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Pharma PES Cartridge Filters

Pharma PES Cartridge Filters

Pharma PES Cartridge Filters

Product catalog summary
Overview: The document provides detailed information about pharmaceutical-grade polyethersulfone (PES) filter cartridges, which are sterilizing grade and optimized for retention with a double-layered membrane. These cartridges are widely used in sterile fill applications for small volume parenterals (SVPs) and biological products, particularly where low binding characteristics are essential, such as in ophthalmics and protein solutions like vaccines.
Construction Materials: The cartridges are constructed with a double-layered asymmetric PES membrane, supported by polypropylene components including media support, end caps, center core, and outer support cage. The sealing method used is thermal bonding, and various O-ring materials are available, including Buna, Viton, EP, Silicone, and FEP encapsulated options.
Performance Specifications: The cartridges are integrity tested and have specific dimensions, with lengths ranging from 5 to 40 inches and an outside diameter of 2.75 inches. The filtration area is 7.0 ft² per 10-inch length. Integrity test specifications are provided for various pore sizes, with air diffusion rates specified at different pressures.
Operating Parameters: Maximum differential pressure is 50 psid forward and 40 psid reverse at 20°C. The operating temperature is 82°C at 10 psid in water, with a recommended changeout pressure of 35 psid. Sanitization and sterilization can be performed using filtered hot water, autoclave, or in-line steam, with specific conditions outlined.
Applications: The cartridges are suitable for diagnostics, vaccines, large volume parenterals (LVPs), SVPs, biologicals, water for injection, and ophthalmics.
Ordering Information: Cartridge order numbers vary based on pore size, end cap type, length, and O-ring material. A detailed coding system is provided for specifying these variables.
Quality Assurance and Standards: The filters are designed for cGMP-compliant processes and meet ISO 9001:2008 standards. They are manufactured in clean rooms, with each filter assigned a lot code for traceability. The materials comply with USP biosafety and FDA requirements for non-toxic materials suitable for repeated food contact.
Validation and Flow Rates: The cartridges are validated using ASTM and HIMA protocols for bacterial retention. Typical flow rates are provided for various pore sizes, with water flow rates specified at a 1 psid pressure differential.
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Catalog excerpts

Pharma PES Cartridge Filters-1

PPS Cartridge Filters Double Layered PES Membrane Dimensions Length Outside Diameter Filtration Area Integrity Test Specifications Per 10-in. length, water wetted membrane Pharmaceutical grade polyethersulfone PPS Filter Cartridges are sterilizing grade cartridges. The polyethersulfone (PES) membrane used in these cartridges is optimized for retention and is double layered for extra security. Polyethersulfone cartridges see broad service in sterile fill applications in SVPs and biological products. Polyethersulfone is particularly suited for the filtration of products whose constituents, such as preservatives and proteins, can adsorb to the media. The low binding characteristics of polyethersulfone make it a good choice for filtration of ophthalmics and valuable protein solutions such as vaccines and other biologicals. PPS Membrane Filter Cartridges are 100% integrity tested. Pore Size < 15 cc/min at 60 psig (4.1 barg) < 15 cc/min at 48 psig (3.3 barg) < 15 cc/min at 35 psig (2.4 barg) < 15 cc/min at 20 psig (1.4 barg) < 15 cc/min at 15 psig (1.0 barg) < 15 cc/min at 12 psig (0.8 barg) < 15 cc/min at 8 psig (552 mbarg) Construction Materials < 15 cc/min at 7 psig (483 mbarg) Filtration Media Double Layered Asymmetric Polyethersulfone (PES) Membrane 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) Maximum Operating Parameters 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. 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. Pharmaceutical Grade Pharmaceutical Grade

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Pharma PES Cartridge Filters-2

Quality Assurance and Standards Critical Process Filtration filters are designed for use in cGMPcompliant processes. Our state of the art manufacturing facility and quality management system both meet ISO 9001:2008 standards. Each operation from assembly and test to cleaning, drying, and packaging is done in appropriately rated clean rooms. Each filter is assigned a lot code to ensure the traceability of manufacturing data and materials. A sophisticated MRP system collects and processes real time data from manufacturing centers and inspection points. This allows variable and attribute data to...

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