|Application Note: Integrity Test Troubleshooting - Beyond Rewet and Retest|
|Filter Integrity Test Methods|
Ficha de dados
|Charged Durapore® Hydrophilic 0.22 μm Cartridge Filters|
|Optiseal® Sanitary Cartridge Housings|
Manuais do usuário
|Hydrophilic Durapore® Cartridges and Capsules User Guide|
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.
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Optiseal Sanitary Cartridge Housings European VersionThe Optiseal housing is designed for sterile filtration of aqueous solutions and gases using Optiseal cartridge filters.
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Optiseal Sanitary Cartridge HousingsThe Optiseal housing is designed for sterile filtration of aqueous solutions and gases using Optiseal cartridge filters.
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|Biopharmaceutical Manufacturing > Downstream Processing > Sterile Filtration > Sterile Liquid > Durapore|
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.
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)|
|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|
|Bubble Point||≥2760 mbar (40 psig) air with water|
|Air Diffusion||≤4 mL/min @ 2.1 bar (30 psig) in water|