urs文件模板(1)
净化工程用户需求标准(URS)【范本模板】
用户需求标准目录1、目的 (3)2、范围 (3)3、法规及指南 (4)4、术语 (4)5、用户需求标准内容 (5)(1)施工单位资质要求: (5)(2)工期要求: (5)(3)二次优化设计 (5)(4)厂房结构装修 (6)(5).空气净化系统 (10)(6).洁净管道系统 (16)(7).生产设备系统 (20)(8).配电和照明系统 (21)(9).厂房验收验证 (22)(10).测试、验证和文件(URS276 □是□否) (23)(11).备注(URS277 □是□否) (23)(12).其他事项 (24)1、目的1.1供应商需要执行一系列预先确定的、系统的工作,以使其设备供货、安装和服务满足本公司质量要求。
供应商收到此URS,将表明所有的要求应在其技术文件(报价)中体现。
本文件的执行将记录和证明洁净工程系统要求的具体内容,供应商应以确认我公司的控制标准为依据进行洁净工程系统设计并最终完成详细设计,为将来的系统验证提供充分依据。
2、范围1.给排水1.1室外给排水室外给水系统:包含给水管道系统(含管道、阀门、水表)及与市政管网并接安装、室外消火栓及喷洒管安装、管沟开挖及回填工程、阀门井砌筑;管道引接至各用水建筑外1米;室外雨水系统:包含雨水管道系统及与市政管网并接安装、雨水井砌筑(但不包含道路内水箅井砌筑); 室外废、污水系统:包含废、污水管道系统及与市政管网、污水处理站出口并接安装,废水井、水封井砌筑;管道引接至污水水处理站外1米;1。
2综合楼、生产车间给排水自来水系统给水:包含室内车间各工艺用水点、卫生间用水、浴室用水管路系统及与室外管网预留点、暖通用水预留点、之水车间用水预留点并接(不包含纯水站、污水处理站内设备及管路系统);包含浴室热水管路系统及热水器;包含卫生洁具,管道引接出室外1米;排水系统:包含废水管道、卫生间污水管道安装(不包含雨水管道);管道引接出室外1米;消防系统:包含室内消火栓箱及管路系统安装;纯化水系统:包含纯化水管路及阀门安装、试验、检测(不包含纯水站内制水设备及管路),管道引接至纯水站1米;1。
厂房设计用户需求(URS)
⼚房设计⽤户需求(URS)
******药业有限公司第 1 页共 7 页⼚房设计⽤户需求(URS)
1 ⽬的
根据公司新建⼚房总体规划及总体设计要求,为了降低污染,保证产品质量,特⾃定URS⽂件。
2 适⽤范围:适⽤于新建⼚房的⽣产⼯艺要求。
3 依据:
3.1《医药⼯业洁净⼚房设计规范》
3.2《建筑设计防⽕规范》
3.3《⼚矿道路设计规范》
3.4《⼯业企业设计卫⽣标准》
3.5《采暖通风空调设计规范》
3.6《采光设计标准》
3.7《照明设计标准》。
4 责任者
4.1质量部:负责对新建⼚房提出质量要求。
4.2⽣产部:负责对新建⼚房提出⽣产要求。
4.3. ⼯程部:负责对新建⼚房提出硬件需求,并与供应商、质量部、进⾏技术交流。
4.4. 项⽬部:负责对新建⼚房的施⼯进⾏监督及跟踪,安期完成⼯程的竣⼯。
6⽤户要求
6.1选址与总平⾯布局
6.2⼯艺过程洁净等级的要求
6.3洁净⼚房⼯艺设计要求
6.4洁净区门的技术要求
6.5回风⼝的技术要求
6.6地坪的技术要求
6.7灯具的技术要求
6.8地漏的技术要求
6.9⽔池的技术要求
6.10传递窗的技术要求
6.11共⽤管道的技术要求
6.12排⽔的技术要求
6.13通讯系统的技术要求
6.14消防系统的技术要求
7.URS确认
供应商确认签名:⽇期:年⽉⽇客户确认签名:⽇期:年⽉⽇。
URS模板
生物安全柜用户需求(URS)
目录
1目的 (3)
2范围 (3)
3依据及参考文件 (3)
4职责 (3)
5缩写和定义 (3)
6用户及系统要求 (3)
6.1URS01:总体要求 (3)
6.2URS02:性能要求 (3)
6.3URS03:技术要求 (4)
6.4URS04:服务要求 (5)
6.5URS05:文件要求 (6)
7变更历史 (6)
8附件 (6)
8.1《URS响应信息表》 (6)
1目的
1.1本URS旨在阐述生物安全柜的用户需求,该URS将作为生物安全柜设备功能要求规范的
基础,并用作设备采购确认的基础资料。
2范围
2.1本URS描述了生物安全柜的基本需求。
3依据及参考文件
3.1YY0569-2005生物安全柜、药品生产质量管理规范2010版。
4职责
4.1设备使用部门负责起草此文件,质量部和工程部负责审核,管理者代表负责批准。
4.2设备采购部门负责执行此文件。
5缩写和定义
6用户及系统要求
6.1URS01:总体要求
6.2URS02:性能要求
6.3URS03:技术要求
6.4URS04:服务要求
6.5URS05:文件要求
7变更历史
8附件
8.1《URS响应信息表》
URS响应信息表
确认/日期:。
URs_-_Reservations_Form_1_pdf439
IACS INTERNATIONAL ASSOCIATIONOF CLASSIFICATION SOCIETIESFORM 1Notice of Reservations Filed ForIACS Unified Requirementsas at June 2009Page 1(Printed on 20/08/2009)UR A1 EquipmentUR Clause Society ReservationVersionA1 A1.2ABS For ships less than 40 m in length, ABS Rules allow with certainconditions wire ropes in lieu of chains.1981A1 A1.3.1ABS ABS' requirements for anchoring equipment for tugs of unrestrictedservice are less than prescribed in UR A1.3.1.3/1994UR A2 Shipboard fittings and supporting hull structures associated with towing and mooring on conventional vesselsUR Clause Society ReservationVersionA2A2.1.6A2.2.6GL GL reserves the right to lower the SWL to be marked on shipboard mooring fittings by factor 1.5. (SWLGL=SWLA2/1.5)The reason for GL’s reservation is, GL do not support a safety conceptutilizing a safety factor of 1.0 for the fittings against the breaking load ofthe ropes attached to the fittings. This has been raised during discussionin Hull Panel several times without feed back.Rev.3UR D4 Self-elevating drilling unitsUR Clause Society ReservationVersionD4D4.4LR Damage stability requirements are not included in the Rules and theextent of defined damage is to be in accordance with Flag requirements.Rev.2 1996UR D5 Column stabilized drilling unitsUR Clause Society ReservationVersionD5D5.6LR Damage stability requirements are not included in the Rules and theextent of defined damage is to be in accordance with Flag requirements.Rev.3 1996UR D6 Surface type drilling unitsUR Clause Society ReservationVersionD6D6.4LR Damage stability requirements are not included in the Rules and theextent of defined damage is to be in accordance with Flag requirements.1979UR E7 CablesUR Clause Society ReservationVersionE72DNV Partly implemented.The following IEC standards is not referred: 60092-373, 60092-374 (asthese standards are beyond our scope)Rev.3 May 2006E73RS RS reserves its position on acceptance of cables other than thosespecified in item 2 of UR E7. These cables will be subject to specialconsideration by RS in each particular case.Rationale: RS Rules requires that cables should have RS type approval.Rev.3 May 2006UR E10 Test Specification for Type ApprovalUR Clause Society ReservationVersionE1010.1ABS Not applied to all internal communication equipment as listed in 10.1.4/May 2004UR E11 Unified requirements for systems with voltages above 1kV up to 15kVUR Clause Society ReservationVersionE1111 1.3LR HV-LV segregation limited to electric cablesRev.2 July 2003E1111 2.2.2LR Specific IP rating mentioned in the UR are not included in LR Rule.Rev.2 July 2003E1111 2.2.3LR Specific IP rating mentioned in the UR are not included in LR Rule.Rev.2 July 2003E1111 2.2.4LR Specific IP rating mentioned in the UR are not included in LR Rule Rev.2 July 2003E1111 2.3.2LR IEC creepage distances and 25 mm/kV minimum mentioned in the URare not included in the rulesRev.2 July 