AseptiSure® KR Standard
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.
- Low protein binding
- High throughputs
- Long service life
- Pre-flushed to minimize particulate release after installation
- Non-toxic material of construction
- Multiple autoclavable/SIP
- Absolute retention
- 100% integrity tested
- High flow rates
- Bioburden maintained below 1000 cfu/device
- Endotoxin level certified to be <0.25 EU/ml
- Unique identification number is laser etched on each filter
- Individual certificate of quality for each device
- Sterilizable by Autoclaving/Steaming in place (SIP)
- For sterile filtration of alkaline fluid streams such as pH adjusters for microbial fermentation processes.
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| Membrane | Hydrophilic PES | ||||
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| Support Layers | Polypropylene | ||||
| Body and Core | Polypropylene | ||||
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| 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 | ||||
| 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 | ||||
| Typical Water Flow Rates (10″ Cartridge filters) |
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*FV is available in Adapter code A0 (7P) adapter and A1 (7P without fin) only
**Size 5″ is available in Adapter code A0 (7P) and A1 (7P without fin) only
Example :
| CPKR | 53 | 01 | A0 | SS | 1 | 01 |
Example for Non Sterile: CPKR5401A0SS101
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