課件案例成果c-p02pr urs for clean garment dryer

1、URS for clean garment dryer惠氏制藥有限公司.WYETH PHARMACEUTICAL CO.,URS 封 頁/ URS Covage設(shè)計 Designed ByName:Date:Signature:校對 Checked ByName:Date:Signature:審核 Reviewed By標(biāo)題/Title: URS for Wet Miller版本/ Ver:1發(fā)布日期/Ie Date (YYMMDD)/No:1. 歷史/History Page：2. 附錄/Appendix版本號 Ver變更描述Change description發(fā)布日期Ied date1WY

2、ETH SUZHOU CHINAUSER REQUIREMENT SPECIFICATION FORClean garment dryerNUMBERClean garment dryer EDITIONDATEAUTHORDESCRIPTIONAPPROVAL SHEETSignatureTitleDatePrepared by:Reviewed by:Approved by: (Pr(PrName) Title) (Pr(PrName) Title) (Pr(PrName) Title) (Pr(PrName) Title) (Pr(PrName) Title) (Pr(PrName) T

3、itle) (Pr(PrName) Title) (Pr(PrName) Title) Clean garment dryerPART 1 - GENERAL1.10SUMND SCOPE6DEFINITIONS6RELATEDQUALITY AS6RANCE7SUBMITTALS7RECORD DRAWINGS9DELIVERY, STORAGE, AND HANDLING9VALIDATION9CODES AND STANDARDS10GUARANTEES/WARRANTIES11PART 2 - PRODUCTS112.1GENER

4、AL11PART 3 - EXECUTION123.1ATION REQUIREMENTS12Clean garment dryerPART 1 - GENERAL1.1SUMND SCOPEA.This specification covers the requirements for design, fabrication anddelivery ofto include acsories, modifications or options mentionedherein or required to meet the project performance requirements.B.

5、Thisdetails performance requirements and various design criteriaidentified by the user and user represen ives for weighing and dispensingoperation in an OSD pharmaceutical environment under cGMP conditions. The system must be compliant to all applicable FDA, SFDA, EU, MHRA,TGA, WHO regulations, howe

6、ver, it is not theent of thistoVendordetail all mechanical, electrical and control requirements.Theshall supply all subordinate components nesary to meet the performancerequirements established herein.Should the Vendor find it nesary todeviate from the specific design and performance requirements de

7、tailed inthisquoion/pro, the Vendor shall clearly s e all deviations in theal and give the reason(s) for each deviation.C.Proven Equipment Only proven equipment is acceptable.Provenequipment is defined as equipmentt has been in continuous operationelsewhere on similar duties for a minimum of three y

8、ears without majorbreakdowns.D.Permanent nameplates shall be permanently affixed on each piece of equipment. The information to be contained on the nameplates shall beidentified by the owner.E.Any exceptions to the URS shall be clearly highlighted in an exceptionsection of the proal.1.2DEFINITIONSA.

9、Owner Wyeth or Wyeths designated represen ive.B.URS User Requirement SpecificationC.FRS Functional Requirement SpecificationD.FAT Factory Acceptance TestE.SAT Site Acceptance TestF.CGMP Current Good Manufacturing PractiG.SOP Standard Operating ProcedureH.OSD Oral Solid Dosage1.3RELATEDSA.N/A1.4QUALI

10、TY ARANCEA.Material Certifications: Certify in writingt materials were manufacturedof specified stainless steel. Certification shall indicate mill heat number.Chemicalysis shall be furnished for eaill heat number.B.Filters shall be non fiber releasing type and shall be provided withaofPerformance an

11、dation including the following:..5.16.mended Usage Materials of Construction Effective Filtration Areaum Differential And Back Pre um Flow Ratesum Temperature Hydrophobic or Hydrophilic Biological Re-Activities Of Material Chemical/Product Compatibility Bacterial Rete

12、ntionExtractablesTemperature And Radiation Stability egrity Test Procedureum Number/ Time Of UsingFilter Replacement SchedulereFilter Sani ion Method/Criteria And Storage Time1.5SUBMITTALSA.Product Data & Sles:1.Submit manufacturers technical product data sheetscomponents, materials, and products in

13、cluded.and catalog cuts forall2.Provide certified drawings for theshowing overall dimens, utilityconnections, port locations, and all other applicable installation drawings.B.Submitmended spare parts list for all system components.C.The vendor shall include with their proal a preliminary schedule in

