swifs fbu equip m and c program v1.4 (07.03.2008).pdf

8/6/2019 SWIFS FBU Equip M and C Program v1.4 (07.03.2008).pdf

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Southwestern Institute of Forensic SciencesCriminal Investigation Laboratory

Forensic Biology Unit

Equipment Maintenance & Calibration Program,Version 1.4

Effective Date: 7/3/2008

Approved by:

Stacy McDonald, Ph.D., Deputy Section Chief Timothy J. Sliter, Ph.D., Section Chief Chris Heartsill, Acting Quality Manager


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Corrections & Revisions Log: Equipment Maintenance & Calibration Program

Effective DateDescription

AuthorizingIndividual

1/11/2005 Revision of Freezer Maintenance procedure Revision of Equipment Checklist

Sliter

8/4/2005 Addition: Orbital Shaking Incubator calibration &maintenance

Sliter

7/11/2006 Revision of Freezer Maintenance, p. 27 Revision of Refrigerator Maintenance, p. 22 Memo dated 7/11/06 modifications to the

Equipment Maintenance & Calibration ProgramManual

Sliter/Dempsey

7/20/2006 Addition of GeneAmp PCR System 9700 sheets Sliter1/23/2008 The existing hardcopy manual was converted to

electronic format. The hardcopy manual was archived.Sliter

1/24/2008 Version 1.0 archived and replaced by Version 1.1 withthe following changes:

Addition of a maintenance & calibration plan forthe Applied Biosystems 7900HT Fast Real-TimePCR System

Revision of the freezer maintenance & calibrationplan to include checks of alarm batteries

Revision of the Centrifuge maintenance &calibration plan to include the Jouan C4-11 andthe Hermle Z 230 M centrifuges

Revision of the refrigerators & freezers WeeklyMaintenance & Calibration Assignments form to

include the dates of checks & monitors.

McDonald

2/28/2008 Changes from Version 1.1 to Version 1.2 Revision of the maintenance programs for

Refrigerators (change in temperature range) Revision of the maintenance program for freezers

(change in temperature range) Revision of the maintenance program for balances

(acceptable tolerance range) Revision of the maintenance program for the ABI

7900HT (additional regular maintenanceactivities)

McDonald

5/28/2008 Changes from Version 1.2 to Version 1.3 Various non-substantive revisions of wording toimprove clarity

Revised: Equipment Maintenance & CalibrationOverview

Revised: Forensic Light procedure (removal of Omnichrome light)

Revised: Genetic Analyzer ABI310 procedure

McDonald /Sliter

Equipment Maintenance & Calibration Program, Version 1.4 (7.3.2008) 2


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Added: Genetic Analyzer ABI3130xl procedure Added: Monthly Equipment Maintenance

Checklist Removed: ABI2400 Thermocycler

7/3/2008 Changes from Version 1.3 to Version 1.4 Revised the wording of the 7900HT procedure to

improve clarity

McDonald/Sliter



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Overview

This manual identifies the critical-use equipment included in the Forensic Biology Units EquipmentMaintenance and Calibration Program, and describes the calibration and maintenance schedules andprocedures for this equipment. Critical-use equipment requires periodic maintenance to assureacceptable operation.

An inventory of all equipment used in the FBU is maintained by the Quality Manager.

The FBU maintains a current listing of all critical-use equipment used for casework analysis, which isincluded in this program document. Only items of critical-use equipment used in casework will fallunder the Equipment and Calibration Program. Items of equipment not used in casework will beremoved from the program.

Any new items of equipment must be validated prior to being used for casework analysis.

Some equipment items (e.g., pipetters) fall under the Institute-wide equipment maintenance and

calibration program and receive external maintenance and calibration according to standards andschedules set by the Institute. These equipment items are identified in this manual. However, for theseitems only the procedures and schedules of maintenance and calibration performed internal to the FBUare contained in this manual. Other records related to external maintenance and calibration aremaintained by the Quality Manager.

