EUROTHERM FLEXIBLE SOLUTIONS BMS & EMS BUILDING MANAGEMENT SYSTEMS & ENVIRONMENTAL MONITORING SYSTEMS

Transcription

1 EUROTHERM FLEXIBLE SOLUTIONS BMS & EMS BUILDING MANAGEMENT SYSTEMS & ENVIRONMENTAL MONITORING SYSTEMS

2 Complete BMS ad EMS Solutios from Eurotherm Why BMS/EMS? Where evirometal coditios could reasoably be expected to have a adverse effect o product quality, the maufacturer shall establish ad maitai procedures to adequately cotrol these evirometal coditios. Evirometal cotrol system(s) shall be periodically ispected to verify that the system, icludig ecessary equipmet, is adequate ad fuctioig properly. These activities shall be documeted ad reviewed. FDA 21 CFR Part Productio ad Process Cotrols, sectio c. Cotrol ad moitorig of storage ad productio eviromets has become a importat issue withi the Pharmaceutical Idustry. The FDA, EMEA ad other regulatory bodies require accurate measuremet ad storage of room parameters ad, if the storage medium is electroic, the methods used must comply with 21 CFR Part 11. The FDA also states i its 21 CFR part that: Maufacturers; authorised distributors of record ad their represetatives shall store ad hadle all drug samples uder coditios that will maitai their stability, itegrity ad effectiveess ad esure that the drug samples are free of cotamiatio, deterioratio, ad adulteratio. Why Eurotherm? The Eurotherm BMS/EMS system is desiged to satisfy the requiremets of regulatory bodies icludig 21 CFR Part 11 ad it offers: Scalable from a sigle room to a plat wide solutio Simplifies validatio usig flexible ad modular stadard fuctios Accurate ad effective cotrol of HVAC systems ad other related equipmet Cetralized ad/or remote cotrol of facilities ad equipmet Real time Moitorig of BMS performace Itelliget alarm capability for early warig of process deviatios Corrective strategies whe stability factors go outside the specificatio Secure maagemet ad storage of evirometal data ad audit trails Predictive maiteace plaig Eergy maagemet Other FDA rules related to evirometal cotrol ad moitorig iclude: : Desig ad costructio features (sectio 10) : Vetilatio, air filtratio, air heatig ad coolig : Warehousig procedures (sectio b) : Productio ad process cotrols ICH Q7A Good Maufacturig Practice Guidace for Active Pharmaceutical Igrediets (sectios 4.2 ad 10)

3 Scalable BMS/EMS Solutios from Eurotherm Eurotherm Buildig Maagemet Systems provide Cotrol, Moitorig, Recordig ad Alarmig of a rage of facilities withi a plat icludig: Productio facilities icludig Aseptic areas Laboratory facilities Warehouse facilities Cold storage facilities Evirometal Chambers Office facilities Fire ad alarm security systems Water purificatio systems Not all existig BMS systems offer a loggig facility ad, for these systems a idepedet moitorig system, EMS, will be eeded. Typically a EMS will provide idepedet moitorig ad loggig of the critical evirometal parameters for GMP, GLP ad GDP facilities.

4 Flexible ad Modular BMS/EMS Solutio Eurotherm BMS/EMS Stadard Modules Eurotherm BMS/EMS solutios are modular ad scalable. They offer all the fuctioality required to cotrol, moitor, record ad alarm, for a sigle room to a plat wide applicatio. They are ideal for Implemetig a ew system Ehacig existig systems EMS for a existig BMS It offers the optios for: Cetralised BMS/EMS Network of local stadaloe BMS/EMS uits Combiatio of cetralised ad local systems to icrease availability ad ease of use Sesor Sesors commuicate measuremet ad status iformatio from the process to the cotrol ad moitorig modules of the BMS/EMS system. Sesors iclude: Temperature Relative Humidity Air pressure or differetial pressures Lumiescece (light level) Particle couters Air Flow patters Gas Level Vibratio Noise Water leak detectio Doors status Fire detectors HVAC healthy status For hazardous rooms itrisically safe devices must be used icludig: Itrisically Safe sesors Itrisically Safe barrier Itrisically Safe IO modules Eurotherm ca offer a rage of the above sesors or alteratively provide iterface to sesors supplied by the user. The block diagram demostrates the various compoets of the Eurotherm BMS/EMS system. All of these compoets are stadard fuctios of the system ad, as well as providig ecessary fuctioality, are desiged with a sharp focus o ease of use ad to reduce validatio effort. Local HMI (Moitorig) Cotrol Cetral HMI (Moitorig) Local Data ad Audit trail loggig Cetral Data ad Audit trail loggig Sesors Local Alarm Cetral Alarm Data Review ad Reports Security Maager Alarm HMI Calibratio Maiteace Process level Local level Plat Level level Services Validatio

