TangenX® SIUS® Gamma TFF Devices embody the performance and efficiency of TangenX® SIUS® Cassettes in a convenient, fully assembled, closed, and irradiated system.
Achieve higher flux, closed device, and connectivity freedom
TangenX® SIUS® Gamma TFF Devices embody the performance and efficiency of TangenX® SIUS® Cassettes in a convenient, fully assembled, closed, and irradiated system.
Simply clamp your TangenX® SIUS® Gamma TFF Device into a holder, connect to a flow path, and go. It's that easy.
Acclaimed performance with up to 30% flux increase over conventional membranes, connectivity freedom, and a library of configurations, converge into one, simple TFF solution.
Use TangenX® SIUS® Gamma TFF Devices for gene therapy applications, bioburden-sensitive operations, and hazardous processes.
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.
CLAMP AND GO. IT'S THAT EASY.
The diversity of connectivity options makes building closed systems a challenge. Genderless AseptiQuik® connectors featured on TangenX® SIUS® Gamma TFF Devices make life easier. Configure a ProConnex® Flow Path based on individual specifications, select a pre-built ProConnex® Flow Path that is ready-to-ship, or simply plug the filtration device into your existing flow path.
Simply clamp your TangenX® SIUS® Gamma TFF Device into a holder, connect to a flow path, and go. It's that easy.
Components
- Hex nut
- Washer
- 2" or 1" tie-rod spacer(s)
- Holder top plate
- TangenX® SIUS® Gamma TFF Device
- Manifold
- AseptiQuick® connectors (genderless)
- Holder bottom plate
TangenX® SIUS® hardware can be purchased separately.
Configured for you
Build a specification based flow path from a library of over 250 components with individual quality
testing.
Ready to Ship
Order a pre-built and quality tested off-the shelf ProConnex® flow path stocked for rapid delivery.
Plug into existing
Leverage the flexibility of genderless connectors and seamlessly connect to your existing flow path.
Simplify connectivity with proconnex®
Custom Proconnex® Flow Paths complete your TFF solution
Custom
- Engineer-designed to customers' specifications
- Choose from over 250 components
- Connections
- Process reservoirs
- Pressure transducers
- Aseptic connectors
Quality
- Individually inspected
- Integrity testing available
- Clean room assembled
- Double-bagged
Bioprocess grade materials
- Class VI
- BSE/TSE free
- Lot traceable
Clamp and go
- Complete flow path or drop-in tube sets
Equivalent performance with ready-to-use convenience
Transition from TangenX® SIUS® Cassettes to TangenX® SIUS® Gamma TFF Devices seamlessly.
Membrane performance is unaffected by exposure to gamma irradiation.
When comparing performance of TangenX® SIUS® Cassettes (solid line) and TangenX® SIUS® Gamma TFF Devices (dashed line):
- Permeate flux is comparable
- BSA rejection varies by less than 1%
Diverse options for your diverse process needs
TangenX® SIUS® Gamma TFF Devices are offered with two membrane chemistries, two screen types, a wide selection of molecular weight cutoffs (MWCO), and a broad range of surface areas. With 96 configurations available, TangenX® SIUS® Gamma TFF Devices accommodate diverse process requirements for ultrafiltration and diafiltration applications from process development to commercial manufacturing.
Membrane chemistries:
- ProStream Membrane
- Neutral charge
- Low protein binding
- Excellent chemical resistance
- HyStream Membrane
- Hydrophilic
- Low protein binding
- minimal fouling with hydrophobic species
Screens:
Validated Manufacturing
Quality Manufacturing
TangenX® SIUS® Gamma TFF Devices are manufactured using a fully validated and documented manufacturing process according to the principles of cGMP. Each device comes with a Quality Assurance Certificate.
Comprehensive Regulatory Support Files
Each TangenX® SIUS® Gamma TFF Device is supported by a Regulatory Support File (available upon request) that includes:
- Product information
- Cassette design
- Materials of construction
- Product performance
- Safety information
- Documentation system
- Product Manufacturing
- Qualification
- Manufacturing Process Validation
- Release Testing
Resources
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