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1、惠氏制扩建项 生产厂惠氏制扩建项 生产厂初步设自控专Project共 7PART1GENERAL 第一部分-Thisspecificationcoversthe requirements fordesign, fabrication and delivery tosories,modificationsoroptionsmentionedhereinorrequiredtomeettheprojectPART1GENERAL 第一部分-Thisspecificationcoversthe requirements fordesign, fabrication and delivery toso
2、ries,modificationsoroptionsmentionedhereinorrequiredtomeettheprojectdetailsperformancerequirementsandvariousdesigncriteriaidentifiedbytheand user represen ives for weighing and dispensing operation in an OSD pharmaceutical ronment under cGMP conditions. The system must be compliant to all applicable
3、 FDA, EU, MHRA, TGA, WHO regulations, however, it is not ent of to detail mechanical, electrical andcontrol requirements.The Vendor shall supplyall subordinate nents sary to meet the performance requirements established Should the findit sarytodeviatefromthespecificdesignandperformance requirements,
4、 the Vendor shall clearly s e all he quo al and give the son(s)foreach Proven Equipment Only proven equipment is Proven equipment is defined s been in continuous operation elsewhere on similar duties for a minimum threeyearswithoutmajorPermanentnameplatesshallbepermanentlyaffixedoneachpieceofequipme
5、nt. ThetobecontainedonthenameplatesshallbeidentifiedbytheAnyexceptionstotheURSshallbeclearlyhighlightedinanexceptionsectionofthe UsePfizerBTstandardcomputerandbuildif O/SshallbeWindows8,WindowsServer2008or UsePfizerBTstandardcomputerandbuildif O/SshallbeWindows8,WindowsServer2008orO/S应为Windows8Windo
6、wsServer2008orShallhaveerfaceatsors(PLC)works ionsandUse rUAprotocolforsanddiscrete使用OPCDAUAUseODBC, OLEDB,JDBCorOPCAE orUAforalarm使用ODBC、OLEDBJDBCOPCAES ic IPsagebyrshall beassignedbythe sitetoavoidandinvalid May provide dual NIC cards for SCADA nodes, one connected to the C-LAN and one theM-LAN(pu
7、t2可以提供双网卡SCADA 节点,一点接C-LAN、一点接M-LANn the automation layer 2 and the layer 3, there may be a firewall. The preferred brand 自动化之间的第二层和第三层, 应设置有。 的首选品牌是西门子PART 3Thesecurityfortheapplicationmustbecapableof .UseraccountsforeachindividualusingtheapplicationshallbelinkedtoaccountkeptsynchronizedwiththeUser
8、s must be capable of being assigned to security he SCADA mayhaverightsaddedinadditiontothose inheritedfromgroupstheuserisaUsers must be capable of being assigned to security he SCADA mayhaverightsaddedinadditiontothose inheritedfromgroupstheuserisamember The system shall be capable ofauto taconfigur
9、edtimeout period. Thetimer shall be setwhenanyinputfromtheoperatorisdetected.ThelogofftimemustbeAssess to the O/S and other non-essential applications shall be prevented by a secure grouppoliciesorsimilarPART4DATA 第四部分- ThesystemshallproviderealtimeandhistoricaldisplaysofShallprovidelocalarchivalcap
10、abilityandability tosend toexternal file server,or Alarms and Events shall be logged with the full user name, date, time, tag, andaction(acknowledged,returntonormal,etc.),asaAlarm setsshallbeyproduct(viaarecipefunction)orequipmentsData Shallbeconfigurableastowhatdatasarecollected. Defaultisoginputsa
11、lldiscrete ThesystemshallproviderealtimeandhistoricalShallprovidelocalarchivalcapabilityandabilitytosendtoexternalScalingThesystemshallproviderealtimeandhistoricalShallprovidelocalarchivalcapabilityandabilitytosendtoexternalScalingAllsvariables, setsand limitsshallbescaledat the PLClevel, at the SCA
12、DA. This will allow o be sent directly from the PLC OPC server to 不是在 直接从PLCOPC enanceMachines / ses Shall e the following information for use in Pfizers Running s us of all motors and other significant equipment t preven Any sensor or instrumen ion t can indicate the condition of significant nents.
13、Thiscanincludevibration,temperature,re andr should provide a cost option for any signals he standard offering When forwardinganyoanexternal source,the systemshallprovidelocal bufferingityofaminimumof3 LocalRecipeRecipes for the specific Unit Operation shall be ained locally with the capability back-
14、up toa network server. The system shall provide the ability tocreate, edit and Recipes for the specific Unit Operation shall be ained locally with the capability back-up toa network server. The system shall provide the ability tocreate, edit and delete sfordifferentproducts,dosesorotherPART5AUTOMATI
15、ONPLATFORM 第五部分-Selectpreferredplatformsforhistorian,SCADA,HMIandPLCbased .,SCADA、HMI和PLC 的首选厂家有Sitestaffexperience,supporttoolsandspareparts rsupportproximitytotherswithPfizeragreements(we havePfizeragreementswithHoneywell, Emerson)Requestequipment bidsnoptionforthe preferred platformsandevaluateba
16、sedoncost ferentialandTCOsavings TCOfactorsinclude:External support is not available or prohibitively expensive or distant to respond tivelyvs.thecostofcustomizingrofferingstofacili ernalAbilitytotroubleshootviasoftwareviewingcapability,diagnosticsscreens,etc.uhavingfullstothesystemcodeandUseofaPCbasedSCADAvs.aproprietaryhardwarebasedHMIshouldalsoUseofaPCbasedSCADAvs.aproprietaryhardwarebasedHMIshould
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