Sartoflow® Expert SU: Versatile Single-Use Tangential Flow Filtration
Flexible Single-Use TFF System for a Range of Modalities
The Sartoflow® Expert SU is a flexible, fully automated single-use TFF system designed for process development through pilot-scale manufacturing of biopharmaceuticals such as mAbs, vaccines, viral vectors, pDNA, highly viscous products, and bioconjugates including ADCs.
Its innovative design allows configuration of up to three process steps on a single skid—mixing, 0.2 µm filtration, and ultrafiltration | diafiltration (UF | DF). All steps are performed in a robust, fully closed single-loop system to ensure process integrity and consistent product quality.
A single system streamlines three process steps (mixing, filtration, and UF | DF) and eliminates product transfer steps to boost cost efficiency.
A gamma-irradiated closed-loop system prevents leaks, eliminates cleaning, and reduces validation efforts.
The system has the flexibility to accommodate various sequences of process steps.
Explore Sartoflow® Expert
Explore the Sartoflow® Expert SU System
The Sartoflow® Expert SU is a modular single-use system offering numerous standard and optional features. The TFF base unit for UF and DF applications can be extended with additional modules and consumables.
Double Jacketed Bag Holder & 20 L 3D Single-Use Mixing Bags
In addition to the recirculation tank, the system is configurable with a second bag holder for an additional mixing solution on the skid. The corresponding Flexsafe® single-use 3D mixing bags allow efficient mixing and temperature control in 1–20 L scale. An integrated sampling port and sensors allow continual quality monitoring. The conical shape of the bags and bag holder enable maximum drainage for highest yields. All materials in product contact are resistant to organic solvents.
Broad Range of Self-contained Units
Sartocube® and Sartocon® Self-Contained Units are pre-sterilized disposable units for use in cGMP environments.
- Available in a variety of MWCOs and in polyethersulfone (PES) and Hydrosart® membrane types
- Pre-flushed, sterile, ready to use
- No need for CIP, water flush and validation
- High product yield and high sustained flux due to low protein-binding membrane
- Glue-free/reduced extractables
Available sizes (m²): 0.14, 0.28, 0.42, 1.4
Each available in MWCO (kDa): 10, 30, 100, 300
Fully Single-Use Closed Loop for Bioburden-Reduced Processing
The single-use flow kits for Sartoflow® Expert SU are gamma-irradiated and can be connected in a fully closed loop, including single-use bags and self-contained TFF cassettes. A 5-piston single-use membrane recirculation pump with overpressure protection is part of the feed flow kit. All materials in product contact are resistant to organic solvents.
- Bioburden reduced
- Chemical compatibility
- Spill-free process and disassembly
- Reduced hands-on time
- No cleaning or validation efforts
Start With Your Ideal Configuration
Start With Your Ideal Configuration
The system’s base unit contains state-of-the-art technology for UF | DF process steps, featuring:
- A filter holder for 0.14, 0.28, 0.42, and 1.4 m² self-contained units
- A recirculation pump and vessel
- Two peristaltic pumps for product and buffer addition
- Pressure, flow, and conductivity sensors
- Automated pneumatic pinch valves
- Automated membrane valves in the retentate (TMP control) and permeate line
- Two connections for external balances
Select additional features to add to the TFF Base Unit, or choose the complete Extension Package—which includes second onboard mixing (e.g., for bioconjugation) and other options—to maximize the system’s capabilities.
TFF Base Unit | Extension Package | |
|---|---|---|
|
| |
| Additional mixing vessel | Not available | Included |
| Sterilizing-grade filtration | Optional | Included |
| Peristaltic media addition pumps (4x) | Optional | Included |
| TCU | Optional | Included |
| Uninterrupted power supply | Optional | Included |
| External display | Not available | Optional |
| Automated toxin transfer (ADC applications) | Not available | Included |
| UV detection | Optional | Optional |
ADC Applications
ADC Manufacturing, Streamlined
Traditionally, ADC synthesis, precipitate removal, and subsequent TFF occur within separate unit operations. Time-consuming and risky transfer steps are necessary between process steps. The Sartoflow® Expert SU is the first fully automated single-use system to streamline these three steps on one system, simplifying ADC processing while enhancing safety for both the operator and product.
Application Note: Performance of Sartoflow® Expert SU in ADC Processes
Learn more about the capabilities of the Sartoflow® Expert SU for ADC processes, configurable to perform incubation, purification, and concentration of ADC synthesis.
Comprehensive Risk Mitigation
Reduce risk with these features:
- Fully closed-loop with chemical compatibility of all materials in product contact
- Integrated overpressure protection in single-use pump head
- Pre-use integrity test of single-use bags
- Operational from outside an isolator or fume hood with detached touch panel and safety door switch
- Uninterrupted power supply: system runs additional 10 minutes in case of power failure to secure the process and data
- Optional UV detection in permeate as protein guard
Three Unit Operations in One Fully Automated Single-Use Solution
Sartoflow® Expert SU streamlines three unit operations on one skid
- Fully closed single-use loop limits bioburden
- Low holdup volume around 400 mL
- Eliminate transfer between unit operations and potential exposure to cytotoxic compounds, thus providing safety for both the operator and the product.
Accelerate Transition to Commercial
One system can facilitate the transition from process development, toxicology studies, and clinical trials to low-volume commercial production, saving time and enabling consistent and reproducible processes. In addition, the system enables the adaption of flexible process sequences for varied conjugation strategies.
Learn More About Sartoflow® Expert
Frequently Asked Questions
Yes, open cassettes can be integrated with the use of adapter plates.
Only the standard versions of the conjugation and recirculation bag are available. However, they offer a variety of connections for inlets, thorough mixing, as well as pH measurement (conjugation bag) or conductivity measurement (recirculation bag).
No. The system’s filter holder is designed to accommodate both Sartocon® Slice and standard Sartocon® formats, providing a high degree of flexibility without the need for an external holder.
The Sartoflow® Expert SU is optimized for 20 L bags to ensure maximum performance and the highest level of process safety.
The mixing and recirculation bags can be integrity-tested, for example using an external Sartocheck®.
