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
2、何正确的清洁,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
3、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 PUR
4、POSE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
5、开始计算）,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
6、 cleaning 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
7、 so important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 o
8、rganisms 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
9、 and A/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 i
10、n a ready-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 - 1
11、0.6,清洁模块 CLEANING 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 CLEA
12、NING MODULE,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
13、时，其酸性消毒剂的pH范围为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
14、毒剂产生抗性,清洁模块 CLEANING 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 batc
15、h number and expiry 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
16、泛用于生产现场的消毒：Eg. used in 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
17、, fungi, viruses and bacterial 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 CLEANI
18、NG MODULE,18,DISINFECTANTS 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 (
19、IPA) have wide microbicidal 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,Oxidizin
20、g disinfectants affect the cell membrane, 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,Phenolic
21、s are the active ingredient in some 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
22、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 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
23、来确认的Phenol is the standard and the rating 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
24、 used in the Clean room is different 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
25、更换一次,清洁模块 CLEANING MODULE,26,EQUIPMENT 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 partic
26、les are shed during cleaning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 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 plas
27、tic ends and head fittings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 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 mo
28、p heads, handles, buckets 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，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 ARE
29、A ?我们如何准备洁净室的清洁,Then filter the WFI into the 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 comple
30、tely and rinsed in WFI消毒剂小包装袋内的消毒剂必须完全倒出，并用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
31、solution:WFI稀释系数为1:128 或1:256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-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
32、灭微生物效果,REASON WHY,清洁模块 CLEANING MODULE,32,CLEANING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 sac
33、hets ensure all the contents have been emptied 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
34、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,CLEANING - NOTES清洁 注意事项,Mixing the solution before proceeding ensures a homogeneous mix在执行清洁前，确保消毒液混合均匀Ensures the dilution factor is correct before applying
35、 to equipment 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Weak solution doesnt kill the micro-organsims消毒液浓度太低的话，不能灭杀微生物Strong solutions harms the surfaces消毒液浓度太高，会损坏表面,REASON WHY,清洁模块 CLEANING MODULE,35,CLEANING PROCESS清洁程序-洁净区清洁,AREA CLEANING,清洁模块 CLEANING MODULE,36,VACUUM PROCESS真空吸尘器清洁,Vacuuming is done
36、 at the end of a batch run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 autoclave tape 在这个过程中会收集地上较大体积的物体，例如：胶塞，灭菌指示带Effective at large particle removal the HEPA filter in the vacuum prevents the redeposit of particles有效清除大颗粒，在真空吸尘器清洁时移除HEPA过滤器，以避免尘埃粒子的再沉积,清洁模块 CLEA
