Nylon Capsule Filters
The PoreCap® series of Nylon Capsule Filters are available in 0.22µm, 0.45µm, and 0.8µm wirh 0.22µm/0.45µm/0.8µm upstream combinationand ard are specially designed and developed for high purity and final filtration application i.e. water, solvents, sterile filtration, organic and aqueous samples filtration.
These filters are available in 1, 2, 5, 8 and 10 inches normal size scale for laboratory to full scale production.
They offer versatile performance in terms of fast flow with excellent throughput. Each capsule filter is validated for retention efficiency, integrity test, flow rate, heat Stability, fibre particle release, extractable and biosafety.
Membrane Characteristics: Assembled with our naturally hydrophilic Nylon 66 membranes, these Nylon Capsule Filters provides excellent chemical compatibility and offer higher throughputs
Materials of Construction
| Membrane: | Nylon |
| 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 at 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 > 4 for Staphylococcus aureus |
Sterilization
| ETO: | Yes |
| GAMMA : | No |
| Non-sterile: | Yes |
| Non-sterile (Gamma strerilizable): | No |
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.
