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TangenX™ SIUS™ 一次性使用 TFF 膜包

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
Compatible

For use with cassette holders from major suppliers (Millipore, Pall, Sartorius)

Validated for GMP
Validated for GMP

Validation Guide and Certificate of Compliance provided to meet regulatory guidelines

Unparalleled savings

80% reduction in filter cost
50% reduction in labor cost
75% reduction in buffer use

 

可放大性
可放大性

From process development to commercial manufacturing

Highly consistent
Pre-sanitized

Packaged with 0.2M NaOH

 

Repligen在ISO 9001质量管理体系下开发和生产用于生物制药行业的产品。我们专注于及时交付高质量、一致且稳健的产品,以确保我们客户的业务连续性。

关于Repligen生产

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.

 

TangenX™ SIUS™ PD Single-use TFF Cassettes

Membrane
surface areas

0.01 meter2
0.02 meter2
0.10 meter2

TangenX™ SIUS™ PD with standard notch
0.850in (21.59mm) Offset

TangenX™ SIUS™ PD with standard notch

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

TangenX™ SIUS™ PD with offset notch

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

TangenX SIUS Cassettes

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
TangenX™ SIUS™ cost/sq. meter
Tangenx™ SIUS™ labor cost chart
TangenX™ SIUS™ buffer use chart

Scalable from process development to commercial scale

Process volume and membrane area determine scale-up from bench to production scale.

Process Volume vs. Membrane Area at 200 L/m2 Volumetric Throughput

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.

TangenX™ SIUS™ 一次性使用 TFF 膜包

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. 

quality-assurance-certificate.jpg

Comprehensive Regulatory Support Files

Each TangenX™ TFF Cassette is supported by a Regulatory Support File (available upon request) that includes:

  • comprehensive-regulatory-support-files.jpgProduct information
  • 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

see TangenX™ Hardware