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真空干燥设备验证方案验证编号：设备编号：艾博生物医药（杭州）有限公司年月目录1.文件批准 (3)1.1. 文件准备和批准 (3)1.2验证参加人员会签 (3)2.概述 (3)3.目的 (3)4.所用测量器具（设备） (3)5.接受标准 (3)6.程序 (3)7.原始记录 (4)7.1. 安装确认记录 (4)7.2. 运行确认记录 (6)7.3. 风险测试：电力中断和恢复 (8)8.偏差报告 (9)8.1. 偏差和修正一览表 (9)8.2. 偏差报告样张 (9)9. 总结报告完成与批准 (10)1.文件批准1.1.文件准备和批准2.概述真空干燥是将被干燥物料处于真空条件下进行（加热）干燥。
它是利用真空泵进行抽气抽湿使工作室内形成真空状态，加快了干燥速率，提高了工作效率。
3.目的真空干燥设备的安装和运行制订确认要求和接受标准，确保设备的安装和运行是符合生产、GMP、安全、环保和当地及国家法规要求的，可以进行工艺验证（PQ和试生产）4.所用测量器具（设备）5.接受标准5.1.运行要求见7.2项5.2.性能要求：a. 最后运行压力小于60pa（0.5mmHg）b. 去水能力大于98%6.程序6.1.安装确认要求6.1.1.设备确认6.1.2. 设备部件确认 6.1.3. 公用系统确认 6.1.4. 文件检查 检查表格见7项6.2. 运行确认要求6.2.1 满载测试56片玻纤。
（每层8片，共7层）称取7片玻纤（编号），记录玻纤放置位置，和重量A 。
位置见图。
第一层第二层6.2.2 用去离子水浸泡6.2.3 天平清零，称取浸泡后的玻纤的重量B 6.2.4 记录拿走玻纤后剩余水的重量C6.2.5 重新清零，重复称取7片玻纤的重量填写数据 6.2.6 将玻纤放进干燥箱，进行干燥处理。
6.2.7 调节温度30℃，真空度 ，达到参数后开始记时。
干燥4小时。
取出玻纤，称取其重量。
6.2.8 计算去水能力，填写表格。
6.2.9重复测试（干燥时间分别6、7、8小时），绘制干燥曲线。
Deviations: Yes __ No __ Verified by (customer):Comments: Rev. B.03.40 Date Printed: 15-Jun-2007 08:34:37Page 1 of 21Qualification Services for Agilent Chemical Analysis InstrumentsClassic EditionAgilent Technologies Installation Qualification for the Agilent 1100/1200 Series HPLC InstrumentInstrument IDProtocol Revision NumberRev. B.03.40Deviations: Yes __ No __ Verified by (customer):Comments: Rev. B.03.40 Date Printed: 15-Jun-2007 08:34:37Page 2 of 21In this ProtocolThis protocol is intended for technical readers in regulated environments who are performing installation qualification (IQ) on the Agilent 1100/1200 Series HPLC instruments.The protocol is divided into the following sections. • Protocol Approval Contents: Fill in forms for approval of protocol by customer and Agilent Technologies• Protocol DetailsContents: Fill in forms for details of the IQ to be performed • Preparation and Installation Contents: Information on site preparation and installation. • DocumentationContents: Details of documentation supplied with the instrument• Instrument Record Contents: Details of all installed modules, including module description, options installed, reference manuals or user ’s guides, and module status • Instrument CheckContents: Details of tests run to check the equipment• Certification of System Qualification Contents: Fill in forms for deviation correction and IQ Certification • Attachments Contents: Relevant forms and checklists© Copyright Agilent Technologies 2000 - 2007All rights reserved. Reproduction, adaptation or translation without prior written permission is prohibited, except as allowed under the copyright laws.Rev. B.03.40, January 2007WarrantyThe information contained in this document is subject to change without notice. Agilent Technologies makes no warranty of any kind to this material, including but not limited to, the implied warranties or merchantability and fitness for a particular purpose. Agilent Technologies shall not be liable for errors contained herein or for incidental or consequential damages in connection with the furnishing, performance, or use of this material.WARNINGFor details of safety see “Safety Information ” in the 1100/1200 Series module reference manual.Table of ContentsRevision History (4)Protocol Approval (5)Protocol Acceptance/Approval by Customer (5)Protocol Acceptance/Approval by Agilent Technologies (5)Customer Details (6)Instrument Details (6)Qualification Details (6)Scope / Purpose (7)Responsibility Matrix (7)Exceptional Conditions (7)Glossary (8)Purchase Order Compliance (9)Preparation & Installation (10)Site Preparation (10)Installation (10)Documentation (11)System Manuals, Reference Manuals, and User’s Guide (11)Equipment Descriptions