PERFORMANCE VERIFICATION IONSCAN LS

Transcription

1 Page of 3 PERFORMANCE VERIFICATION IONSCAN LS Smiths Detection 30 Technology Dr. Warren, NJ Copyright Smiths Detection 004 All rights reserved. Reproduction, adaptation or translation without prior written permission is prohibited, except as allowed by copyright laws. Warranty The information contained in this document is subject to change without notice. Smiths Detection - makes no warranty of any kind with regards to this material, including, but not limited to, the implied warranties or merchantability and fitness for a particular purpose. Smiths Detection - shall not be liable for errors contained herein or for incidental or consequential damages in connection with the furnishing, performance, or use of this material.

2 Page of 3 PRE EXECUTION PROTOCOL APPROVAL SMITHS DETECTION - PROTOCOL APPROVAL I agree that the Performance Verification (PV) procedures, assembled by Smiths Detection, are appropriate for the equipment defined in the table of contents. Name Signature Date CUSTOMER PROTOCOL APPROVAL I agree that the PV procedures in this document are applicable to the equipment defined in the table of contents. Name Signature Date QUALITY PROTOCOL APPROVAL I agree that the PV procedures in this document are applicable to the equipment defined in the table of contents. Name Signature Date POST EXECUTION PROTOCOL APPROVAL SMITHS DETECTION - PROTOCOL APPROVAL I agree that the PV procedures, assembled by Smiths Detection, are appropriate for the equipment defined in the table of contents. Name Signature Date CUSTOMER PROTOCOL APPROVAL I agree that the PV procedures in this document are applicable to the equipment defined in the table of contents. Name Signature Date QUALITY PROTOCOL APPROVAL I agree that the PV procedures in this document are applicable to the equipment defined in the table of contents. Name Signature Date

3 Page 3 of 3 INSTRUMENT TO BE VERIFIED IONSCAN MODEL# Serial Number Firmware Version Operational Time Negative Mode Positive Mode Sample Count TEST LOCATION Instrument underwent Perfromance Verification as of the date this protocol was performed. Company Name Address Department Building Number Room Date Perfromance Verification performed Verified by (Signature) Date

4 Page 4 of 3 TABLE OF CONTENTS PRE EXECUTION PROTOCOL APPROVAL... SMITHS DETECTION - PROTOCOL APPROVAL... CUSTOMER PROTOCOL APPROVAL... QUALITY PROTOCOL APPROVAL... POST EXECUTION PROTOCOL APPROVAL... SMITHS DETECTION - PROTOCOL APPROVAL... CUSTOMER PROTOCOL APPROVAL... QUALITY PROTOCOL APPROVAL... INSTRUMENT TO BE VERIFIED... 3 TEST LOCATION... 3 TABLE OF CONTENTS... 4 PARTS AND MATERIALS... 6 REQUIRED TEST PARTS AND MATERIALS... 6 REQUIRED TEST STANDARDS... 6 GENERAL INSTRUCTIONS... 7 SIGNATURE PROTOCOL... 7 DATE FORMAT... 7 ERROR CORRECTION... 7 NO-ENTRY SPACES... 7 TEST PROCEDURE... 7 DESORBER SEAL CHECK... 8 PURPOSE... 8 BACKGROUND... 8 TEST EQUIPMENT LIST... 8 PROCEDURE... 8 RESULTS... 8 NOISE CHECK... 9 PURPOSE... 9 BACKGROUND... 9 TEST EQUIPMENT LIST... 9 PROCEDURE... 9 RESULTS... 9 CALIBRANT ION CHECK... 0 PURPOSE... 0 BACKGROUND...0 PROCEDURE... 0 RESULTS...

5 Page 5 of 3 REACTANT ION CHECK... PURPOSE... BACKGROUND... PROCEDURE... LIMIT OF DETECTION CHECK... 3 PURPOSE... 3 BACKGROUND...3 TEST EQUIPMENT LIST... 3 PROCEDURE... 3 RESULTS... 3 INJECTION REPEATABILITY CHECK... 4 PURPOSE... 4 BACKGROUND...4 TEST EQUIPMENT LIST... 4 PROCEDURE... 4 RESULTS... 4 DETECTOR LINEARITY CHECK... 5 PURPOSE... 5 BACKGROUND...5 TEST EQUIPMENT LIST... 5 PROCEDURE... 5 RESULTS... 6 CARRYOVER CHECK... 7 PURPOSE... 7 BACKGROUND...7 TEST EQUIPMENT LIST... 7 PROCEDURE... 7 RESULTS... 8 SUMMARY OF PERFORMANCE VERIFICATION... 9 FINAL CONCLUSION... 9 APPENDIX... 0 NOISE ANALYSIS... 0 REGRESSION ANALYSIS... DETERMINATION OF INJECTION REPRODUCIBILITY... REVISION HISTORY... 3