14、months, from time of receipt of purchase order, for majortone tasks.The project schedule should reflect a minimum two-k duration for eachreviewtone.D.Vendoration should be provided in hard copy, as well aselectronic format (CD).E.The vendor shall supply equipment manuals in accordance with Wyeths pr

15、eferred format listed below. This list is not to be construed as an all-inclusive list as vendors may provide additional sections specific to the operations and ma enance of the equipment. At a minimum, a table ofcontents, tabs separating each section with the section title appearing oneach tab, and

16、 page numbers corresponding to the page numbers definedwithhe table of contents are required.1.Cover page defining the equipment make/m/serial number, purchase ordernumber and date, general equipment description, and Wye by Wyeth).Table of contents with corresponding section/page numbersEquipment re

17、ceiving, handling and installation procedures.sset number (provided2.3.4.Utility requirements including steady s e and peak consumption and connection specifications.Installation and re-assembly procedures.Sequence of Operation..9.10.11.Changeovrocedures.Electrical and Mechanical controls.Lub

18、rication and Preven ive Maenance, Procedures and Schedules. Trouble shooting and repair guide with spel tool requirements.Bill of Materials (with correspondingr name, address, contact information,andr part number and the part number defined by the equipment manufactureras used to order through them

19、and as defined on Safety precautions.Consumable spare parts list (with correspondingpanying drawings).12.13.r name, address, contactinformation, andr part number and the part number defined by the equipmentmanufacturer as used to order through them and as defined ondrawings).panying14.Drawings (thre

20、e view dimenal equipment arrangement, patic, mechanical,electrical, control, PLC ladder logic, other) of a form Control Logic.Software/Program license information.ceptable to Wyeth.8.Backup ofputer software program on CD or equivalent.Literature for the equipment itself and literature pert

21、aining to those parts purchasedby the equipment manufacturer from other companies.19.Original or copies of manuals and/or instruction sheets whichpanied and/ort pertao the partb-systems purchased by the equipment manufacturer fromthe equipment manufacturerpp rs.20.Contact information (address,ephone

22、, facsi,) for equipmentmanufacturarts, service, sales, etc.21.Cleaning procedures including list of product contact parts, disassembly and assembly procedures, list of acceptable cleaning and sanitizing agents, spe l precautions.List of change parts by part number keyed to drawings and product sku a

23、nd/or full identifying product description.Minimum of three CDs containing the above information plus CDs or equivalent ofsoftware required to restore, back up, modify, or install required programs.22.23.F.Refer to Part 3 ation for number of required complete sets ofmanuals to be provided at time of

24、 delivery.1.6RECORD DRAWINGSA.Upon completion, submit certified record drawings updated to as-builtsus.1.Maenance Data:a.Submit ma enance data and parts lists for all system materials and products. Include the following: product data, shop drawings, and record drawings, in a ma enance manual format.

25、Include the following information for equipment items:b.1)Description of function, normal operating characteristics and limiions,performancecurves,engineeringdataandtests,andcomplete nomenclature and commerl numbers of replacement parts.2)Ma enance procedures for routine preven ive ma enance trouble

26、shooting; disassembly, repair, and reassembly; aligning adjusting instructions.Servicing instructions and lubrication charts and schedules.andand3)2.Validation Data:a.Submit comple y traceable records for all materials, components,andconsumables for the welds incorporatedo the system.b.c.Submit data

27、 regarding the conduct of the cleaning required by this specification. Submit surface finish report for product contact material indicating finish polish,cleaning and passivation.1.7DELIVERY, STORAGE, AND HANDLINGA.Deliver products to the project properly identified with names, mnumbers, types, grad

28、es, compliance labels, and other information needed for identification.B.Before or, at least, at the time of delivery, provide 5 complete sets ofmanuals wiminimum of 2 having originalation.C.Protect stored equipment from moisture and dirt.D.Allernal and external parts assembled shall be suitably sup

29、ported and/orbraced to prevent damage or scratching to polished surfaand transporting.during handlingE.Prior to shipment, all othorts and appurtenanshall be provided withcaps or plugs.Plastic, cardboard or wood covers are not acceptable.1.8VALIDATIONA.Refer to theation requirements in section 3.1.B.