and Figures (11)Consumables (11)Declaration of Conformity (11)Module Details (11)Instrument Record (11)Degasser (12)Quaternary Pump (13)Autosampler (14)Thermostatted Column Compartment (15)Variable Wavelength Detector (16)Instrument Check – VWD/MWD/DAD (17)Declaration of Change Control (19)Certification of System Qualification (20)IQ Certification (20)Deviation Record/Cross-Reference (20)Attachments / Supporting Documents (21)Deviations: Yes __ No __ Verified by (customer):Comments:Rev. B.03.40Date Printed: 15-Jun-2007 08:34:37 Page 3 of 21Revision HistoryREVISION HISTORYRevision: B.03.40Date: January 2007Changes: Removed date text from cover sticker box.Accommodated new DAD (G1315D), MWD (G1365D), and ALS (G1329B) modules.Glossary – Deleted reference to NAMAS, added reference to UKAS.Instrument Record – Updated text describing location of VWD flow cell serial number.Document Revision DateB.03.30 March 2006B.03.20 July 2005B.03.10 July 2003B.03.00 September 2002B.02.00 December 2001B.01.20 November 2000B.01.01 July 2000B.01.00 June 200009.00 January 200005.00 April 199998.10.01 October 199898.07.01 July 199897.08.01 August 199796.01.01 January 1996Deviations: Yes __ No __ Verified by (customer):Comments:Rev. B.03.40Date Printed: 15-Jun-2007 08:34:37 Page 4 of 21PROTOCOL APPROVALUse this protocol to qualify and record the installation of the 1100/1200 Series HPLC instrument.Protocol Acceptance/Approval by CustomerA signoff area has been provided at the bottom of each page in case an internal SOP requires review and acceptance of every page in this document. If page-by-page signoff is not required, use the area to document deviations only. Acceptance of the entire document is complete when the Certification of System Qualification is reviewed and signed by the responsible parties.Per-page signoff in this protocol Yes/No RequiredRequired only for pages that contain dataRequired only for pages that contain deviationsI have reviewed this document and agree that it provides appropriate procedures for the Installation Qualification (IQ) of the equipment for which it has been configured. Customer Name (Print) Signature Date Additional review, if required by customer.Reviewer’s Name/Title (Print) Signature Date Protocol Acceptance/Approval by AgilentTechnologiesI agree that the IQ procedures in this document, assembled by Agilent Analytical Qualification Services, are appropriate for the equipment defined within and reflect the current Agilent qualification procedure.Qualified Service Representative’s Name (Print) Signature DateDeviations: Yes __ No __ Verified by (customer):Comments:Rev. B.03.40Date Printed: 15-Jun-2007 08:34:37 Page 5 of 21Customer DetailsThe customer listed below is the owner/user of the instrument.Company Name LocationDepartment ContactInstrument DetailsThis IQ will be performed on the instrument listed below. Details for this instrument’s modules are included in the Instrument Record section. All of the instrument’s modules, equipment, and manuals will be installed in the location listed below.Instrument ID LocationQualification DetailsThe following details apply to the IQ performed on the instrument listed above. Qualified Service Representative’s Name Date IQ PerformedDeviations: Yes __ No __ Verified by (customer):Comments:Rev. B.03.40Date Printed: 15-Jun-2007 08:34:37 Page 6 of 21Scope/PurposeSCOPE / PURPOSEThis protocol applies to the installation qualification (IQ) of analytical systems described in the Instrument Record section. It defines the methods and documentation used to evaluate the system for installation according to defined specifications