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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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