1、惠氏制擴建項 生產(chǎn)廠惠氏制擴建項 生產(chǎn)廠初步設(shè)自控專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應(yīng)為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可以提供雙網(wǎng)卡SCADA 節(jié)點，一點接C-LAN、一點接M-LANn the automation layer 2 and the layer 3, there may be a firewall. The preferred brand 自動化之間的第二層和第三層, 應(yīng)設(shè)置有。 的首選品牌是西門子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 直接從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 的首選廠家有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