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1、Page:SOP#:Eff. Date:Supersedes:4/92-4001.022006.12.282006.7.1STANDARD OPERATING PROCEDURE题目：Title纯化水系统的质量监测MONITORING THE PURIFIED WATER SYSTEM起草/修订人：Author日期：Date部门主管审查：Dept. Head Approval日期：DateQA批准：Approved by QA日期：Date分 发：Distribution:QA、QC、工程QA, QC, Engineering目的：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
2、合要求。PURPOSE:This document defines the procedure for routine quality monitoring and deviation 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 i
3、s applicable to the routine monitoring on purified water system (including purified water generator system, use points and sampling points)During the non-routine monitoring period (such as validation, re-validation and special studies), the monitoring will be conducted in accordance with the specifi
4、c protocol. The routine monitoring can be paused during such non-routine monitoring period.参考文件：REFERENCE AND ATTACHMENT:SOP/题目 SOP/TITLE记录/附件/题目 FORMS/ATTACHMENTS/TITLE1-3002偏差调查附件1：纯化水系统中的使用点和取样点Deviation InvestigationsAttachment 1: Point-of-use and sampling point locations in the purified water s
5、ystemF-02-014纯化水系统取样记录Purified water system sampling logbook定 义：N/ADEFINITIONS:规 程：PROCEDURE:责 任 人操 作RESPONSIBILITYACTION1.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
6、 pipes.1.1.2循环管路系统：纯化水的循环分配管路。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 loop2.1.1.1对于有4至7天的正常工作周，每周（至少
7、每隔23天1次）取样监测2次。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, rou
8、tine sampling 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 ti
9、me.责 任 人操 作RESPONSIBILITYACTION2.1.2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 generator system (note: such water sample will be sent
10、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 weeks2.1.2.1.2精密过滤器出水Output water after the fine filter2.2监测项目Test items2.2.1微生物限度Microbial limit test
11、2.2.1.1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 quarter.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
12、次。Loop return, Output water after fine filter will be tested once per two weeks.QC3.取样、检验SAMPLING AND TESTING3.1通则General菌检操作员3.1.1遵循取样区域的最低衣着要求，或穿洁净的化验室工作服。MicrobiologistFollow the minimum gowning requirements for the area being sampled or wear a clean lab coat.3.1.2在取水样时，应遵循无菌操作方法。Follow aseptic technique when collecting water samples.责 任 人操 作RESPONSIBILITYACTION菌检操作员3.1.3在取水样时，应肉眼检查是否有水滴泄漏，或有可见的破损。MicrobiologistWhen collecting water samples, visually inspect the water drops for leaking or visible damage.3.1.4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 laborator
