ClariSure® PA Standard
MDI ClariSure® PA mini cartridge filters are 100% polypropylene, very high retention efficiency pleated cartridge filters offering large filtration area.
These filters have heat stable construction and are used as pre-filters to sterilizing membrane cartridge filters.
| 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 |
- Pre-filtration of fermentor air
- Pre-filtration of small volume parenterals
| Construction | |||||
| Pore size | 0.2μm, 0.5μm, 1μm, 1.2μm, 2.5μm, 5μm, 8μm, 10μm | ||||
| Filter Media | Polypropylene | ||||
| Support Layers | Polypropylene | ||||
| Body and Core | Polypropylene | ||||
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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, 100 cycles | ||||
| Assurance | |||||
| Toxicity | Passes Bioreactivity test, In Vivo, as per USP <88> 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 :
| CPPA | 56 | 05 | A0 | SS | 1 | 01 |
Example for Non Sterile: CPPA5605A0SS101
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