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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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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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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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