Purcise™ SLE 0.2 μm PES Sterilizing-Grade BriScale A50 Capsule Filter for Filterability Study Pack of 10

In stock
Part No. A50BBSLESA1QP
Regular price $75.00 USD
Filter Size
Connectors
Sterility
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*Not for medical use

The BriScale™ A50 filter has a filtration area of 20 cm² with 1/4"-1/2" stepped hose barb inlet/outlet connectors. They are ideal for material testing and screening in the process development stage.

Purcise™ SLE features sterilizing-grade filters with double-layer hydrophilic Polyethersulfone (PES) membrane, offering low protein adsorption and excellent filtration efficiency, making them a preferred solution for final sterile filtration in biopharmaceutical manufacturing processes.

Features

  • Double Layer Hydrophilic Polyethersulfone (PES) Membrane: 0.45 μm pre-filter + 0.2 μm final filter membrane, ensuring high throughput and flow rate. Exceptional chemical compatibility. Low adsorption and low leachable.
  • Sterilizing -grade Filter: Bacterial Retention validated according to ASTM F838, each filter is integrity tested prior to release.
  • 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

  • Sterile filtration of terminal products
  • Sterile filtration of biological products
  • Blood and serum products
  • Sterile filtration of vaccine products
  • Pre-column/ultra-filtration protection
  • Filtration of intermediate products/stock solutions

Quality Standards

  • ISO 9001: 2015 Quality Management System
  • Manufactured for use in conformance with cGMP
  • COA/COQ provided with shipment
Physical Properties Filter Format BriScale™ Capsule Filter
Scale Process Development, for Filterability Test
Filtration Area 20 cm²
Pore Size 0.2 μm (final-filter)
Pre-filter 0.45 μm
Bubble Point ≥0.39 MPa at 20 °C, water wetted, air
Materials Membrane Material Polyethersulfone (PES)
Housing Material Polypropylene (PP)
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 Sterilization Method Non-sterile - Autoclavable

Pre-sterilized - Gamma irradiation at 25 kGy
Package Pack Size Pack of 10
Packaging Individually packed in a double PE bag

 

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