AseptiCap® KSO 1", 2", 5", 8"
mdi AseptiCap® KSO are polyethersulfone membrane capsule filters offering wide pH (1-14) compatibility. These filters are specially designed for alkaline fluid streams in bio-pharma manufacturing processes, with added advantage of high throughputs and low hold up volumes.
These capsule filters offer serial filtration incorporating a large pore size upstream membrane to protect the downstream membrane for enhanced throughputs.
AseptiCap® KSO are validated for use in pharmaceutical and bio-pharmaceutical applications.
- Wide pH compatibility (1-14)
- Absolute retention
- Low protein binding
- Light weight and self supporting
- Low hold up volume
- Very high flow rates
- 100% Integrity tested
- Total traceability
- Scale up of new drug delivery systems
- Bioburden removal from cell harvest supernatants
- Sterilization of bio-pharmaceuticals such as vaccines and therapeutic proteins
- Sterilization of oncology drugs
- Sterilization of buffers
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| Membrane | Polyethersulfone | ||||
| Final Filter Pore Size |
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| Prefilter Pore Size |
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| Support Layers | Polypropylene | ||||
| Housing | Polypropylene | ||||
| Size | |||||
| Size |
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| Effective Filtration Area (Nominal) |
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| Dimension (End to End) - ½" Hose Barb I/O |
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| Dimension (End to End) - 1½" Sanitary Flange Inlet ½" Single Step Hose Barb Outlet |
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| Dimensions (End to End) - ¾" Sanitary Flange I/O |
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| Dimension (End to End) - 1½" Sanitary Flange I/O |
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| Dimension (End to End) - ½" Single Step Hose Barb I/O |
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| Operational Radius (with Vent/ Drain) |
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| Vent and Drain | ¼" Hose Barb with Silicone "O" rings for 2", 5" and 8" only | ||||
| Integrity Testing / Retention | |||||
| Bubble Point |
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| Operational | |||||
| Max. Operating Temperature | 80 °C @ ≤ 2 Kg/cm2 | ||||
| Max. Differential Pressure | 4 Kg/cm2 @ 30 °C | ||||
| pH Compatibility | Compatible with pH range of 1-14 | ||||
| Sterilization By Gas | Sterilization by Ethylene Oxide | ||||
| Sterilization By Autoclave | Autoclavable at 125° C for 30 minutes, 25 cycles, cannot be in-line steam sterilized | ||||
| Bacterial Retention |
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| Assurance | |||||
| Fiber Release | Complies with USFDA CFR Title 21,210.3 (b) (6) | ||||
| TOC and Conductivity | Meets the WFI requirements of USP <643> for Total Organic Carbon after a 3 liter WFI flush and <645> for Conductivity after a 3 liter WFI flush | ||||
| Particle Release | The filtrate complies with USP <788> test for particulate matter in injections | ||||
| Oxidizable Substances | Passes test as per USP | ||||
| Quality Management System | ISO-9001 Certified | ||||
| USFDA | DMF No. 015554 | ||||
| Biosafety | Passes Biological Reactivity test, In-Vivo, as per USP <88> for Class VI plastics Passes the Biological Reactivity Tests,In Vitro for Cytotoxicity as described in USP <87> | ||||
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**1” Capsule Filters are not available with ½” Single step Hose Barb, ½” MNPT and 3/8" Hose Barb
***Male luer slip is available only in 1” capsule filter as outlet
****3/16" Hose Barb end connection is available in:
- 1" and 2" capsule filters as inlet and outlet
- 5" capsule filters as outlet only
Example :
| DKOX | 52 | 01 | EE | X | X | 1 | 01 |
