WeekendShutdownofValidatedAirHandlingSystems

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Introduction
Pharmaceutical and health care cleanrooms are large consumers of energy due primarily to the requirement to maintain air change rates, pressurisation,temperatureor humidity conditions in the rooms. In investigations carried out by the HVAC Special working group the possibility of switching off someoftheHVACsystemsfor periodsofnonproductionwas identifiedasanopportunityto save a significant amount of energy. During Spin III of the HVAC SWG, two healthcare companieswhooperatecGMP validated cleanrooms undertook a set of experimental procedures to facilitate the switch off of GMP AHU systems at weekends (out of production hours). This case study details the procedure followed to obtain the required data to allow weekend shutdown of Cleanroom Air Handling Systems in both of the successfulfacilities.

Sundays and during this period Air Handling Systems have remained active in order to ensure that cleanliness is maintained in the cleanroom withouttherequirementtocarry out specific cleaning to the environment. The status quo in relationtoweekendoperationof AHUs was challenged and the site managed to agree a procedure to prove if the weekend shutdown of 4 HVAC systems (8 AHUs in total) could be carried out without adversely affecting the performance of the rooms. The following Steps were followedduringtheinvestigation process:

(b) Heat Savings = average heat input x No. of hours for which the AHUs will be switchedoff. (c) Cooling Savings = Average cooling input x No. of hoursforwhichtheAHUwillbe switchedoff. In more broadbrush terms, if the operation of the HVAC system does not vary from weekdays to weekends then thesavingscanbecalculatedas a ratio of the weekend to weekdaysystemenergycosts.

STEP 4: Once the magnitude

ofpotentialsavingsareknown, obtain management buyin to the evaluation exercise of the risk associated with weekend shutdown of the specific AHUs. This ensured all stakeholders in safety and quality reviews were focussed on change as a potentially viableopportunity.

STEP 1: Evaluate which AHU

Systems are operating in areas that are not occupied by production personnel or product attheweekends.Thenumberof AHUs that could potentially be switched off should be documented.

STEP5:Meetwithproduction
managers and other stakeholders such as Environmental Health & Safety (Exposure issues), Quality Control(productimpactissues), Facilities/Engineering & Maintenance (Plant and controls issues). Outputs from initial meetings included consensus on risk mitigation stepsincluding: Failure Mode & Effects Analysis(FMEA)

STEP 2: Calculate the number

of hours annually that each AHU systemcanbeswitchedofffor.

STEP3:Calculatethemonetary
savings associated with the weekend shutdown. There were 3elementstotheprimaryenergy savingswhichwere: (a) Fan savings = Fan runningkWhxNo.ofhoursfor which the AHUs will be switchedoff

Facility1
The facility in question has operated several cleanrooms to ISO8 standard for the past 10 years or so. In the past number of years there has been no production on Saturdays or

HVAC SWG SPIN III Weekend Shutdown Factsheet v.1

WeekendShutdownofValidatedAirHandlingSystems Test Plan shutdowns withmicrobialtesting

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remedial steps were setout as actionsarisingfromtheFMEA.

STEP 6: if the tests prove that Test Procedure there is no impact on quality Weekend Shutdown of safety or the environment as a CleanroomAHU
result of shutting down at weekends then the permanent engineering solution should be implemented. This might entail Building Management System modificationsinordertoactivate schedulersonthesystemsothat the start and stop times of the AHUscanbeprogrammed. One of the outcomes of the FMEA for AHU weekend shutdown was to carry out a series of tests on the weekend shutdowns to ascertain the impactonmicrobialgrowth. The most onerous AHU system wasselectedtobesubjectedto atrialshutdown.Thesequence ofeventsforthetrialshutdown wereasfollows: 1. The cleanroom was locked to ensure that no access wasallowedtothearea. 2. The supply and return AHUs were switched off and locked out at 8:00 on Friday monrning to allow a 72hourshutdown(tocater for a bank holiday weekend)testtobecarried out. 3. After 72 hours the rooms were unlocked and microbial (Growth promotion testing in accordance with site specific procedures) and environmental testing was carried out and samples analysedinlaboratory. 4. A deep clean of the entire cleanroom was completed before switching the Air

Handling System back on. Theshutdownandcleaning procedures followed were those normally used for Christmasshutdowns. 5. As positive results were receivedfromthesampling 2 further tests were scheduled to prove that consistent results were achieved. 6. Following the 3 sets of positive test results, approvalwasgiventoallow aweekendshutdownofthe AHUs to be carried out for up to 72 hours without the requirement for a deep cleaninthecleanroom.The modification to the BMS includedanoverridebutton on the BMS AHU page and localtothecleanroom.

Failure Mode and Effects Analysis

A Failure Mode and Effects Analysis (FMEA) is technique for analyzing the causes, risks, and effects of potential systems or component failures that is used as a basis for prevention and contingency planning. All possible failures and their potential effects are listed and ranked according to severity of impact and probability of occurrence so that prevention efforts can be focused on the most critical issues. The issues which were highlighted during the weekend AHU shutdown FMEA were primarily the risk of exposure to product which may remain in the cleanroom over a weekend and quality and cleanlinessissuesassociatedwith not having airhandling systems in operation. These and other risks were analysed, ranked and

ResultsandReplicability
The switching off of 4 cleanrooms in the healthcare facility has allowed savings of approximately 25,000 per annum to be made. The engineering cost to achieve the savings was mainly internal manhourcostsinthetestingwith some minor costs for BMS modifications.

