|Bubble Point Test Method Using Durapore® 0.22 µm Hydrophilic Membrane with 60/40 IPA|
|Charged Durapore® Hydrophilic 0.22 μm Cartridge Filters|
Optiseal Cartridge Filters with Charged Durapore 0.22 µm MembraneOptiseal 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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|Biopharmaceutical Manufacturing > Downstream Processing > Sterile Filtration > Sterile Liquid > Durapore|
Charged Durapore 0.22 µm hydrophilic cartridge filters are sterilizing-grade filters manufactured from polyvinylidene fluoride (PVDF) membrane modified to give it a net positive charge.
Charged Durapore 0.22 µm hydrophilic cartridge filters 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.
|Effective Filtration Area||1.9 ft2 (0.2 m2) per 4-inch (10.2 cm) Optiseal® cartridge
7.4 ft2 (0.7 m2) per 10-inch (25.4 cm) cartridge
14.8 ft2 (1.4 m2) per 20-inch (50.8 cm) cartridge
22.2 ft2 (2.1 m2) per 30-inch (76.2) cartridge
|Materials of Construction||Modified polyvinylidene fluoride (PVDF) membrane with a net positive charge.
Non-woven polypropylene pleat supports upstream and downstream.
Rigid polypropylene outer sleeve, core, end caps and adapter. Silicone O-rings.
|Endotoxin Removal||Charged Durapore® membrane samples exhibit LRV >5 when challenged with 106 pg/mL of purified Escherichia coli (Type 055:B5 LPS) endotoxins|
|Integrity Test||Each cartridge must pass our integrity test, which is correlated to the B. diminuta ASTM® bacterial challenge test.|
|Bacterial Retention||Cartridges are quantitatively retentive of Brevundimonas diminuta ATCC® 19146 at a minimum challenge level of 107 CFU (colony forming units) per cm2 of filtration area using ASTM® F-838-83 methodology.|
|Air Bubble Point in Water at 23 °C||≥2760 mbar (40.0 psig)|
|Bacterial Endotoxin||Aqueous extraction contains|
|Thermal Stress Resistance||135 °C, 30 minutes, up to 10 times, Steam-in-Place|
|Hydraulic Stress Resistance||80 psid (5.5 bar) at 25 °C in the forward direction
50 psid (3.4 bar) at 25 °C in the reverse direction
|Component Material Toxicity||Component materials meet the criteria of the USP <88> Reactivity Test for Class VI Plastics.|
|Oxidizable Substances||Autoclaved (126 °C, 30 minutes) 4-inch (10.2 cm) Optiseal® cartridges will meet the current USP WFI Oxidizable Substance requirements after a 0.5-liter water flush.
Autoclaved (126 °C, 30 minutes) 10-inch (25.4 cm) cartridges will meet the current USP WFI Oxidizable Substance requirements after a 1.0-liter water flush per 10-inch
(25.4 cm) cartridge.
|USP <88> Safety||Autoclaved (126 °C, 60 minutes) cartridges are non-toxic per USP <88> Safety Test.|
|Non-Fiber Releasing||Charged Durapore® CCGL and LCGL cartridge filters are manufactured with a PVDF membrane which meets the criteria for a non-fiber releasing filter as defined in the Code of Federal Regulations 21 CFR 210.3 (b) (6).|
|Gravimetric Extractables||Autoclaved at 126 °C for 30 minutes, 4-inch (10.2 cm) Optiseal® cartridge has ≤10 milligrams extractables in water after 24-hour static soak at room temperature.|
|Air Diffusion in Water at 23 °C|| ≤ 4.0 cc/min at 30 psid (2.07 bar) in the forward direction per 4-inch (10.2 cm) Optiseal® cartridge.
≤ 10.0 cc/min at 30 psid (2.07 bar) in the forward direction per 10-inch (25.4 cm) cartridge.
|Water Flow Rate/Pressure Drop||≤ 8 psid (0.55 bar) at 2 gpm (7.6 Lpm) per 4-inch (10.2 cm) Optiseal® cartridge at 23 °C.
≤ 3 psid (0.21 bar) at 2 gpm (7.6 Lpm) per 10-inch (25.4 cm) cartridge at 23 °C.