AseptiSure® KS Standard
MDI AseptiSure® KS PES membrane mini cartridge filters are serial filtration devices with a layer pore size upstream PES membrane layer to protect the downstream final PES membrane layer from premature clogging and to give enhanced throughputs, thus resulting in better economics.
MDI Aseptisure® KS filters are validated for key performance parameters such as retention efficiency, chemical compatibility, extractables, heat stability and flow rates. These are available in a variety of pore sizes to suit specific microfiltration needs in critical and specialized process applications.
| 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 and higher throughputs with biological streams. |
| High Throughputs: | Translates to lower filtration costs, less number of filter changes and overall economy of operations. |
| Low Extractables: | Means less addition to impurity profile of the biological product from the filters. |
- Bioburden reduction from cell harvest supernatants
- Filtration of equilibrating, washing and elution buffers for chromatography columns
- Sterilization of buffers
- Sterilization of adjuvants
- Sterilization of Large Volume Parenterals
- Sterile filtration of WFI
| Construction | |||||
| Membrane | Hydrophilic PES | ||||
| Final Filter Pore Size |
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| Support Layers | Polyester | ||||
| Body and Core | Polypropylene | ||||
| Size | |||||
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| Effective Filtration Area (Nominal) |
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| Integrity Testing / Retention | |||||
| Bubble Point |
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| Microbial Retention |
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| Air Diffusion Flow (10″) |
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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 | ||||
| Typical Water Flow Rates (10″ Cartridge filters) |
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| 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 – 10 | ||||
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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
***0.45µm Cartridge filters are available with 0.65µm or 0.8µm upstream layer only
Example :
| CPK5 | 53 | 01 | A0 | SS | 1 | 01 |
Example for Non Sterile: CPK55301A0SS101
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