Durapore 0.45 µm Hydrophilic Cartridge Filter

Description

Durapore 0.45 µm hydrophilic filters are manufactured from polyvinylidene fluoride (PVDF) membrane with a cellulose ester (RW06) prefilter layer for greater throughput and polypropylene components for broad chemical compatibility. They also exist without prefilter layer.

Durapore filters are 100% integrity tested during manufacturing to guarantee integrity.

Regulatory Compliance

Filters with hydrophilic Durapore membrane are designed, developed, and manufactured in accordance with a Quality Management System approved by an accredited registering body to an ISO® 9000 Quality Systems Standard and are shipped with a Certificate of Quality. Each cartridge filter is integrity tested during manufacturing and is supported by a Validation Guide for compliance with regulatory requirements.

For traceability and easy identification, each device is marked with the product name and identifying characteristics.

Typical Applications

Durapore 0.45 µm hydrophilic filters remove particles and microorganisms from aqueous liquid streams. These filters are ideally suited for large volume parenteral or ophthalmics manufacturing, where prefiltration is either unnecessary or already present at an earlier point in the process, or where protein binding must be minimized.

Specifications (return to top)

	Per 10-inch Cartridge - w/ Prefilter	Per 10-inch Cartridge - w/o Prefilter
Materials of Construction
Filter		Hydrophilic PVDF
RW Prefilter Layer
O-rings		Silicone
Filtration Area, m2		0.69
Maximum Differential Pressure, bar (psid)		Forward: 5.5 (80) @ 25 °C; 1.7 (25) @ 80 °C; 0.35 (5) @ 135 °C. Reverse: 3.5 (50) @ 25 °C
Bacterial Endotoxins
Gravimetric Extractables		≤20 mg after 24-h soak in water
Oxidizable Substances
Sterilization		30 SIP cycles of 30 min @ 135 °C; 30 autoclave cycles of 60 min @ 126 °C
Integrity Tests
Bubble Point at 23 °C		≥1930 mbar (28 psig) air with water
Air Diffusion at 23 °C		≤15 mL/min @ 1.5 bar (22 psig) in water
Component Material Toxicity	Component materials meet the criteria of the USP <88> Reactivity Test for Class VI Plastics. These products meet the requirements of the USP <88> Safety Test, utilizing a 0.9% sodium chloride extraction.
Good Manufacturing Practices	These products are manufactured in a facility which adheres to FDA Device Good Manufacturing Practices.
Non-fiber Releasing	Component materials meet the "non-fiber releasing" criteria as defined in 21 CFR 210.3 (b) (6).
Indirect Food Additive	All component materials meet the FDA Indirect Food Additive requirements cited in 21 CFR 177–182.

Typical Clean Water Flow Rate vs Pressure Drop

0.45 µm Hydrophilic Durapore Cartridge without prefilter (CVHL PP)

0.45 µm Hydrophilic Durapore Cartridge with prefilter (CVHL TP)

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