Nanodrop - Indiana CTSI
Contents
1. 1 17 Record that the calibration check has been completed the status of the test pass fail the initials of the staff member performing the action and the date on which it occurred on the maintenance log see appendix A 6 4 1 17 1 Clean the pedestals in accordance with section 6 1 1 1 in this SOP 6 4 1 18 Submit completed copies of Appendix A for review and approval 6 4 1 18 1 File reviewed copy and any associated maintenance records in the equipment binder located in the operations office 6 4 2 Calibration as needed 6 4 2 1 Contact Thermo Fisher Scientific to set up the recalibration Once recalibration is completed attach a copy of the recalibration documentation to Appendix A 6 5 SOFTWARE UPDATES 6 5 1 Periodic upgrades are available for the Nanodrop Software at http nanodrop com 6 5 2 Document any upgrades modifications on Appendix A 6 6 TROUBLESHOOTING 6 6 1 Refer to Nanodrop ND 1000 Spectrophotometer V3 8 Users Manual 7 REFERENCES 7 1 Nanodrop ND 1000 Spectrophotometer V3 8 Users Manual 7 1 1 Located in the SSF shared folder 7 1 2 Alternatively downloadable from the Thermo Scientific Nanodrop Products Website http nanodrop com SOP SF 3 11 02 SOP FOR MAINTAINING THE NANODROP ND 1000 Page 7 of 7 8 DOCUMENTATION 8 1 Maintenance logs are submitted for review by SSF Management and maintained per SF 1 6 Controlled Document Management SOP 8 2 Records are maintained per SF 1 6 C2. 4 1 2 6 4 1 3 6 4 1 4 6 4 1 5 6 4 1 6 Complete Section 6 3 1 before proceeding with the calibration check Using IU login and password log in to Nanodrop lab computer Open the Nanodrop ND 1000 software and click on the Utilities and Diagnostics button that appears on the main menu Then click on Calibration Check Add luL of DI water to the lower pedestal close the arm and click OKAY Clean the upper and lower pedestals when the Nanodrop finishes analyzing the sample 3 5 seconds Raise the sample arm and clean the sample off both pedestals with a dry Kimwipe or similar product Enter the Target Absorbance found on the CF 1 vial into the software see Figure 2 below SOP SF 3 11 02 SOP FOR MAINTAINING THE NANODROP ND 1000 Page 5 of 7 Customer Guidance a m n 6 4 2007 1 44PM Emer the target absorbance for CF 1 at 350 am and 1 0 mm path Then edd es tut water sample and select Blank ew TargetAbs 360nm 1 0mmpath D Measurementnm 350 Replicates 0 Comectonnm 600 LO mm Poth 02mm Path Torget Abs 6000 0 000 Current Abs i NeN NeN Ave Abs NaN NaN o bod 3 8 4 i Error i NaN NoN Std Dev NoN NoN o gt b n ro od 1mm Path 0 2 mm Poth Measured Absorbance vs Target o o w i e gt 4 i z o z 010 G i J 220280 300 350 400 450 S00 550 600 650 700 750 Wavelength nm 3341
3. Form Version 02
4. annually at minimum 6 3 1 1 General cleaning of pedestals 6 3 1 1 1 Apply 5ul of DI water to the bottom pedestal with an appropriate dispensing pipette 6 3 1 1 2 Lower the upper pedestal arm to form a liquid column and let it sit for approximately 2 3 minutes SOP SF 3 11 02 SOP FOR MAINTAINING THE NANODROP ND 1000 6 3 1 1 3 6 3 1 1 4 6 3 1 1 5 Page 3 of 7 Wipe away the water from both the upper and lower pedestals with a dry Kimwipes or similar product If a more rigorous cleaning is required e g instances of protein residue buildup repeat steps 6 3 1 1 1 through 6 3 1 1 3 substituting 0 5M HCL for DI water followed by another round of steps 6 3 1 1 1 through 6 3 1 1 3 using DI water to remove any residual HCL Record that pedestal cleaning has been completed the initials of the staff member performing the action and the date on which it occurred on the maintenance log see appendix A 6 3 1 2 Reconditioning of pedestals 6 3 1 2 1 6 3 1 2 2 6 3 1 2 3 6 3 1 2 4 6 3 1 2 5 Open the vial containing PR 1 and use the applicator provided in the kit to remove a pin head sized amount of the compound Apply a very thin and even layer of PR 1 to the surface of the upper and lower pedestals and let dry for 30 seconds Aggressively rub the surface of the upper and lower pedestals using a dry Kimwipe or similar product until all of the compound residue is removed Remove any excess lint cre
