Cleaning validation(CV) protocol清洁验证方案

Cleaning validation CV protocol of Mixing tank Storage tank Transfer vehicle and Pipeline 配液罐 储液罐 移配液罐 储液罐 移 液车及其管道清洁验证方案液车及其管道清洁验证方案 Prepared by 起草 Date 日期 Reviewed by 审阅 Date 日期 Approved by 批准 Date 日期 共 10 页 第 2 页 Table of contents 目目 录录 1 0 Summarize 概述概述 3 2 0 Purpose 验证目的验证目的 3 3 0 Responsibility 验证职责验证职责 3 3 1 Validation team 验证小组 3 3 2 Production department 生产部 4 3 3 Equipment department 设备部 4 3 4 Quality department 质量部 5 4 0 Validation scope 验证范围验证范围 5 5 0 Validation content 验证内容验证内容 5 5 1 Cleaning procedure 清洗规程 5 5 2 Sample Plan 取样计划 5 5 3 Test and Evaluation 测试和评估 8 5 4 Re validation and re validation period 拟定再验证及验证周期 9 5 5 Conclusion 验证方案结论 10 6 0 Approval of validation protocol 验证方案最终批准验证方案最终批准 10 共 10 页 第 3 页 1 0 Summarize 概述概述 Mixing tank storage tank transfer vehicle and pipeline were used in alcohol wipe workshop for the 70 Isopropyl alcohol solution s storage and transporting Because this system cleaning effect may affects the quality of the product so we will perform a cleaning validation CV for this system 配液罐 储液罐 移液车及其管道用于酒精擦片车间的药液 配料 储存及药液运送 该系统的清洗效果直接影响到产品的质量 因此我们 将对本系统进行一个清洁验证 2 0 Purpose 验证目的验证目的 Confirm cleaning procedure of mixing tank storage tank transfer vehicle and pipeline was reliability to perform the cleaning procedure right after a number of chemical pollution 确认配液罐 储液罐 移液车及其管道的清洗规程的可靠性 执行清洁程序后 不对后一批 药液产生污染 3 0 Responsibility 验证职责验证职责 3 1 Validation team 验证小组验证小组 3 1 1 Responsible for approval of protocol 负责验证方案审批 3 1 2 Responsible to coordinate the work of validation ensure the implement of this protocol effectively 负责验证的协调工作以保证本验证方案 规定项目的顺利实施 3 1 3 Responsible for approval of validation report 负责验证报告的审批 3 1 4 Responsible for signing and issue the certification of validation 负 共 10 页 第 4 页 责验证证书的发放 3 1 5 Responsible for affirmed the period of validation 负责验证周期的确 认 3 2 Production department 生产部生产部 3 2 1 Responsible for draft the protocol 负责验证方案的起草 3 2 2 Responsible for collected all validation data and submitted to the validation team 负责收集各项验证记录 报验证小组 3 2 3 If this protocol need to change because of specific cause Equipment department should be responsible to fill the application and approval form of protocol change 若因特殊原因需变更原验证方案时 应负责 填写 验证方案变更申请及批准书 报验证小组批准 3 2 4 Responsible for operation cleaning and maintenance of equipment 负责设备的操作 清洗和维护保养 3 2 5 Responsible for implement of this protocol 负责验证方案的实施 3 2 6 Responsible for identified the re validation period and protocol 负 责拟定再验证方案及周期 3 3 Equipment department 设备部设备部 3 3 1 Responsible for installing adjusting the equipment and recording 负责设备的安装 调试并作好相应记录 3 3 2 Responsible for the calibration of equipment and meter 负责仪器仪 表的校正 3 3 3 Responsible for providing mainly parameter of equipment 负责提供 与设备有关的主要参数 共 10 页 第 5 页 3 3 4 Responsible for assisting implement of this protocol 负责协助验 证方案的实施 3 4 Quality department 质量部质量部 3 4 1 The representative of Quality department should be involved in the approval of validation protocol and report 质量部负责人参与验证方案 验证 报告的审阅 3 4 2 Responsible for assisting the calibration of equipment and meter 负责协助仪器仪表的校正 3 4 3 QA was responsible to supervise the validation process QA 对验证 的过程实施监督 4 0 Validation scope 验证范围验证范围 Mixing tank storage tank transfer vehicle and pipeline 配液罐 储液罐 移液车及其管道清洗消毒验证 5 0 Validation content 验证内容验证内容 5 1 Cleaning procedure 清洗规程清洗规程 5 1 1 According to YJ SMP PR 005 Daily cleaning procedure of Production equipment 按 YJ SMP PR 005 生产设备日常清洁和清洗指南操作 Validate three continued lots 连续进行三个批次的验证 5 1 2 The equipment operators should be trained and the training record should be finished and archived before they performed this procedure 在设备 的操作人员执行清洁程序之前应该接受培训并完成培训记录及归档 