AseptiSure® KR Mini
MDI AseptiSure® KR mini cartridge filters incorporate a low protein binding PES membrane with polypropylene drainage layers to ensure pH compatibility from 1-14 making these ideal for alkaline fluid streams.
| Consistent and Reliable Quality: | AseptiSure® 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 |
| Low Protein Binding: | Results in increased overall product yield with biological streams. |
| High Throughputs: | Translates to lower filtration costs, less number of filter changes and overall economy of operations. |
| Low Extractables: | mean less addition to impurity profile of the biological product from the filters. |
- For sterile filtration of alkaline fluid streams such as pH adjusters for microbial fermentation processes.
| Construction | |||
| Membrane | Hydrophilic PES | ||
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| Support Layers | Polypropylene | ||
| Body and Core | Polypropylene | ||
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| Operational | |||
| Max. Operating Temperature | 80 °C @ < 2 Kg/cm² (30 psi) | ||
| Max. Differential Pressure | < 3.5 Kg/cm² (50 psi) @ 25 °C | ||
| Reverse Pressure | < 0.7 Kg/cm² (10 psi) @ 25 °C | ||
| Sterilization | Autoclavable/In-line steam sterilizable at 121 ° C for 30 minutes, 25 cycles | ||
| Assurance | |||
| Toxicity | Passes Bioreactivity test, In Vivo, as per USP <88> for Class VI plastics | ||
| Cytotoxicity | Passes Biological Reactivity Tests, In Vitro, USP <87> for cytotoxicity | ||
| 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 | ||
| 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. | ||
| TOC/Conductivity at 25 °C | Meets the WFI requirements of USP <643> for Total Organic Carbon and USP <645> for Water Conductivity after a specified volume of purified water flush | ||
| Quality Management System | ISO-9001 Certified | ||
| USFDA | DMF No. 015554 | ||
| pH Compatibility | Compatible with pH range of 1 – 14 | ||
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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 :
| CPKR | 53 | 01 | H0 | SS | 1 | 01 |
Example for Non Sterile: CPKR5301H0SS101
| File Type | Download |
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| Datasheet | Download |
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