Amendment 1 Questions and Answers.pdf

QUESTIONS AND RESPONSES

PREVENTATIVE MAINTENANCE PLAN FOR SCIEX AGILENT 1200 LCMS SYSTEM

HU000122Q0038

1. What vendor has been maintaining this LCMS instrument?

Response: Ion Technology Support is the most recent service provider for the Mass Spectrometer (MS).. The HPLC system has been serviced almost exclusively by Agilent although some of the maintenance and repairs have been through Remi.

2. How has this instrument been maintained? (ex. Does this instrument currently receive annual / bi-annual PM services?)

Response: The mass spectrometer should be receiving Preventive Maintenance (PM) visits every 6 months; the HPLC system should have a PM routine performed annually. However, the estimated actual time between PMs for the mass spectrometer is closer to 7-8 months and 13-14 months on the HPLC system.

3. When was the last PM Service performed (both the 4000 QTRAP and AG1200)?

Response: The last PM on the MS was in Aug. of 2021; the last PM on the HPLC system was April of 2021.

4. Is the instrument (both the 4000 QTRAP MS and AG1200LC) currently running to OEM specifications?

Response: Both instruments are functional, however, the mass resolution of the MS has degraded to the point where it probably does NOT meet OEM specifications (for instance if this instrument was being using in a clinical (diagnostic) or rigorous testing application (ex., FDA, NIST, or commercial manufacturing facility), it probably would not be in compliance with standard guidelines.

5. Are the MS and LC currently in need of repair?

Response: No.

6. What model computer is currently running the Mass Spec system? Does USUHS need to upgrade the acquisition computer on the instrument?

Response: Dell Optiplex XE2. No, the computer was upgraded in Jan. 2019 by the OEM.

7. What operating system is currently being used on the acquisition computer?

Response: Windows 10 Enterprise 2016 LTSB.

8. What version of the starter package of software is currently running the system (ex. SCIEX OS- MQ, Multiquant and/or which version of Analyst)?

Response: Analyst 1.7.

9. Does the end user need to be upgraded into the latest version of operating software (there is no mention of software coverage in the SOW)?

Response: No, Software has not been covered by the PM procedure.

10. Please confirm the serial number that was provided for the LC: Binary Pump, model G1312A, s/n DE63061376.

Response: The model and serial number for the Binary Pump component of the LCMS system is correct. Additionally the three (3) other working components of the fully functional HPLC system to be services are:

Degasser – Model G1379B, Serial JP82011069

AutoSampler -- Model G1367B, Serial DE64557460

Column Oven -- Model G1316A, Serial DE90375304

The AutoSampler listed is not the original AutoSampler from when the HPLC system was purchased from the OEM; due to functional issues USU was given a replacement for the original, non-functioning AutoSampler. The HPLC system, as far as Agilent is concerned, is designated by the serial number of the Binary Pump, and if Agilent’s manufacture/service records were to be referenced by a vendor, there would be a discrepancy due to the swap.