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Alternative In Vitro Methods for the Determination of Viral Capsid Structural Integrity
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Single-Use System Integrity I: Using a Microbial Ingress Test Method to Determine the Maximum Allowable Leakage Limit

Saeedeh Aliaskarisohi1, Marc Hogreve2, Carole Langlois3

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|April 21, 2019
PubMed
Summary

This study developed an aerosol microbial ingress test to determine the maximum allowable leakage limit (MALL) for single-use systems (SUSs). The method accurately predicts microbial ingress, enhancing drug safety and manufacturing reliability.

Keywords:
Maximum allowable leakage limit (MALL)Microbial ingress testingSingle-use system (SUS)Single-use system integrity (SUSI)

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Area of Science:

  • Biopharmaceutical Manufacturing
  • Microbial Integrity Testing
  • Risk Assessment

Background:

  • Single-use systems (SUSs) are increasingly used in biopharmaceutical manufacturing, making their integrity critical for drug safety and cost-effectiveness.
  • Assessing microbial ingress and leakage in SUSs requires robust scientific methods to ensure product quality and patient safety.
  • Existing integrity testing methods need enhancement to reliably predict potential microbial contamination risks.

Purpose of the Study:

  • To design and validate an aerosol microbial ingress test for determining the Maximum Allowable Leakage Limit (MALL) of single-use systems (SUSs).
  • To develop a predictive model for MALL based on experimental data, considering various physical and microbial factors.
  • To establish a scientifically sound method for assessing the microbial integrity of SUSs under simulated real-world conditions.

Main Methods:

  • Developed an aerosol microbial ingress test using film patches (ethylene vinyl acetate and polyethylene) with laser-drilled defects (1-100 µm).
  • Exposed test units filled with culture media to a standardized aerosol of *Bacillus atrophaeus* spores under varying pressures (0-300 mbar).
  • Utilized logistic regression analysis to statistically determine the MALL based on observed microbial ingress over a 14-day incubation period.

Main Results:

  • The microbial integrity test successfully detected bacterial ingress through defects as small as 3 µm.
  • Estimated MALL values were determined for typical use-case conditions: 10-20 µm for storage and 2-10 µm for shipping.
  • The study demonstrated a probabilistic approach to MALL determination, integrating defect size, material properties, and microbial challenge.

Conclusions:

  • The developed aerosol microbial ingress test provides a reliable and accurate method for predicting the MALL of single-use systems.
  • This method enhances the scientific basis for single-use system integrity (SUSI) assessment, improving drug safety and manufacturing assurance.
  • The findings support more accurate risk assessments and informed decisions regarding the use and integrity validation of SUSs in biopharmaceutical processes.