IQ/OQ Protocol - Purifier Logic Biological Safety Cabinets
Contents
1. Those deficiencies are to be followed with an instruction for Corrective Actions Once acceptable results are obtained the deficiency is accepted by initialing the Corrective Action Step Deficiency followed by Corrective Action Initial2. IQ OQ Protocol Installation Qualification Operation Qualification Purifier Logic Series Biological Safety Cabinets Labconco No 1058602 Rev Available at www labconco com or by e mail in Word 2000 document Protecting your FA laboratory environment LABCONCO Labconco Corporation 8811 Prospect Avenue Kansas City MO 64132 Product Service 1 800 522 7658 1 816 333 8811 Labconco Purifier Logic Series BSC s IQ OQ Protocol 1058602 Revision Purpose and Scope This Qualification Protocol is solely intended to be used with Labconco Purifier Logic Series Biological Safety Cabinets which are new or relocated Models 34300 Series 34400 Series 34500 Series 34600 Series 34308 Series 34408 Series 34508 Series 34608 Series 34410 Series 34610 Series It is written to assist the end user in validation of predetermined specifications The protocol begins with planning the site for the piece of equipment and therefore is of value prior to receipt of delivery Responsibilities End User The ultimate user or otherwise appointed personnel in the lab is responsible to ensure 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 with the installation and operation It is therefore essential that users lab managers and safety officers work together to broaden the scope of this doc
3. applications been reviewed with the Safety Officer For cabinets to be connected to exhaust systems has a facilities manager or qualified HVAC person reviewed and approved the site plans for placement of exhaust duct N A For units requiring exhausting to the outside have the exhaust blower ductwork dampers and canopy connection been ordered N A Has the room building been evaluated for adequate air changes with the device Labconco Purifier Logic Series BSC s IQ OQ Protocol 1058602 Revision Has the heating and cooling load been considered in the planning All 3 Logics 77 BTU hr All 4 Logics 99 BTU hr All 5 Logics 115 BTU hr All 6 Logics 139 BTU hr Y N A N ld Gas Services Has the facilities manager been consulted with regard to gas vacuum requirements N A Does the BSC ordered received have service valves to match expectations Connections to service valves are 14 OD metal and require a shut off valve WARNING The use of flammable gasses or solvents within the BSC should be avoided Excessive heat may alter the laminar airflow and could potentially damage the HEPA filter A Safety Officer should approve the use of flammable materials within the cabinet N A le Electrical Service Refer to the Electrical Requirements section of the User s Manual for a list of model numbers and their corresponding electrical ratings Are services ava
4. d if a cabinet is found to have exceeded its certification due date Is the next required certification noted in your quality system s preventive maintenance or certification schedule 2 Maintenance 2a U V Lamp If equipped the U V Lamp should be replaced at least annually to remain effective Or the U V Maintenance Timer can track the hours of operation and supply an alert 2b Towel Catch The towel catch screen located in the rear under the worksurface should be checked for any foreign debris when the cabinet is cleaned 2c Fluorescent Regular maintenance should ensure that the Lamp Fluorescent Lamp is operating properly 2d Prefilter Some cabinets have a rouging prefilter adhered optional to the towel catch If desired inspect the condition of the prefilter clean or replace regularly 2e Postfilter Some cabinets that exhaust back into the room optional may have been ordered with an activated carbon postfilter If equipped replace filter regularly to control odors Labconco Purifier Logic Series BSC s IQ OQ Protocol 1058602 Revision D Summary Labconco Purifier Logic Series BSC s IQ OQ Document 1058602 Revision Equipment Location Serial 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 the deficiency or unacceptable results
5. he BSC Do all users understand techniques for Q Cleaning amp disinfection of the cabinet s interior 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 Oooooo Cleaning 3a Exterior Cleaning Has the exterior of cabinet been cleaned of dust that accumulated throughout installation 3b Interior Cleaning Have the BSC s interior surfaces been cleaned and disinfected appropriately for the work that is about to be performed in it Has the towel catch screen located in the rear under the worksurface been checked for any foreign debris requiring removal Labconco Purifier Logic Series BSC s IQ OQ Protocol 1058602 Revision C Performance Qualification NOTE This Performance Qualification section is only a recommendation of some basic items to consider for your protocol Your protocol should include tests and inspections that are pertinent to the applications performed within the equipment Step Description Suggested Criteria 1 Periodic Certification la Cabinet Certification should be done at a minimum Performance annually An experienced certifier can verify the cabinet s performance Is the BSC s current certification within the acceptable timeframe set by your organization Has there been a procedure establishe