6 Page 6 of 3 PARTS AND MATERIALS The following parts and materials are required for running the Perfromance Verification. REQUIRED TEST PARTS AND MATERIALS Quantity Item.0 µl or 5 µl Syringe Solution Standards Kit pk Teflon Filters (p/n 68340) pk Teflon Membranes (p/n ) Teflon Card, Ring Assembly IM3 Software Manager Version Personal computer running Windows 000 Computer Interface Cable Excel Software Package 00 ml Pesticide Grade or similar hexanes 00 ml Pesticide Grade or similar Acetone REQUIRED TEST STANDARDS Quantity Solution ml 5 pg/ul TNT in hexanes ml 50 pg/µl TNT in hexanes ml 00 pg/µl TNT in hexanes ml 50 pg/µl TNT in hexanes ml 00 pg/µl TNT in hexanes ml 50 pg/µl TNT in hexanes ml 500 pg/µl TNT in hexanes ml 5 ng/ul TNT in hexane ml 50 pg/ul diazepam in acetone ml 00 pg/µl diazepam in acetone ml 50 pg/µl diazepam in acetone ml 00 pg/µl diazepam in acetone ml 50 pg/µl diazepam in acetone ml ng/µl diazepam in acetone ml 5ng/uL diazepam in acetone Solutions prepared by Smiths Detection - using certified analytical standards.,4,6-tnt Diazepam Analyte Concentration Supplier Lot No.

7 Page 7 of 3 GENERAL INSTRUCTIONS SIGNATURE PROTOCOL TESTED BY: Signature and/or initials of Smiths Detection Field Service Engineer, or other personnel performing tests. Date indicates the date test was executed. ACCEPTED BY: Signature and/or initials of customer representative. QA ACCEPTED: Signature and/or initials of customer QA department responsible for reviewing data. DATE FORMAT Unless otherwise specified by the customer, the proper format for the date is: dd/mon/yy. Where the month is the first three letters of the month. eg. 0FEB04 ERROR CORRECTION In the event of an entry error, cross out the incorrect value with a single line and write the correct entry. Initial and date the error. If space does not allow, footnote the error, and correction at the bottom of the page. eg. 0FEB04 NO-ENTRY SPACES Any entry that is not filled in (ie. test not necessary, space for comments not needed, etc.) should be crossed out with one diagonal line. Write a short reason, or N/A on the line along with initials and date. TEST PROCEDURE. Turn instrument on and put into negative ion mode.. Load latest version of instrument default negative mode control parameters. 3. Verify detection algorithm for TNT. 4. Allow instrument to come ready and wait an additional hour before proceeding with test. 5. Perform all checks in negative ion mode. 6. Switch instrument to positive ion mode. 7. Load latest version of instrument default positive mode control parameters. 8. Verify detection algorithm for diazepam. 9. Allow instrument to come ready and wait an additional hour before proceeding with test. 0. Perform all checks in positive ion mode.

8 Page 8 of 3 DESORBER SEAL CHECK PURPOSE To verify that when the IONSCAN-LS performs an analysis and the desorber stage moves up and seals the sample substrate between the desorber and the inlet, a proper seal is obtained. BACKGROUND To analyze a sample, the sample substrate is inserted into the tray on the front of instrument and the slide is moved to the right to introduce the sample into the analyzer. When the analysis cycle starts, the desorber moves up and seals the sample between the desorber heater and the IMS inlet. As the sample is heated the sample carrier gas (clean dry air) sweeps the desorbed vapors into the IMS detector. In order to ensure efficient sample transfer the sample should be properly sealed between the desorber and the inlet to ensure no air escapes out the side. TEST EQUIPMENT LIST. Teflon filter card assembly with standard Teflon filter (p/n 68340) PROCEDURE This test is performed in negative ion mode only.. Allow IONSCAN-LS unit to come ready.. Assemble a new Teflon filter, card and ring. 3. Insert filter card into IONSCAN and analyze. 4. After the analysis, check for seal on bottom of Teflon filter. 5. Record below if the seal on the bottom of Teflon filter is even and centered on the filter. RESULTS Properly Centered Imprint Improperly Centered Imprint Is the imprint of seal on the bottom of Teflon filter (shown in gray) even and centered on the filter as shown in the figure above? Comments

