- Description
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Details
0.1μm AseptiPrime KS 1", 2", 5", 8"- AseptiPrime KS are sterilizing grade PES membrane capsule filters specially designed for very high throughput.
- It incorporates a highly asymmetric PES membrane prefilter to provide enhanced protection to the well proven and widely accepted sterilization grade final mdi PES membrane.
- These are available in a wide range of sizes and end connections to suit a multitude of sterilization applications in biopharmaceuticals for process development,pilot scale and production batch sizes.
- AseptiPrime KS filters meet key process requirements such as absolute retention, high protein recoveries and low extractables
Features:-
Absolute retention -
100% integrity tested -
Low protein binding -
Low extractables -
Very low hold up volume in filters
Applications:Sterile Filtration of:-
Cell culture media -
Cell culture media containing serum -
Media additives
Specifications:Catalogue No LSCPF14 CONSTRUCTION Final Filter Membrane 0.1μm Polyethersulfone Prefilter Membrane 0.3 μm or 0.5 μm Asymmetric Hydrophilic PES Support Layers Polyester Plastic parts Polypropylene Integrity Testing / Retention Bubble Point > 31psi with IPA/ Water solution 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 Dimension (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 Clean water Flow Rate @ 10 psi with ½" Hose Barb Connection 1.3 lpm 2.5 lpm 4.8 lpm 6.5 lpm 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 @ < 30 psi (2 Kg/cm²) Max. Differential Pressure 60 psi (4 Kg/cm²) @ 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. Can not 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 Microbial Retention LRV > 7 for Acholeplasma laidlawii ATCC 23206 per cm² of filter area Non Fiber Releasing Passes test as per USP and comply with USFDA 21 CFR Part 210.3(b)(6) for fiber release Particle Release The filtrate complies with USP <788> test for particulate matter in injections 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 TOC/Conductivity at 25 °C Meets the WFI requirements of USP for TOC <643> and Conductivity <645> after a 3 liter flush Quality Management SystemISO-9001 CertifiedUSFDADMF No. 015554 - Additional Information
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Additional Information
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