VP纯化水系统验证方案

Purified Water System Validation Protocol纯化水系统验证方案Approval of the Purified Water System Validation Protocol纯化水系统验证方案的审批Title 职务Name 姓名Signature 签字Date 日期Written By 起草人Reviewed By 复核人Approved By 批准人TABLE OF CONTENTS1 Summarize/概述32 Purpose/验证目的43Validation Team and Responsibilities/验证人员及职责43.1Validation Team Member/工程验证小组成员43.2 Responsibilities/职责44 Content, Method and Criterion/验证内容、方法及合格标准54.1Beforehand Qualification/预确认安装前确认54.2 Installation qualification/安装确认74.3 Operation qualification/运行确认114.4 Performance Qualification/性能确认125 Deviation and deal with method/验证过程中的偏差及处理146 Validation Conclusion/验证结果评定与结论147.Revalidation Periods/再验证周期158Validation Schedule/验证时间安排15附件161 Summarize/概述The company commissioned the Jiaxing Jiame Water Treatment Engineering Co., Ltd. for the purified water system design and installation, the system product capacity of water is 3 / h, using of two grade reverse osmosis process to obtain purified water.Tap water after adding coagulant (PAC) was pumped by original water pump through multimedia filters, activated carbon filter for filtration and adsorption treatment to remove particulate impurities, colloid, chlorine, organic matter, etc. The free chlorine content of the water is less than 0.1ppm, SDI 4.Then Via precision filter to remove particles greater than 5u, entered the two grade reverse osmosis system use of membrane separation technology, desalinate the majority of ions in water, SiO2, organic colloids and other impurities, water production stored in a purified water storage tank, by ultraviolet sterilizers to kill bacteria that may exist in the terminal, after the booster pumps and precision filters, through the stainless steel pipe to various purified water use points, used for ingredients, equipment and containers cleaning, washing clothes and so on. Parts of the purified water through the circulation pipe back to the purified water storage tank.Simple process as follows: raw water (drinking water) original water tank flocculant dosing system multi-medium filter activated carbon filter Soft Water systems Filters a high-pressure pump reverse osmosis unit alkali dosing two high-pressure pump system reverse osmosis unit purified water tank and water pumps ultraviolet disinfection Terminal filter use point.公司纯化水系统为委托嘉兴嘉美水处理工程设计安装，制水能力为3/h，利用二级反渗透工艺来制取纯化水。饮用水参加絮凝剂(PAC)后由原水泵增压后进多介质过滤器、活性炭过滤器的过滤和吸附处理，除去水中颗粒状杂质、胶体、余氯、有机物等，使出水游离氯含量小于，SDI4，再经精密过滤器除去水中大于5u的颗粒后进入二级反渗透系统，利用膜别离技术的高脱盐率，除去水中大部份离子、SiO2、有机物胶体等杂质，二级反渗透系统产水贮存于一只纯化水贮罐，经紫外线杀菌器杀死可能存在的细菌等后由终端水泵增压并经微孔过滤器过滤，通过不锈钢管道送至各纯化水用水点，用于配料用水、设备及容器具清洗、工作服清洗等。部份纯化水通过循环管道回至纯化水贮罐。简易流程为：原水饮用水原水箱絮凝剂加药系统多介质过滤器活性炭过滤器阻垢剂加药系统保安滤器一级高压泵一级反渗透装置碱加药系统二级高压泵二级反渗透装置纯化水箱送水泵紫外线杀菌装置终端微孔过滤器使用点。2 Purpose/验证目的Through purified water system installation, operation and performance qualification to prove its ability to steady provided supply of quality and quantity qualified water.对纯化水系统的安装、运行和性能进行验证，以证明其有能力稳定地供给规定数量和质量的合格用水。3Validation Team and Responsibilities/验证人员及职责3.1Validation Team Member/工程验证小组成员Project validation team comprises of Production Management Department, Quality Management Department, Equipment Engineering Division and the operator, maintenance worker, QC personnel. The manager of the production management department is the leader of this validation team. Validation team members see attachment 2.工程验证小组由生产管理部、质量管理部、设备工程科和操作工、维修工、QA、QC组成，由生产管理部经理任工程验证组组长，验证小组成员见附件2。3.2 Responsibilities/职责Equipment Engineering Division: Draft the validation protocol, Technical document qualification and implemented the validation, draft the validation report.Production Management Department: Review the validation protocol; Assist the engineering Division implementation the validation work.Quality Management Department: Review the validation protocol, finished the relative analytical work.Validation Committee Director: Approved the validation protocol and the validation report.