9 Page 9 of 3 NOISE CHECK PURPOSE To verify the IONSCAN-LS detector is operating within the defined acceptance limits for system noise. BACKGROUND Noise is an important characteristic that specifies a detector s performance. Low noise level is especially important when analyzing compounds at low trace levels. IONSCAN detector noise primarily originates from micro-phonic noise (motion of guard grid relative to collector plate) and preamp noise (resistance noise). The root mean square noise is determined by using a built in Ionscan Manager Software function to measure the root mean square noise in a defined drift time interval. RMS Amp RMS (root mean square) amplitude of the signal over all segments of the Seg Range, in the drift time interval specified. P-P Amp Displays the peak-to-peak amplitude of all segments of the range (difference between maximum and minimum of all segments). TEST EQUIPMENT LIST. Instrument Manager Software. (IM Software). PROCEDURE Negative Ion Mode. With slide tray down run three blank samples.. Acquire sample plasmagram with IM software. 3. With built in IM software function, measure RMS and Peak to Peak noise from msec and record in table. Positive Ion Mode. With slide tray down run three blank samples.. Acquire sample plasmagram with IM software. 3. With built in IM software function, measure RMS and Peak to Peak noise from msec and record in table. RESULTS Specified Tolerance Negative Ion Mode Positive Ion Mode Time Interval msec msec Recorded RMS noise < 3 du Peak to Peak noise < 5 du Are noise levels in negative ion mode within specified tolerances? Are noise levels in positive ion mode within specified tolerances?

10 Page 0 of 3 CALIBRANT ION CHECK PURPOSE To verify that a calibrant peak is present in the correct position in both positive and negative modes. BACKGROUND After the IONSCAN unit has warmed up and temperatures have stabilized, the unit searches for the presence of the calibrant peak before the unit goes into READY mode. The IONSCAN-LS unit uses the calibrant peak position to determine the drift times of all analyte peaks which have been programmed in based on the equation below: t anal d K K o = anal t o cal cal d wheret anal d calibrant peak, K anal o and calibrant peaks. is the expected drift time of the analyte ion, t cal and K cal o d is measured drift time of the are the programmed reduced ion mobility values of the analyte Parameters which effect the calibrant ion drift time are drift tube temperature, inlet temperature, drift flow rate, ambient atmospheric pressure and humidity level of the drift gas. All these parameters are either controlled or compensated for. The instrument controls drift tube and inlet temperature and drift flow. An air purification cartridge provides clean dry air for the instrument to use. An absolute pressure transducer determines the absolute pressure that is used to determine the expected position of calibrant. The IONSCAN-LS is designed to operate only when the calibrant peak is identified by its internal algorithm. This test will verify that the calibrant algorithm is properly programmed in and the IONSCAN-LS is detecting it within manufacturer s specifications. PROCEDURE Negative Ion Mode. Record in the table below if the instrument is in READY mode.. Note calibrant installed in instrument. 3. From configuration file, note calibrant Ko. 4. Run a blank sample and record the FWHM and Max Amplitude and delta of the calibrant. Positive Ion Mode. Record in the table below if the instrument is in READY mode.. Note calibrant installed in instrument. 3. From configuration file, note calibrant Ko. 4. Run a blank sample and record the FWHM and Max Amplitude and delta of the calibrant.

