| Construction |
| Pore size |
0.2µm |
| Media |
Polyethersulfone Membrane |
| Diameter |
7mm |
| Outer Tube Length |
42.8mm |
| Inner Tube Length |
21.5mm |
| Housing |
Polypropylene |
Operational |
| Operating Temperature Range |
80°C max |
| Maximum Sample Volume |
750µl |
| Receiver Volume |
750µl |
| Effective Filtration Area (EFA) |
0.28 cm² |
| Hold-up Volume |
< 5 µl |
| Maximum Centrifugal Force |
5600 x g @ 10,000 rpm |
| pH Range |
2-14 |
Assurance |
| Non Fiber Releasing |
Passes test as per USP and comply with USFDA 21 CFR Part 211.72 for fiber release |
| 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 |
| CE Certification |
Comply with the requirements of Medical Device Directive, 93/42/95 (MDD) for Medical Device Class-1 |
| USFDA |
DMF Type V No. 15554 |