Drug Product Formulation
Preserving the drug product during the final formulation is critical, not just from a quality standpoint, but also to prevent the risk of significant waste. The Flexsafe® Pro Mixer, designed with its levitating impeller, ensures the integrity of the drug product during sterile and aseptic operations. Pre-designed Solutions (PDS) for either sterile or aseptic connections and disconnections, with options of single-use or integrated sensors, ensure safe and reliable use throughout the final formulation process.
During drug formulation, the drug substance is mixed with other buffers and excipients to obtain the final drug product concentration and composition before final filtration, fill and finish in its final container.
The Flexsafe® Pro Mixer is designed to ensure quality throughout the process, with options that allow in-line efficiencies in both sterile and aseptic operations, such as:
- Sterile connections, disconnections, and liquid additions;
- Pumping and sterile weld or seal;
- Aseptic connections under ISO laminar airflow;
- Sterile pH monitoring with integrated or single-use pH sensors;
- In-line pH adjustment;
- Temperature monitoring and adjustment;
- Sterile sampling for quality control testing offline;
- Fully closed 8” diameter top port for sterile mixing;
- Sterile or aseptic filling and draining;
- Drain valves to avoid hold-up volumes into the tubes; and more.
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.
The intelligent PDS with single-use and integrated sensors enable you to meet the requirements for cGMP operations, with features including:
- Bottom lines with a combined Tuflux® Silicone and Tuflux® TPE tubing ended by an Opta® SFT connector to allow pumping and sterile weld or seal
- Integrated single-use pH sensor and thermowell for in-line monitoring and control
- Top lines with Tuflux® Silicone tubing and Opta® SFT connector for sterile pH adjustment
- Bottom line with Tuflux® Silicone tubing and clave needleless port for sterile sampling
- Bottom or top line with Tuflux® Silicone tubing and Opta® SFT connector for sterile liquid additions
- A fully closed 8” diameter top port for sterile mixing
PDS Without Single-Use Sensors
The Flexsafe® Pro Mixer PDS without single-use sensors, where sterile samples are taken for off-line controls, can be used in aseptic or sterile operations:
Aseptic operations under ISO laminar airflow features include:
- Filling and draining lines with Tuflux® Silicone tubing and Tri-Clamp 1 ½” sanitary flange
- Addition and pH adjustment lines with Tuflux® Silicone tubing and quick coupler connector
- Sampling line with Tuflux® tubing and clave needleless port
Sterile operation features includes:
- Filling and draining lines with a combined Tuflux® Silicone and Tuflux® TPE tubing ended by an Opta® SFT connector
- pH adjustment top lines with Tuflux® Silicone tubing ended by Opta® SFT connector
- Sampling line with a clave needleless port
- Liquid addition lines with Tuflux® Silicone tubing ended by Opta® SFT connector