三足离心机安装确认方案.docx

设 备 验 证 方 案Equipment Qualification Protocol主题：201车间 S S L 6 0 0 三足式上卸料离心机IQ 验证方案Title: Installation qualification of GSHT-300 Coating machine in Plant206验证编号/Validation S.N.：日期/Date：设备编号/Equipment S.N.：页数/total pages：山 东 孔 府 制 药 股 份 有 限 公 司SHANDONG PHARMACEUTICAL CO., LTD.1. S S L 6 0 0 三足式上卸料离心机验证方案的审批Review and approve validation protocol of the GSHT-300 coating machine职能Function部门 Department姓名Name签名Signature日期Date起草/Drafter201车间/Plant 201审核/Reviewer201 车间/Plant 201审核/Reviewer201车间/Plant201审核/ReviewerQA审核/Reviewer机械动力部/Machine andPower Dep.批准/ApprovalQA/qualityassurance批准/Approval机械动力部/Machine andPower Dep.2. S S L 6 0 0 三足式上卸料离心机验证方案的历史修订记录/ GSHT-300 coating machines validation protocol revision history版本Version日期Date方案修订者Protocol revised by whom批准人Approval修订说明 Revision description10目录 Contents1、验证概述 Validation overview 32、验证小组成员及职责 Members of Validation team and their concerned responsibilities 33、设备概述及工艺流程 Equipment overview and process flow 34、设备安装确认（IQ）Equipment installation qualification 44.1 安装确认内容 Installation qualification content 44.2 随机文件及附件确认 Documents with shipment and accessories qualification. 44.3 安全/防范 safety/precaution 54.4 专项安装确认 special installation qualification 55、验证用校验仪器及设备测控仪表确认 Qualifiation of calibration instruments and Measure&control meters of equipments 105.1 验证用校验仪器确认 Qualification of calibration instrument forvalidation using 105.2 设备所属测控仪表确认 Qualification of measure & control meters 106、结论 Conclusion 116.1 偏差分析 Deviation analysis 116.2 安装确认结论 Installation qualification conclusion 117、人员培训 Personnel training 118、附件 Appendix 111、验证概述 validation overviewS S L 6 0 0 三足式上卸料离心机将用于原料药的生产，为了保证 S S L 6 0 0 三足式上卸料离心机的安装符合生产工艺要求，本方案规定了该设备的安装确认内容。确认结果用于鉴定该系统的设备的安装及配套设施的 配置能够满足设计标准和 GMP 要求。This GSHT-300 coating machine will be used for the coating of Perrigo (UK) Ibuprofen tablets. In order to ensure that the installation of the GSHT-300 coating machine can meet theproductionprocess requirements,thisprotocolspecifiedthe installation qualification content. The Validation results are used for verifying that the installation of the equipment and the configuration of auxiliaryfacilitiescanmeetthedesignstandardandtheGMP requirements.本方案适用于山东孔府制药有限公司 201车间 2 台 S S L 6 0 0 三足式上卸料离心机的安装确认。This protocol applies to the installation qualification of the GSHT-300coatingmachineinplant206,ShandongXinHua pharmaceutical Co., Ltd.姓名 Name部门Department职务Function职责Responsibility201 车间/plant201工程师Engineer起草验证方案、验证报告 draftvalidation protocol and report201车间/plant201主任Director审核验证方案、验证报告 reviewvalidation protocol and report计量电气部/MetrologyDep.主管Supervisor负责计量仪器仪表校验审核 review measuring instrument calibrationQA主管Supervisor审核验证方案、验证报告 reviewvalidation protocol and report机械动力部/Machine and主管Supervisor审核验证方案、验证报告 reviewvalidation protocol and report2 、验证小组成员及职责 Members of validation team and their responsibilitiesPower Dep.QA经理助理Assistant manager批准验证方案、验证报告 approve validation protocol and report机械动力部/Machine andPower Dep.经理Manager批准验证方案、验证报告 approve validation protocol and report3、设备概述及工艺流程 Equipment overview and process flow2 0 1 车 间 共 有 S S L 6 0 0 三足式上卸料离心机2台（编号分别为C101、C102），由江苏牡丹离心机制造有限公司制造，均安装在山东孔府制药有限公司201车间合成区，用于原料药生产过程中的离心工序。This GSHT-300 coating machine is made by ZIBO IMA-XINHUA PHARMATECH Co., Ltd. and will be equipped in the coating room (room No. 402) of Plant 206. This machine will be used for the coating step during the production.该设备主要由转鼓部件、橡胶减震器、电动机、变频器、制动单元组成。料液经过离心机达到固液分离的目的。固体形成滤饼存留在离心机转鼓内，滤液通过滤包后通过管道进入滤液储罐。