and intended use. Successful completion of this protocol provides a high degree of assurance that the system is installed correctly and capable of normal start-up. It does not indicate that the system is performing according to the published acceptance limits. Only an OQ/PV can provide that assurance.Responsibility MatrixAgilent TechnologiesAgilent Technologies Qualification Services personnel who are trained and knowledgeable about the equipment and procedures perform the IQ. The Agilent Technologies representative records, signs, and dates fields as indicated by the protocol.CustomerCustomers must read and approve this procedure, which is only part of the compliance process, before the qualification begins. The customer must also supply support services required for installation. These services include dedicated electrical service, climate control, purified gasses or solvents, and disposal facilities. System hardware must be under configuration control and the customer is responsible for documenting changes and maintaining configuration change control procedures.The customer must review, accept, archive, and maintain security of the delivered record of qualification.Qualification of a system is in effect only if the system remains intact. Exceptional ConditionsAny exceptional conditions found during the IQ must be documented immediately. Agilent Technologies personnel review the conditions and identify actions that can correct the problem.Performance of the IQ does not bind Agilent Technologies to perform repairs that are necessary because of normal instrument wear or transfer of the equipment to a new location. Agilent Technologies can charge a fee to re-qualify an instrument that does not pass the qualification test. If a new instrument fails the IQ, it may be covered under manufacturer's warranty if it meets all of the conditions of the warranty. Deviations: Yes __ No __ Verified by (customer):Comments:Rev. B.03.40Date Printed: 15-Jun-2007 08:34:37 Page 7 of 21Glossary GLOSSARYChange Control Form- A document provided by the customer, which accounts for deviations from the original equipment configuration as established by Agilent and the customer.Configuration - A grouping of instruments designated by the customer and/or Agilent to operate together.Customer - An individual or company that has requested service from Agilent in exchange for payment.Declaration of Conformity - Documentation provided by Agilent certifying the performance of the equipment meets standards and/or specifications established by the manufacturer throughout the product.DKD– Deutscher Kalibrierdienst.ISO– International Organization for Standardization.NIST– National Institute of Standards and TechnologyQualified Service Representative- A representative of Agilent or an individual authorized by Agilent whose responsibility is to install, service, and /or qualify Agilent equipment.Qualification Stickers– (1) A label physically attached to an individual instrument or system notifying the user of the status of the equipment's adherence to established criteria. (2) A label applied to the front cover of this document, which demonstrates authenticity.Standard Operating Procedure(SOP) - A document, which describes an operation in sufficient detail to allow for consistent performance of the operation, independent of the operator.UKAS– United Kingdom Accreditation ServiceDeviations: Yes __ No __ Verified by (customer):Comments:Rev. B.03.40Date Printed: 15-Jun-2007 08:34:37 Page 8 of 21Purchase Order ComplianceDeviations: Yes __ No __Verified by (customer):Comments: Rev. B.03.40 Date Printed: 