ClariCap GS 25mm,50mm
mdi ClariCap GS lab scale capsule filters are ready to use, disposable filtration devices. These are specially designed filters incorporating a microglass fiber and a downstream Polypropylene membrane final layer and are used as pre-filters in biopharmaceuticals process development 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 Polypropylene layer prevents fiber release into the downstream.
- High Flow Rates
- High Throughput
- Very High Retention
- Compact Design
- Pre-filtration of cell culture media
- Pre-filtration of serum solutions
- Clarification of cell harvest supernatants
- Pre-filtration of protein solutions
- Pre-filtration of high value difficult to filter drug solutions
- Pre-filtration of difficult to filter small volume parenterals
- Polishing of turbid solutions
| Construction | |||
| Pore size | 0.7µm, 1µm, 1.5µm,2µm | ||
| Filter Media | Multilayered Microglassfiber | ||
| Downstream Layer | Polypropylene | ||
| Body and Core | Polypropylene | ||
| Size | |||
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| Operational | |||
| Max. Operating Temperature | 60 °C | ||
| Max. Differential Pressure | 3Kg/cm² (42 psi) @ 30 °C | ||
| Burst Pressure | >8Kg/cm² | ||
| Sterilization By Gas | Sterilizable by Ethylene Oxide | ||
| Sterilization By Autoclave | Autoclavable at 125°C for 30minutes, 30 cycles 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 | ||
| Particle Shedding | Passes USP test for particulates in injections | ||
| Quality Management System | ISO-9001 Certified | ||
| USFDA | DMF No. 015554 | ||
ClariCap GS- 25mm
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Example :
| IGKX | 06 | 05 | MN | X | X | 1 | 04 |
Example for Non Sterile: IGSX0605MNXX104 Example for EO Sterile: IGSX0605MNXX204
ClariCap GS- 50mm
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Example :
| VGSX | 10 | 05 | BB | X | X | 1 | 02 |