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APSEA Sterilizing-Grade Liquid Filter

Cobetter APSEA cartridge is a double-layer membrane filter: polypropylene pre-filtration layer and asymmetric PES membranes for bacterial reduction, LRV/cm2 > 6
Recommended Applications：
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Description

Features

  • Excellent long life and cost-effective
  • Asymmetric, high loading capacity, bacterial reduction pre-filtration

Applications

  • Bacterial reduction before final sterilization and filtration
  • Reduces bioburden

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"
69 mm 0.22 μm 0.66 m2
69 mm 0.45 μm 0.66 m2
69 mm 0.65 μm 0.66 m2
69 mm 0.8 μm 0.66 m2
69 mm 1.0 μm 0.66 m2
69 mm 1.2 μm 0.66 m2
69 mm 3.0 μm 0.66 m2
69 mm 5.0 μm 0.66 m2
69 mm 8.0 μm 0.66 m2
69 mm 10.0 μm 0.66 m2


Integrity Test Standards @10inch，20°C

Membrane Pore Size Bubble Point
0.22 μm ≥ 0.11 MPa，60% IPA, 40% Water, Air test
0.45 μm ≥ 0.07 MPa，60%  IPA, 40% Water, Air test
0.65 μm ≥ 0.04 MPa，60%  IPA, 40% Water, Air test


Bacterial Retention

Model Content
APSEA 0.22 μm LRV/cm2 ＞6 for 10? cfu/cm2 Brevundimonas diminuta（ATCC 19146）
APSEA 0.45 μm LRV/cm2 ＞6 for 10? cfu/cm2 Serratia marcescens (ATCC 14756)


Sterilization

In-line steam sterilization Up to 100 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 APSEA 0022   0.22 μm DOE   平壓 05   5英寸 S   Silicone P
0045   0.45 μm HTF   222/尖頭式 10   10英寸 E   EPDM
0065   0.65 μm HSF   226/尖頭式 20   20英寸 V   Viton
0080   0.8 μm HTCG   222/平頭式 30   30英寸 P   FEP/PFA encapsulated O-rings
0100   1.0 μm HSCG   226/平頭式 40   40英寸
0120   1.2 μm
0300   3.0 μm
0500   5.0 μm
0800   8.0μm
1000   10.0μm

* Example：APSEA0022DOE05SP (APSEA，0.22μm，Double open end，5 inch，Silicone，Pharmaceutical)

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