15-Jun-2007 08:34:37Page 9 of 21PURCHASE ORDER COMPLIANCEComplianceCompare this instrument to the customer ’s purchase order, which is attached to this protocol. The customer verifies the entry. Customer Purchase Order Acceptance (Complies/Does Not Comply) Verified by Customer DatePreparation & InstallationPREPARATION & INSTALLATIONSite PreparationUse the Site Preparation Specification, which is attached to this protocol, to determine the suitability of the installation site and the availability of appropriate utilities, consumables, and supplies. The customer is responsible for complying with the requirements of the specification.The following 1100/1200 Series site preparation specifications are available from Agilent Technologies.Description Date or Revision* 1100/1200 Site Preparation Specification1100/1200 HPLC Value System Site Preparation Specification1100/1200 LC/MSD Site Preparation Specification* Record the date or revision for the checklist(s) used, all others record N/AInstallationThe qualified service representative performs the installation according to the Hardware Installation Checklist that is attached to this protocol.The following 1100/1200 Series hardware installation checklists are available from Agilent Technologies.Description Part Number* 1100/1200 Hardware Installation Checklist1100/1200 HPLC Value System Hardware Installation Checklist1100/1200 LC/MSD Hardware Installation Checklist* Record the date or revision for the checklist(s) used, and for all others record N/A.Site requirements and installation instructions are also included in the reference manuals for each module.Deviations: Yes __ No __ Verified by (customer):Comments:Rev. B.03.40Date Printed: 15-Jun-2007 08:34:37 Page 10 of 21DocumentationDOCUMENTATIONSystem Manuals, Reference Manuals, and User’s GuideThe reference manuals and user’s guide supplied with the instrument as part of the installation are detailed in the Instrument Record section of this protocol. Manuals may be provided in printed or electronic form. System manuals supplied with the 1100/1200 Series instrument are listed below.Title Part NumberEquipment Descriptions and FiguresFigures of instrument connections and descriptions of functions of the components are included in the reference manuals above.ConsumablesExpendables and consumables are included in the reference manuals and can be ordered as follows.§From the Agilent Chemical Analysis Consumables and Accessories Catalogue§Online at /cag/main.htmlDeclaration of ConformityDeclarations of Conformity are supplied with each 1100/1200 Series module and attached to this protocol.Module DetailsTo fully document the installation, record details for each module installed in this instrument in the Instrument Record section.INSTRUMENT RECORDProcedureEnter the required information and results into the tables on the following pages.Deviations: Yes __ No __ Verified by (customer):Comments:Rev. B.03.40Date Printed: 15-Jun-2007 08:34:37 Page 11 of 21DegasserMain Pump:DegasserDescription1100/1200 Series vacuum degasser Manufacturer Agilent TechnologiesModel number G1322ASerial number Other identifying reference*Firmware revision* Supplied by the customer.The following reference manual is supplied with the degasser module.Title Part NumberReference manual* G1322 -* Complete the part number.Record the status of the vacuum degasser module after you turn on the power for the module and, if applicable, turn on, initialize, and warm up the module.Status Expected Status CommentReady When vacuum level achievedDeviations: Yes __ No __ Verified by (customer):Comments:Rev. B.03.40Date Printed: 