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Biopharm PES Cartridge Filters

Biopharm PES Cartridge Filters

Biopharm PES Cartridge Filters

Product catalog summary
Overview
Biopharmaceutical grade BPS cartridge filters are designed for critical bioburden reduction applications in the biopharmaceutical industry. They utilize a hydrophilic asymmetric polyethersulfone (PES) membrane, known for excellent flow rates and high throughput, making them suitable for filtering bacteria in buffers, USP Water for Injection (WFI), and other biopharmaceutical products.
Construction Materials
The filters are constructed with PES membrane, polypropylene media support, end caps, center core, and outer support cage. Sealing is achieved through thermal bonding, and various O-ring materials are available, including Buna, Viton®, EP, Silicone, and FEP encapsulated options.
Dimensions and Specifications
Filters are available in lengths from 5 to 40 inches and have an outside diameter of 2.75 inches. The filtration area is 7.0 ft² per 10-inch length. Integrity tests specify air diffusion rates for various pore sizes, ensuring performance under specified conditions.
Operating Parameters
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
Filters can be sanitized using filtered hot water, autoclave, or in-line steam, with specific conditions for each method. Chemical sanitization is also possible using standard industry chemicals.
Applications
These filters are used in various applications, including buffers, feedstocks, SVPs, LVPs, solvents, and vaccines.
Compliance and Safety
Materials used in the filters meet USP Class VI and FDA requirements for non-toxic and non-fiber releasing filters. They also comply with bacterial endotoxin limits for water for injection.
Quality Assurance
The manufacturing facility meets ISO 9001:2008 standards, ensuring high-quality production in clean rooms. A sophisticated MRP system supports continuous quality and cost improvements.
Validation
BPS cartridges are validated according to ASTM F 838-05 and HIMA protocols, ensuring bacterial retention efficacy.
Flow Rates
Typical flow rates are provided for various pore sizes, with extrapolation possible for housings with multiple elements.
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Catalog excerpts

Biopharm PES Cartridge Filters-1

BPS Cartridge Filters PES Membrane Applications Buffers and Feedstocks Outside Diameter Filtration Area Integrity Test Specifications 10-inch cartridge, water wetted membrane Pore Size 0.03 μm Biopharmaceutical grade PS filters are hydrophilic and manufactured with asymmetric polyethersulfone (PES) membrane. PES membrane exhibits excellent flow rates with high throughput. BPS cartridge filters are used for critical bioburden reduction applications in the biopharmaceutical industry. Specific applications for BPS filters are bacteria removal in buffers, USP Water for Injection (WFI), SVPs, LVPs and other biopharmaceutical products. The filter elements are 100% integrity tested during production. Polyethersulfone is particularly suited for the filtration of products that contain elements that adsorb to the media, such as preservatives and proteins. The lower binding characteristics of polyethersulfone make it a good choice for filtration of valuable protein solutions such as vaccines and biologicals. Construction Materials Filtration Media 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) Air Diffusion Rate < 30 cc/min at 60 psig (4.1 barg) < 30 cc/min at 48 psig (3.3 barg) < 30 cc/min at 35 psig (2.4 barg) < 30 cc/min at 20 psig (1.4 barg) < 30 cc/min at 15 psig (1.0 barg) < 30 cc/min at 12 psig (0.8 barg) < 30 cc/min at 8 psig (552 mbarg) < 30 cc/min at 7 psig (483 mbarg) 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) Sanitization/Sterilization Filtered Hot Water 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. Biopharmaceutical Grade

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Biopharm PES Cartridge Filters-2

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. 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...

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