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Pharma Nylon 6,6 Cartridge Filters

Pharma Nylon 6,6 Cartridge Filters

Pharma Nylon 6,6 Cartridge Filters

Product catalog summary
Overview: Pharmaceutical Grade PNM Membrane Filter Cartridges are sterilizing grade nylon cartridges optimized for retention. They are widely used in sterile fill applications, bioburden management, and solvent filtration due to their broad compatibility and low extractables.
Construction Materials: The cartridges are constructed with Nylon 6,6 membrane, polypropylene support materials, and various O-ring options including Buna, Viton, and Silicone.
Dimensions: Cartridges range from 5 to 40 inches in length with a nominal outside diameter of 2.75 inches and a filtration area of 7.0 ft² per 10-inch length.
Applications: Suitable for diagnostics, medications, LVPs, SVPs, biologicals, WFI water, and bulk pharmaceutical chemicals.
Integrity Test Specifications: The cartridges have specific air diffusion rates for different pore sizes, ensuring effective filtration.
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.
Sanitization/Sterilization: Methods include filtered hot water, autoclave, and in-line steam, with specific conditions for each. Chemical sanitization is limited to mild agents like 1% hydrogen peroxide.
Quality Assurance and Standards: The filters comply with cGMP processes, ISO 9001:2008 standards, and USP biosafety and FDA compliance for non-toxic materials.
Validation: PNM cartridges are validated for bacterial retention using ASTM and HIMA protocols.
Flow Rate: Typical flow rates are provided for various pore sizes, with extrapolation possible for different configurations.
Ordering Information: Cartridges can be customized based on pore size, end cap type, length, and O-ring material, with specific codes for each option.
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Catalog excerpts

Pharma Nylon 6,6 Cartridge Filters-1

PNM Cartridge Filters Nylon 6,6 Membrane Bulk Pharmaceutical Chemicals Integrity Test Specifications Per 10-in. length, water wetted membrane Pore Size 0.10 μm 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) Dimensions Length Outside Diameter Filtration Area 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. < 15 cc/min at 48 psig (3.3 barg) 0.22 μm PNM Membrane Filter Cartridges are sterilizing grade nylon cartridges. The nylon membrane used in these cartridges is optimized for retention. Nylon cartridges see broad service in sterile fill applications in SVPs and as bioburden management filters in LVPs. Media and service liquid filtration are other common applications for this cartridge. Nylon is particularly suited for the filtration of solvents because of its broad compatibility and low level of extractables. < 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) 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 Nylon does not tolerate aggressive chemical sanitization protocols. Nylon membrane cartridges are best sanitized with 1% hydrogen peroxide or 1% hydrogen peroxide and peracetic acid. Various manufacturers use different concentrations of active ingredients. Refer and adhere to the manufacturer’s instructions for sanitizing nylon membrane. Pharmaceutical Grade

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Pharma Nylon 6,6 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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