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

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Single-Use System Integrity I: Using a Microbial Ingress Test Method to Determine the Maximum Allowable Leakage Limit (MALL).

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This study establishes a 2 µm maximum allowable leakage limit (MALL) for single-use systems (SUSs) integrity, linking liquid leaks to microbial contamination and validating non-destructive testing methods for pharmaceutical manufacturing.

Keywords:
Single-use system (SUS)gas flow rate through microchannelsliquid leak testingmaximum allowable leakage limit (MALL)microbial ingress testingsingle-use system integrity (SUSI)

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Area of Science:

  • Biopharmaceutical Manufacturing
  • Materials Science
  • Process Validation

Background:

  • Single-use systems (SUSs) are critical in biopharmaceutical manufacturing, requiring robust integrity assurance.
  • Understanding failure mechanisms like microbial ingress and liquid leaks is essential for validating SUS integrity.
  • Previous studies focused on specific aspects, necessitating a holistic approach to integrity assurance.

Purpose of the Study:

  • To establish a holistic approach for integrity assurance of single-use systems (SUSs).
  • To determine the maximum allowable leakage limit (MALL) for microbial ingress and liquid leaks in SUSs.
  • To validate non-destructive physical integrity test methods for SUSs.

Main Methods:

  • Testing of artificially created defects (1-130 µm) in EVA and PE multilayer films.
  • Microbial ingress and liquid leak testing under various process conditions.
  • Characterization of gas flow through defects to develop predictive models.
  • Mathematical modeling to predict MALL and correlate gas flow to leak size.

Main Results:

  • A MALL of 2 µm was determined for microbial integrity.
  • Liquid leakages were prevented under most severe use-case conditions.
  • A strong correlation between liquid leakage and microbial contamination was observed.
  • Mathematical models were developed for predicting MALL and leak size from gas flow data.

Conclusions:

  • The study successfully integrated microbial, liquid, and gas flow data for SUS integrity assurance.
  • Validated non-destructive physical integrity test methods with detection limits correlated to the MALL were developed.
  • The findings provide a robust framework for ensuring the integrity of single-use systems in pharmaceutical manufacturing.