Super-Dura Filter Cartridges are designed for the majority of pharmaceutical liquids, but especially for solvent-containing liquids and ophthalmic solutions. These filters are composed of a hydrophilic PTFE membrane which provides excellent chemical and heat tolerance.
• 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℃ plastics
• TOC/Conductivity at 25 ℃: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].
Antibiotics
LVP & SVP
Ophthalmic Solutions
Disinfectants and Sanitizing Agents
Large Batch Solutions
Solvent-containing Liquid
Materials of Construction
Filter Media | SLHPF Single-Layer Hydrophilic PTFE Membrane DLHPF Double-Layer Hydrophilic PTFE Membrane |
Support | Polypropylene |
Core/Cage/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 | 0.65m² / 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) |
Ordering Infomation
Type | Removal Ratings | End Cap | Nominal Length | Seal Material | Industry |
SLHPF DLHPF | 0022=0.22μm 0045=0.45μm 0100=1.0μm 2222=0.22+0.22μm 4545=0.45+0.45μm | HSF=226 /Fin (PBT Insert) HSC=226 /Flat (PBT Insert) HTF=222 /Fin (PBT Insert) HTC=222 /Flat (PBT Insert) DOE=Double Open End | 05= 5" 10=10" 20=20" 30=30" 40=40" | S=Silicone E=EPDM V=Viton P=PFA/Viton | P = Pharmaceutical |