15-Jun-2007 08:34:37 Page 12 of 21Quaternary PumpMain Pump:Quaternary PumpDescription1100/1200 Series quaternary pump Manufacturer Agilent TechnologiesModel number G1311ASerial number Other identifying reference*Firmware revision* Supplied by the customer.Options installedThe following quaternary pump module options are available from Agilent Technologies.Description OptionSeal wash option #030LAN communication interface #500The following reference manual is supplied with the quaternary pump module.Title Part NumberReference manual* G1311 -* Complete the part number.Record the status of the quaternary pump module after you turn on the power for the module and, if applicable, turn on, initialize, and warm up the module.Status Expected Status CommentReady When flow startedDeviations: Yes __ No __ Verified by (customer):Comments:Rev. B.03.40Date Printed: 15-Jun-2007 08:34:37 Page 13 of 21AutosamplerDeviations: Yes __ No __ Verified by (customer):Comments: Rev. B.03.40 Date Printed: 15-Jun-2007 08:34:37Page 14 of 21AutosamplerDescription 1100/1200 Series autosampler Manufacturer Agilent TechnologiesModel number G1313A/G1329A/G1329B Serial numberOther identifying reference* Firmware revision* Supplied by the customer.Options installedThe following autosampler module options are available from Agilent Technologies.DescriptionOption Expanded injection range option #020 Multi-draw kit#021 LAN communication interface #500The following reference manual is supplied with the autosampler module.TitlePart Number Reference manual*G1313 – G1329 –* Complete the part number as applicableRecord the status of the autosampler module after you turn on the power for the module and, if applicable, turn on, initialize, and warm up the module.Status Expected Status CommentReadyAfter initializationThermostatted Column CompartmentDeviations: Yes __ No __ Verified by (customer):Comments: Rev. B.03.40 Date Printed: 15-Jun-2007 08:34:37Page 15 of 21Thermostatted Column CompartmentDescription 1100/1200 Series thermostatted column compartmentManufacturer Agilent Technologies Model number G1316A/G1316BSerial numberOther identifying reference* Firmware revision* Supplied by the customer.Options installedThe following thermostatted column compartment module options are available fromAgilent Technologies.DescriptionOption Column switching option#055Micro column switching option G1388A #055The following reference manual is supplied with the thermostatted column compartment module.TitlePart Number Reference manual*G1316 -* Complete the part number.Record the status of the thermostatted column compartment module after you turn on the power for the module and, if applicable, turn on, initialize, and warm up the module.StatusExpected Status CommentReady After initializationVariable Wavelength DetectorDeviations: Yes __ No __ Verified by (customer):Comments: Rev. B.03.40 Date Printed: 15-Jun-2007 08:34:37Page 16 of 21Variable Wavelength DetectorDescription 1100/1200 Series variable wavelength detectorManufacturer Agilent TechnologiesModel number G1314A/G1314B/G1314CSerial numberOther identifying reference* Firmware revision* Supplied by the customer.Options installedFlow cell serial number** Depending on the age of the cell, the serial number is located on the rear of the front plate orengraved on the cell body.The following variable wavelength detector module options are available from Agilent Technologies.DescriptionOption Semi-micro flow cell #016 Standard flow cell #018 Micro flow cell#020 High Pressure flow cell#021 LAN communication interface #500The following reference manual is supplied with the variable