ClariSure® GK Mini
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 | |||
| Filter Membrane | Hydrophilic PES | ||
| Prefilter Membrane | Microglassfiber | ||
| Support Layers | Polyester | ||
| Body and Core | Polypropylene | ||
| Size | |||
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| 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 | ||
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*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:
| CGKX | 50 | 04 | E0 | SS | 1 | 01 |
Example for Non Sterile: CGKX5004E0SS101
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