设备工程科：负责设备验证方案的起草及验证工作的具体实施，起草验证报告。生产部：复核验证方案，协助设备工程科进行验证工作的实施。质量部：负责验证文件的审核，负责相关检验任务。验证委员会主任：负责设备及公用工程系统验证方案及报告的批准。Validation process should be strictly in accordance with the approved validation protocol, if need to change for special reasons, they should fill out the the validation protocol change application and approval forms (attachment 1), according to the original review and approval procedures for the approval before the Executive the change.验证过程应严格按照本方案规定的内容进行，假设因特殊原因确需变更时，应填写?验证方案变更申请及批准书?(附件1)，按原审批程序批准后执行。4 Content, Method and Criterion/验证内容、方法及合格标准4.1Beforehand Qualification/预确认安装前确认 Document Qualification/资料确认Confirmed that the relevant document to support the verification is complete, fill out confirm records in attachment 3./确认支持本验证的相关资料是否齐全，确认记录填写于附件3Document name/资料名称Confirm method/确认方法Purified water system, the detailed design requirements and technical parameters of major equipment纯化水系统详细设计要求及主要设备技术参数Consult equipment archives查阅技术档案Ordering the contract, specifications and related technical information纯化水系统主要组成设备订货合同、说明书及相关技术资料Consult equipment archives查阅技术档案Mainly equipments Certificates各设备检验合格证Consult equipment archives查阅技术档案Purified water quality standards纯化水质量标准Consult CP-2005查阅技术档案查阅药典2005版纯化水标准Purified Water System Flow Chart纯化水系统工艺流程图Consult equipment archives and attached attachment 4.查阅技术档案查阅并附于附件4Purified water system operation and maintenance standard operation procedures纯化水系统操作和维护保养标准操作规程Consult the relative SOP查阅技术档案Purified water system sample standard operating procedures纯化水取样标准操作规程Consult the relative SOP查阅技术档案Purified water system cleaning standard operating procedures纯化水系统清洁标准操作规程Consult the relative SOP查阅技术档案Out of the box inspection records开箱验收记录Consult equipment archives查阅技术档案Installation and commissioning records安装调试记录Consult equipment archives查阅技术档案Test Run Record试运行记录Consult equipment archives查阅技术档案Pipeline Pressure Test Record管道试压记录Consult equipment archives and attached attachment 5.查阅并附于附件5Pipe cleaning records before use管道使用前清洗记录Consult equipment archives and attached attachment 6.查阅并附于附件6Pipeline passivation Records管道钝化记录Consult equipment archives and attached attachment 7.查阅并附于附件7Pipe disinfection record before use管道使用前消毒记录Consult equipment archives and attached attachment 8.查阅并附于附件8Water purification water system network diagram纯化水系统用水网络图Consult equipment archives and attached attachment 9.查阅附于附件9Qualification proof of the equipment supplier各设备生产企业资质证明材料Consult equipment archives and attached attachment 10.查阅附于附件10The equipment inspection reports各设备检验报告Consult equipment archives and attached attachment 11.查阅附于附件11 Instrument calibration verification/仪器、仪表的检定或校验确认Instruments used in System such as Pressure gauges, conductivity meter, etc. shall be calibrated, and within the validity period. The confirm records be filled in attachment 12. Instruments as follow must be calibrated.系统所用的压力表等及检测所用的电导率仪等须经检定或检验合格，并在检定有效期内，确认记录填写于附件12。以下仪器仪表必须经过校验。Instrument Name/名 称Specification/型 号规格Count/数 量Pressure gauges/耐振压力表MPa4Pressure gauges/耐振压力表0-1MPa7conductivity meter/电导率仪/1PH meter /PH计/1 After service Qualification/售后效劳确认Check the purified water system supplier after service information and assure it is complete. The information include supplier name, address, phone, should filled in the attachment 13.检查各主要设备售后效劳资料是否齐全。包括单位名称、地址、联系 、保修及维修等详细资料，确认记录填写于附件13。 Installation qualification/安装确认 Public Media Connect, confirmation records fill in attachment 14.