2003E1111 2.4.1LR LR rule applies to all generators of rating 1500kVA and aboveirrespective of voltage ratingRev.2 July 2003E1111 2.4.2LR LR rule applies to fault currents in excess of 5A in impedance earthedcircuits onlyRev.2 July 2003E1111 2.4.5LR LR rule permits the use of suitable fuses for overload protection Rev.2 July 2003E1111 3.2LR LR rule applies to all generators and motors utilised for electricpropulsion applications only irrespective of voltage rating Rev.2 July 2003E1111 4.1LR LR rules do not require low liquid level alarm and trip or load reductionfacilities mentioned in the URRev.2 July 2003E1111 6.2.2LR LR rules do not specifically require locking facilities on circuit breakersfor high voltage applications mentioned in the URRev.2 July 2003E1111 6.2.3LR LR rules do not specifically require the provision of shutters mentionedin the URRev.2 July 2003UR E13 Test requirements for Rotating MachinesUR Clause Society ReservationVersionE13 4.8 Table 1item 8DNV Partly implementedOverspeed test, Applicable for type test only.Corr.1 May 04/Rev.1 May 01E13E13/3 Table 1IRS Overspeed tests for generators and motors are not considered necessaryduring routine testing, also these are difficult to put in practice due toreluctance from manufacturers. As far as type tests are concerned,overspeed test is included in IRS Rules.Rev.1 May 2001UR E20 Installation of electrical and electronic equipment in engine rooms protected by fixed water-based local application fire-fighting systems (FWBLAFFS)UR Clause Society ReservationVersionRev.5 Nov 2005E20All DNV Partly implementedIn accordance with IMO FP48 WP4, DNV has made these requirementsapplicable for “Installation of electrical and electronic equipment inengine rooms protected by fixed water-based local applicationfire-fighting systems” operating with salt water systems only.May 04E20-NK NK admits to apply UR E20 for electrical and electronic equipmentlocated within areas protected by FWBLAFFS and those within adjacentareas exposed to direct spray having a degree of protection of IP22which got a satisfactory result of actual test using fresh water.UR F2 Aluminium Coatings on Board Oil Tankers and Chemical TankersUR Clause Society ReservationVersion1/1998F2F2ABS ABS is not convinced that the restrictions on use of aluminiumcoatings/aluminized pipe are justified by the perceived hazards. ABSdoing research on the matter.UR F5 Pump room alarmsVersionUR Clause Society ReservationRev.1 1973F5Entirely LR LR’s policy is not to include statutory requirements in the Rules.UR F7 Portable instruments for measuring oxygen and flammable vapour concentrations VersionUR Clause Society ReservationRev.2 May 1999F7Partly LR LR Rules do not require portable oxygen analysers for single hulltankers.UR F9 Lighting and sighting ports in pump room/engine room bulkheadsUR Clause Society ReservationVersion1971F9Entirely LR As advised in Mr Wade’s telefax to Council Members dated 12 May1995, the requirements for fire protection, detection and extinction forships covered by the SOLAS Convention were removed from LR Rulesand Regulations for the Classification of Ships with effect from 26 July1995. Compliance with SOLAS is a pre-requisite for classification.However, the Rules do contain requirements for fire protection,detection and extinction for cargo ships of less than 500 gross tons butUR F9 is no longer implemented in these Rules as the use of lightingand sighting ports is now obsolete in our experience.UR F34 Low Pressure Carbon Dioxide Smothering SystemsVersionUR Clause Society ReservationRev.1 1989F34All DNV N/A To be deleted (replaced by IACS UI SC170)F34Entirely LR As advised in Mr Wade’s telefax to Council Members dated 12 May Rev.1 19891995, the requirements for fire protection, detection and extinction forships covered by the SOLAS Convention were removed from LR Rulesand Regulations for the Classification of Ships with effect from 26 July1995. However, compliance with SOLAS is a pre-requisite forclassification.Accordingly, UR F34 is not implemented in LR Rules and Regulationsfor the Classification of Ships.The Rules do, however, contain requirements for fire protection,detection and extinction for cargo ships of less than 500 gross tons andfor fishing vessels of between 12 and 45 metres in length.UR I2 Structural Requirements for Polar Class ShipsUR Clause Society ReservationVersionI2I2.13GLGL reserves its position to perform buckling strength calculations on the basis of DIN 18800Rev.1UR K3 Keyless fitting of propellers without ice strengtheningUR ClauseSociety ReservationVersionK3AllDNVFull Reservation on existing K3.The proposed planned revision 5 of the IACS working group was implemented in the DNV Rules in January 2006.Corr.2 June 1998UR M2 Alarm Devices of Internal Combustion EnginesUR Clause Society ReservationVersionM2M2ABSABS Rules only require plan review and survey of engines of 100 kW and over. Therefore ABS does not implement this UR for engines in the range 37 to 100 