Mem-Pleat SG & Pur-MAXX SG
2Pages

■ Vaccines 1 Buffer Solutions Sterilizing Grade Polyethersulfone Elements ■ Cell Culture Purification Final filtration of WFI & CIP Water Strainrite's Sterilizing Grade Pleated Cartridges are engineered to meet the highest standards of microorganism control for sterile fluids. These filter elements are validated for complete removal of Brevundimonas diminuta (ATCC 19146) at test concentrations of 107 CFU/cm2 (Colony Forming Units). This product is ideally suited for applications where microorganism contamination causes product defects or extra processing time due to increase fluid instability. These cartridges are produced utilizing a unique multi-pleated configuration integrating highly asymmetric and hydrophillic polyethersulfone membrane with exceptional pleat support materials. This novel multi-pleated approach increases cartridge life, strength and durability, and allows our filter cartridges to withstand multiple sterilization cycles without sacrificing product integrity. These cartridges comply with FDA CFR Title 21 and USP Biological Reactivity for Class VI Plastics. By combining these ultra pure components with the low protein binding features of highly asymmetric hydrophillic polyethersulfone membrane makes them perfect for applications in the biopharmaceutical and bottled water industries. Mem-Pleat SG & Pur-MAXX SG • Validated 0.2 pm absolute rated membrane configuration • High surface area membrane offers excellent life and flux rates while providing absolute filtration • Absolute-rated dual layer membrane provides reliable, consistent and repeatable filtrate quality • Low pressure drops yield higher flow rates and reduced processing time • Non-fiber shedding polypropylene support materials eliminate fiber migration • Pleat design for greater surface area: longer service life, fewer change outs and reduced operating costs • 100% Thermally bonded construction • Integrity tested • High strength design allowing for extended use and multi autoclave and hot water sanitization cycles • 316 SS reinforced end treatments • All materials of construction are FDA compliant with CFR Title 21 and are bio-safe in accordance with USP Class VI • Validation guide available on request Performance Characteristics Integrity Test Values Pore Size Bubble Point Test Pressure Air Diffusion USP Physiochemical Tests for Plastics Ultrapure water extracts from multiple lots of cartridges were tested and shown to have values that comply with USP limits. Test Results USP Limit

Materials of Construction Filter Media Polyethersulfone End Caps Polypropylene Pleat Support Material Polypropylene Maximum Operating Temperature 180°F (82°C) Continuous Duty Cage/Core Polypropylene Toxicity Cartridge materials meet USP Class VI and CFR 21 for food and beverage contact Seals Buna N Fluorocarbon EPDM Silicone Sterilization Cartridge can be sterilized via steam or Autoclave: 20 times at 275°F (135°C) Cartridge may be sanitized in place with common sanitizing agents, contact factory for chemical compatibility Sealing Thermal Bond Reinforcing Ring 316 Stainless Steel Packaging...