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Pharma Polypropylene Membrane Cartridge Filters

Pharma Polypropylene Membrane Cartridge Filters

Pharma Polypropylene Membrane Cartridge Filters

Product catalog summary
Overview: The document details the specifications and applications of Pharmaceutical Grade PPM Cartridge Filters, designed for the pharmaceutical industry. These filters are made with hydrophobic polypropylene membranes suitable for aggressive solvents and gases.
Construction Materials: The filters are constructed entirely from polypropylene, including the filtration media, support, end caps, center core, and outer support cage. Sealing is achieved through thermal bonding, and various O-ring materials are available, such as Buna, Viton, and Silicone.
Dimensions and Specifications: Cartridges range from 5 to 40 inches in length with a nominal outside diameter of 2.75 inches. The filtration area is 7.0 ft² per 10-inch length. Integrity tests are conducted using a 60/40 IPA/water solution, with specific air diffusion rates for different pore sizes.
Operating Parameters: The maximum differential pressure is 50 psid forward and 40 psid reverse at 20°C. The operating temperature is up to 82°C at 10 psid in water. Recommended changeout pressure is 35 psid.
Sanitization and Sterilization: Cartridges can be autoclaved at 121°C or steam sterilized at 135°C. Chemical sanitization is also possible using standard industry chemicals.
Applications: These filters are suitable for gases, compressed air, tank vents, chemicals, solvents, and bulk pharmaceutical chemicals.
Compliance and Quality Assurance: The filters meet USP Class VI standards and FDA compliance for non-fiber releasing filters. They are manufactured in ISO 9001:2008 certified facilities, ensuring traceability and quality control.
Validation: Filters are validated according to ASTM F 838-05 and HIMA protocols for bacterial retention, with specific challenges for different pore sizes.
Flow Rates: Typical flow rates are provided for both liquid and air/gas, with specific values for 0.10 μm and 0.22 μm pore sizes.
Ordering Information: The document provides a detailed coding system for ordering cartridges based on pore size, end cap type, length, and O-ring material.
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Catalog excerpts

Pharma Polypropylene Membrane Cartridge Filters-1

PPM Cartridge Filters Pleated Polypropylene Membrane Tank Vents Bulk Pharmaceutical Chemicals Dimensions Length Outside Diameter Filtration Area Integrity Test Specifications Per 10 in. length, 60/40 IPA/water wetted membrane Pore Size PPM Membrane Filter Cartridges are manufactured for the specified needs of the pharmaceutical industry. Manufactured with inherently hydrophobic polypropylene membrane, these cartridges are designed for use in the filtration of aggressive solvents and as compressed gas and vent filters. Each cartridge module is individually diffusion tested using 60/40 IPA and water before it is released from manufacture. The cartridge surface area, filter core design, pleat configuration, and pleat packing density have been optimized to provide increased cartridge life resulting in lower filtration operating costs. Rugged construction ensures repeatable steaming and testing. Construction Materials < 30 cc/min at 40 psig (2.89 barg) < 30 cc/min at 35 psig (2.4 barg) Maximum Operating Parameters 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) Filtration Media Polypropylene Membrane Media Support In-line Steam Center Core Outer Support Cage For all elevated temperature procedures above, a stainless steel support ring is required. Sealing Method Thermal Bonding Chemical Sanitization Buna, Viton® (or FKM), EP, Silicone, FEP Encapsulated Silicone, FEP Encapsulated Viton (or FKM) 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. Pharmaceutical Grade

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Pharma Polypropylene Membrane Cartridge Filters-2

The materials used to construct pharmaceutical grade PM cartridge 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. PPM cartridge filters comply with Title 21 CFR sections 210.3 (b)(6) and 211.72, for non-fiber releasing filters. The levels of bacterial endotoxins in aqueous extracts from pharmaceutical-grade cartridge filters are below current USP limits as specified for water for injection. PPM cartridge filters...

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