Durapore CBR 0.2 µm Bioburden Reduction Cartridge Filters
Superior filters for controlled low bioburden levels in biopharmaceutical fluids
Description
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.
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. 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.
Cartridge Filters
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.
Superior filters for controlled low bioburden levels in biopharmaceutical fluids
Description
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.
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. 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.
Cartridge Filters
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.
規格說明 ：
| Per 10-inch Cartridge Filter | |
| Filtration Area, m2 | 0.69 |
| Materials of Construction | |
| Filter membrane | Hydrophilic PVDF |
| Film Edge | Polypropylene |
| Membrane Supports | Polypropylene |
| Structural Components | Polypropylene |
| O-rings | Fluorocarbon rubber or 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 |
| Integrity Test | |
| 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 |
| 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 | The extractables level was equal to or less than 25 mg per 10-inch cartridge after 24 hours in water at controlled room temperature. |
| 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. |
| Good Manufacturing Practices | These products are manufactured in a facility which adheres to FDA Device Good Manufacturing Practices. |
| Indirect Food Additive | All component materials meet the FDA Indirect Food Additive requirements cited in 21 CFR 177-182. |
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