PVDF Capsule Filters
The PoreCap® series of PVDF (Polyvinylidene Fluoride) capsule filters are ready-to-use sterile grade filtration devices that offer low protein binding.
Assembled with our advanced PVDF Membrane technology, these filters are best suited for filtration of valuable protein solutions such as vaccines, antibodies, plasma products and hormonal injectables.
Manufactured in-house in ISO Class 8 cleanrooms, these devices incorporate highly efficient sterilizing grade PVDF Membranes safely placed inside a Polypropelene housing.
Crafted with precision & expertise, the PoreCap® PVDF capsule filters are easy to install & use as they eliminate the need to clean and validate the stainless-steel housing separately.
Membrane Characteristics: The PoreCap® PVDF Capsule filters incorporate filters incorporate hydrophilic PVDF membrane that offer high flow rates, a high number of sterilization cycles, and ultra-low protein binding.
Materials of Construction
| Membrane: | Polyvinylidene fluoride |
| 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 |
| Autoclavable: | 25 autoclave cycles @125°C |
Bubble Point
| 0.22µm: | ≥ 3447 mbar (50 psi) (with water wetted) |
| 0.45µm: | ≥ 2069 mbar (30 psi) (with water wetted) |
Max Air Diffusion Flow (for 10″ Capsule)
| 0.22µm: | ≤ 20 mL/min @ 2482 mbar (36 psi) (with water wetted) |
| 0.45µm: | ≤ 20 mL/min @ 1517 mbar (22 psi) (with water wetted) |
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 |
| 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. |
| 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.
