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APSBR Sterilizing-Grade Liquid Filter

The Cobetter APSBR is a sterilizing grade filter. The unique asymmetric hydrophilic polyethersulfone membrane provides excellent filtration performance and reliable filter loading. Resistant to repeated steam sterilization. It can fully meet the filtration requirements of pharmaceutical processes.
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Description

Features

  • Excellent long life and cost effective
  • Broad chemical compatibility (pH 1-14) to effectively handle a wide range of pharmaceutical filtration processes
  • Asymmetric membrane design for increased loading capacity

Applications

  • Chinese medicine injection filtration
  • Sterile filtration of sterile raw materials
  • Sterile filtration for eye drops, liquid sterile filtration
  • 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 0.1μm 0.58m2
69mm 0.22μm 0.58m2
69mm 0.45μm 0.58m2
69mm 0.65μm 0.58m2
69mm 0.8μm 0.58m2
69mm 1.2μm 0.58m2


Integrity Standard @10inch，20°C

Membrane Pore Size Bubble Point Diffusion Flow (Air)
0.1μm ≥ 0.38 MPa (water), Air test ≤ 30 ml/min @ 0.35 MPa (water)
0.22μm ≥ 0.34 MPa (water), Air test ≤ 30 ml/min @ 0.25 MPa (water)
0.45μm ≥ 0.22 MPa (water), Air test ≤ 28 ml/min @ 0.16 MPa (water)
0.65μm ≥ 0.12 MPa (water), Air test ≤ 20 ml/min @ 0.10 MPa (water)
0.8μm ≥ 60 kPa (water), Air test ≤ 20 ml/min @ 48kPa (water)
1.2μm ≥ 50 kPa (water), Air test ≤ 20 ml/min @ 40 kPa (water)


Bacterial Retention

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


Sterilization

In-line steam sterilization Up to 55 cycles (135 °C for 30 min and differential pressure < 30 kPa per cycle)
Autoclave
Up to 200 cycles (130 °C for 30 min 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 APSBR 0010   0.1μm DOE   Double Open End 05   5 inch S   Silicone P
0022   0.22μm HTF   222/Fin 10   10 inch E   EPDM
0045   0.45μm HSF   226/Fin 20   20 inch V   Viton
0065   0.65μm HTCG   222/Flat 30   30 inch P   FEP/PFA encapsulated O-rings
0080   0.8μm HSCG   226/Flat 40   40 inch
0120   1.2μm

* Example：APSBR0010DOE05SP (DPSHSL，0.1μm，Double Open End，5 inch，Silicone，Pharmaceutical)

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