This equipment mainly consists of Dosing unit, Horizontal atresy pan, Core temperature probe, Ventilationunit,Pistols-supporting-armforsugar-coatingprocess, Control panel, Air treatment unit, Dust collector, Pistols for filming process, Paddle unit, Outlet air system. It can be used for both filming and sugar coating process. Spraying system for filming coating is made up of film pump, low pressure pipeline (with air), and spray gun battery. For sugar coating, there are sugar coating pump, high pressure pipeline(without air), spray gun battery, and solution recyle valve.Coating solution is mixed completely, and transferred to spray gun through dosing unit. The air will be filtered and dehumidified through the air treatment system before entering into the coating pan, and then heated to appropriate temperature. In the coating pan, adjust pan speed to mix tablets completely, and exhaust system discharges the air out of pan. At last the air will be exhausted through filter.4.安装验证（IQ）Installation qualification4.1 安装确认内容 Installation qualification content安装验证主要对设备各组成部分的组装，电气系统及相关配套设 施的连接，安装位置等进行确认，并确认每项测试都符合规定要求。 任何影响该机正常工作的异常情况均应予以纠正并记录下来，作为偏 差进行分析，并在验证报告中进行说明。Installation qualification ismainly to confirm the assembling of the component part, the connection of the electrical system and related facilities and installation location to meet to corresponding request. Any unusual situations, which can impact the normal operation of the equipment, should be corrected and recorded as a deviation to analyze, and make an introduction in validation report.4.2 随机文件以及附件确认 Documents with shipment and accessoriesqualification.序号Serial number项目 Item检查结果 Check results结论Conclusion1离心机总装图Equipment instructionmanual2离心机主部件图description of inverters of booster pump and filmpump3离心机安装图 pressure, temperature and humidity sensordescription4电器原理图 layout of equipment5一次、二次接线图 equipment pneumatic system design documentation6离心机主要外购件型号，规格，检验等证明文件 equipment electrical system designdocumentation7安装使用说明书 IQ/OQ documents fromIMA8质量保证文件FAT validation documents9产品合格证 Materials confirmation for the parts that directly contact with the drugproducts.10主要部件材质证明 Spare partslist12主要部件检验报告 lubricant list12出厂检查实验报告The engineering drawing forGSHT-300 coating machine design and installation.检查人 Checked by： 日期 Date：复核人 Reviewed by：日期 Date：4.3 安全/防范 Safety/Precaution4.3.1 进行验证及安装人员要遵循设备使用手册中的安全事项，做好 相关的安全防护，注意人身及设备安全和环境保护。Validation andinstallation personnel should follow safety warnings specified in User Manual, make appropriate safety precaution measure, and pay attention to safety of person & facility and environment protection.4.3.2 电器保护 electric appliance protection序号Serial number项目 Item方法和要求 Method and requirement检查结果 Check results结论Conclusion1紧急停机功能 emergency stop function检查紧急停机工具有效 check and confirm that all local emergency stop buttons areeffective.2断电保护power-off protection设备有有效的断电装置effective power-off devices3防护装置protective有防止挤压、划伤、电击、烫伤的 装置 have device to preventdeviceextrusion, scratch, electric shock and scald4标识 mark有相应的安全标识， 起警示作用have corresponding safety warnings5电气保护 electric protection具有断路器、热保护继电器 have circuit breaker and thermoprotection relay6接地保护 earthing protection设备各部分均有接地保护 each part of the equipment has earthing protection检查人 Checked by： 日期 Date：复核人 Reviewed by：日期 Date：偏差分析 deviation analysis：结论 conclusion：评价人 Evaluated by：日期 Date：4.4 专项安装确认 special installation qualification序号Serial number检查项目 Check item检查要求 Check requirement检查方法 Check method检查结果Check the result结论Conclusion1设备外观/machine设备外观应整洁，无缺目检设备外观无appearance陷/the machineappearance should be clean and intact明显破损/visualinspection, no damage2安装位置/installation