|Application Note: Integrity Test Troubleshooting - Beyond Rewet and Retest|
|Filter Integrity Test Methods|
|Millipore Steam Sterilization & Integrity Testing Procedures|
|Evaluation of Recovery Filters for Use in Bacterial Retention Testing of Sterilizing-Grade Filters|
Carter, Jeff; Vol. 50, No.3 / May-June
Vol. 50, No.3 / May-June 1996
|Hydrophilic Durapore® Cartridges and Capsules User Guide|
|Wetting Instructions for Filter Units with Durapore Membrane|
OptiScale® Capsule Filters for Aseptic Processing ApplicationsOptiScale<sup>®</sup> capsules, with a large variety of filtration media options, are a family of convenient, disposable filters ideal for media selection, process screening and scaling.
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Multimedia Durapore® Capsule FiltersProviding sterility assurance, high flow rates and extended throughputs, low extractables, and broad chemical compatibility.
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|Biopharmaceutical Manufacturing > Downstream Processing > Sterile Filtration > Sterile Liquid > Durapore|
Durapore® Multimedia filters combine a 0.22 µm hydrophilic Durapore membrane with an upstream Milligard® prefilter media, providing sterility assurance, high flow rates and extended throughputs, low extractables, and broad chemical compatibility. The combination of prefiltration media and final sterilizing membrane in one filter results in process compression and improved economics.
Multimedia cartridge filters are ideally suited for processes that require maximum pressure differentials. Cartridges are robust, strong, resilient and are designed to withstand multiple steam-in-place cycles.
Multimedia filters 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 marked 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.
|Per 10-inch Cartridge Filter|
|Single Layer Prefilter||0.69 m²|
|Double Layer Prefilter||0.56 m²|
|Materials of Construction|
|Filter||Mixed Cellulose Esters (MCE)
Polyvinylidene Fluoride (PVDF)
|Prefilter||Mixed Cellulose Esters (MCE)|
|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|
|Integrity Test, Bubble Point||≥3450 mbar (50 psig) air with water|
|Integrity Test, Air Diffusion|
|Single Layer Prefilter||≤13.3 mL/min @ 2.75 bar (40 psig) in water|
|Double Layer Prefilter||≤10.8 mL/min @ 2.75 bar (40 psig) in water|
|Bacterial Retention||Quantitative retention of 107 CFU/cm2 Brevundimonas diminuta (ATCC® 19146) per ASTM® F838-83 methodology|
|Bacterial Endotoxins||Aqueous extraction contains ≤0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test|
|NVR Gravimetric Extractables|
|Single Layer Prefilter||The extractables level was equal to or less than 45 mg per 10-inch cartridge after 24 hours in water at controlled room temperature.|
|Double Layer Prefilter||The extractables level was equal to or less than 70 mg per 10-inch cartridge after 24 hours in water at controlled room temperature.|
|Oxidizable Substances||Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥5 L|
|Sterilization||6 autoclave or SIP cycles of 30 min @ 123 °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 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.|