K10动态环境监测方案.docVIP

Doc Number BSB-GP-026-02 Revision 2.0 Effective 2011-04-21 Doc Type Form(K10) 空调动态环境监测方案K10）Air conditioning dynamic environment monitoring protocol ID: RQ 065/2-R2 Confidential Information Page PAGE 1/ NUMPAGES \* MERGEFORMAT 8 受 受 控 CONTROLLED COPY Revision history: Release 1.0: Initial Release Release 1.1: 1.Add the number of maximum participants in room in the record 2.Add the identification of mold and spore in the record Name Function Signature and Date Author Knight WANG Quality Control Reviewer(s) Jay SUN Validation Engineer Hong WEI QC Supervisor Jackie PENG Production Manager Approver Yinzi DIAO QA QC Manager 目的 /Purpose 由于产品的本身属性，培养基产品（PPM= pre-poured media） 对生产的洁净度要求需要控制在ISO7的环境下进行,因此该方案定义了如何在PPM生产动态情况下进行环境监测，其中包括浮游菌, 沉降菌和接触试验的取样方法，取样点和取样频率。 As a result of the product itself attributes, PPM product need ISO 7 requirements for production. The protocol defines how to monitor the environment in a PPM production dynamic environment, including samples method, samples point and samples frequency of floating bacteria, settling bacteria and contact experiments 范围 /Scope 该方案仅可以适用于梅里埃（上海）生物制品有限公司培养基产品（PPM）的生产区域，其位于上海梅里埃的生产楼一楼。 This protocol is applicable to the PPM Production area in BSB only, which is located on the first floor of production building in BSB 职责/responsibilities 部门/Dept 职责/ RESPONSIBILITIES QC团队/QC team 准备动态环境取样方案, 培训生产操作员取样方法 完成动态环境监测的孵育和读数记录 完成动态环境监测的趋势分析和报告 Preparing the protocol, training the Production operator to collect the samples Performing the sample incubation and record Complete the dynamic environment of trend analysis and report 生产团队/Production team 完成动态环境的取样 Performing the sample collection in the dynamic environment 实验方案/Experiments protocol 浮游菌检测/floating bacteria test 取样 Sampling 采样器进入被测房间前先用消毒房间的消毒剂灭菌,然后在紫外传递窗进入罐装间。 Sampler should be clean with disinfectant from sterilization disinfection room first before entering the room, and then it should be entered to UV windows. 用消毒剂擦净