kW.1971UR M3 Speed governor and overspeed protective deviceUR ClauseSociety Reservation VersionM32.3DNVPartly implemented 3 steps in lieu of 2Rev.5 Feb 06UR M5 Mass production of internal combustion engines, procedure for inspectionUR Clause Society ReservationVersionM5M5.1ABSABS does not limit its application of UR M5 for mass production of internal combustion engines to those having cylinder bore not exceeding 300 mm.1/1987M5All DNVFull reservation.DNV plans to amend and align its reference documents (rules, etc.) in line with the outcome from the IACS Project Team established to review the relevant requirements.Rev. 1 1987M5M5.1NKNK admits to apply UR M5 for mass production of internal combustion engines having cylinder bore not exceeding 320mm.Rev.1/1987UR M6 Test pressures for parts of internal combustion enginesUR ClauseSociety ReservationVersionM6AllDNVFull reservation.DNV plans to amend and align its reference documents (rules, etc.) in line with the outcome from the IACS Project Team established to review the relevant requirementsRev.3 May 1998UR M14 Mass production of internal combustion engines: definition of mass productionUR Clause Society ReservationVersionM14AllDNVFull reservation.DNV plans to amend and align its reference documents (rules, etc.) in line with the outcome from the IACS Project Team established to review the relevant requirements.1973UR M18 Parts of internal combustion engines for which material tests are requiredUR Clause Society ReservationVersionM18M18.3ABS For repair of IC engines with bores 300mm or less, ABS does not insist on certification of connecting rods.1972M18AllDNVFull reservation.DNV plans to amend and align its reference documents (rules, etc.) in line with the outcome from the IACS Project Team established to review the relevant requirementsRev.4 Jun 2000M18Partly LRThis is a question of mass produced and non-mass produced engines.LR Rules do not refer to mass produced engines; the requirements are based on bore size alone, i.e. less than or greater than 400 mm.Rev.4 Jun 2000UR M19 Parts of internal combustion engines for which nondestructive tests are requiredUR Clause Society ReservationVersionM19AllDNVFull reservation.DNV plans to amend and align its reference documents (rules, etc.) in line with the outcome from the IACS Project Team established to review the relevant requirements.1974UR M21 Mass production of internal combustion engines: type test conditionsUR ClauseSociety ReservationVersionM21AllDNVFull reservation.DNV plans to amend and align its reference documents (rules, etc.) in line with the outcome from the IACS Project Team established to review the relevant requirements.1974, Corr. Sept 2003UR M23 Mass production of engines: Mass Produced Exhaust Driven TurbochargersUR ClauseSociety ReservationVersionM23AllDNVFull reservation.DNV plans to amend and align its reference documents (rules, etc.) in line with the outcome from the IACS Project Team established to review the relevant requirements.Rev. 3 1991M23M23.1RINAThis UR is applied by RINA to turbochargers fitted on diesel engines having a power of 1000 kW and above.For the others turbochargers (i.e. fitted on diesel engines having a power less than 1000 kW) RINA requires they are delivered with the works'certificate relevant to the bench running test and the hydrostatic test.Rev.3 1991UR M24 Rules concerning use of crude oil or slops as fuel for tanker boilersUR ClauseSociety ReservationVersionM24M24BV This UR refers to offshore Rules only.Rev.1 1976M24M24NK NK does not apply crude oil or slops as fuel for tanker boilers.Therefore, this UR will not be implemented1/1976M24M24RINAThis UR was introduced in a RINA Rule for the assignment of a special class notation (in force since 1980) never applied. The above mentioned RINA Rule has consequently been deleted.1/1976UR M32 Definition of diesel engine typeURClauseSocietyReservationVersionM32Note 1DNV Partly implemented.DNV practices this requirement with the exception of Note 1, theconditions alter slightly as well as we use other parameters than power,namely cylinder pressure and speed.1979UR M34 Scantlings of coupling flangesUR Clause Society ReservationVersionM34All DNV Full reservation.- M34.1: DNV uses combined stress criteria with credit for frictiontorque instead of the UR diameter formulae.- M34.3: DNV rules deviate when r/d>0.08- M34.4: DNV rules have no direct restriction to r/d, but shaftcalculations will tend to limit this ratio.1980UR M35 Alarms, remote indications and safeguards for main reciprocating I.C. engines installed in unattended machinery spacesUR Clause Society ReservationVersionM35Table 1 Item6Table 1 Item8Table 2 Item2DNV Partly introduced.The DNV rules are basically in line with UR M35, however deviate insome respect:- Table 1 Item 6 "Oily contamination of engine cooling water system"- Table 1 Item 8 "Scavenge air system"; DNV rules does not requirescavenge air receiver water level- Table 2 Item 2 "Oil mist concentration in crankcase"; DNV rulesaccept also alternatives to the oil mist detectorRev.4 1999UR M44 Documents for the approval of diesel engines UR Clause Society Reservation VersionM44Item 22Item 27DNV Partly Implemented- Item 22: Material specifications of main parts with information onNDT and pressure tests. DNV rules request this, but in general forinformation only, not for approval. NDT is required for approval onlyfor crankshafts and connecting rods.