|Application Note: Integrity Test Troubleshooting - Beyond Rewet and Retest|
|Establishing Product Specific Bubble Point Specifications For Sterilizing-Grade (0.22 µm) Durapore® Filters|
|Filter Integrity Test Methods|
|Millidisk® Cartridges and Millipak® Disposable Capsules (MilliporeSigma)|
|Sterile and Gamma Compatible Sterilizing-grade Durapore® 0.1 μm and 0.22 μm Filters (MilliporeSigma)|
|Sterilizing-grade Durapore® 0.22 µm Hydrophobic Filters|
Hydrophobic Durapore® 0.22 µm Capsule FiltersReliable filters for the sterile filtration of gases and liquids. Eliminate the time and expense associated with assembling, cleaning, and validating stainless steel housings.
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Hydrophobic Durapore® 0.22 µm Optiseal® Cartridge FiltersReliable filters for the sterile filtration of gases and liquids. Featuring a unique cartridge-to-housing sealing mechanism, these Optiseal Durapore cartridges offer maximum sterility assurance.
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|Biopharmaceutical Manufacturing > Downstream Processing > Sterile Filtration > Sterile Liquid > Durapore|
Reliable filters for the sterile filtration of gases and liquids
Durapore hydrophobic membrane cartridges are sterilizing-grade filters that provide sterility assurance, high flow rates and high throughput. They are used for sterile tank and gas venting, as well as for the filtration of liquids in small and large volume systems. Durapore 0.22 µm hydrophobic polyvinylidene fluoride (PVDF) membrane reliably eliminates contaminants and microorganisms in sterilizing applications, even at high pH.
Cartridges are robust, resilient and are designed to withstand multiple steam-in-place cycles.
Filters with hydrophobic Durapore 0.22 µm 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 comprehensive Validation Guide for compliance with regulatory requirements.
For traceability and easy identification, each filter is labeled with the product name and identifying characteristics.
Multiple Formats Available
Durapore cartridge filters are available in four cartridge lengths, from five to thirty inches, and provide a full range of filtration areas to suit every size system. Three connection options are offered for easy adaptation to existing housings.
|Per 10-inch Cartridge Filter|
|Filtration Area||0.69 m²|
|Materials of Construction|
|Filter media||Polyvinylidene Fluoride (PVDF)|
|Bubble Point at 23 °C||≥1240 mbar (18 psig) nitrogen with 60/40 % IPA/water|
|Nitrogen Diffusion at 23 °C||≤10 mL/min @ 1.7 bar (25 psig) with water|
|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|
|Bacterial Endotoxins||Aqueous extraction contains ≤0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test|
|Bacterial Retention||Quantitative retention of 107 CFU/cm2 Brevundimonas diminuta (ATCC® 19146) per ASTM® F838-83 methodology|
|Sterilization||30 SIP cycles of 30 min @ 126 °C; 30 autoclave cycles of 60 min @ 126 °C|