BNM Capsule Filters Nylon 6,6 Membrane Applications uffers and Feedstocks B BNM capsules see broad service in bioburden management for filling operations as well as for buffers, feedstocks, purified water, WFI, and other media. Additional applications for BNM capsule filters include filtration of 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. Designed for sterilizing filtration Optimized for retention F inal filtration of USP Purified Water and WFI, buffers Bioburden reduction in SVPs and LVPs Broad solvent compatibility BNM 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 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 Biopharmaceutical Grade Biopharmaceutical grade NM capsules are designed to be used for sterilizing grade filtration. The Nylon 6,6 membrane is optimized for retention. BNM capsule filter elements are 100% integrity tested during production.

Integrity Test Specifications Pore Size Max Diffusion Rate (cc/min -water wetted membrane) Biopharmaceutical grade NM capsule 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: 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 biopharmaceutical grade NM capsule filters are non-toxic...