Description
Hall Pyke’s Superdura SLHPF Hydrophilic PTFE
Features and Benefits
- Hydrophilic PTFE membrane which requires no pre-wetting
- Excellent chemical compatibility especially for solvent-containing liquids
- Minimal preservative binding in ophthalmic solutions
- Clean hydrophilic membrane with very low gravimetric extractable
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].
Typical Application of Superdura SLHPF Hydrophilic PTFE
- Antibiotics
- LVP & SVP
- Large Batch Solutions
- Ophthalmic Solutions
- Disinfectants and Sanitising Agents