wavelength detector module.TitlePart Number Reference manual*G1314 -* Complete the part number.Record the status of the variable wavelength detector module after you turn on the power for the module and, if applicable, turn on, initialize, and warm up the module.StatusExpected Status CommentReady When lamp ignitedDeviations: Yes __ No __ Verified by (customer):Comments: Rev. B.03.40 Date Printed: 15-Jun-2007 08:34:37Page 17 of 21INSTRUMENT CHECK – VWD/MWD/DADThis instrument check demonstrates that all modules of the instrument are correctly installed and connected. It is not a test of the instrument performance.ProcedureNote : Skip this check if an OQ/PV will be performed immediately after the IQ. TheOQ/PV injections serve as a final check and demonstrate that all modules of the instrument are correctly installed and connected. 1. Make a single injection of the isocratic test standard using the Conditions below. 2. Compare the resulting chromatogram with the typical chromatogram shown in the figure. 3. Attach the chromatogram, the sample ’s certificate of analysis, and the column ’s test certificate to this protocol and complete the appropriate columns in the Attachments/Supporting Documents section.ConditionsFlow 1.500 ml/minute Stop time~8.00 minutesSolvent A binary/quaternary 30% (HPLC-grade water)Solvent A isocratic 100% (30% water/70% acetonitrile) Solvent B70% (HPLC-grade acetonitrile) Wavelength VWD254 nmWavelength DAD/MWD Sample: 254/4 nm, reference: 500/100 nm Injector volume 1.0 µlColumn temperature25.0°C or ambientAgilent 1100/1200 Series InstrumentDegasser – always with quaternary pump, optional with othersIsocratic, binary, or quaternary pumpAutosampler, preparative autosampler, well plate sampler, or manual injectorColumn compartment – optional Detector – VWD, MWD, DAD Standard flow cell installed Control module or ChemStationDeviations: Yes __ No __ Verified by (customer):Comments: Rev. B.03.40 Date Printed: 15-Jun-2007 08:34:37Page 18 of 21Condition (continued)ColumnAgilent P/N 993967-902Zorbax Eclipse XDB-C18 150 x 4.6 mm i.d.StandardAgilent P/N 01080-687040.15 wt.% dimethylphthalate, 0.15 wt.% diethylphthalate0.01 wt.% biphenyl, 0.03 wt.% o-terphenyl in methanolIf the instrument ’s configuration is different from the one shown above, attach the conditions that match the instrument ’s specifications to this protocol.Typical ChromatogramA typical chromatogram for this analysis is shown in the figure. The exact profile of the chromatogram depends on chromatographic conditions. Variations in solvent quality, column packing, standard concentration, and column temperature may affect peak retention and response.Chromatogram with UV DetectorDeclaration of Change ControlDECLARATION OF CHANGE CONTROLThis document is under change control. Revision history is maintained and printed on each document. Access to the master documents is limited to process owners. Documents receive periodic review and cannot be assigned an evergreen status. The qualification performed according to this document refers only to thehardware/software configuration in place at the time of the qualification.Agilent Technologies recommends that instrument configuration change management procedures be in place to maintain the validation process. Any changes to the analytical or computer hardware or software must be clearly specified. A change management system provides a means for determining the degree of re-qualification required according to the extent of the changes made. All details of the changes, completed tests, and test results must be thoroughly recorded and documented. Note: Instrument