| Construction |
| Pore size |
0.2µm, 0.45µm |
| Media |
Polyethersulfone (PES) Membrane |
| Prefilter Membrane |
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 |
0.8 cm² |
4.15 cm² |
| Bubble Point |
0.2 µm |
> 50 psi (> 3.52 Kg/cm2) |
| 0.45 µm |
> 32 psi (> 2.25 Kg/cm2) |
| Hold-up Volume(with air purge) |
<20µl |
<50µl |
| Sterilization |
By Gas |
Sterilizable by Ethylene Oxide |
| Sample Volume |
< 10 ml |
< 100 ml |
| Retention Efficiency |
0.2µm |
LRV >7 for Br. diminuta per cm² of filter area |
| 0.45µm |
LRV >7 for Sr. marcescens per cm² of filter area |
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 |
