| Construction |
| Pore size |
0.2μm, 0.45μm, 0.8μm, 1.2µm, 5µm |
| Membrane |
Cellulose Nitrate Membrane Disc Filters |
| Size |
13mm, 25mm, 47mm |
Operational |
| Bubble Point |
0.2μm |
> 50psi (3.52Kg/cm²) with water |
| 0.45μm |
> 32psi (2.25Kg/cm²) with water |
| Water Flow Rate |
0.2μm |
> 20ml/min/cm² @ 0.70 Kg/cm² @ 27 °C |
| 0.45μm |
> 45ml/min/cm² @ 0.70 Kg/cm² @ 27 °C |
| 0.8μm |
> 200ml/min/cm² @ 0.70 Kg/cm² @ 27 °C |
| Retention Efficiency |
0.2μm |
LRV > 7 for Br. diminuta |
| 0.45μm |
LRV > 7 for Sr. marcescens |
| Sterilization |
CN |
Autoclavable at 121°C for 30 minutes |
| CN-S |
Pre-sterilized with EO |
| Maximum Operating Pressure |
5Kg/cm² |
Maximum Operating Temperature |
80°C continuous flow with water |
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 |
| 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 |
