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    PQ Test Protocol MPA Sphere 20231211 064846

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    Ali Rizvi
    This document outlines the results of a periodic quality test on a Novartis Pharmaceuticals MPA Sphere instrument. The overall test result was failed as one of the individual tests, the signal to noise test, did not meet its minimum requirement. The document provides details on the instrument configuration and test parameters as well as the results, spectra, and pass/fail status of each test.

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    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd

    PQ Test Protocol MPA Sphere 20231211 064846

    Uploaded by

    Ali Rizvi
    35 views5 pages
    This document outlines the results of a periodic quality test on a Novartis Pharmaceuticals MPA Sphere instrument. The overall test result was failed as one of the individual tests, the signal to noise test, did not meet its minimum requirement. The document provides details on the instrument configuration and test parameters as well as the results, spectra, and pass/fail status of each test.

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    PQ_Test_Protocol_MPA_Sphere_20231211_064846

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    This document outlines the results of a periodic quality test on a Novartis Pharmaceuticals MPA Sphere instrument. The overall test result was failed as one of the individual tests, the signal to noise test, did not meet its minimum requirement. The document provides details on the instrument configuration and test parameters as well as the results, spectra, and pass/fail status of each test.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    35 views5 pages

    PQ Test Protocol MPA Sphere 20231211 064846

    Uploaded by

    Ali Rizvi
    This document outlines the results of a periodic quality test on a Novartis Pharmaceuticals MPA Sphere instrument. The overall test result was failed as one of the individual tests, the signal to noise test, did not meet its minimum requirement. The document provides details on the instrument configuration and test parameters as well as the results, spectra, and pass/fail status of each test.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    of 5

    OVP - PQ Test Protocol

    Company: Novartis Pharmaceuticals


    Operator: Admin
    Instrument Type: MPA Sphere
    Optics Configuration: Sphere Background with: NIR, Quartz, RT-Pbs [External]
    Accessory: None
    Instrument Serial Number: 2006068
    Instrument Firmware Version: 1.470 Oct 5 2006
    OPUS/DB Version: OPUS 8.5(SP1) Build: 8, 7, 10 / DB: 8,7,10,139
    Overall Test Result FAILED
    Test expires: Test failed
    Test Date/Time: 12/11/2023, 6:48:46 AM (GMT-8)
    Test Spectra Path: C:\Users\Public\Documents\Bruker\OPUS_8.7.10\Validation\Data
    \20231211\064846
    Date of last PQ Reference
    Measurement: 12/11/2023
    Comment:

    Signal to Noise Test

    Minimum S/N(area 1): 500 Measured S/N: 2969

    100% Line Test

    Maximum 100% Line Deviation: 0.5 Measured 100% Line Deviation: 0.52

    Interferogram Peak Test

    Minimum Amplitude[%] : 70 Measured Amplitude[%]: 100.0

    Energy Test

    Maximum allowed Value: 30 Measured Value: 0.3

    Wavenumber Accuracy Test - BRM 2065 (37.0 Deg. C, Peak is T. corr.)

    Sample Material: BRM 2065


    Specified Peak: 10245.50 cm-1 Maximum Deviation: 0.60 cm-1
    Measured Peak: 10245.80 cm-1
    Corrected Peak: 10245.53 cm-1 Measured Deviation: 0.03 cm-1

    Photometric Reproducibility Test - Glass Filter A

    Maximum Deviation[%]: 0.8 Measured Deviation[%]: 0.04

    Overall Test Result = FAILED

    Date and Signature Date and Signature

    ________________
    Page 1 of 5 Page Signature
    OVP - PQ Test Protocol
    Signal to Noise Test, Spectra
    100% Line Test, Spectra
    Energy Test, Spectra
    101.0
    99.5 100.0 100.5
    Transmittance [%]
    99.0

