FlexAct® Systems

The new benchmark for operational flexibility.

FlexAct® is a new system that enables you to custom-configure single-use solutions for entire biomanufacturing steps. The FlexAct® system consists of the central operating module that offers the widest variety of configuration options so you can take complete control of practically any steps in upstream and downstream processing.

FlexAct® BP

Disposable Solution For Buffer Preparation

Components
The FlexAct® BP configurable disposable buffer preparation solution
consists of:

  • Flexel® for LevMixer® System for Palletank®
  • Weighing platforms
  • FlexAct® BP Central Operating Module with accessories
  • Multiple bag assembly configurations with Palletanks®

Description
The FlexAct BP configurable disposable buffer preparation solution is a standardized configurable disposable solution (CDS) dedicated to buffer preparation steps in biopharmaceutical processes. The FlexAct BP addresses the entire development cycle and production capacity needs from 50 to 1,000 L for buffer preparation. The integration of monitoring & control features for pH, pump speed and fluid level control is a further milestone for the implementation of process relevant single use equipment.
The integrated controls allow end-users to perform other tasks during the buffer preparation operation. Combined with a Flexel® for LevMixer® System and multiple Palletanks® the multifunctional Central Operating Module enables the user the install, operate and monitor a fully single use unit operation.

FlexAct® CH

Disposable Solution For Cell Harvest

Components
The FlexAct® CH configurable disposable cell harvest solution consists of:

  • FlexAct® COM Central Operating Module with accessories
  • L-drum trolley for up to 4 L-drums for easy and safe harvest operation
  • Bag assembly configurations with integrated sterilizing grade filter and a transfer set with implemented single use pressure sensor
  • Weighing platforms or Palletanks® with load cells

 

Description
The FlexAct® CH is a standardized configurable disposable solution (CDS) dedicated to cell harvest steps in biopharmaceutical processes. The FlexAct® CH addresses the entire development cycle and production capacity needs from 50 to 1.000 L for cell harvest. The integration of monitoring & control features for pressure, pump speed and fluid level control is a further milestone for the implementation of process relevant single use equipment.
The integrated control allows end-users to perform other tasks during the cell harvest operation. Combined with a Palletank® and designed bag assemblies the multifunctional Central Operating Module enables the user the install, operate and monitor a fully single use unit operation.

FlexAct® MF

Solutions for Single-Use Manifold Bags

Components
FlexAct® MF configurable single-use manifold bag filling solution consists of:

  • Single-use bag manifold
  • Rack to hold bag manifold
  • Valve unit
  • Precision weighing platform
  • FlexAct® MF Controller with manifold filling software
  • Printer for batch protocol

 

Description

FlexAct® MF is the first automated system for single-use manifold bag filling in industrial biopharmaceutical processes. The system combines high accuracy and reproducible filling. With its automatically-generated batch record and individual bag label, traceability is secured. No operator manipulation is requested during the complete filling process thanks to the integrated control and automation.
FlexAct® MF addresses the entire development cycle and production capacity needs from 50 ml to 5 l for manifold bag filling.
FlexAct® MF is available in the horizontal bag version with a maximum of 10 bags and 20 for the vertical version.

FlexAct® MP

Disposable Solution For Media Preparation

Components
The FlexAct® MP configurable media preparation solution consists of:

  • Flexel® for Magnetic Mixer
  • Weighing platforms or Palletank® for Magnetic Mixer with load cells
  • FlexAct® COM Central Operating Module with accessories
  • Multiple bag assembly configurations with Palletank®

 

Description
The FlexAct® MP is a standardized configurable disposable solution (CDS) dedicated to media preparation in biopharmaceutical processes. The FlexAct® MP addresses the entire development cycle and production capacity needs from 50 to 1,000 L for media preparation. The integration of monitoring & control features for pH, temperature, pressure, pump speed and fluid level control is a further milestone for the implementation of process relevant single use equipment.
The integrated control allows end-users to perform other tasks during the media preparation operation. Combined with a Flexel® for Magnetic Mixer1 and Palletank® the multifunctional Central Operating Module enables the user to install, operate and monitor a fully single use unit operation.

FlexAct® UD

Single use Solution for Ultrafiltration & Diafiltration

The FlexAct® UD combines innovative Single use technology with Crossflow filtration performance for ultrafiltration and diafiltration (UD) applications used in many downstream processes.

Description
FlexAct® UD is the first – and the one and only – system for single-use ultrafiltration processing. Featuring a capsulated presterilized Crossflow Bag Loop assembly, this innovative member of the FlexAct® family also includes a preflushed Self Contained Hydrosart Sartocube® with a membrane area of 3.5m2. These preflushed filter elements speed up your processes, while saving you substantial quantities of WFI needed for rinsing.
The FlexAct® UD trolley provides a Sartocon® hydraulic holder for operating the Sartocon® Self Contained Sartocube®. It also has two pressure transmitters, overpressure protection and a single-use 4-piston diaphragm pump head optimized for sheer-sensitive products. Moreover, the 50 l recirculation bag is conveniently equipped with a single-use impeller driven by a magnetic mixing drive unit. Additionally it readily connects to the cassette loop using our safe Opta® sterile connectors.

