Cleaning validation(CV) protocol ofMixing tank、Storage tank、Transfer vehicle and Pipeline 配液罐、储液罐、移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：Table of contents目录1.0 Summarize概述 (3)2.0 Purpose验证目的 (3)3.0 Responsibility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 (5)5.0 Validation content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 (10)1.0 Summarize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: 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：3.1 Validation team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：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：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。
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：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: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：5.1 Cleaning procedure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：5.2.1 Swab samples擦拭取样：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)Mixing tank配液罐顶部喷淋装置后方 1 200底面搅拌浆遮挡处 2 200中部内表面 3 200 Storage tank储液罐顶部内表面 4 200中部内表面 5 200底部内表面 6 200Transfer vehicle移液车顶部内表面7 200 中部内表面8 200 底部内表面9 2005.2.2 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10 500（250*2）Storage tank储液罐液体管道出口11 500（250*2）Transfer vehicle移液车液体管道出口12 500（250*2）5.2.3 Hold time of cleaning 清洁保持时间：Conduct sample and testaccording to 5.2.1 at 1 week, 2 weeks, 3 weeks, 4 weeks after cleaningmixing tank, storage tank, transfer vehicle and pipeline placed in normalworkshop 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。