5 Accurate Cotrol with Redudacy Optio Moitorig BMS/EMS offer a wide rage of optios for moitorig the plat. Iformatio ca be moitored locally, cetrally ad remotely. Access to the system is protected. Users must logi to gai access to fuctioality, defied by their access level. Plat iformatio is moitored through stadard ad custom displays ad icludes: Live data Mimics with live data Multi laguage support Iformatio received from the plat is grouped together i various forms to allow the users to rapidly access the required iformatio. The system utilises a easy to use, hierarchical methodology of presetig the ecessary iformatio to the users icludig: Plat overview Area overview Idividual room overview Idividual cotrol loop view Idividual sesor view Groupig by type (e.g. temperature, humidity, pressure) Data collected from the plat are liked together ad displayed as treds usig olie ad historical tredig withi the system. Treded data are available i various groups e.g. by room, by type (temperature, pressure etc.) Cotrol The purpose of this compoet is to provide the cotrol of the ecessary parameters for each idividual room/area. It offers stadard cotrol fuctioality, e.g. PID loops, to accurately cotrol the various evirometal coditios of the room. It also provides the fuctioality required to cotrol devices such as pumps, motors ad valves, e.g. start/stop with ecessary iterlocks. Operatio ca be cofigured to be automatic, semi-automatic, maual or ay combiatio of these. Idividual rooms/areas may be operated i differet modes; the selectig of which is access cotrolled by authorised users: Idle: Optio for turig off the cotrol of the critical parameters I operatio: Automatic cotrol of critical parameters Maiteace: Automatic ad Maual cotrol of critical parameters. This mode is also used for calibratio of sesors. BMS offer the facility for adjustig cotrol parameters (e.g. setpoits, alarm limits, toleraces, time delays) i order to achieve the desired coditio i each room. This feature is oly available to users with the appropriate access permissios. The system provides a full audit trail of these chages icludig electroic sigatures. The moitorig facility also provides the user with access to stadard features of the system accordig to their access level, icludig: Access cotrol with password protectio for idividual user accouts, iactivity timeout ad password expiry Alarms Treds Alarm set poit cofiguratio Cotrol parameter cofiguratio Calibratio facilities Maiteace facilities Batch displays Electroic sigatures Cofiguratio utilities Multi laguage support

6 Data Loggig ad Audit Trail Desiged to Satisfy 21 CFR Part 11 Data Loggig Data loggig is a key requiremet for BMS/EMS systems. 21 CFR Part 11 requires that logged data will be tamper proof ad will iclude critical evirometal parameters (temperature, humidity, pressure, particulate sizes, etc), with audit trails icludig: Accurate time ad date stamps Alarms ad evets User actios ad details (e.g. setpoit chages) User otes Electroic Sigatures Logi/Logout Eurotherm s BMS/EMS systems log plat data to tamper proof files ad SQL relatioal databases. Data loggig ca be offered as: Local loggig (Tamper proof file) Cetral loggig (SQL database) Local ad cetral loggig (Tamper proof files ad SQL database) The availability of logged data ca be sigificatly icreased by the local ad cetral loggig optio. This allows data collectio i multiple devices to further protect vital plat data. Typically a BMS/EMS system comprises of a umber of distributed uits where each uit has its ow iteral clock. Time sychroisatio is icluded to esure accurate time ad date stamps, as required by 21 CFR Part 11, to a kow clock source. The BMS/EMS system offers provisios for electroically copyig data for archive ad export facility to commo packages (e.g. Excel, Word, PDF, etc.) for viewig of secure records i huma readable format. Other features of the system iclude: Power ad etwork recovery automatic procedures FTP server to put the data o a cetral server Scheduled trasfers The system ca be cofigured to provide loggig for o-critical parameters icludig: System evets Equipmet failure Equipmet performace ad maiteace Eergy usage Sesors Process level

