Assessing Particle Generation In The LevMixer™ 10 L Single-Use Mixing System

Particulate control is essential in biopharmaceutical manufacturing, especially during final fill, where filtration is no longer an option. This evaluation of the LevMixer™ 10 L single-use mixing system tested particle generation over 24 hours of high-speed mixing under extreme temperatures. Results showed that both visible and sub-visible particle levels remained stable and well within USP <788> and Cytiva specifications. Most particles were present at the start, with no significant increase during operation, even at 4 °C and 40 °C. These findings suggest that the system does not contribute to particle generation during mixing, making it a reliable choice for particulate-sensitive applications. For teams focused on product purity and patient safety, especially in downstream processing, this data offers strong validation.

Explore the full application note to see detailed particle evolution graphs and learn more about the system’s performance under stress.