eShop » Process Filtration » Prefiltration » Purcise™ PLE 0.45 μm PES Brisip SP3 Capsule Filter Steam-In-Place (SIP)

Purcise™ PLE 0.45 μm PES Brisip SP3 Capsule Filter Steam-In-Place (SIP)

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Part No. SP3SSPLESP1P
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*Not for medical use

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
  • COA/COQ provided with shipment
Physical Properties Filter Format Bricap™ SP3 Capsule Filter
Scale Production Scale
Filtration Area 0.15 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)
Port Insert 316L Stainless Steel
Housing Polyetherimide (PEI)
O-ring / Seal Silicone
Operating Conditions Max. Differential Pressure (Forward) 0.55 MPa at 25 °C
0.1 MPa at 80 °C
Max. Differential Pressure (Reverse) 0.21 MPa at 25 °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 Autoclavable: 10 cycles for 30 min at 131 °C

SIP: Steam-in-place 8 cycles for 60 min at 135 °C (Differential Pressure <30 kPa).
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.