integrated 

Modular, plug-and-play hardware with peristaltic pump 

The KrosFlo® KMPi TFF System achieves an unparalleled combination of integration, configurability and automation through modular, plug-and-play hardware.  All components, either directly or indirectly, connect to the main KrosFlo® KMPi peristaltic pump, which then communicates with the KF Comm 2 software for control and monitoring.

  • 可针对简单的应用,如浓缩(C)或洗滤(D),配置最低数量的部件
  • Plug-and-play additional components for fractionation (F) and multi-step processes (i.e. CDC/D/C)

Click on the tabs below to explore different combinations of concentration and diafiltration configurations using the KrosFlo® KMPi System.

Concentrate with a streamlined configuration

C = Concentration D = Diafiltration F = Feed

Add a scale and auxiliary pump to access diafiltration applications

C = Concentration D = Diafiltration F = Feed

Build process understanding with increased sensors

C = Concentration D = Diafiltration F = Feed

  integrated

Configurable ProConnex® Flow Paths

ProConnex® 流路是用于切向流过滤的定制化、可配置的完整流路装置,其经工程设计过程而得以强化。该类流路装置可使用中空纤维和/或平板膜包TFF过滤器,在符合ISO指南的ISO 7级洁净室内生产,经预灭菌处理,适配于上游或下游处理应用。

ProConnex® Filter Assemblies

  integrated

通过专利主板,
双向传输数据

An advanced microprocessor-based controller is integrated into the main KrosFlo® KMPi System pumps, enabling plug-and-play hardware component behavior. Bi-directional communication is established between the KF Comm 2 software and hardware components, such as the Automatic Back Pressure Control Valve, scales, auxiliary pumps and the Konduit device.

 AUTOMATED

Menu-driven Software for Optimized TFF

KF Comm 2 Software, backward compatible with legacy KrosFlo® KR2i and KrosFlo® KMPi Systems, is conveniently installed on any computer using the Windows Operating System. The software is compatible with Chrome, Mozilla, Firefox and Microsoft Explorer browsers and is always current with automatic software and firmware updates. 

  • 用于KrosFlo® TFF 系统的专利软件
  • 提供21CFR Part 11合规版本,以验证用于GMP工艺
  • 直观的工作流,13种操作模式

KF Comm 2 软件

  AUTOMATED

自动背压控制阀

Repligen独家技术,自动背压控制阀为每个TFF工艺增加跨膜压(TMP)控制,减少操作员手动操作时间,提高工艺可再现性。 

  • 按用户设置的设定点,自动调整管夹距离
  • 在整个工艺运行过程中,维持均一的TMP,降低膜污染
  • 在微滤应用中,控制滤液压力和流速
  • 使用兼容管号:13、 14、 16、 25、 HP15、 17、 HP24、 18、 HP35、 36 和 HP36
  • 可用于自动调节进样、回流、滤液或跨膜压力 
  AUTOMATED

Monitor and evaluate conductivity, UV and temperature 

Konduit is an add-on module ready to use with the KrosFlo® KR2i and KMPi TFF Systems, with the ability to scale from 2mL to 500L process volumes.

电导率范围 0.1 - 100 mS/cm
温度范围0-70°
压力范围 可达 75 psi (5 bar)
尺寸(L x W x H): 7¾" x 4¾" x 4½"
重量 1.6 kg

  READY TO SCALE FAST

Ideal for Gene Therapy from Lab to Manufacturing

Run TFF development experiments and compliant small-scale manufacturing runs on a single platform. Start with the KrosFlo® KR2i System with  volumes as low as 10 mL. Scale up to 500 L with the KrosFlo® KMPi System while maintaining pump design, system architecture and software.

  • 在同一平台内进行规模放大和规模缩小
  • 针对不同应用进行工艺序列配置(C、D和CFC/D/C)
  • Modern 21 CFR Part 11 compliance software built on secure Microsoft® SQL Server 
  READY TO SCALE FAST

Scalable From Lab-scale to Process-scale

The KrosFlo® family of TFF Systems for concentration and diafiltration supports scale up from process development to commercial manufacturing.

