Pharma Positively Charged Nylon 6,6 Cartridge Filters

Product catalog summary

Overview: Pharmaceutical Grade PNC Membrane Filter Cartridges are sterilizing grade filters featuring a positively charged Nylon 6,6 membrane. These cartridges are designed for enhanced retention of particles below the rated pore size and are widely used in sterile fill applications, bioburden management, media preparation, and solvent filtration due to their broad compatibility and low extractables.

Construction Materials: The cartridges are constructed with a positively charged Nylon 6,6 membrane, supported by polypropylene components, and sealed using thermal bonding. O-rings are available in various materials including Buna, Viton, EP, Silicone, and FEP encapsulated options. All materials are FDA accepted and validated to pass USP Class VI toxicology tests.

Dimensions and Operating Parameters: 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. Maximum differential pressure is 50 psid forward and 40 psid reverse at 20°C. Operating temperature is up to 82°C at 10 psid in water, with a recommended changeout pressure of 35 psid.

Sanitization and Sterilization: Cartridges can be sanitized using filtered hot water, autoclave, or in-line steam, with specific conditions requiring a stainless steel support ring. Chemical sanitization is limited to 1% hydrogen peroxide or peracetic acid solutions.

Applications: These filters are suitable for diagnostics, dialysis, LVPs and SVPs, biologicals, water for injection, and endotoxin reduction, with a removal efficiency of up to 99.9% for endotoxins.

Integrity Test Specifications: The air diffusion rate for water-wetted membranes varies by pore size, with specific limits for each size.

Quality Assurance and Standards: Filters are designed for cGMP-compliant processes and meet ISO 9001:2008 standards. Each filter is traceable through a lot code, and manufacturing data is collected in real-time for quality improvements.

USP Biosafety and FDA Compliance: Materials meet USP Class VI and FDA requirements for non-toxic, repeated food contact applications. Endotoxin levels in aqueous extracts are below USP limits.

Validation: Cartridges are validated according to ASTM F 838-05 and HIMA protocols for bacterial retention, with specific challenge organisms for each pore size.

Flow Rate: Typical flow rates are provided for various pore sizes, with extrapolation allowed for multiple elements and higher pressure drops.

Ordering Information: Cartridge order numbers include variables for pore size, end cap type, length, and O-ring material, with specific codes provided for each option.

Catalog excerpts

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 assembly...

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