| CGKX5304A0SS101 |
| CGKX5401A0SS101 |
| CGKX5404A0SS101 |
| CGKX5504A0SS101 |
| CGKX5601A0SS101 |
| CGKX5604A0SS101 |
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 high value difficult to filter drug solutions
- Polishing of turbid solutions
| Construction |
| Pore size |
0.1μm, 0.2μm, 0.5μm |
| Final Filter Membrane |
Hydrophilic PES |
| Prefilter Membrane |
Microglassfiber |
| Support Layers |
Polyester |
| Body and Core |
Polypropylene |
| Size |
| Size |
|
| Effective Filtration Area (Nominal) |
| 2500cm² | 5000cm² | 10000cm² | 15000cm² |
|
| 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 30minutes, 25 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 | | 0.1µm | 36 | | 0.2µm | 01 | | 0.5µm | 04 | | | 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: CGKX5604A0SS101
