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APSNDB Sterilizing-Grade Liquid Filter

Very low adsorption using a single-layer hydrophilic asymmetric polyethersulfone membrane
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Description

Features

  • Hydrophilic polyethersulfone membranes offer very low adsorption and broad chemical compatibility
  • Asymmetric membranes for higher loading capacity and lower costs
  • Sterilization for simple solvents, effective bacterial reduction for some complex fluid applications

Applications

  • Buffer sterile filtration

Quality

  • 100% Integrity testing in manufacturing
  • Each filter is fully traceable with unique serial number
  • Manufactured in a facility which adheres to ISO 9001:2015 Practices

Flow Rate Characteristics

Specifications

Materials of Construction

Membrane Hydrophilic polyethersulfone (PES)
Support Polypropylene (PP)
Core/Cage/End Caps Polypropylene (PP)
End Cap Inserts Polybutylene terephthalate (PBT)
Seal Material Silicone / EPDM / Viton
FEP/ PFA encapsulated O-rings


Operating Conditions

Max. Operating Temperature
80°C
Max.Operating Pressure
0.69 MPa@25°C
0.40 MPa@60°C
0.24 MPa@80°C
Max. Differential Pressure (Forward)
0.69 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


Filtration Area

Outer Diameter Membrane Pore Size Area/10"
69mm 0.22μm 0.55m2


Integrity Standard @10inch,20°C

Membrane Pore Size Bubble Point
0.22μm ≥ 0.32 MPa (water), Air test


Bacterial Retention

Model Content
APSNDB 0.22μm Bacterial quantitative retention of 10? cfu/cm2 Brevundimonas diminuta (ATCC 19146) accordingto ASTM F838 methodology.


Sterilization

In-line steam sterilization Up to 30 cycles (135 °C for 30 min and differential pressure < 30 kPa per cycle)


Regulatory Compliance

  • Autoclaved filter 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).
  • Aqueous extraction from a cartridge contains less than 0.25EU/ml as determined by Limulus Amebocyte Lysate (LAL), meeting requirements of USP<85>.
  • Meet the requirement of USP <87> In Vitro Cytotoxicity Test.
  • Component materials meet the requirements of the current USP<88> for plastic class VI-121°C.
  • All component materials meet the FDA Indirect Food Additive requirements cited in 21 CFR 177-182.
  • Based on the current information from our suppliers, all component materials used in the manufacture of this product are animal-free.


End Cap


Ordering Information

Outer Diameter Type Membrane Pore Size End Cap Nominal Length Seal Material Industry
69mm APSNDB 0022   0.22μm DOE   Double Open End 05   5 inch S   Silicone P

HTF   222/Fin 10   10 inch E   EPDM

HSF   226/Fin 20   20 inch V   Viton

HTCG   222/Flat 30   30 inch P   FEP/PFA encapsulated O-rings

HSCG   226/Flat 40   40 inch

* Example:APSNDB0022DOE05SP (DPSHSL,0.22+0.1μm,Double Open End,5 inch,Silicone,Pharmaceutical)

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