PNC Capsule Filters Positively Charged Nylon 6,6 Membrane edical device rinse water M Endotoxin control PNC Capsules are hydrophilic and manufactured with the highest quality charged Nylon 6,6 membrane. The capsules are sterilizing grade and the positive charge enhances its ability to remove particles smaller than its rated pore size, such as endotoxins in water streams or water based solutions. PNC capsule elements are 100% integrity tested during production. PNC capsule filters are ideal for bacteria and endotoxin control in water systems, including WFI, rinse water for vials and other packaging, water-based bulk chemicals, and SVPs and LVPs. Positively charged to enhance removal of particles smaller than the rated pore size PNC capsule filters are made using FDA listed Nylon 6,6 membrane layers and FDA listed polypropylene molded components. The filter materials passed all standard USP material safety tests for products used in the making of pharmaceutical products. Bacteria and endotoxin control in water, bulk chemicals E xcellent throughput PNC Capsule Filters - Filtration Area Capsule Length Charged Nylon 6,6 Membrane 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 Positively Charged, Nylon 6,6 Membrane Gases Operational Pressure Operating Temperature Media Support Forward Differential Pressure 50 psid (3.4 bard) at 20 °C (68 °F) Center Core Reverse Differential Pressure Outer Support Cage Sealing Method Thermal Bonding Recommended Changeout Pressure Pharmaceutical Grade Dialysis water

Integrity Test Specifications Max Diffusion Rate (cc/min -water wetted membrane) PNC capsules 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: Pore Size 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. Endotoxin Removal The materials used to make PNC capsule filters are non-toxic and meet the requirements for the MEM Elution Cytotoxicity Test...