11 Page of 3 RESULTS READY after hour? Calibrant Calibrant Ko Calibrant FWHM Calibrant Max Amp Calibrant delta Negative Ion Mode Positive Ion Mode Ready after hour? Calibrant Ko within expected range (See table)? Calibrant FWHM within expected range (See teble)? Calibrant Max Amp greater than threshold listed (See table)? Calibrant delta within + 60? Negative Ion Mode Positive Ion Mode Calibrant Ko Range FWHM Range Max Amp Threshold Isobutyramide Nicotinamide nitrobenzonitrile

12 Page of 3 REACTANT ION CHECK PURPOSE To verify that reactant peaks are present in the correct position in the negative mode. BACKGROUND In the negative mode, a reactant is added via a diffusion source in the sample path to aid in the ionization process. Since the IONSCAN-LS does not actively monitor the reactant level, as it does the calibrant, it is necessary to verify the level to establish that the instrument is operating within specifications. This is done by evaluating the reactant level at the beginning and end of a series of consecutive runs. The IONSCAN-LS must maintain a minimum level over the course of the analyses. PROCEDURE Negative Ion Mode Only. Run a blank sample with no substrate present.. Scroll through segments and using the gaussian fit function, find the maximum amplitude of the reactant peak nearest 7.0ms. 3. Run 5 consecutive analyses (starting each analysis as soon as the IONSCAN-LS comes READY) with no substrate present. 4. On the last sample, scroll through segments and using the gaussian fit function, find the maximum amplitude of the reactant peak nearest 7.0ms. Initial Reactant Amplitude Reactant Amplitude after Sample series. Maximum Reactant Amplitude Amplitude Threshold 600 du 00 du Max Amp above threshold?

13 Page 3 of 3 LIMIT OF DETECTION CHECK PURPOSE To verify the IONSCAN-LS is able to detect a minimum quantity of TNT and diazepam. BACKGROUND To demonstrate IONSCAN-LS units ability to detect 5 pg TNT in negative ion mode and 50 pg diazepam in positive ion mode. TEST EQUIPMENT LIST. Teflon membrane (p/n ). 5 pg/µl trinitrotoluene solution in hexane pg/µl diazepam solution in acetone 4. 5 or 0 µl syringe PROCEDURE Negative Ion Mode Set up:. Place a Teflon membrane in the swipe tray and close tray. Run three blank samples. 3. Deposit a µl aliquot of 5 pg/µl TNT solution in the middle of the Teflon membrane. 4. Allow aliquot to evaporate for 5 seconds then analyze the sample. 5. Record if TNT was detected. 6. Repeat steps 3 to 5 two more times. Positive Ion Mode Set up:. Place a Teflon filter in the swipe tray and close tray.. Run three blank samples. 3. Deposit a µl aliquot of 50 pg/µl diazepam solution in the middle of the Teflon membrane. 4. Allow aliquot to evaporate for 5 seconds then analyze the sample. 5. Record if diazepam was detected. 6. Repeat steps 3 to 5 two more times. RESULTS Run Run Run 3 Was TNT detected? Was diazepam detected? Was 5 pg of TNT detected? Was 50 pg of diazepam detected?

14 Page 4 of 3 INJECTION REPEATABILITY CHECK PURPOSE To verify IONSCAN-LS reproducibility associated with the analysis of sample aliquots is within acceptable limits. BACKGROUND The injection volume precision is based on a sequence of runs where a TNT standard is used in negative mode and diazepam standard is used in positive ion mode. These standards are injected 5 times, always with the same volume. The average cumulative amplitudes are determined for each sample and the relative standard deviation of the average is calculated for positive and negative mode. TEST EQUIPMENT LIST. Teflon membrane (p/n ). 0.5 ng/µl diazepam in acetone ng/µl trinitrotoluene in hexane 4. 5 or 0µL syringe PROCEDURE Negative Ion Mode. Place a Teflon membrane in the swipe tray and close tray.. Run 3 blank samples. 3. Deposit a µl aliquot of the TNT solution on the Teflon membrane. 4. Allow aliquot to evaporate for 5 seconds then analyze the sample. 5. Record Cumulative Amplitude in table below. 6. Repeat steps 3-5 four more times. 7. Calculate Relative Standard Deviation. Positive Ion Mode. Place a Teflon membrane in the swipe tray and close tray.. Run 3 blank samples. 3. Deposit a µl aliquot of the diazepam solution on of the Teflon membrane. 4. Allow aliquot to evaporate for 5 seconds then analyze the sample. 5. Record Cumulative Amplitude in table below. 6. Repeat steps 3-5 four more times. 7. Calculate Relative Standard Deviation. RESULTS Sample Sample Sample 3 Sample 4 Sample 5 Average Std Dev Relative Standard Deviation (RSD) Is RSD < 0 % 0.5 ng TNT Negative Ion Mode(Cum Amp) 0.5 ng Diazepam Positive Ion Mode(Cum Amp)