The major portion of this manual consists of maintenance and calibration procedures and schedules forinstruments that are maintained by the FBU. Current logs are maintained either on or close to theequipment items, or in a separate equipment log notebook. Past equipment logs are retained in anarchived log notebook.

The contents of this manual reflect current calibration and maintenance procedures. As calibration andmaintenance procedures are updated, and as the inventory of equipment changes, the manual will berevised accordingly.

Related documentation:

1. Current equipment log notebook 2. Archived equipment log notebook

Equipment Maintenance & Calibration Process

Each item of equipment included in the program will undergo periodic calibration checks andmaintenance as described in this manual. The schedule for calibration and maintenance varies accordingto the specific equipment item. Categories of schedule calibration and maintenance are as follows:

1. As Needed. Maintenance and/or calibration will be performed as necessary, as determined bythe equipment users.

2. Routine. Maintenance and/or calibration will be performed prior to and/or after each use.

3. Weekly. Maintenance and/or calibration will be performed each week.



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4. Monthly. Maintenance and/or calibration will be performed each month.

5. Regular Monthly. Maintenance and/or calibration will be performed each month prior to thefirst casework use of the item that month.

6. Semi-annual. Maintenance and/or calibration will be performed twice per calendar year atapproximately 6 month intervals.

7. Annual. Maintenance and/or calibration will be performed once per year.

Logs and Checklists

Unless otherwise indicated in specific equipment procedures, equipment maintenance and/or calibrationactivities will be recorded on appropriate logs or checklists.

Assignments, Monitoring & Review

As appropriate, maintenance and/or calibration tasks will be assigned to staff. For regularly scheduledtasks (e.g., weekly and monthly tasks), assignments will be made through written assignment sheets thatwill provide space for staff members to initial for completion of the assigned tasks. Completion of assigned maintenance and calibration tasks will be monitored by a second individual. Assignmentsheets will provide a space for monitors to initial for completion of monitoring activities. Assignmentsheets will be reviewed by an assigned reviewer to assure completion of all required actions.Assignment sheets will be filed in the current equipment log notebook.



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Equipment Maintenance & Calibration Overview

Note: Refer to procedure sheets for details regarding maintenance & calibration activities for eachinstrument.

As Needed performed as necessary, as determined by users

Routine performed prior to use and/or after useWeekly performed once per week Monthly performed once per monthRegular Monthly performed each month prior to first casework use that monthSemi-annual performed twice per calendar year, at approximately six month intervalsAnnual performed once per calendar year

Equipment Category AnnualSemi-

AnnualRegularMonthly Monthly Weekly Routine

AsNeeded

Autoclaves X Balances Q X X

Centrifuges X X Crosslinkers, UV X X Forensic light - Crimescope X X Freezers X X X Genetic Analyzers - ABI 310 X X X Genetic Analyzers - ABI 3130xl X X X Hoods Fume hoods, Biologicalcabinets & PCR hoods

XQ

Incubators dry air X X X Incubators dry block X X Milli-Q Plus water system XQ

pH Meters X X Pipetters XQ Refrigerators X Speed-Vacs X Thermocyclers Geneamp 9600 X X Thermocyclers Geneamp 9700 X X Thermocyclers ABI 7900HT X X Temperature verification system X X Thermometers XQ Water baths X X X

X Calibration is the responsibility of the Forensic Biology UnitQ - Calibration is the responsibility of the Quality Manager



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AUTOCLAVES

ANNUAL MAINTENANCE

Perform the following as applicable for individual instruments:

1. Drain and clean chambers.

2. Drain exhaust bottles

3. Check safety valves

AS NEEDED MAINTENANCE

1. Drain and clean chambers. ( Not logged. )

2. Drain exhaust bottles. ( Not logged. )



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BALANCES

REGULAR MONTHLY MAINTENANCE

1. At the beginning of each month, use the NIST traceable certified weight standards set, provided

by the Drug laboratory, to verify accuracy of the balance within designated ranges. Record thedate, the certified weight standards used, the reading determined by the certified weightstandards, and the difference in the last decimal point measured on the Balance Maintenance Logmonthly calibration check section.

