欣梗科技股份有限公司

產品介紹項目

KrosFlo® TFF Systems | Manufacturing量產級切向流濃縮透析系統，符合cGMP與FDA規範之切向流濃縮裝置，處理體積10 L-5000 L。

KrosFlo® TFF Systems | Manufacturing

is manufactured under cGMP standards for the tangential flow filtration of validated pilot production processes.

Brochure使用手冊

Repligen KTF 切向流分離濃縮系統 (Tangential Flow Filtration System)可直接從小體積放大至量產等級。

操作體積為up to 5000 L，可搭配Cassette (Max. filter area:20m2 )或Hollow Fiber (Max. filter area:17.2m2 )，

並能符合FDA的生產流程，在cGMP標準規範下進行，擁有UL(美國), CE(歐盟) 和 CSA(加拿大) 認證的cGMP文件，

是生物醫藥量產的理想選擇。

Application Flexibility

- 擁有cGMP 的規範與流程版本

- 擁有數位壓力指示計

- 擁有磁力的流速指示計

- 圓錐凹槽設計FDA等級樣品桶(PP, 50, 250 & 500 liter )

- 防爆系統設計 (Explosion proof system design)

- 擁有GMP或非GMP兩種系統設計選擇

Specification	KrosFlo® KTF Process System
Typical process volumes	Up to 5000 Liters
Max. filter area	2 each up to 17.2 m2 (Hollow Fiber)
Configurable Components
Pump	Multiple MagLev pump sizes
Flow rate	Pumps 1 and 2, up to 85 LMP
Max. Pressure	2.5 Bar
Min. hold up volume	< 0.5 Liter
Tubing	≤ 1" ID
Membranes	Hollow fibers
Retentate Flow meter Permeate Flow meter	Clamp-on flow meter Ultrasonic Clamp-on or flow through Ultrasonic
Feed Scale	Tank 4-20 mA or Ethernet
Cabinet width	24" or 30"
Modes of TFF (Client Base)	Conc, Diaf, Final Conc, Fed Batch+
Flow Path	Sterile ProConnex® Flow Path
TMP control	Non-invasive / No Product Contact
Pressure sensors	Multiple sizes
Frame	Stainless Steel 304, <35Ra
Auxiliary pumps	Tri Lobe SS Perisaltic pump
Software and HMI
PLC	Allen Bradley
Software	IFix 6.0 iHistorian Dream Reports E-signature
Delta V	Connectivity to Delta V
GMP	21CFR11 Enabled