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Pharma PTFE Membrane Capsules

Pharma PTFE Membrane Capsules

Pharma PTFE Membrane Capsules

Product catalog summary
Overview: The document provides detailed specifications and applications for Pharmaceutical Grade PTM Capsule Filters with PTFE Membrane, designed for air and process gas filtration, vent filtration, and final filtration of non-aqueous liquids.
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 media. The sealing method used is thermal bonding.
Applications: These filters are suitable for solvent filtration, process gas, fermentation air, compressed air filtration, and tank vent filters, specifically catering to the pharmaceutical industry's critical needs.
Operating Parameters: The maximum operating pressures are 80 psi for liquids and 60 psi for gases 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, with a recommended changeout pressure of 35 psid.
Flow Rates: The document includes a table showing typical air and water flow rates at a one psi pressure differential across a 2-inch capsule with 1.0 ft² of media.
Integrity Test Specifications: The filters undergo integrity testing with a 60/40 IPA/water wetted membrane, with specified bubble points for different pore sizes.
Sanitization/Sterilization: The filters can be autoclaved at 250°F for 30 minutes and sanitized using industry-standard chemical concentrations. They are not suitable for steam use.
Compliance: The materials meet USP Class VI - 121°C Plastics requirements and FDA regulations for repeated food contact. They also comply with USP limits for bacterial endotoxins.
Validation: PTM capsules are validated using ASTM F 838-05 and HIMA protocols for bacterial retention, with specific challenge levels for different pore sizes.
Quality Assurance: The manufacturing process adheres to ISO 9001:2008 standards, with real-time monitoring and traceability of materials and processes.
Ordering Information: The document provides a detailed guide for ordering, including micron ratings, lengths, inlet and outlet types, and non-sterile options.
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Catalog excerpts

Pharma PTFE Membrane Capsules-1

PTM Capsule Filters PTFE Membrane Solvent Filtration Tank Vent Filters Pharmaceutical grade TM capsules are manufactured for the critical needs of the pharmaceutical industry. Made with highly hydrophobic polytetrafluoroethylene (PTFE) membrane, these capsules are used for filtration of non-aqueous liquids, aggressive solvents, compressed gases, and as vent filters. Each module is individually tested using the water intrusion method before it is released from manufacture. 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 Designed for filtration of air and process gases V ent filtration for the protection of tank contents Final filtration of solvents, alcohols and other non-aqueous liquids PTM 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 Pharmaceutical Grade

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Pharma PTFE Membrane Capsules-2

Integrity Test Specifications 60/40 IPA/water wetted membrane PTM capsules are validated using test procedures that comply with the intent of both ASTM F 838-05 and HIMA protocols for the determination of bacterial retention. The challenge level is 107 organisms per cm2 of filter media; 0.22 μm challenged with Brevundimonas diminuta; 0.45 μm challenged with Serratia marcescens. Pore Size Bubble Point Critical Process Filtration can provide validation assistance. Quality Assurance and Standards The materials used to construct pharmaceutical grade PTM capsule filters are non-toxic and meet the...

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