2. The measurement values should be within 3% of the calibration weight.

Corrective action: If the difference is greater than 3%, then recalibrate the balance accordingto the calibration procedures listed in the operators manual. Upon completion of therecalibration, check the accuracy of the balance against the certified weight standards, thereadings determined by the certified weight standards, and then record the readings on theBalance Maintenance Log.

ROUTINE MAINTENANCE1. Prior to use ensure that the balance is level and wipe away any debris with a soft brush.

2. Prior to daily use, determine the accuracy of the balance with designated ranges by using thesecondary weight specific for the balance. Record the date, the reading determined by thesecondary weight, and the difference in the last decimal point measured on the BalanceMaintenance Log. This determination need only be made once on the day of use.

3. The measurement values should be within 3% of the calibration weight.

Corrective action: If the difference is greater than 3%, then recalibrate the balance accordingto the calibration procedures listed in the operators manual. Upon completion of the

recalibration, check the accuracy of the balance against the certified weight standards, thereadings determined by the certified weight standards, and then record the readings on theBalance Maintenance Log.

ANNUAL MAINTENANCE

1. Active balances are calibrated using NIST traceable standards, cleaned, and/or repaired by anexternal vendor each year. Records of external calibration and maintenance are retained by theQuality Manager.



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CENTRIFUGES

Eppendorf Microcentrifuges

ANNUAL MAINTENANCE

1. Check RPM. Using a tachometer, determine the speed at the following rotations per minute(rpm): 14,000, 6,000, and 3,000 settings. Place reflective tape on the rotor head. Use a tool tokeep the lid open. Place the tachometer over the rotor head. Wait for a stable reading. Recordthe reading from the tachometers digital display.

2. Check timer. Using a laboratory timer, compare the microcentrifuge timer to it. Record thereading.

Corrective actions: If the rpm measured by the tachometer varies excessively from themicrocentrifuge speed control setting and/or if the microcentrifuge timer varies excessively fromthe laboratory timer, then the unit should be serviced by a qualified technician.

3. Check motor brushes. Inspect the motor brushes and replace if less than inch according to theoperators manual instructions.


1. Clean Housing. Using a soft cloth or sponge, clean the housing with a 10% bleach solution ormild detergent. ( Not logged. )

2. Clean Rotor. Using a soft cloth or sponge, clean the rotor with a mild detergent. To clean therotor, remove it from the centrifuge, then place it upside down on a protective surface. Removethe three screws, then separate the spring plate and the rotor tray from the rotor plate. Next,remove the tube holders from the rotor plate. Lastly, use a mild detergent to clean the rotorparts. Reassemble the rotor according to the operators manual instructions. ( Not logged. )

Jouan C4-11 centrifuge

ANNUAL MAINTENANCE

1. Check RPM. Using a tachometer, determine the speed at the following rotations per minute(rpm): max, 6,000, and 3,000 settings. Place reflective tape on the rotor head. Use a tool to keepthe lid open. Place the tachometer over the rotor head. Wait for a stable reading. Record thereading from the tachometers digital display.

2. Check Timer. Set timer to 3 minutes and check against a laboratory timer. Record the reading.

Corrective actions: If the rpm measured by the tachometer varies excessively from thecentrifuge speed control setting and/or if the centrifuge timer varies excessively from thelaboratory timer, then the unit should be serviced by a qualified technician.

3. Check motor brushes. Check the motor brushes and replace if less than 13mm according to theoperators manual instructions.



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Hermle Z 230 M centrifuge

ANNUAL MAINTENANCE

1. Check RPM. Using a tachometer, determine the speed at the following rotations per minute(rpm): 12,000 and 9,000. Place reflective tape on the rotor head. Use a tool to keep the lid open.Place the tachometer over the rotor head. Wait for a stable reading. Record the reading from the

tachometers digital display.2. Check timer. Set timer to 3 minutes and check against a laboratory timer. Record the reading.

Corrective actions: If the rpm measured by the tachometer varies excessively from thecentrifuge speed control setting and/or if the centrifuge timer varies excessively from thelaboratory timer, then the unit should be serviced by a qualified technician.



