Positively Charged Nylon Capsule Filters
Nupore PoreCap® positively charged Nylon-66 membrane capsule filters are absolute retention filters for endotoxin removal and sterilization of liquids.
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 hydrophilic, autoclavable, heat resistant, non-media migrating and biologically inert filters with wide chemical compatibility, ideal for filtration and sterilization of buffers, organic solvents and injectables.
Materials of Construction
| Membrane: | Positively Charged Nylon-66 |
| Housing: | Polypropylene |
| Core: | Polypropylene |
| End Connections: | Polypropylene |
| Rings: | Silicone (Only with 1/4" MNPT) |
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″ Capsule)
| 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.