5 2 Sample Plan 取样计划取样计划 5 2 1 Swab samples 擦拭取样 共 10 页 第 6 页 5 2 1 1 sketch map of cotton 棉签擦拭图 5 2 1 2 Worst case and sampling location 最差条件和取样位置 Those location as following were not easy to be cleaned so we will sample in those location 易进行清洗 因此在下列位置取样 Total 6 Sampling locations 总共 6 个取样点 Table1 表 1 Part Name 部件名称 Sample location 取样位置 Sample No 取样点编号 Sample area 取样面积 cm2 顶部喷淋装置后方1200 底面搅拌浆遮挡处2200 Mixing tank 配液罐 中部内表面3200 顶部内表面4200 中部内表面5200 Storage tank 储液 罐 底部内表面6200 顶部内表面7200 中部内表面8200 Transfer vehicle 移 液车 底部内表面9200 5 2 2 Final Rinse samples 淋洗水取样 Total 3 Sampling locations 总共 3 个取样点 Part Name 部件名称 Sample location 取样位置 Sample No 取样点编号 Sample Volume 取样体积 cm2 Mixing tank 配液罐 液体管道出口10500 250 2 Storage tank 储液罐 液体管道出口11500 250 2 Transfer vehicle 移液车 液体管道出口12500 250 2 5 2 3 Hold time of cleaning 清洁保持时间 Conduct sample and test 共 10 页 第 7 页 according to 5 2 1 at 1 week 2 weeks 3 weeks 4 weeks after cleaning mixing tank storage tank transfer vehicle and pipeline placed in normal workshop conditions Because the concentration of Isopropyl alcohol will decrease as the storage time pass the residue of isopropyl alcohol in first time is the highest so microbial test was enough for this validation Finally we can determine the hold time of cleaned equipment according to the test results 将清洁以后的配液罐 储液罐 移液车及其管道放置在车间正常环境 中 至 1 周 2 周 3 周 4 周 分别按 5 2 1 再次取样进行测试 因为随着储 存时间推移 对于异丙醇残留量来说只会减少 第一次测试的异丙醇残留量是 最高的 因此只需进行微生物测试 根据检测结果确定设备清洁后的保持期 5 2 4 Sampling record 取样记录 Sampling record 取样记录取样记录 Product Name 产品名称 Equipment 设备 Batch No 批号 Part Name Visual Inspection Sampled for 部件名称 目检 取样 清洁 不清洁 1 2 3 4 5 6 7 8 9 10 共 10 页 第 8 页 11 12 Remarks 备注 Sampled by date 取样人 日期 Reviewed by date 复核人 日期 5 3 Test and Evaluation 测试和评估测试和评估 5 3 1 Appearance inspection 外观检测 5 3 1 1 Test method 检查方法 Visual inspect the inside and outside surface of those equipment 目测设备内外表面洁净情况 5 3 1 2 Acceptance criteria 认可标准 The inside and outside surface were clear no dirt 设备内外表面光洁 无污物 5 3 1 3 Appearance inspection record 外观检查记录表格 Date 清洗日期 Clean Status of inside outside surface visual 设备内外壁洁净情况 目测 Inspected by date 检查人 日期 QA Review date QA 复核 日期 5 3 2 Chemical test 化学检测 5 3 2 1 Method 检测方法 Because Isopropyl alcohol was easy to be cleaned by water the residue of the Rinse samples was more than that of the surface samples So we need test the residue of the final rinse samples only To 250mL of water sample in 5 2 2 in a suitable flask observe if it is clear and test the residue of isopropyl alcohol by GC Gas chromatography 由于异丙醇易于被水清洁 由最终管道排除的液体的浓度远远大于表面残留的 浓度 因此只需对罐管道出口的样品进行化学检测 分别取 5 2 2 项下水样 共 10 页 第 9 页 250mL 观察性状是否为澄明液体 并用气相色谱法测定异丙醇残留量 5 3 2 2 Acceptance criteria 认可标准 The residue of isopropyl alcohol was not more than 10ppm 异丙醇残余量不得大于 10ppm 5 3 2 3 Chemical test record 化学检测记录表格 LOT 批号 Clean Date 清洗日期 Appearance 性状 Residue 异丙醇残余量 Tested by date 检测人 日期 Evaluation 评 价 Qualification 确 认 Reviewed by date 复核人 日期 Validation team date 验证小组 日期 5 3 3 Microbiological test 微生物检测 5 3 3 1 Method 检测方法 Take the sample in 5 2 1and 5 2 2 Carry out Microbiological test 取 5 2 1 及 5 2 2 项下样品 做微生物检测 5 3 3 2 Acceptance criteria 认可标准 Total bacteria count 10CFU ml 清洗水微生物菌落数 10CFU ml 5 3 3 3 Microbiological test record 微生物检测记录表格 LOT 批号 Clean Date 清洗日期 Total count 菌落数 CFU ml Residue 异丙醇残余量 Tested by date 检测人 日期 Evaluation 评 价 Qualification 确 认 Reviewed by date 复核人 日期 Validation team date 验证小组 日期 5 4 Re validation and re validation period 拟定再验证及验证周期拟定再验证及验证周期 Re validation will be performed as this protocol or supplement protocol 共 10 页 第 10 页 drafted per actual Situation when there were major changes or maintenance in this equipment and any exception in manufacture process and any trouble in the utilitie