Optiseal Cartridge Filters with Charged Durapore 0.22 µm Membrane

Optiseal Cartridge Filters with Charged Durapore 0.22 µm Membrane

Description
Optiseal hydrophilic cartridge filters with charged Durapore 0.22 µm membrane are sterilizing-grade filters manufactured from polyvinylidene fluoride (PVDF) membrane modified to give it a net positive charge.


Typical Applications
Endotoxin Removal
Optiseal 0.22 µm hydrophilic cartridge filters with charged Durapore are designed for the removal of endotoxins from pharmaceutical-grade water systems. Endotoxins will easily pass through a 0.22 µm sterilizing-grade membrane filter where size exclusion is the only retention mechanism. However, because endotoxins are negatively charged, a positively charged membrane can aid in the removal of endotoxins that are far smaller than the rated pore size of the filter. The filters are certified for an LRV > 5 when challenged with 10⁶ pg/mL of purified E. coli endotoxin (Type 055:B5 LPS) in water.

Low Preservative Binding
Adsorptive loss of quaternary amines and other positively charged preservatives can be minimized by using cationically charged Durapore.


Specifications    (return to top)

Materials of Construction Filter Hydrophilic PVDF Supports Polypropylene O-ring Silicone O-rings Connections   Double O-rings (2-123) with hold-down tabs Filtration Area, m2 (ft2) 0.18 Maximum Differential Pressure, bar (psid) Forward - 5.5 (80) @ 25 °C; 3.5 (50) @ 80 °C; 0.35 (5) @ 121 °C; Reverse - 3.5 (50) @ 25 °C Bacterial Retention Quantitative retention of 107 CFU/cm2 Brevundimonas diminuta (ATCC® 19146) per ASTM F838-83 methodology Bacterial Endotoxins <0.5 EU/mL as determined by the LAL test Gravimetric Extractables ≤10 mg after 24-h soak in water Oxidizable Substances Will meet the USP Oxidizable Substances Test requirements after a water flush of ≤500 mL Toxicity Component materials meet the requirements of the USP Class VI Biological Test for Plastics. The cartridges also meet the requirements of the USP General (Mouse) Safety Test. Sterilization 10 SIP cycles of 30 min @ 135 °C Integrity Test Bubble Point ≥2760 mbar (40 psig) air with water Air Diffusion ≤4 mL/min @ 2 bar (30 psig) in water

Typical Clean Water Flow Rate vs Pressure Drop

Optisael Cartridge with Charged Durapore Membrane Water Flow Rate