Element Data Sheet E70 SuporLife® 200 Cartridge Filters Description Specifications SUPORLIFE 200 cartridges are validated, sterilizing-grade filters featuring two layers of SUPOR® polyethersulfone membrane with an upstream 0.8 µm layer for prefiltration and protection of the downstream 0.2 µm sterilizing grade layer. SUPORLIFE media is low preservative and protein binding and can provide higher flow rates and longer life with biological solutions. Materials Autoclave/Steaming • Membrane: serial layers of SUPOR polyethersulfone membrane • Support materials and structural components: polypropylene • O-ring: Silicone 1 Autoclave: • 2.5 hrs (30 minute liquid cycles) at 250°F (121°C) In situ Steam: • 5 hrs (1 hour cycles) at 288°F (142°C) • 0.2 µm sterilizing grade • Built-in prefilter layer • Thermal bonded construction eliminates adhesive extractables • Meets USP Biological Reactivity for Class VI-121°C plastics • Integrity testable • Sterilizable by autoclave or in-situ steam • Manufactured for use in compliance with GMP • Manufacturing Quality System Certified to ISO 9000 Standards • Validation Guide available Applications • Sterile filtration of pharmaceuticals, biologicals, serum, buffers, media • Pharmaceutical product additives, bulk products and intermediates • Recombinant proteins • Water • Fermentation feed stocks Microbial Removal Ratings 5 Aqueous Extractables (NVR) 2 6 • Typically <34 mg per 10 in. (254 mm) element • 0.2 µm sterilizing grade (Liquid) Filter Area (nominal) Per 10 in. (254 mm) Element: • 5.0 ft2 (4650 cm2) Dimensions (nominal) • Lengths: 5" (12.7 cm), 10" (25.4 cm), 20″ (50.8 cm), 30" (76.2 cm), 40" (101.6 cm) • Diameters: 2.7" (6.9 cm) 2.9" (7.4 cm) Configuration (Code 7) 3 • Double 226 O-ring adapter • Finned end, bayonet lock Typical Operating Conditions 4 Maximum Differential Pressure/Temp.: • 60 psid (4.1 bar) at ambient temperature • 30 psid (2.1 bar) at 185°F (85°C) Maximum Differential Pressure/ Temperature (Reverse): • 15 psid (1 bar) at ambient temperature 1 2 3 4 5 6 © Copyright 2000 by Pall Corporation. All rights reserved. Other polymers available. Lot samples retain >10 7 cfu/cm 2 of Brevundimonas diminuta per mod. ASTM F838-83 and FDA guidelines. Alternate adapter codes available. Using compatible fluids. Cartridge adapters with encapsulated support rings are recommended to be used in elevated temperature applications or when heat sterilization is being used. Lab tests to establish multi-cycle resistance. Filters should be qualified in actual use. Contact Pall for recommended procedures. In water at 74°F (20°C), after autoclaving. Quality/Bio-safety Recommended Integrity Test Integrity (100% Unit Release Test) • Correlated to microbial retention Biological Tests: • Meets USP Biological Reactivity, In Vivo, for Class VI-121°C plastics Effluent Quality Tests 7 • Meets Cleanliness per USP Particulates in Injectables • Non-Fiber-Releasing per 21 CFR • Non-Pyrogenic per USP Bacterial Endotoxins (<0.25 EU/ml) • Meets USP limits for TOC and Conductivity under Purified Water after flushing • Meets USP limits for pH under Packaged Water after flushing Steam Resistance: Lot samples multi-cycle autoclave challenged Max. Forward Flow limit (Air test gas, water wet) • ≤15 cc/min at 45 psig (3.1 bar) Minimum Bubble Point • 51 psig (3.1 bar), water wet Typical Liquid Flow Rate (at 1 cp) • 1.8 gpm/psid/10" length (9.9 lpm/0.1 bar/25.4 cm) 7 Per lot sample soak or rinse-up flush aliquots. Part Numbers/Ordering Information Part Number* 8 SCS92DP7*S Length Code* Removal Rating 1, 2, 3, or 4 0.2 µm * Select Length Code: 1 = 10" (25.4 cm), 2 = 20" (50.8 cm), 3 = 30" (76.2 cm), 4 = 40" (101.6 cm). 8 Code 7 (226/Fin/SS) adapter is standard. Alternate configurations: Code 5 is 222/Flat/SS (= Pall Code 3), Code 6 is 222/Fin/SS (= Pall Code 8); SS indicates steamable with encapsulated support ring. S suffix = Silicone O-rings (standard). Note: For sizing or other information, contact your local Pall distributor. Specifications and availability: The information provided is a guide to the part number structure and possible options. Product availability may be subject to change without notice. All specifications are nominal. This literature was reviewed for accuracy at the time of publication. For current information on the products and test methodologies, consult your local Pall distributor. 2200 Northern Boulevard East Hills, New York 11548-1289 Visit us on the Web at www.pall.com/biopharmaceuticals 800.717.7255 toll free 516.484.5400 phone 516.625.3610 fax for the latest information delivered to any fax machine, anywhere in the world. This automatic system operates 24 hours a day, seven days a week. Call 1.516.942.0523 from outside the USA. Select-A-FAX* 800.664.7255 [email protected] e-mail Pall Corporation has offices and plants throughout the world in locations including: Argentina, Australia, Austria, Belgium, Brazil, Canada, China, France, Germany, Hong Kong, India, Indonesia, Ireland, Italy, Japan, Korea, Malaysia, Mexico, the Netherlands, New Zealand, Norway, Poland, Puerto Rico, Russia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, United Kingdom, United States, and Venezuela. Distributors are located in all major industrial areas of the world. © Copyright 2000, Pall Corporation. Pall, , SuporLife, Supor are trademarks of Pall Corporation. ® Indicates a Pall trademark registered in the USA. *Select-A-FAX is a registered trademark of Fax Information Network of America, Inc. © Copyright 2000 by Pall Corporation. All rights reserved.
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