AseptiSure® KS Mini
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. |
- Sterile liquid filtration
- Filtration of proteinaceous liquid where minimum protein loss is desired, such as sera, culture soups and recombination proteins, antibodies etc.
- Filtration of media, buffers etc.
- Water filtration
| Construction | |||
| Membrane | Hydrophilic PES | ||
| Final Filter Pore Size |
|
||
| Prefilter Pore Size |
|
||
| Support Layers | Polyester | ||
| Body and Core | Polypropylene | ||
| Size | |||
| Size |
|
||
| Effective Filtration Area (Nominal) |
|
||
| Integrity Testing / Retention | |||
| Bubble Point |
|
||
| Microbial Retention |
|
||
| 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 – 10 | ||
|
|
|
|
|
|
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
*0.45µm cartridge filters are available with 0.65µm or 0.8µm upstream layer only
**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 :
| CPKX | 50 | 01 | E0 | SS | 1 | 01 |
Example for Non Sterile: CPKX5001E0SS101
Have questions or need assistance?
Our team is here to help! Contact us today, and we’ll get back to you as soon as possible.