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ive humidity,room differential pressure / airflow directionand number of particles under control, meaningimportant savings in HVAC consumption.SmartCR software has been specifically developedfor the high quality demanding pharmaceuticalindustry. It has been conceived with a conservativefunctioning to ensure the stability of the criticalparameters of the controlled environment at alltimes.The benefits of the ACH optimization are:www.telstar.com
WHITE PAPER Reduction of capital costs: Lower airflowsresult in smaller fans, which reduce both theinitial investment and construction cost. A 20percent decrease in ACH will enable close to a50 percent reduction in fan size. Nevertheless,ACH optimization requires a complex and moreefficient control system with the integration ofair particle counters monitoring system. Reduction of energy consumption:The energysaving opportunities are comparable to thepotential fan size reductions. According to thefan affinity laws, the fan power is proportionalto the cube of air changes rates or airflow. Areduction in the air change rate by 30% resultsin a power reduction of approximately 66%.How does Smart Cleanroom work? Conventional Mode: constant supply airflowby setting the ACH according to the design. ECO Mode: variable supply flow adjusted byAPC captures.Conventional mode sets the ACH in a pre-defineddesign value. The room air changes are controlledby a PID loop with a fixed airflow set point. Whenthe system starts, the HVAC system provides ACHdesign value until reaching a permanent regime.If the ECO Mode option is selected (“ECO ON”button) the APC will start running automaticallywhen system starts.Once the system is stabilized in conventionalmode working within the limits of temperature,The SmartCR is an engineering solution forcleanroom environmental control composed ofan automatic HVAC system with the followingelements: AHU provided with EC fan (for energy savingand to have better control of the fan speed). Fan flow control. Room temperature and humidity control(temperature and relative humidity transmitterscontrolling the cooling and the heatingregulation valves in the AHU coils). Airbone Particles Counters (hereafter APC)for continuous airborne particle counting andmonitoring. Motorized dampers (Variable Air Volumetype) in supply air net to maintain the airflowconstant in the rooms. Motorized dampers in return air net for roomdifferential pressure control. Pressure transmitters for room differentialpressure control.relative humidity and differential pressures, theECO mode starts reducing the AHU fan speedgradually in controlled steps until finding theupper limit of number of particles admitted in thestandards and regulations.Regulation is made with the 0.5µm particleThe environmental cleanliness grade can beconfigured in the system:The SmartCR solution provides 2 operatingmodes: Azbil Telstar. June2019count measures but if the 0.5µm particle countmeasure exceeds limits, regulation made by APCis stopped. While the system is working underreal-time monitoring ECO mode, if an alarm eventthat drives the cleanroom out of specificationsoccurs, the SmartCR automatically switchesto conventional mode to use the maximumtheoretical ACH to return fast within the specifiedwww.telstar.com
WHITE PAPERlimits, ensuring the same recovery time as inconventional systems. Alarms are recorded andstored.The user can also limit the range established inregulations, setting a number of particles as atarget:SmartCR is provided with a setup option to selectthe type of particles regulation to be performedby the control loop: At rest or in operation.During the commissioning of the system, theminimum airflow to achieve the correct roomcleanliness classification in “at rest” conditionsis set. The maintenance of the environmentalconditions within the specified limits is verifiedduring at least 12 hours. Then the system ischallenged to recover room conditions outof specifications, generating temperature andrelative humidity excursions.Finally, the stability of differential pressuresis tested at the minimum airflow previouslyset. When opening the doors, the pressuredifferential changes, a reversal of the direction ofthe airflow is possible and contamination couldenter the cleanroom. It is therefore necessaryto achieve and maintain a stable pressure underall circumstances. Every change in the room orreference pressure causes the control systemto respond and vary the airflow to or from thecontrolled space.Commissioning tests reveals that the ACH whenno operations are carried out can be significantlyreduced achieving very low airflows with aremarkable energy saving. In some cases, airflowis even limited by ventilation requirements.However, in small rooms the limiting factor thatappears is pressure control: the minimum airflowmay be defined as the minimum needed toprevent backflows or to keep cascades.The SmartCR solution has been implemented ontwo different control systems both 21CFR Part 11and data integrity compliant: Controller and touch screen with correspondingaudit license. Controller with a SCADA applicationwith historian database and audit license:centralized BMS control system with all dataregisters stored and recorded in a uniquedatabase, all parameter settings audited and allconfigurations GAMP V, and 21CFR Part 11compliantNeed more information? Please, contact us:pr@telstar.comFrom Telstar we express our gratitude for your interestand your feedbackwww.telstar.com
WHITE PAPERConclusionReferencesIt can be concluded that the new HVAC controlsystem reduces airflows ensuring environmentalconditions within specifications. This reductionon the ACH decreases the power consumptionsignificantly not only on HVAC fans, but alsothe cooling and heating water. The system isrobust, conservative and allows the user severalconfigurations (grades, working conditions,maximum admissible number of particles, etc).Specially developed for the pharmaceuticalindustry, the control system is CFR21 Part 11compliant.ISPE Good Practice Guide: Heating, Ventilation,and Air ConditioningISO Standards for Cleanrooms and AssociatedControlled Environments, www.iso.org. ISO 14644-1 Part 1: Classification of AirCleanliness ISO 14644-2:200 Part 2: Specifications forTesting and Monitoring to Prove ContinuedCompliance with ISO14644-1EU GMP Volume 4 “EU Guidelines to GoodManufacturing Practice”, www.ec.europa.eu.US FDA CFR Title 21 Food and Drugs, www.fda.gov.About the authorsAna Fernández GarcíaAna Fernández García, Pharmaceutical Technology Manager at Telstar’s CRSEngineering, holds a MEng in Industrial Engineering from the UPM (Madrid, Spain)together with a MEng in Chemical Engineering from CPE (Lyon, France). Aftersome years working in the Pharmaceutical industry, Ana jointed the EngineeringDepartment at Telstar in 2007, participating in and managing a wide variety ofcleanroom engineering, construction and turnkey projects. Since 2017, Ana is incharge of Conceptual Designs.Xavier BarreraXavier Barrera studied Industrial Technical Engineering and specialized in Industrialelectronics at the EUSS University in Barcelona. After finishing his studies in 2004 heworked for several companies focused in different industries; automotive, aeronauticsand printing. He gained extensive experience in the automation field during thistime. In 2014, Xavier joined Telstar Projects as a Control Engineer, participating ina wide variety of projects related to the Life Science industry. Xavier is currentlyCRS Electricity & Control Manager at Telstar leading his team to develop pharmaengineering and turnkey projects.About TelstarTelstar, part of the azbil Group, is a company specialized in the development of engineering &construction projects, integrated process equipment and GMP consultancy solutions, including turnkeyprojects and critical installations, for companies associated with Life & Health Sciences (pharmaceutical& biotechnology, healthcare, cosmetic, veterinary and food & beverage industries, hospitals, laboratories& research centers). Acknowledged as one of the 10 major suppliers for the pharmaceutical industry,Telstar is one of the few international manufacturers able to offer integrated process solutions for thebiopharmaceutical industry with in-house sterilization, freeze drying, containment, process water & wastetreatment, clean air and cold storage technologies. Azbil Telstar. June 2019www.telstar.com
Smart Cleanroom Smart Cleanroom (hereafter SmartCR) is a flexible solution for cleanroom control based on the idea of reducing the power consumption of the HVAC system, decreasing the air changes in turbulently ventilated cleanrooms, working always inside the ranges that ensure the classification air quality,
