ClariSure® GP Mini
MDI ClariSure® GP Mini cartridge filters are specially designed multilayered precision filtration devices. These cartridge filters act as throughput enhancers, specially in case of difficult to filter solutions.
A microglassfiber upstream layer retains very fine colloidal particles and a downstream polypropylene layer checks any kind of media migration.
Consistent and Reliable Quality: | ClariSure® GP 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 |
High Throughputs: | Translates to lower filtration costs, less number of filter changes and overall economy of operations. |
Total Traceability | Unique identification number is laser etched on each other. |
- Pre-filtration of difficult to filter solutions
- Pre-filtration of difficult to filter SVP like Oxytetracycline
Construction | |||
Pore size | 0.5µm, 1µm, 2µm | ||
Filter Media | Microglassfiber | ||
Support Layers | Polypropylene | ||
Body and Core | Polypropylene | ||
Size | |||
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Operational | |||
Max. Operating Temperature | 80 °C @ < 30 psi (2 Kg/cm²) | ||
Max. Differential Pressure | 50 psi (3.5 Kg/cm²) @ 25 °C | ||
Sterilization | Autoclavable/In-line Steam Sterilizable at 121°C for 30 minutes, 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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*G0 adapter code is not available with any elastomer. Please mention XX in place of elastomer code while ordering
**Adapter code F0 is available only in 5” cartridge filters
Example:
CPGP | 50 | 05 | E0 | SS | 1 | 01 |
Example for Non Sterile: CPGP5005E0SS101
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