7 Alarms ad Evets Reportig A importat feature of the BMS/EMS system is its Alarms ad Evets fuctioality. All alarms ad evets are time stamped ad logged for log term retetio ad validatio to 21 CFR Part 11. Idividual plat data ca be cofigured to have oe or a combiatio of the followig alarms: Absolute alarms Deviatio alarms Rate of Chage alarms Delayed alarms Excursio alarms Local HMI (Moitorig) Cotrol Cetral HMI (Moitorig) The system ca be cofigured to provide other alarms icludig; Sesor break Equipmet failures Network failure Maiteace ad calibratio alarm Alarms ca be cofigured as critical, o-critical or as a evet. Critical alarms will require maual ackowledgemet ad o-critical will be auto-ackowledged. Alarm selectio ad setpoit settigs are available to the users with the appropriate access level ad critical alarms ca be cofigured to require a Electroic Sigature for chages. Alarm ackowledgemet ad all chages to alarm settigs are automatically logged as required by 21 CFR part 11. All alarms ad evets are reported through local, cetral, ad remote HMI paels. They are displayed i the Alarm Summary ad Alarm History pages which provide a sort facility for the iformatio. Alarms ca be grouped by their criticality ad fuctio to esure idividual alarms ca be quickly accessed. Other features of the BMS/EMS alarm system iclude: Audible alarm otificatio Notificatio of alarm coditios to desigated users o a desigated telephoe umber Local pritig of alarms ad evets Local Data ad Audit trail loggig Cetral Data ad Audit trail loggig Local Alarm Cetral Alarm Data Review ad Reports Security Maager Alarm HMI Calibratio Maiteace Local level Plat Level level Services Validatio

8 Easy to Use, Comprehesive Reportig Review ad Reportig The BMS/EMS system provides a comprehesive review ad reportig system. The system offers two methods for collectig data: Local data collectio Data collected locally i a secure format ad archived cetrally i a filig system Cetral data collectio Data collected i a cetral historical SQL relatioal database These methods may be combied ad, i both cases, the system provides the facility to create reports for idividual rooms. A umber of stadard report templates are provided alog with the facility for users to create their ow reports. Iformatio ca be automatically trasferred ad accessed from stadard Microsoft Office packages. Realtime ad historical treds Multiple data plots Search by batch or by room Batch tred aalysis Golde Batch aalysis Stadard ad custom SQL queries Direct isertio to Excel, Word Quick report geeratio with stadard templates

9 Easy to Operate at every Level Security Maager Security Maager offers sigificat operatio cost savigs ad ease of use by allowig maiteace of user accouts ad passwords from oe or multiple locatios. If a user eeds to chage their password they ca do so o a local istrumet or PC ad this will be automatically distributed across all systems to which they have access. Maiteace ad Calibratio Maiteace is a essetial part of ay BMS/EMS system. Maiteace iformatio o various elemets of the system (e.g. last calibratio date, calibratio due date, last maiteace date, maiteace due date) is show o multiple displays throughout the system. The system ca provide warigs if calibratio/maiteace dates for idividual equipmet are approachig ad/or exceeded. Access permissio ca be give to idividual users to select maiteace modes for the followig: Sesors Equipmet (e.g. pumps, motors, valves) Maiteace mode ca also be selected for a give area e.g. a room or a zoe of the plat. While i maiteace mode the idividual equipmet or area will be clearly idetified o the display usig colour ad text. The system ca be set to suppress alarms ad stop loggig parameters for associated equipmet at this time. Selectio ad the de-selectio of the maiteace mode will be logged as a evet i the audit trail. Easy to use calibratio tools are icluded i the system for use durig maiteace mode. Selectio ad de-selectio of the calibratio mode is logged i the audit trail. A commo security tool across multiple product rages Chage i oe place, deploy to may Support for multiple security zoes Built-i audit trail for 21 CFR Part 11 validatio Automatic versio cotrol Support for electroic sigatures Local HMI (Moitorig) Cetral HMI (Moitorig) Cotrol Local Data ad Audit trail loggig Cetral Data ad Audit trail loggig Sesors Local Alarm Cetral Alarm Alarm Data Review ad Reports Security Maager HMI Calibratio Maiteace Process level Local level Plat Level level Services Validatio

