IQ/OQ Protocol
Contents
1. Annually check the fluid level of the Lexsolrm heat transfer fluid with the label applied to the side of the reservoir Has this been included in the preventive maintenance plan N A 11 Labconco Product Service 1 800 522 7658 1 816 333 8811 Labconco FreeZone Triad Stoppering Tray Dryer IQ OQ Protocol 1059502 Revision A 3 Personnel Training 3a User Training Have personnel that will use the Triad Related to Stoppering Tray Dryers been adequately Equipment trained Are personnel familiar with Y N All the buttons knobs and displays on the control panel The use of vacuum grease Opening closing and venting samples Cleaning of the freeze dryer and neutralization of acids 3b User s Manual Are the personnel who are to use or maintain the Triad Stoppering Tray Dryers able to locate Y N the User s Manual for the machine 12 Labconco Product Service 1 800 522 7658 1 816 333 8811 Labconco FreeZone Triad Stoppering Tray Dryer IQ OQ Protocol 1059502 Revision A C Summary Labconco FreeZone Triad Stoppering Tray Dryers IQ OQ Document 1059502 Rev Equipment Location FreeZone Ser 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 Those deficiencies are to be followed with an instruction for2. Corrective Actions Once acceptable results are obtained the deficiency is accepted by initialing the Corrective Action Step Deficiency followed by Corrective Action Initial 13 Labconco Product Service 1 800 522 7658 1 816 333 8811
3. IQ OQ Protocol Installation Qualification Operation Qualification FreeZone Triad Stoppering Tray Dryer and Lyophilizer Freeze Dry Systems Labconco No 1059502 Rev A Available at www labconco com or by e mail in Word 2000 document Protecting your TaN laboratory environment LABCONCO Labconco Corporation 8811 Prospect Avenue Kansas City MO 64132 Product Service 1 800 522 7658 1 816 333 8811 Labconco FreeZone Triad Stoppering Tray Dryer IQ OQ Protocol 1059502 Revision A Purpose and Scope IQ and OQ This Qualification Protocol is solely intended to be used with Labconco FreeZone Triad Stoppering Tray Dryers which are new or relocated This document is to be used to validate the following models Models FreeZone Triad Stoppering Tray Dryer 7400030 7400040 This document 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 The use of this document does not replace the need for the User s Manuals 7373300 Information within the User s Manual is required to complete this IQ OQ Protocol If the manual has been misplaced copies can be obtained from the manufacturer or down loaded from their website www labconco com Responsibilities End User The ultimate user or otherwise appointed personnel in the lab is responsible to ensure the freeze dryer is
4. information on shipping damage claims 2b Triad Stoppering Place the Triad Stoppering Tray Dryer on top of Tray Dryer the work surface or stand Installation Caution Triad Stoppering Tray Dryers are extremely heavy Follow safe lifting guidelines Has the vacuum pump been connected using Y N the rubber hose and clamps provided 2c Data acquisition Operation of the Triad Stoppering Tray Dryer using the RS may be monitored using a computer 232 receptacle Y N Interconnect Cable 7537801 with a 25 pin D sub male serial connector or Cable 7537800 with a 9 pin D sub male serial connector is available N A If the Interconnect Cable is required has it been installed 4 Labconco Product Service 1 800 522 7658 1 816 333 8811 Labconco FreeZone Triad Stoppering Tray Dryer IQ OQ Protocol 1059502 Revision A 2d Electrical Plug the Tray Dryer into a dedicated electrical Connection outlet Has the electrical service been verified to be adequate in size voltage amperage and Y N frequency The ID plate on the rear of the freeze dryer has the electrical requirements Electrical Has the ground on the electrical service been Y N Grounding verified 5 Labconco Product Service 1 800 522 7658 1 816 333 8811 Labconco FreeZone Triad Stoppering Tray Drye B Operational Qualification r IQ OQ Protocol 1059502 Revision A Step Description Specification or Acc eptanc
5. 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 document through careful 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 applying the Triad Stoppering Tray Dryer Records should be stored in a safe easily retrievable location The location of the equipment and required validation should be included in the company s quality system Manufacturer Labconco Corporation certified ISO 9001 is responsible to fully test each Triad Stoppering Tray Dryer prior to shipment The manufacturer must retain these records Labconco s staff of Product Service Representatives and Product Specialists can assist with information on the purchase delivery and installation Labconco is not responsible for the actual installation or validation processes 1 Labconco Product Service 1 800 522 7658 1 816 333 8811 Labconco FreeZone Triad Stoppering Tray Dryer IQ OQ Protocol 1059502 Revision A Performance Qualification Once the Triad Stoppering Tray Dryer has been checked for proper installation and operation its per