15 Page 5 of 3 DETECTOR LINEARITY CHECK PURPOSE To verify the detector shows a linear response over a working range. BACKGROUND Detectors become non-linear when the amount of the test compound increases above a certain limit. The linearity test is based on a sequence of runs where a TNT solution or Diazepam solution is injected several times from vials containing different concentrations using the same injection volume. When the cumulative amplitudes associated with each peak are plotted against the concentrations, the points should lie on a straight line. The correlation of this calibration curve is used as one criterion to measure detector linearity. Five standards will be analyzed to evaluate linearity. TEST EQUIPMENT LIST. Teflon membrane (p/n ). 50,00,50, 00,50 pg/µl diazepam solutions in acetone 3. 50,00, 50, 00, 50 pg/µl TNT solutions in hexane 4. 5 or 0 µl syringe PROCEDURE Negative Ion Mode. Place a Teflon membrane in the swipe tray and close tray.. Run three blank samples. For each TNT solution: 3. Deposit a µl aliquot onto a Teflon membrane. 4. Allow aliquot to evaporate for 5-7 seconds then analyze the sample. 5. Record the CumAmp in the table below. 6. Repeat steps 3-5 two more times. 7. Use a suitable program to plot concentration versus average cumulative amplitude and to calculate the r value based on the equation y = ax + b. Positive Ion Mode. Place a Teflon membrane in the swipe tray and close tray.. Run three blank samples. For each diazepam solution: 3. Deposit a µl aliquot onto a Teflon membrane. 4. Allow aliquot to evaporate for 5-7 seconds then analyze the sample. 5. Record the CumAmp in the table below. 6. Repeat steps 3-5 two more times. 7. Use a suitable program to plot concentration versus average cumulative amplitude and to calculate the r value based on the equation y = ax + b.

16 Page 6 of 3 RESULTS Sample Conc. pg/µl Sol 00 Sol 00 Sol Sol Sol Slope = Intercept = r = Is r > 0.98? TNT Linearity Results Diazepam Linearity Results Run Run Run 3 Average Run Run Run 3 Average

17 Page 7 of 3 CARRYOVER CHECK PURPOSE After a detection, one PASS should be obtained before analyzing the next sample. The purpose of this test is to determine the amount of carryover that occurs after analyzing a large sample. BACKGROUND To test carryover when an injection is done from a vial filled with a sample of high concentration. TEST EQUIPMENT LIST. 500 pg/µl TNT solution. ng diazepam solution 3. Teflon membrane (p/n ) 4. 5 or 0 µl syringe PROCEDURE Negative Ion Mode. Place a Teflon membrane in the swipe tray and close tray.. Run three blank samples. 3. Deposit a µl aliquot of the ng/µl TNT solution on the Teflon membrane. 4. Allow aliquot to evaporate for 5-7 seconds then analyze the sample. 5. Record TNT Cumulative Amplitude in the table below. 6. Run blank samples and record Cumulative Amplitude of TNT peak until a PASS is obtained. 7. Repeat steps 3-6 two more times. If first blank was clean skip this step. Positive Ion Mode. Place a Teflon membrane in the swipe tray and close tray.. Run three blank samples. 3. Deposit a µl aliquot of the ng/µl diazepam solution on the Teflon membrane. 4. Allow aliquot to evaporate for 5-7 seconds then analyze the sample. 5. Record diazepam Cumulative Amplitude in the table below. 6. Run blank samples and record Cumulative Amplitude of diazepam peak until a PASS is obtained 7. Repeat steps 3-6 two more times. If first blank was clean skip this step.

18 Page 8 of 3 RESULTS TNT Carry Over Check Sample 500 pg TNT (TNT Blank. (TNT CumAmp) CumAmp) Blank Blank Blank 3 3 Average Is % carryover at 500 pg level < %? Sum of TNT CumAmp Response for Blanks % Carry Over: (Sum of Blank/ ng response) x 00 Diazepam Carry Over Check Sample.0 ng diazepam (CumAmp) 3 Average Blank. (diazepam CumAmp) Blank Blank Blank 3 Sum of diazepam CumAmp Response for Blanks % Carry Over: (Sum of Blank/ 0 ng response) x 00 Is % carryover at ng level < %?

