Sartoflow® STD 20L Recirculation Bag

Key Facts


The Sartoflow® 1000 single-use 20L recirculation bag is designed for the Sartoflow® 1000 TFF system.

Features & Benefits

  • Fast turnaround

  • Reduced cleaning validation

  • Minimized bioburden risk and product carryover in a multi-product facility

Type
Item No.: 
809-02J
Availability: 
Qty. Graduation
2

*Custom/bulk order quotes are provided within 72 hours of request.

Complete 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

  • Sartoflow® STD 1000 ½" – Retentate

  • Sartoflow® STD 1000 ½" – Permeate

  • optional Sartoflow® STD 1000 ½" – Bag

Quality 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
  • Material Tubings
    Platinum cured silicone, reinforced in high pressure sections

Operating Conditions

  • Operating Pressure
    Max. 4 bar | 58 psi

Product Information

  • Brand
    Sartoflow®
  • Type
    20L Bag

Sterility/Purity

  • Delivery Condition
    Gamma irradiated

Usage Protocols

  • Gamma Irradiation
    Minimum dose of 25 kGy