Drug Substance Purification
Drug substance purification is a critical process step due to the risk of impurities being introduced either during the process or with the products used in biomanufacturing – but the integrity of the drug substance can also be at risk. The Flexsafe® Pro Mixer features a levitating impeller to preserve the drug substance during low shear blending applications and a design that supports taking off-line samples for other quality control tests prior to sterile filtration.
Building on more than 20 years’ experience designing Single-use Fluid Management Solutions, we established Pre-Designed Solutions (PDS) to offer simple, safe, fast and more affordable supply chain options. For every media, buffer, harvest, downstream intermediate, drug substance and drug product process step, Flexsafe® Pro Mixer PDS assure consistent quality and robust change control.
PDS for Mixing
PDS for mixing during drug substance purification are designed with the following features for efficiency and quality control:
- Aseptic filling and draining operations under ISO laminar air flow: bottom lines with Tuflux® Silicone tubing and Tri-Clamp 1 ½” sanitary flange.
- Integrated single-use pH sensor and/or thermowell for in-line monitoring and control.
- Top lines with Tuflux® Silicone tubing and quick coupler connector for pH adjustment.
- Bottom line with Tuflux® Silicone tubing and clave needleless port for sampling.
- Bottom lines with Tuflux® Silicone tubing and quick coupler connector for liquid additions.
- Fully closed 8” diameter top port for safe mixing.