| Construction |
| Pore size |
0.2µm, 0.45µm |
| Membrane |
Hydrophobic PTFE |
| Length |
5" |
10" |
20" |
30" |
| EFA (Effective Filtration Area) |
2000cm² |
6000cm² |
12000cm² |
18000cm² |
| Support Layers |
Polypropylene |
Operational |
| Max. Operating Temperature |
80 °C @ < 30 psi (< 2 Kg/cm²) |
| Max. Differential Pressure |
50 psi (3.5 Kg/cm²) @ 25 °C |
Bubble Point
(70% IPA Wetted) |
0.2μm |
22psi (1.54Kg/cm²) |
Air Diffusion Flow Rate
For 10" Cartridge filters (70% IPA Wetted)
|
0.2μm |
<45ml/min @ 16psi (1.12Kg/cm²) |
| 0.45μm |
<45ml/min @ 8psi (0.56Kg/cm²) |
| Sterilization |
Autoclavable at 121°C for 30minute, 100 Cycles. |
Assurance |
| Toxicity |
Passes Bioreactivity test, In Vivo, as per USP for Class VI plastics |
| Bacterial Retention |
LRV> 7 for B. diminuta per cm² of filter area as per ASTM F 838-05 |
| Bacterial Endotoxin |
Aqueous extracts exhibit < 0.25 EU/ml as established by Limulus Amebocyte Lysate (LAL) Test |
| Non Fiber Releasing |
Passes test as per USP and comply with USFDA 21 CFR Part 211.72 for fiber release |
| pH Compatibility |
Compatible with pH range of 1 - 14 |
| 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 |
