PES Cartridge Filters
The NuCart® series of PES capsule filters are ready-to-use sterile grade filtration devices available in 0.1µm and 0.22µm, and different sizes as per requirements. 0.45µm is for bioburden and particulate reduction.
Assembled with our advanced PES (Polyethersulfone) Membrane, these filters guarantee optimal bacterial retention and are a go-to choice for filtration of large volume parenteral drugs (LVPs), injectables, API buffers, water for injections and beverages.
Manufactured in-house in ISO Classified cleanrooms, these devices incorporate highly efficient sterilizing grade Asymmetric Polyethersulfone and are used with an external 316L grade stainless steel housing.
Designed with a unique construction structure and an advanced pleating technology, these PES cartridge filters offer high flow rates and ensure sterile filtration of liquids.
Membrane Characteristics: Each NuCart® PES Cartridge filter incorporates our high throughput hydrophilic PES membrane that offers excellent chemical compatibility and withstands a wide pH range. Available in single layer or dual layer options, these are absolute retention filters and offer excellent contaminant removal capacity.
Materials of Construction
| Membrane: | Polyethersulfone |
| Housing: | Polypropylene |
| Core: | Polypropylene |
| End Connections: | Polypropylene |
Operational Parameters
| Max Temp: | 80 °C @ ≤ 2 Kg/cm² |
| Max Pressure: | 3.5 Kg/cm² @ 25 °C for forward, 0.7 Kg/cm² @ 25 °C for reverse |
Bubble Point
| 0.10µm:: | ≥ 1931 mbar (28 psi) (50% IPA) |
| 0.22µm:: | ≥ 3447 mbar (50 psi) (with water wetted) |
| 0.45µm:: | ≥ 2069 mbar (30 psi) (with water wetted) |
Max Air Diffusion Flow (for 10″ Cartridge):
| 0.10µm:: | ≤ 30 mL/min @ 3447 mbar (50 psi) (with water wetted) |
| 0.22µm:: | ≤ 20 mL/min @ 2482 mbar (36 psi) (with water wetted) |
| 0.45µm:: | ≤ 20 mL/min @ 1517 mbar (22 psi) (with water wetted) |
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 |
| Extractables: | Tested according to BioPhorum Operations Group (BPOG) guideline. Report is available upon request. |
| Indirect food additive: | Meets the FDA Indirect Food Additive requirements cited in 21 CFR 177.1520 |
| 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.
