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DLHPVDF/LHPVDF Sterilizing-Grade Liquid Filter

Cobetter DLHPVDF series cartridges are made of double-layer hydrophilic PVDF membranes; PVDF has very low protein adsorption properties, making it especially suitable for culture fluid, biological reagents, sterile vaccine filtration. At the same time, DLHPVDF has low leachables, wide chemical compatibility, and very excellent temperature resistance.
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Description

Features

  • Very low protein adsorption properties
  • Good corrosion, oxidation and heat resistance
  • Low leachables
  • Good chemical compatibility
  • 100% integrity testing to ensure sterilization performance

Applications

  • Blood products filtration
  • Culture media filtration
  • Antibiotic sterile filtration
  • Biological reagents filtration
  • Vaccine 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 polyvinylidene fluoride (PVDF)
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"
DLHPVDF 69 mm 0.22+0.1 μm 0.55 m2
69 mm 0.22+0.22 μm 0.55 m2
69 mm 0.45+0.22 μm 0.55 m2
69 mm 0.45+0.45 μm 0.58 m2
69 mm 0.65+0.45 μm 0.58 m2
LHPVDF 69 mm 0.1 μm 0.58 m2
69 mm 0.22 μm 0.58 m2
69 mm 0.45 μm 0.58 m2
69 mm 0.65 μm 0.58 m2


Integrity Test Standards @10inch，20°C (DLHPVDF)

Membrane Pore Size Bubble Point Air Diffusion
0.22+0.22 μm ≥ 0.32 MPa (water), Air Testing ≤ 16 ml/min @ 0.28 MPa (water)
0.45+0.22 μm ≥ 0.32 MPa (water), Air Testing ≤ 20 ml/min @ 0.28 MPa (water)
0.45+0.45 μm ≥ 0.16 MPa (water), Air Testing
0.65+0.45 μm ≥ 0.12 MPa (water), Air Testing ≤ 10 ml/min @ 0.1 MPa (water)


Integrity Test Standards @10inch，20°C (LHPVDF)

Membrane Pore Size Bubble Point Air Diffusion
0.1 μm ≥ 0.16 MPa，Wetted with 60% IPA, Air Test ≤ 30 ml/min @ 0.386 MPa，Water Wetting
0.22 μm ≥ 0.32 MPa，Water wetting, Air Testing ≤ 20 ml/min @ 0.28 MPa，Water Wetting
0.45 μm ≥ 0.12 MPa，Water wetting, Air Testing ≤ 10 ml/min @ 0.10 MPa，Water Wetting
0.65 μm ≥ 0.10 MPa，Water Wetting, Air Testing


Bacterial Retention

Model Content
DLHPVDF 0.22+0.22 μm Bacterial quantitative retention of 10? cfu/cm2 Brevundimonas diminuta (ATCC 19146) accordingto ASTM F838 methodology.
DLHPVDF 0.45+0.22μm
DLHPVDF 0.45+0.45 μm Bacterial quantitative retention of 10? cfu/cm2 Serratia marcescens (ATCC14756) according to ASTM F838 methodology.
DLHPVDF 0.65+0.45 μm
LHPVDF 0.1μm Bacterial quantitative retention of 10? cfu/cm2 Brevundimonas diminuta (ATCC 19146) accordingto ASTM F838 methodology.
LHPVDF 0.22μm
LHPVDF 0.45 μm Bacterial quantitative retention of 10? cfu/cm2 Serratia marcescens (ATCC14756) according to 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

DLHPVDF (Double-layer)

Outer Diameter Type Membrane Pore Size End Cap Nominal Length Seal Material Industry
69mm DLHPVDF 2210   0.22+0.1μm DOE   Double Open End 05   5 inch S   Silicone P
2222   0.22+0.22μm HTF   222/Fin (PBT insert) 10   10 inch E   EPDM
4522   0.45+0.22μm HSF   226/Fin (PBT insert) 20   20 inch V   Viton
4545   0.45+0.45μm HTCG   222/Flat (PBT insert) 30   30 inch P   FEP/PFA encapsulated O-rings
6545   0.65+0.45μm HSCG   226/Flat (PBT insert) 40   40 inch


LHPVDF (Single-layer)

Outer Diameter Type Membrane Pore Size End Cap Nominal Length Seal Material Industry
69mm LHPVDF 0010   0.1μm DOE   Double Open End 05   5 inch S   Silicone P

0022   0.22μm HTF   222/Fin (PBT insert) 10   10 inch E   EPDM

0045   0.45μm HSF   226/Fin (PBT insert) 20   20 inch V   Viton

0065   0.65μm HTCG   222/Flat (PBT insert) 30   30 inch P   FEP/PFA encapsulated O-rings

HSCG   226/Flat (PBT insert) 40   40 inch


* Example：DLHPVDF2210DOE05SP (DLHPVDF，0.22+0.1μm，Double open end，5 inch，Silicone，Pharmaceutical)

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