ClariPro® GK-γ Inline
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 throughput
- 100% integrity tested
- Low protein binding
- High flow rates
- Biologically Inert
- Easy Installation
- Bioburden maintained below 1000 cfu/device
- Endotoxin level certified to be <0.25 EU/ml
- Widest range of end connections
- Products available for total scalability from a few ml to thousands of liters
- Total traceability through unique serial number for each filter
- Individual certificate of quality for each device
- Sterilizable by Autoclaving or Ethylene Oxide
- 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 | |||
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| Max. Differential Pressure |
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| 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 as per USP <85> | ||
| 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 | Passes test as per USP <1231> | ||
| 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 |
a: Gamma sterilized filters cannot be gamma irradiated again
*Female Luer Lock is available as Inlet only
**Male Luer Slip is available as Outlet only
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 |
a: Gamma sterilized filters cannot be gamma irradiated again
*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
Example for Non Sterile: VGKX1004BBRX102 Example for Gamma Sterile: VGKX1004BBXX302
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