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CROSSLINKERS, UV

ROUTINE MAINTENANCE

1. Check the calibration record. Check the calibration record of the instrument prior to use.

a. If the cross-linker was calibrated within the previous two-week period, then nocalibration is needed prior to use.

b. If no calibration was performed in the previous two-week period, then the instrumentmust be calibrated before use.


1. As needed (based upon the calibration record check, see above), perform calibration using theinternal dosimeter according to the procedure detailed on the Cross-linker CalibrationWorksheet.

a. Enter the calibration into the Maintenance & Calibration Log for the instrument.

2. Check the UV lamp tubes in the instrument at the time of calibration.

a. Replace non-functional tubes as necessary.

b. Note: Exposure time is adjusted based upon the calibration using the internal dosimeter.Therefore, the instrument may be used when not all lamp tubes are functioning.



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FORENSIC LIGHT CRIMESCOPE

ROUTINE MAINTENANCE

1. Record on the log sheet the time duration that the lamp is in use each time the light source is

used.AS NEEDED MAINTENANCE

1. Use lens paper or a Kimwipe to clean the external optics. ( Not logged. )

2. Replace the Xenon bulb after 800-1200 hours of use, depending upon the level of power outputof the bulb. Replace bulbs as described in the operators manual.



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FREEZERS


1. Remove ice buildup from the door gasket as necessary. ( Not logged. )

2. Defrost cabinet as necessary. ( Not logged. )

WEEKLY MAINTENANCE

1. Record temperature from the digital display (on certain designated models) or from thethermometer located inside the unit.

a. Cabinet temperature must be within -15 oC to -25 oC.

b. For the -80 oC freezer used for evidence storage, the temperature must be less than -20 oC.

Corrective action: If the cabinet temperature falls outside of the stated tolerance range, then

notify a supervisor for further evaluation and to determine the appropriate response.2. Note: Because of the high frequency of temperature checks, an occasional missed week of

temperature recording will not be considered inconsistent with the general policy of weeklytemperature checks.

ANNUAL MAINTENANCE

1. Wash condenser filter. Inspect the filter. If it is dirty, clean filter by rinsing under water.

2. Clean condenser fan. Check the condenser fan for dust. If it is dusty, spray fans withcompressed air to remove dust.

3. Alarm battery. Check the alarm battery.

a. The batteries for some freezers can be checked by removing the lead from the terminaland noting a subsequent alarm.

Corrective action: If the alarm does not sound, the battery should be replaced.

b. Batteries for some of the freezers require testing with a multimeter.

Corrective action: If the voltage reads below 10 V the battery should be replaced.

4. Defrost cabinet. Inspect the cabinet and defrost if necessary.

5. Remove ice from gasket. Inspect the door gasket and remove ice if necessary.



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GENETIC ANALYZERS - ABI 310

YEARLY MAINTENANCE

1. Run a full-system diagnostic.

MONTHLY MAINTENANCE

1. Defragment the computer hard drive.

2. Archive Run files. Transfer files to the appropriate instrument folder on the Y: drive. Placearchived files in the Archived Files folder within the Run folder and indicate the date the fileswere archived. If space on the hard drive is limited, delete archived files.


1. Change capillaries and electrodes as needed. ( Not logged. )

2. Construct new matrices as needed.

3. Run a full-system diagnostic following major maintenance activities, such as replacinglasers.



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GENETIC ANALYZERS - ABI 3130xl

MONTHLY MAINTENANCE

1. Run the Water Wash Wizard.

2. Flush the water trap.3. Defragment the computer hard drive.

4. Archive Run files. Transfer files to the appropriate instrument folder on the Y: drive. Placearchived files in the Archived Files folder within the Run folder and indicate the date the fileswere archived. If space on the hard drive is limited, delete archived files.

WEEKLY MAINTENANCE

1. Replace the polymer.

2. Restart the computer and instrument.

AS NEEDED MAINTENANCE1. Change capillary array as needed.

a. Run the spatial calibration when the capillary is changed.

