- Description
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Details
AseptiCap KL/KS 1", 2", 5", 8"AseptiCap KL/KS PES membrane capsule filters are available in a wide range of pore sizes, sizes and end connections to suit a multitude of sterilization applications in biopharmaceuticals for process development, pilot scale and production batch sizes.Features:Consistent and Reliable Quality: AseptiCap capsule filters are produced with ISO 9001 certified quality management systems. Regulatory Compliance: Meet all pharmacopeial and compendia requirements and are registered with USFDA DMF #015554 Low Protein Binding: Results in increased overall product yield High Throughputs:
Translates to lower filtration costs, less number of filter changes and overall economy of operations. Low Extractables:
Mean less addition to impurity profile of the biological product from the filters. Applications:-
Bioburden reduction from cell harvest supernatants -
Filtration of equilibrating, washing and elution buffers for chromatography columns -
Sterilization of biopharmaceuticals such as vaccines and therapeutic proteins -
Sterilization of buffers -
Sterilization of adjuvants
Specifications:Catalogue No LSCPF08 CONSTRUCTION Membrane Hydrophilic PES Final Filter Pore Size 0.2µm 0.45µm Support Layers Polyester Body and Core Polypropylene Prefilter Pore Size (in case of AseptiCap KS) 0.8µm, 0.65µm, 0.45µm 0.8µm, 0.65µm Integrity Testing / Retention Bubble Point > 50psi (3.52Kg/cm²) with Water > 30psi (2.11Kg/cm²) with Water Microbial Retention LRV >7 for Brevundimonas diminuta (ATCC 19146) per cm² LRV >7 for Serratia marcescens (ATCC 14756) per cm² Size Size 1" 2" 5" 8" Effective Filtration Area (Nominal) 250cm² 500cm² 1000cm² 2000cm² Dimension (End to End) - ½" Hose Barb I/O 90 mm 112 mm 164 mm 215 mm Dimension (End to End) - 1½" Sanitary Flange Inlet ½" Single Step Hose Barb Outlet -- 111 mm 162 mm 212 mm Dimensions (End to End) - ¾" Sanitary Flange I/O 91 mm 103 mm 155 mm 205 mm Dimension (End to End) - 1½" Sanitary Flange I/O 91 mm 110 mm 161 mm 211 mm Dimension (End to End) - ½" Single Step Hose Barb I/O -- 115 mm 165 mm 217 mm Operational Radius (with Vent/ Drain) 30 mm 65 mm 65 mm 65 mm Vent and Drain ¼" Hose Barb with Silicone "O" rings for 2", 5" and 8" only OPERATIONAL Max. Operating Temperature 80 °C @ < 2 Kg/cm² (30 psi) Max. Differential Pressure < 4 Kg/cm² (60 psi) @ 30 °C pH Compatibility Compatible with pH range of 1-10 Sterilization By Gas Sterilizable by Ethylene Oxide Sterilization - By Autoclave Autoclavable at 125°C for 30 minutes, 25 cycles and it cannot be in-line steam sterilized Shelf Life 3 years after EO sterilization ASSURANCE Toxicity Passes Bioreactivity test, In Vivo, as per USP <88> for Class VI plastics Cytotoxicity Passes Biological Reactivity Tests, In Vitro, USP <87> for cytotoxicity Bacterial Endotoxin Aqueous extracts exhibit < 0.25 EU/ml as established by Limulus Amebocyte Lysate (LAL) Test Bioburden Bioburden level is < 1000 cfu/filter device as per ANSI/AAMI/ISO 11737-1 : 1995 Non Fiber Releasing Passes test as per USP and comply with USFDA 21 CFR Part 210.3(b)(6) for fiber release Indirect Food Additive All Polypropylene components meet the FDA Indirect Food Additive requirements cited in 21 CFR 177.1520 Extractables with WFI Passes test as per USP Good Manufacturing Practice These products are manufactured in a facility which adheres to Good Manufacturing Practices Oxidizable Substances Within limits as specified in USP Particle Shedding Passes USP test for particulates in injectables TOC/Conductivity at 25 °C Meets the WFI requirements of USP <643> for Total Organic Carbon and USP <645> for Water Conductivity after a specified volume of purified water flush Quality Management System ISO-9001 Certified USFDA DMF No. 015554 -
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