configuration change management is not the responsibility of Agilent Technologies.Deviations: Yes __ No __ Verified by (customer):Comments:Rev. B.03.40Date Printed: 15-Jun-2007 08:34:37 Page 19 of 21Certification of System QualificationCustomer Name (Print Name) Signature DateQualified Service Representative (Print Name) SignatureDateRev. B.03.40 Date Printed: 15-Jun-2007 08:34:37Page 20 of 21CERTIFICATION OF SYSTEM QUALIFICATION IQ CertificationDeclaration of Certification TypeCertification type** Specify initial (first time IQ performed) or requalification (reoccurring).The analytical system identified in the Instrument Details section has yielded the following results .Summary of ResultsAll qualification tests were successfully completed. PassSome of the qualification tests required correction in order to successfully complete.*Pass after correctionSome of the qualification tests were not successfully completed.**Fail*Attach a Deviation Report that describes the corrective action that was taken. The DeviationReports associated with this document are listed below. If a deviation is due to a process change (Product Support Bulletin, Service Note, and so on), attach a copy of the change notification. ** Agilent Technologies recommends that the system be removed from service until it is repaired.Deviation Record/Cross-ReferenceDeviation #Page #Brief Description of the ProblemReport Attached (Yes/No)*Resolution Date**Attach a Deviation Correction Report Form and supporting documentation to the Attachments section of this protocol.Attachments / Supporting DocumentsDeviations: Yes __ No __ Verified by (customer):Comments: Rev. B.03.40 Date Printed: 15-Jun-2007 08:34:37Page 21 of 21ATTACHMENTS / SUPPORTING DOCUMENTSThe documents listed below are referred to but not included in the body of this protocol.DocumentAttached (Yes/No)Number of Pages1. Site Preparation Specification Checklist2. Hardware Installation Checklist3. Declarations of Conformity4. Customer Purchase Order5. Instrument Check Chromatogram6. Sample Certificate of Analysis7. Documentation supplied with the column。
如有你有帮助，请购买下载，谢谢！方案编号：真空冷冻干燥机验证方案验证方案汇签1 验证方案起草2验证方案的审核3验证方案批准目录1．项目概述2．验证目的3．验证范围如有你有帮助，请购买下载，谢谢！4．验证小组成员及职责5．验证内容5.1 设行确认（DQ）5.2 文件起草及培训5.3 安装确认（IQ）5.4 运行确认（OQ）5.5 性能确认（PQ）5.6 异常情况处理程序6．再验证周期7. 验证结果与评定1. 项目概述安装在冻干粉针车间的LYO-23（CIP）型真空冷冻干燥机，用于对冻干溶液进行冷冻干燥，除去溶液中的水分，并得到干燥的目的。
该机器所用冷冻干燥的原理是将药品溶液经过冷冻后，在低气压（即真空）状态下，不经过液态，直接由固态升华至气态，并由解吸附的方法除去制品中水分的工艺过程。
该机器整个系统包括一个干燥箱（内有可间接加热和制冷的板层）、一个水捕捉器（冷凝器）、一套冷热媒循环系统、一套制冷系统、一套电加热系统、一套真空系统、一套控制系统、一套液压压塞系统、一套在位清洗系统（CIP）和相关的安全连锁装置。
干燥箱（冻干箱体）及板层：采用优质的AISI316L材料，内表层粗糙度Ra≤0.5μm，箱体内所有的角均为圆弧形。
板层采用薄形空心夹板形式，平整度达到±0.5mm/m，板层的制冷采用间接方式，平衡时温差不大于±1℃。
冷热媒循环系统采用阿法拉伐板式交换器和丹麦格兰富循环泵，能彻底消除导热油的泄漏。
制冷系统：采用3个压缩机组，每个压缩机组均有独立的循环系统，既可制冷板层，又能制冷冷凝器，其中任何一套系统出故障，机器仍可正常工作。
真空系统：采用2个真空泵组和1个罗茨泵组，确保极限真空，空载极限真空≤1Pa。
控制系统：系统连锁保护，以防止不必要的误操作。
用户可实现屏幕操作，也可使用电脑进行远程管理和操作。
液压系统：采用高质量阀件制成的液压泵和油缸组成液压系统，彻底消除液压油的泄漏问题。
精心整理设备验证文件（安装IQ、运行OQ、性能PQ）设备名称：气流粉碎机?设备型号：YQ100-18.运行确认（OQ） (6)9.性能确认（PQ） (7)10验证结果的评审与验证结论 (7)11文件修订变更历史 (7)12.附件： (8)12.1培训记录 (11)12.2安装确认记录 (12)12.3运行确认记录 (18)12.4性能确认记录 (25)1．验证方案审批设备特点：干法超细超微粉碎。
2.3主要技术参数处理量：0.8～15kg/H粉碎后成品粒径：D50:0.5～100um（可调）压缩空气耗量:1.5～1.8m3/min压缩空气压力:0.8～1.0Mpa粉碎温度:≤20℃3.目的通过验证，保证气流粉碎机安装并运行后，工作性能符合生产工艺和生产规模的要求，标准操作程序符合生产操作要求。
4.范围567.7.1检7.27.3公用工程确认公用工程符合要求，包括水、电、汽等。
应记录实际测量的数据，如电压、压力等。
检查及确认表见附表7.37.4图纸确认图纸标题、编号、版本号和日期以及图纸保存位置。
已批准的图纸或竣工图准确代表已安装的系统，如有差异，并已经在图纸上标注。
检查及确认表见附表7.47.5备件清单列出已购买并且到位的所有设备易损件、易耗品。
检查及确认表见附表7.57.6仪表和校准确认检查并确认YQ100-1型气流粉碎机各仪器仪表的校验情况：列出设备上的所有仪表，检查确认所有的仪器仪表已经校验，并都贴有在有效期内的绿色合格证。
检查及确认评价表见附表7.67.7润滑剂确认列出设备上所有润滑点。
使用的所有润滑剂都已记录下来，并且确定每一种润滑剂都符合其特定用途。
