mdi -Pre-sterilized Cellulose Nitrate Membrane Disc Filter

• Sterility testing
• Filtration of aqueous solutions
• Product and water Microbiology

Construction

• Membrane : Cellulose Nitrate
• Pore size : 0.2μm, 0.45μm, 0.8μm
• Diameter : 47mm

Operational

• Max. Operating Temperature : 80°C continuous
• Max. Differential Pressure : 5Kg/cm²
• Sterilization By Autoclave : Autoclavable at 121°C for 30 minutes
• Bubble Point (0.2 µm) : > 50psi (3.52Kg/cm²) with water
• Bubble Point (0.45 µm) : > 32psi (2.25Kg/cm²) with water
• Retention Efficiency (0.45µm) : LRV > 7 for S. marcescens
• Retention Efficiency (0.2µm) : LRV > 7 for B. diminuta, As per ASTM F838-05
• Water Flow Rate (0.2μm) : > 20ml/min/cm² @ 10 psi @ 27 °C
• Water Flow Rate (0.45μm) : > 45ml/min/cm² @ 10 psi @ 27 °C

Assurance

• 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 injectables
• Oxidizable Substances : Within limits as specified in USP
• Quality Management System : ISO-9001 Certified
• USFDA : DMF No. 015554

• Absolute Retention
• Hydrophilic
• Non-media migrating
• High Flow Rates
• Biologically inert
• Consistent and Reliable Quality: Cellulose Nitrate Membrane Disc Filter Type- CN disc filters are produced with ISO 9001-2008 certified quality management systems.
• Regulatory Compliance: Meet all pharmacopeial and compendia requirements and are registered with USFDA DMF #015554