5. maintaining the Nanodrop ND 1000 and for documenting the maintenance 5 MATERIALS 5 1 Reagents 5 1 1 CF 1 Calibration fluid aqueous potassium dichromate K2xCR2O7 Fisher cat CF1 stored at room temp 5 1 2 DI Water from lab sink 5 1 3 Pedestal Reconditioning Kit PR 1 Kit stored at room temp Fisher cat PR1KIT 5 1 4 0 5M HCL standard lab grade room temp optional 5 2 Supplies 5 2 1 Can of compressed air 5 2 2 Gauze Pad 5 2 3 Kimwipes or similar product 5 2 4 Nanodrop Calibration software downloaded from the Nanodrop Products website http nanodrop com 5 2 5 Nanodrop Software 5 2 6 Paperclip or small screwdriver 5 3 Equipment 5 3 1 Pipette or other suitable dispensing unit capable of accurately dispensing 1 2uL SF 3 3 5 3 2 Vortex 6 PROCEDURE 6 1 OPERATION 6 1 1 Operation of the Nanodrop 1000 is defined in SOP SF 4 16 SOP for DNA Quality Control 6 2 CLEANING 6 2 1 Routine cleaning is performed before each batch run and in between samples during the process of evaluating the quantity quality of DNA as defined by SOP SF 4 16 6 2 2 Required component cleaning occurs on a semi annual basis at minimum and is defined under Section 6 3 1 for routine maintenance 6 3 MAINTENANCE NOTE All maintenance may be performed by Thermo Fisher at the discretion of the SFF staff The maintenance should be documented on Appendix A and a copy of the work performed should be attached 6 3 1 Routine Semi
6. 52 1 17 48 26 6 4 1 7 Add luL of de ionized water to the lower pedestal close the pedestal arm and select Blank 6 4 1 8 Clean the upper and lower pedestals when the Nanodrop finishes analyzing the sample 3 5 seconds 6 4 1 8 1 Raise the sample arm and clean the sample off both pedestals with a dry Kimwipe or similar product 6 4 1 9 Vortex vigorously the ampoule of CF 1 Calibration Fluid before opening to ensure the solution is thoroughly mixed 6 4 1 9 1 Tap the ampoule gently on a hard surface to ensure all solution is collected in the bottom portion of the ampoule 6 4 1 10 Carefully open the ampoule of CF 1 Calibration Fluid by wrapping a gauze pad around the neck and breaking the ampoule 6 4 1 10 1 NOTE The CF 1 Calibration Fluid is supplied in a single use vial It must be used within one hour of opening as exposure to the environment or another container may cause a significant change in concentration 6 4 1 10 2 Record the lot number and expiration date of the CF 1 fluid on Appendix A Also note the time the ampoule was opened 6 4 1 11 Add luL of CF 1 to the lower pedestal close the pedestal arm and click Measure SOP SF 3 11 02 SOP FOR MAINTAINING THE NANODROP ND 1000 Page 6 of 7 6 4 1 12 Clean the upper and lower pedestals when the Nanodrop finishes analyzing the sample 3 5 seconds 6 4 1 12 1 Raise the sample arm and clean the sample off both pedestals with a dry Kimwipe or s
7. Page 1 of 7 ate IND IAN A CTS STANDARD OPERATING PROCEDURE 2a Clinical and Hanslatlonal Sciefices institute Indiana CTSISp eciinen StorageFa cility TITLE STANDARD OPERATING PROCEDURE FOR MAINTAINING THE NANODROP ND 1000 SPECTROPHOTOMETER CHAPTER 3 Equipment Issue Date 0 03 4 Effective Date 10 0 5 1y SOP SF 3 11 02 SUPERSEDES SOP N A AUTHORED BY aL DATE 20 j 4 Indiana CTSI SF Lab Staff APPROVAL a nee Peel DATE OLY OF 20 Mf IndianaCTSI SSF Director QA APPROVAL haart LAr pare _ 0 03 14 Quality Compliance Specialist 1 REVISION 1 1 Reformatted the Procedure section to include sections on Operation Cleaning Maintenance Calibration and Function Verification 1 2 Added a note to Section 6 3 to specify that it is acceptable for Thermo Fisher techs to perform maintenance at the discretion of SSF staff 1 3 Edited procedure involving calibration check due to new Nanodrop version software Update references accordingly 1 4 Modified Section 6 4 1 10 to add that the CF 1 fluid used in calibration checks must be used within one hour of opening and that the lot number and expiration date needs to be recorded Appendix A updated accordingly 1 5 Section 6 4 1 14 was updated with a note that provides the acceptance criteria for the Calibration Check 1 6 Section 6 4 2 was modified to include directives for attaching a copy of the PM documentation to Appendix A Appendix A upda
8. ated by rubbing the Kimwipe on the pedestal from around the pedestal by spraying compressed air over the pedestal Record that pedestal reconditioning has been completed the initials of the staff member performing the action and the date on which it occurred on the maintenance log see appendix A 6 3 1 3 Cleaning the Solenoid 6 3 1 3 1 6 3 1 3 2 6 3 1 3 3 6 3 1 3 4 6 3 1 3 5 Lay the Nanodrop ND 1000 on its side with the source fiber black fiber optic cable facing up Open the arm of the sampling mechanism Manually depress the solenoid plunger using a paperclip or small screwdriver and spray compressed air down the solenoid plunger hole See Fig 1 below Return the instrument to its normal upright position Record that solenoid cleaning has been completed the initials of the staff member performing the action and the date on which it occurred on the maintenance log see appendix A SOP SF 3 11 02 SOP FOR MAINTAINING THE NANODROP ND 1000 Page 4 of 7 6 3 2 Non Routine 6 3 2 1 6 3 2 2 6 3 2 3 If the Nanodrop is not functioning properly consult user s manual If unable to resolve notify SSF management Contact Thermo Fisher to order replacement parts or for repairs as necessary Document any repairs modifications on Appendix A Attach any documentation received 6 4 CALIBRATION AND FUNCTION VERIFICATION 6 4 1 Calibration Check to be performed semi annually at minimum 6 4 1 1 6
