.6 to 3.0当LpH被稀释时，其酸性消毒剂的pH范围
13、为2.6 3.0,清洁模块 CLEANING MODULE,14,DISINFECTANT ROTATION消毒剂轮换,Vesphenellst is an alkaline disinfectantVesphenellst 为碱性消毒剂LpH st is an acidic disinfectantLpH st 为酸性消毒剂Rotation of disinfectants ensures that that micro-organisms dont build up a tolerance to the disinfectant消毒剂的轮换使用应确保微生物不会对消毒剂产生抗性,清洁模块 C
14、LEANING MODULE,15,Klercide 70/30Klercide 杀孢子剂,Klercide 70/30 is a 70%IPA sterile ready to use sprayKlercide 70/30 为 70%的无菌IPA（异丙醇），可直接使用70%IPA and 30%deionised water由为 70%的IPA（异丙醇）和30%的去离子水配制而成The 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Bottles have a batch number and expiry
15、 date-once opened they will have a ONE month shelf life瓶身贴有批号，标示有有效期，开封后有效期为一个月,清洁模块 CLEANING MODULE,16,Klercide 70/30Klercide 杀孢子剂,Works to kill micro-organisms but requires a contact time to be effective用于杀灭微生物，生效要求一定的接触时间Quick and easy to use简单便于使用Has a number of uses onsite广泛用于生产现场的消毒：Eg.used in
16、 Grade A/B as gloved hands sanitiser 例如：用于A/B级区手套的消毒Eg.for cleaning or wiping down of equipment例如：用于设备清洁擦拭,清洁模块 CLEANING MODULE,17,Spor-KlenzSpor-Klenz杀孢子剂,Spor-Klenz is a ready to use sporcidal disinfectantSpor-Klenz 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 bact
17、erial spores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 going into the Grade A/B area that cannot be autoclaved.Or when 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A/B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，用于对维修工具的消毒,清洁模块 CLEANING MODULE,18,DISINFECTANTS
18、 WE USE我们所使用的消毒剂,EFFICENCY消毒效果,Disinfectants cannot sterilise the object or area消毒剂不能灭菌物体或洁净区,清洁模块 CLEANING MODULE,19,DIFFERENT 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 CLEANING MODULE,20,DIFFERENT DISINFECTANTS各种消毒剂,Alcohols(IPA)have wide microbicidal
19、activity,are non corrosive to surfaces醇类(IPA)对广泛的微生物有效，对各种表面不会有腐蚀效果They leave little residue due to the evaporation可挥发，残留量小Alcohols(IPA)are not effective against fungal or bacterial spores醇类(IPA)对真菌或细菌孢子无效,清洁模块 CLEANING MODULE,21,DIFFERENT DISINFECTANTS各种消毒剂,Oxidizing disinfectants affect the cell m
20、embrane,this 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亡Sodium Hypochlorite and Chlorine are oxidizing agents次氯酸钠和氯为氧化剂Household example of these would be Bleach 家用的消毒剂也有这类型的，例如：漂白剂,清洁模块 CLEANING MODULE,22,DIFFERENT DISINFECTANTS各种消毒剂,Phenolics are the active ingredient in som
21、e disinfectants and mouthwashes酚类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 bacteria对广谱细菌能够有效杀灭They do not harm surfaces but there is residual build up对各种表面没有危害，但是存在残留,清洁模块 CLEANING MODULE,23,DIFFERENT DISINFECTANTS各种消毒剂,Quaternary ammoniums are effective against bacteria but
22、 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 CLEANING MODULE,24,EFFECTIVENESS OF DISINFECTANTS消毒剂消毒效果,The effectiveness of a disinfectants is done by comparing 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Phenol is the standard and the ra
23、ting system is called the“Phenol Coefficient”已知标准为苯酚，其评级系统被称为“苯酚系数”The test disinfectant is compared with Phenol on a 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，与苯酚对比来确认,清洁模块 CLEANING MODULE,25,EQUIPMENT USED TO CLEAN VACUUM CLEANER所使用的清洁设备-真空吸尘器,The Vacuum cleaner used in the Clean room is different f
