Hydrophobic PES Capsule Filters
The PoreCap® series of Hydrophobic PES (Polythersulfone) capsule filters are developed for sterile filtration of gases/air and provide
high purity to meet filtration requirements of biopharmaceutical and pharmaceutical processing.
They are made of absolute rated hydrophobic PES membrane and offer fast air flow with excellent throughput. Each filter is integrity & flow rate tested and validated for heat Stability, fibre particle release, extractables and biosafety. They are ensured for microbial retention efficiency with bacterial challenge test as per ASTM F838-05 to provide sterility assurance for critical venting applications.
Materials of Construction
| Membrane: | Hydrophobic Polyethersulfone |
| 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 for forward, 0.7 Kg/cm² @ 25 °C for reverse |
| Autoclave: | 30 autoclave cycles @125 °C |
Bubble Point
| 0.22µm: | ≥1380 mbar (20 psi) (with 50% IPA) |
| 0.45µm: | ≥ 690 mbar (10 psi) (with 50% IPA) |
Microbial Retention
| 0.22µm: | LRV > 7 for Brevundimonas Diminuta |
| 0.45µm: | LRV > 7 for Serratia marcescens |
Sterilization
| ETO: | Yes |
| Gamma: | Yes |
| Non-sterile: | Yes |
| Non-sterile (Gamma strerilizable): | Yes |
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. 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.
