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Research ArticleResearch

Single-Use System Integrity IV: A Holistic Approach Based on Compiled Scientific Study Data

Marc Hogreve
PDA Journal of Pharmaceutical Science and Technology March 2023, 77 (2) 133-144; DOI: https://doi.org/10.5731/pdajpst.2022.012794
Marc Hogreve
Product Development, Sartorius Stedim Biotech GmbH, Goettingen, Germany
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  • For correspondence: marc.hogreve@sartorius.com
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    Figure 1

    Pressure ranges used for integrity science studies.

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    Figure 2

    Test setup (A) and test sample (B) for microbial ingress testing.

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    Figure 3

    Test setup (A) and test sample (B) for liquid leakage testing.

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    Figure 4

    Test setup for flow rate measurement.

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    Figure 5

    Probability curves for microbial ingress in polyethylene film; (A) 0 mbar, (B) 70 mbar, (C) 150 mbar, and (D) 300 mbar.

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    Figure 6

    Experimental data and models comparing microbial ingress and liquid leakage; (A) ethylene vinyl acetate film and (B) polyethylene film.

Tables

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    TABLE I

    Number of Test Samples per Pressure and Film Type

    Pressure (Mbar)070150300
    EVA (300 µm)2884545150
    PE (400 µm)28819445150
    Total1205
    • EVA, ethylene vinyl acetate; PE, polyethylene.

    • View popup
    TABLE II

    Bacterial Growth vs total Number of Test Samples per Film Type and Test Pressure

    Pressure070150300
    Film TypeEVAPEEVAPEEVAPEEVAPE
    Nominal defect size [µm]Bacterial Ingress/Total Samples
    10/70/20/10/50/300/30
    20/180/180/80/20/20/60/302/30
    31/6*0/10/22/48/302/30
    40/10/31/5
    50/10/340/42/417/3010/30
    60/21/3
    70/11/11/1
    82/32/61/3
    90/2
    100/300/300/11/311/50/2
    121/1
    131/1
    150/300/301/130/311/23/4
    161/1
    171/1
    200/301/30*0/131/312/31/1
    250/300/301/131/311/1
    300/300/301/11/12/23/3
    351/1
    401/300/301/11/12/23/3
    501/306/301/14/43/34/4
    603/33/32/21/1
    703/31/11/1
    751/1
    8014/3015/302/21/1
    903/31/11/1
    10014/3022/301/11/11/1
    1101/11/1
    1201/11/1
    1301/1
    1501/1
    • EVA, ethylene vinyl acetate; PE, polyethylene.

    • View popup
    TABLE III

    Defect Sizes Showing a 10% Probability for Microbial Ingress

    EVA Film
    Pressure (mbar)Defect Size (µm)
    056.62
    703.62
    1504.18
    3002.00
    PE Film
    045.87
    709.78
    1501.96
    3002.83
    • EVA, ethylene vinyl acetate; PE, polyethylene

    • View popup
    TABLE IV

    Number of Test Samples per Pressure, Model Solution, and Film Type

    Pressure (Mbar)70150300
    Model SolutionWaterTSBWaterTSBWaterTSB
    EVA (300 µm)66-666
    EVA (360 µm)6631266
    PE (400 µm)1815-31515
    Total135
    • EVA, ethylene vinyl acetate; PE, polyethylene; TSB, tryptic soy broth.

    • View popup
    TABLE V

    Liquid Leakages vs Total Number of Test Samples per Film Type, Model Solution, and Test Pressure

    Model SolutionWaterTSB
    Applied Pressure (Mbar)Nominal Defect Size (µm)No. of Leaking Samples /No. of Tested SamplesNo. of Leaking Samples /No. of Tested Samples
    EVA 300 µmEVA 360 µmPE 400 µmEVA 300 µmEVA 360 µmPE 400 µm
    300103/33/35/63/3
    53/30/34/6
    33/33/36/6
    20/30/30/30/30/3
    15010
    50/36/12
    31/3
    20/30/3
    70253/33/3
    203/3
    153/33/3
    103/33/33/32/31/33/3
    53/33/3
    30/3
    20/30/30/30/30/3
    • EVA, ethylene vinyl acetate; PE, polyethylene; TSB, tryptic soy broth.

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PDA Journal of Pharmaceutical Science and Technology: 77 (2)
PDA Journal of Pharmaceutical Science and Technology
Vol. 77, Issue 2
March/April 2023
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Single-Use System Integrity IV: A Holistic Approach Based on Compiled Scientific Study Data
Marc Hogreve
PDA Journal of Pharmaceutical Science and Technology Mar 2023, 77 (2) 133-144; DOI: 10.5731/pdajpst.2022.012794
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Keywords

  • Single-use system (SUS)
  • single-use system integrity (SUSI)
  • maximum allowable leakage limit (MALL)
  • microbial ingress testing
  • liquid leak testing
  • gas flow rate through microchannels

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Single-Use System Integrity IV: A Holistic Approach Based on Compiled Scientific Study Data
Marc Hogreve
PDA Journal of Pharmaceutical Science and Technology Mar 2023, 77 (2) 133-144; DOI: 10.5731/pdajpst.2022.012794

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