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HSGPFP Sterilizing-Grade Gas Filter

Cobetter HSGPFP series filter cartridge is made of PTFE membrane. Its support is made of polyphenylene sulphide and can resist higher temperature. It is widely used in gas sterile filtration in pharmaceutical, biological products, fermentation industry. The intrinsic hydrophobicity as well as 100% integrity testing ensure absolute sterilization.
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Description

Features

  • Filter membranes are intrinsically hydrophobic, ensuring absolute sterilization under dry or wet conditions
  • Antioxidant components and support layer for longer service life time
  • Polyphenylene sulphide support for high temperature resistance
  • Option of repeated steaming sterilze in-line and autoclave
  • 100% integrity test of the cartridge before delivery and can be tested during use to ensure the integrity of the cartridge and the effect of sterilization

Applications

  • Aseptic air inlet and exhaust filtration for fermentation tanks, storage tanks, batching tanks, etc.
  • Sterile filtration of aseptic packaging gases
  • Sterile filtration of compressed air and nitrogen
  • Sterile filtration of corrosive gases

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 Hydrophobic polytetrafluoroethylene (PTFE)
Support Polyphenylene sulfide (PPS)
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
0.34 MPa@80°C
Max. Differential Pressure (Forward)
0.69 MPa@25°C
0.40 MPa@60°C
0.34 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"
68 mm 0.01 μm (According to gas particle retention efficiency)
0.68 m2
68 mm 0.22 μm (According to liquid bacterial challenge retention efficiency)
0.68 m2


Integrity Test Standards @10inch,20℃

Membrane Pore Size Bubble Point 空氣擴(kuò)散流 Water Flow Test
0.01 μm/0.22 μm ≥ 0.11 MPa, 60% IPA, 40% Water, Air test
≤ 16 ml/min @ 0.08 MPa, 60% IPA, 40% Water
≤ 0.53 ml/min @ 0.25 Mpa


Bacterial Retention

Model Content
HSGPFP 0.22 μm Bacterial quantitative retention of 10? cfu/cm2 Brevundimonas diminuta (ATCC 19146) accordingto ASTM F838 methodology.
HSGPFP 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 cycles (145 °C for 30 min and differential pressure < 30 kPa per cycle)+ up to 50 cycles ( for reverse, differential pressure <10 kPa), in total up to 150 cycles
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

Outer Diameter Type Membrane Pore Size End Cap Nominal Length Seal Material Industry
Blank   68mm HSGPFP 0001   0.01 μm DOE   Double Open End 05   5 inch S   Silicone P
71   71mm 0022   0.22 μm HTF   222/Fin 10   10 inch E   EPDM

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

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:HSGPFP0001DOE05SP (HSGPFP,0.01μm,Double open end,5 inch,Silicone,Pharmaceutical)

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