KrosFlo® KR2i
2 ml - 15 L

KrosFlo® KMPi
100 mL - 500 L

KrosFlo® KTF
10 L - 2000+ L

KrosFlo® KMPi TFF System

The fully integrated KrosFlo® KMPi TFF System consists of hardware, software and flow path components. Key hardware components include: a digital peristaltic pump, auxiliary pumps and an automatic back pressure valve.

The KF Comm 2 software features a multi-language interface for complete monitoring and control and an optional 21 CFR Part 11 environment. Add tubing and sanitize/sterilize your own flow path around a Spectrum® hollow fiber filter or build a closed and gamma-irradiated ProConnex® Flow Path from over 250 components.

Click on the links below to explore different features.

 

Optimized for use with Repligen Hollow Fiber Filter Modules

  主要
应用
体积 进口 / 出口 侧面
端口
标尺
长度
有效长度 (cm)
长度 (cm)

面积

MiniKros Sampler

               
MiniKros-Sampler.png 小体积批量TFF 3 L -15 L 0.75" TC 0.75" TC 1 x FL
2 x FL
3 x FL
20
41.5
65
25
47
70
490 – 1000 cm2
1000 - 2200 cm2
1600 - 3400 cm2

MiniKros

               
MiniKros.png 中试规模TFF 5 L - 50 L 1.5" TC 0.75" TC 1 x FL
2 x FL
3 x FL
20
41.5
65
25
46
70
0.16 - 0.31 m2
0.32 - 0.65 m2
0.51 - 1.0 m2

KrosFlo®

               
KrosFlo.png 生产规模TFF 10 – 100L 3" TC 1.5" TC 1 x FL
2 x FL
3 x FL
20
41.5
65
23
46
69
0.78 - 1.6 m2
1.65 - 3.25 m2
2.55 - 5.10 m2

部件和配件

  • IP 33 级外壳
  • 600 RPM 泵,带可逆驱动
  • 90-260 Vrms @ 50/60 Hz
  • 标准 Easy Load 3 泵头,适用高精度13、14、16、25、17 和 18 号L/S管。
  • (选配) Easy Load 3 泵头,适用高性能15、24、35、36号L/S管。
  • ETL注册,带CE/UL/cUL标识
  • 泵驱动尺寸:10.5 in x 8 in x 8 in
KONDUiT可增加:
  • 用于UF/DF的终点电导控制
  • 用于从药物递送颗粒中洗滤去除游离药物的终点UV控制
  • 用于特定分子浓缩时的终点UV控制
  • 用于膜穿透的UV警报
  • 提供A260 和 A280 光源

*UV 部件单独销售

传感器

  • 检测并显示4个压力值:进样压力、回流压力、滤液压力和跨膜压(TMP)
  • 用户定义的压力警报和停机设定点
  • 提供多种不同接头类型 (鲁尔和TC) 及结构材料选择 (PS、PC)

天平 

在TFF工艺过程中,维持用户设定的进样重量设定点以及总滤液重量。

KrosFlo® KR Jr Auxiliary Pump

辅助泵自动增加或降低缓冲液/产品添加至进样容器的速度。

Manufacturing Centers of Excellence

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。

Repligen manufacturing sites are located in Massachusetts, California, and New Jersey in the United States and in Sweden, France, The Netherlands,  Germany and Estonia.

地点

Expert Project Management

客户至上。

Repligen DNA 为您提供支持。我们的目标是提供卓越的客户体验,并为所有 Repligen 产品和服务高效成功的采用及实施提供支持。

  • Field Application Support
  • 客户服务
  • 现场服务工程师

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规格

Description

规格

工艺体积 可达500L
过滤器面积 最高 5.1 m2
主泵/进样泵 最高 11LPM (650 RPM)
压力传感器 最多 3 个鲁尔端口类型、聚砜、一次性使用 (-0.48 - 5.2bar)
天平 60Kg (已包括);可选配: 60Kg、200Kg、500Kg 和 1000Kg
辅助泵 KrosFlo® Research I,600 RPM
管路 PharmaPure,TPE,管号 #26、#73 和 #82
TMP 控制 自动背压控制阀 (非侵入式/无产品接触)
容器 10L 聚丙烯,含 4-端口盖和底部排液
作为HMI的平板电脑 Microsfot Surface Pro
软件 KF Comm 2,可选配21CFR part 11软件包
合规 UL & CE 认证