- Item 27: Cooling water system. DNV rules request this, but forinformation only, not for approval.Reduced extent for cylinder bores less than 150 mm.Rev.7 May 2004UR M51 Programme for trials of i.c. engines to assess operational capabilityUR Clause Society ReservationVersionM51M51.2.1.3b ABS Test at 110% power for 30 minutes is not in ABS Rules.1987M51M51.2.2ABS This paragraph for special operating conditions is not in the ABS Rules.1987M51 1.12.1DNV Partly Implemented- 1.1: 25% test is taken out in the DNV rules.- 2.1: Reduced testing hours in DNV rules for small main engines.- 2.1: For aux. engines, DNV rules specify test time 1 hour, whileIACS require 4 hours.Rev.2 Jul 2003UR M52 Length of aft stern bush bearingUR Clause Society ReservationVersionM522DNV Partly implemented.DNV rules do not indicate any direct lower limit for bearing length. Thislength however, will be limited by load and damping characteristicswith respect to whirling.1986UR M56 Marine Gears - Load Capacity of Involute Parallel Axis Spur and Helical GearsUR ClauseSociety ReservationVersionM56All DNVPartly implemented.DNV use and accept alternative criteria for calculation of gears. Very much in line with recognised international standards. DNV hasimplemented updates from ISO 6336 which is the source for both M56and DNV. M56 has not been updated accordingly.Rev.1 1994Corr 1996M56M56.1.2RINARINA does not consider design approval of gears having rating less than 220 kW for main propulsion or 110 kW for essential service auxiliaries necessary, taking into account that they are mass produced according to standardized design criteria widely experienced in service and built by specialized manufacturers.RINA, in any case, requires factory acceptance tests and sea trials to be performed for gears intended for main propulsion and essential auxiliaries.Rev.1 1994/Corr. 1996UR M58 Charge air coolersUR Clause Society ReservationVersionM58AllDNVFull reservation.DNV rules do not request works material certificates, and accept hydraulic testing to be carried out at maximum working pressure only.1994UR M59 Control and safety systems for dual fuel diesel enginesUR Clause Society ReservationVersionM593.1,3.2 (1) and (2),4.1,8.1,9.1.2.cDNVPartly implemented.UR M59 has been partly implemented in the DNV rules, do however not specifically list all requirements stated in the UR. (This applies to UR item nos. M59.3.1, 59.3.2 (1) and (2), 59.4.1, 59.8.1 and 59.9.1.2.c.)M59 will continue to be evaluated in machinery panel.1996UR M60 Control and Safety of Gas Turbines for Marine Propulsion UseURClauseSocietyReservationVersionM601.1,1.2,2.2DNVPartly implemented.The DNV rules deviate slightly from IACS UR M60 concerning monitoring requirements as follows:- Ref. UR M60.1.1.DNV rules do not require a specific maximumoverspeed limit of 15%. DNV requirements are related to preventing the turbine speed from exceeding the maximum permissible speed as defined by the Manufacturer.- Ref. UR M60.1.2. DNV do not require separate speed governors for speed control and over speed protection. However, the control system must be capable of controlling the speed due to sudden turbine load drop without activating the over speed shut down function.- Ref. UR M60.2.2. DNV rules request “step to idle” (not “shut down”)for h) “excessive high vacuum pressure at compressor inlet”.DNV rules have no action requirements related to exhaust temperature.DNV does not require automatic shut down due to item e) “excessive axial displacement”. DNV only require that applications which may experience thrust load directional variations must be provided with an axial proximity probe in the high speed driven string. At the next rule revision DNV will implement a requirement for alarm in case ofchanged thrust load direction. DNV considers this to provide the highest vessel safety level, as shutdowns not strictly needed are detrimental to vessel safety.