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Biopharm PTFE Membrane Capsules

Biopharm PTFE Membrane Capsules

Biopharm PTFE Membrane Capsules

Product catalog summary
Overview: The document provides detailed specifications and applications for Biopharmaceutical Grade BTM Capsule Filters with PTFE Membrane, designed for critical applications in biopharmaceutical processing. These filters are used for fermentation air, process gas, solvent filtration, compressed air filtration, non-aqueous solutions, and tank vents.
Construction Materials: The filters are constructed using polypropylene for housing, media support, end caps, center core, and outer support cage, with a PTFE membrane for filtration. The sealing method used is thermal bonding.
Applications: These filters are suitable for fermentation air, process gas, solvent filtration, compressed air filtration, non-aqueous solutions, and tank vents.
Operating Parameters: The maximum operating pressure for liquids is 80 psi at 20°C, and for gases, it 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, at 20°C. The recommended changeout pressure is 35 psid.
Flow Rates: The document provides typical air and water flow rates at a one psi pressure differential across a single 2-inch capsule with 1.0 ft² of media. Air/gas flow rates and liquid flow rates are specified for different micron ratings.
Integrity Test Specifications: The integrity of the filters is tested using a bubble point test for different pore sizes, with specific psig values provided for each.
Sanitization/Sterilization: The filters can be autoclaved at 250°F for 30 minutes in multiple cycles and sanitized using industry-standard chemical concentrations. They are not suitable for steam use.
Compliance and Validation: The materials meet USP Class VI and FDA requirements for non-toxic and non-fiber releasing filters. Validation is based on ASTM Method F838-05 and HIMA protocols.
Quality Assurance: Manufacturing and quality systems meet ISO 9001:2008 standards, with real-time monitoring and traceability of materials and processes. Each capsule is integrity tested before release.
Ordering Information: The document provides detailed ordering information, including micron ratings, lengths, inlet and outlet options, and examples of order numbers.
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Catalog excerpts

Biopharm PTFE Membrane Capsules-1

BTM Capsule Filters PTFE Membrane Solvent Filtration Non-Aqueous Solutions Tank Vents The capsule media surface area, filter core design, pleat configuration and pleat packing density have been optimized to provide increased life resulting in lower filtration operating costs. Optimized for maximum filter life F iltration of air and process gases V ent filtration for the protection of tank contents F iltration of solvents, alcohols and other non-aqueous liquids BTM Capsule Filters - Filtration Area Capsule Length PTFE Membrane Flow Rate / Filtration Area The following table represents typical air and water flow at a one psi (69 mbar) pressure differential across a single 2 inch capsule with 1.0 ft ² (930 cm²) of media with 1/2” FNPT ports. The liquid test fluid is water at ambient temperature. The gas test fluid is compressed air at ambient temperature. Higher pressure drops are acceptable, but as flows increase the pressure drop of the housing becomes more apparent. Air/Gas Flow Rates Liquid Flow Rates Construction Materials Maximum Operating Parameters Liquid Operational Pressure Filtration Media PTFE Membrane Gases Operational Pressure Media Support Operating Temperature Center Core Outer Support Cage Sealing Method Thermal Bonding Forward Differential Pressure 50 psid (3.4 bard) at 20 °C (68 °F) Reverse Differential Pressure Recommended Changeout Pressure Biopharmaceutical Grade Biopharmaceutical grade TM capsules are manufactured for critical applications in biopharmaceutical processing. Made with highly hydrophobic polytetrafluoroethylene (PTFE) membrane, these capsules are used for filtration of fermentation air, solvents and alcohols, compressed gases, and as vent filters. Each module is individually tested using the water intrusion method before it is released from manufacture.

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Biopharm PTFE Membrane Capsules-2

Integrity Test Specifications Biopharmaceutical grade TM capsules are validated using test procedures based on ASTM Method F838-05 and HIMA protocols. The challenge level is 107 organisms per cm2 of filter media: (per 1.0 ft2 (930 cm2) 60/40 IPA/water wetted membrane) Pore Size Bubble Point 21 psig (1.45 barg) 15 psig (1.0 barg) 9 psig (621 mbarg) 6 psig (414 mbarg) 0.22 μm challenged with Brevundimonas diminuta; 0.45 μm challenged with Serratia marcescens; Critical Process Filtration can provide validation assistance. The materials used to construct biopharmaceutical grade BTM capsule filters...

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