Critical Control System - Storer Services
Tracer Summit Critical Control SystemMay 2004BAS-PRC017-EN
IntroductionLife science—Addressingyour needsTrane is focused on understanding theimposing business challenges of lifescience companies. We understand theintense competitive pressures and thecompressed time lines required tosucceed in this highly regulated industry.Increased enforcement efforts by theU.S. Food and Drug Administration (FDA)have compliance management, facilityoperations, and IT resources on alert.The massive costs of a compliance orvalidation shortcoming cannot beafforded. Trane is responding to thesechallenges with solutions that includemechanical equipment, complianceenabled controls, and validationdocumentation templates.Trane is designing solutions for facilitiesdevoted to research, development,manufacturing, and product stabilityacross the life science industry. Ourintegrated systems provide tightlycontrolled environments forpharmaceuticals, genome projects,medical devices, and a full range ofbiotechnology products.Trane—People, systems,and technology to give youa business advantagePartnering with Trane can provide ameasurable competitive advantage inthe fast-paced world of life science. Youbenefit from maximum uptime, plustime savings, from the constantavailability of all compliance data. Ourstrong relationships with the specializedfirms capable of successfully designingand constructing life science facilitiesalso help ensure the seamless successof this entire critical process.As the only major HVAC and controlscompany, Trane can provide thestandardized solution bundling and jobcoordination benefits that others cannotmatch. The integration of Trane HVACequipment and controls, teamed withthe corporate-engineering and validationexpertise and the local support of theTrane organization, provides a single,valuable business partner for: Increasing speed to market—themost hotly pursued success factor inthe life science industry Incorporating reliable building systems Reducing risk Saving installation and operationalcosts Managing regulatory complianceTracer Summit CriticalControl SystemAs part of Trane's Life ScienceCompliance Environment offering, theTracer Summit building automationsystem provides complete buildingcontrol through a single, integratedsystem. The Tracer Summit CriticalControl System is an enhanced versionof Tracer Summit that provides completeenvironment management for all FDAregulated areas, from research todistribution.This FDA-compliance-enabled controlsystem is designed with extensivedocumentation and reporting capabilitiesto meet FDA 21 CFR Part 11. The TracerSummit Critical Control System willkeep your facilities aligned with FDAinitiatives on “21st Century” practices,by providing: User security by authority level Audit trails for event and accesstracing Display and reporting capabilities forcritical environmental parameters The following are trademarks or registered trademarks of their respective companies ororganizations: ARCNET from Datapoint Corporation; BACnet from ASHRAE; LonTalk fromEchelon Corporation, Modbus from Schneider Automation, Inc.; SQL Server from SybaseCorporation; CenTraVac, Tracer Summit, Trane, and VariTrane from American Standard Inc;Internet Explorer, Microsoft, Windows, and Windows XP from Microsoft Corporation in theUnited States and other countries. 2 2004 American Standard Inc. All rights reserved.BAS-PRC017-EN
ContentsIntroduction . . . . . . . . . . . . . . . . . . . . . . . . .2Life science—Addressing your needs . . . . . . . . . . . 2Trane—People, systems, and technologyto give you a business advantage . . . . . . . . . . . . 2Tracer Summit Critical Control System. . . . . . . . . . 2Features and benefits . . . . . . . . . . . . . . . . .4Pre-engineered applications. . . . . . . . . . . . . . . . . . .Alarm management . . . . . . . . . . . . . . . . . . . . . . . . .Audit trail . