| Construction |
| Pore size |
0.2µm |
| Membrane |
0.2 μm Hydrophilic PES |
| Prefilter Membrane |
0.8 µm, 0.65µm or 0.45 μm Hydrophilic PES |
| Length |
5" |
10" |
20" |
30" |
| EFA (Effective Filtration Area) |
2000cm² |
5500cm² |
11000cm² |
16500cm² |
| Support Layers |
Polyester |
Operational |
| Max. Operating Temperature |
80 °C @ < 30 psi (< 2 Kg/cm²) |
| Max. Differential Pressure |
50 psi (3.5 Kg/cm²) @ 25 °C |
| Bubble Point |
> 50psi (3.52Kg/cm²) with Water |
| Air Diffusion Flow (10" Cartridge Filter) |
< 30ml/min @ 37 psi (2.6Kg/cm²) with Water |
| Sterilization |
Autoclavable/steam sterilization at 121°C for 30minute, 30 Cycles. |
Assurance |
| Toxicity |
Passes Bioreactivity test, In Vivo, as per USP for Class VI plastics |
| Cytotoxicity |
Passes Biological Reactivity Tests, in vitro, USP <87> for cytotoxicity |
| 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 - 10 |
| 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 |