公用介质连接确认，确认记录填写于附件14。.1 Power Supply Installation confirmation/电源安装确认Item/工程Standard/合格标准Method/确认方法electric voltage/电压380V20 VMultimeter test/万用表检测the line of electricity demand/进线要求Three-phase five-wire/三相五线On-site inspection/现场检查YJV-4+BVR-1On-site inspection/现场检查Ground Protection/接地保护Grounding resistance is less than 4/接地电阻小于4Ohmmeter measurements/欧姆表测量.2 Water supply installation confirmation/进水安装确认Item/工程Standard/合格标准Method/确认方法Water quality requirements/水质要求Should meet drinking water health standards (GB 5749-2006)/应符合生活饮用水卫生标准GB 5749-2006See Water Quality Test Report/见水质检测报告Pressure/压力0.4MpaMeasured with pressure gauge/压力表测量Pipe diameter/管道管径DN32Measured with vernier caliper/游标卡尺测量Pipe material/管道材质PPInspection by Visual/目测 Purified water pipeline and Valves installation confirmation, the records fill in attachment 15./纯化水管道及阀门(3路)安装确认，确认记录填写于附件15.Item/工程Standard/合格标准Method/确认方法Work press/操作压力0.4MpaMeasured with pressure gauge/压力表测量Pipe diameter/管道管径DN322 Measured with vernier caliper/游标卡尺测量Pipe material/管道材质SS304 Consult pipe material certificate document and attach it in attachment16./检查材质证明并附于附件16Valves material/阀门材质SS304 Consult pipe material certificate document and attach it in attachment16./检查材质证明并附于附件16Installation requirement/ 安装要求Using hot-melt-type welding joint connecting the health-quick, circular layout, smooth, no dead ends; each water point of use of diaphragm valves, the water intake point and the outlet layout drawings based on design requirements./采用热熔式氩弧焊与卫生快装接头连接，循环布置，光滑、无死角；每个用水点采用隔膜阀，各取水点及出水口的布置依据图纸设计要求。Inspection by Visual and check the relative records./目测及检查相关记录 purified water tank installation (A total of 1, water storage capacity of 1m3)/纯化水储罐安装确认(一只，贮水量为1m3) .1 Method: Inspection by Visual, Measured with vernier caliper and Consult material certificate document and attach it in attachment16, records fill in attachment 17.确认方法：目测、游标卡尺测量、检查材质证明(附于附件16),确认记录填写于附件17。.2 Standards/合格标准：（1） Tank inside and outside surface is polished, smooth surface./储罐内外外表经过抛光，外表光洁。（2） Inside surface and sealed head: Material SS304 stainless steel, thickness 4mm/内筒体及封头：材质SS304不锈钢，厚度4mm。（3） Connectors and related auxiliary equipment/连接口及相关配套设备： Purified water Inlet(top)/ 纯化水入口(顶部)：DN15 Purified water Outlet(bottom)/纯化水出口(底部)：DN20 Limber hole(bottom of the lowest)/排污口底部最低位置：DN15 Clean hole (at the top of the middle position): DN32 With 3600 rotary cleaning ball, material SS304./清洗口(顶部正中位置)：DN32，配3600旋转清洗球，材质SS304不锈钢。 Breath hole (top)/呼吸口(顶部)：DN15 purified water storage tank SCBA installation/纯化水储罐空气呼吸器安装确认.The record fill in attachment 18./确认记录填写于附件18。Item/工程Standard/合格标准Method/确认方法Body material/壳体材质SS304 Consult material certificate document and attach it in attachment16./检查材质证明并附于附件16Filter material/过滤材质Polypropylene/聚丙烯Consult material certificate document and attach it in attachment16./检查材质证明并附于附件16Seal method/密封方法Melt together/热熔合Consult certificate document and attach it in attachment16./检查证明并附于附件16Hole Diameter/孔径mConsult certificate document and attach it in attachment16./检查证明并附于附件16 Critical parts material qualification./关键部位材质确认.The records fill in attachment19./确认记录填写于附件19。Parts name/部件Requirement/要求Method/确认方法Body material/壳体材质Media and requirements/介质及要求Original water pump/原水泵Stainless steel/不锈钢/Consult material certificate document and attach it in attachment16./检查材质证明并附于附件16Multi-media filter/多介质过滤器FRPQuartz sand, anthracite/石英砂、无烟煤Consult material certificate document and attach it in attachment16./检查材质证明并附于附件16Activated carbon filters/活性炭过滤器FRPActivated carbon/活性炭Consult material certificate document and attach it in attachment16./检查材质证明并附于附件16Security filters/保安滤器Stainless steel/不锈钢Polyethylene fiber/聚乙烯纤维Consult material certificate document and attach it in attachment16./检查材质证明并附于附件16High-pressure pump/高压泵Stainless steel/不锈钢/Consult material certificate document and attach it in attachment16./检查材质证明并附于附件16Cleaning Pumps/清洗泵Stainless steel/不锈钢/Consult material certificate document and attach it in