- Description
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Details
AseptiCap KL/KS-γ 25mm, 50mm- AseptiCap KL/KS- γ are gamma sterilizable disposable PES membrane capsule filters offering a convenient lab scale solutions for process development with identical materials of construction for easy scale up to pilot scale and finally production scale filters.
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 LSCPF10 CONSTRUCTION Membrane Hydrophilic PES Final Filter Pore Size 0.2µm 0.45µm Prefilter Pore Size 0.8 µm, 0.65µm, 0.45µm 0.8 µm, 0.65µm Support Layers Polyester Body and Core Polypropylene 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 25 mm 50 mm Effective Filtration Area (Nominal) 5cm² 20cm² Dimension (End to End) - Female Luer Lock Inlet/ Male Luer Slip 23 mm -- Dimension (End to End) - ¼" SHB -- 79 mm Dimension (End to End) - ¾" Sanitary Flange Inlet I/O -- 51 mm Operational Radius (with Vent/ Drain) 15 mm 28 mm OPERATIONAL Max. Operating Temperature 55 °C 60 °C Max. Differential Pressure 5 Kg/cm² (75 Psi) @ 25°C 3 Kg/cm² (42 Psi) @ 30°C Burst Pressure >14 Kg/cm² >8 Kg/cm² Hold-up Volume(with air purge) <50µL <300µL pH Compatibility Compatible with pH range of 1-10 Sterilization - By Autoclave Autoclavable at 125°C for 30minutes, 1 cycle after gamma irradiation and it cannot be in-line steam sterilized Sterilization - By Irradiation Gamma Irradiatiable up to 50 kGy Shelf Life 2 years after gamma 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 - Additional Information
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Additional Information
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JAINSONS (INDIA) REGD.Since 1957Serving Above 52 Countries
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