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High Throughput Microfluidic Rapid and Low Cost Prototyping Packaging Methods
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Single-Use System Integrity II: Characterization of Liquid Leakage Mechanisms.

Saeedeh Aliaskarisohi1, Chethan Kumar2, Marc Hogreve3

  • 1Product Development, Sartorius Stedim Biotech GmbH, Germany; saeedeh.aliaskarisohi@sartorius.com.

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|November 17, 2020
PubMed
Summary

This study establishes the maximum allowable leakage limit (MALL) for flexible single-use packaging, identifying a critical leak size between 2-10 µm to prevent liquid egress and ensure product integrity. This finding correlates directly with microbial ingress test results.

Keywords:
Integrity testingLiquid leak testingMaximum allowable leakage limit (MALL)Microbial ingress testingSingle-use system (SUS)Single-use system integrity (SUSI)

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Area of Science:

  • Materials Science
  • Biotechnology
  • Packaging Engineering

Background:

  • Flexible single-use packaging systems are increasingly used in sensitive applications.
  • Ensuring package integrity is crucial to prevent product contamination and maintain efficacy.
  • Understanding liquid leakage mechanisms in microchannels is key to defining safety limits.

Purpose of the Study:

  • To investigate liquid leakage mechanisms in multilayer plastic films for single-use packaging.
  • To establish a Maximum Allowable Leakage Limit (MALL) for liquid egress.
  • To correlate liquid leak test results with microbial ingress tests.

Main Methods:

  • A specifically designed liquid leak test was employed to determine leakage time.
  • Artificial leaks (2-25 µm) were created in multilayer plastic film patches (EVA and PE).
  • Microscopic investigations (light microscopy, computed tomography) analyzed microchannel physics and geometries.

Main Results:

  • The MALL for liquid egress was determined to be between 2 µm and 10 µm.
  • This leak size ensures no liquid leakage is observed after 30 days under simulated use conditions.
  • A direct correlation was observed between the liquid leak test and microbial ingress test results.

Conclusions:

  • The established MALL provides a quantifiable measure for package integrity in single-use systems.
  • The liquid leak test is a reliable indicator for predicting microbial barrier performance.
  • These findings support the development of robust and safe single-use packaging solutions.