TangenX® SIUS® Cassettes are the first purpose-built single-use cassettes for tangential flow filtration, delivering unparalleled savings in filter cost, labor cost and buffer use.
TangenX® SIUS® SINGLE-USE TFF CASSETTES
TangenX® SIUS® Single-use TFF Cassettes deliver the performance of reusable cassettes with single-use convenience at a fraction of the cost.
In traditional TFF, filters are used in a process and then cleaned between uses with a clean in place (CIP) operation. This requires a significant investment in system capacity, raw materials, energy, and time.
Validated for GMP use, TangenX® SIUS® Single-use TFF Cassettes are a convenient alternative delivered ready to use with either ProStream or HyStream membranes, and a complete range of pore sizes and flow-channel configurations. Pre-sanitized and packaged with 0.2M NaOH, the cassettes are engineered with optimized channel geometry and enhanced device rigidity to ensure that hydraulic performance is maintained during processing and scale-up.
Interchangeable
With TangenX® PRO Reusable TFF Cassettes - same channel geometry, same membrane chemistry
Compatible
For use with cassette holders from major suppliers (Millipore, Pall, Sartorius)
Validated for GMP
Validation Guide and Certificate of Compliance provided to meet regulatory guidelines
Unparalleled savings
50% reduction in labor cost
75% reduction in buffer use
80% reduction in filter cost
Scalable
From process development to commercial manufacturing
Pre-sanitized
Packaged with 0.2M NaOH
Repligen develops and manufactures products for the biopharmaceutical industry under an ISO 9001 quality management system. We focus on the timely delivery of high quality, consistent and robust products, to ensure business continuity for our customers.
TangenX® SIUS® PD FOR PROCESS DEVELOPMENT
During process development, the aim is to select the most promising membrane candidates while making related decisions regarding feed pressure, trans-membrane pressure (TMP) and screen geometry. TangenX® SIUS® PD Single-use TFF Cassettes save valuable time and resources by eliminating cleaning cycles between experiments. Designed for processing volumes from tens of milliliters to several liters, TangenX® SIUS® PD Cassettes enable linear scale processing over a wide range of operating volumes.
To ensure fit with cassette holders from other manufacturers, TangenX® SIUS® PD Single-use TFF Cassettes are offered with two different notch patterns at the end of the cassette.
Shop now for TangenX® PD Cassettes
Membrane
surface areas
0.01 meter2
0.02 meter2
0.10 meter2
TangenX® SIUS® PD with standard notch
0.850in (21.59mm) Offset
This format fits the following cassette clamps and holders:
- TangenX® SIUS® PD Cassette Clamps
- TangenX® PRO PD Cassette Holders
- Pall - Centramate Holder (CM018LV, FS001K10)
TangenX® SIUS® PD with offset notch
0.756in (19.21mm) Offset
This format fits the following third part cassette holders:
- Sartorius - Sartocon Slice holder (17525-01, 17521-02)
- GE - Kvick Lab Holder (KLPH01SSU, KLHR0105000SS)
- Millipore - Pellicon Mini Holder (XX42PMINI)
TangenX® SIUS® FOR SCALE-UP AND COMMERCIAL MANUFACTURING
Membrane
surface areas
0.5 meter2
1.5 meter2
2.5 meter2
When the primary membrane candidate has already been chosen as a process parameter, the production method needs to be verified and production materials produced for toxicology or pre-clinical trials, and ultimately for large-scale commercial production. TangenX® SIUS® Single-use TFF Cassettes provide reliable cassette-to-cassette consistency, ensuring that processes can scale to commercial production levels.
Unparalleled Process and Cost Efficiencies
80% Reduction in Filter Cost
50% Reduction in Labor Cost
75% Reduction in Buffer Use
Scalable from process development to commercial scale
Process volume and membrane area determine scale-up from bench to production scale.
Multiple Channel Configurations
Tangential flow filtration cassettes create turbulence at the membrane's surface and minimize fouling. The result is an increase in performance with a higher permeate flux. TangenX® SIUS® Cassettes are offered in three different channel configurations to best suit the application. The channel configuration refers to the type of turbulence promoter incorporated into the feed channel of a cassette.
L Screen - A medium channel or L screen is offered in all TangenX® SIUS® Cassette formats. The screen creates turbulence at the membrane's surface ensuring outstanding permeate flux with minimal fouling. This channel configuration requires the lowest pumping rate and yields the highest cross flow velocity. This type of channel is best suited for clarified feed streams over a wide range of viscosities.
EP Screen - A coarser screen channel, the EP channel is offered in all TangenX® SIUS® Cassettes. The screen geometry of this single-use cassette can process feed streams with a higher viscosity and reduce the overall pressure drop. It is scalable from 100cm2 to 2.5m2, packaged sanitized and compatible with existing cassette holders and FPIs. This type of channel is best suited for processes that use shear sensitive feed streams.
J Channel - A open channel or J channel is offered in all TangenX® SIUS® Cassettes. A 0.5mm flow spacer separating the membrane creates an open feed flow channel. This type of channel creates the least amount of turbulence while still minimizing fouling. It also requires the highest pumping rate to pass particulates. This type of channel is best suited for unclarified feed streams and is used for processes such as cell harvest operation.
Validated Manufacturing
Quality Manufacturing
TangenX® Cassettes are manufactured in a fully validated and documented manufacturing process according to the principles of cGMP. Each cassette comes with a Quality Assurance Certificate.
Comprehensive Regulatory Support Files
Each TangenX® TFF Cassette is supported by a Regulatory Support File (available upon request) that includes:
- Cassette design
- Materials of construction
- Product performance
- Safety information
- Documentation system
- Product Manufacturing
- Qualification
- Manufacturing Process Validation
- Release Testing
TangenX® SIUS® HARDWARE
TangenX® SIUS® TFF Hardware includes:
- SIUS® cassette clamps
- SIUS® filter plate inserts
Resources
Rapid, Simple, and Versatile Manufacturing of Recombinant Adena-Associated Viral Vectors at Scale
TangenX™ Donation Adds to Bioexpression and Fermentation Facility Training Capabilities
Implementing a Single-use TFF System in a cGMP Biomanufacturing Facility
Economic Impact of Adopting Single-use TFF Flat Sheet Cassettes
AAV Studies Deploying a Closed, Irradiated, Single-use Flat Sheet TFF Device
by David Bianchi, Carl Breuning, Michael LaBreck, Shelly Parra, Mary Jo Wojtusik, Repligen Corporation
Alex Meola, Michael Mercaldi, Thomas Thiers, Homology, Medicines Inc.
Repligen Corporation
Homology, Medicines Inc.
July 2020