cartridge filters, filters
Consistent and Reliable Quality:
| ClariSure® cartridge filters are produced with ISO 9001-2008 certified quality management systems.
|
Regulatory Compliance:
| Meet all pharmacopeial and compendia requirements and are registered with USFDA DMF #015554
|
|
- Pre-filtration of fermentor air
- Pre-filtration of small volume parenterals
| Construction |
| Pore size |
0.2μm, 0.5μm, 1μm, 1.2μm, 2.5μm, 5μm, 8μm, 10μm |
| Filter Media |
Polypropylene |
| Support Layers |
Polypropylene |
| Body and Core |
Polypropylene |
| Size |
| Size |
|
| Effective Filtration Area |
|
| Operational |
| Max. Operating Temperature |
80 °C @ < 30 psi (2 Kg/cm²) |
| Max. Differential Pressure |
50 psi (3.5 Kg/cm²) @ 25 °C |
| Sterilization |
Autoclavable/In-line steam sterilizable at 121 °C for 30 minutes, 100 cycles |
| Assurance |
| Toxicity |
Passes Bioreactivity test, In Vivo, as per USP <88> for Class VI plastics |
| Non Fiber Releasing |
Passes test as per USP and comply with USFDA 21 CFR Part 210.3(b)(6) for fiber release |
| Indirect Food Additive |
All Polypropylene components meet the FDA Indirect Food Additive requirements cited in 21 CFR 177.1520 |
| Extractables with WFI |
Passes test as per USP |
| Good Manufacturing Practice |
These products are manufactured in a facility which adheres to Good Manufacturing Practices. |
| Oxidizable Substances |
Within limits as specified in USP |
| Particle Shedding |
Passes USP test for particulates in injectables |
| Quality Management System |
ISO-9001 Certified |
| USFDA |
DMF No. 015554 |
| | | Size | Length
| Code | | 2.5" | 50 | | 5" | 53 | | | Pore Size | | Pore Size | Code | | 0.2µm | 01 | | 0.5µm | 04 | | 1µm | 05 | | 1.2µm | 10 | | 2.5µm | 06 | | 5µm | 07 | | 8µm | 17 | | 10µm | 08 | | | Adapter | | Code | | 4463 | E0 | | 4463B | H0 | | 4440 | U0 | Seal-K
| G0* | Seal-O
| F0** | Seal-M
| J0 | | | Elastomer | | Code | | Silicone | SS | | | Sterility | | Code | | Non Sterile | 1 | | | Pack Size | | Pack Size | Code | | 1 | 01 | |
*G0 adapter code is not available with any elastomer. Please mention XX in place of elastomer code while ordering
**Adapter code F0 is available only in 5” cartridge filters
Example :
Example for Non Sterile: CPPA5005U0SS101
