Biopharm High Capacity PES Cartridge Filters


Catalog excerpts

Biopharm High Capacity PES Cartridge Filters - 1

BCWPS Cartridge Filters High Capacity Polyethersulfone Membrane Applications Buffers and Feedstocks Outside Diameter Filtration Area Integrity Test Information Representative samples from each manufacturing lot are tested for integrity to ensure consistent performance. BCWPS Filters are hydrophilic and manufactured with high capacity polyethersulfone (PES) membrane. The proprietary membrane casting process creates a thick membrane with high contaminant holding capacity, excellent retention characteristics and high flow rates. Filter elements from each manufacturing batch are integrity tested during production. BCWPS cartridge filters are used for critical bioburden reduction applications in the biopharmaceutical industry. Specific applications for BCWPS filters are bacteria removal in buffers, USP Water for Injection (WFI), SVPs, LVPs and other biopharmaceutical solutions. Maximum Operating Parameters BCWPS cartridges also see service in removing organic and other contaminants from wash water and clean in place solutions used in piping and other systems. High capacity PES is particularly suited for the filtration of products that contain elements that can adsorb to the media, such as preservatives and proteins. The lower binding characteristics of PES make it a good choice for filtration of valuable protein solutions such as vaccines and other biopharmaceuticals. Construction Materials Filtration Media High Capacity Polyethersulfone (PES) Membrane Media Support Center Core Outer Support Cage Sealing Method Thermal Bonding Buna, Viton® (or FKM), EP, Silicone, FEP Encapsulated Silicone, FEP Encapsulated Viton (or FKM) Differential Pressure • Forward Operating Temperature Recommended Changeout Pressure 82 °C (180 °F) at 10 psid (0.69 bard) in water 35 psid (2.4 bard) 90 °C (194 °F), 30 minutes, multiple cycles, max 3 psid forward flow In-line Steam For all elevated temperature procedures above, a stainless steel support ring is required. Chemical Sanitization Performed using industry standard concentrations of hydrogen peroxide, paracetic acid, sodium hypochlorite, and other selected chemicals. Total Performance Critical Process Filtration, Inc. is a vertically integrated manufacturer of filtration products to industries in which filtration is considered a critical part of the manufacturing process. We supply a complete line of products and services to help you cost effectively satisfy all your filtration requirements from a single source. Biopharmaceutical Grade

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Biopharm High Capacity PES Cartridge Filters - 2

The materials used to construct biopharmaceutical grade filters are non-toxic and meet the requirements for the MEM Elution Cytotoxicity Test and the requirements for Biological Reactivity Tests in the current version of the United States Pharmacopeia (USP) for Class VI - 121 °C Plastics. In addition, the materials meet the requirements listed by the FDA as appropriate for use in articles intended for repeated food contact as specified in Title 21 CFR sections 174.5, 177.1500, 177.1520, 177.1630, 177.2440, and 177.2600 as appropriate. BCWPS filters comply with Title 21 CFR sections 210.3...

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