| Pore size |
0.7µm, 1µm, 1.5µm, 2µm |
| Filter Media |
Multilayered Microglassfiber |
| Body and Core |
Polypropylene |
| Size |
| Length |
|
| Dimension (End to End) – ¾” Sanitary Flange I/O |
|
| Dimension (End to End) – 1½” Sanitary Flange I/O |
| 205 mm |
330 mm |
600 mm |
855 mm |
|
| Dimension (End to End) – ½” Single Step Hose Barb |
| 218 mm |
336 mm |
630 mm |
890 mm |
|
| Dimensions (End to End) Inline Capsule Filters – 1½” Sanitary Flange Inlet ½” Single Step Hose Barb Outlet |
| 212 mm |
334 mm |
620 mm |
870 mm |
|
| Dimension (End to End) – 1″ Hose Barb I/O |
|
| Operational |
| Operational Radius (with Vent/ Drain) |
|
| Dimension (End to End) – 3/8″ Hose Barb I/O |
| 211 mm |
332 mm |
634 mm |
885 mm |
|
| Vent and Drain |
¼” Hose Barb with Silicone “O” ring |
| Max. Operating Temperature |
80 °C @ < 30 psi (2 Kg/cm²) |
| Max. Differential Pressure |
60 psi (4 Kg/cm²) @ 30 °C |
| Sterilization By Gas |
Sterilizable by Ethylene Oxide |
| Sterilization By Autoclave |
Autoclavable at 125 °C for 30 minutes, 30 cycles and it cannot be inline steam sterilized |
| Assurance |
| Shelf Life |
3 years after EO Sterilization |
| Toxicity |
Passes Biological Reactivity tests, In Vivo, as per USP <88> for Class VI plastics |
| Bacterial Endotoxin |
Aqueous extracts exhibit < 0.25 EU/ml as established by Limulus Amebocyte Lysate (LAL) Test as per USP <85> |
| Bioburden |
Bioburden level is < 1000 cfu/filter device as per ISO 11737-1 : 2018 |
| Non Fiber Releasing |
Passes test as per USP and comply with USFDA 21 CFR Part 210.3(b)(6) for fiber release |
| Particle Release |
The filtrate complies with USP <788> test for particulate matter in injections |
| Indirect Food Additive |
All Polypropylene components meet the FDA Indirect Food Additive requirements cited in 21 CFR 177.1520 |
| Extractables with WFI |
Passes NVR test as per USP <661> |
| Good Manufacturing Practice |
These products are manufactured in a facility which adheres to Good Manufacturing Practices. |
| Oxidizable Substances |
Within limits as specified in USP <1231> |
| Quality Management System |
ISO-9001 Certified |
| USFDA |
DMF No. 015554 |