| Construction |
| Pore size |
0.2µm, 0.45µm |
| Media |
Hydrophilic PVDF Membrane |
| Prefilter Membrane |
Borosilicate Microglassfiber |
| Diameter |
13mm |
25mm |
| Inlet |
Female luer-lock |
| Outlet |
Male luer slip |
| Housing |
|
Operational |
| Max. Operating Temperature |
55 °C |
| Max. Differential Pressure |
75 psi @ 25° C |
| Effective Filtration Area |
0.8 cm² |
4.15 cm² |
Hold-up Volume(with air purge) |
< 20 µL |
< 50 µL |
Sample Volume |
< 10 ml |
< 100 ml |
Retention Efficiency |
0.2µm |
LRV >7 for Br. diminuta |
| 0.45µm |
LRV >7 for Sr. marcescens |
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 |