attachment16./检查材质证明并附于附件16reverse osmosis system element/一、二级反渗透元件Stainless steel/不锈钢TFCConsult material certificate document and attach it in attachment16./检查材质证明并附于附件16UV sterilizers/紫外线杀菌器Stainless steel/不锈钢/Consult material certificate document and attach it in attachment16./检查材质证明并附于附件16Microporous filter (the number is 2)/微孔过滤器(2个)Stainless steel/不锈钢0.22m nylon filter /m尼龙液体过滤芯Consult material certificate document and attach it in attachment16./检查材质证明并附于附件16Terminal pump/ 终端水泵Stainless steel/不锈钢/Consult material certificate document and attach it in attachment16./检查材质证明并附于附件16 Pipeline pressure test, clean, passivation and disinfect qualification./管道分配系统的试压、清洗、钝化、消毒确认.1 Qualification method/确认方法Inspect the pipeline pressure test record(attachment 5), clean record before use(attachment 6),pipeline passivation records(attachment 7) and pipeline disinfect records(attachment 8)./检查纯化水管路试压记录(附件5)、纯化水管道使用前清洗记录(附件6)、纯化水管道钝化记录(附件7)、纯化水管道使用前消毒记录(附件8).2 Standards/合格标准（1） Pipeline pressure test/管路试压：Pressure test with Water, experimental pressure is 0.6Mpa which is 1.5 times working pressure (0.4MPa); the pipeline should be no leakage under the pressure./用水试压，实验压力为工作压力0.4MPa的倍即0.6Mpa，整个管路在实验压力下应无渗漏发生。（2） Pipeline clean, passivation and disinfect/管道清洗、钝化、消毒 Purified water cycle pipeline Pre-washed: The purified water tank, pump and pipeline to connect into a cycle path, add sufficient amount of purified water to purified tank, open the pump to cycle for 15 minutes, open the drain valve, and then continue cycle./纯化水循环预冲洗：将纯水罐、水泵与管路连接成一个循环通路，在纯水罐中注入足够量的纯化水，开启水泵进行循环，循环15分钟后，翻开排水阀，边循环边排放。 Alkaline Cleaning: The sodium hydroxide (chemically pure and above) with hot water (temperature 90 or above) preparation of 1% (w / v) solution (500L), with the circulation pump more than 30 minutes (after 30 minutes opening Each water point of the valve for 10 seconds to wash their), open the drain valve, discharge lye./ 碱液清洗：将氢氧化钠化学纯以上用热水温度90以上配制成1%w/v的溶液(500L)，用水泵循环30分钟以上期间隔30分钟后开启每个用水点阀门10秒钟对其进行清洗，翻开排水阀，排放碱液。 Rinse: Add purified water to purified water storage tank, start the pump, open the drain valve, rinse while discharge, discharge time should be no less than 30 minutes, until the conductivity of the water in the tank and the conductivity of outlet water is the same. / 冲洗：将纯化水参加纯水罐，启动水泵，翻开排水阀，边冲洗边排放，排放时间应不少于30分钟，直至各出水口水的电导率与纯水罐中水的电导率一致。 Passivation: The nitric acid (chemically pure and above) preparation of 5% of the acid (500kg), injection of pure water tank, recycling 120 minutes, using sodium hydroxide adjust PH=7 and discharge./钝化：将硝酸化学纯以上配制成5%的酸液(500kg)，注入纯水罐，循环120分钟，用氢氧化钠中和后排放。 Rinse: Rinse with purified water, no less than 30 minutes, until the conductivity of import and export purified water is the same./冲洗：用纯化水冲洗，时间不少于30分钟，直至进出口纯化水的电导率一致。 Disinfection: preparation of 3% hydrogen peroxide disinfecting solution, add it to the pure water tank and start the pump, loop for 30 minutes (every 10 minutes opening discharge valve for each water point 10 seconds of its disinfection)./消毒：配制3%的双氧水消毒液，注入纯水罐，启动水泵，循环30分钟期间每隔10分钟开启每个用水点阀门排放10秒对其进行消毒。 Rinse: Rinse with purified water, no less than 30 minutes, until the conductivity of import and export purified water is the same./冲洗：用纯化水冲洗，时间不少于30分钟，直至进出口纯化水的电导率值一致。 Operation qualification/运行确认 Control and safety protection performance confirmation/控制及平安保护性能确认Records fill in attachment 20./确认记录填写于附件204.1 Qualification Method/确认方法Check and assure that the control system and the corresponding direction is normal; over-voltage protection function, the water level automatic control functions, overload and short-circuit protection function, STOP function is accurate and effective.