Superdura SLHPF Hydrophilic PTFE

Description

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.

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].

Filter Media	SLHPF Single-Layer Hydrophilic PTFE Membrane DLHPF Double-Layer Hydrophilic PTFE Membrane
Support	Polypropylene
Core/Cage/End Caps	Polypropylene

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	0.65mÇ / Φ 69-10 inch

Inline Steam Sterilisation	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)

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)

File name: Super-Dura-SLHPF.pdf
File size: 746KB