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Agilent Technologies
Operation al Qu al ification/Performan ce Verificati on
for the Agilent 78908 Series GC/MSD System
lnstrument lD
Comments:
1
ln this Protocot
This protocol is intended for technical readers in regulated environments who are
perforrring operational qualification/perfonnance verification (OQ/PV) on AgiIent
Technologies GCiMS Syster-ns.
ProtocoI Approval
Contents: Fill in fbrms for approval of protocol by customer and Agilent Technologies.
Protocol Dctails
Contents: Fill in fbrms fbr details of the OQ/PV to be pertbrrred.
Equipment List
Clontents: Equipment required to perform thc OQ/PV tests.
Qualilication Ovcrvicw
Contents: General qualification procedure, individual test ovelview, and acceptance lirnits.
Procedures and Results
Clorltents: Procedures and results for general qualitrcation, preparation and tests.
Form ulas (if reqLrested)
Cor-rtents: Formulas and figures tbr evaluation of test results.
Certification of System Qualification
Clontents: F'ill in fbrms for deviation correction and OQ,fV celtillcation.
Attachmcnts/Supporting Docu ments
Contents: Relevant forms and data produced
Warranty
The infbrrnation contained irr this document is subject to change rvithout notice. Agilent Technologies
rrakes no warranty of any kind to this material, incltrding but not limited to, the implied wananties or
merchantability and fitness lbr a particular purpose. Agilent Tecl.urologies shall not be liable for errors
conlained herein or tbr incidental or consequential damages in connection with the furnishing,
performance. or use of this material.
Clomments:
Table of Contents
Comments:
Rev. A.02.20 Date Printed: 2l-Lpr-2021 15:44:54 I Pae.- 3 of 15
Protocol Approval
PROTOCOL APPROVAL
Use this protocol to qualify and record the configuration and operation of the GC
instrument.
A sign offarea has been provided at the bottom ofeach page in case an internal SOP
requires review and acceptance of every page in this document. If page-by-page sign
off is not required, use the area to document deviations only. Acceptance of the entire
document is complete when the Certifrcation of System Qualification is reviewed and
signed by the responsible parties.
I have reviewed this document and agree that it provides appropriate procedures for
the Operational Qualification (OQ) of the equipment for which it has been configured
Gustomer Details
The customer listed below is the owner/user of the instrument.
lnstrument Details
The procedures in this OQ/PV will be performed on the instrument listed below.
Initial
Initial or Requalification Datc OQ/PV Last Perfonned if Requalification
Qualification Details
The following details apply to the OQ/PV performed on the instrument listed above.
1 lime / vcar
Frequency of OQ/PVs
Clommcnts:
Instrument Record
GC/MSD System
INSTRUMENT REGORD
s977
Model Number Serial Number Instrument ID.t Description
c70118 us1743M029 Mass Selective Detector
For comprehensive system details, see the Installation Qualification.
* The mainfiame serial number is required. Include instrument IDs
for all accessories.
** Optional customer supplied information (asset number, system number, system name, and so on)
7890
Model Nurnber Serial Number' Instrument ID Description
:134408 us r 7433054 Gas Chromatograph
For comprehensive system details, see the Installation Qualification.
* Ihe mainframe serial number is required. lnclude instrument IDs
for all accessories.
++ Optional customer supplied information (asset number, system number, system nqme, and so on)
Comments:
Instrument Preparation
System Inspection/lnlet Preparation
. Are there any apparent safety issues in the GCiMSD system and surrounding
atea?
No No Pass KMl0l-04-2021
. Are all the power, signal, and remote cables connected properly?
Comments:
Basic Operation and Safety Tests
Does the systern successtully cornplete the self-test without reporting errors?
Result (YesNo) Acceotance Pass,iFail Verified bv; Date
Yes Yes Pass KM 01-04-2021
* lf this i,s lha c:Lrstomer's systetfi, close the ChemStotion sessittrt befbre y.nt,er c.y-clins the GC. A Not
LleoJv stttltts is nul ttn crrot.
