AseptiSure KS Mini 2.5", 5"
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.
- Ex Tax: $0.00
|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
|Final Filter Pore Size||
|Prefilter Pore Size||
|Body and Core||Polypropylene|
|Integrity Testing / Retention|
|Effective Filtration Area (Nominal)||
|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 ANSI/AAMI/ISO 11737-1 : 1995|
|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.