| Construction |
| Pore size |
0.2µm |
| Membrane |
0.2 µm Hydrophobic PVDF |
| Length |
1" |
2" |
5" |
8" |
| EFA (Effective Filtration Area) |
230cm² |
500cm² |
1000cm² |
2000cm² |
| Support Layers |
Polyester |
| Body and Core |
Gamma Stable Polypropylene |
Dimension
(End to End) |
1½" Sanitary Flange |
93 mm |
111 mm |
161 mm |
213 mm |
| Quick Connector |
101 mm |
121 mm |
167 mm |
218 mm |
| ¼" SHB |
94 mm |
121 mm |
173 mm |
231 mm |
| ½" HB |
91 mm |
113 mm |
164 mm |
215 mm |
| ¾" Sanitary Flange |
91 mm |
113 mm |
164 mm |
215 mm |
| Operational Radius (with Vent/ Drain) |
30 mm |
65 mm |
65 mm |
65 mm |
| Vent and Drain |
1/4" Hose Barb with double Silicone "O" rings |
Operational |
| Max. Operating Temperature |
80°C @ 2Kg/cm² (30 psi) |
| Max. Differential Pressure |
4 Kg/cm² (60 psi) @ 30° C |
Minimum Acceptable
Bubble Point with 60% IPA |
≥ 1.12 Kg/cm² (17 psi) |
| Sterilization |
By Irradiation |
Gamma Irradiatable up to 50 kGy |
| By Gas |
Sterilizable by Ethylene Oxide |
| By Autoclave |
Autoclavable at 121°C for 30minute, 3 Cycles. Can not be steam sterilized |
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 |
| 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 |
| USFDA |
DMF Type V No. 15554 |