0.1µm AseptiSure® KS Standard
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
- 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)
- Sterile Filtration of Culture media for mammalian cell culture
| Construction | |||||
| Membrane | Hydrophilic PES | ||||
| Final Filter Pore Size | 0.1µm | ||||
| Prefilter Pore Size | 0.2 µm 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 | ||||
| Air Diffusion Flow (10″) | < 29ml/min @ 50 psi (3.51 Kg/cm²) with Water | ||||
| 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) | 22 lpm @ 0.70 Kg/cm² @ 27 °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 211.72 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
Example :
| CPKX | 53 | 36 | E0 | SS | 1 | 01 |
Example for Non Sterile: CPKX5336E0SS101
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