Materials of Construction | Super-Dura Hydrophilic PTFE Membrane
| Filter Media | SLHPF – Single-Layer Hydrophilic PTFE Sterile Membrane
DLHPF – Double-Layer Hydrophilic PTFE Sterile Membrane |
| Support | Polypropylene |
| Core/Cage/End Caps | Polypropylene |
Operating Conditions | Super-Dura Hydrophilic PTFE Membrane
| 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 |
| Max. Differential Pressure Reverse | 3.0 bar (44 psi) at 25 °C 1.0 bar (15 psi) at 80 °C |
| Effective Filtration Area | 0.65m² / Φ 69-10 inch |
Sterilization
| Inline Steam Sterilization | up to 10 cycles (135°C for 30min< 0.3 bar per cycle), SLHPF up to 35 cycles (135°C for 30min< 0.3 bar per cycle), DLHPF |
| Autoclave | up to 120 cycles (130°C for 30min per cycle) |
Integrity Test Data
| Bubble Point | BP: ≥ 0.32 MPa (water), DLHPF(0.22 µm) |
| Diffusion Flow | DF: ≤ 30 ml/min/10″@ 0.22 MPa, DLHPF(0.22 µm) |
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, and EU framework regulation [1935/2004/EC].
Hall Pyke Ordering Information
|
SLHPF |
Removal Ratings |
End Cap |
Nominal Length |
Seal Material |
-P |
| 0022=0.22µm | HSF= 226/Fin (PBT Insert) | 05=5″ | S= Silicone | ||
| 0045=0.45µm | HSC= 226/Flat (PBT Insert) | 10=10″ | E= EPDM | ||
| 0100=1.0µm | HTF= 222/Fin (PBT Insert) | 20=20″ | V= Viton | ||
| HTC= 222/Flat (PBT Insert) | 30=30″ | P= PFA/Viton | |||
| DOE= Double Open End | 40=40″ | ||||
| DLHPF [Double-Layer] |
2222=0.22+0.22µm | ||||
| 4545=0.45+0.45μm |