19 Page 9 of 3 SUMMARY OF PERFORMANCE VERIFICATION Check DESORBER SEAL CHECK Negative ION Mode Positive Ion Mode NOISE CHECK CALIBRANT ION CHECK REACTANT ION CHECK LIMIT OF DETECTION INJECTION REPEATABILITY CHECK DETECTOR LINEARITY CHECK CARRYOVER CHECK FINAL CONCLUSION Did Instrument pass all of the tests in the above table? Yes (PASSED PERFORMANCE VERIFICATION) No (FAILED PERFORMANCE VERIFICATION) Comments:

20 Page 0 of 3 APPENDIX In this appendix the documentation of mathematical or statistical formulas used in the tests described in the previous chapters are discussed. NOISE ANALYSIS During an analysis, multiple scans are co-added to define a segment of analysis and the total number of segments defined by the analysis time. For example a typical scan period is 0 msec, 0 scans are co-added to define segment of analysis (0.4 sec) and the analysis time is 8 seconds giving 0 segments of analysis. The IM3 software noise analysis feature calculates signal and peak-to-peak amplitude data in the specified drift time interval. A drift time interval at the beginning of the analysis is selected which is free of peaks. The following data is then displayed in the top left corner of the plasmagram: Seg Range: RMS Amp: P-P Amp: Max P-P Seg: Max P-P Amp: Range of segments used in the calculations. RMS (root mean square) amplitude of the signal over all segments of the Seg Range, in the drift time interval specified. Displays the peak-to-peak amplitude of all segments of the range (difference between maximum and minimum of all segments). Specifies the segment with the highest peak-to-peak amplitude. Shows the peak-to-peak amplitude of the Max P-P Seg. 3D Plasm agram 40 Peak Height (du) Drift Time (ms) IN THE ABOVE FIGURE NOISE WOULD BE ANALYZED OVER THE DRIFT TIME INTERVAL FROM 5.0 TO 5.3 MSEC. EACH OF THE LINES IN THE FIGURE IS A SEGMENT OF ANALYSIS. DATA SET OVER WHICH NOISE ANALYSIS IS PERFORMED: aij signal (du) for segment j at point i in drift time s j Number of scans per segment for segment j n, n Range of indices ( i ) over which RMS and Peak-to-Peak noise is to be calculated k, k Range of segments ( j ) over which RMS and Peak-to-Peak noise is to be calculated

21 Page of 3 Define: u b b j = ( n n + ) u i= u a ij Min( a u j, min ij j ) = For n i n = Max( aij u ) For n i n j, max j σ j = u [ aij u j ] i= u ( n n + ) Therefore, the RMS Amp= σ = k j= k σ j s j k j= k s j Max P-P Amp: Maximum Peak-to-Peak Amplitude: b = Max b [ b ] P P j, max j,max For j= k, k Max P-P Seg: Segment associated with Max P-P amplitude kmax = Value of j on which b p-p based Further: min Min( b j, min ) max Max( b j, max b = b = Therefore, P-P Amp= b abs = ( b max bmin ) )

22 Page of 3 REGRESSION ANALYSIS The linearity test uses regression analysis during the evaluation. Linearity is derived from the linear function: Let: N = number of discrete observations X i = independent variable, i th observation Y i = dependent variable, i th observation Determination of coefficients: X Y b N = i = N = i = Y X i i N { ( X i X )( Yi Y )} i= = N ( X i X ) i= a = Y bx Regression Coefficient: r = Y X = a + bx N { ( X i X )( Yi Y )} N N ( X ) ( ) i X Yi Y i= i= i= DETERMINATION OF INJECTION REPRODUCIBILITY N = number of replicate samples A = Measured value associated with i th sample i Average A Standard Deviation SD = N i= = N A i N ( Ai A) i= N (Results are a small sampling) Relative Standard Deviation RSD SD 00 = A

23 Page 3 of 3 REVISION HISTORY. Revision.00, Effective Date, August 9, 00. Revision.00, Effective Date, July 7, 003 Removed Calibrant and Reactant Ion Check. Removed Data Acquisition tables from Test Procedure Added option to use Teflon membrane filters 3. Revision 3.00, Effective Date, March 4, 004 Modifications based on Version 6.40, Installation and Operation Qualification of IONSCAN-LS, Effective Date, March 4, Revision 4.00, Effective Date, August 0, 0 Updated method to be similar to PV documentation for IONSCAN-LS/HPI