2. Run new spectral calibrations as needed.

3. Replace water and run buffer as needed. ( Not logged. )

4. Clean instrument surfaces as needed. ( Not logged. )



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HOODS FUME HOODS, BIOLOGICAL CABINETS & PCR HOODS

ANNUAL MAINTENANCE

Captair 1000GP

1. Air velocity test. An air velocity test is administered by Institute personnel under the direction of the Quality Manager. Test results are maintained by the Quality Manager.

2. Filter replacement. Filters will be replaced yearly.

Fume hoods

1. Air velocity test. An air velocity test is administered by Institute personnel under the direction of the Quality Manager. Test results are maintained by the Quality Manager.

Misonix PCR Workstation1. Air velocity test. An air velocity test is administered by Institute personnel under the direction of

the Quality Manager. Test results are maintained by the Quality Manager.

Nuaire Laminar Flow Hood

1. Annual certification. The instrument will be tested/evaluated (as described below) and certifiedyearly:

a. Supply velocity evaluation.

b. Filter leak test and filter replacement as required

c. Smoke intrusion/induction test

i. Clean air device test

ii. Prefilter evaluation

iii. Lighting intensity evaluation

iv. Sound level determination



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INCUBATORS DRY AIR

VWR Incubator Model 1575

ANNUAL MAINTENANCE

Temperature Calibration (adapted from operation instructions pg. 15)

1. To enter set point mode on the controller, press either the UP or DOWN arrow pad one time.NOTE: The digital display will start to blink, going from bright to dim. While blinking, thedigital display is showing the set point.

2. To change the set point, use the UP and DOWN arrow pads. If the arrow pads are not pressedfive seconds, the display will stop blinking and will read the temperature of the unit.

3. Allow the incubator to stabilize for at least 24 hours. Compare the incubator temperatureindicated on the digital display with the temperature measured with a NIST traceable referencethermometer. Record the Temperature. Incubator temperature should be within +/- 2 oC.

4. Corrective action: If the temperature controller fails to calibrate, then the incubator should beserviced by a qualified technician.

ROUTINE MAINTENANCE

1. Record the temperature from the digital display prior to use. Incubator temperature should bewithin +/- 2 oC of the target operating temperature.

Corrective action: If the temperature of the instrument differs from the target operatingtemperature by more than +/- 2 oC, then adjust the instruments temperature setting. Allow theinstrument to equilibrate before using.


1. Clean the interior parts of the incubator as needed. Do not use bleach. Remove the interior partsand clean with a mild soap and water solution. Rinse with distilled water and wipe dry with asoft cloth. ( Not logged. )



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INCUBATORS DRY BLOCK

ROUTINE MAINTENANCE

1. Monitor temperature prior to use. Assure that the temperature is within the acceptable range for

the equipment/process.a. Corrective action. If the measured temperature is outside the acceptable temperature

range (see the temperature log sheet for each instrument), adjust the temperature control.Wait for the temperature of the block to equilibrate before using.

2. Record the operating temperature on the appropriate temperature log sheet.


1. Unplug the instrument and clean the block and heater with warm water and a mild detergent.( Not logged. )



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MILLI-Q PLUS SYSTEM


MU-15 ultrafiltration cartridge (adapted from operators manual pp. IV-3 to IV-7)

1. The overall procedure will use approximately 80 liters of water. Make sure the feed waterstorage tank contains the proper amount.

2. Dilute 5 ml of 5% bleach into 100 ml of Milli-Q water.

3. In another beaker have 50 ml of Milli-Q water.

4. Turn off the power at the main power switch.

5. Flick the switch on the Meg-O-Meter control box to the Standby position. Connect tubingfrom both the UF flush valve (i.e., bottom of UF bowl) and the 3-way valve to drain.

6. Open the 3-way valve to Product mode and direct the flow to drain. Make sure the system isnot under pressure by slowly opening the flush valve below the UF cartridge.

7. Using a 50 ml syringe, draw up the 5% chlorine solution. Open the cover of the Milli-Q systemand attach the syringe outlet to the Luer connector of the sanitization valve on the UF housing.

