| Construction |
| Pore size |
0.2µm, 0.45µm |
| Membrane |
Nylon- 66 |
| Size |
1" |
2" |
5" |
8" |
| EFA (Effective Filtration Area) |
260cm² |
900cm² |
1800cm² |
2700cm² |
| Support Layers |
Polyester |
| Body and Core |
Polypropylene |
| Vent and Drain |
1/4" Hose Barb with double Silicone "O" rings |
Operational |
| Max. Operating Temperature |
80 °C @ < 30 psi (2 Kg/cm²) |
| Max. Differential Pressure |
60 psi (4 Kg/cm²) @ 30 °C |
| Bubble Point |
0.2μm |
> 15psi (1.05Kg/cm²) with 50% IPA Wetted |
| 0.45μm |
> 10psi (0.7Kg/cm²) with 50% IPA Wetted |
| Sterilization |
Autoclavable at 121°C for 30minute |
Assurance |
| Toxicity |
Passes Bioreactivity test, In Vivo, as per USP for Class VI plastics |
| Cytotoxicity |
Passes Biological Reactivity Tests, in vitro, USP <87> for cytotoxicity |
| Bacterial Retention |
LRV> 7 for B. diminuta per cm² of filter area as per ASTM F 838-05 |
| Bacterial Endotoxin |
Aqueous extracts exhibit < 0.25 EU/ml as established by Limulus Amebocyte Lysate (LAL) Test |
| Non Fiber Releasing |
Passes test as per USP and comply with USFDA 21 CFR Part 211.72 for fiber release |
| pH Compatibility |
Compatible with pH range of 1 - 10 |
| Extractables with WFI |
Passes test as per USP |
| Fractional Dissolution |
Comply with USFDA 21 CFR Part 177.1520 |
| Oxidizable Substances |
Within limits as specified in USP |
| Quality Management System |
ISO-9001:2008 Certified |
| USFDA |
DMF Type V No. 15554 |