Comments:
Back Inlet Test
S/SL Inlet Leak Test
Comments:
GC Oven Temperature Accuracy Test
Comments:
RFPA Test
RFPA TEST
Results
RFPA Test
Record the outcome of the rninimizatiot procedure included in the previous section.
Typical
Measured Customer
ltern Range of Pass/Fail Veritled Bv/Date
Value Specification
Operation
Minimized value
360 <ll00uV Pass KNv07-04-2021
at 800 m/z (Vi)
Comments:
Declaration of Change Control
Mass Axis
59.00 59.00 +/- 0.20 Pass KMl01-04-2021
ttrlz- 69
Mass Axis
219.00 219.00 +t- 0.20 Pass KM/07-0.1-202 I
rlz:219
Mass Axis
s02.06 502.00 +l- 0.20 Pass KMl07-04-202r
n/z- 502
Mass Axis
70.03 70.00 +/- 0.20 Pass KM/07-04-2021
mlz- 1O
Mass Axis
220.00 220.00 +/- 0.20 Pass KMt07-04-2021
mlz:220
Mass Axis
503.07 503.00 +/- 0.20 Pass KMl07-04-2021
mlz:503
lsotope Ratio
1.45 1.50 to 1.60 % Pass KMl07-04-2021
70169
lsotope Ratio
4.31 3.20 to 5.40 Yo Pass Kj|i1/07-04-2021
22012r9
lsotope Ratio
10.39 7.90 to 12.30 0/o
Pass KMIOT-04-2021
s03lso2
Abundance
)1.23 > 40.00 Yo Pass KW07-04-2021
Ratio 219169
Abundance o/"
5.87 > 2.40 Pass Kls.,.IOT-04-2021
Ratio 502169
Abundance
7.77 <20.00% Pass KMt07-04-2021
Ratio l8/69
Abundance
Ratio 28/69
t.s2 10.00 % Pass KMl07-04-2021
Comments:
Declaration of Change Control
This document is under change control. Revision history is maintained and printed on
each document. Access to the master documents is limited to process owners.
Documents receive periodic review and cannot be assigned an evergreen status. The
qualification perlbrmed according to this document refers only to the
hardware/software configuration in place at the time of the qualification.
Agilent Technologies recommends that instrument configuration change management
procedures be in place to maintain the validation process. Any changes to the
analytical or computer hardware or software must be clearly specified. A change
management system provides a means for determining the degree of re-qr-ralification
required according to the extent of the changes made. All details of the changes,
completed tests, and test results must be thoroughly recorded and documented.
Note: Instrument conf,rguration change management is not the responsibility of
Agilent Technologies.
Comments:
Certification of System Qualification
Sumrnary of Results
*Attach a Devialion Corection Reporl Form and supporting documenlation to the Attachntents
section of this protocol.
Attached Number of
Document (Yes/No) Pages
1. Etune and Tune Evaluation Report (EI) Yes
Notice
Comments:
.Extraction Source Autotune - 5977
timestamp: 07-Apr-27 1:03 PM (UTC+07;00) GCMS 59778
R\GCM S\1\5977\etu ne. u us7743M029
Ion Polarity Pos PFTBA Open
I
il Em i ssi on 34.6 [4ass Gain -388
Electron Enero\ lo.o Mass Offset -21
Filament 1 Amu Gain 1366
lepel I er 3.39 Amu Offset 139.63
Ion Focus 89.8 width219 -0.030
Entrance Lens 7t.6 DC Polarity Pos
Ent Lens Offset 1 0.28 HED Enable On
Ion Body 10.0 0 Elvl Volts t387.7
0
Exlraator Lens
Scan SDeed
3_00
Low High Step Speed Threshold Peaks Base Abundance Total Ion
0.00 701.00 0.10 3 100 280 69.00 476,760 1,800,619
lrri;;5 (al'.)