Thesecondfacilityoperates
a GMP clean room facility commissioned and validated to meet with the requirements of theregulatorybodies.Thefacility promotes a data driven decision

HVAC SWG SPIN III Weekend Shutdown Factsheet v.1

WeekendShutdownofValidatedAirHandlingSystems makingprocessinallareasofthe business including the area of EnergyManagement. A cross functional project team was formed including personnel from all potentially affected departments. The departments included Production, Engineering, Quality and Validation.

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the fact that the system historicallyoperates24hoursper day7daysperweekfor50weeks per year. The systems were commissioned and validated to operate continuously and therefore no assessment of the impacts of a system shutdown wascarriedout.

during the trial (temperature probeslocatedintheductunable to measure actual room temp) etc.

ThePlan
All of the areas identified during the brainstorming session which were of concern to the team were identified. Measurements required to support the decision making process were also identified and temporary measurement instrumentation wasusedasrequired.TheDesign of Experiments was outlined as per Figure 1. An appropriate shutdown was identified where the HVAC systems were going to be shut down for planned maintenance and as such presented an ideal opportunity to carry out the experiment and gather the required data. All of the HVAC systems on site interact with each other and as such numerous trials and measurements were conducted toensurethatsufficientdatawas gathered.

Brainstorming
The project team met up to devise a project plan to gather the required data to facilitate a management decision on the implementation of the project. The brainstorming involved the following: Identification of possible qualityimplications Identification of safety risks Identification of mechanicallimitations Limitations on time for trialimplementation

Prioritization
The initial activity included analysing the HVAC units to determinetheareastofocusthe efforts on. This was carried out by reviewing the energy aspects review and prioritising the most significant areas where energy is used in the HVAC systems. From this analysis three systems were prioritised which accounted for the greatest potential for energy savings. The project team brainstormed the potential activities possible which would yield energy savings. The most significant energy saving identified was the potential to shut down the three HVAC systemsoutofproductionhours.

TheBarriers
One of the most significant barrierstotheimplementationof the shutdown of the system outside of production hours is

Eachoftheareaswerediscussed in detail and all identified concerns were documented. These concerns included pressure reversal to adjacent GMP areas, temperature increases humidity excursions, heat gainsfrom process equipment, solar gains, personnel access, existing BMS controls temperature monitoring

Results
The results of the experiment illustrated that is is possible and practical to shut down GMP HVAC systems out of production hoursandyieldsignificantenergy savings effective cost savings of justover55,000annually.

HVAC SWG SPIN III Weekend Shutdown Factsheet v.1

WeekendShutdownofValidatedAirHandlingSystems

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DesignofExperiments:ScopeofWorks
The primary aim of the experiment is to gather sufficient data during the experiment with the system operatingintheproposedoperationtosupportthevalidationrequirementsoftheGMParea.Allsystems onsiteinteractwitheachotherandassuchnumeroustrialsandmeasurementswillberequiredtoensure thatsufficientdataisgatheredtosupportthechangecontrolprocess.

System X
ThefollowingprocedurewillbeadoptedduringthedesignofexperimentstobecompletedonsystemX includingSupplyAHU1andAHU2overtheexperimentalperiod. Ensurenoactivitiesinarea Ensureallproducthasbeenremovedfromtheareaandstoredaspercurrentprocedures. Turnoffallproductionequipmentinarea(reductioninheatgains) Setuptemperatureandhumiditymonitorsinthefollowingrooms:X,Y,Z,(roomswithhighest heatgains,basedonglazingandequipmentlocatedinthevariousrooms) Takescreenshotsofdifferentialpressures,temperaturesandhumilitiespriortoshuttingdown thesystems Shutdownsystemandrecordthetime. Measuresystempressures(betweensystemXandsystemYsystemXandsystemZandsystemX andsystemV). Takescreenshotsofthedifferentialpressuresandtemperaturesofthesystemwiththesystem off. Monitorthesystemovera24hourperiod(oraslongaspossible) RestartsystemXusingarestartramp(toensurenopressurereversalsoccur) MonitorthepressuresinsystemsY,ZandVduringstartuptoensurethatnopressurereversals occur. VerifytheeffectsofthistrialwithsystemDonandoffanddetermineiftheproposedoperation canonlyoccurwithsystemVoff SystemXdifferentialpressurestomonitorduringtrialareasfollows:

AtoB,DtoE,FtoG, ObservethepressureswithdoorAtoBopenandclosed.

ThisisasampleDOEonly.Eachsystemexperimentrequirescarefulconsiderationtoensuresufficientdataisrecorded onenvironmentalconditionsduringthetrialtosatisfythecGMPrequirementsofthearea.
HVAC SWG SPIN III Weekend Shutdown Factsheet v.1