Charged Durapore® 0.22 µm Optiseal® Cartridge Filters
Optiseal® hydrophilic cartridge filters with charged Durapore 0.22 µm membrane are sterilizing-grade filters manufactured from PVDF membrane modified to give it a net positive charge.
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Optiseal® hydrophilic cartridge filters with charged Durapore 0.22 µm membrane are sterilizing-grade filters manufactured from PVDF membrane modified to give it a net positive charge. Menos
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Categorias
| Biopharmaceutical Manufacturing > Downstream Processing > Sterile Filtration > Sterile Liquid > Durapore |
Description
Typical Applications
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.
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®.
| Materials of Construction | ||
| Filter | Polyvinylidene Fluoride (PVDF) | |
| Supports | Polypropylene | |
| O-ring | Silicone (SI) | |
| Connections | ||
| Cartridge Code | Not Applicable | |
| Filtration Area | 0.18 m² | |
| Maximum Differential Pressure, bar (psid) | Forward: 5.5 bar (80 psid) @ 25 °C; 3.5 bar (50 psid) @ 80 °C; 0.35 bar (5 psid) @ 121 °C. Reverse: 3.5 bar (50 psid) @ 25 °C KEEP | |
| Bacterial Retention | Samples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 10⁷ CFU/cm² using ASTM® F838 methodology. | |
| Bacterial Endotoxins | Aqueous extraction contains ≤0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test | |
| Toxicity | Component materials meet the criteria of the USP <88>Reactivity Test for Class VI Plastics. This product is non-cytotoxic per ISO® 10993-5 and USP <87> Cytotoxicity MEM Elution Test | |
| Total Organic Carbon (TOC) /Conductivity | Samples exhibited < 500 ppb TOC per USP <643> after sterilization and a WFI water flush of 2.0 L at 250 mL/min per 4 in. Optiseal® cartridge | |
| Sterilization | 10 SIP cycles of 30 min @ 135 °C | |
| Integrity Test | ||
| Bubble Point | ≥3100 mbar (45 psig) air with water | |
| Air Diffusion | ≤4 mL/min @ 2.1 bar (30 psig) in water | |
Typical Clean Water Flow Rate vs Pressure Drop
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Optisael Cartridge with Charged Durapore Membrane Water Flow Rate