Tatget rn/z Actual m/z Abund Rel Abund Iso m/z Iso Abund Iso Ratio
69.00 69.00 47 6,160 1 00.0% 70.10 7,083 1.5%
21 9.00 219.0 0 427,L84 88.5olo 220.00 19,128 4,50/o
tem Verificatlon for GCMS 59778 hied Apr 07 13:La:22 202I Page 1
'1, 6cMstsm kd.tion Sour..addune- dlne u - tcApTUREI trx
f rt. r,n. Vaculm k.dE Pnamtur ailc Dj.gndj.r rB M 66phi6 Hdp -E
-o
Mars Mltr k Msn
502@ 1772 27938 15G 7@i.9
Path D: \BNM\OQPV\SMART\GCMS 59778\
Fi 1e FIDO3 . D
0n 0'1 Apr 2021 14-:15
FIDO3
t Compounds Qvafue
c14 1 57 125482 0.22 g/L 98
c1s 1 .825 \/ 124948 0.22 g/L 96
c16 2 . L27 57 724029 0.22 q/L 99
t Compounds Qvalue
c14 1 .527 5't L22963 0.2L g/L 97
c15 1 .825 57 125337 0.22 g/L 98
c15 2 . L26 s7 124094 0.22 g/L 98
Compounds Qvalue
ca4 1. 527 5'/ 725563 0.22 g/L 91
c15 1. 825 51 726160 o.22 g/L 9l
2. L27 51 L24491 o.22 g/L 99
t Compounds Qvalue
c1-4 l - 627 57 124673 0. 22 g/L e]
c15 t.825 57 L23937 0. 22 g/L 96
c16 2 -L27 5't 1-252L2 0. 22 s/L 98
L Comoounds Qvalue
1) CL4 1 621 51 t-25408 a.22 g/L 98
2) C1s 1 825 57 1-2623 0 a.22 g/L 91
3) C16 2 L2'1 57 724962 0.22 g/L 99
t Compounds Qvalue
c14 1. 51 r23661 0. 22 g/L 91
c15 1. 825 51 t-27 061 0. 22 g/L e]
c16 2. 1-26 51 l-24499 0. 22 g/L 98
quaf I f rer out of range (m) = manual integration (+) = signafs summed
IRM Calibration
Not Apolicable DA Method Default. m
Status
Comment
Erpected Barcode Sample Amount
Dual Inj Vol 1 TuneName etune.u
singleQuadrupole
5.00.34
Firmware version
Chromatograms
OE
1.5
0.5
3.2 3.4 3.6 3.8 4 4.2 4.4 4.6 4.8 5 5.2 s.4 5.6 5.8 6 6.2 6.4 6.6 6.8 7 7.2 7.4 7.6 -7.8
Counts vs. Acquisition Time (min)
Agilent Technologies
Qualitative Analysis Report
x10 s
2.5
.1.5
0.5
3.2 3.4 3.6 3.8 4 4.2 4.4 4.6 4.8 5 5.2 5.4 5.6 5.8 6 6.2 6.4
Counts vs. Acquisition Time (min)
-- End Of Report -
',: AgilentTechnologies
I
'|}. AgilentTechnologies
Certificate of Completion
Title Of Course: ANCE-GCMS-2-041-D: 5977 EIICIIHES MSD GC-MS OPER. H/W S/W Intro, Rcpair
and Troubleshooting
All Service and Support training certilicates have the following specific limitations.
A ce rlificale for Service and Support training is onl1, vali6 while employed by Agilent Tcchnologies or while working as an Agilent-atrthorized sen,ice
provider', through u,hich thc servicc cnrployec has ongoing access to Agilent'st Safety AIo1s, Selvice Notes, rnternal technical updates. update training, cun'ent
docurentation, technical support, curreflt parts, and parls Lrpdates. Completion of lraining alone, r'vithont boing emplol,cd by r\gitcnt Technologies. cloes not
clualily an individtial to saf'ely' install, service or maintaitr Agilent products.