ClariSure® GK Standard
MDI ClariSure® GK hydrophilic PES membrane mini cartridge filters offer a microglassfiber upstream layer with a PES membrane final filter to combine high dirt holding capacities with efficient retention of colloidal particles to give clear downstream in case of difficult to filter turbid solutions.
- Low protein binding
- High throughputs
- Long service life
- Pre-flushed to minimize particulate release after installation
- Non-toxic material of construction
- Multiple autoclavable/SIP
- Absolute retention
- 100% integrity tested
- High flow rates
- Bioburden maintained below 1000 cfu/device
- Endotoxin level certified to be <0.25 EU/ml
- Unique identification number is laser etched on each filter
- Individual certificate of quality for each device
- Sterilizable by Autoclaving/Steaming in place (SIP)
- 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 | |||||
| Final Filter Membrane | Hydrophilic PES | ||||
| Prefilter Membrane | Microglassfiber | ||||
| Support Layers | Polyester | ||||
| Body and Core | Polypropylene | ||||
| Size | |||||
| Size |
|
||||
| Effective Filtration Area (Nominal) |
|
||||
| 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 | ||||
| Oxidizable Substances | Passes test as per USP <1231> | ||||
| Particle Shedding | The filtrate complies with USP <788> test for particulate matter in injections | ||||
| Quality Management System | ISO-9001 Certified | ||||
| USFDA | DMF No. 015554 | ||||
|
|
|
|
|
|
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
*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 :
| CGKX | 56 | 04 | A0 | SS | 1 | 01 |
Example for Non Sterile: CGKX5604A0SS101
Have questions or need assistance?
Our team is here to help! Contact us today, and we’ll get back to you as soon as possible.