6. 816 333 8811 Labconco FreeZone Triad Stoppering Tray Dryer IQ OQ Protocol 1059502 Revision A Routine Maintenance Below are helpful hints to be included in the organization s preventive maintenance plan 2a Vacuum Grease Vacuum grease should be applied to rubber components as required In general vacuum grease should be the first step in troubleshooting vacuum leaks Thin layers of grease are adequate for all seals Only use grease specially formulated for low vacuum service Grease is not required on the door gasket Use grease only on the inner and outer sealing surfaces of the rubber manifold valve body Is vacuum grease readily available and documented Type of grease used 2b Inspect for Wear amp Damage Has there been a procedure to periodically inspect the interior metal surfaces for corrosion due to acids Are there awareness and a maintenance procedures to check the clear acrylic door for chips cracks deep scratches or chemical attack WARNING This is a safety issue Implosion can occur with damaged or corroded components Will all the rubber components be periodically inspected so that they are free from drying cracks or deterioration 2c Refrigeration System Cleaning At least annually will the refrigeration condenser be cleaned of dust that would restrict free airflow Include in the preventive maintenance schedule 2d Heat Transfer Fluid
7. Manual for electrical requirements Are services available for the equipment to be connected to an electrical circuit of adequate size and the proper voltage All models are shipped with a power cord with NEMA 6 20P plug Does this match the available receptacle Is a plug available to match the service outlet at the installation site N A ld Optional Features Serum bottles ampules flasks and related accessories are not included with the Triad Stoppering Tray Dryer Have these been considered available for this application 3 Labconco Product Service 1 800 522 7658 1 816 333 8811 Labconco FreeZone Triad Stoppering Tray Dryer IQ OQ Protocol 1059502 Revision A Is a suitable vacuum pump available or has it been ordered Refer to the User s Manual Y N It must have a displacement of at least 144 liters per minute and be capable of achieving an ultimate vacuum total pressure of 002 mBar The power cord should have a reverse IEC 320 plug to plug into the rear of the Triad 2 Prior to Operation 2a Damage Claims Have the delivered products been inspected for any signs of damage that may have occurred while in transit Keep packaging materials Y N until inspection is complete WARNING Do not attempt to pull a vacuum on a Triad Stoppering Tray Dryer with any damage to the clear door Implosion and potential for injury can occur If damaged refer to the User s Manual for
8. e 1 800 522 7658 1 816 333 8811 Labconco FreeZone Triad Stoppering Tray Dryer IQ OQ Protocol 1059502 Revision A lj Verify The vacuum level indicated on the LCD display Displayed is measured at the rear of the chamber The Vacuum value was calibrated at the factory by correlating its reading with that of a reference gauge The calibration was performed at a very low level approximately 0 010 mBar NOTICE Factory calibration was performed using a precision Active Piranni Gauge calibrated to a Capacitance Manometer standard Despite the system s calibration and repeatability the readings taken at such a low level of vacuum should only be considered as a verification of a leak free system Vacuum swings can be attributed to contamination of surfaces which could take days to outgas Adjustments are discouraged Before any adjustments are made to the factory calibration of the vacuum measurement answer positively to each of these questions 1 Is the vacuum standard being used to verify the freeze dryer accepted by the organization to be precise and has it been calibrated recently 2 Is the level of accuracy we are attempting to reach pertinent to the freeze drying applications Does the vacuum display correlate to the Y N reference gauge N A Ref Instrument If vacuum is to be calibrated contact Labconco Product Service for calibration procedure 10 Labconco Product Service 1 800 522 7658 1
