Hydrophilic Multilayer Durapore 0.45/0.22 µm Cartridge Filters

Hydrophilic Multilayer Durapore 0.45/0.22 µm Cartridge Filters

Description
The combination of hydrophilic low protein binding 0.45 µm Durapore polyvinylidene fluoride (PVDF) membrane and sterilizing-grade 0.22 µm Durapore membrane in a single cartridge is the superior choice for clean and sterile processes due to low extractables, broad chemical compatibility, and its non-fiber releasing properties. Sterilizing-grade, hydrophilic Multilayer Durapore 0.45/0.22 µm filters maximize process efficiency by providing high product recovery and extended throughput with low pressure drops.

Hydrophilic Multilayer Durapore 0.45/0.22 µm cartridge filters provide high throughput with minimal differential pressure. Cartridges are robust, strong, resilient and are designed to withstand multiple steam-in-place cycles.


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 labeled with the product name and identifying characteristics.


Multiple Formats Available
A full range of filtration areas is available to suit varying application requirements and a variety of connection options are offered to meet your application and housing requirements.


Typical Applications
Hydrophilic Multilayer Durapore 0.45/0.22 µm filters are recommended for a wide range of pharmaceutical and biological liquid applications including: the filtration of therapeutics, vaccines, antibiotics, blood fractionations, bulk pharmaceutical and other downstream biotechnology processing solutions where protein binding must be minimized. Hydrophilic Multilayer Durapore filters are ideally suited to applications requiring high sterility assurance, high product purity and high product yield.


Specifications    (return to top)

Per 10-inch Cartridge Filter Filtration Area, m2 0.55 Materials of Construction Filter Hydrophilic PVDF Supports Polypropylene Structural Components Polypropylene O-ring Silicone 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, intermittent Bubble Point ≥3450 mbar (50 psig) air with water Air Diffusion ≤10.8 mL/min @ 2.8 bar (40 psig) in water TOC/Conductivity Autoclaved cartridges meet the WFI requirements of USP (643) for Total Organic Carbon and USP (645) for Water Conductivity after a WFI water flush of 16 liters at 25 °C Bacterial Retention Quantitative retention of 107 CFU/cm2 Brevundimonas diminuta ATCC® 19146 per ASTM methodology. Bacterial Endotoxins <0.25 EU/mL as determined by the LAL test Oxidizable Substances Will meet the USP Oxidizable Substances Test requirements after a water flush of ≤1.5 L Sterilization 30 SIP cycles of 30 min @ 135 °C; 30 autoclave cycles of 60 min @ 126 °C 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

Cartridge Filter 0.45/0.22 µm Multilayer Durapore