Cross-flow Filtration Mineral (Inorganic) Membranes & Systems for Biopharmaceuticals: Kerasep™

For more than 20 years, Novasep Process has been designing, building and selling optimized mineral membrane systems for pharmaceutical and biopharmaceutical applications.

Novasep offers tangential filtration systems from ultrafiltration to microfiltration including reliable mineral Kerasep™ membranes.

 

Typical Applications

• Concentration,
• Purification,
• Extraction,
• Buffer exchange of:
  • Cell cultures
  • Viruses
  • Endogenous/exogenous cell compounds
  • Proteins
  • Polysaccharides

Mineral (Inorganic) Membranes - Product Line

	Kerasep™
Support	Monolithic TiO2 - Al2O3
External diameter/length	25 mm/1178 mm
Number of channels	7 (X), 8 (E) 19 (W), 27 (T), 52 (K)
Filtration area per membrane (m2)	0.155 (X), 0.21 (E), 0.245 (W), 0.35 (T), 0.52 (K)
Diameter of channels (mm)	6 - 4.8 - 3.5 - 2.7 - 2.2
Layers	ZrO2/TiO2
Bursting pressure	80 bar
Service pressure	10 bar
Chemical resistance	pH: 0 - 14 e.g: Ethanol, Methanol, Phenol, Chloroform
Sterilisation - SIP	High pressure hot water up to 121°C
CIP conditions	NaOH, HNO3, O3, NaClO
Temperature limitation	up to 80°C
Quality	FDA approved materials, cGMP documentation

Cut-off

Kerasep™
Ultrafiltration	Microfiltration
1 kD	0.1 µm
5 kD	0.2 µm
15 kD	0.45 µm
50 kD
150 kD
300 kD

Materials of construction

• carter: 316 L stainless steel quality
• gaskets: Silicone, EPDM, Viton, Kalrez
• sanitary fittings, internal finish better than 0.4 µm, electropolished

Connections

3 clamp connections

Systems

• fully automated systems or manual process control program
• compact design
• cGMP compliant systems
• filtration flow monitoring
• validated software compliant with 21 CFR part 11 and GAMP 4
• ergonomic design
• ASME: code of construction

Options

• design for ATEX zone
• CIP/SIP
• solvent recovery systems

 

 

Novasep Process Biopharma Process & Products Development Services

Novasep Process offers complete process development services, and provides performance guarantees for the processes supplied.

Benefits and Advantages

Experience

For more than 20 years, Novasep Process has been designing, building and selling optimized mineral membrane systems for pharma and biopharma applications.

We provide product from lab to industrial units, process modeling and engineering design allowing easy and perfect process integration.

Products

We offer tangential filtration systems from ultrafiltration to microfiltration including reliable mineral (inorganic) Kerasep™ membranes, for your pharma and biopharma applications.

Novasep Process offers mineral (inorganic) membranes especially adapted to solvent and/or SIP bio-applications.

Expertise

Unique teams of chemists, biochemists, process and computer engineers combine their complementary talents to develop and continuously improve pharma and biopharma separations.

Other

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