Flexact® Modular | Single-use Automated Solutions
The Flexact® Modular, engineered for single-use downstream and liquid processing when manufacturing biologics across a wide range of scales and molecules.
The modular design enhances flexibility in process scale capability and adaptability while reducing clean room footprint and improving overall equipment efficiency. Its design allows the realization of ballroom / dance floor concepts where many unit operations are closed or functionally closed thus supporting multiproduct downstream lines and rapid campaign changeovers. The new design utilizes our single-use cGMP tested sensor and actuator technologies to realize state of art process automation, data generation and control.
The automation system (software, equipment and process flow) is designed for ANSI-S88, which guarantees seamless integration into various distributed control systems (DCS) and manufacturing execution systems (MES). Further, due to its open architecture, the system allows the implementation of new and advance process analytical technologies (PAT). Lastly, it drastically improves the project execution & system delivery time enabling better facility setup times and your product time to market.
What can the Flexact® Modular Platform do?
Automation sequence:
- Pre-flush of filters (optional)
- Prefill supply tank
- Media powder addition
- Homogenization (pH control)
- Final fill and pH adjustment (acid & base)
- Filter transfer to receiving tank(s)
The Flexact® MP is a standardized configurable solution dedicated to biopharmaceutical processes. Addressing the entire development cycle and production capacity needs from 50 L to 3.000 L. The system provides recipe based control for all critical parameters. The automation allows operators to perform other tasks during the media preparation operation.
The unit operation is often placed in a separate media preparation room/area (clean room area 1). Challenges are the sterile and most often mycoplasma free filtration and filling into a receiving bag. The media has to have a defined pH and Conductivity value. The media is prepared with different components which could have a low solubility or a high viscosity. Media components could be added solid (powder addition via mixing bags) or liquid (via 2D bags and titration line). The pH adjustment depends on the buffer strength, acid/base strengths-volume and titration line diameter. Therefore, scale down trials are recommended.
Automation sequence:
- Pre-flush (optional)
- Prefill supply tank
- Buffer powder addition
- Homogenization (conductivity monitoring)
- Final fill and liquid adjustment
- Filter transfer to receiving tank(s)
The Flexact® BP is a standardized configurable solution dedicated to buffer preparation in biopharmaceutical processes. Addressing the entire development cycle and production capacity needs from 50 L to 3.000 L. The system provides recipe based control for all critical parameters. The automation allows operators to perform other tasks during the media preparation operation.
The unit operation is often placed in a separate buffer preparation room/area (clean room area 1). Challenges are the powder mixing time and particulate filtration filling into a receiving bag. The buffer can have a defined pH and conductivity value. The buffer is prepared with different components which could have a low solubility or a high viscosity. Buffer components could be added as a solid (powder addition via antistatic bags) or liquid (via 2D bags and titration line). The adjustment depends on the buffer strength, acid/base strengths, volume and titration line diameter. Therefore, scale down trials are recommended.
Automation sequence:
- Pre-flush & drain of depth filters
- Filter transfer from bioreactor to receiving tank
- Buffer flush
The Flexact® CC is a standardized configurable solution dedicated to cell removal clarification in biopharmaceutical processes. The system manages the removal of cells & clarification of supernatant from a production bioreactor via recipe based control, ending with cell free solution in a receiving tank. Throughout the whole application the system collects all critical process parameters into the electronic batch record.
Automation sequence:
- Pre-flush of filters (optional)
- Fill supply tank with column cycle n
- Low pH adjustment (acid)
- Timed incubation in the 1st tank
- Transfer to 2nd tank
- Neutralization (base)
- Filter transfer to temperature controlled receiving tank
- Fill supply tank with column cycle n+1
The Flexact® VI is a standardized configurable solution dedicated to virus inactivation in biopharmaceutical processes. Available in two application variants (1-tank or 2-tank), the system manages the low pH cycles of virus inactivation via recipe based control, ending with a particulate filtration transfer to a receiving tank. Throughout the whole application the system collects all critical process parameters into the electronic batch record.
Automation sequence:
- Pre-flush & wetting (for optional pre-use virus filter integrity test)
- Equilibration
- Filtration
- Post-flush (for post-use integrity test via Sartocheck 5)
- Post use Integrity Test
The Flexact® VR is a standardized configurable solution dedicated to virus removal in biopharmaceutical processes. Addressing the entire production volume needs from 50 L to 2.000 L. The system includes a wide range low pulsation single-use pump system to cover the volume needs. All critical application steps are recipe controlled with the collection of all critical process parameters into the electronic batch record.
Automation sequence:
- Fill recirculation tank
- Isolated buffer flush of filter (optional sanitization )
- Concentrate (TMP or constant flux control)
- Diafiltrate
- Final concentrate (TMP or constant flux control)
- Filter transfer to external recovery (optional)
The Flexact® CF combines innovative single-use technology and recipe based control to give superior crossflow filtration performance. Filter-loop-assemblies for solution are supplied sterile and ready to use. All hardware, software and wetware is optimized for ultrafiltration and diafiltration applications used in many downstream processes like purification of monoclonal antibodies or recombinant proteins.
What is the Flexact® Modular?
Flexact® Modular is the 3rd generation of the Flexact® single-use automation platform. It takes the accumulated learnings of more than 10 years of single-use bioprocessing experience in order to modularize the design for the biomanufacturing industry downstream and liquid processing needs. It is made up of:
- Hardware (electrical and mechanical),
- Wetware (consumable process contact)
- Software (automation and control)
- Common technical documents (qualification & technical documentation to support GMP / validation)
- Project management (complex project handling from you request for information (RFI) to site acceptance test SAT))
What options come with Flexact® Modular?
The Flexact® Modular engineering template and design space brings together many of Sartorius single-use Separation and Fluid Management bioprocessing technologies into a ready to produce package. Unless selecting a pre-engineered template for the manufacturing support or pilot production, a Flexact® Modular Solution package will be project managed from initial request to your site acceptance test. This can be combined with your upstream single-use bioreactor needs or as a standalone unit operation.
