Durapore® CBR 0.2 µm Cartridge FiltersSuperior filters for controlled low bioburden levels in biopharmaceutical fluids
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Hydrophilic Durapore CBR 0.1 µm filters are ideal for clean processes due to low extractables, broad chemical compatibility and its non-fiber releasing properties. Hydrophilic Durapore CBR 0.1 µm Bioburden Reduction polyvinylidene fluoride (PVDF) membrane is recommended for applications requiring mycoplasma reduction and small particle and microorganism removal. Typical applications include the filtration of serum, tissue culture media and media additives. Hydrophilic Durapore CBR 0.1 µm filters are ideally suited to applications where bioburden should be maintained at very low levels.
The Durapore CBR hydrophilic 0.1 µm cartridge filters are superior filters for controlled low bioburden in tissue culture media and serum.
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.
|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||≥4830 mbar (70 psig) air with water|
|Air Diffusion at 23 °C||≤20 mL/min @ 3.9 bar (56 psig) in water|
|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|
|Extractables||≤25 mg after 24-h soak in water|
|Downstream Cleanliness/Effluent Particle Level||After a 200 L flush at 8 L/min: ≤10 particles per liter (particle diameter ≥1.0 µm)|
|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.|
|Non-Fiber Releasing||These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.|
|European Pressure Equipment Directive||All component materials meet the FDA Indirect Food Additive requirements cited in 21 CFR 177-182.|