location201 车间合成区及附近机房/coating room,206 plant. auxiliary machine installed in auxiliary machine room离心机主体、防爆控制箱安装于合成区，主电气控制柜安装于机房/pan body, control panel and dosing unit equipped in coating room. Auxiliaries such as dust collector, air treatment unit and electric cabinet installed in auxiliary machine room4设备电源/machine power supply400V5% 50Hz 元器件 终端(component terminal)、PLC 电源 (power supply)24V5%检测提供三相380V 电源及辅助 电源 24V/check three phase power supply380V,auxiliary supply 24V6设备铭牌/machine nameplate检查设备铭牌并将数据记录在附件1 中/check the nameplate and write down corresponding data铭牌各项数据记录在附表中/data of nameplate should bein appendix2recorded in appendices7标识与指示/mark and direction氮气、排气、进料、出液等管路标示齐全/all medium pipelines (compressed air, steam, pure water, slurry ) are marked correctly目检设备各管路 均有标示/visual inspection of pipeline mark9离心机主机/atresy pan转鼓直径600mm/material AISI316L, contact parts with a polishing surface, roughness Ra=0.4um检查转鼓直径符合要求/check pan materials meet requirement所有与物料接触部分材质为SUS304不锈钢/material of rolling ring is stainless steel, make pan level检查材质证明符合要求/check for material certification of the rolling ring, use gradienter to monitor the level of pan转鼓筒体与拦液板及转鼓底衬包满焊，焊缝打磨光滑，无卫生死角，内外表面抛光处理/make sure the tensioning of rotate chains is in accordance with requirement符合图样及标准/check tensioning of chains meets standard17转鼓筒体壁厚6mm/equipped lighting lamp insidepan , check for pan earthing brushes检查转鼓筒体壁厚符合要求visual inspection oflights and earthing brushes10主电机/spraying system and dosing unit主电机铭牌并将数据记 录于附表 2 中 /gun slipping supporting-arm material AISI304检查主电机铭牌将数据记录附表2 中/check for material certification of gun slipping supporting-arm主电机防爆等级为ExdBT4检查电机的防爆等级14卸料装置/unloading device直径 180mm 的不锈钢 管（AISI316）/the 180 diameter stainless steel tube(AISI316)用直尺测量直径，并检查材质 证明/measure diameter with rule and checkmaterial certification可固定于打开门前的锅 上/ fixed to front door of pan试验卸料装置可安装与锅门前/ unloading device can be fixed to front door of pan15桨叶单元/paddle unit桨叶安装、旋转方向正 确/the paddles is installed correctly, and rotate in the correct direction确认桨叶安装正确，旋转方向符 合要求/make certain paddles equipped correctly and direction of rotation meets requirement材质 316L 不锈钢/material is 316l stainless steel检查材质证明/check for material certification16清洗单元/wash unit清洗单元与设备各 部件连接正确/wash unit and componentconnected correctly检查清洗单元安装位置与图纸相 符/check wash unit location is in accordance with drawing排水杯的密封性良好/pan cup discharge valve seal is watertight将锅内加入少量水，观察排水杯 密封性/add a little water to pan to check pan cup discharge valve seal清洁剂泵电机铭牌及过 流保护有效/detergent pump motor nameplate, thermal circuit breaker is effective检查清洁剂泵铭牌将数据记录附 表 3 中，并检查 有相应过流继电 器/check detergent pump nameplate, write down the data in appendix3, and check for corresponding thermal circuit breaker增压泵电机铭牌型号 PROCACS-MB 及过流 保护有效/booster pump motor nameplate model PROCACS-MB, effective thermal circuit breaker检查增压泵电机铭牌将数据记录 附表 4 中，并有 相应的过流继电 器/check booster pump motor nameplate, write down the data in appendix4, and check for corresponding thermal circuit breaker增压泵变频器调整设置 正确/booster pump inverter has been adjusted correctly检查增压泵变频器频率设置正确 符合要求/check booster pump inverter has been set as request17保温罐/tank with heating device保温罐接触浆液部分材质 316L/material of parts in contact with product is316L检查材质报告符合要求/check material report meets request保温罐铭牌/nameplate of tank with heating device检查保温罐铭牌将数据记录附表4 中/check nameplate of tank with heating device and write down the data in appendix 4安装有熔断器/fixed fuse protector检查有保护熔断器/check for fuse protector气动搅拌桨安装正确/pneumatic stirring paddles are installed correctly确认气动搅拌桨安装符合要求/make certain pneumatic stirring paddles installation meets standard检查人 Checked by： 日期 Date：复核人 Reviewed by：日期 Date：偏差分析 Deviation analysis：结论 Conclusion：评价人 Evaluated by：日期 Date：4.4空 气 处 理 单 元 安 装 确 认airtreatmentunitinstallation qualification由于合同购置空气处理单元 9 月份到货，为提前进行实验参数的再确认，为正式注册批生产提供参考，利用厂家临时提供的一套空气 处理单元做本次中试生产。