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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Especificações
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Documentation
Informações técnicas
| Título |
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| Application Note: Integrity Test Troubleshooting - Beyond Rewet and Retest |
| Filter Integrity Test Methods |
Ficha de dados
| Título |
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| Charged Durapore® Hydrophilic 0.22 μm Cartridge Filters |
| Optiseal® Sanitary Cartridge Housings |
Manuais do usuário
| Título |
|---|
| Hydrophilic Durapore® Cartridges and Capsules User Guide |
Produtos e aplicações relacionadas
Famílias de produtos
Charged Durapore® 0.22 µm Cartridge FiltersCharged Durapore<sup>®</sup> 0.22 µm hydrophilic cartridge filters are sterilizing-grade filters manufactured from polyvinylidene fluoride (PVDF) membrane modified to give it a net positive charge.Saiba mais >> |
Optiseal Sanitary Cartridge Housings European VersionThe Optiseal housing is designed for sterile filtration of aqueous solutions and gases using Optiseal cartridge filters.Saiba mais >> |
Optiseal Sanitary Cartridge HousingsThe Optiseal housing is designed for sterile filtration of aqueous solutions and gases using Optiseal cartridge filters.Saiba mais >> |
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| Antibody Purification |
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| Optiseal® |
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 | |
| Gravimetric Extractables | The extractables level was equal to or less than 10 mg per 4-inch cartridge after 24 hours in water at controlled room temperature. | |
| 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 @ 2.1 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