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .System security . . . . . . . . . . . . . . . . . . . . . . . . . . . . .System and data integrity . . . . . . . . . . . . . . . . . . . .Compliance documentation and consulting . . . . . .Reports and trends . . . . . . . . . . . . . . . . . . . . . . . . . .System integration . . . . . . . . . . . . . . . . . . . . . . . . . .The Trane advantage . . . . . . . . . . . . . . . . . . . . . . . .444555666System architecture . . . . . . . . . . . . . . . . . .7Specifications . . . . . . . . . . . . . . . . . . . . . . .8System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8PC Workstation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8Data historian . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8Building control unit . . . . . . . . . . . . . . . . . . . . . . . . . 8BACnet PICS—BCU . . . . . . . . . . . . . . . . . . . . . . . . . . 9BACnet PICS—PC Workstation. . . . . . . . . . . . . . . . 10BAS-PRC017-EN3
Features and benefitsPre-engineered applicationsThe Tracer Summit system has the mostextensive library of pre-engineeredenvironment-control applications in theindustry. These applications, such aschiller-plant and variable-air-volumesystem control, bring an added level ofreliability to potentially complexsystems. Pre-engineered applicationsprovide: Consistent solutions, independent oflocation, making systems easier tomaintain and service Reduced risk of re-inventing solutionson a per project basis Solutions, engineered with Traneexpertise, that are pre-tested in thefactory for safe, reliable, and energyefficient equipment and systemoperation Quick startup and checkout,minimizing installed costsAlarm managementWith increasing amounts of valuableproduct and complex systems in today’slife science facilities, system alarms canpotentially be costly if the identification,troubleshooting, and resolution isdifficult to accomplish. Considerationsalso must be made after the alarmoccurs to prevent the abnormalcondition from reappearing, includingidentifying the root cause andimplementing corrective actions.mobile phones, and pagers. Foradditional flexibility, e-mail alarm routingcan also be scheduled to send alarmmessages to different e-mail addressesbased on the day of the week or eventhe time of day.After the alarm is received, the on-callsystem operator can utilize the manyfeatures of the Tracer Summit alarm logto troubleshoot the issue. The alarm logallows alarms to be easily accessed,acknowledged, or deleted by approvedsystem operators. A series of filters canbe used to show only the desiredalarms, and critical alarms can be set upwith custom messages and graphics toaid in alarm resolution.Alarm integrity is maintained throughoutbecause all alarms are immediatelycaptured in the secure audit trail upongeneration. All user activities associatedwith alarms, such as acknowledgementsand deletions, are also captured by theaudit trail.Audit trailThe Tracer Summit Critical ControlSystem provides a detailed,comprehensive audit trail to tracksystem alarms and electronically signedoperator activities. From a critical chilleralarm to a setpoint change, theseelectronic records are seamlessly storedin a secure data historian. Each entry inthe audit trail includes a date and timestamp, operator name, object name, anda description of the alarm or activity. Thisinformation can be sorted by date/time,operator name, or by individual systemobjects, and a report can be displayed,exported, and printed (Figure 1).With the ease of automatic capture andon-demand retrieval of data, the TracerSummit audit trail is just the tool youneed to ensure the long-term reliabilityand performance of your buildingsystems, with the added result ofexpediting FDA system reviews.Figure 1. Audit Trail Report generated from Tracer SummitAlso, the system’s ability to route anddisplay alarms must match the needs ofthe person or persons using the system.Tracer Summit Critical Control Systemhas the flexibility and the robustnessrequired to meet even the mostproficient user’s needs.When an alarm occurs in the system,the program immediately routes thealarm according to the administratordefined configuration. Configurationoptions include routing the alarm to apager, printer, or any of the TracerSummit workstations on the system.Alarms can also be sent by e-mail to anydevice that has the ability to receivee-mail messages, such as PCs, PDAs,4BAS-PRC017-EN
System securityFigure 2. Security setup in Tracer SummitPreventing unauthorized access is abasic, but very important, function ofany building automation system. Thevalue of the systems and data utilized bythe life science companies makessecurity an issue of critical importance.The security model offered by the TracerSummit Critical Control System iscomprehensive and can be customizedfor each user (Figure 2). Securityfeatures include: Unique, confidential, user-definedpasswords Password aging User lockout after multiple unsuccessful log-in attempts Inactivity timeouts User archiving Change-description and sign-offrequirements for systemconfiguration changes and alarmacknowledgementsAccess for each individual user can becontrolled by system function,application, and object type. This allowsrestrictions based on user qualifications,such as training, or on responsibilities,such as building area.System and data integrityUnauthorized user access is not the onlythreat to critical systems. Technicalissues can also put your systems at riskif the appropriate precautions are nottaken to increase system and dataintegrity.With all of the time, effort, and expenseof validating the system and loggingcritical system data, keeping criticalsystem components and data in asecure location is a must.Trane understands the importance ofthese assets to your business and hasengineered a data historian usingMicrosoft SQL Server technology. Thishistorian maintains the integrity of allsystem-critical data, including audit traildata, in a central location. Systembackup and data-archiving utilities arealso included to protect yourinvestment.5Compliance documentationand consulting Functional Specification (FS)Design Specification (DS)Installation Qualification (IQ)Operation Qualification (OQ)Performance Qualification (PQ)A key element of the validation processis having complete and detaileddocumentation (Figure 3). The highConsulting services are also availableimportance of the documentation isfrom experienced staff at Trane andreflected in the potentially high cost ofthrough any of our independentgenerating it. The Tracer Summit Criticalvalidation industry partners.Control System comes with a completeset of standard documentationtemplates. TheseFigure 3. Validation process documentationtemplates canshorten thepreparation time forand reduce the costof validation.Templatedocuments include: Validation MasterPlan (VMP) User Requirements Specification (URS)BAS-PRC017-EN
Reports and trendsFigure 4. Mean Kinetic Temperature Report setupViewing current, as well as previous,system operations provides invaluableinformation for optimal system operationand troubleshooting. The Tracer Summitreporting and trending capabilitiesprovide this ability.For example, calculating and monitoringthe mean kinetic temperature (MKT) isrequired by good warehousing anddistribution practices when storingperishable goods, such aspharmaceuticals. The Tracer SummitMKT standard report allows life sciencecustomers to easily calculate thisparameter over a user-defined timeperiod (Figure 4).Tracer Summit has a large library ofother standard reports as well, includingthose for each piece of Traneequipment, which provides a valuablesource of record-keeping andtroubleshooting data. Custom reportscan also be defined for any desiredvalues in the system, including suchdata as energy usage or run-timereporting.The Tra er must be supplied for use as adata historian. Assuming that the serverwill be used for Tracer Summit CriticalControl System use only, the hardwareselection must meet the followingminimum requirements: Windows 2000 or Windows 2003Server Windows SQL 2000 (standard orEnterprise) database8 1 GHz processor with a 512 K cache1 GB RAM2 quantity 36 GB SCSI hard drivesRAID1 Parity SystemUPS recommendedBuilding control unitPower requirementsNominal rating120/240 Vac; 50 or 60 Hz; 1 pHVoltage utilization range120 Vac, nominal: From 98 to 132 Vac240 Vac, nominal: From 196 to264 VacMaximum current6.0 A at 120 Vac dedicated circuitbreakerOperating environmentTemperatureFrom 32 F to 120 F (0 C to 50 C)Relative humidityFrom 10% to 90%, non-condensingStorage environmentTemperatureFrom -50 F to 150 F (-46 C to 66 C)Relative humidityFrom 10% to 90%, non-condensingEnclosureNEMA-1Dimensions19 in. high 16 in. wide 6 in. long(482 mm 406 mm 152 mm)Weight20 lb (9.1 kg) shipping15 lb (6.8 kg) net (hanging)MountingWall-mounted with ¼ in. hardwareClearances (recommended minimum) 12 in. (30 cm) at top, bottom, andsides 36 in. (91 cm) in front 46 in. (1.2 m) above floor (for wallmounted BCU)UL listing UL-916-PAZX—energy management CUL-C22.2—energy management—CanadaFCCFCC part 15, Class ACE Emissions: EN55022 Class B Immunity: EN50082-2:1995 Industrial Safety: EN61010-1 A2:1995MemoryStandard capacityFLASH: 2 MBEEPROM: 256 KBRAM: 1 MBHigh capacityFLASH: 4 MBEEPROM: 516 KBRAM: 2 MBBatteryNo battery is required. The clock ismaintained for a minimum of three daysby the super capacitor. All otherprograms are backed up by nonvolatilememory.BACnet communicationsTracer Summit communicates todevices that support: Communication based on the BACnetASHRAE/ANSI 135 standard ENV-1805-1/ENV-13321-1 10 Base-T dedicated Ethernet(ISO/IEC 8802-3) or TransmissionControl Protocol/Internet Protocol(TCP/IP) compatible networkLonTalk communicationsTracer Summit communicates todevices that support: Communication based on theEIA-709.1 (LonTalk ) standard LonTalk standard network variabletypes (SNVTs) FTT-10A transceivers Twisted-pair physical mediaModbus communicationsTracer Summit communicates todevices that support the ModbusRemote Terminal Unit (RTU) protocolusing the Tracer Summitcommunications bridge.BAS-PRC017-EN
BACnet PICS—BCUStandard object typessupportedBasic informationObject typesVendor nameTraneProduct nameTracer Summit BCUProduct descriptionTracer SummitBuilding Control UnitBACnet standard applicationservices supportedApplicationserviceSupportAnalog inputCreatableDeletableAnalog outputCreatableDeletableBinary inputCreatableDeletableBinary cuteCreateObject DeleteObject ReadProperty ReadPropertyMultiple WriteProperty Ethernet (ISO/IEC 8802.3), 10-BASE-FLWritePropertyMultiple ARCNET, coax busConfirmedPrivateTransfer UnConfirmedPrivateTransfer Data link layerBACnet/IP (Annex J)Ethernet (ISO/IEC 8802.3), 10-BASE-2Ethernet (ISO/IEC 8802.3), 10-BASE-TARCNET, fiber starARCNET, coax starReinitializeDeviceTimeSynchronization Who-HasPoint to point, EIA-232Special functions Maximum APDU size inoctets474 Segmented requestssupported, window size1Segmented responsessupported, window size1I-Have Who-Is I-Am Character sets supportedANSI, X3.49BAS-PRC017-EN
BACnet PICS—PCWorkstationStandard object typessupportedObject typesBasic informationDeviceVendor nameTraneProduct nameTracer Summit PCWorkstationProduct descriptionTracer Summit PCWorkstationInitiateSupportedData link layerBACnet/IP (Annex J)Ethernet (ISO/IEC 8802.3), 10-BASE-2Ethernet (ISO/IEC 8802.3), 10-BASE-TBACnet standard applicationservices supportedApplicationserviceSupportEthernet (ISO/IEC 8802.3), 10-BASE-FLExecuteARCNET, coax busARCNET, fiber star10CreateObject DeleteObject ReadProperty ReadPropertyMultiple WriteProperty WritePropertyMultiple ConfirmedPrivateTransfer UnConfirmedPrivateTransfer ReinitializeDevice TimeSynchronization Who-Is I-Am ARCNET, coax starPoint to point, EIA-232Special functionsMaximum APDU size inoctets474Segmented requestssupported, window size1Segmented responses supported, window size1Character sets supportedANSI, X3.4BAS-PRC017-EN
TraneA business of American Standard Companieswww.trane.comFor more information, contact your local Traneoffice or e-mail us at comfort@trane.comLiterature Order NumberBAS-PRC017-ENFile ng LocationInlandTrane has a policy of continuous product and product data improvement and reserves the right tochange design and specifications without notice.
Tracer Summit Critical Control System As part of Trane's Life Science Compliance Environment offering, the Tracer Summit building automation system provides complete building control through a single, integrated system. The Tracer Summit Critical Control System is an enhanced version of Tracer Summit that provides complete
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I. Critical Limits A. Definition of Critical Limits For every Critical Control Point (CCP) identified, there must be a Critical Limit (CL), or a parameter to indicate whether or not the control measure is, in fact, controlling the identified hazards. The definition of CLs by different organizations or agencies is shown in Table 1. With the
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