Summary of Potential Cause of Protein Particulate Formation by Tight Clearance and/or Close Contact in Different Drug Product Processing Systems
| Drug Product Processing System | Presence of Tight Clearance (<5 mm) | Presence of Close Contact | Significant Particle Formation |
|---|---|---|---|
| Top Mounted Mixer | No | No | No |
| Magnetic Mixer | No | Yes | Yes |
| Mavadrive™ Mixer | Yes | Yes | Yes |
| LevMixer® | Yes (3 mm) | No | No |
| Mobius® Mixer | Yes (4 mm) | No | No |
| JetMixer™ | Yes | Yes | Yes |
| Standard Stir Bar (SB1) | Yes | Yes | Yes |
| Stir Bar with Plastic Ring (SB2) | Yes | Yes | Yes |
| Stir Bar on Tri-Stand (SB3) | Yes (<1 mm) | Yes | Yes |
| Top-Entry Stir Bar (SB4) | No | No | No |
| Rotary Piston Pump | Yes (<0.1 mm) | Yes | Yes |
| Double-Gap Rheometer | Yes (0.4 mm) | No | No |
| Cone-Plate Rheometer | Yes (0.01 mm at tip) | No | No |
| Parallel-Plate Rheometer | Yes (0.10 mm) | No | No |