BPVWL Cartridge Filters High Capacity PVDF Membrane Applications SVPs Plasma Products Dimensions Length Outside Diameter Integrity Test Information Representative samples from each manufacturing lot are tested for integrity to ensure consistent performance. Biopharmaceutical grade PVWL filters are made using hydrophilic polyvinylidene fluoride (PVDF) membrane. The proprietary membrane casting process creates a thick membrane with excellent retention characteristics and flow rates and low protein binding. BPVWL cartridges are used for a wide range of critical applications in the biopharmaceutical production. Applications include bioburden reduction in buffers and media, water for injection (WFI), solvents, alcohols and other liquids. Our filters provide high efficiency, validatable performance protecting sterilizing grade filters. PVDF is particularly suited for the filtration of products containing elements that can adsorb to the media, such as preservatives and proteins. The very low binding nature of PVDF makes it a good choice for filtration of valuable protein solutions such as vaccines, plasma products, MAb products, other biopharmaceuticals as well as products that contain low amounts of preservatives. Construction Materials Filtration Media High Capacity Polyvinylidene Fluoride (PVDF) 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) 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 Performed using industry standard concentrations of hydrogen peroxide, paracetic acid, sodium hypochlorite, and other selected chemicals. 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. 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. BPVWL filters comply with Title 21 CFR sections 210.3 (b)(6)...