- Ref. UR M60.3, table 1. DNV rules do not request alarm for “oil fuel temperature” and “oil fuel supply pressure”. At the next rule revision DNV will implement a requirement for alarm related to low oil fuel temperature. This to be applicable for turbines running on oil fuels where oil fuel heaters are required to avoid viscosity problems.1997UR M62 Rooms for emergency fire pumps in cargo shipsUR ClauseSociety ReservationVersionM62ABSThe UR cannot be uniformly implemented until "adequately" isquantified and therefore is not being implemented by ABS at this time.Feb 2002UR N1 One man bridge operated shipsUR Clause Society ReservationVersionN1AllIRSRequirements concerning navigation are not presently part of IRS Rules.Also, there are no ships of this type in IRS class.1992UR P2 Rules for Piping Design, Construction and TestingUR ClauseSociety ReservationVersionP2P2.5.5.5& Table 4ABSPost weld heat treatment for oxyacetylene welding is not in ABS Rules.1/1987 &Corr.Nov 2001P2 2.3.1LR Pipe requirements given in Materials Pt 2 which is called up UR P2 Rules for Piping Design, Construction and Testing - 2.3 MaterialsUR Clause Society ReservationVersion Rev.2 Nov 2001P2 2.3.3LR No restriction on systems in LR RulesRev.2 Nov 2001P2 2.3.4LR Design temperature is common, no mention of vibration or shock Rev.2 Nov 2001P22.3.4LRThe upper pressure limit in the UR is not given by LR nor is the prohibition from manifold useRev.2 Nov 2001P2 2.5.3.2LR Use of tack welds not covered UR P2 Rules Piping Design, Construction and Testing - 2.5 WeldingUR Clause Society ReservationVersion Corr. Nov 2001P2 2.5.4LR 0.3 Mo alloy steel not in RulesCorr. Nov 2001P2 2.5.5.5LR Requirements for heat treatment of oxy acet welded pipes not given Corr. Nov 2001P2Table 3 LR 0.3mo steel not included and slightly tighter tempsCorr. Nov 2001P2Table 3LR0.3mo steel not included note 3 acted on, notes 1 & 2 do not appear to be coveredCorr. Nov 2001P22.6.1.1.1.2LRLR do not specify a min of 10% or the type of testingUR P2 Rules for Piping Design, Construction and Testing - 2.6 Non destructive testing of welds and acceptance criteriaUR Clause Society ReservationVersion1987P22.8.1LRMembrane stress limitation not quotedUR P2 Rules for Piping Design, Construction and Testing - 2.8 Hydrostatic tests of pipingUR Clause Society ReservationVersion Rev.1, Corr Nov 2001UR P2.7 Rules for Piping Design, Construction and Testing - Types of connectionsUR ClauseSociety ReservationVersionP2.7P2.7.4NKNK admits the use of slip-type slip-on joints to steam piping of which design pressure is 1.0 MPa or less, for cargo heating on open decks in tankers.Rev.2 Nov 2001UR P6 Shell Type Exhaust Gas Heated Economizers that may be isolated from the steam plant systemUR ClauseSociety ReservationVersionP6P6.3.2P6.3.3P6.3.3.1P6.3.4ABSThe ABS technical committee considers that the requirements go beyond the recommendations of the MAIB and would imposeunwarranted technical design changes on safety valve manufacturers.May 2005P6P6.3.2P6.3.3P6.3.3.1P6.3.4RINANo sufficient experience is available on construction and installation of special design safety valves and bursting discs.May 2005UR S4 Criteria for the use of high tensile steel with minimum yield Stress of 315 N/mm 2, 355N/mm 2 and 390 N/mm 2UR ClauseSociety ReservationVersionS4S4ABSABS reserves against the k-factor for steel with a yield point of 390N/mm2 for the longitudinal strength calculation of Container Carriers with plate thickness greater than 51mm when additional special analyses are applied.Rev.2 Apr 2007S4S4DNVPartly implementedDNV reserves against application of the k-factor for steel with minimum yield stress = 390 N/mm2 for ships with DNV class notation Container Carrier provided that a fatigue assessment is performed.Rev.2 Apr 2007S4S4GLGL reservation against the k-factor for steel with a yield point of 390N/mm (2008)Rev.2UR S6 Use of steel grades for various hull members - ships of 90m in length and aboveUR Clause Society ReservationVersionS6S6.2 & 6.3ABSUntil further experiences are gained, service temperatures cooler than -40C will be in the Rules as guidance. Design temperature for members in the current ABS Rules is being retained pending unification of polar ship requirements.2/1996S66.2, 6.3RSRS has implemented UR S6 with regard to item 6.1 only. National requirements similar to S6.2 have been implemented in RS Rules.2/19963/May 20024/July 20035/Sept 2007UR S7 Minimum Longitudinal Strength StandardsUR Clause Society ReservationVersionS7S7.1RSWith respect to item 7.1, RS uses different criteria for ships in service for calculating minimum longitudinal strength standards. Thisreservation however does not apply to tankers with length over 130 m.3/1989UR S10 Rudders, sole pieces and rudder hornsUR ClauseSociety ReservationVersionS10S10.8.3GL For self-lubricating gearings, clearances less than 1.5 mm on diameter may be accepted on the basis of the manufacturer’s specification.Rev.1 1990S10RSPartially implemented, but rudder strength calculation method in RS Rules is more detailed and universal.Rev.1 1990Corr.July 2003UR S11 Longitudinal Strength StandardUR ClauseSociety ReservationVersionS11S11.5ABS For certain type/size ships, ABS accepts alternate approach involving ultimate strength assessment.Rev.1 1993S11S11.5BVBuckling strength has not been implemented. Equivalent criteria have been introduced to be coherent with other parts of BV Rules with regard to loads and corrosion margins.Rev.1 1993S11S11.5GL GL reserves its position to perform buckling strength calculations on the basis of DIN 18800.Rev.5 Jan 2006S11S11.5NKStructural