    9000 8000 7000 6000 5000


    Wavenumber cm-1
    1 PQ_MPA_Sphere_Energy_1.0
    2 PQ_MPA_Sphere_Energy_2.0
    3 PQ_MPA_Sphere_Energy_3.0
    4 PQ_MPA_Sphere_Energy_4.0
    5 PQ_MPA_Sphere_Energy_5.0

    1 1f36c60d-377e-4152-8afa-80fdd5772ef6
    2 4627c3a0-a7f2-46ce-85be-b3d71a9bcea7
    3 db032420-eefd-4ac7-974a-84c98faf579d
    4 9ad49670-06bc-4c90-a3b6-3625dafb2561
    5 ffb2dced-08fe-46c8-991c-f07c0e821f3a

    Energy Test, Measurement Parameters


    Number of Scans: 10 Preamplifier Gain: Ref
    Resolution [cm-1]: 8 Zero filling: 2
    Aperture: Open Phase Correction: Power Spectrum
    Acquisition Mode: Double Sided,Forward-Backward Velocity: 10 KHz
    Apodization Function: Blackman-Harris 3-Term Phase Resolution: 128
    Low Pass Filter: 10 KHz High Pass Filter: Open

    ________________
    Page 2 of 5 Page Signature
    OVP - PQ Test Protocol
    Interferogram Peak Test, Spectrum
    0.4
    0.2
    0.0
    -0.2
    -0.4

    14000 12000 10000 8000 6000 4000 2000 0


    Points
    PQ_MPA_Sphere_Energy_1.0

    1f36c60d-377e-4152-8afa-80fdd5772ef6

    Interferogram Peak Test, Measurement Parameters


    Number of Scans: 10 Preamplifier Gain: Ref
    Resolution [cm-1]: 8 Zero filling: 2
    Aperture: Open Phase Correction: Power Spectrum
    Acquisition Mode: Double Sided,Forward-Backward Velocity: 10 KHz
    Apodization Function: Blackman-Harris 3-Term Phase Resolution: 128
    Low Pass Filter: 10 KHz High Pass Filter: Open

    ________________
    Page 3 of 5 Page Signature
    OVP - PQ Test Protocol
    Wavenumber Accuracy Test BRM 2065 (37.0 Deg. C, Peak is T. corr.), Spectrum

    10245.80
    0.8
    Absorbance Units
    0.4 0.6
    0.2

    10300 10250 10200 10150


    Wavenumber cm-1
    PQ_MPA_Sphere_Frequency.1

    c4485a57-bcde-4a7d-a1e8-9617e5933b2a

    Wavenumber Accuracy Test BRM 2065 , Measurement Parameters


    Number of Scans: 32 Preamplifier Gain: Ref
    Resolution [cm-1]: 4 Zero filling: 8
    Aperture: Filter BRM2065 Phase Correction: Power Spectrum
    Acquisition Mode: Double Sided,Forward-Backward Velocity: 10 KHz
    Apodization Function: Blackman-Harris 3-Term Phase Resolution: 64
    Low Pass Filter: 10 KHz High Pass Filter: Open

    ________________
    Page 4 of 5 Page Signature
    OVP - PQ Test Protocol
    Photometric Reproducibility Test - Glass Filter A, Spectrum
    25
    Transmittance [%]
    10 15 520

    10000 9000 8000 7000 6000 5000


    Wavenumber cm-1
    PQ_MPA_Sphere_GFA.0

    391458b8-3cb7-47b3-b248-5b447a2601de

    Photometric Reproducibility Test - Glass Filter A, Measurement Parameters


    Number of Scans: 32 Preamplifier Gain: Ref
    Resolution [cm-1]: 8 Zero filling: 2
    Aperture: Filter NG9 Phase Correction: Mertz
    Acquisition Mode: Double Sided,Forward-Backward Velocity: 10 KHz
    Apodization Function: Blackman-Harris 3-Term Phase Resolution: 64
    Low Pass Filter: 10 KHz High Pass Filter: Open

    ________________
    Page 5 of 5 Page Signature

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