无菌工艺培训(默沙东).ppt
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1、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 mat
2、erials 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 Phar
3、maceutical 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
4、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。
5、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
6、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 conta
7、minates 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
8、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
9、 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
10、)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 MODULECL
11、EANING 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
12、 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 o
13、bjects 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
14、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
15、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
16、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 trace
17、ability 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 r
18、ate 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 Whe
19、n 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
20、 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
21、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-
22、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
23、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
24、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
25、 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 ster
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- 无菌 工艺 培训 默沙东
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