ClariSure® GS Standard
MDI ClariSure® GS mini cartridge filters are multilayered, high throughput filters, specially designed for difficult to filter solutions.
It is a very high efficiency pre-filter combining the unique abilities of microglassfiber filter media to retain colloidal particles and heat calendered polypropylene filter media to ensure non media migration.
| Consistent and Reliable Quality: | ClariSure cartridge filters are produced with ISO 9001-2008 certified quality management systems. |
| Regulatory Compliance: | Meet all pharmacopeial and compendia requirements and are registered with USFDA DMF #015554 |
- 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 protein Solutions
- Pre-filtration of high value difficult to filter drug solutions
- Polishing of turbid solutions
| Construction | |||||
| Pore size | 0.7µm, 1µm | ||||
| Filter Media | Microglassfiber | ||||
| Body and Core | Polypropylene | ||||
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| Max. Operating Temperature | 80 °C @ < 30 psi (2 Kg/cm²) | ||||
| Max. Differential Pressure | 50 psi (3.5 Kg/cm²) @ 30 °C | ||||
| Sterilization | Autoclavable/In-line steam sterilizable at 121 °C for 30minutes, 30 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 | ||||
| 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 injectables | ||||
| Quality Management System | ISO-9001 Certified | ||||
| USFDA | DMF No. 015554 | ||||
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* FV is available in Adapter Code A0 (7P) and A1 (7P without fin) only
**Size 5″ is available in Adapter Code A0 (7P) and A1 (7P without fin) only
Example :
| CPGS | 56 | 41 | A0 | SS | 1 | 01 |
Example for Non Sterile: CPGS5641A0SS101
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