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DLHPVHBR/LHPVHBR Sterilizing-Grade Liquid Filter

Cobetter's DLHPVHBR/LHPVHBR series filter cartridge is made of hydrophilic and positively-charged PVDF membrane. PVDF's unique very low protein adsorption performance makes it particularly suitable for filtration of culture fluids, biological reagents, sterile vaccines, etc. At the same time, DLHPVHBR/LHPVHBR has low leachables, wide chemical compatibility, and very excellent temperature resistance.
Recommended Applications：
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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 product filtration
  • Antibiotic solution sterile filtration
  • Biological reagent 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"
DLHPVHBR 69 mm 0.1+0.1 μm 0.58 m2
69 mm 0.22+0.1 μm 0.58 m2
69 mm 0.22+0.22 μm 0.58 m2
69 mm 0.45+0.22 μm 0.58 m2
69 mm 0.65+0.22 μm 0.58 m2
LHPVHBR 69 mm 0.22 μm 0.58 m2
69 mm 0.45 μm 0.58 m2


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

Membrane Pore Size Bubble Point Air Diffusion
0.1+0.1 μm ≥ 0.48 MPa (water), Air Testing ≤ 15 ml/min @ 0.386 MPa (water)
0.22+0.1 μm ≥ 0.48 MPa (water), Air Testing ≤ 20 ml/min @ 0.386 MPa (water)
0.22+0.22 μm ≥ 0.32 MPa (water), Air Testing ≤ 18 ml/min @ 0.28 MPa (water)
0.45+0.22 μm ≥ 0.32 MPa (water), Air Testing ≤ 20 ml/min @ 0.28 MPa (water)
0.65+0.22 μm ≥ 0.32 MPa (water), Air Testing ≤ 20 ml/min @ 0.28 MPa (water)


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

Membrane Pore Size Bubble Point Air Diffusion
0.1 μm / ≤ 30 ml/min @ 0.386 MPa (water)
0.22 μm ≥ 0.32 MPa (water), Air Testing ≤ 20 ml/min @ 0.28 MPa (water)
0.45 μm ≥ 0.12 MPa (water), Air Testing ≤ 10 ml/min @ 0.10 MPa (water)


Bacterial Retention

Model Content
DLHPVHBR 0.22+0.1μm Bacterial quantitative retention of 10? cfu/cm2 Brevundimonas diminuta (ATCC 19146) accordingto ASTM F838 methodology.
DLHPVHBR 0.22+0.22μm
DLHPVHBR 0.22+0.1μm
DLHPVHBR 0.45+0.22μm
DLHPVHBR 0.65+0.22μm
LHPVHBR 0.1μm Bacterial quantitative retention of 10? cfu/cm2 Brevundimonas diminuta (ATCC 19146) accordingto ASTM F838 methodology.
LHPVHBR 0.22μm


Sterilization

In-line steam sterilization DLHPVHBR Up to 150 cycles (135°C for 30 min, differential pressure <30kPa in the forward direction with 100 cycles and <10kPa in the reverse direction with 50 cycles)
LHPVHBR Up to 70 cycles (135°C for 30 min and differential pressure <30kPa)
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

DLHPVHBR (Double-layer)

Outer Diameter Type Membrane Pore Size End Cap Nominal Length Seal Material Industry
69mm DLHPVHBR 1010   0.1+0.1μm DOE   Double Open End 05   5 inch S   Silicone P
2210   0.22+0.1μm HTF   222/Fin 10   10 inch E   EPDM
2222   0.22+0.22μm HSF   226/Fin 20   20 inch V   Viton
4522   0.45+0.22μm HTCG   222/Flat 30   30 inch P   FEP/PFA encapsulated O-rings
6522   0.65+0.22μm HSCG   226/Flat 40   40 inch


LHPVHBR (Single-layer)

Outer Diameter Type Membrane Pore Size End Cap Nominal Length Seal Material Industry
69mm LHPVHBR 0022   0.22μm DOE   Double Open End 05   5 inch S   Silicone P

0045   0.45μm 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：DLHPVHBR1010DOE05SP (DLHPVHBR，0.1+0.1μm，Double open end，5 inch，Silicone，Pharmaceutical)

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