24、rom 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The vacuum is fitted with a HEPA filter which filters the exhaust air being discharged in the Cleanroom 洁净室所使用的真空吸尘器配备有HEPA过滤器，用于过滤从洁净室排除的空气The HEPA filter on the vacuum is changed every 6 months吸尘器中的HEPA过滤器每6个月更换一次,清洁模块 CLEANING MODULE,26,EQUIPMENT
25、 USED TO CLEAN MOP HEADS/WIPES/IPA所使用的清洁设备-拖把头/抹布/IPA,The mop heads are foam拖把头材质为泡沫塑料The mop head is covered with wipes to ensure pieces of foam 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The wipes are lint free to ensure no particles are shed during cleaning抹布为无绒材质，以确
26、保在清洁过程中不会有微粒脱落The wipes are gamma irradiated to ensure sterility抹布应通过伽马曲线灭菌来确保无菌性,清洁模块 CLEANING MODULE,27,EQUIPMENT USED TO CLEAN MOP BUCKETS/HANDLES所使用的清洁设备-拖把桶/拖把杆,Plastic buckets with stainless steel wringers拖把桶为塑料材质，提手为不锈钢材质Mop handles are aluminum with plastic ends and head fittings拖把杆为铝材质，杆末端为
27、塑料材质的杆套Equipment should be checked regularly if the plastic has deep scratches or appears brittle it should 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的现象，应进行更换,清洁模块 CLEANING MODULE,28,HOW DO WE PREPARE TO CLEAN THE AREA?我们如何准备洁净室的清洁,Components have been autoclaved mop heads,handles,buckets and wringers ar
28、e 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，拖把杆，拖把桶，不锈钢提手等The disinfectants are ready to use in a sterile pouch消毒剂已装入无菌袋备用Wipes and IPA are sterile and ready to use抹布和IPA已灭菌备用下一步是什么？,WHAT IS THE NEXT STEP?,清洁模块 CLEANING MODULE,29,HOW DO WE PREPARE TO CLEAN THE AREA?我们如何准备洁净室的清洁,Then filter the WFI into th
29、e buckets过滤WFI到拖把桶中Add the disinfectant and mix the solution加入消毒剂，混合Start to clean开始清洁是上面这么回事么？,IS THIS WHAT HAPPENS?,清洁模块 CLEANING MODULE,30,CLEANING清洁 为什么？,The accurate dispense of WFI is criticalWFI的放入量是非常关键的The disinfectant sachet must be emptied completely and rinsed in WFI消毒剂小包装袋内的消毒剂必须完全倒出，并用
30、WFI对包装袋进行冲洗WFI should not be added to the disinfectant应避免WFI被倒入消毒剂盛装容器中The solution must be mixed before proceeding在执行清洁前，配制的消毒液应混合均匀,WHY?,清洁模块 CLEANING MODULE,31,CLEANING清洁 原因,WFI dilution factors of 1:128 or 1:256 are accurate process measurements of the solution:WFI稀释系数为1:128 或1:256为准确的消毒液配置比例If
31、its too weak it will not be as effective at killing the micro-organisms 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,leave residues that could affect the equipment or it may not 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设备，影响灭微生物效果,REASON WHY,清洁模块 CLEANING MODULE,32,CL
32、EANING清洁 原因,The disinfectant sachets are an exact volume to be a 1:128 or 1:256 dilution小包装的消毒剂的装量应适用1：128或1：256的比例稀释If volume of sachets are not used the solution will be again either 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浓度太低或太高Rinsing the sachets ensure all the contents have been empti
33、ed from sachet用WFI冲洗小包装袋，应确保所有的内容物都被冲洗出袋子,REASON WHY,清洁模块 CLEANING MODULE,33,CLEANING清洁 原因,WFI is added first as the disinfectant sachets are concentrated.As one or two drops splashed could:因为消毒剂的浓度很高，应先加入WFI，如果有一两滴消毒剂洒落可能会造成：Alter the dilution factor稀释因数的改变Erode the equipment or surfaces that it has splashed onto because it is so concentrated因为浓度高，腐蚀掉落在的设备或表面,REASON WHY,清洁模块 CLEANING MODULE,34,CL
