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
|
Total Traceability
| Unique identification number is laser etched on each other.
|
- 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 |
| Prefilter Membrane |
Microglassfiber |
| Support Layers |
Polyester |
| Body and Core |
Polypropylene |
| Size |
| Size |
|
| Effective Filtration Area |
|
| Materials of Construction |
| Filter Membrane |
Hydrophilic PES |
| 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 |
| Cytotoxicity |
Passes Biological Reactivity Tests, In Vitro, USP <87> for cytotoxicity |
| 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 |
| Type | ClariSure® GK Mini
| CGKX | | | Size | | Size | Code | | 2.5" | 50 | | 5" | 53 | | | Pore Size | | Pore Size | Code | | 0.1µm | 36 | | 0.2µm | 01 | | 0.5µm | 04 | | | 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: CGKX5004E0SS101
