Biopharm PES Capsules

Biopharm PES Capsules

Biopharm PES Capsules

Product catalog summary
Overview: The document provides detailed specifications and applications for Biopharmaceutical Grade BPS Capsule Filters with a Polyethersulfone (PES) membrane. These filters are designed for high flow rates and throughput, suitable for bioburden reduction in the biologicals industry.
Construction Materials: The filters are constructed using polypropylene for housing, media support, end caps, center core, and outer support cage. The sealing method is thermal bonding.
Applications: BPS capsule filters are used in buffers, feedstocks, SVPs, WFI water, LVPs, solvents, and vaccines. They are particularly effective for filtering products containing preservatives and proteins due to their low adsorption characteristics.
Operating Parameters: The maximum liquid operational pressure is 80 psi at 20°C, and gases operational pressure is 60 psi at 20°C. The operating temperature is 43°C at 30 psi in water. Forward and reverse differential pressures are 50 psid and 40 psid, respectively.
Flow Rate and Filtration Area: The document includes a table showing typical water flow rates at a one psi pressure differential across various capsule lengths and pore sizes.
Sanitization/Sterilization: Capsules can be autoclaved at 250°F for 30 minutes and sanitized using industry-standard chemical concentrations. They are available in both pre-sterilized and non-sterilized forms.
Integrity Test Specifications: The document outlines test pressures and maximum diffusion rates for various pore sizes, ensuring the filters meet ASTM F 838-05 and HIMA protocols for bacterial retention.
Compliance and Quality Assurance: The filters comply with USP Biosafety and FDA requirements for non-toxic materials. They are manufactured under ISO 9001:2008 standards, ensuring high quality and traceability.
Ordering Information: The document provides a detailed guide for ordering, including options for micron ratings, sterilization, length, and inlet/outlet types.
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Catalog excerpts

Biopharm PES Capsules-1

BPS Capsule Filters PES Membrane Applications Buffers and Feedstocks WFI Water Polyethersulfone 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 biologicals. Excellent flow rates with high throughput D esigned for minimal leachables and extractables Low adsorption of proteins and preservatives Flow Rate / Filtration Area The following table represents typical water flow at a one psi (69 mbar) pressure differential across a single 2 inch capsule with 1.0 ft² (930 cm²) of media with 1/2” FNPT ports. The test fluid is water at ambient temperature. Higher pressure drops are acceptable, but as flows increase the pressure drop of the housing becomes more apparent. Pore Size * For approximate flow rates for 5” through 30” capsules, refer to the appropriate cartridge data sheet BPS Capsule Filters - Filtration Area Media PES Membrane Maximum Operating Parameters Liquid Operational Pressure Filtration Media Gases Operational Pressure Operating Temperature Media Support Forward Differential Pressure 50 psid (3.4 bard) at 20 °C (68 °F) Center Core Reverse Differential Pressure Outer Support Cage Sealing Method Thermal Bonding Recommended Changeout Pressure Biopharmaceutical Grade Biopharmaceutical grade PS capsules are hydrophilic and manufactured with the highest quality asymmetric polyethersulfone (PES) membrane. PES membrane exhibits excellent flow rates with high throughput. BPS capsule filters are used for bioburden reduction applications in the biologicals industry. Specific applications for BPS capsule filters are bacteria removal in buffers, USP Water for Injection (WFI), SVPs, LVPs and other biological products. The filter elements are 100% integrity tested during production. Validated for use in multiple biopharmaceutical applications Construction Materials

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Biopharm PES Capsules-2

Integrity Test Specifications Pore Size Biopharmaceutical grade filters typically exhibit low levels of non-volatile residues. Max Diffusion Rate (cc/min -water wetted membrane) Quality Assurance and Standards Critical Process Filtration uses state of the art computer controlled equipment to consistently produce high quality products as well as significantly reduce hand operations that can compromise quality. All manufacturing and testing is continuously monitored in real time so that data can be quickly and easily analyzed to facilitate improvements in both quality and cost. The Critical Process...

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*Prices are pre-tax. They exclude delivery charges and customs duties and do not include additional charges for installation or activation options. Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates.