Flexsafe® Pro Mixer technology allows low shear mixing to preserve the drug during viral inactivation. The single-use sensors are integrated for safe and reliable use across the process steps.
Low pH viral inactivation of downstream process intermediates consists of 3 steps:
- The pH of the downstream intermediate is first reduced and maintained at low pH for a validated period of time, usually at pH 3–4 for an hour, until the virus is totally inactivated.
- The low pH inactivation is followed by a neutralization step where the pH is increased, usually up to pH 7–8.
- After neutralization there is a final filtration.
All three steps require mixing for inactivation, neutralization and homogenization.
To ensure that the entire content of the first mixer is inactivated, including droplets on the mixer wall or dead volume inside tubing, some processes are operated using 3 single-use mixing bags: 1 for low pH viral inactivation, 1 for neutralization and 1 for homogenization of the filtered drug substance.
Some processes are operated with two single-use mixing bags by combining the 2 mixing steps for low pH inactivation and neutralization into the same single-use mixing bag.
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 Low pH Virus Inactivation and Neutralization
PDS for Low pH Virus Inactivation and Neutralization are designed with the following features and components to deliver a safe, reliable and efficient virus inactivation:
- Fully closed 8” diameter top port for safe mixing
- Integrated single-use pH sensor and thermowell for in-line monitoring and control of the inactivation process
- Top lines with Tuflux® Silicone tubing and quick coupler connector for pH adjustment
- Bottom lines with Tuflux® Silicone tubing and Tri-Clamp 11” sanitary flange for filling and draining
- Bottom lines with Tuflux® Silicone tubing and clave needleless port for sterile sampling
The following options are also available to support a range of processes:
- Lines for other liquid additions with Tuflux® Silicone tubing and quick coupler connector
- Drain valves to avoid hold-up volume into the tubes.
PDS for Post Filtration
PDS for post filtration are designed with the following features to ensure quality standards and efficiency:
- Integrated thermowell for temperature monitoring and control
- Tuflux® Silicone tubing with an Opta® SFT female ending to allow sterile connection and disconnection of the adequate filter line
- Tuflux® Silicone tubing with a Tri-Clamp 1 ½” sanitary flange at the end for draining
- A bottom line with Tuflux® Silicone tubing and clave needleless port for sterile sampling
- A bottom line with Tuflux® Silicone tubing and quick coupler connector for liquid additions