0.1µm AseptiSure® KS Mini
MDI Aseptisure® KS 0.1µm double layer PES membrane mini cartridge filters are validated for mycoplasma removal and are used for sterile media filtration in mammalian cell culture.
The upstream PES membrane layer protects the downstream PES membrane layer from premature clogging. The membrane pore structure is specially designed to give high throughputs, thus resulting in better economics
| 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 Filtration of Culture media for mammalian cell culture
| Construction | |||
| Membrane | Hydrophilic PES | ||
| Final Filter Pore Size | 0.1µm | ||
| Prefilter Pore Size | 0.2µm or 0.45 µm | ||
| 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 | > 26 psi (1.82 Kg/cm²) with 50% IPA
> 65 psi (4.56 Kg/cm²) with Water |
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| Microbial Retention | LRV >7 for Acholeplasma laidlawii (ATCC 23206) per cm² | ||
| 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 | ||
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*G0 adapter code is not available with any elastomer. Pleasemention XX in place of elastomer code while ordering
**Adapter code F0 is available only in 5” cartridge filters
Example :
| CPKX | 53 | 36 | E0 | SS | 1 | 01 |
Example for Non Sterile: CPKX5336E0SS101
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