| CPGS5310A0SE101 |
| CPGS5310A0SR101 |
| CPGS5310A0SS101 |
| CPGS5310A0SV101 |
| CPGS5410A0SE101 |
| CPGS5410A0SR101 |
| CPGS5410A0SS101 |
| CPGS5410A0SV101 |
| CPGS5410B0SE101 |
| CPGS5410B0SR101 |
| CPGS5410B0SS101 |
| CPGS5410B0ST101 |
| CPGS5410B0SV101 |
| CPGS5410C0SE101 |
| CPGS5410C0SR101 |
| CPGS5410C0SS101 |
| CPGS5410C0SV101 |
| CPGS5410D0SE101 |
| CPGS5410D0SR101 |
| CPGS5410D0SS101 |
| CPGS5410D0SV101 |
| CPGS5441A0SS101 |
| CPGS5510A0SE101 |
| CPGS5510A0SR101 |
| CPGS5510A0SS101 |
| CPGS5510A0SV101 |
| CPGS5510B0SE101 |
| CPGS5510B0SR101 |
| CPGS5510B0SS101 |
| CPGS5510B0ST101 |
| CPGS5510B0SV101 |
| CPGS5510C0SE101 |
| CPGS5510C0SR101 |
| CPGS5510C0SS101 |
| CPGS5510C0SV101 |
| CPGS5510D0SE101 |
| CPGS5510D0SR101 |
| CPGS5510D0SS101 |
| CPGS5510D0SV101 |
| CPGS5541A0SS101 |
| CPGS5610A0SE101 |
| CPGS5610A0SR101 |
| CPGS5610A0SS101 |
| CPGS5610A0SV101 |
| CPGS5610B0SE101 |
| CPGS5610B0SR101 |
| CPGS5610B0SS101 |
| CPGS5610B0ST101 |
| CPGS5610B0SV101 |
| CPGS5610C0SE101 |
| CPGS5610C0SR101 |
| CPGS5610C0SS101 |
| CPGS5610C0SV101 |
| CPGS5610D0SE101 |
| CPGS5610D0SR101 |
| CPGS5610D0SS101 |
| CPGS5610D0SV101 |
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
|
- Precipitate removal post viral inactivation
- Pre-filtration of cell culture media
- Pre-filtration of serum and other viscous biologicals
- Pre-filtration of serum solutions
- Clarification of cell harvest supernatant
- Pre-filtration of protein Solutions
- Pre-filtration of high value difficult to filter drug solutions
- Polishing of turbid solutions
| Construction |
| Pore size |
0.7µm, 1µm |
| Filter Media |
Microglassfiber |
| Body and Core |
Polypropylene |
| Size |
| Size |
|
| Effective Filtration Area (Nominal) |
| 1700cm² |
3400cm² |
6800cm² |
10200cm² |
|
| Operational |
| Max. Operating Temperature |
80 °C @ < 30 psi (2 Kg/cm²) |
| Max. Differential Pressure |
50 psi (3.5 Kg/cm²) @ 30 °C |
| Sterilization |
Autoclavable/In-line steam sterilizable at 121 °C for 30minutes, 30 cycles |
| Assurance |
| Toxicity |
Passes Bioreactivity test, In Vivo, as per USP 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 | | Size | Code | | 5"** | 53 | | 10" | 54 | | 20" | 55 | | 30" | 56 | | | Pore Size | | Pore Size | Code | | 0.7µm | 41 | | 1µm | 05
| | | Adapter | | Code | | 7P | A0 | | 7P without fin | A1 | | 28 with fin | C0 | | 'O' | D0 | | | Elastomer | | Code | | Silicone | SS | | Viton | SV | | EPDM | SE | | FEP Encapsulated Viton | FV* | | | Sterility | | Code | | Non Sterile | 1 | | | Pack Size | | Pack Size | Code | | 1 | 01 | |
* FV is available in Adapter Code A0 (7P) and A1 (7P without fin) only
**Size 5" is available in Adapter Code A0 (7P) and A1 (7P without fin) only
Example :
Example for Non Sterile: CPGS5641A0SS101
