ClariCap® PP Small
MDI ClariCap® PP polypropylene capsule filters type ClariCap® PP have been designed for particle removal applications in liquids and air/gases. These are suitable for use in pharmaceutical and biopharmaceutical prefiltration applications.
The pleated polypropylene filtration media and all polypropylene polymer housing has high heat resistance and exhibits very wide chemical compatibility. These offer high retention efficiency thereby enhancing the performance (life and efficiency) of terminal sterilization filters.
MDI ClariCap® PP capsule filters offer ease of use because of negligible assembly time as compared to standard stainless steel filtration housing assemblies. These do away with the requirement of cleaning and validation of conventional filtration housing assemblies.
| Consistent and Reliable Quality: | ClariCap® capsule filters are produced with ISO 9001 certified quality management systems. |
| Regulatory Compliance: | Meet all pharmacopeial and compendia requirements and are registered with USFDA DMF #015554 |
- Pre-filtration of high value drug solutions
- Pre-filtration of drug vehicles
- Pre-filtration of air to small fermentors
| Construction | |||||
| Membrane | Polypropylene | ||||
| Pore size | 0.5µm, 1µm, 2.5µm, 5µm, 10µm, 20µm | ||||
| Support Layers | Polypropylene | ||||
| Body and Core | Polypropylene | ||||
| Size | |||||
| Size |
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| Effective Filtration Area (Nominal) |
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| Dimension (End to End) – ½” Hose Barb I/O |
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| Dimension (End to End) – Quick Connector |
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| Dimension (End to End) – ¼” SHB |
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| Dimension (End to End) – ¾” Sanitary Flange I/O |
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| Dimension (End to End) – 1½” Sanitary Flange I/O |
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| Dimension (End to End) – ½” Single Step Hose Barb I/O |
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| Dimensions (End to End) Inline Capsule Filters – 1½” Sanitary Flange Inlet ½” Single Step Hose Barb Outlet |
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| Operational Radius (with Vent/ Drain) |
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| Vent and Drain | ¼” Hose Barb with double Silicone “O” rings for 2″, 5″ and 8″ only | ||||
| Operational | |||||
| Max. Operating Temperature | 80 °C @ < 30 psi (2 Kg/cm²) | ||||
| Max. Differential Pressure | < 60 psi (4 Kg/cm²) @ 30 °C | ||||
| Sterilization | Autoclavable at 125 °C for 30 minutes, 30 cycles and it cannot be inline steam sterilized | ||||
| Assurance | |||||
| Toxicity | Passes Bioreactivity test, In Vivo, as per USP for Class VI plastics | ||||
| 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 | ||||
| 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 | ||||
| Quality Management System | ISO-9001 Certified | ||||
| USFDA | DMF No. 015554 | ||||
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*1” Capsule Filters are not available with ½” Single step Hose Barb, ½” MNPT and 3/8″ Hose Barb
**Male luer slip is available only in 1” capsule filter as outlet
***3/16″ Hose Barb end connection is available in:
- 1″ and 2″ capsule filters as inlet and outlet
- 5″ capsule filters as outlet only
Example :
| DOLX | 53 | 04 | CC | X | X | 1 | 01 |
Example for Non Sterile: DOLX5304CCXX101
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