ClariPro® GK Inline
MDI ClariPro® GK are lab scale hydrophilic PES membrane capsule filters are ready to use, disposable filtration devices. These are specially designed filters incorporating a microglass fiber upstream layer and a downstream PES membrane final layer and are used as pre-filters in biopharmaceutical process development laboratories for difficult to filter solutions.The microglass fiber layer offers high dirt holding capacity and efficient retention of colloidal particles to give clear downstream in case of difficult to filter turbid solutions. The downstream PES membrane offers absolute retention, and low protein binding along with high flow rates.
- High Flow Rates
- High Throughput
- Very High Retention
- Low Protein Binding
- Compact Design
- Precipitate removal post viral inactivation
- Pre-filtration of serum solutions
- Clarification of cell harvest supernatants
- Polishing of turbid solutions
| Construction | |||
| Membrane | Hydrophilic PES | ||
| Pore size | 0.1µm, 0.2µm, 0.5µm | ||
| Prefilter Membrane | Microglassfiber | ||
| Support Layers | Polyester | ||
| Body and Core | Polypropylene | ||
| Size | |||
| Size |
|
||
| Effective Filtration Area (Nominal) |
|
||
| Operational | |||
| Max. Operating Temperature |
|
||
| Max. Differential Pressure |
|
||
| Burst Pressure | >8 Kg/cm² | ||
| Sterilization By Gas | Sterilizable by Ethylene Oxide | ||
| Sterilization By Autoclave | Autoclavable at 125°C for 30minutes, 25 cycle and it cannot be In-line steam sterilized | ||
| Shelf Life | 3 years after EO sterilization | ||
| Assurance | |||
| Toxicity | Passes Bioreactivity test, In Vivo, as per USP <88> for Class VI plastics | ||
| Bacterial Endotoxin | Aqueous extracts exhibit < 0.25 EU/ml as established by Limulus Amebocyte Lysate (LAL) Test | ||
| Bioburden | Bioburden level is < 1000 cfu/filter device as per ISO 11737-1 : 2018 | ||
| Non Fiber Releasing | Passes test as per USP and comply with USFDA 21 CFR Part 210.3 (b)(6) for fiber release | ||
| Particle Release | The filtrate complies with USP <788> test for particulate matter in injections | ||
| Indirect Food Additive | All Polypropylene components meet the FDA Indirect Food Additive requirements cited in 21 CFR 177.1520 | ||
| Good Manufacturing Practice | These products are manufactured in a facility which adheres to Good Manufacturing Practices | ||
| Oxidizable Substances | Within limits as specified in USP | ||
| Quality Management System | ISO-9001 Certified | ||
| USFDA | DMF No. 015554 | ||
ClariPro® GK- 25mm
|
|
|
|
|
|
|
|
||||||||||||||||||||||||||||||||||||||||||||||||||
Example :
| IGKX | 06 | 04 | MN | X | X | 1 | 04 |
Example for Non Sterile: IGKX0604MNXX104 Example for EO Sterile: IGKX0604MNXX204
ClariPro® GK- 50mm
|
|
|
|
|
|
|
|
||||||||||||||||||||||||||||||||||||||||||||||||||||
*¼” Stepped Hose Barb and ¾” Sanitary Flange are available in filters with vent only
**¼” Single Step Hose Barb and Female luer lock is available in filters without vent only
| VGKX | 10 | 04 | BB | X | X | 1 | 02 |
Example for Non Sterile: VGKX1004BBXX102 Example for EO Sterile: VGKX1004BBXX202
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.