8. Open the sanitization valve and inject 100 ml chlorine.

9. Inject 10 ml of Milli-Q water to displace the chlorine from the sanitization valve. Close thevalve.

10. Switch from Standby to Operate. Turn on the power. Then run the system for 20 seconds todisperse the chlorine throughout the cartridge. Afterwards, return the switch to standby.

11. Turn the UF flush valve at the bottom of the UF cartridge housing to the fully opened position.

12. Leave the system overnight to allow the 5% chlorine solution to sanitize the UF cartridge andbowl. The automatic recirculation mode will remove the sanitatn gradually during the night.

13. Next morning perform the following:

a. Turn the UF cartridge flush valve to its normal position slower drip.

b. Turn the 3-way valve to the Recirculation position.

c. Place the Pump Control Switch in the Operation position.

d. Monitor the water quality at the Meg-O-Meter. When the quality reaches the desiredlevel (i.e., 10 to 18 M -cm), the water is ready for use.

FINAL filter replacement

1. Wrap Teflon tape around the filter unit threads.

2. Secure the final filter unit carefully into the Pont-of-Use Module final filter adapter.

3. Remove the cap from the bell-housing.

4. Turn the 3-way valve to Product. Then loosen the vent-cap on the filter unit to allow the air toescape.



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5. Close the vent and flush the final filter unit for 2 minutes prior to initial use.

6. Turn the 3-way valve to Recirculate mode and the pump control switch to Standby orproceed with normal operation.

Meg-O-Meter test

1. Press test button while Pump Control Switch is in the Operate position. The Meg-O-Metershould read 10 megohm-cm.

OTHER MAINTENANCE

1. The Super-C Cartridge, the two Ion-Ex cartridges, and the Organex-Q cartridge are to bereplaced every five years by an external vendor.

2. The feed water storage tanks (i.e., deionized water tanks) are replaced once every four months oras needed by an external vendor.



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pH METERS

ROUTINE MAINTENANCE

1. Calibration. Before use, perform calibration of the instrument with two calibration buffers.

Make sure to use buffer solutions that have not expired. ( Not logged. )


1. Replace electrode as necessary.

2. Replace electrode solution as necessary. ( Not logged. )



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PIPETTERS

SEMI-ANNUAL MAINTENANCE

1. The pipetter calibration and maintenance program is managed for the Institute as a whole by

the Quality Manager.2. The calibration of active pipetters will be checked twice per year.

a. One check will be performed by Institute personnel following procedures established bythe Quality Manager.

b. A second check will be performed by an outside vendor chosen by the Institute.

3. All official records of pipetter calibration, maintenance, and repair will be maintained by theQuality Manager.



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REFRIGERATORS

WEEKLY MAINTENANCE

1. Record temperature from the thermometer located inside the unit. Cabinettemperature must be within the range 2 oC to 8 oC.

Corrective action: If the cabinet temperature falls outside of the range of 2 oC to 8 oC, thennotify the quality officer or supervisor to determine the proper course of action.

Note: Because of the high frequency of temperature checks, an occasional missed week of temperature recording will not be considered inconsistent with the general policy of weeklytemperature checks.



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SAVANT SPEEDVACs


Use a mild detergent solution on a sponge or gauze to wipe the chamber dry of any solvents. Anyexcess moisture in the chamber is removed on the next SpeedVac run. (Not logged. )



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THERMOCYCLERS GENEAMP 9600

ANNUAL MAINTENANCE

Diagnostic Tests. Diagnostic tests are run automatically by the systems microprocessor unit. To run

diagnostic tests1. Turn on the Geneamp PCR thermocycler and select Diag from the Utilities menu.

2. Enter the number that corresponds to the test that needs to be run:

a. Heater Test (Diagnostic Test #2)

b. Chiller Test (Diagnostic Test #3)

c. System Performance Test (Diagnostic Test #4)

3. Press Enter

4. When the test is complete, record the results on the maintenance log.

5. Repeat for all tests.Temperature Calibration Verification Test. This test is run Using Diagnostic test #5. Refer to theattached instructions to complete the test.

