Pharma Positively Charged Nylon 6,6 Cartridge Filters


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Pharma Positively Charged Nylon 6,6 Cartridge Filters - 1

PNC Cartridge Filters Positively Charged Nylon 6,6 Membrane Dialysis Applications Endotoxin Reduction Integrity Test Specifications Per 10-in. length, water-wetted membrane Pore Size 0.10 μm Filtration Media Positively Charged Nylon 6,6 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) Note: All materials of construction are FDA accepted. Final assemblies have been validated to pass USP Class VI toxicology extractable tests, oxidizable substances for plastics, endotoxin level, and other quality tests. Dimensions Length Outside Diameter Filtration Area < 15 cc/min at 35 psig (2.4 barg) Construction Materials < 15 cc/min at 48 psig (3.3 barg) PNC Membrane Filter Cartridges are sterilizing grade cartridges with charged Nylon 6,6 membrane. The nylon membrane used in these cartridges is positively charged for enhanced retention of particles below the rated pore size of the filter. Nylon cartridges see broad service in sterile fill applications in SVPs and as bioburden management filters in LVPs. Media preparation and service liquid filtration are other common applications for this cartridge. Positively charged nylon is particularly suited for endotoxin removal in water systems. Nylon is also used for filtration of solvents because of its broad compatibility and low level of extractables. < 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. Endotoxin Removal PNC filters removed up to 99.9% of endotoxin when challenged with between 3EU/ml and 240EU/ml. Pharmaceutical Grade

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Pharma Positively Charged Nylon 6,6 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. 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...

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