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DPSHPC Sterilizing-Grade Liquid Filter

The DPSHPC series filter cartridge is composed of a unique PES filter membrane developed and improved by Cobetter. It can remove small particles, bacteria and endotoxins in the solution. The endotoxin removal efficiency in the physiological saline solution is more than 99%.
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Description

Features

  • Modified PES
  • Fast flow rate and high throughput
  • pH1-14 tolerant
  • Can be pre-disinfected with NaOH
  • Good sterilization performance

Applications

  • Sterile and depyrogenation filtration for LVP and SVP
  • Sterile and depyrogenation filtration for antibiotic solution
  • Sterile and depyrogenation filtration for physiological saline and other solvents

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


Integrity Test Standards @10inch,20°C

Membrane Pore Size Bubble Point Diffusion Flow (Air)
0.22+0.22μm ≥ 0.32 MPa (water), Air test ≤ 28 ml/min @ 0.275 MPa (water)


Bacterial Retention

Model Content
DPSHPC 0.22μm Bacterial quantitative retention of 10⁷ cfu/cm² Brevundimonas diminuta (ATCC 19146) accordingto ASTM F838 methodology.


Sterilization

In-line steam sterilization Up to 50 cycles (135 °C for 30 min and differential pressure < 30 kPa per cycle)
Autoclave Up to 50 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 DPSHPC 2222   0.22+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:DPSHPC2222DOE05SP (DPSHSL,0.22+0.22µm,Double open end,5 inch,Silicone,Pharmaceutical)

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