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IQ/OQ/PQ ProtocolInstallation Qualification/Operation Qualification/Performance QualificationPurifier Logic SeriesBiological Safety CabinetsLabconco No. – 1058603, Rev. A, ECO L395Available at labconco.com

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Labconco Purifier Logic Series BSC’s IQ/OQ/PQ Protocol #1058603Revision APurpose and ScopeThis Qualification Protocol is solely intended to be used with Labconco Purifier Logic SeriesBiological Safety Cabinets, which are new or relocated.Models:30231 Series30238 Series30241 Series30248 Series30348 Series30251 Series30258 Series30261 Series30268 Series30368 SeriesIt is written to assist the end-user in validation of predetermined specifications. The protocolbegins with planning the site for the piece of equipment and therefore is of value prior to receiptof delivery.ResponsibilitiesEnd-User – The ultimate user or otherwise appointed personnel in the lab is responsible toensure the BSC is installed and operating properly. This document can assist in that validation.This document cannot however anticipate every application or unique situation encountered withthe installation and operation. It is therefore essential that users, lab managers and safety officerswork together to broaden the scope of this document through cautious forethought.End-User Employer – The employer is responsible for supporting the validation throughadequate resources and training. The organization shall also ensure the validation process hasbeen fully carried out prior to use of the BSC. Records should be stored in a safe, easilyretrievable location. The location of the BSC, preventive maintenance and certificationschedules should be documented in the company’s quality system.Cabinet Certifier – All BSC’s must be certified prior to use. A qualified certifying technicianmust do this process with calibrated instruments. The cabinet must be certified upon installation,on a scheduled annual basis and whenever the cabinet is moved to a new location. Certificationis the key requirement of this protocol.Manufacturer – Labconco Corporation, certified ISO-9001, is responsible to fully test thePurifier Logic BSC to NSF 49 requirements prior to shipment. The manufacturer must retainthese records. Their staff of Product Service Representatives and Product Specialists can assistwith information on the purchase, delivery and installation. Labconco is not responsible forcarrying out the actual installation or validation processes.1

Labconco Purifier Logic Series BSC’s IQ/OQ/PQ Protocol #1058603Revision APerformance QualificationOnce the Purifier Logic has been checked for proper installation and operation, its performancemay be validated. Labconco cannot recommend specific procedures to do this. The performancevalidation should be designed to meet the specifications and accuracy required of the application.In general this requires establishing acceptance criteria, inspecting and testing the results withcalibrated equipment and qualified personnel. Some basic suggestions are included after theOperational Qualification section.2

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Labconco Purifier Logic Series BSC’s IQ/OQ/PQ Protocol #1058603Revision AA. Installation QualificationStep Description1Site Planning1aProperairflowsSpecification or Acceptance CriteriaResultYESNOIs the Purifier Logic to be located in a roomwith windows that will remain closed?YNIs the cabinet to be located away from heavyfoot traffic, doors, fans, ventilation registersand any other air-handling devices that coulddisrupt its airflow patterns?YN1bMountingSurfaceHave accommodations been made forplacement of the Purifier Logic on cabinetryor stand of suitable strength and proper height?YN1cSpaceRequirementsRefer to Appendix B in User’s Manual. Hasadequate floor space been provided forplacement of the cabinet?YNIs there proper overhead clearance for thePurifier Logic ? There must be 6-inches, (150mm) above the exhaust cover for units notconnected to exhaust systems.YNCertain applications require the BSC to beexhausted to the outside. Have the applicationsbeen reviewed with the Safety Officer?YNFor cabinets to be connected to exhaustsystems, has a facilities manager or qualifiedHVAC person reviewed and approved the siteplans for placement of exhaust duct?YN1dExhaustRequirementsFor units requiring exhausting to the outside,have the exhaust blower, ductwork, dampers,and canopy connection been ordered?Has the room/building been evaluated foradequate air changes with the device?3N/AYNN/AYN