9. imilar product 6 4 1 13 Use individual luL samples of the CF 1 Calibration check fluid for testing the calibration Repeat 10 times Repeat steps 6 4 1 11 and 6 4 1 12 nine more times total of ten 6 4 1 14 The calibration check results are displayed on screen in the Customer Guidance 6 4 1 15 test box after the 10 measurement indicating if the test passed or failed 6 4 1 14 1 NOTE The displayed on screen results must state Within calibration specifications in order for the test to pass This means that the instrument is working within 3 of target at the 1 0 mm Path and the standard deviations for the 1 0 mm Path and the 0 2 mm Path are lt 0 011 and lt 0 005 respectively 6 4 1 14 2 If the instrument does not pass the calibration check using luL samples immediately rerun the calibration check procedure Section 6 4 1 using 2uL samples Document all actions on Appendix A 6 4 1 14 3 If the instrument does not pass the calibration after using 2uL samples recalibration is required Notify SSF Management Proceed to Section 6 4 2 for calibration procedure Save the calibration check results in the Nanodrop file folder on the shared drive when finished with the calibration check 6 4 1 16 Print a copy of the results and attach them to Appendix A Record that this action has been completed the initials of the staff member performing the action and the date on which it was completed on Appendix A 6 4
10. ontrolled Document Management 8 3 Deviations are managed per the SF 1 9 Deviation Management SOP 9 APPENDICES 9 1 The current version of each of the following appendices is used to guide and implement this SOP APPENDIX A Nanodrop ND 1000 Semi Annual Maintenance Log 1 Page SOP SF 3 11 02 SOP FOR MAINTAINING THE NANODROP ND 1000 Appendix A Nanodrop ND 1000 Semi Annual Maintenance Log Page 1 of 1 Serial Number Month Year The following Preventative Maintenance should be completed on a semi annual basis at minimum Task Completed Were 2ul Status Initials Date Comments If No samples Explain warranted General Cleaning of Pedestals Yes 7 No NA NA Recondition Pedestals Yes No NA NA Cleaned Solenoid Yes No NA NA Calibration Check Yes No Yes No Pass Fail Calibration Check Results Y N NA NA Printed amp attached ERN Recalibration if i ion i Yes No NA NA necessary NA Recalibration Ves Ne documentation attached NA NA NA if applicable CF 1 Calibration Check Fluid Lot Exp Date Time CF 1 opened Time check was completed Difference lt 1 hour oYes No PM performed by a Thermo Fisher service rep and a copy of the documentation is attached Additional comments include documentation of non routine maintenance repairs and software updates Reviewed by Date SOP SF 3 11 SOP FOR MAINTAINING THE NANODROP ND 1000
11. ted accordingly 2 PURPOSE 2 1 This Standard Operating Procedure SOP defines the procedure used in the Indiana CTSI Specimen Storage Facility SSF to maintain the Nanodrop ND 1000 spectrophotometer and ensure that it is properly calibrated for reporting consistent and accurate results 3 PRINCIPLE 3 1 The Nanodrop ND 1000 spectrophotometer is used in the SSF to measure the concentration and purity of DNA It is imperative that proper maintenance be performed on a consistent basis to ensure that the spectrophotometer is calibrated and reporting accurate and precise measurements 3 2 For the Nanodrop ND 1000 spectrophotometer the wavelength is auto calibrated based on known peaks in the xenon lamp spectra each time the software is started and therefore no calibration is SOP S F 3 11 02 SOP FOR MAINTAINING THE NANODROP ND 1000 Page 2 of 7 required by the user Calibration of the path length accuracy is generally not required as field experience has shown that the path does not change appreciably even after several years of heavy use To ensure that the Nanodrop is working properly and does not experience a significant drift in path length accuracy the SSF will check the calibration semi annually Refer to the Nanodrop ND 1000 User s Manual for any pictorials of parts and locations not included in this SOP 4 SCOPE 4 1 This SOP applies to all SSF personnel performing maintenance for the Nanodrop ND 1000 It defines the process for
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