检查控制系统运行及相应指示是否正常；过压保护功能、水位自动控制功能、过载及短路保护功能、“急停功能是否准确有效。.2 Standards/合格标准The control system and the corresponding directions is normal; over-voltage protection function, the water level automatic control functions, overload and short-circuit protection function, E-STOP function are accurately and efficiently.控制系统运行及相应指示正常；过压保护功能、水位自动控制功能、过载及短路保护功能、“急停功能准确有效。 Two grade reverse osmosis low-pressure cleaning qualification/二级反渗透装置低压清洗确认.1Qualification method/确认方法Measured with stopwatch and inspection by visual/用秒表测量、目测.2 Standard/合格标准Every normal run, automatic low-pressure washing, original water pump start and low-pressure washing Two grade reverse osmosis systerm, the high-pressure pump 3-minute delay to start. The records fill in attachment 21.每次正常开机，装置自动进行低压冲洗，原水泵开启对二级反渗透装置低压冲洗后，高压泵延时3分钟启动，确认记录填写于附件21。 Performance Qualification/性能确认Qualification method/确认方法（1） Operation according to the SOP No.HS/SOP-CF-001按?纯化水系统操作、维护保养标准操作规程?HS/SOP-CF-001操作和清洗消毒。（2） Open the purified water system in operation continuous 3 days, after running 1 hour every day, every use point open 10 minutes, the rest purified water returned to purified water storage tank for recycling. Sample the purified water of the purified water storage tank, the total outlet, the total return hole and test. All items should be qualified before start the next validation step.开启纯化水系统连续运行3天，每天运行制水1小时后，各用水点依次放水10分钟，其余纯水分别回到纯化水贮罐进行循环，纯化水贮罐、总出水口、总回水口依次取样，检测全部合格后再进行下步验证。（3） Under normal circumstances, the verification process should monitor the water quality continued for 21 days, running the system 8 hours per day, sample and detect the purified water every day after the system running 1 hour, all water points open in turn for 10 minutes, the rest were returned to water purified storage tank to cycle./正常情况下，验证过程的水质监控持续21天，每天运行8小时，每天运行制水1小时后，各用水点依次放水10分钟，其余纯水分别回到纯化水贮罐进行循环。（4） The sampling method is as follows (the distribution of water points see water purification water system network diagrams, attachment 10):/具体取样方法如下各取水点的分布见纯化水系统用水网络图,附件10： Sample the purified storage, the total outlet, the total return hole every day during the validation./纯化水贮罐、总出水口，总回水口在确认的全过程中每天取样检测。 Each cycle, the water sampling points, to take turns to ensure that all water points, rounds to take a times, each time samples were marked and recorded water intake numbers/每个周期，各用水点每天轮流取样，保证各用水点轮取1次，每次取样均注明取水口编号并记录。 If due to sampling, testing and other factors, resulting in the individual water quality failure, we must consider re-sampling test. The re-sample as follows:由于取样，化验等因素，会出现个别水质不合格现象，必须考虑重新取样化验。方法如下：A. In the unqualified use of point and then take a sub-sample. /在不合格的使用点再取1次样。B. Retest the unqualified item./重新化验不合格指标。C. Retest result must be qualified./重测这个指标必须合格。D. If the retest result is failure, the validation is failure and should do new validation process. /再次测定不合格，验证重新开始。Sample points as follow/各取水点编号如下：A1Sampling hole/纯水取样口A2Purified water storage tank/纯化水贮罐A3Total outlet/总出水口A4Total return hole/总回水口A5Purified room/提纯间A6Recrystallization room/重结晶间A7Clothes washing room/洗衣间A8Tools clean room/器具洗涤间A9Clean tools clean room/洁具洗涤间Sample method: According to the SOPNo. HS/SOP-QC-079/取样方法：按?纯化水取样标准操作规程操作?HS/SOP-QC-079Test Standard: CP (2005)/ 检验依据：按中华人民共和国药典2005年版二部纯化水质量标准确定。Acceptance level: CP (2005)/ 合格标准：中华人民共和国药典2005年版二部纯化水标准项下。According to the above sampling methods， sampling points and sampling frequency to do, for three cycles, each cycle of 7 days, the results of all sample should be qualified. The performance qualification record attached attachment 23.按上述方案规定的取样方法及取样点按相应的取样频率对纯化水系统进行3个周期，每个周期7天的各项指标的检测，结果所有取样点的水质均合格。性能确认报告附于附件235 Deviation and deal with method/验证过程中的偏差及处理Through the equipment installation, operation, performance, inspection and confirmed that all the validation result is consistent with the standard. If there is any deviation in the validation process, should analyze the causes of dev