Labconco Purifier Logic Series BSC’s IQ/OQ/PQ Protocol #1058603Has the heating and cooling load beenconsidered in the planning?Revision AYNN/AAll 3' Type A2 Logic 785 BTU/hrAll 4' Type A2 Logic 990 BTU/hrAll 5' Type A2 Logic 1331 BTU/hrAll 6' Type A2 Logic 1672 BTU/hr1dGas ServicesHas the facilities manager been consulted withregard to gas/vacuum requirements?YN/ANDoes the BSC ordered/received have servicevalves to match expectations?YN/ANConnections to service valves are ¼' OD metaland require a shut-off valve.WARNING: The use of flammable gasses orsolvents within the BSC should be avoided.Excessive heat may alter the laminar airflowand could potentially damage the HEPA filter.A Safety Officer should approve the use offlammable materials within the cabinet.1eElectricalServiceRefer to the Electrical Requirements section ofthe User’s Manual for a list of model numbersand their corresponding electrical ratings. Areservices available for the BSC to be connectedto a dedicated circuit with over-currentprotection of adequate size and the propervoltage?YN1fDeliveryRequirementsIf the BSC has not been delivered yet, havearrangements been made with the facility ordelivery agent to have equipment capable ofgently handling a packaged skid of this size andweight? (Refer to Chapter 3 of the User’sManual.)YNIs there a clear path from the loading platformto the final destination in the lab?YNWhen required, will there be equipment tomove the cabinet onto the final mountingsurface/stand? (Refer to Chapter 3 of theUser’s Manual.)YN4

Labconco Purifier Logic Series BSC’s IQ/OQ/PQ Protocol #10586032Prior toOperation2aDamageClaimsRevision AYNYNThe cabinet has been mounted to a substantialsupporting stand or cabinet that has beenchecked for level?YNThe cabinet or stand is set at a suitable heightfor the operator to work ergonomically?YNBefore attempting to operate the sash, removethe side panels and verify that; the sash cables are centered on thepulleys, the weight restraining pin under eachweight has been removed and discarded,YNThe User’s Manual and Small Parts Kit isshipped under the work surface. These havebeen unpacked and stored for future use.YNIf the optional Drain Valve provided is to beinstalled, it has been sealed and fastened to theunderside of the work surface per the User’sManual.YNThe BSC has been inspected for any signs ofdamage that may have occurred while in transitor within the building? Keep packagingmaterials until inspection is complete.If so, refer to the User’s Manual for informationon shipping damage claims.2bSet UpSee Installation Instruction Sheet affixed to thesash for photos and details.2c2d2eDrain ValveElectricalConnectionsGas ServicesN/AIs the BSC connected to a dedicated electricalcircuit of proper voltage and amperage? Seeidentification plate on the front surface of theelectrical box above the front panel.YNDuplex receptacle(s) inside the cabinet areoperational? Do the GFI test and reset buttonswork properly (115V models only)?YNN/AA qualified technician has installed thegas/vacuum services? Checked for leaks?YN/ANVerified that valves are labeled for the propergas/vacuum?YN/AN5

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Labconco Purifier Logic Series BSC’s IQ/OQ/PQ Protocol ision AIf exhausted to the outside, a qualified installerhas completed the connections to the BSC?YN/ANIf exhausted to the outside, the exhaust systemto the BSC is ON continuously?YN/ANPress the Light Switch ON, does theFluorescent Light illuminate the interior of thecabinet?YNDoes the Blower operate with the BlowerSwitch ON and the sash open?YNIf equipped, does the U.V. Light, mounted inthe upper-rear of the interior, operate when theU.V. Light Switch is turned ON and the sash isfully closed?YNDoes the sash rise smoothly to the appropriateheight for the model indicated on the ID Plate?N/AYNDo the audible and visual alarms indicate whenthe sash has been raised above the 8 or 10-inchpositioning mark?YNDoes the Alarm Mute button stop the audiblealarm for approximately 5 minutes whenpressed?YNThe BSC has been posted with warnings to notbe used until certified.YNSeries 30231, 30241, 30251 & 30261 shouldhave a 10-inch sash opening.Series 30238, 30248, 30348, 30258, 30268 &30368 should have an 8-inch sash opening.6