1. Use the following values for the Block Calibration to calculate the average block temperature:

a. Block Calibration for GeneAmp 9600 s/n 6938

i. Low Offset (@40 oC) 0.0 o

ii. High Offset (@95 oC) 0.1 o

b. Block Calibration for GeneAmp 9600 s/n S00492iii. Low Offset (@40 oC) 0.0 o

iv. High Offset (@95 oC) 0.1 o

2. Record the results on the maintenance form.

3. Refer to Chapter 8 of the operators manual and instructions included with the TemperatureVerification System for additional details.

Temperature Uniformity Test. Use Program #99 to conduct this test. Refer to the attachedinstructions to complete the test. Record the results on the maintenance form. Refer to Chapter 8 of theoperators manual and instructions included with the Temperature Verification System for additional

details.Corrective Actions: If the instrument does not pass the five diagnostic tests and the temperatureuniformity test, then it must be serviced before use.


1. Clean the sample wells. ( Not logged. )



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a. The instrument must be turned off, and the block must be at room temperature.

b. Remove the sample tray from the block and set aside.

c. Wipe the inside of the sample wells thoroughly with a cotton swab soaked in isopropanol.

2. Clean the heated cover. ( Not logged. )

a. Slide the cover back about one third (1/3) of the way towards the back of its range.b. Lift the cover through the notches in the rail and set it down on its side. DO NOT pull

the heated cover away from the instrument.

c. Soak a clean cloth with isopropanol and gently wipe the bottom of the cover.

3. If sample contamination of the block is suspected, then perform steps 1 and 2 using 5%bleach solution.



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THERMOCYCLERS GENEAMP 9700

ANNUAL MAINTENANCE

Diagnostic Tests. Diagnostic tests are run automatically by the systems microprocessor control. Torun diagnostic tests:

1. Turn on the 9700 system and press F4 (Util ).

2. Press F1 (Diag ).

3. Press System from the Diagnostics Screen.

4. Enter the number that corresponds to the test that needs to be run:

a. Rate Test F1

b. Cycle Test F2

5. Press Enter.

6. When the test is completed, record the results on the maintenance form.

Temperature Calibration Verification Test. This test is run using Diagnostic Test F3 (TmpVer).Refer to the attached instructions to complete the test.

1. Use the following values for the Block Calibration to calculate the average block temperature:

a. Low Offset (@45 oC) 0.0 oC

b. High Offset (@85 oC) 0.1 oC

2. Record the results on the maintenance form. Refer to the operators manual and instructions

included with the Temperature Verification System for additional details.

Temperature Uniformity Test

1. On the Temperature Verification Screen select F2 (TNU).

2. Refer to the attached instructions to complete the test.

3. Record the results on the maintenance form.

4. Refer to the operators manual and instructions included with the Temperature VerificationSystem for additional details.

Corrective Actions: If the diagnostic tests and the temperature uniformity test are not passed, thenarrange for service.


1. Clean sample wells. ( Not logged. )

a. Make sure that the instrument is turned off and at room temperature.



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b. Remove the sample tray from the block and set aside.

c. Using a cotton swab soaked in isopropanol, wipe the inside of the sample wellsthoroughly.

2. Clean heated hood. ( Not logged. )

a. Slide the cover back.

b. Soak a clean cloth with isopropanol and gently wipe the bottom of the cover.

