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Purcise SLE Sterilizing-Grade Filter Cartridge

In stock
Part No. ASLEN107SQP
Capsule Format
Pore Size
Length

Polyethersulfone (PES) material, optimal filter for final filtration.

Specifications

Materials Membrane Hydrophilic Polyethersulfone(PES)
Support Polypropylene(PP)
Core/Cage/End Cap Polypropylene(PP)
Cartridge End Cap Inserts Polybutylene terephthalate (PBT)
Cartrdige End Cap O-rings Silicone/EPDM/Fluoroelastomer/PFA encapsulated O-rings
Filtration Area A-Standard Cartridge (10")-0.55m²
H-High Area Cartridge 1(10")-0.8m²
L-High Area Cartridge 2(10")-1.04m²
Operating Conditions Max. Operating Temperature 80°C
Max. Differential Pressure (Forward) A-Standard Cartridge/ H-High Area Cartridge 1:
0.69 MPa @ 25°C
0.40 MPa @ 60°C
0.24 MPa @ 80°C

 

L-High Area Cartridge 2:
0.55 MPa @25°C
0.40 MPa @ 60°C
0.24 MPa @ 80°C
Max. Differential Pressure (Reverse) 0.30 MPa @25°C
0.10 MPa @ 80°C
Sterilization Option A-Standard Cartridge/
H-High Area Cartridge 1		 Can be steam sterilized for 30 minutes at 135 °C with 50 cycles (< 30 kPa);
Can be autoclaved 50 cycles for 30 minutes at 130°C
L-High Area Cartridge 2 Can be steam sterilized for 30 minutes at 135 °C with 30 cycles (< 30 kPa);
Can be autoclaved 30 cycles for 30 minutes at 130°C
Quality Standards Integrity 100% Integrity testing
Traceability Each filter with a unique serial number
QMS ISO 9001:2015
Package Pack Size 1/pk
Packaging Double PE bag


Features

  • Low adsorption and low leachables
  • Unwetted filter can be steam sterilized directly

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

Regulatory Compliance

  • Effluent meets the USP<788> requirement of particulate matter in large volume injection.
  • Component materials meet the criteria for a “Non-fiber-releasing filter”as defined in 21 CFR 210.3(b)(6).
  • Retention of 10⁷ cfu/cm² Brevundimonas diminuta(ATCC 19146) according to ASTM F838.
  • Aqueous extraction from a cartridge contains less than 0.25EU/ml as determined by Limulus Amebocyte Lysate (LAL), meeting requirements of USP<85>.
  • Components meet the requirement of USP <87> In Vitro Biological Reactivity Test.
  • Components meet the criteria of the USP <88> Biological Reactivity Test for Class V-121 °C plastics.
  • Components meet the FDA indirect Food Additive requirements cited in 21 CFR177-182.
  • Based on the current information from our suppliers, all components used in the manufacture of this product are animal-free.


*Contact us for more specification details.