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DGPFMP/GPFMP Sterilizing-grade Gas Filter

Cobetter DGPFMP Series Filter Cartridges are composed of double-layer hydrophobic PTFE membrane and a thick thermal resistant polypropylene core. They are highly recommended for air and gas sterile fltration of pharmaceutical, biopharmaceutical and fermentation industries. Both inherently hydrophobic and 100% integrity testing ensure absolute sterilization. Cobetter GPFMP Series Filter Cartridges are composed of single-layer hydrophobic PTFE membrane and a thick thermal-resistant polypropylene core. They are highly recommended for air and gas sterile fltration of pharmaceutical,biopharmaceutical and fermentation industries. Both inherently hydrophobic and 100% integrity testing ensure absolute sterilization.
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Description

Features

  • Absolute sterilization in dry or wet conditions
  • High flow rates, low pressure drop, higher retention efficiency
  • Better temperature and pressure resistance with a thick thermal-resistance polypropylene core
  • High temperature resistance, optional SIP or repeated autoclave
  • 100% integrity tested before delivery ensure filter's integrity and sterilization performance when using

Applications

  • Vent filtration for fermenter, storage tank, mix tank, etc
  • Aseptic packaging air sterile filtration
  • Compressed air and nitrogen gas sterile filtration
  • Corrosive gases sterilization

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 (Air)

Specifications

Materials of Construction

Membrane Double-layer or Single-layer hydrophobic polytetrafluoroethylene (PTFE)
Support Polypropylene (PP)
Core/Cage/End Caps Polypropylene (PP)
End Cap Inserts 316L Stainless Steel, 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"
DGPFMP 68 mm 0.003 μm (gas) 0.75 m²
68 mm 0.22 μm (liguid) 0.75 m²
GPFMP 68 mm 0.01 μm (gas) 0.68 m²
68 mm 0.22 μm (liquid) 0.68 m²


Integrity Test Standards @10inch,20℃ (DGPFMP)

Membrane Pore Size Bubble Point Diffusion Flow (Air) Water Flow Test
0.003 μm/0.22 μm ≥ 0.11 MPa,60% IPA, 40% Water, Air test ≤ 20 ml/min @ 0.08 MPa,60% IPA, 40% Water ≤ 0.50 ml/min @ 0.25 Mpa


Integrity Test Standards @10inch,20℃ (GPFMP)

Membrane Pore Size Bubble Point Diffusion Flow (Air) Water Flow Test
0.01 μm/0.22 μm ≥ 0.10 MPa,60% IPA, 40% Water, Air test ≤ 24 ml/min @ 0.095 MPa,60% IPA, 40% Water ≤ 0.75 ml/min @ 0.25 Mpa


Bacterial Retention

Model Content
DGPFMP 0.22 μm Bacterial quantitative retention of 10⁷ cfu/cm² Brevundimonas diminuta (ATCC 19146) accordingto ASTM F838 methodology.
DGPFMP 0.003 μm Retention efficiency for > 1×10⁸ pfu Bacteriophage Phi-X174 (ATCC 13706-B1) phage aerosol LRV > 7
GPFMP 0.22 μm Bacterial quantitative retention of 10⁷ cfu/cm² Brevundimonas diminuta (ATCC 19146) accordingto ASTM F838 methodology.
GPFMP 0.01 μm Retention efficiency for > 1×10⁸ pfu Bacteriophage Phi-X174 (ATCC 13706-B1) phage aerosol LRV > 7


Sterilization

In-line steam sterilization Up to 100 forward cycles and 50 reverse cycles (145 °C for 30 min, differential pressure < 30 kPa per forward cycle and differential pressure < 10 kPa per reverse cycle)
Autoclave Up to 400 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

DGPFMP (Double-layer)

Outer Diameter Type Membrane Pore Size End Cap Nominal Length Seal Material Industry
Blank   68mm DGPFMP S003   0.003 µm DOE   Double Open End 05   5 inch S   Silicone P

0022   0.22 µm HTF   222/Fin 10   10 inch E   EPDM

SSF   226/Fin (SS insert) 20   20 inch V   Vition

HSF   226/Fin (PBT insert) 30   30 inch P   FEP/PFA encapsulated O-rings

SSCM   226/Flat (SS insert) 40   40 inch

HSCG   226/Flat (PBT insert)


GPFMP (Single-layer)

Outer Diameter Type Membrane Pore Size End Cap Nominal Length Seal Material Industry
Blank   68mm GPFMP 0001   0.01 µm DOE   Double Open End 05   5 inch S   Silicone P

0022   0.22 µm HTF   222/Fin 10   10 inch E   EPDM

SSF   226/Fin (SS insert) 20   20 inch V   Vition

HSF   226/Fin (PBT insert) 30   30 inch P   FEP/PFA encapsulated O-rings

SSCM   226/Flat (SS insert) 40   40 inch

HSCG   226/Flat (PBT insert)


*Example:DGPFMPS003DOE05SP (DGPFMP,0.003µm,Double open end,5 inch,Silicone,Pharmaceutical)

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