Best Practices to Quantify and Identify Particulate Matter on the Interior Surfaces of Single-Use Systems.

Area of Science:

• Biopharmaceutical manufacturing
• Analytical chemistry
• Materials science

Background:

• Single-use systems (SUSs) are widely used in biopharmaceutical manufacturing for their convenience and scalability.
• Visual inspection of interior surfaces of SUSs is limited in detecting particulate matter due to size, complexity, and lack of transparency.
• Particulate matter on SUS surfaces poses a contamination risk to final drug products, especially in aseptic processing.

Purpose of the Study:

• To address the limitations of current methods for detecting particulate matter on the interior surfaces of SUSs.
• To establish reliable test methods for quantifying and identifying particulate matter on SUS surfaces.
• To propose best practices for the extraction and analysis of particulate matter from SUSs.

Main Methods:

• Extraction of particulate matter using qualification methodology from a published ASTM standard.
• Concentration of extracted particulate matter via filtration onto a membrane filter.
• Particle counting and sizing using automated membrane microscopy.
• Chemical identification using infrared microscopy and/or automated confocal Raman microscopy.

Main Results:

• Effective procedures for extracting particulate matter from SUS interior surfaces were developed.
• Automated membrane microscopy enabled rapid particle counting and sizing.
• Infrared and Raman microscopy provided detailed chemical identification of particulate matter.

Conclusions:

• The described methods provide a reliable approach for assessing particulate matter contamination in SUSs.
• These methods overcome the limitations of traditional pharmacopeial standards like USP <788> for SUS analysis.
• Implementing these best practices enhances the safety and quality of biopharmaceutical products manufactured in SUSs.