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| 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 |
| Construction | |
| Membrane | Cellulose Nitrate |
| Pore size | 0.2μm, 0.45μm, 0.8μm, 1.2µm, 5µm |
| Diameter | 90mm, 142mm, 293mm |
| 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 @ 0.70 Kg/cm² @ 27 °C |
| Water Flow Rate (0.45μm) | > 45ml/min/cm² @ 0.70 Kg/cm² @ 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 |