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Research ArticleResearch

Single-Use System Integrity III: Gas Flow Rate through Laser-Drilled Microchannels in Polymeric Film Material

Saeedeh Aliaskarisohi, Tomasz Urbaniak and Marc Hogreve
PDA Journal of Pharmaceutical Science and Technology January 2022, 76 (1) 9-18; DOI: https://doi.org/10.5731/pdajpst.2021.012631
Saeedeh Aliaskarisohi
Product Development, Sartorius Stedim Biotech GmbH, Germany
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Tomasz Urbaniak
Product Development, Sartorius Stedim Biotech GmbH, Germany
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Marc Hogreve
Product Development, Sartorius Stedim Biotech GmbH, Germany
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  • For correspondence: marc.hogreve@sartorius.com
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References

  1. 1.↵
    U.S. Pharmacopeial Convention, General Chapter <1207> Packaging Integrity Evaluation—Sterile. In USP 42—NF 37, USP: Rockville, MD, 2019.
  2. 2.↵
    ASTM International, ASTM E3244- 20 Standard Practice for Integrity Assurance and Testing of Single-Use Systems. ASTM: West Conshohocken, PA, 2020.
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    Single-Use System Integrity I: Using a Microbial Ingress Test Method to Determine the Maximum Allowable Leakage Limit (MALL). PDA J. Pharm. Sci. Technol. 2019, 73 (5), 459–469.
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    Single-Use System Integrity II: Characterization of Liquid Leakage Mechanisms. PDA J. Pharm. Sci. Technol. 2020, 75 (3), 258–272.
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    1. Gilchrist J. E.,
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    Energetic Analysis of the Hagen-Poiseuille Law. Tec-Science web site. https://www.tec-science.com/mechanics/gases-and-liquids/energetic-analysis-of-the-hagen-poiseuille-law/ (accessed Jan 1, 2021).
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    Fluid Flow Through Calibrated Orifices. Lenox Laser web site. https://lenoxlaser.com/publications/fluid-flow-through-calibrated-orifices/ (accessed Jan 12, 2021)
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    1. Peiyi W.,
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    Measurement of Friction Factors for the Flow of Gases in Very Fine Channels Used for Microminiature Joule-Thomson Refrigerators. Cryogenics. 1983, 23 (5), 273–277.
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    1. Valougeorgis D.
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    1. Verma B.,
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    Semiempirical Correlation for the Friction Factor of Gas Flowing through Smooth Microtubes. J. Vac. Sci. Technol., A 2009, 27 (3), 584–590.
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  12. 12.↵
    1. Arkilic E. B.,
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    Gaseous Slip Flow in Long Microchannels. Fluid Dyn. Res 1995, 1–16.
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    1. Dongari N.,
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    Analytical Solution of Gaseous Slip Flow in Long Microchannels. Int. J. Heat Mass Transfer 2007, 50 (17–18), 3411–3421.
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    Variational Iteration Method for Two-Dimensional Steady Slip Flow in Micro-Channels. Arch. Appl. Mech. 2011, 81 (11), 1597–1605.
    OpenUrl
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PDA Journal of Pharmaceutical Science and Technology: 76 (1)
PDA Journal of Pharmaceutical Science and Technology
Vol. 76, Issue 1
January/February 2022
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Single-Use System Integrity III: Gas Flow Rate through Laser-Drilled Microchannels in Polymeric Film Material
Saeedeh Aliaskarisohi, Tomasz Urbaniak, Marc Hogreve
PDA Journal of Pharmaceutical Science and Technology Jan 2022, 76 (1) 9-18; DOI: 10.5731/pdajpst.2021.012631

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Single-Use System Integrity III: Gas Flow Rate through Laser-Drilled Microchannels in Polymeric Film Material
Saeedeh Aliaskarisohi, Tomasz Urbaniak, Marc Hogreve
PDA Journal of Pharmaceutical Science and Technology Jan 2022, 76 (1) 9-18; DOI: 10.5731/pdajpst.2021.012631
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Keywords

  • SUS
  • Single-use system
  • SUSI
  • Single-use system integrity
  • Gas flow rate through microchannels
  • MALL
  • Maximum allowable leakage limit

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