members subject to hull girder bending and shear stress applying in S11.5.1 for buckling strength have partly been applied in NK rules but all longitudinal members have not been applied.Rev.5 Jan 2006S11S11RINAThis UR S11 is substantially applied. In the Rules for the classification of ships effective from 1st June 2000, the UR formulation has been modified to make it consistent with the general rule criteria, however without significant modifications to the final results.Rev.1 1993UR S14 Testing Procedures of Watertight CompartmentsUR ClauseSociety ReservationVersionS14S14.3NKNK has partly implemented this UR because some requirements which are considered impracticable still remain in S14.3.Rev.2 May 2001UR S17 Longitudinal strength of hull girder in flooded condition for single side skin bulk carriers URClause Society Reservation Version S17S17.5ABS This paragraph requires that permissible axial buckling stress meet S11.This is being adhered to for deck and bottom plating. When this isapplied to a Panamax bulk carrier, 14.5 mm topside tank bottom platinghad to be increased to 17 mm. We do not think this was / is the intent ofS17 and are applying axial stress check only to the deck and bottom structures and request that UR be changed to clarify its applicability.1/1997S17S17.5GLGL reserves its position to perform buckling strength calculations on thebasis of DIN 18800.Rev.7 Feb 2006UR S21 Evaluation of Scantlings of Hatch Covers and Hatch Coamings of Cargo Holds of Bulk Carriers, Ore Carriers and Combination Carriers (Rev.4)URClause Society Reservation Version S21S21.3.6GL GL reserves its position to perform buckling strength calculations on thebasis of DIN 18800.Rev.4 Jul 04/Corr.1 Oct 04UR S26 Strength and securing of small hatches on the exposed fore deckURClause Society Reservation Version S261.4DNV Partly implemented.The requirement will not be retroactively implemented for all ships.Rev.3 Aug 06S26S26.3.2NK For ships which will be less than 10 years of age on 1 January 2004, NKaccepts postponement to the date of the first scheduled intermediate orspecial survey after that date in such a case where an intermediate orspecial survey of the ship is not scheduled between 1 January 2004 andthe date on which the ship reaches 10 years of age. It is same as the duedate for ships, which will be 10 years of age or more on 1 January 2004.Because it is impracticable for ships in question to implement this clauseof the UR Rev.3 Aug 06UR S27 Strength requirements for fore deck fittings and equipmentURClause Society Reservation Version S27S27.3.2NK Same as the reservation of UR S26.3.2.Rev.4 Nov 04UR S30 Cargo hatch cover securing arrangements for bulk carriers not built in accordance with UR S21URClause Society Reservation Version S30S30.1.2NK Same as the reservation of UR S26.3.2.Rev.1 Aug 03UR S31 Renewal criteria for side shell frames in single side skin bulk carriers and OBO carriers not built in accordance with UR S12 Rev.1 or subsequent revisionsURClause Society Reservation Version S31S31.1NK Same as the reservation of UR S26.3.2Rev.4 Apr 2007UR W26 Requirements for welding comsumables for aluminium alloysUR Clause Society Expected Implementation DateVersion。
URS模板
URS模板
生物安全柜用户需求(URS)
目录
1目的 (3)
2范围 (3)
3依据及参考文件 (3)
4职责 (3)
5缩写和定义 (3)
6用户及系统要求 (3)
6.1 URS01:总体要求 (3)
6.2 URS02:性能要求 (3)
6.3 URS03:技术要求 (4)
6.4 URS04:服务要求 (5)
6.5 URS05:文件要求 (6)
7变更历史 (6)
8附件 (6)
8.1 《URS响应信息表》 (6)
1目的
1.1本URS旨在阐述生物安全柜的用户需求,该URS将作为生物
安全柜设备功能要求规范的
基础,并用作设备采购确认的基础资料。
2范围
2.1本URS描述了生物安全柜的基本需求。
3依据及参考文件
3.1YY0569-2005生物安全柜、药品生产质量管理规范2010版。
4职责
4.1设备使用部门负责起草此文件,质量部和工程部负责审核,管理者代表负责批准。
4.2设备采购部门负责执行此文件。
5缩写和定义
6用户及系统要求
6.1URS01:总体要求
6.2URS02:性能要求
6.3URS03:技术要求
6.4URS04:服务要求
6.5URS05:文件要求
7变更历史
8附件
8.1《URS响应信息表》URS响应信息表
确认/日期:。
注射剂生产线URS技术文件
小容量注射剂生产线URS技术文件(附件)XXX药业股份有限公司目录: (2)一、项目名称 (4)二、买方现有条件................. .. (4)三、产品特性及描述(供参考)...... . (5)四、设备选购要求..... . (5)五、设备的材质要求 (6)六、技术文件支持 (6)七、确认与培训...... (8)八、投标响应需知. ....... (9)九、水针联动线生产流程图 (10)十、主要技术参数性能汇总表.... (11)(一)、全自动超声波清洗机 (11)(二)、热风循环灭菌烘箱 (20)(三)、安瓿拉丝灌封机.. (32)十一、主要技术功能、质量控制与检验(需求书) (41)(一)、基本组成 (41)1、全自动超声波洗瓶机 (41)2、热风循环灭菌烘箱 (41)3、安瓿拉丝灌封机 (41)4、全自动生产线组成............... . (41)(二)、主要技术规格 (41)(三)、技术规格要求及功能说明 (42)1、全自动超声波洗瓶机功能说明 (43)2、热风循环烘箱功能说明 (44)3、安瓿拉丝灌封机功能说明 (48)(四)质量与检验 (49)十二、设备制造材质与配置响应 (51)(一)-1、全自动超声波洗瓶机制造材质表................ (51)全自动超声波洗瓶机材质 (51)(一)-2、全自动超声波洗瓶机主要配置清单 (52)⑴、全自动超声波洗瓶机主要机械配件清单 (52)⑵、全自动超声波洗瓶机主要电气配件清单 (53)(二)-1、热风循环灭菌烘箱制造材质表 (55)热风循环灭菌烘箱材质 (55)(二)-2、热风循环灭菌烘箱主要配置清单 (56)⑴、热风循环灭菌烘箱主要机械配件清单 (56)⑵、热风循环灭菌烘箱主要电气配件清单 (57)(三)-1、安瓿拉丝灌封机材制造材质表 (59)安瓿拉丝灌封机材质 (59)(三)-2、安瓿拉丝灌封机主要配置清单 (60)⑴、安瓿拉丝灌封机主要机械配件清单 (60)⑵、安瓿拉丝灌封机主要电气配件清单 (61)十三、招标要求与技术文件列表 (62)1、招标需求 (62)2、提供详细文件资料及数据 (67)3、其他条款 (69)十四、设备制造厂家最终报价 (70)一、项目名称项目名称:水针注射液生产线项目编号:数量:1套(3台)全自动超声波清洗机1台、热风循环灭菌烘箱1台、安瓿拉丝灌封机1台规格:兼容1ml~10ml安瓿瓶现以规格:2ml定线二、买方现有条件a.可供公用系统电力:380V±10%、50Hz、3P+N+PE压缩空气:≤0.7MPa、0.22um级别过滤;冷冻水:7至10℃蒸汽:工业饱和蒸汽,供气压力0.3至0.4MPab.自然气候条件年平均气温:X℃最高气温:X℃最低气温:X℃环境年平均相对湿度:X%12月(最低)平均相对湿度:X%6月(最高)平均相对湿度:X%c.海拔高度<Xmd.工作制度:250天/年,1班/天,8小时/班。
