PTFE Capsule Filters
The PoreCap® series of PTFE capsule filters are known for their high efficiency, chemical resistance, and thermal stability. The hydrophobic properties of PTFE make it the most preferred filtration product for use in sterilization and filtration of air, gases, and solvents to ensure product safety and integrity.
Manufactured in-house in ISO Classified cleanrooms with a unique construction structure and advanced pleating technology, our PTFE Capsule filters are highly recommended for sterile tank venting , nitrogen blanketing and single use applications
Membrane Characteristics: The PoreCap® PTFE capsule filters incorporate hydrophobic PTFE membranes that offer robust chemical resistance, impressive thermal stability and ability to withstand multiple autoclave cycles.
Materials of Construction
| Membrane: | Polytetrafluoroethylene (PTFE) |
| 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 Cycle: | 100 autoclave cycles @125°C, 90 autoclave cycles @135°C |
Bubble Point
| 0.22µm: | ≥ 1380 mbar (20 psi) (with 70% IPA) |
| 0.45µm: | ≥ 690 mbar (10 psi) (with 70% IPA) |
Max Air Diffusion Flow (for 10″ Capsule):
| 0.22µm: | ≤ 40 mL/min @ 1104 mbar (16 psi) (with 70% IPA) |
| 0.45µm: | ≤ 40 mL/min @ 552 mbar (8 psi) (with 70% IPA) |
Microbial Retention
| 0.22µm: | LRV > 7 for Brevundimonas Diminuta |
| 0.45µm: | LRV > 7 for Serratia marcescens |
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. |
| 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 |
| Food contact material: | (EU) No. 1935/2004, (EU) No. 10/2011 |
| 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.
