Pharma Nylon 6,6 Capsules


Catalog excerpts

Pharma Nylon 6,6 Capsules - 1

PNM Capsule Filters Nylon 6,6 Membrane Applications SVPs and LVPs Buffers and Other Media PNM capsules are designed to be used for sterilizing grade filtration. The high quality nylon membrane is optimized for retention. PNM capsule filter elements are 100% integrity tested during production. Nylon capsules 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 membrane. Designed for sterilizing filtration Additional applications for PNM capsule filters include final filtration of bulk pharmaceutical chemicals, USP Purified Water, Water for Injection (WFI), buffers, solvents, alcohols and other excipients. Nylon is particularly suited for the filtration of solvents because of it’s broad compatibility and low level of extractables. Optimized for retention F inal filtration of bulk chemicals, USP Purified Water and WFI, buffers Bioburden reduction in LVPs Broad solvent compatibility PNM Capsule Filters - Filtration Area Capsule Length Flow Rate / Filtration Area The following table represents typical water flow at a one psi (69 mbar) pressure differential across a single 2 inch capsule with 1.0 ft ² (930 cm²) of media with 1/2” FNPT ports. The test fluid is water at ambient temperature. Higher pressure drops are acceptable, but as flows increase the pressure drop of the housing becomes more apparent. 0.10 μm Pore Size * For approximate flow rates for 5” through 30” capsules, refer to the appropriate cartridge data sheet Construction Materials Maximum Operating Parameters Liquid Operational Pressure Filtration Media Gases Operational Pressure Media Support Operating Temperature Center Core Outer Support Cage Sealing Method Thermal Bonding Forward Differential Pressure 50 psid (3.4 bard) at 20 °C (68 °F) Reverse Differential Pressure Recommended Changeout Pressure Pharmaceutical Grade Bulk Pharmaceutical Chemicals Solvents

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Pharma Nylon 6,6 Capsules - 2

Integrity Test Specifications Pore Size PNM capsule filters are validated using test procedures based on ASTM Method F838-05 and HIMA protocols. The challenge level is 107 organisms per cm2 of filter media: Max Diffusion Rate (cc/min -water wetted membrane) 0.22 μm challenged with Brevundimonas diminuta; 0.45 μm challenged with Serratia marcescens; 0.65 μm challenged with Saccharomyces cerevisiae. Critical Process Filtration can provide validation assistance. Quality Assurance and Standards The materials used to construct pharmaceutical grade PNM capsule filters are non-toxic and meet the...

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