37、NING MODULE,37,MOPPING PROCESS拖把擦拭,Wet mopping is the most effective method for removing particle contaminants from the area. 用湿拖把拖地，是移除洁净区的尘埃粒子污染是最有效的方法The two bucket method ensures that the 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,清洁模块 CLEANING MODULE,38,TWO BUCKET SYSTEM两拖把桶
38、系统,Bucket One (1) is used to apply the fresh disinfectant solution桶一(1)用于更新消毒液Bucket Two (2) is used to rinse the mop, and to hold the used disinfectant solution桶二(2)用于清洗抹布和盛装使用过的消毒液,1,2,清洁模块 CLEANING MODULE,39,SURFACE CONTACT表面接触,For the effective removal of contaminants there must be 100% contact
39、on the surface area with the mop and the disinfectant 为确保有效移除污染物，应用抹布和消毒液100%接触所清洁表面Frames, hinges are difficult to clean and special attention should be paid to these areas 一些难以清洁的表面，例如：架子，铰链等，清洁时应对这些区域特别注意,清洁模块 CLEANING MODULE,40,YOU MISSED ME!你把我给忘了！,AAGH啊啊啊,DOOR FRAME 门框,HINGE铰链,清洁模块 CLEANING MO
40、DULE,41,MOPPING ISSUES擦拭注意事项,Over wetting of the mop head can redeposit the contaminants拖把头抹布太湿了会造成污染物的再沉积 这是为啥呢？,HOW ?,清洁模块 CLEANING MODULE,42,MOPPING ISSUES擦拭注意事项,Wet the mop head 湿的拖把头Mop the surface 擦拭表面多的水Excess water,CONTAMINANTS FROM CLEANING清洁造成污染,清洁模块 CLEANING MODULE,43,MOPPING TECHNIQUES擦拭
41、技巧,DRIEST 尽量拧干,WETTEST最湿,CLEANIEST清洁效果最好,DIRTIEST还是埋汰,清洁模块 CLEANING MODULE,44,MOPPING TECHNIQUES FOR CEILINGS擦拭技巧-对天花板,Use unidirectional strokes this can be left to right, or right to left but not mixed单向擦拭，可以从左到右，也可以从右到左，但是，不可以一会向左一会向右混合！Avoid over wetting of mop head as splashes could land on top
42、 of LAF cart or other equipment in the area避免使用过湿的拖把，水渍可能会溅落到洁净区内层流罩或其他设备上,清洁模块 CLEANING MODULE,45,MOPPING TECHNIQUES FOR WALLS AND WINDOWS擦拭技巧-对墙面和窗户,Use unidirectional strokes, this must be from TOP to BOTTOM单向擦拭，必须从上到下Strokes must be OVERLAPPING擦拭必须重叠 这是为什么呢？,WHY?,清洁模块 CLEANING MODULE,46,MOPPING
43、TECHNIQUES FOR WALLS AND WINDOWS擦拭技巧-对墙面和窗户,The mop head should be rinsed off and fresh disinfectant applied regularly拖把头应定期冲洗和更新消毒液,WHY?,清洁模块 CLEANING MODULE,47,MOPPING TECHNIQUES FOR WALLS AND WINDOWS擦拭技巧-对墙面和窗户,You should NOT be able to clean a whole length of wall with one application of disinfe
44、ctant你不可能在使用一次消毒液的情况下就将整个墙面清洁完,WHY?,清洁模块 CLEANING MODULE,48,MOPPING TECHNIQUES FOR WALLS AND WINDOWS擦拭技巧-对墙面和窗户,The Cleaning process is CRITICAL to the area, the pace should be slow and deliberate, the same as normal operations清洁程序对洁净区来说是非常关键的，清洁速度应慢，清洁应仔细，和正常的操作一样,WHY?,清洁模块 CLEANING MODULE,49,MOPPI
45、NG TECHNIQUES FOR WALLS AND WINDOWS擦拭技巧-对墙面和窗户,The purpose of Cleaning is to remove as many particles or contaminates as possible from the area清洁的目的在于尽可能的将洁净区的尘埃粒子和污染物移除When you rush around, you sweat and generate particles.当你在洁净室东奔西跑的时候，你会流汗，产生尘埃粒子,清洁模块 CLEANING MODULE,50,PARTICLE GENERATION尘埃粒子的产生
46、,清洁模块 CLEANING MODULE,51,WIPING SURFACES擦拭表面,When wiping tables or surfaces use unidirectional strokes 在擦拭桌子或表面时应单向操作Strokes should be slightly overlapping擦拭应稍微重叠Refold wipe after each pass so surface is exposed to a fresh wipe surface 每次擦拭后，折叠抹布，这样表面总是接触的新的抹布表面,清洁模块 CLEANING MODULE,52,MOPPING TECHN
47、IQUES FOR FLOORS擦拭技巧-地面,Use unidirectional strokes单向擦拭The stroke must be a pulled stroke应为拉向擦拭The strokes must be slightly overlapping擦拭应稍微重叠The stroke must be the length you can reach comfortably with the mop擦拭长度应为使用拖把时能够正常够到的长度Avoid over wetting the mop head 避免过度润湿拖把头,清洁模块 CLEANING MODULE,53,AFTER
48、 CLEANING清洁后,The next step after cleaning is to: 清洁过后的操作：Update the Status Boards更新状态标识Fill in the Lumac Logbook填写清洁日志,清洁模块 CLEANING MODULE,54,CLEANING VERIFICATION清洁确认,After the cleaning process there is process controls in place to ensure that it was effective在完成清洁程序后，应有工艺控制来确保清洁的有效性 工艺控制在哪？,WHAT ARE THE PROCESS CONTROLS?,清洁模块 CLEANING MODULE,55,CLEANING VERIFICATION清洁确认,We perform routine weekly Environmental Monitoring of the areas我们每周对洁净区进行环境监测In-line system - Particle Monitoring在线系统-尘埃粒子监测Settle Plates沉降菌Air Sampling空气采样Rodac Plates表面接触碟采样,