生产设备URS文件模板
目录1.文件审批 (2)2目的 (3)3范围 (3)4法规和国家标准 (3)法规 (3)行业标准 (3)国家标准 (3)5工艺描述及产品介绍 (3)5.1工艺/流程描述 (3)5.2产品介绍 (4)6. 用户及系统要求 (4)6.1. URS要求 (4)6.1.1. URS01:设备整体要求 (4)6.1.2. URS02:具体技术要求 (4)6.1.3. URS03:安全及环保要求 (6)6.1.4. URS04:文件资料要求 (6)6.1.5. URS05:服务与维修要求 (7)6.1.6. 供应商对项目要求的确认 (7)7. 缩略词附件 (8)8. 文件修订变更历史 (8)9. 附件 (8)1.文件审批起草审核批准2目的本用户需求文件旨在从项目和系统的角度阐述用户的需求,总括了用户对该项目的质量要求(GMP),描述了用户对该设备的工作过程及功能的期望。
主要包括相关法规符合度和用户的具体需求,这份文件是构建起项目和系统的文件体系的基础,同时也是系统设计和验证的可接受标准的依据。
设备生产商(供应商)应在规定的时间内完成并达到本用户需求的设计目标和可接受的质量标准。
在本URS中用户仅提出基本的技术要求和设备的基本要求,并未涵盖和限制卖方设备具有更高的设计与制造标准和更加完善的功能、更完善的配置和性能、更优异的部件和更高水平的控制系统。
投标方应在满足本URS的前提下提供卖方能够达到的更高标准和功能的高质量设备及其相关服务。
卖方的设备应满足中国有关设计、制造、安全、环保等规程、规范和强制性标准要求。
如遇与卖方所执行的标准发生矛盾时,应按较高标准执行(强制性标准除外)。
3范围本用户需求书所列技术要求适用于设备的采购。
新的设备在设计、制造技术及性能上达到国内先进水平,符合中国新版GMP要求。
4法规和国家标准法规液体灌装机用于乳酸钠溶液、乳酸的灌装,必须符合的要求,主要包括:GMP(2010年修订)及其附录中国药品生产验证指南(2003版)产品生产工艺规程《中国药典》2015年版二部行业标准GBZ 1-2010 工业企业设计卫生标准GB20021-2004中华人民共和国制药机械行业标准QB/T 2754-2005 定容式液体定量灌装机5工艺描述及产品介绍5.1工艺/流程描述车间此过程不断重复进行,物料在设备设定的工艺条件下完成沸腾快速干燥生产过程。
设备URS模板(精制内容)
机用户需求标准你的签名表明你已清楚了解本文件及附件内容,充分理解并认可本文件的所有条款。
Prepared by / 编制者部门:签名/日期:Reviewed by / 审核者部门:签名/日期:部门:签名/日期:部门:签名/日期:部门:签名/日期:Authorized by / 批准者部门:签名/日期:本文件根据需要应分发于以下部门:质量部01质量部、02 生产技术部、03设备计量室颁发任何对本文件及其附件的目的、内容或标准进行的改变或修正都必须起到改善的作用,并详细记录本文件的修订及变更历史,并且在执行以前必须取得批准。
版本号修订日期修订原因文件变更控制号1.0 新订N/A目录1.目的 (4)2.范围 (4)3.术语及定义 (4)3.1GMP:药品生产质量管理规范 (4)3.2URS:用户需求说明 (4)3.3FAT:工厂验收测试 (4)3.4SAT:现场验收测试 (4)3.5DQ:设计确认 (4)3.6IQ:安装确认 (4)3.7OQ:运行确认 (4)3.8PQ:性能确认 (4)3.9GAMP:良好自动化生产规范 (4)3.10PLC:程序控制器 (4)4.职责 (4)4.1需求方职责 (4)4.2供应商职责 (4)5.项目概述 (4)5.1项目简介及背景 (5)5.2主要用途 (5)5.3工艺流程 (5)5.4主要生产产品 (5)6.供货范围(主要设备及数量) (5)7.法规与标准 (5)7.1药品法规要求 (5)7.2国家标准要求 (5)7.3行业标准要求 (6)7.4公司管理制度要求 (6)8.用户需求标准 (6)。
立体库URS模板
目录一、简介 (3)二、工程符合的标准及规范 (5)三、工程内容及范围 (5)四、工程技术要求 (10)4.1 总体要求 (10)4.2 堆垛机技术要求 (10)4.3 码垛机器人技术要求 (11)4.4 货架技术要求 (11)4.5 穿梭车技术要求 (12)4.6 出入库输送、分拣系统技术要求 (13)4.7 控制系统软硬件技术要求 (13)4.8 设备维护要求 (14)4.9 设备表面处理及色彩要求 (15)4.10 电气技术要求 (15)4.11 EHS、安全要求 (16)4.12 文件要求 (16)五、服务要求 (17)5.1 测试服务 (17)5.2 备品备件要求 (17)5.3 包装运输要求 (17)5.4 培训及服务 (17)六、改版信息 (18)一、简介:1.本用户需求标准(URS)是为了规定XXXXXX有限公司自动化仓库系统的技术要求,为该系统的招标提供技术依据,并作为后续验证工作的基础。
2.使用功能:成品的储存和供货。
建筑面积:主体库房的空间尺寸为120(M)长×62(M)宽×22(M)高(见CAD 图)。
各投标方可根据情况做出最佳设计3.功能分区:生产车间区、联廊输送区、机器人码垛区、自动库区、入库整理区、出库整理区、月台区4.货位要求及规划:本工程规划分两期完成,第一期先完成4条巷道,约4巷*2*79列*13层=8216 个托盘位。
每层货架高度1500MM,仓库屋顶最低处22M高。
5.货型尺寸:1200MM*1400MM*(1290)MM(长*宽*高)( 高度请根据情况设计)。
6.货物重量(含托盘):MAX1200KG/PL。
7.托盘尺寸:1200MM*1400MM*170MM(长*宽*高)。
8.环境要求:常温2-30℃,相对湿度20%-80%。
9.运作模式:所有的物料都采用WMS系统进行管理、通过堆垛机系统、输送系统共同协作完成进出库工作。
10.管理软件系统:WMS系统完成对自动库所有管理工作。
二维运动混合机URS(样本1)
安徽衡济堂灵芝产业开发有限公司目录1.目的 (3)2.范围 (3)3.缩写列表 (3)4.设备标准 (3)5.设备安装地点描述 (4)6.设计、施工范围 (4)7.用户及系统要求 (5)7.1 URS01:系统能力和主要工艺要求 (5)7.2 URS02:设备设施及公用系统要求 (6)7.3 URS03:电气要求 (7)7.4 URS04:安全要求 (7)7.5 URS05:自控系统要求 (8)7.6 URS06:材质要求 (9)7.7 URS07:文件要求 (11)7.8 URS08:对供应商的要求 (12)7.9 URS09:服务与维修的要求 (13)7.10 URS10:时间要求 (14)7.11 URS11:附件 (15)1.目的该文件旨在从项目和系统的角度阐述用户对健蜂灵类固体制剂二维运动混合机的需求,主要包括相关法规符合度和用户的具体需求,这份文件是构建起项目和系统的文件体系的基础,同时也是该设备设计、安装和验证的可接受标准的依据,本文件中未列出的具体要求,以最新相关版本的法律或行业标准为依据。
2.范围2.1本用户需求(URS)及其附件是对湿法制粒机的设计、生产、安装、检查和测试、文件、交付的说明和最低要求。
2.2该设备的主要用途是:完成工艺要求的混合。
4.设备标准设备必须合以下标准、规范:4.1法规《药品生产质量管理规范》(2010年修订)及附录中华人民共和国药品管理法实施条例4.2国家、行业标准JB/T20017-2009药用摇滚运动混合机药品生产自动化管理规范(GAMP)4.3安全标准工业自动化仪表工程施工验收规范 GBJ—93—86电气装置安装工程低压电器施工质量验收规范GB50245-96所有电气设备的电线和电缆必须依据ICE标准安全:达到国内相关标准及CE标准要求参照欧洲电器安全规范(CE)执行GB5226.1-2002 / IEC60204-1《机械安全机械电气设备第1部分:通用技术条件》5.设备安装地点描述该设备安装完成后,除了要符合国内新版GMP要求,还要求符合FDA-cGMP 和EU-GMP 标准。
EMS URS模板
洁净室尘埃粒子在线监测系统用户需求书日期: 2010年11月1.总则1.1 本用户需求书所列技术要求适用于药品生产关键区域的尘埃粒子在线环境监测系统的采购。
新引进的设备在设计、制造技术及性能上达到国际先进水平, 符合中国、欧盟和FDA的GMP要求。
1.2 本URS描述了该粒子计数器的基本需求, 包括:工作性能需求、关键技术参数要求、安全要求、符合中国、欧盟和FDA的GMP要求和安装及其他要求。
同时, 这份用户要求文件也是开展后续相关验证工作的基础, 包括SAT草案和报告、IQ草案和报告、OQ草案和报告、PQ草案和报告。
1.3 在本URS中用户仅提出基本的技术要求和设备的基本要求, 并未涵盖和限制卖方设备具有更高的设计与制造标准和更加完善的功能、更完善的配置和性能、更优异的部件和更高水平的控制系统。
投标方应在满足本URS的前提下提供卖方能够达到的更高标准和功能的高质量设备及其相关服务。
卖方的设备应满足中国有关设计、制造、安全、环保等规程、规范和强制性标准要求。
如遇与卖方所执行的标准发生矛盾时, 应按较高标准执行(强制性标准除外)。
1.4供货范围1.4.1一套尘埃粒子在线环境监测系统及软件(系统具有浮游菌在线采样的扩展能力);1.4.2尘埃粒子传感器;1.4.3一用一备自动切换的真空泵系统;1.4.4控制柜, 控制器及相关A/D转换模块;1.4.5声光报警系统;1.4.6符合21 CFR Part 11关于电子签名、电子记录要求的控制软件系统;1.4.7监控电脑采用知名品牌,数据采用热备份设计, 保证数据安全性;1.4.8须提供良好的服务器设计, 保证系统运行的稳定性和可靠性;1.4.9 提供能满足两年正常运作要求的备品备件。
1.5投标人资质投标人应有行业内大型制药企业粒子在线监测系统的项目经验, 以及施工经验;企业应通过ISO9001认证或相应的质量认证, 并提供证书报告。
2.适用的法规和指南(1)本URS中系统设备应符合的标准:(2)FDA cGMP,工业指导意见;(3)中国: 最新版GMP附录一无菌药品的生产等;(4)欧盟: GMP 2008 Annex1;软件系统须符合21CFR Part 11 电子记录, 电子签名;ISO14644, ISO14698。
URS模版
纯化水储存分配系统用户需求User Requirement Specifications版次:A编号:URS-MF-009生效日期: 2011-05-23审核批准注:本文件共14页,所描述为原料楼纯化水储存分配系统的工艺技术要求,请文件审核和批准人员仔细阅读每一页后,将意见和建议单独附页在本文件后,在本页签名即代表已审阅并批准本文件的每一页。
目录1.简介 (2)1.1项目介绍 (2)1.2目的 (2)1.3文件概述 (2)1.4供应范围 (2)1.5项目标准 (2)1.6简写 (2)1.7参考书目 (3)2.总则 (3)2.1总体要求 (3)3.纯化水管道分配系统 (3)3.1纯化水贮罐 (4)3.2纯化水分配泵 (4)3.3 换热器 (5)3.4 循环分配管道 (5)3.5在线清洗(CIP)、在线消毒 (6)3.6 仪器、仪表 (6)4.控制系统(纯化水分配系统) (8)5.验证 (9)6.文件 (9)7.公用工程 (10)8.噪音水平 (10)9.质量控制 (10)10.维修 (11)11.售后服务及培训 (11)12.变更记录 (11)13.附录 (11)正文1.简介1.1项目介绍本项目为***********制药有限公司原料车间纯化水储存和洁净管道分配系统。
