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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 10? cfu/cm2 Brevundimonas diminuta (ATCC 19146) accordingto ASTM F838 methodology.
DGPFMP 0.003 μm Retention efficiency for > 1×10? pfu Bacteriophage Phi-X174 (ATCC 13706-B1) phage aerosol LRV > 7
GPFMP 0.22 μm Bacterial quantitative retention of 10? cfu/cm2 Brevundimonas diminuta (ATCC 19146) accordingto ASTM F838 methodology.
GPFMP 0.01 μm Retention efficiency for > 1×10? 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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