| Construction |
| Pore size |
0.2µm, 0.45µm |
| Membrane |
PTFE Membrane |
| Prefilter Membrane |
Multilayered Borosilicate Microglassfiber |
| Diameter |
13mm |
25mm |
| Inlet |
Female luer-lock |
| Outlet |
Male luer slip |
| Housing |
Polypropylene
|
Operational |
| Max. Operating Temperature |
55 °C |
| Max. Differential Pressure |
75 psi @ 25° C |
| Effective Filtration Area (EFA) |
0.8 cm² |
4.15 cm² |
| Hold-up Volume(with air purge) |
<20µl |
<50µl |
| Sample Volume |
< 10 ml |
< 100 ml |
Clean Water Flow Rate @ 20 psi
|
0.2µm |
> 10 ml/min |
> 50 ml/min |
| 0.45µm |
> 20 ml/min |
> 100 ml/min |
| 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 |
