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DLHPFB Sterilizing-Grade Liquid Filter

Cobetter DLHPFB filter is designed for sterile filtration of the majority of pharmaceutical liquids, especially for solvent-containing liquids and ophthalmic solutions.
Recommended Applications：
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Description

Features

  • Hydrophilic PTFE membrane which requires no pre-wetting
  • Excellent chemical compatibility(pH 1-14), especially suitable for solvent-containing liquid filtration
  • Low preservative-adsorption with ophthalmic solutions
  • Very low extractables/leachables

Applications

  • Antibiotic sterile filtration
  • Disinfectant and sanitizing agent sterile filtration 
  • Water-based or organic solvent-based liquid sterile filtration
  • Ophthalmic solution sterile filtration
  • Liquid 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 polytetrafluoroethylene (PTFE)
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 0.56 m2
69 mm 0.45 μm 0.65 m2


Integrity Test Standards @10inch，20°C

Membrane Pore Size Bubble Point
0.22μm ≥ 0.30 MPa (water), Air test
0.45μm ≥ 0.20 MPa (water), Air test


Bacteria Retention

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


Sterilization

In-line steam sterilization Up to 35 cycles (135 °C for 30 min and differential pressure < 30 kPa per cycle)
Autoclave Up to 120 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 DLHPFB 0022   0.22 μm DOE   Double Open End 05   5 inch S   Silicone P
0045   0.45 μm HTF   222/Fin (PBT insert) 10   10 inch E   EPDM

HSF   226/Fin (PBT insert) 20   20 inch V   Viton

HTCG   222/Flat (PBT insert) 30   30 inch P   FEP/PFA encapsulated O-rings

HSCG   226/Flat (PBT insert) 40   40 inch

* Example：DLHPFB0022DOE05SP (DLHPFB，0.22μm，Double open end，5 inch，Silicone，Pharmaceutical)

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