所有设备的设计、制造、材质、检查和测试、包装和交付、SAT(现场接收测试)部分将由双方人员共同实施并签署各项有关报告,以上活动必须严格按照本采购要求和相关的标准与规范来进行。
1.2目的●本文旨在描述***车间对公用工程洁净管道系统的总的要求,描述设计常规功能、外观及能力方面。
●文件旨在为供应商提供信息以找出技术解决方法。
1.3文件概述●本文旨在为供应商提供设计所需要的信息以找出技术解决方法●本文旨在描述用户洁净管道系统的设计、材料、安装、检查和测试、调试、文件和交付的说明和最低要求。
●本文包括但不限于对洁净管道基本的技术要求、工艺要求、技术要求、卫生要求、自动控制要求、法规和规范的符合性要求。
urs(用户需求说明)
用户需求URS(user requirement specification)即用户需求说明,是指使用方对设备、厂房、硬件设施系统等提出的自己的期望使用需求说明,这个需求综合根据自己的使用目的、环境、用途等提出自己具体的方案,设备供应商依据客户提供的URS方案。
需求的程度和细节应与风险、复杂程度相匹配,其中可以针对待设计的厂房、设施、设备等考虑以下内容:法规方面的要求(GMP要求、环保要求等)安装方面的要求和限制(尺寸、材质、动力类型、洁净级别等)功能方面的要求文件方面的要求(供应商应提供的文件及格式要求,如图纸、维护计划、使用说明、备件清单等)下述建议的用户需求说明文件模板,具体内容可根据实际需要进行增减。
项目介绍针对项目和目的的简要介绍法规要求GMP要求安全要求环保要求安装要求地面承重安装尺寸可用的公用系统(压缩空气、洁净蒸气等)安装要求洁净级别房间环境条件(温湿度等)可用的能源配置材质要求(重点考虑接触产品的部件)运行要求原辅料、包装材料、产品的规格标准设备效率、产能工艺参数范围(速度、温度等)电气、自动控制自动控制过程的要求计算机化系统的验证要求安全电气或机械锁电气保护压力保护文件所有需要供应商提供的文件(技术图纸、备件清单、操作手册、维护建议等)DQ设计确认是只对设备或设施进行设计方面的检查确认的过程,确保符合我们要求的一个过程。
1、建设厂房或采购设备的时候,首先我们需要建立一个叫客户需求的文件,即URS。
客户需求(URS)是甲方在熟悉自己工艺,并完成风险分析后,针对某个设施或设备,提出自己期望的要求。
这个要求由设计院设计成为设计图和方案。
当这个设计到甲方后,甲方需要对设计图纸和方案进行验收,那么这个过程就是我们所说的设计确认。
而客户需求文件就是DQ的检查标准,所以十分重要。
下面红色字体是赠送的精美网络散文欣赏,不需要的朋友可以下载后编辑删除!!谢谢!!!一一条猎狗将兔子赶出了窝,一直追赶他,追了很久仍没有捉到。
库房URS
温度 10℃-30℃ 相对湿度 45%-75%
温度 20℃以下 相对湿度 45%-65%
温度 2℃-8℃ 相对湿度 ≤80%
无
相对湿度 ≤80%
无
相对湿度 ≤80%
无
相对湿度 ≤80%
温度 30℃以下 温度 10℃-30℃ 相对湿度 45%-75%
URS4-11 化工原料阴凉库 温度 20℃以下 相对湿度 ≤80%
8 附件
用户需求 URS 库房 URS 版本号 页码
01 7 / 10
制订者/日期
复核者/日期
公司名称 文件类型 文件名称 文件编号 生效日期
附件 1
编号 URS2-1 URS2-2 URS2-3 URS2-4 URS2-5 URS2-6 URS2-7 URS3-1 URS3-2 URS3-3 URS3-4 URS3-5 URS3-6 URS3-7 URS3-8 URS3-9 URS3-10 URS3-11 URS4-1 URS4-2 URS4-3 URS4-4 URS4-5 URS4-6 URS4-7 URS4-8 URS4-9 URS4-10 URS4-11 URS4-12 URS4-13 URS4-14 URS4-15 URS4-16
采取隔热、散热等防火保护措施,确保安全。
库房土建要考虑消防安全基础设施项目,库房设防火墙、
URS3-5 防火门(防火卷帘门设在防火墙上),库房周边设有消防
栓等。
URS3-6 存放甲乙丙类危险品的库房应有消防安全自动报警装置
库房设计要按照要求充分考虑防火和人员的安全疏散问
URS3-7 题。在办公室、库房、安全出口(紧急逃生门)等处设置
库房内按面积与高架货位配置相应托盘,且运输工具 URS7-13 (叉车、地牛)能配套使用,标签库配备专用标签柜。
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用户需求说明文件
XXXXXXXXXX公司
XXX年
目录
1.文件审批.................................................. 错误!未定义书签。
2目的....................................................... 错误!未定义书签。
3范围....................................................... 错误!未定义书签。
4法规和国家标准............................................. 错误!未定义书签。
法规......................................................... 错误!未定义书签。
行业标准..................................................... 错误!未定义书签。
国家标准..................................................... 错误!未定义书签。
5工艺描述及产品介绍......................................... 错误!未定义书签。
工艺/流程描述................................................ 错误!未定义书签。
产品介绍..................................................... 错误!未定义书签。
6. ..............................................................用户及系统要求错误!未定义书签。
. URS要求.................................................. 错误!未定义书签。
URS01:设备整体要求........................................ 错误!未定义书签。
URS02:具体技术要求........................................ 错误!未定义书签。
URS03:安全及环保要求...................................... 错误!未定义书签。
URS04:文件资料要求........................................ 错误!未定义书签。
URS05:服务与维修要求...................................... 错误!未定义书签。
供应商对项目要求的确认..................................... 错误!未定义书签。
7. ................................................................. 缩略词附件错误!未定义书签。
8. ............................................................ 文件修订变更历史错误!未定义书签。
9. ....................................................................... 附件错误!未定义书签。
1.文件审批
2目的
本用户需求文件旨在从项目和系统的角度阐述用户的需求,总括了用户对该项目的质量要求(GMP),描述了用户对该设备的工作过程及功能的期望。
主要包括相关法规符合度和用户的具体需求,这份文件是构建起项目和系统的文件体系的基础,同时也是系统设计和验证的可接受标准的依据。
设备生产商应在规定的时间内完成并达到本用户需求的设计目标和可接受的质量标准。
在本URS中用户仅提出基本的技术要求和设备的基本要求,并未涵盖和限制卖方设备具有更高的设计与制造标准和更加完善的功能、更完善的配置和性能、更优异的部件和更高水平的控制系统。
投标方应在满足本URS的前提下提供卖方能够达到的更高标准和功能的高质量设备及其相关服务。
卖方的设备应满足中国有关设计、制造、安全、环保等规程、规范和强制性标准要求。
如遇与卖方所执行的标准发生矛盾时,应按较高标准执行(强制性标准除外)。
3范围
本用户需求书所列技术要求适用于新项目颗粒剂车间沸腾搅拌干燥机生产线设备的采购。
新的设备在设计、制造技术及性能上达到国内先进水平,符合中国新版GMP要求。
4法规和国家标准
法规
新建的沸腾搅拌干燥机生产线用于颗粒剂车间前工序制粒产品的沸腾搅拌干燥生产。
因此必须符合要求,主要包括:
中国GMP(2010年修订)及其附录
中国药品生产验证指南(2003版)
GEP良好工程管理规范
《中国药典》2010年版
行业标准
GBZ 1-2010 工业企业设计卫生标准
GB20021-2004中华人民共和国制药机械行业标准
JB/T20045-2005沸腾干燥机标准
国家标准
GB-52261-2002 机械安全机械电气设备第一部分:通用技术条件
GB-8196-87 机械设计防护罩安全要求
5工艺描述及产品介绍
工艺/流程描述
车间前工序由摇摆颗粒机制粒的湿颗粒经传送带送至沸腾搅拌干燥机的真空进料口处,湿颗粒经真空吸入设备喷雾干燥室内经过滤的空气加热后从气流分布板进入干燥室,一定的气流速度让其中的粉粒物料因气流的推动及自身重力的共同作用而悬浮形成流化态,同时搅拌耙动料层加强流态化,强化了热气流与料层的传质、传热过程,气流所携热量使水分随气流迅速蒸发排除。
此过程不断重复进行,物料在设备设定的工艺条件下完成沸腾快速干燥生产过程。
本文所述的一条沸腾搅拌干燥机生产线,由主机系统、新风处理系统、引风及消声系统、换热系统、电气控制操作系统、流化床系统、自动清洗系统等组成,用于车间制粒前工序湿颗粒的干燥生产。
产品介绍
待生产的产品如下:
·品种一(规格2mg/片)
片重:150mg;冲模:7mm浅弧冲;片型:圆形片,批量:10~30kg,颗粒为粉末较多的细粉,流动性较好。
·品种二(规格250mg/片)
片重:500mg;冲模:15mm×7mm异型冲;片型:胶囊形片,批量:10~30kg,颗粒为细粉,流动性较好。
·品种三(规格100mg/片)
片重:200mg;冲模:9mm浅弧冲;片型:圆形片,批量:10~30kg,颗粒为粉末较多的细粉,流动性一般。
6.用户及系统要求
6.1.URS要求
6.1.1.URS01:设备整体要求
6.1.2.URS02:具体技术要求
6.1.3. URS03:安全及环保要求
编号要求内容
6.1.4.URS04:文件资料要求
6.1.5.URS05:服务与维修要求
6.1.6.供应商对项目要求的确认
参见附件1。
7.缩略词附件
8.
在具体实施过程中,如本文件有不妥之处,可以对本文件进行相应的修改,但对本文件及其附件中的任何内容进行任何修改都必须通过已制定的变更程序,经审核和取得有关部门批准后才能修改和执行。
9.附件
附件1 URS符合性确认表格
附件1 URS符合性确认表格
该表格由供应商填写,确保本文件的要求得到供应商的书面回馈。