3. If sample contamination of the block is suspected, then perform steps 1 and 2 using 5%bleach solution.



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THERMOCYCLER - ABI 7900HT FAST REAL TIME PCR SYSTEM

SEMI-ANNUAL MAINTENANCE

1. Perform a spectral calibration (Pure Dye Run).

2. Perform a Background Run.3. Check the Applied Biosystems Web Site for any software updates; install as necessary.

MONTHLY MAINTENANCE

1. Perform a Background Run.

2. Defragment the computer hard drive.

3. Archive the SDS files.

a. Copy the SDS files located in the SDS Documents folder to the appropriate instrumentfolder on the networked Y:\ drive.

i. The SDS Documents folder on the instrument computer is: D:\AppliedBiosystems\ SDS Documents

ii. The 7900HT data archive folder on the Y:\ drive is: Y:\ForensicSciences\Shared\PES-Instrument Data\7900HT Data

4. Move the SDS files on the instrument computer (which have been archived to the Y:\drive)from the SDS Documents folder to a backup folder on the instrument computer.

a. Files are moved to a backup folder on the instrument computer so that they remain easilyaccessible to analysts.

b. On the instrument computer, open the D:\AppliedBiosystems\SDS Documents\Files_Archived_to_Y_Drive folder and create a subfolder.

i. Name the subfolder by the date the files were archived to the Y:\ drive (e.g.,05May2008 ).

c. On the instrument computer, move the SDS files located in the SDS Documents folder(D:\Applied Biosystems\SDS Documents ) to the newly created backup subfolder (forinstance, D:\AppliedBiosystems\ SDS Documents\ Files_Archived_to_Y_Drive\ 05May2008 ).

d. When space on the instrument computer hard drive becomes limited, the oldest fileslocated in the D:\AppliedBiosystems\ SDS Documents\ Files_Archived_to_Y_Drive folder may be deleted.

i. These files remain in the archived data folder on the Y:\ drive.



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THERMOCYCLER TEMPERATURE VERIFICATION SYSTEM

ANNUAL MAINTENANCE

1. Annual calibration will be performed by Applied Biosystems.

ROUTINE MAINTENANCE

1. Decontaminate the probe before and after use with a solution of 20% bleach. ( Not logged. )



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THERMOMETERS

Mercury and Alcohol Thermometers

ANNUAL MAINTENANCE1. NIST-traceable mercury-in-glass thermometers are maintained and calibrated by the

Quality Manager as an Institute resource. Records of calibration are maintained by theQuality Manager.

2. Laboratory mercury and alcohol thermometers will be checked against a NIST-traceablethermometer once per year

3. Single temperature calibration checks will be performed at temperatures in the range of operation of the thermometer.a. Thermometers used in refrigerators and freezers will be checked in an equilibrated

ice-water mixture.b. Thermometers used in water baths and incubators will be checked in equilibrated

water baths.4. Temperature readings on the laboratory thermometer should be +/- 1 division from the

NIST-traceable thermometer.a. Corrective Action. If the laboratory thermometer differs from the NIST-traceable

thermometer by more than 1 division, then the amount of deviation is recorded on thethermometer log sheet, and the laboratory thermometer temperature readings areadjusted in accordance with the deviation.

Tegam Digital Reference Thermometer

ANNUAL MAINTENANCE1. The Tegam Digital Reference Thermometer is calibrated once per year by an outside vendor

against a NIST-traceable standard.

Gemini Water Bath Digital Temperature Indicator

ANNUAL MAINTENANCE

1. The calibration of the Gemini water bath digital temperature indicator is checked annuallyusing the Tegam Digital Reference Thermometer

2. The difference between the Gemini temperature indicator and the Tegam Thermometer isrecorded in the maintenance log and on the instrument, and an appropriate correction factoris applied to the Gemini temperature indicator measurement.



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WATER BATHS

ANNUAL MAINTENANCE

1. Temperature verification checks are performed once per year.

a. Depending upon the instrument, checks are done using either a calibrated laboratorymercury thermometer, or the TEGAM Digital Reference Thermometer.

ROUTINE MAINTENANCE

1. Before use, record the water bath temperature on the instrument temperature log.

a. Depending on the instrument, the temperature may be measured using either a calibratedlaboratory thermometer, or the instruments digital temperature display.

2. In order for the water bath to be used, the temperature must be +/- 2 oC from the targettemperature.

Corrective action. If the instrument temperature is outside the acceptable operating range,then adjust the temperature setting appropriately. Allow the instrument to equilibrate. Thenrecheck the temperature before use.


1. Drain water and clean the bath with a mild detergent as necessary. ( Not logged. )