Positively Charged Nylon Cartridge Filters
Nupore Nucart® positively charged Nylon-66 membrane cartridge filters are sterilizing grade filters for endotoxin removal and sterilization of buffers, organic solvents and injectables.
The positively charged Nylon-66 membrane has a cationic functional group added to the membrane which provides an extra functionality of retaining smaller negatively charged particles such as endotoxins.
These are available from 3″ to 40″ sizes in absolute pore size rating of 0.22μm & 0.45μm.
Materials of Construction
| Membrane: | Positively Charged Nylon-66 |
| Housing: | Polypropylene |
| Core: | Polypropylene |
| End Connections: | Polypropylene |
Operational Parameters
| Max Temp: | 80 °C @ ≤ 2 Kg/cm² |
| Max Pressure: | 3.5 Kg/cm² @ 25 °C |
| Autoclavable: | 1 Autoclave cycle @121°C |
Bubble Point
| 0.22µm: | ≥ 3447 mbar (50 psi) (with water wetted) |
| 0.45µm: | ≥ 2069 mbar (30 psi) (with water wetted) |
| 0.80µm: | ≥ 965 mbar (14 psi) (with water wetted) |
Max Air Diffusion Flow (for 10″ Cartridge)
| 0.22µm: | ≤ 20 mL/min @ 2483 mbar (36 psi) (with water wetted) |
| 0.45µm: | ≤ 20 mL/min @ 1517 mbar (22 psi) (with water wetted) |
| 0.80µm: | ≤ 20 mL/min @ 689 mbar (10 psi) (with water wetted) |
Microbial Retention
| 0.22µm: | LRV > 7 for Brevundimonas Diminuta |
| 0.45µm: | LRV > 7 for Serratia marcescens |
| 0.80µm: | LRV > 7 for Staphylococcus aureus |
Regulatory Compliance
| Endotoxin releasing: | <0.25 EU/mL as determined by the LAL test |
| Particle release: | Meets the requirements of WFI set by USP |
| Non-fiber releasing: | Meets the criteria for a non-fiber releasing filter as per USP |
| Material toxicity: | All components meet the requirements of the USP Reactivity Test for Class VI Plastics Filters meet the requirements of USP Biological Reactivity Tests in Vitro Cytotoxicity |
| Bacterial challenge test: | Filters with the claim passed the bacterial challenge testing using Brevundimonas diminuta (ATCC 19146) at a minimum challenge concentration 1x10⁷ CFU/cm² (0.22 µm) per ASTM F838-20. |
| Quality: | Manufactured in accordance with ISO 9001 and ISO 13485 certified quality management system |
Drug Specific Filter Validation Services
Through, nSure Validation Services, we offer a complete range of filter validation services to qualify your molecules with our Filters in accordance with the requirements listed in PDA TR#26 and in compliance with international regulatory bodies such as USFDA and EU GMP.
Filter Integrity Test
Bacterial Retention Testing (BRT)
Chemical Compatibility Test
Throughput Study
Extractables & Leachables