30、Following installation the WET MILLERprocedures including;X wildergo qualification1.Installation QualificationC.Responsibilities:1.The Equipment Vendor shall be responsible for:a.b.Providing optional pricing for providing IQ protocols and execution support.Providing any designation, including specif

31、ications, drawings andmanuals, required for the development and execution of validation protocols.c.Providing troubleshooting and assistance in addressing deviationsoccur during execution of the validation protocols.t mayThe Owner (or 3rd Party Represen ive) shall be responsible for:2.a.b.c.d.Manage

32、ment of validation activates.Development of validation protocols. Execution of Installation Qualifications.Review and approval of all related validation protocols, procedures, and finalreports.e.Providing assistance with the execution of approved protocols, as nesary.1.9CODES AND STANDARDSA.ASHRAE:A

33、mericanSocietyofHeating,RefrigeratingandAir-Conditioning Engineers, Inc.B.ASME:American Society of Mechanical Engineers.C.ASTM:American Society for Testing and Materials.D.ANSI: American National Standard InstituteE.cGMP/FDA:Current Good Manufacturing Practiof the Food and DrugAdministration, United

34、 S es department of Healnd Human Servi.F.IEEE: Institute of Electrical and Electronics EngineersG.ISA: Instrumen ion Society of AmericaH.NEMA:National Electrical Manufacturers Assotion.I.NFPA:National Fire Protection Assotion.J.SFDA:S e and Food Drug Administration, P.R. ChinaK.WHO:World Healthaniza

35、tionL.TGA:Therutic Goods AdministrationM.EU: European UnionN.MHRA:Medicines and Healthcare products Regulatory AgencyO.SSOC: China Instrument and Control SocietyP.IEC:ernational Electrical Code.Q.SAWS:S e Administration of Work Safety.R.NIST:National Institute of Standards and Technology.S.ISO:ernat

36、ionalanization of Standardization1.10 GUARANTEES/WARRANTIESA.Equipment manufacturer shall include the following:1.Guarantee equipment performanceapplication and specification data.t is published in manufacturers catalogued2.3.Guarantee system performance and validatability as specifiedhis.Unconditio

37、nally guarantee equipment, materials, and workmanship for period of one(1) year or more from date established for commencement of guarantees/warranties or date for commencement of correction of defective work.During this period,equipment manufacturer shall promptly provide equipment, and servinesary

38、 to correct defectsthe time, labor, material,t may occur all at no cost toPART 2 - PRODUCTS2.1GENERAL最小產(chǎn)能：15kg/次（干衣物）；Minimal capacity: 15kg/lot (dry clothes),B.Materials of Construction304 不銹鋼或滿足 SFDA 要求；304 stainless steel or meet the SFDA requirement.C.Product Specification設(shè)備適用的產(chǎn)品有：潔

39、凈區(qū)使用的衣物；Suitable product: garment usedhe clean room.D.Cleaning Requirement手動清潔/自動清潔，且無死角；Manual or automatic cleaning, without dead leg.E.Automation Requirement自動化操作，參數(shù)在干燥機面板中控制，干燥程序可選，可任意設(shè)定烘干時間、烘干最高溫 度和自動倒運轉(zhuǎn)；其余參見“Project Diamond - URS - Automation.doc”automatic operating, parameters should be displ

40、ayed in garment dryanel, drying time,altemperature and Automatic transport transfer can be adjustable; the rest see project Diamond - URS- Automation.doc F.Operation /Functional Description操作空間、方式和噪音符合EHS 要求；中途開門自動停止運轉(zhuǎn)，到設(shè)定烘干時間自動停止運轉(zhuǎn)并發(fā)出信號提示；過濾器上下方及裝衣門上方均可安裝 DOP 檢測口，方便用戶進行完整性測試，高效過濾器必須耐高溫；設(shè)計有強冷風(fēng)功能，真空包

41、裝后衣物不產(chǎn)生返潮現(xiàn)象；一次烘干時間不超過 60minsA.Capacity要求提品說明書、合格等相關(guān)文件；要求提供三年以上的保修服務(wù)；The operation space, style and noise should meet the requirements of Pfizer EHS;When halfway opening the door, the drying program can automatically stop running, when reachthe setting drying time, the program can automatic stop wipp

42、arent signal;Above and below the filter, and the top of the charging door should be convenient for installation the DOP tester, HEPA filter must be high temperature resistant;The drying machine should have strong cooling function, the vacuum packaging of the clothesshould nove dphenomenon;One drying

43、 cycle is no moren 60mins.Product specifications, three years warranty service;s and other relateds should be provided and requiredG.Batch RequirementNAH.Validation Requirementsee“Project Diamond - General Validation Requirements.docx”I. Connection ScheduleEHS RequirementSEE“Project Diamond - General EHS Requirements v3.docx”puter and Computer Validation RequirementS