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Installation Operational Qualification
Serstech Arx+
Installation Qualification (IQ)
Operational Qualification (OQ)
Serstech AB, 2021

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Summary of Contents for Serstech Arx+

  • Page 1 Installation Operational Qualification Serstech Arx+ Installation Qualification (IQ) Operational Qualification (OQ) Serstech AB, 2021...
  • Page 2 For Serstech Arx+ the Qualification Plan includes • Installation Qualification (IQ) • Operational Qualification (OQ) In this document Installation Qualification (IQ) &...
  • Page 3 Part A – Installation Qualification (IQ) Installation Qualification for Serstech Arx+ The Installation Qualification (IQ) Test verifies that the Serstech Arx+ (both firmware and hardware), its accessories and peripheral systems (PC software) are present and have been installed in accordance with installation specifications. (Serstech Arx+ will hereinafter be...
  • Page 4 Installation Operational Qualification Accessories In Table 2 the accessories provided by Serstech is listed. Go through all accessories you to confirm that all components are present. Table 2: Verification of listed accessories Item Image Expected Number Pass/Fail number delivered Glass vials...
  • Page 5 Installation Operational Qualification Manuals Check the presence of manuals and fill in table 3. Table 3. Verification of manuals Manual format Delivered Yes/No Electronic form Paper form Sign. Service engineer Sign. Company representative ……………………………………………. ……………………………………………. Serstech AB, 2021...
  • Page 6 Table 4 presents the technical characteristics for the indicator. Table 4: Technical characteristics of Serstech Arx+ Item Specification...
  • Page 7 Installation Operational Qualification Installation Qualification for client application ChemDash Pro+ Chemdash, provided by Serstech, is a standalone PC application used for data storage, management, and review. Chemdash gives the ability to review data, creating reports and building user defined libraries. Follow the below steps to get started: 1.
  • Page 8 For Serstech Arx+ Indicator installation it is recommended not to attempt to repair the product by yourself. • In case of failure or damage please contact Serstech or your Serstech reseller for service matters. • Always follow your organization’s procedure and regulations for the handling of unknown substances.
  • Page 9 In order to perform Operational Qualification (OQ) for the indicator is needed to perform a series of tests with a Serstechs’ System Testing software. The Serstechs’ System Testing software has been designed and developed by Serstech (Sweden) and follows specific procedures based on the ASTM International “Standard Practice for Testing the Performance of Scanning Raman Spectrometers”...
  • Page 10 The calculated standard deviation of the “spectrum without fixed pattern noise” is the background noise. Please fill in the Table 10 the information you obtained from the dark background-hot pixels test. Serstech AB, 2021...
  • Page 11 Target values Acceptance Obtained value Pass/Fail range Background 2500 Cts ≤ 3000 Cts Mean Background 50 Cts ≤ 100 Cts Noise Hot pixels ≤ 2 Hot pixels (700 2800) Sign. Service engineer Sign. Company representative ……………………………………………. ……………………………………………. Serstech AB, 2021...
  • Page 12 FWHM values and is given in cm Fill in the results you obtained in the Table 7 below. Table 7: Optical resolution results –1) –1) Expected (cm Measured (cm Within range, Yes/No Pass/Fail < 11 Sign. Service engineer Sign. Company representative ……………………………………………. ……………………………………………. Serstech AB, 2021...
  • Page 13 Obtained value Pass/Fail range Count rate 110 Cts/ms >50 Cts/ms –1 801.3 cm Baseline noise 30 Cts ≤ 60 Cts 1800 ≤ 1500 Exposure time 500 ms ≤ 750 ms Sign. Service engineer Sign. Company representative ……………………………………………. ……………………………………………. Serstech AB, 2021...
  • Page 14 Table 9: x-axis accuracy and stability test for cyclohexane peak positions ASTM Peak Measured Peak Difference within Pass/Fail positions (cm-1) (2) Positions (cm-1) +/- 4 (cm-1) 801.3 1028.3 1266.4 1444.4 Sign. Service engineer Sign. Company representative ……………………………………………. ……………………………………………. Serstech AB, 2021...
  • Page 15 Installation Operational Qualification This manual is issued by: Serstech AB Contact information: Åldermansgatan 13 SE-227 64 Lund, Sweden Email: info@serstech.com Version 2.0: March 2021 Serstech AB, 2021...