9. e Criteria Result YES NO 1 Freeze Dryer la Start Up With the switch ON Stoppering control in Vacuum set point set 55 C With the Triad Stopp Does the vacuum pump continue to operate Record the time it starte Triad Stoppering Tray Dryer s Power Vac Release control in the close position Empty serum vials with loose stoppers on the four corners of the shelf Temperature probe taped to the top center of the shelf with aluminum tape Door on the Tray Dryer latched amp closed Vacuum pump plugged into the back of the Triad Stoppering Tray Dryer and its power switch turned on if so equipped Room ambient temperature 68 F or cooler Manual set point system temperature set at manual mode press the Run Stop button and the Vac button Does the Triad Stoppering Tray Dryer s Y N refrigeration system start Allow refrigeration and vacuum pump to the raise position at 0 040 mBar ering Tray Dryer in the start Y N d lb Did the Triad Stoppering Tray Dryer shelf Y N Cooling of the temperature reach 55 C 1 C within 3 Shelf and hours of starting collector Did the Triad Stopperin starting temperature reach 80 C within 1 hours of g Tray Dryer collector Y N 6 Labconco Product Service 1 800 522 7658 1 816 333 8811 Labconco FreeZone Triad Stoppering Tray Dryer IQ OQ Protocol 1059502 Revision A Ic Vacuum L
10. eaks Does the system reach a displayed vacuum level 0 030 to 0 050 mBar in 2 hours Y N ld Heating of the Raise the set point of the shelves to 50 C and Shelves press Enter on the Triad Stoppering Tray Dryer Y N Monitor the displayed temperature for the shelves Does the temperature of the shelves reach 50 C 1 C within 1 hour le Automatic To test the programmability function set the Mode display to Auto and enter any parameters for a new program for example Prefreeze Time 3 hr Segment 1 Ramp 1 5 C min Hold 55 C Time 1 0 hr Segment 2 Ramp 1 5 C min Hold 50 C Time 0 20 hr Segment 3 Ramp 1 5 C min Hold 24 C Time 0 20 hr Large temperature swings and long hold times will prolong the test Y N Run the new program Does the vacuum pump N A turn ON when Prefreeze is completed Continue with the program If Automatic Does the system s temperature rise and fall as Y N Mode programmed N A 7 Labconco Product Service 1 800 522 7658 1 816 333 8811 Labconco FreeZone Triad Stoppering Tray Dryer IQ OQ Protocol 1059502 Revision A lg Verify The shelf temperature indicated on the LCD Displayed display during Manual and Auto Segments 1 Temperature thru 5 is measured where the heat transfer fluid enters the shelves The collector temperature is measured where the refrigerant leaves the collector The values were calibrated at the factory by correlating readings wi
11. formance can be validated Labconco cannot recommend 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 making several runs and testing the results with calibrated equipment and qualified personnel 2 Labconco Product Service 1 800 522 7658 1 816 333 8811 Labconco FreeZone Triad Stoppering Tray Dryer IQ OQ Protocol 1059502 Revision A A Installation Qualification Step Description Specification or Acceptance Criteria Result YES NO Site Planning la Work surface stand weight requirements The Triad Stoppering Tray Dryer weighs 400 pounds The vacuum pump weighs at least an additional 45 pounds Is the location where the Triad Stoppering Tray Dryer will be located stable and capable of safely supporting the required weight Y N lb Space Requirements Refer to the Appendix in the Triad Stoppering Tray Dryer User s Manual for dimensions of the model you have chosen Has overhead and working space been provided for the equipment A minimum of 3 inches is required between the back and sides of a Triad Stoppering Tray Dryer and the wall for proper airflow through the refrigeration system Additional space is required on the left side if freeze drying will be performed in flasks Ic Electrical Service Refer to the User s
12. th that of a reference gauge attached to thermocouples inside the rear of the machine The T type red blue thermocouples can be accessed only by removal of the back cover of the Triad Stoppering Tray Dryer CAUTION Electrical Shock Hazard Disconnect power to the unit prior to removal of any covers Does the collector display correlate to the Y N reference gauge meter 2 C N A Does the Shelf display correlate to the Y N reference gauge meter 2 C N A Ref Instrument If the temperature does not correlate contact Labconco Product Service for calibration procedure lh Stoppering Rotate the Stoppering knob to the lower Operation position Did the top platen slowly lower from the top and did each serum vial seal with the stoppers N A Rotate the Stoppering knob to the raise position Y N Did the platen return to its highest position N A 8 Labconco Product Service 1 800 522 7658 1 816 333 8811 Labconco FreeZone Triad Stoppering Tray Dryer IQ OQ Protocol 1059502 Revision A li Temperature The shelf temperature probe can be verified by Probes placing it into an ice bath Agitate a crushed ice and water bath and place the temperature probes into it Does the displayed temperature read between 1 C and 1 C N A If the temperature does not correlate contact Labconco Product Service for calibration procedure 9 Labconco Product Servic
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