BNM Cartridge Filters Nylon 6,6 Membrane Applications Buffers and Feedstocks Outside Diameter Filtration Area Integrity Test Specifications Water-wetted membrane Pore Size 0.10 μm Biopharmaceutical grade Nylon 6,6 membrane filter cartridges are made using Nylon 6,6 membrane. The Nylon membrane used in these cartridges is optimized for retention. Nylon cartridges see broad service in bioburden management for filling operations as well as for buffers, feedstocks, purified water, WFI, and other media. BNM cartridges are also used for the filtration of solvents because of Nylon’s broad compatibility and low level of extractables. 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) Air Diffusion Rate < 30 cc/min at 48 psig (3.3 barg) < 30 cc/min at 35 psig (2.4 barg) < 30 cc/min at 20 psig (1.4 barg) < 30 cc/min at 15 psig (1.0 barg) Maximum Operating Parameters Differential Pressure • Forward (in water) Operating Temperature Recommended Changeout Pressure 82 °C (180 °F) at 60 psid (4.1 bard) in water 35 psid (2.4 bard) 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. 90 °C (194 °F), 30 minutes, multiple cycles, max 3 psid forward flow In-line Steam Total Performance 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. Biopharmaceutical Grade

The materials used to construct biopharmaceutical grade filters are non-toxic and meet the requirements for the MEM Elution Cytotoxicity Test and the requirements for Biological Reactivity Tests in the current version of the United States Pharmacopeia (USP) for Class VI - 121 °C Plastics. In addition, the materials meet the requirements listed by the FDA as appropriate for use in articles intended for repeated food contact as specified in Title 21 CFR sections 174.5, 177.1500, 177.1520, 177.1630, 177.2440, and 177.2600 as appropriate. BNM filters comply with Title 21 CFR sections 210.3 (b)(6)...