eShop » Process Filtration » Prefiltration » Purcise™ PLE 0.45 μm PES High Area (0.69-0.8 m²) Filter Cartridge Prefiltration

Purcise™ PLE 0.45 μm PES High Area (0.69-0.8 m²) Filter Cartridge Prefiltration

In stock
Part No. HPLES102SP
Filter Size
Code
O-ring Material
Loading locations...
*Not for medical use

Cobetter Filter cartridges are available in a complete range of lengths from 2.5" to 40", providing flexible scale-up solutions from laboratory development and pilot studies to full-scale manufacturing. Designed with excellent compatibility and scalability, the cartridge filters support seamless process transfer and linear scale-up while maintaining consistent filtration performance across different stages.

Purcise™ PLE 0.45 μm hydrophilic PES membrane designed for efficient particle removal and process protection applications. The PES membrane offers low protein binding to minimize product loss while maintaining broad chemical compatibility across a wide range of process fluids. It is suitable for buffer filtration and protective prefiltration steps upstream of chromatography columns and ultrafiltration processes.

Features

  • Double Layer Hydrophilic Polyethersulfone (PES) Membrane: 0.8 μm pre-filter + 0.45 μm final filter membrane. Good chemical compatibility. Low leachables.
  • Linear Scale Up: Available in syringe filter for filterability study, small-scale capsule filter for process development, and large-scale capusle filter and filter cartridge for commercial GMP manufacturing.

Applications

  • Buffer filtration
  • Pre-column/ultra-filtration protection

Quality Standards

  • ISO 9001: 2015 Quality Management System
  • Manufactured for use in conformance with cGMP
  • Each product is integrity tested prior to release
  • Unique serial number for full traceability
  • COA/COQ provided with shipment
  • Validation documents are available upon request
Physical Properties Filter Format Cartridge Filter
Scale Production Scale
Filtration Area 0.4 m², 0.8 m², 1.6 m², 2.4 m², 3.2 m²
Pore Size 0.45 μm (final-filter)
Pre-filter 0.8 μm
Bubble Point (per 0.55 m²) ≥0.27 MPa at 20 °C, water wetted, air
Materials Membrane Material Polyethersulfone (PES)
Support Fleece Polypropylene (PP)
Housing Polypropylene (PP)
O-ring / Seal Silicone / EPDM / Fluoroelastomer
Operating Conditions Max. Differential Pressure (Forward) 0.69 MPa at 25 °C
0.4 MPa at 60 °C
0.24 MPa at 80 °C
Max. Differential Pressure (Reverse) 0.3 MPa at 25 °C
0.1 MPa at 80 °C
Regulatory Compliance Compliance USP <788> Particulate Matter
USP <87> Cytotoxicity
USP <88> Biological Reactivity
FDA Indirect Food Additives, 21 CFR 177-182
ADCF Materials
Bacterial Retention 10⁷ cfu/cm² Brevundimonas diminuta (ATCC 19146) according to ASTM F838
Bacterial Endotoxin Endotoxin Limit of WFI System<0.25 EU/mL with the Limulus Amebocyte Lysate (LAL), USP <85>
Non-Fiber Releasing The products meet the criteria as defined in 21 CFR 210.3(b)(6)
Sterility Delivery Condition Non-sterile
Sterilization Method Can be SIP for 30 min at 135 °C 50 cycles (<30kPa)

Can be autoclaved 50 cycles for 30 min at 130 °C
Package Pack Size Pack of 1
Packaging Individually packed in a double PE bag

 
What are the main applications of prefiltration products?

Prefilters are primarily used to reduce microbial bioburden and enhance the capacity of sterilizing/virus removal filters.

What materials are primarily used for Cobetter prefiltration products?

Cobetter prefilters are primarily made of PES and PVDF, with PP and GF options available for coarse prefiltration or feed clarification.

What are the main pore sizes available for Cobetter prefiltration membranes?

Cobetter prefilters are available in pore sizes of 0.2 µm, 0.45 µm, 0.65 µm, 0.8 µm, and 1.2 µm, etc.