应使用食品级润滑油，除非食品级润滑油会影响某个系统的性能，不在工作空间内或附近使用，并且市场上没有相应的食品级润滑油。
润滑油不应当带来污染的风险。
检查及确认表见附表7.77.8检查7.9检7.10各项技7.118.8.1IQ8.1.2确认在IQ部分中确认的所有系统的仪表在执行OQ工作时，仍然在校准有效期内，检查及确认表见附表8.1.2。
□□□□干燥公司编号：设备验证文件设备名称：双锥真空干燥机设备型号：SZG系列设备编号：_______________________起草人：_____________批准人：_____________日期：_____________目录1．验证方案 (1)2．验证报告 (3)3．验证记录 (4)4．安装确认记录 (4)5．运行确认记录 (5)6．性能确认记录 (8)1、概述SZG双锥真空干燥机是将物料处在真空条件下进行加热干燥，利用真空泵进行抽气抽湿，加快了干燥速率。
按设备设计参数、性能进行确认，验证是否符合工艺要求。
按GMP要求验证与药品直接接触，面内构件是否光洁、平整易洗、整体无缺陷。
2、验证步骤2.1安装确认2.1.1检查技术资料完整性a)安装布置图b)使用说明书c)电气原理图d)产品合格证e) 设备材质报告2.1.2安装检查a)设备基础要符合设计要求。
b)主机和墙壁的距离>800mm,工作空间应高于主机高度至少1000mm。
c)设备需清洗，特别是更换品种及停用时，要求场地有自来水，并有排水装置。
d)主机安装完毕，应用水平尺校平。
2.2运行确认根据使用说明，并在额定负载条件下进行干燥测试。
a)电气安全检查。
b)检查各联结件是否紧固，转动是否灵活。
2.3性能确认2.3.1检查技术资料标准操作，保养、清洗程序。
2.3.2干燥均匀度。
2.3.3用实际生产物料进行性能确认方法a)取实际生产物料，按工艺要求生产。
b)通过5小时的干燥，在容器内采取8个点的样品检查含湿均匀度。
设备验证报告年月日表1设备验证记录安装确认表2运行确认（一）（电气安全）表3运行确认(二)(运行测试)表4性 能 确认表5水份取样检验记录批号___________ 日期_______________ 时间________________ 投料量_____________干燥时间____________表6标准操作程序1、目的：严格按本规范操作，强化设备使用与管理，从而保证产品的质量。
目录1预验证结果 (1)1.1验证所需文件资料 (1)1.2备品备件检查 (1)1.3仪器材质及结构确认 (1)2仪器安装确认结果 (1)2.1公用介质的连接 (1)2.2安装技术情况 (1)3 仪器运行结果确认 (1)4仪器性能确认结果 (1)5验证结果评价及建议 (1)6总结论 (1)为确认真空干燥箱能满足化验室不耐高温物体的干燥要求，由设备工程部、质量管理部相关人员组成真空干燥箱验证小组，按《真空干燥箱验证方案》规定的项目，于年月日～年月日对真空干燥箱进行了预确认、安装确认、运行确认检查，并进行了性能验证，验证期间未对验证方案进行修改。
现对验证过程中所取得的数据进行收集和整理报告如下：1预确认结果1.1验证所需文件资料检查仪器档案，确认本仪器验证所需的资料如说明书、操作规程等齐全完整。
检查结果见附件3。
1.2关键性仪表及消耗性备品经验证小组现场查验，认为本仪器的备品备件齐全，能保证仪器出现故障时及时维修。
具体见附件4。
1.3仪器材质及结果确认经验证小组现场查验，认为本仪器结构合理。
符合GMP及设计要求。
仪器材质及结构检查结果见附件5。
1.4仪器、仪表校正验证小组在验证前对仪器附带的关键性仪表如温控仪及验证用的仪器的校验情况进行了检查，确认所有仪表均经过了校正，并在有效期内，检查情况见附件6。
2仪器的安装确认结果：2.1公用介质的连接验证小组中设备工程部人员根据仪器生产厂家设计安装要求，实地测量检查了本仪器主要的公用介质电源的连接情况，确认其连接正确，电源接地良好，达到正常使用条件符合要求，检查情况见附件7。
2.2安装情况及结论验证小组经实地检查，确认本仪器安装环境符合设计及GMP要求，仪器摆放水平稳固，安装台面平整，仪器周围留有一定的空间，方便操作和维修，能保证仪器运行过程中各项性能达到预定要求（检查情况见附件8）。
3仪器运行确认结果验证小组按照验证方案的规定，进行了本仪器各项功能实验，结果仪器运行正常，便于调节，仪器操作规程可行，系统空载运行稳定，可以进行性能验证。
验证文件XXXX 药业股份有限公司目录一、确认背景： (2)二、设备信息： (2)三、验证目的： (2)四、适用范围： (3)五、组织与职责： (3)六、确认实施情况： (4)七、风险评估： (5)八、培训管理： (6)九、运行确认： (7)十、异常情况处理： (23)十一、设备确认与评价： (23)十二、再验证周期： (24)十三、相关附件： (24)十四、修订记录： (24)一、确认背景：中药提取车间因生产需求,依据变更申请（变更编号：XXXXX）,拟购进一台MJY20-4（20m ²）真空带式干燥机。
依据经批准的真空带式干燥机URS（编号：XXXXXX），经过选型、设计确认，最终选定厂家为上海敏杰制药机械有限公司；型号为MJY20-4（20m²）真空带式干燥机。
该型号设备于2019年04月购进，现依据管理要求对其进行设备运行确认。
二、设备信息：2.1基本信息：2.2设备结构与工作原理：2.3主要技术参数三、验证目的：依据《药品生产质量管理规范（2010年修订）》及公司验证相关规定要求对新购进设备进行设备运行确认，本次确认旨在安装确认工作已经结束且合格，以确认设备各种控制功能符合设计要求，能在规定的操作范围内稳定运行且达到设计标准。
四、适用范围：本方案仅适用于本次对新购进设备中药提取车间MJY20-4（20m²）真空带式干燥机的运行确认。
五、组织与职责：5.1参与本次确认的组织、部门、人员及其验证职责：5.1.1参与本次验证委员会的成员：5.1.2验证委员会职责：验证委员会负责人职责：对本次确认的所有工作做最终的决策；负责批准本次确认方案、确认报告；负责批准本次确认过程中偏差、变更。
验证委员会委员职责：协助验证委员会负责人对整个确认工作进行管理；负责审核确认方案、确认报告；指定本部门人员参与本次确认的实施。
5.1.3本次确认小组：5.1.4确认小组工作职责：组长（XXX）职责：负责本次运行确认的领导工作，对本次运行确认的整个过程负责，运行确认阶段过程中出现的偏差、变更的审核；负责对运行确认的评价工作；负责设备运行确认阶段风险点的建立。
3Q模板IQOQPQ验证方案模版1.引言1.1目的：本验证方案旨在评估和验证设备、工具或工艺的合规性，并确保其能够满足质量管理体系的要求。
2.范围2.1设备/工具/工艺描述：详细描述将要进行验证的设备、工具或工艺的名称、型号和功能。
2.2验证目标：明确验证的目标，例如设备/工具/工艺的准确性、稳定性和可重复性等。
3.管理概况3.2项目团队：列出参与此验证的成员和其角色。
3.3计划：制定详细的时间表，包括验证计划、验收条件和步骤。
4. 安装资质验证 (Installation Qualification, IQ)4.1目标：验证设备/工具/工艺是否安装正确，并符合规定的设备要求和标准。
4.2验证步骤包括但不限于：4.2.1设备/工具/工艺验证：检查设备是否符合规定的设备要求和标准。
4.2.2安装位置验证：确认设备是否安装在适当的位置，并符合规定的安全要求。
4.2.3供应和支持验证：检查设备的供应和支持情况，包括供应电源、仪器、相关设备和文档等。
4.2.4校准验证：验证设备是否经过校准并符合规定的标准。
4.3结果记录：记录验证的结果，包括设备/工具/工艺是否通过验证以及验证过程中发现的任何问题。
5. 运行资格验证 (Operational Qualification, OQ)5.1目标：验证设备/工具/工艺是否能够按照预期运行，并在规定的操作范围内工作。
5.2验证步骤包括但不限于：5.2.1运行参数验证：验证设备在规定的操作参数下是否正常运行。
5.2.2性能验证：验证设备是否满足规定的性能标准，例如准确度、响应时间等。
5.2.3控制系统验证：验证设备的控制系统是否按照预期运行，并能够实现预设的控制功能。
5.3结果记录：记录验证的结果，包括设备/工具/工艺是否通过验证以及验证过程中发现的任何问题。
6. 运行质量验证 (Operation Qualification, OQ)6.1目标：验证设备/工具/工艺是否能够持续稳定地运行，并在规定的操作条件下保持一致的性能。