FlexAct® VI

Disposable Solution For Low pH Virus Inactivation

Components
The FlexAct® VI configurable low pH virus inactivation solution consists of:

  • Flexel® Palletank® for LevMixer®
  • Weighing platforms or Palletanks® for LevMixer® with load cells
  • FlexAct® COM Central Operating Module with accessories
  • Acid|Base peristaltic dosing pumps for controlled pH adjustment
  • Bag assembly configurations with Palletanks®

 

Description
The FlexAct® VI is a standardized configurable disposable solution (CDS) dedicated to low pH virus inactivation steps in biopharmaceutical processes. The FlexAct® VI addresses the entire development cycle and production capacity needs from 30 to 650 L for low pH virus inactivation. The integration of monitoring & control features for pH, temperature, pressure, pump speed and fluid level control is a further milestone for the implementation of process relevant single use equipment.
The integrated control while pH adjustment, incubation and neutralization steps allows end-users to perform other tasks during the low pH virus inactivation operation. Combined with a Flexel® Palletank® for LevMixer®1 and Palletanks® the multifunctional Central Operating Module enables the user the install, operate and monitor a fully single use unit operation.

FlexAct® VR

Disposable Solution For Virus Filtration

Components
The FlexAct® VR configurable disposable virus filtration solution consists of:

  • FlexAct® COM Central Operating Module with accessories
  • Bag assembly configurations with integrated prefilters, sterilizing grade filter and a transfer set with implemented single use pressure sensor
  • Weighing platforms or Palletanks® with load cells

Description
The FlexAct® VR is a standardized configurable disposable solution (CDS) dedicated to virus filtration steps in biopharmaceutical processes. The FlexAct® VR addresses the entire development cycle and production capacity needs from 50 to 1,000 L for virus filtration. The integration of monitoring & control features for pressure, pump speed and fluid level control is a further milestone for the implementation of process relevant single use equipment.
The integrated control allows end-users to perform other tasks during the virus filtration operation. Combined with a Palletank® and designed bag assemblies, the multifunctional Central Operating Module enables the user to install, operate and monitor a fully single use unit operation.

Ease of use gives you peace of mind

FlexAct® ideally combines functional design with user-friendly features. Each FlexAct® system is easy and convenient to maneuver, provides optimal access for changing the application-specific components without tedious cleaning needs and thus ensures maximum mobility. The single-use products, such as bags, tubing, connectors and filter capsules, are pre-assembled to the greatest extent possible. This means you can install an entire unit operation rapidly and securely. In addition, the single-use configuration protects your staff members, handling potentially hazardous fluids.

PAT in implemented action

The control unit with touch-screen operation enables accurate control of the pump and monitoring of the pH, temperatur and weight. The user interface is known from our BIOSTAT® bioreactors and Sartoflow® crossflow systems.

Set-up time and resources drastically reduced

When it comes to readiness, FlexAct® is extremely fast, so you‘ll be up and running in no time. The reason: All single-use products, such as bags, tubing, connectors and filter capsules, etc., are pre-assembled to the greatest extent possible and delivered as ready-to-connect units for easy installation on the central operating module. This minimizes set-up time. The central operating module itself can be universally used for a wide variety of applications. That means there is no need to make multiple investments when you have applications that change frequently, and this will save you substantial time and effort.

Excellence

Operational excellence for all future needs.

The core of FlexAct®, the central operating module (COM), has been designed to be used in any application. This means you can quickly reconfigure FlexAct® in just a few easy steps. For example, take the FlexAct® BP for buffer preparation and effortlessly convert it into FlexAct® VR for virus removal. And it goes without saying that the technologies and products used in FlexAct® are scalable. This makes FlexAct® a future-proof system in every respect; one that gives you the greatest possible flexibility.

Flexibility

FlexibDiscover real operational flexibility.

The system set-up is performed within minutes and needs substantially less preparation time compared with existing solutions. Once the operation is performed, the system can be as fast rigged-off without the needs of tedious cleaning. Set-up and disassembly ease allow for more efficient and faster equipment utilization adding to the overall process capacities.

The primary driver behind the FlexAct® initiative is the development of single-use equipment which meets all process operations improving efficiency and speed. Sartorius Stedim Biotech specialists have analyzed the process environment and the operating procedures thoroughly and developed an operator friendly multifunctional central operating module (COM

Trust in exceptional expertise.

Sartorius Stedim Biotech has established multiple manufacturing sites with consistent industrial processes and state-of-the-art utilities. The expertise of designing single-use solutions based on collaborative supplier management and customer demand planning assures a flexible and robust supply chain that can cope with strong market growth.

Sartorius Stedim Biotech quality systems for single-use products follow applicable ISO and FDA regulations for medical devices. Design, manufacture and sterilization processes are conducted under conditions that mirror biopharmaceutical operations and meet cGMP requirements.

Scalability

All technologies and products used in FlexAct® can be scaled as required. This means maximum flexibility for selecting volumes to be processed.

Extractables|Leachables

All FlexAct® components are supported by our well-known validation documentation. Our core competency of extractable|leachable testing are a service benchmark.

Fluid Management Technologies

FlexAct® from Sartorius Stedim Biotech gives you access to the complete portfolio of the market leader in bags and fluid management systems.

Filtration Technologies

FlexAct® draws from probably the widest and most innovative range of filtration technologies offered. Whether you need a configuration for sterile filtration or virus filtration, all products used in FlexAct® are scalable.

Purification Technologies

FlexAct® integrates all purifcation technologies into solutions for downstream processing.
Configurable and scalable single-use solutions enable our clients to design biopharmaceutical processes safe and easy. Qualified service and process engineers support the integration process.

Documents

Brochure

FlexAct® (1.4 MB)

Environmental Impact of single-use technologies  (3.0 MB)

Data sheets

FlexAct® BP  (1.2 MB)

FlexAct® CH  (375 KB)

FlexAct® MP (1.7 MB)

FlexAct® UD  (883 KB)

FlexAct® VI  (688 KB)

FlexAct® VR  (942 KB)

More information

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