Quality Standards
- Bacterial quantitative retention of 107 CFU/cm2 Brevundimonas
- Diminuta (ATCC 19146) according to ASTM F838 methodology
- 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
Full Regulatory Compliance with following
- Bacterial Endotoxin: Aqueous extraction of autocalved filter contains <0.25 EU/ml as determined by Limulus Amebcyte Lysate (LAL), USP<85>.
- Non-fiber Releasing: Component materials meet the criteria for a “ Non-fiber-releasing filter ” as defined in 21 CFR 210.3(b)(6).
- Component Material Toxicity:
Meet the requirement of USP <87> In Vitro Cytotoxicity Test ;
Meet the Criteria of USP<88> Biological Reactivity Test for Class VI-121°C plastics - TOC/Conductivity at 25 °C：Autoclaved filter effluent meet the USP<643> for Total Organic Carbon and USP<645> for Water Conductivity per WFI requirements after a UPW flush of specified volume.
- Particle Shedding: Autoclaved filter effluent meet the USP<788>for large volume Injections.
- Indirect Food Additive: All component materials meet the FDA Indirect Food Additive requirements cited in 21 CFR 177-182.
Typical Applications
- Antibiotics
- Aggressive Solvents
- Biological Agents
- Blood Products
- Chemicals
- Cold and Hot WFI
- Ophthalmic Solutions
- Sanitizing Agents
Materials of Construction
| Filter Media | LHPVND: Single-Layer Hydrophilic PVDF Sterile Membrane |
| DLHPVNDR: Double-Layer Hydrophilic PVDF Sterile Membrane | |
| Support | Polypropylene |
| Cage/Core/End Caps | Polypropylene |
Operating Conditions
| Max. Operating Pressure | 6.9 bar (100 psi) at 25 °C |
| 4.0 bar (58 psi) at 60 °C | |
| 2.4 bar (35 psi) at 80 °C | |
| Max. Differential Pressure | Forward 6.9 bar (100 psi) at 25 °C |
| 4.0 bar (58 psi) at 60 °C | |
| 2.4 bar (35 psi) at 80 °C | |
| Reverse 3.0 bar (44 psi) at 25 °C | |
| 1.0 bar (15 psi) at 80 °C | |
| Effective Filtration Area | 0.58m²/ Φ 69-10 inch |
Sterilization
| Inline Steam Sterilization (LHPVND & DLHPVNDR) | Up to 100 forward cycles and 50 reverse cycles (135 °C for 30 min < 0.3 bar per cycle) |
| “Autoclave (LHPVND & DLHPVNDR) “ | up to 400 cycles (130°C for 30min per cycle) |
Ordering Information
| LHPVND | Removal Ratings | End Cap | Nominal Length | Seal Material |
| [Single-Layer] | 0010 = 0.10µm | HSF = 226/Fin (PBT Insert) | 05 = 5″ | S = Silicone |
| 0022 = 0.22µm | HSC = 226/Flat (PBT Insert) | 10 = 10″ | E = EPDM | |
| 0045 = 0.45µm | HTF = 222/Fin (PBT Insert) | 20 = 20″ | V = Viton | |
| 0065 = 0.65µm | HTC = 222/Flat (PBT Insert) | 30 = 30″ | P = PFA/Viton | |
| 0100 = 1.0µm | DOE= Double Open End | 40 = 40″ |
| “DLHPVNDR [Double-Layer]” | |
| 2222 = 0.22+0.22µm | |
| 2245 = 0.22+0.45µm” | |
| 6545 = 0.65+0.45µm | |
| 2210 = 0.22+0.1µm | |
| 4545 = 0.45+0.45µm | |
| 6522 = 0.65+0.22µm | |
| 6510 = 0.65+0.1µm | |
| 4510 = 0.45+0.1µm |