6. ilable for the BSC to be connected to a dedicated circuit with over current protection of adequate size and the proper voltage 1f Delivery Requirements If the BSC has not been delivered yet have arrangements been made with the facility or delivery agent to have equipment capable of gently handling a packaged skid of this size and weight Refer to Chapter 3 of the User s Manual Is there a clear path from the loading platform to the final destination in the lab When required will there be equipment to move the cabinet onto the final mounting surface stand Refer to the Getting Started section of User s Manual Labconco Purifier Logic Series BSC s IQ OQ Protocol 1058602 Revision Prior to Operation 2a Damage Claims The BSC has been inspected for any signs of damage that may have occurred while in transit or within the building Keep packaging materials until inspection is complete If so refer to the User s Manual for information on shipping damage claims 2b Set Up The cabinet has been mounted to a substantial supporting stand or cabinet that has been checked for level The cabinet or stand is set at a suitable height for the operator to work ergonomically Before attempting to operate the sash remove the side panels and verify that Q the sash cables are centered on the pulleys Q the weight restraining pin under each weight has bee
7. ks cabinet Does the Blower operate with the Blower Y Switch ON and the sash open If equipped does the U V Light mounted in Y the upper rear of the interior operate when the U V Light Switch is turned ON and the sash is N A fully closed Does the sash rise smoothly to the appropriate Y height for the model indicated on the ID Plate Series 34300 34400 34410 34500 34600 34610 should have a 10 inch sash opening Series 34308 34408 34508 34608 should have an 8 inch sash opening Do the audible and visual alarms indicate when Y the sash has been raised above the 8 or 10 inch positioning mark Does the Alarm Mute button stop the audible Y alarm for approximately 5 minutes when pressed Labconco Purifier Logic Series BSC s IQ OQ Protocol 1058602 Revision B Operational Qualification Step Description Specification or Acceptance Criteria Result YES NO Certification la Initial Certification Prior to use has a qualified certifier tested the cabinet to the NSF 49 standard the cabinet was listed under Has the certifier labeled the BSC with the successful certification date Certification should be done annually Has the next required certification been added to your quality system s preventive maintenance or certification schedule Training 2a User Training Have all users been properly trained on the safety theory of operation and limitations of t
8. n removed and discarded See Installation Instruction Sheet affixed to the sash for photos and details The User s Manual and Small Parts Kit is shipped under the work surface These have been unpacked and stored for future use 2c 2d Drain Valve Electrical Connections If the optional Drain Valve provided is to be installed it has been sealed and fastened to the underside of the work surface per the User s Manual Is the BSC connected to a dedicated electrical circuit of proper voltage and amperage See identification plate on the front surface of the electrical box above the front panel NOTE The cabinet should be posted with warnings not to be used until certified N A Duplex receptacle s inside the cabinet are operational Do the GFI test and reset buttons work properly 115V models only N A Labconco Purifier Logic Series BSC s IQ OQ Protocol 1058602 Revision 2e Gas Services A qualified technician has installed the Y gas vacuum services Checked for leaks N A Verified that valves are labeled for the proper Y gas vacuum N A 2f Exhaust If exhausted to the outside a qualified installer 1 System has completed the connections to the BSC N A If exhausted to the outside the exhaust system Y to the BSC is ON continuously N A 2g Basic Press the Light Switch ON does the Y Operational Fluorescent Light illuminate the interior of the Chec
9. nd specific procedures to do this The performance validation 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 with calibrated equipment and qualified personnel Some basic suggestions are included after the Operational Qualification section Labconco Purifier Logic Series BSC s IQ OQ Protocol 1058602 Revision A Installation Qualification Step Description Specification or Acceptance Criteria Result YES NO Site Planning la Proper airflows Is the Purifier Logic to be located in a room with windows that will remain closed Is the cabinet to be located away from heavy foot traffic doors fans ventilation registers and any other air handling devices that could disrupt its airflow patterns 1b Mounting Surface Have accommodations been made for placement of the Purifier Logic on cabinetry or stand of suitable strength and proper height Ic Space Requirements Refer to Appendix B in User s Manual Has adequate floor space been provided for placement of the cabinet Is there proper overhead clearance for the Purifier Logic There must be 6 inches 150 mm above the exhaust cover for units not connected to exhaust systems ld Exhaust Requirements Certain applications require the BSC to be exhausted to the outside Have the
10. ument through cautious forethought End User Employer The employer is responsible for supporting the validation through adequate resources and training The organization shall also ensure the validation process has been fully carried out prior to use of the BSC Records should be stored in a safe easily retrievable location The location of the BSC preventive maintenance and certification schedules should be documented in the company s quality system Cabinet Certifier All BSC s must be certified prior to use A qualified certifying technician must 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 Certification is the key requirement of this protocol Manufacturer Labconco Corporation certified ISO 9001 is responsible to fully test the Purifier Logic BSC to NSF 49 requirements prior to shipment The manufacturer must retain these records Their staff of Product Service Representatives and Product Specialists can assist with information on the purchase delivery and installation Labconco is not responsible for carrying out the actual installation or validation processes Labconco Purifier Logic Series BSC s IQ OQ Protocol 1058602 Revision Performance Qualification Once the Purifier Logic has been checked for proper installation and operation its performance may be validated Labconco cannot recomme
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