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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.
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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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