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Sartoflow® STD 1000 1/2" - Permeate

Tech Support Documents
Sartoflow® STD 1000 1/2" - Permeate
 

Key Facts

The Sartoflow® 1000 single-use permeate flow kit is designed for the Sartoflow® 1000 TFF system, with a focus on the American market.

Features & Benefits

  • Fast turnaround
  • Reduced cleaning validation
  • Minimized bioburden risk and product carryover in a multi-product facility
Type
Item No.: 
809-02F
*Custom/bulk order quotes are provided within 72 hours of request.
Sartoflow® STD 1000 1/2" - Permeate
Sartoflow® STD 1000 1/2

Key Facts

The Sartoflow® 1000 single-use permeate flow kit is designed for the Sartoflow® 1000 TFF system, with a focus on the American market.

Features & Benefits

  • Fast turnaround
  • Reduced cleaning validation
  • Minimized bioburden risk and product carryover in a multi-product facility
Item No.:
809-02F

Overview

Specifications

Choose your Sartoflow® 1000 Single Use Flow Kits

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½" Single Use Flow Kit for the Sartoflow® 1000 System

The complete Sartoflow® 1000 flow kit contains the following products:

  • Sartoflow® STD 1000 ½" – Feed (809-03D)
  • Sartoflow® STD 1000 ½" – Retentate (809-03F)
  • Sartoflow® STD 1000 ½" – Permeate (809-02F)
  • Optional Sartoflow® STD 1000 ½" – Bag (809-02J)

Standards for the Sartoflow® 1000 Single-Use Flow Kits

  • Manufactured in a controlled environment (Class 7 in operation according to ISO 14644)
  • Feature components tested for biocompatibility and certified according to USP<88>
  • 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
  • Process Step
    • Pilot
    • 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<88
    • 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

Connections (Physical)

  • Connections
    TC
  • Connector(s)
    0.75" Tri-clamp

Dimensions

  • Inner Diameter
    1/2"

Features

  • Reusable
    No

General Specifications

  • Tubing
    Platinum cured silicone, reinforced in high pressure sections

Materials of Construction

  • Connector Material
    Polypropylene (PP)
  • Material Tubings
    Platinum cured silicone, reinforced in high pressure sections

Operating Conditions

  • Operating Pressure
    Max. 4 bar | 58 psi

Product Information

  • Brand
    Sartoflow®
  • Type
    Permeate

Sterility/Purity

  • Delivery Condition
    Gamma irradiated

Usage Protocols

  • Gamma Irradiation
    Minimum dose of 25 kGy