10 Total Lifecycle Support Alarm Notificatio Nomiated users ca be quickly otified of alarm coditios via the telephoe system. The system offers: Real-time alarm otificatio triggered from the plat system Esured the delivery of the messages Easy to cofigure tools Logi facilities ad security patters Redudacy optios Services Services eed to be provided from the begiig of the project, through the project developmet ad commissioig, ad for the lifetime of the system. Eurotherm offers a complete rage of services such as: Expertise to assist with the User Requiremet Specificatio Project, Applicatio ad Validatio egieerig Commissioig (e.g. calibratio) ad qualificatio egieerig Traiig courses coverig products, cotrol theory, validatio etc. Helpdesk ad o call services Product services Moitorig users, icludig off-site, ca access plat iformatio via a secure web portal. Local HMI (Moitorig) Cetral HMI (Moitorig) Cotrol real-time data visualisatio Multi laguage facilities Support for multiple widows Itegrated iformatio from diverse data sources Local Data ad Audit trail loggig Cetral Data ad Audit trail loggig Sesors Local Alarm Cetral Alarm Alarm Data Review ad Reports Security Maager HMI Calibratio Maiteace Process level Local level Plat Level level Services Validatio

11 Stadard, Advaced Fuctioality Validatio BMS/EMS A key requiremet for BMS/EMS solutios is validatio. Where evirometal coditios (e.g. temperature, humidity, differetial pressure, air flow, sterility, cotaimet) have a direct impact o product purity, safety, quality or efficacy they eed to be moitored agaist predetermied limits ad logged. I this case the BMS/EMS system used for collectig ad loggig the data eeds to be validated. Accordig to ISPE guidelies, it is good practice to moitor the performace of equipmet such as fas, coil ad cotrol compoets, but it is ot a regulatory requiremet. Documetatio Validatio documetatio eeds to be provided through the life cycle of the BMS/EMS system. Eurotherm ca offer a rage of documetatio services followig GAMP guidelies ad i accordace with customer requiremets: User Requiremet Specificatio Fuctioal Specificatio Desig Specificatio Hardware Testig Code Review Factory Acceptace Test Istallatio Qualificatio Operatioal Qualificatio Periodic review GAMP LIFECYCLE Plaig Reportig Specificatio Verificatio Operatioal Chage Implemetatio Desig Review, Risk Maagemet, Chage Cotrol, Traceability Maitaiig the Validated State Cocept Project Operatio Retiremet Mea Kietic Temperature (MKT) Calculatio Measuremet ad recordig of temperatures is vital to the storage of perishable goods, but there is more tha oe way to record a average. The ICH defies the mea kietic temperature as beig A sigle derived temperature that, if maitaied over a defied period of time, affords the same thermal challege to a drug substace or drug product as would be experieced over a rage of both higher ad lower temperatures for a equivalet defied period. MKT expresses the cumulative thermal stress experieced by a product at varyig temperatures durig storage ad distributio. It differs from other meas (such as a simple umerical average or arithmetic mea) i that higher temperatures are give greater weight i computig the average, recogisig the accelerated rate of thermal degradatio of materials at higher temperatures. The mea kietic temperature is calculated as beig: the mea kietic temperature i K the heat of activatio, kJ.mole 1 the uiversal gas costat, x10-3kj.mole 1.k 1 the daily average temperature (K) day 1 the daily average temperature (K) day the total days i the calculatio There are a umber of iterpretatios of how this calculatio is achieved usig real samples: All sample values fed ito formula Maximum/miimum samples fed ito formula separately (recommeded by the FDA) Arithmetic mea of maximum ad miimum fed ito formula (recommeded i the US Pharmacopeia ad by the UK MCA) Eurotherm miimises the implemetatio ad operatio cost of providig MKT data by makig all of the above methods as itegral part of our solutio with: A choice of stability testig period (hourly / daily / weekly) A choice of samplig frequecy (from 1 miute to 1 hour) Optio to remove idividual probes from the calculatio (e.g. durig a calibratio process) Corrective actio i case stability is out of specificatio Secure ad low cost custom reportig

