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1、题目： 纯化水系统的质量监测TitleMONITORING THE PURIFIED WATER SYSTEM起草/修订人：日期AuthorDate部门主管审查：日期Dept. Head ApprovalDateQA批准：日期Approved by QADate分 发：QA、QC、工程Distribution: QA, QC, Engineering目的：PURPOSE:制订纯化水系统的日常质量监测及偏差处理规程，确保纯化水的质量符合要求。 This document defines the procedure for routine quality monitoring and deviat
2、ion disposition on purified water system to ensure the purified water quality meets the requirement.范围：适用于公司内纯化水系统（包括纯化水制备系统、纯化水使用点及取样点）的日常质量监 测。在非日常监测(如验证、再验证以及要求的研究)期间，根据具体的监测方案进行；在此 期间相关的日常监测暂停。SCOPE:This SOP is applicable to the routine monitoring on purified water system (includingpurified wate
3、r generator system, use points and sampling points)参考文件：REFERENCE AND ATTACHMENT:SOP/题目 SOP/TITLE1-3002偏差调查Deviation InvestigationsDuring the non-routine monitoring period (such as validation, re-validation and special studies), the monitoring will be conducted in accordance with the specific protoc
4、ol. The routine monitoring can be paused during such non-routine monitoring period.记录/附件/题目 FORMS/ATTACHMENTS/TITLE附件1：纯化水系统中的使用点和取样点Attachment 1: Point-of-use and sampling point locations in the purified water systemF-02-014 纯化水系统取样记录Purified water system sampling logbook定 义： N/ADEFINITIONS:规 程：PRO
5、CEDURE:题目： 纯化水系统的质量监测TitleMONITORING THE PURIFIED WATER SYSTEM责任人操作RESPONSIBILITY ACTION1. 系统描述SYSTEM DESCRIPTION1.1 纯化水系统由 2 部分组成： Purified water system consists of 2 portions:1.1.1 制备系统：包括相应的设备单元和管路。Generator system：Elements include the appropriate equipment unit and the pipes.1.1.2 循环管路系统：纯化水的循环分
6、配管路。Pipe loop: Distribution loop.1.2 纯化水系统中的使用点和取样点，见附件 1。 The point-of-use and sampling point locations in the purified water system please see Attachment 1.2. 日常监测ROUTINE MONITORING2.1 监测点及监测频率 Monitoring points and sampling frequency2.1.1 循环管路 Pipe loop 2.1.1.1 对于有4至7天的正常工作周，每周(至少每隔23天1 次)取样监测2次。
7、如果工作周为3天或更少，则每次取样 1 次。如果由于停产而不使用水，日常取样可不进行。 Collect water samples twice per week (at least once every two or three days) for normal workweeks of four to seven days. If the workweek is three days or less, collect samples once per week. If the water is not being used due to a shutdown, routine samplin
8、g may not be performed.2.1.1.1.1 纯化水贮罐、循环管路紫外灯后出水、总回水： 每次均取样。Storage tank, sampling point after UV sterilizer in the circulating system, loop return: should be sampled each time.2.1.1.1.2其余使用点/取样点：每次从其中随机抽取一点Other points-of-use and sampling points: one point will be sampled random each time.题目：Title
9、纯化水系统的质量监测MONITORING THE PURIFIED WATER SYSTEM责任人操作RESPONSIBILITY ACTION2.1.2 制备系统（仅供参考） Generator system （for information only）2.1.2.1 每月（一般为每月的第一个工作周）取样监测 1次。Collect water samples once a month （normally, the first week every month）.2.1.2.1.1 纯化水系统的原水（注：每年至少送卫生防疫部 门检验一次）Source water of the generato
10、r system （note: such water sample will be sent to the local government department of hygiene and epidemic for testing annually, as a minimum. 2.1.2.1.2 保安过滤器出水Output water after the Safety filter2.1.2.2 每 2周取样监测 1 次。Collect water samples once per two weeks 2.1.2.1.2 精密过滤器出水Output water after the fin
11、e filter2.2 监测项目 Test items2.2.1 微生物限度Microbial limit test2.2.1.1细菌、霉菌、酵母菌：“2.1”中的所有监测点Bacteria, Mildew and Microzyme: All monitoring points described in “2.1”.2.2.1.2 大肠杆菌：纯化水贮罐、总回水、精密过滤器出水，每季度 检测一次。E. Coli: Storage tank, loop return and Output water after the fine filter should be tested once a qu
12、arter.2.2.2 理化指标Chemical test items2.2.2.1 总回水、精密过滤器出水：每 2周检测一次。Loop return, Output water after fine filter will be tested once per two weeks.QC 3. 取样、检验SAMPLING AND TESTING3.1 通则General菌检操作员 3.1.1Microbiologist3.1.2遵循取样区域的最低衣着要求，或穿洁净的化验室工作服。 Follow the minimum gowning requirements for the area bein
13、g sampled or wear a clean lab coat. 在取水样时，应遵循无菌操作方法。Follow aseptic technique when collecting water samples.题目：Title纯化水系统的质量监测MONITORING THE PURIFIED WATER SYSTEM责任人操作RESPONSIBILITY ACTION菌检操作员Microbiologist3.1.33.1.4在取水样时，应肉眼检查是否有水滴泄漏，或有可见的破损。When collecting water samples, visually inspect the water
14、 drops for leaking or visible damage.将理化检验样品送至化验室检验；将菌检样品送至菌检室检验。 Take chemistry samples to the laboratory for testing, and Send microbiology samples to microbiological laboratory for testing.3.1.4.1 微生物限度检查的样品不能立即检验的，应存放于冰箱中冷 藏，并于取样后 24 小时内完成检验。If the samples for microbiological testing cannot be t
15、ested immediately, these samples must be stored in the refrigerator and must be tested within 24 hours after sampling.3.2 理化检验样品的取样。Samples for Chemicals Testing. Follow these steps.3.2.1在取样前，不需用 75%乙醇擦拭取样口。Do not need to sanitize the sampling port with 75% ethanol prior to collecting the water sample.3.2.2 用两个洁净的500ml带盖三角瓶。 Use two clean 500 ml flasks with cap.3.2.3 在三角瓶上作好标记，注明日期、样品描述(如，建筑物、房间等) Label the flask with date, sample description (such as building, room, etc).3.2.4 取样前，将三角瓶至少淋洗3次。Rinse the flask at least three times before collect
