量產cGMP型KrosFlo® KTF TFFSystems ( up to 5,000 L )

產品介紹:

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

規格訊息:

KrosFlo® TFF Systems | Manufacturing

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

 

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

  • Configure for multiple applications
  • iFIX software programmed for TFDF® applications
  • Fully compatible with ProConnex® TFDF® Flow Paths
  • Line 1 supports TFDF® clarification (1500 cm2)
  • Line 2 supports UF/DF (6000 cm2)
 

-  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

 

更多產品資訊......

 

產品影片:

詢價車:

  • Part NO.
  • Qty
  • Inquiry
  • KrosFlo Pilot Plus System
  • 10 L to 5,000 L
  • 1/set
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