12 Eurotherm: Iteratioal sales ad service Uderstadig ad providig local support is a key part of Eurotherm busiess. Complemetig worldwide Eurotherm offices are a whole rage of parters ad a comprehesive techical support team, to esure you get a service you will wat to go back to. AUSTRALIA Sydey Eurotherm Pty. Ltd. T (+61 2) F (+61 2) E ifo.au@eurotherm.com AUSTRIA Viea Eurotherm GmbH T (+43 1) F (+43 1) E ifo.at@eurotherm.com BELGIUM & LUXEMBOURG Moha Eurotherm S.A/N.V. T (+32) F (+32) E ifo.be@eurotherm.com BRAZIL Campias-SP Eurotherm Ltda. T (+5519) F (+5519) E ifo.br@eurotherm.com CHINA Eurotherm Chia T (+86 21) F (+86 21) E ifo.c@eurotherm.com Beijig Office T (+86 10) F (+86 10) E ifo.c@eurotherm.com Guagzhou Office T (+86 20) F (+86 20) E ifo.c@eurotherm.com DENMARK Copehage Eurotherm Damark AS T (+45 70) F (+45 70) E ifo.dk@eurotherm.com FINLAND Abo Eurotherm Filad T (+358) F (+358) E ifo.fi@eurotherm.com FRANCE Lyo Eurotherm Automatio SA T ( ) F ( ) E ifo.fr@eurotherm.com GERMANY Limburg Eurotherm Deutschlad GmbH T ( ) 2980 F ( ) E ifo.de@eurotherm.com HONG KONG Eurotherm Hogkog T (+85 2) F (+85 2) E ifo.hk@eurotherm.com INDIA Cheai Eurotherm Idia Limited T (+91 44) F (+91 44) E ifo.i@eurotherm.com IRELAND Dubli Eurotherm Irelad Limited T (+353 1) F (+353 1) E ifo.ie@eurotherm.com ITALY Como Eurotherm S.r.l T ( ) F ( ) E ifo.it@eurotherm.com KOREA Seoul Eurotherm Korea Limited T (+82 31) F (+82 31) E ifo.kr@eurotherm.com NETHERLANDS Alphe a/d Rij Eurotherm B.V. T ( ) F ( ) E ifo.l@eurotherm.com NORWAY Oslo Eurotherm A/S T (+47 67) F (+47 67) E ifo.o@eurotherm.com POLAND Katowice Ivesys Eurotherm Sp z o.o. T (+48 32) F (+48 32) E ifo.pl@eurotherm.com SPAIN Madrid Eurotherm España SA T (+34 91) F (+34 91) E ifo.es@eurotherm.com SWEDEN Malmo Eurotherm AB T (+46 40) F (+46 40) E ifo.se@eurotherm.com SWITZERLAND Wollerau Eurotherm Produkte (Schweiz) AG T (+41 44) F (+41 44) E ifo.ch@eurotherm.com UNITED KINGDOM Worthig Eurotherm Limited T ( ) F ( ) E ifo.uk@eurotherm.com U.S.A. Leesburg VA Eurotherm Ic. T (+1 703) F (+1 703) E ifo.us@eurotherm.com Represeted by: ED56 Eurotherm is also represeted i the followig coutries: Algeria Azerbaija Bahrai Bagladesh Bei Bosia ad Herzegovia Bulgaria Burkia Faso Cameroo Caada Czech Republic Egypt Georgia Greece Guiea-Coakry Hugary Idoesia Ira Iraq Israel Ivory Coast Japa Jorda Kazakhsta Keya Kuwait Latvia Lithuaia Malaysia Mali Mexico New Zealad Niger Nigeria Oma Pakista Philippies Puerto Rico Qatar Romaia Russia Saudi Arabia Serbia ad Moteegro Sigapore Slovak Republic Sloveia South Africa Sri Laka Thailad Togo Tuisia Turkey Turkmeista UAE Ukraie Uzbekista Copyright Eurotherm Limited 2008 Ivesys, Eurotherm, the Eurotherm logo, Chessell, EurothermSuite, Mii8, Eyco, Eyris, EPower ad Woderware are trademarks of Ivesys plc, its subsidiaries ad affiliates. All other brads may be trademarks of their respective owers. All rights are strictly reserved. No part of this documet may be reproduced, modified, or trasmitted i ay form by ay meas, or may it be stored i a retrieval system other tha for the purpose to act as a aid i operatig the equipmet to which the documet relates, without the prior writte permissio of Eurotherm limited. Eurotherm Limited pursues a policy of cotiuous developmet ad product improvemet. The specificatios i this documet may therefore be chaged without otice. The iformatio i this documet is give i good faith, but is iteded for guidace oly. Eurotherm Limited will accept o resposibility for ay losses arisig from errors i this documet. Part No. HA Issue 2 Prited o recycled paper i Eglad 10.08