The pressure hold/drop integrity test; its correlation to diffusive flow

Area of Science:

• Filtration Technology
• Microbial Control
• Process Engineering

Background:

• Traditional filter integrity testing can be invasive and risk downstream contamination.
• Accurate integrity testing is crucial for sterile filtration processes in pharmaceutical and biopharmaceutical industries.

Purpose of the Study:

• To introduce and validate the pressure-drop/hold procedure as a non-destructive method for diffusive flow integrity testing of filters.
• To demonstrate the correlation between pressure decay measurements and organism retention data for sterilizing-grade filters.

Main Methods:

• Utilizing pressure transducers to measure pressure loss upstream of the filter.
• Performing arithmetic conversion of pressure decay curves into diffusive airflow curves.
• Employing automated integrity test machines for sensitive pressure drop measurements.

Main Results:

• The pressure-drop/hold procedure allows integrity testing without breaching the downstream system.
• The method effectively identifies leaks from faulty seals, incorrect filter types, or flawed filters.
• Correlation of pressure decay with organism retention data enables the procedure to serve as a validated integrity test.

Conclusions:

• The pressure-drop/hold procedure is a reliable and non-destructive method for filter integrity testing.
• Automated test machines are recommended for accurate and sensitive measurements, enhancing filter integrity assurance.
• This method prevents the use of compromised filtration systems, ensuring product safety and process efficiency.