本处理单元与合同购置空气处理单元的差 别是：本处理单元末端过滤器为 F9 中效过滤器，合同购置空气处理 单元为高效过滤器 H13。本次验证将对本空气处理单元进行验证，等 合同购置处理单元到货后再进行一次 IQ。Air supply unit will bedelivered to Xinhua in Sep. In order to confirm the experiment parameters to provide reference for official registration batch production, we decide to use a temporary air supply unit in this pilot scale trial. The difference between them is this temporary air supply unit adopts the F9 intermediate efficiency filtration rather than the H13 high efficiency filtration as our URS required. The qualification, specially for the new air supply unit with H13 filter, will be conducted again as soon as the new air supply unit is available.空 气 处 理 单 元 安 装 确 认 表airtreatmentunitinstallationqualification list：确认项目qualification检查要求Check requirement检查方法Check method检查结果check result结论conclusionitem空 气 处 理 单 元具有聚氨酯保温板，内层 不锈钢外层喷塑钢板/check for polyurethane heated board, internal surface is stainless steel and external surface is painted stain board目检内层有不锈钢 板，检查材质证明符 合要求/visualinspection of internal surface , check material certificationmeets requirement过滤器安装密封良好，初（G4）、 中（F9）过滤器型号/check for filter seal and elementary/medium filter model检查过滤器型号，目 测安装良好，将数据 记录附表 3 中/checkfor filter model and installation, and write down the data inappendix3蒸汽、冷水组件连接正确/connection of steam and cooling battery is correct蒸汽、冷水管路连接 于标示相符/connection of steam and cooling pipeline is in accordance withstandard预加热组件连接正确/pre-heating battery connection is correct预加热连接于标示相 符/connection ofpre-heating battery is in accordance withstandard处理电机铭牌/check for disposal检查处理电机铭牌并motor nameplate将数据记录附表 3 中/check for disposal motor nameplate and record the data inappendix3进气、排气流量阀开启状态 check for opening state of inlet/outlet airflow valve观察进气、排气流量 阀状态/observe opening state ofinlet/outlet airflowvalve偏差分析 Deviation analysis：结论 Conclusion：评价人 Evaluated by：日期 Date：接受标准 acceptance criterion：以上检查项目主要对包衣机的基本情 况、锅检查、进气、排气处理系统检查、排水检查、喷射系统检查、 清洗系统检查、剂量单元检查，且安装确认中每项检测都到达预期值， 则确认通过。Above inspection items mainly check for basic case of thecoating machine, pan, in/outlet disposal system, water draining system, spraying system, wash system, dosing unit. Qualification can be passed until every test has achieved expected results.5 、 验 证 用 检 验 仪 器 及 设 备 测 控 仪 表 确 认 qualification of theconcerned calibration instruments and equipment measure&control meters for validation using5.1 验证用检验仪器确认 Qualifiation of calibration instruments andMeasure&control meters of equipments序号 serialnumber仪表名称instrument name型号 model计量编号 measuringnumber鉴定单位verification unit有效日期expiry date1万用表multimeterVC890D2水平仪gradienterTOP LEVEL2001-1B3噪声计audio-noise meter4风速仪 air speedmeter5红 外 测 温 仪 infrared radiation thermometerST182417502C16.1038计量电气部Metrology Dep.2011.2.245.2 设 备 所 属 测 控 仪 表 的 检 验 确 认qualification of auxiliarymeasure and control instrument序号 serial number仪表名称 Instrument name型号、量程 model、 measuring range使用位置 using position计量编号 Metrology number检验单位 inspection unit检验日期 inspection date有效期 expiry date1双金属温度计/bimetal thermometer空气处理单元进风/inlet air of air treatment unit检 查 统 计 设 备 所 属 关 键 仪 表 校 验 和 基 本 运 行 情 况 。 Check for calibration and basic operational aspect of key auxiliary meters2双金属温度计/ bimetal thermometer空气处理单元出风/outlet air of air treatment unit3双金属温度计/ bimetal thermometer保温