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.
- 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 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
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| Hydrophilic PES | ||||
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| Polyester | ||||
| Polypropylene | ||||
| Integrity Testing / Retention | ||||
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| 80 °C @ < 2 Kg/cm² (30 psi) | ||||
| 3.5 Kg/cm² (50 psi) @ 25 °C | ||||
| < 0.7 Kg/cm² (10 psi) @ 25 °C | ||||
| Autoclavable/In-line steam sterilizable at 121° C for 30 minutes, 25 cycles | ||||
| Passes Bioreactivity test, In Vivo, as per USP <88> for Class VI plastics | ||||
| Passes Biological Reactivity Tests, In Vitro, USP <87> for cytotoxicity | ||||
| Aqueous extracts exhibit < 0.25 EU/ml as established by Limulus Amebocyte Lysate (LAL) Test | ||||
| Bioburden level is < 1000 cfu/filter device as per ISO 11737-1 : 2018 | ||||
| Passes test as per USP and comply with USFDA 21 CFR Part 210.3(b)(6) for fiber release | ||||
| All Polypropylene components meet the FDA Indirect Food Additive requirements cited in 21 CFR 177.1520 | ||||
| Passes test as per USP | ||||
| These products are manufactured in a facility which adheres to Good Manufacturing Practices. | ||||
| Within limits as specified in USP | ||||
| Passes USP test for particulates in injectables. | ||||
| 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 | ||||
| ISO-9001 Certified | ||||
| DMF No. 015554 | ||||
| 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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