Multi Layer Hydrophilic PES Membrane for Sterile Filtration in Biopharmaceutical

The Filter cartridge with porous structure is characterized by a unique highly asymmetric, double-layer hydrophilic polyethersulphone membrane, specifically designed for extremely demanding sterilizing filtration in biopharmaceutical industry. 21 CFR materials of construction, USP Biological Safety Test for Plastics - Class VI, Validation Guide and Drug Master File (DMF) eases validation and regulatory submissions. They provide the finest, most efficient and reliable performance for critical prefiltration applications. Biological Grade Cartridges are well-suited for critical applications where superior flow, microbial reduction and particle retention at 0.1, 0.2, 0.45, 0.65 and 0.8 micron are needed. Low potein binding features makes it suitable for aseptic processing in biophamceuticals as well as food & beverages industry.

• Superior flow rate reducing process time
• Good heat resistant
• Low protein binding, maximizing yields
• Long service life
• Biologically inert

• Integrity testable
• All cartridges are rinsed with high-purity water
• Provides excellent compatibility with a wide-range of chemicals

• Serums & and blood fractions
• Biologicals
• Chromatography column protection
• Orals and topicals
• Vaccines
• Parenterals (SVP, LVP)
• Ophthalmics
• Media and fermenter feed streams
• Cell culture fl uids
• High protein feed streams

• Reagents and Buffers
• High purity DI water and WFI systems
• Bacterial Growth Media
• Process Water
• Pre-filtration
• Pharmaceutical Intermediates
• Bulk pharmaceutical chemicals
• Liquid
• Solvent filtration

Specifications
Materials of Construction

• Membrane : Multi Layer Hydrophilic Polyethersulfone
• Membrane Supports : Polypropylene
• Cage, Core, End Caps : Polypropylene
• O-Rings : Silicone, EPDM, Viton, Buna etc

Dimensions

• Diameter ø68
• Length 5 inch, 10 inch, 20 inch, 30 inch, 40 inch

Pore Size

• 0.22+0.1, 0.22+0.22, 0.45+0.22

Operating Conditions
Maximum Forward Differential Pressure :
• 4.2 bar @ 23°C
• 1.5 bar @ 85°C
Filtration Area, ft²
• 4.8 ft² per 10-inch cartridge

Bio-Safety
Filter effluent is non-pyrogenic per USP   bacterial endotoxin ( <0.25 EU/ ml)

Sterilization & Autoclaving
Steam in Place or Autoclave Sterilization @ 123 °C
Validation Guide available upon request.