ClariPro® GK-γ 25mm, 50mm
mdi ClariPro® GK- γ gamma sterilizable hydrophilic PES membrane capsule filters are ready to use, disposable filtration devices. These filters are specially designed filters incorporating a microglassfiber upstream layer and a downstream PES membrane layer and are used as pre- filters in biopharmaceutical process development laboratories for difficult to filter solutions.
- 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 |
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| Effective Filtration Area (Nominal) |
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| Dimension (End to End) - ¾" Sanitary Flange I/O |
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| Dimension (End to End) - ¼" SHB |
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| Dimension (End to End) - Female Luer Lock Inlet/ Male Luer Slip Outlet |
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| Operational Radius (with Vent/ Drain) |
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| Operational | |||
| Max. Operating Temperature |
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| Max. Differential Pressure |
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| Burst Pressure | >8 Kg/cm² | ||
| Sterilization By Autoclave | Autoclavable at 125°C for 30minutes, 1 cycle after gamma irradiation and it cannot be in-line steam sterilized | ||
| Sterilization By Irradiation | Gamma Irradiatable up to 50 kGy | ||
| Shelf Life | 2 years after Gamma 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-γ 25mm
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Example :
| IGKX | 06 | 04 | MN | R | X | 1 | 04 |
Example for Non Sterile: IGKX0604MNRX104 Example for Gamma Sterile: IGKX0604MNXX304
ClariPro® GK-γ 50mm
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Example :
| VGKX | 10 | 04 | BB | X | X | 1 | 02 |
*Gamma sterilized filters cannot be gamma irradiated again
**¼" Stepped Hose Barb and ¾" Sanitary Flange are available in filters with vent only
***Female luer lock is available in filters without vent only
Example for Non Sterile: VGKX1004BBRX102 Example for Gamma Sterile: VGKX1004BBXX302
| Datasheet | Download |