Sartoflow® 4500 SU Flow Kits

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Sartoflow® 4500 SU Flow Kits
 

Key Facts


The Sartoflow® 4500 single-use flow kit is designed for the Sartoflow® 4500 TFF system.

  • Single-use design
  • Gamma irradiated
  • Controlled environment manufacturing
  • Quick installation

Benefits

  • Fast turnaround: Quickly switch between products without extensive cleaning.
  • Reduced risk: Minimize contamination and product carryover.
  • Precise monitoring: Integrated sensors ensure accurate process control.
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Sartoflow® 4500 SU Flow Kits
Sartoflow® 4500 SU Flow Kits

Key Facts


The Sartoflow® 4500 single-use flow kit is designed for the Sartoflow® 4500 TFF system.

  • Single-use design
  • Gamma irradiated
  • Controlled environment manufacturing
  • Quick installation

Benefits

  • Fast turnaround: Quickly switch between products without extensive cleaning.
  • Reduced risk: Minimize contamination and product carryover.
  • Precise monitoring: Integrated sensors ensure accurate process control.
Item No.:
Sartoflow_4500_SU_Flow_Kits_1

Overview

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Single-Use Flow Kit for the Sartoflow® 4500 System


Elevate your tangential flow filtration process with the Sartoflow® 4500 single-use flow kits, designed specifically for the Sartoflow® 4500 system.

The Sartoflow® 4500 flow kit contains the following products:

  • Sartoflow® STD 4500 1" – Feed
  • Sartoflow® STD 4500 1" – Diafiltration
  • Sartoflow® STD 4500 1" – Buffer & WFI
  • Sartoflow® STD 4500 1" – Retentate
  • Sartoflow® STD 4500 1/2" – Permeate
  • Sartoflow® STD 4500 – Pump Head

Standards for the Sartoflow® 4500 Flow Kit

  • Manufactured in a controlled environment (Class 7 in operation according to ISO 14644)
  • Feature components tested for biocompatibility and
  • certified according to USP
  • Components are compliant with EMA410/01 Rev3 requirements with regards to TSE | BSE
  • Manufactured according to a validated assembly process
  • Supplied double-bagged and irradiated with a minimum
    dose of 25 kGy
  • The quality management system is ISO 9001 compliant

Applications

  • Application
    • Purification of mAbs, ADC, vaccines, viral vectors, and recombinant proteins
    • Concentration
    • DNA Concentration
    • Antibody Purification
    • Desalting
    • Buffer Exchange
    • Protein Concentration
    • Single Use Processing
  • Application Area
    • Concentration
    • Buffer exchange
  • Process Step
    • Commercial Manufacturing
    • Clinical Trial Manufacturing

Compliance Information

  • Quality Standards
    • Manufactured in a controlled environment (Class 7 in operation according to ISO 14644)
    • Feature components tested for biocompatibility and certified according to USP
    • Components are compliant with EMA410/01 Rev3 requirements with regards to TSE | BSE
    • Manufactured according to a validated assembly process
    • Supplied double-bagged and irradiated with a minimum dose of 25 kGy
    • The quality management system is ISO 9001 compliant

Materials of Construction

  • Connector Material
    Polypropylene (PP)
  • Material Tubings
    Platinum cured silicone, reinforced in high pressure sections
  • Tubing Material
    Platinum-Cured Silicone with PET reinforcement

Operating Conditions

  • Operating Pressure
    Max. 4 bar | 58 psi

Product Information

  • Brand
    Sartoflow®

Sterility/Purity

  • Sterilization Method
    Gamma irradiation

Usage Protocols

  • Gamma Irradiation
    Minimum dose of 25 kGy