|Bubble Point Ratio Determination for LpH se (1:256)|
Durapore® CBR 0.1 µm Cartridge FiltersSuperior filters for controlled low bioburden in tissue culture media and serum
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A trusted name in the industry for over 25 years, hydrophilic Durapore® 0.2 µm polyvinylidene fluoride (PVDF) membrane offers consistent and reliable performance for bioburden reduction and particle removal. Hydrophilic Durapore® CBR devices are ideal for clean processes due to low extractables, broad chemical compatibility and its non-fiber releasing properties. Hydrophilic Durapore® CBR 0.2 µm Bioburden Reduction filters are recommended for applications requiring bioburden reduction and small particle removal across a wide range of pharmaceutical and biological liquids and intermediate bulk pharmaceutical products. Typical applications for the Durapore® CBR 0.2 µm filters include the filtration of diagnostics, diluents, bulk pharmaceutical products, serum, tissue culture media and media additives.
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. A detailed Certificate of Quality is available on request. Each cartridge filter is integrity tested during manufacturing and is supported by a Validation Guide. For traceability and easy identification, each filter is labeled with the product name and identifying characteristics.
Durapore® CBR 0.2 µm hydrophilic cartridge filters provide high throughput and flow rates with minimal differential pressure. Cartridges are robust, strong, resilient and are designed to withstand multiple steam-in-place cycles. Each Durapore® CBR cartridge filter is integrity tested during the manufacturing process. Code 7 and Code 0 connections are available to suit your application and housing needs.
|Per 10-inch Cartridge Filter|
|Filtration Area||0.69 m²|
|Materials of Construction|
|Filter membrane||Polyvinylidene Fluoride (PVDF)|
|O-rings||Fluorocarbon rubber or Silicone|
|Maximum Differential Pressure, bar (psid)||Forward: 5.5 bar (80 psid) @ 25 °C; 1.7 bar (25 psid) @ 80 °C; 0.35 bar (5 psid) @ 135 °C. Reverse: 3.5 bar (50 psid) @ 25 °C, intermittent|
|Bubble Point at 23 °C||≥3100 mbar (45 psig) air with water|
|Air Diffusion at 23 °C||≤13.3 mL/min @ 2.75 bar (40 psig) in water|
|Total Organic Carbon (TOC) /Conductivity||Autoclaved filter effluent meets the WFI requirement of USP <643>, for Total Organic Carbon and USP <645>|
|Bacterial Retention||Samples of the Durapore® membrane used in these cartridges are tested for bacterial retention and meet the criteria for sterilizing grade performance as defined by the ASTM test method using Brevundimonas diminuta at a minimum challenge concentration of 1 x 107 CFU/cm2|
|Non-Fiber Releasing||Durapore membrane meets the criteria for a “non-fiber releasing” filter as defined in 21 CFR 210.3 (b) (6)|
|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.|
|Indirect Food Additive||Durapore® membrane meets the FDA Indirect Food Additive requirements cited in 21 CFR 177.2910. All component materials meet the FDA Indirect Food Additive requirements cited in 21 CFR 177-182 based on information provided by raw material suppliers.|