Charged Durapore 0.22 µm Hydrophilic Cartridge Filters

Description

Typical Applications

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.

Endotoxin Removal

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.

Specifications
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 cm²of 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.

Typical Water Flow Rate

Charged Durapore Cartridge Water Flow Rate

Compare	Catalogue No.	Pore Size (µm)	Cartridge Nominal Length, in (cm)
	CCGL01TP1	0.22	10 (25)
	CCGL02TP1	0.22	20 (50)
	CCGL03TP1	0.22	30 (75)

Compare	Catalogue No.	Pore Size (µm)	Cartridge Nominal Length, in (cm)
	CCGL51TP1	0.22	10 (25)
	CCGL52TP1	0.22	20 (50)
	CCGL53TP1	0.22	30 (75)

Compare	Catalogue No.	Pore Size (µm)	Cartridge Nominal Length, in (cm)
	CCGL71TP1	0.22	10 (25)
	CCGL72TP1	0.22	20 (50)
	CCGL73TP1	0.22	30 (75)

Compare	Catalogue No.	Pore Size (µm)	Cartridge Nominal Length, in (cm)
	CCGL81TP1	0.22	10 (25)
	CCGL82TP1	0.22	20 (50)
	CCGL83TP1	0.22	30 (75)

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