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1、Subject/主题LovastatinTablets20mgCleaningValidationProtocol鲨鱼软骨片清洁验证方案文件编号：Tableofcontents目录1. Responsibility职责2. Purpose目的3. Frequency周期4. RelevantSOPs相关的SOPs5. Equipment设备6. TestMethod测试方法7. AcceptanceCriteria接受限度8. RiskAnalysis风险分析9. SamplingPlan抽样计划10. Actiontakenwhenout-of-limitresultfound对不符合接受限
2、度的测试结果所采取的措施12. Revalidation再验证13. CleaningValidationExecutiveRecord清洁验证过程记录14. Conclusion结论Attachments附件Writtenby:制订者：Date:日期：Reviewedby:复核者：Date:日期：Approvedby:批准者：Date:日期：Approvedby:批准者：Date:日期：1. Responsibility职责QAisresponsibleforplanthecleaningvalidation.QA负责整个清洁验证的安排QCisresponsibleforsamplingan
3、danalysis.QC负责抽样及测试ProductionDepartmentisresponsibleforperformingcleaningproductionequipment.生产部负责设备的清洁.2. Purpose目的ThepurposeofthiscleaningvalidationprotocolistodemonstratethatthecleaningprocedureusedtocleanJHZ-250Bhighshearmixer/granulator,threedimensionalmixer,CT-C-2HotAirCirculatingDrier,JZF-400
4、granulators&millKorschPH300-36TabletPress,BGD-150Dhigh-efficiencycoatingmachineandDPP-250BblisterpackagingmachinecaneffectivelyremoveresiduesoftheproductsmanufacturedinZS-650VortexOscillator/CompactSieve,JHZ-250Bhighshearmixer/granulator,threedimensionalmixer,CT-C-2HotAirCirculatingDrier,JZF-400gran
5、ulators&millKorschPH300-36TabletPress,BGD-150Dhigh-efficiencycoatingmachineandDPP-250Bblisterpackagingmachinetoapredeterminedlevelthatdoesnotraiseanysafetyconcerns.清洗验证方案的目的是证明JHZ-250B高效湿法制粒机、HLD-1000B型料斗式混合机清洁操作规程、CT-T-II型热风循环烘箱、JZF-400型整粒、粉碎机、KorschPH-300-36旋转式压片机、BGD-150D型高效包衣机和DPP-250B型多功能自动铝塑包装
6、所使用的清洗程序能够有效地除去产品残留，达到预先确定的限度，从而达到对下批产品无影响。3. Frequency周期ThecleaningvalidationstudyisperformedafterthreeconsecutivemajorcleaningsofZS-650VortexOscillator/CompactSieve,JHZ-250Bhighshearmixer/granulator,threedimensionalmixer,CT-C-2HotAirCirculatingDrier,JZF-400granulators&millKorschPH300-36TabletPress
7、,BGD-150Dhigh-efficiencycoatingmachineandDPP-250BblisterpackagingmachineafterthemanufactureofLovastatinTablets.连续三批生产后，进行清洗验证研究。4. RelevantSOP相关的SOPsSOP-PD-304-00CleaningprocedureforHLSG-300HighSpeedMixer/GranulatorHLSG-300型高效湿法混合制粒机清洁操作规程SOP-PD-304-00CleaningprocedureforLF120E-Bairpillow-dryGranula
8、torLF120E-B型沸腾干燥制粒机清洁操作规程SOP-PD-310-00CleaningprocedureforZP43HighSpeedrotarytabletpress高效ZP43旋转式压片机清洁操作规程SOP-PD-307-00CleaningprocedureforHLD-1000BHoppertypeofblenderHLD-1000B型料斗式混合机清洁操作规程SOP-PD-306-00CleaningprocedureforYK-160granulatorsYK-160整粒机清洁操作规程SOP-PD-311-00CleaningprocedureforBG-300Ehigh-e
9、fficiencycoatingmachineBG-300E型高效包衣机清洁操作规程SOP-PD-313-00CleaningprocedureforDPH-130、DPP-250BblisterpackagingmachineDPH-130、DPP-250型铝塑袍罩包装机清洁操作规程ESS-VD007Validationguideline-cleaning验证指南-清洁验证ESS-VD011Surfacesamplingforcleaningvalidation清洗验证设备表面取样|ESS-VD014Selectionoftheworstcaseincleaningvalidation清洁验
10、证中最坏情况的选择SOP-QC-1075检验操作规程ESS-GM066|MicrobeTest微生物限度检测法5.Equipments设备No.序号EquipmentNo.设备编号EquipmentName设备名称ProductContactSurfaceArea与产品接触面积（m2）1HLSG-300highspeedmixer/granulatorHLSG-300高效湿法混合制粒机2.81LF120E-Bairpillow-dryGranulatorLF120E-B沸腾干燥制粒机器5.903ZP43TabletPressZP43旋转式压片机64METALDETECTOR金属探测仪0.35H
11、LD-1000BHLD-1000BHoppertypeofblenderHLD-1000B型料斗式混合机5.256YK-160granulatorsYK-160型整粒机0.377DPH-130DPP-250blisterpackagingmachineDPH-130、DPP-250型多功能自动铝塑包装机1.08BG-300Ehigh-efficiencycoatingmachineBG-300E型高效包衣机8.43TotalProductContactSurfaceArea（m2）与产品接触面积总和（m2）99.625.1 ListofEquipment设备清单ThelistofEquipme
12、ntusedinthemanufactureofLovastatinTablets:有关鲨鱼软骨片生产线的所有机器列出如下：1. HLSG-300highspeedmixer/granulatorHLSG-300高效湿法混合制粒机2. LF120E-Bairpillow-dryGranulatorLF120E-B沸腾干燥制粒机器3. ZP43TabletPressZP43TabletPressP43旋转式压片机4. METALDETECTOR金属探测仪5. HLD-1000BHLD-1000BHoppertypeofblenderHLD-1000B型料斗式混合机6. YK-160granula
13、torsYK-160型整粒机7. DPH-130DPP-250blisterpackagingmachineDPH-130、DPP-250型多功能自动铝塑包装机8. BG-300Ehigh-efficiencycoatingmachineBG-300E型高效包衣机Table1表1:5.2ValidationScope验证范围HLSG-300highshearmixer/granulatorHLSG-300高效湿法制粒机LF120E-Bairpillow-dryGranulatorLF120E-B沸腾干燥制粒机器ZP43TabletPressZP43旋转式压片机METALDETECTOR金属探测
14、仪HLD-1000BgranulemixerHLD-1000B型料斗式混合机YK-160granulatorsYK-160型整粒机DPH-130、DPP-250blisterpackagingmachineDPH-130、DPP-250型多功能自动铝塑包装机BG-300Ehigh-efficiencycoatingmachineBG-300E型高效包衣机6. TestMethod测试方法Thecleaningvalidationstudiesarebasedontheswabbingtechniqueandrinsingsampling.Theselectedswabsshouldbechar
15、acterizedfortheirsuitabilityandarecoverytestshouldbeperformedpriortothevalidationstudies.Thevalidationstudiesincludeswabbingofthemainsurfaceareaaswellasthehard-to-cleanlocations.Swabbingandringingiscarriedoutfortheactiveingredient.清洁验证研究用擦拭取样法和最终淋洗水取样。验证研究之前，选择的棉签的特性应适合并进行回收率研究。验证研究包括主要表面积和难清洁部位的擦拭。对活性成分擦拭取样和淋洗水取样。SamplingMethod抽样方法SwabSampling擦拭法Ringingsampling最终淋洗水取样法7. AcceptanceCriteria接受限度VisualInspection目测检查A
