一．目的Objective 规范公司各类清洁剂和消毒剂的配制方法、使用范围及配制、使用过程注意事项，确保清洁剂、消毒剂的合理使用，防止产生污染和交叉污染。 Standardise the preparation method、scope of use and notes of detergent and disinfectant，ensure the reasonable use of them to avoid contamination and cross-contamination.
二．适用范围Scope 适用于各车间清洁剂和消毒剂的配制和使用过程。 Apply to the preparation and using course of detergent and disinfectant in the workshop.
三．责任者Responsibilities 卫生员及其它清洁剂和消毒剂使用人员：按本规程要求进行清洁剂和消毒剂的配制、使用。 The sanitation man / user: Prepare and use the disinfectant according to the content of this SOP. 班长/IPC人员：按本规程要求对清洁剂和消毒剂的配制、使用情况进行检查复核。
The team leader、IPC: Supervise and ensure this SOP to act effectively. 车间主任/QA巡检员：按本规程要求对清洁剂和消毒剂的日常使用过程进行监督检查。 Workshop director、Patrol members：Supervise and inspect the use of detergent and disinfectant is follow this SOP.
四．相关定义Definition 清洁剂：是指用于去除被清洁表面存在的物理或化学性质可见残留物以及潜在微生物残留物的一种介质。 Detergent: It is a media that used to remove the physical or chemical visible residues on the surface or residues of potential microbial. 消毒剂：消毒时所使用的化学试剂，应能使致病微生物数量在5-10分钟内下降99.999%。 Disinfectant: It is a chemical reagent used in the disinfection，should enable the number of pathogenic micro-organisms decreased by 99.999% within 5-10 minutes.
五．工作程序Procedure 1.清洁剂Detergent 1.1.使用原则The principle of using 洁净级别 清洁剂种类 使用要求 Cleanliness levels Variety of Detergent Requirements of using
A/B级区域 A/B-clean areas
0.2%、1%或2%氢氧化钠溶液或WFI
0.2%、1%or 2% sodium hydroxide solution and WFI 进入A/B级区域
的清洁剂需经过除菌过滤，清洁剂清洁表面不得超出其规定使用范围.The detergent must be aseptic when it was used in A/B-clean areas，and detergent must be used for the correct areas.
C级区域 C -clean areas and 食用洗洁精Edible cleanser essence、0.2%、1%或2%氢氧化钠溶液0.2%、1%or 2% sodium hydroxide solution、洗手液/洗衣液Hand sanitizer and liquid detergent、CIP100、WFI、Pure water
D级区域 D -clean areas
食用洗洁精Edible cleanser essence、0.2%、1%或2%氢氧化钠溶液0.2%、1%or 2% sodium hydroxide solution、洗手液/洗衣液Hand sanitizer and liquid detergent、2.0%Na2CO3溶液Solution of 2.0%Na2CO3、CIP100、WFI、Pure water
一般区General area 食用洗洁精Edible cleanser essence、洗衣粉Detergent powder、0.2%、1%或2%氢氧化钠溶液0.2%、1%or 2% sodium hydroxide solution、洗手液/洗衣液Hand sanitizer and liquid detergent、洁厕粉Toilet-cleaning powder、Pure water、Drinking water 1.2.食用洗洁精Edible cleanser essence 1.2.1.组成Composition 本品主要含表面活性剂、水助溶剂、软化水。 This product mainly contains surfactant, water cosolvent, softened water. 1.2.2.使用Use －适用于各种设备、容器具、工器具及玻璃、陶瓷表面的清洗，清洗设备时，仅限于设备外表面的清洁。 Apply to clean all kinds of equipment、containers、tools and the surface of glass、ceramic. It only used for cleaning the tools and equipment (outside surface)。 －在工艺用水中加入适量的洗洁精，配成清洗液，用抹布等工具蘸洗。 Pour appropriate amount of cleaner essence into the process water, and mix them to detergent，then use the rag to dipping wash. 1.2.3.贮存及注意事项Storage and Precautions －应置于阴凉处，避热、避光保存。 Should be placed in a cool place, avoid heat, protected from light. －优选无特殊气味、应用广泛的常用品牌，如白猫洗洁精。 Preferred no special odor, widely used brands, such as white cat detergent. 1.3.洗衣粉Detergent powder 1.3.1.组成Composition 本品主要含表面活性剂、代磷助剂、进口白色蛋白酶。 This product mainly contains surfactants, replacing phosphorus additives, imported white protease. 1.3.2.使用Use －适用于一般区各种不与药品直接接触的设备、工器具及玻璃、陶瓷表面 的清洗以及一般区工作服、工作鞋的清洗。 Apply to clean all kinds of equipment、tool and the surface of glass、ceramic which don’t contact with the production directly in general area，and clothes、shoes in general area. －在工艺用水中加入适量的洗衣粉，配成溶液，用抹布等工具蘸洗。 Pour appropriate amount of detergent powder into the process water, and mix them to solution, then use the rag to dipping wash. 1.3.3.贮存及注意事项Storage and notes －应置于阴凉、干燥处，避热、避湿、避光。 Put the detergent on the cool、dry place, avoid the heat、wet and light. －不慎溅入眼中，即用水冲洗。 If not be careful to splash into the eyes, wash with water immediately. －水温为室温为宜，切忌用70℃以上的热水。 The appropriate temperature of water is room temperature, don’t use the water above 70℃. －优选无特殊气味、应用广泛的常用品牌洗衣粉，如佳佳。 Preferred no special odor, widely used brand of detergent powder, such as Jiajia detergent powder. 1.4.0.2%、1%或2%氢氧化钠溶液0.2%、1%or 2% sodium hydroxide solution 1.4.1.使用Use 本品用于管道、贮罐及容器、工具的清洗处理。 This product apply to clean the pipeline and tank、container and tool. 1.4.2.配制Preparation －称取2gNaOH＋998g工艺用水溶解混匀，即可配制成0.2%的氢氧化钠溶液。 Weigh 2g NaOH＋998g process water , dissolve them and mix evenly to make into the 0.2% sodium hydroxide solution. －称取1gNaOH＋99g工艺用水溶解混匀，即可配制成1%的氢氧化钠溶液。 Weigh 1g NaOH＋99g process water , dissolve them and mix evenly to make into the 1% sodium hydroxide solution. －称取2gNaOH＋98g工艺用水溶解混匀，即可配制成2%的氢氧化钠溶液。 Weigh 2g NaOH＋98g process water , dissolve them and mix evenly to make into the 2% sodium hydroxide solution. 1.4.3.贮存及注意事项Storage and notes －应置于阴凉、干燥处，避热、避湿、避光。 Put the detergent on the cool、dry place, avoid the heat、wet and light. －不慎溅入眼中，即用水冲洗。 1.5.洗手液/洗衣液Hand sanitizer and liquid detergent 1.5.1.组成Composition 本品主要含磺酸、AES、6501。 This product mainly contains sulphur acid, AES, 6501. 1.5.2.使用Use －用于手的清洗或洁净区工作服、鞋的清洗。