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TangenX® SIUS® Single-use TFF Cassettes

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.

在传统TFF中,工艺中使用的过滤器通常会在两次使用之间通过在线清洗(CIP)操作进行清洗。这会显著增加系统处理能力、原材料、电力以及时间的投入。 

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. 

可与TangenX™ SIUS™

With TangenX® PRO Reusable TFF Cassettes - same channel geometry, same membrane chemistry

兼容所有市售
兼容所有市售

可与行业主要供应商(Millipore、Pall、Sartorius)的夹具兼容

验证用于GMP工艺
验证用于GMP工艺

提供验证指南及合格证书,以符合监管指南

无可比拟的成本节省

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

可放大性
可放大性

从工艺开发到商品化生产

高度的一致性
预消毒

以0.2M NaOH包装

 

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.

Shop now for TangenX® PD Cassettes

 

TangenX™ SIUS™ PD 一次性使用 TFF 膜包

膜表面积

0.01 m2
0.02 m2
0.10 m2

TangenX® SIUS® PD with standard notch
0.850in (21.59mm) 偏置

TangenX™ SIUS™ PD 标准槽口

这种构型可匹配下列膜包卡盘和夹具:

  • TangenX® SIUS® PD Cassette Clamps
  • TangenX® PRO PD Cassette Holders
  • Pall - Centramate 夹具 (CM018LV、FS001K10)

TangenX® SIUS® PD with offset notch
0.756in (19.21mm) 偏置

TangenX™ SIUS™ PD 偏置槽口

这种构型可匹配以下第三方膜包夹具:

  • Sartorius - Sartocon Slice 夹具 (17525-01、17521-02)
  • GE - Kvick Lab 夹具 (KLPH01SSU、KLHR0105000SS)
  • Millipore - Pellicon Mini 夹具 (XX42PMINI)

TangenX® SIUS® FOR SCALE-UP AND COMMERCIAL MANUFACTURING

膜表面积

0.5 m2
1.5 m2
2.5 m2

TangenX SIUS 膜包

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.

无可比拟的工艺和成本效益

过滤器成本降低80%
劳动力成本降低50%
缓冲液使用降低75%
TangenX™ SIUS™ 成本/每平方米
Tangenx™ SIUS™ 劳动力成本图
TangenX™ SIUS™ 缓冲液使用图

可从工艺开发规模放大至商品化生产

处理体积和膜表面积决定了从实验室到生产的规模放大。

工艺体积 vs. 膜表面积 @ 200 L/m2 单位体积吞吐量

多种流道构型

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

经验证的生产过程

高质量生产

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

完整法规支持文件

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

  • comprehensive-regulatory-support-files.jpg产品信息
  • 膜包设计
  • 结构材料
  • 产品性能
  • 安全信息
  • 文件系统
  • 产品生产
  • 质量确认
  • 生产工艺验证
  • 出厂检测

 

TangenX® SIUS® HARDWARE

TangenX® SIUS® TFF Hardware includes:

  • SIUS® cassette clamps
  • SIUS® filter plate inserts

see TangenX® Hardware