Labconco Purifier Logic Series BSC’s IQ/OQ/PQ Protocol #1058603Revision AB. Operational QualificationStep aining2aUser TrainingSpecification or Acceptance CriteriaResultYESNOPrior to use, has a qualified certifier tested thecabinet to the NSF 49 standard the cabinet waslisted under? Has the certifier labeled the BSCwith the successful certification date?YNCertification should be done annually. Has thenext required certification been added to yourquality system’s preventive maintenance orcertification schedule?YNHave all users been properly trained on thesafety, theory of operation and limitations ofthe BSC?YNDo all users understand techniques for: Cleaning & disinfection of the cabinet’sinterior, Loading supplies and equipment, Avoiding cross contamination, Not disturbing the laminar flow, Spill control and clean up, Shutting down the cabinet, If equipped, use of the U.V. light?YN3Cleaning3aExteriorCleaningHas the exterior of cabinet been cleaned of dustthat accumulated throughout installation?YN3bInteriorCleaningHave the BSC’s interior surfaces been cleanedand disinfected appropriately for the work thatis about to be performed in it?YNInspect the towel catch screen located in therear under the worksurface for any foreigndebris, remove any foreign objects from thetowel catch.YN4AlarmOperation7

Labconco Purifier Logic Series BSC’s IQ/OQ/PQ Protocol #1058603Revision A4aSash PositionAlarmRaise the sash above the operational sash heightof 8 or 10-inches. Does the BSC signal a“Alarm - Sash Height” message screen?YN4bAirflow AlertUsing a notebook or cardboard block the largeseries of airflow slots on the air inlet grille.Does the BSC: The internal motor/blower audiblyincrease speed? Signal an “Alert – Airflow” messagescreen?YN4cAirflow Alarm(Optional onA2)If the BSC has been equipped with the optionalairflow sensor – Raise the exhaust HEPA filtercover or block the black airflow sensor inlet,does the BSC signal an “Alarm – Airflow”message screen?YN4dCanopy Alarm If the BSC has been equipped with the optional(Optional – A2 Ventus Canopy Connection – Raise the frontonly)exhaust flap on the canopy until the side(intake) flap opens, does the BSC signal an“Alarm – Canopy” message screen?YN8

Labconco Purifier Logic Series BSC’s IQ/OQ/PQ Protocol #1058603Revision AC. Performance QualificationNOTE: This Performance Qualification section is only a recommendation of some basicitems to consider for your protocol. Your protocol should include tests and inspections thatare pertinent to the applications performed within the equipment.Step nceSuggested CriteriaCertification should be done at a minimumannually. An experienced certifier can verifythe cabinet’s performance. Is the BSC’s current certification withinthe acceptable timeframe set by yourorganization? Has there been a procedure establishedif a cabinet is found to have exceeded itscertification due date?Is the next required certification noted in yourquality system’s preventive maintenance orcertification schedule?2Maintenance2aU.V. LampIf equipped, the U.V. Lamp should be replacedat least annually or every 6,000-hours to remaineffective. Or, the U.V. Maintenance Timer cantrack the hours of operation and supply an alert.2bTowel CatchThe towel catch screen located in the rear underthe worksurface should be checked for anyforeign debris when the cabinet is cleaned.2cFluorescentLampRegular maintenance should ensure that theFluorescent Lamp is operating properly.2dBSC PanRegularly clean and maintain the pan locatedunderneath the removable work surface. Ifinstalled clean the drain valve.2ePrefilter(optional)Some cabinets have a prefilter installed with thetowel catch. If desired, inspect the condition ofthe prefilter, clean or replace regularly.9

Labconco Purifier Logic Series BSC’s IQ/OQ/PQ Protocol #10586032fPostfilter(optional)Some cabinets that exhaust back into the roommay have an activated carbon postfilter. Ifequipped, replace filter regularly to controlodors.2gCanopy (A2only)(optional)For Class II Type A2 BSCs connected toexhaust through a canopy: the alarm function ofthe canopy should be exercised regularly forproper operation.10Revision A

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Labconco Purifier Logic Series BSC’s IQ/OQ/PQ Protocol #1058603Revision AD. SummaryLabconco Purifier Logic Series BSC’s IQ/OQ/PQ Document 1058603 Revision AEquipment LocationSerial No. Model No.User Protocol Revision (or Date published)Contact (print name):Title:Review the “Response” columns for answers of “NO.” Use the area below to describe thedeficiency or unacceptable results. Those deficiencies are to be followed with aninstruction for “Corrective Actions.” Once acceptable results are obtained, the deficiencyis “accepted” by initialing the Corrective Action.StepDeficiency followed by Corrective Action11Initial

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