0.2µm AseptiCap® KSO-γ Small
MDI AseptiCap® KSO-γ are gamma sterilizable polyethersulfone membrane capsule filters offering wide pH (1-14) compatibility.These filters are specially designed for alkaline fluid streams in biopharma 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-γ 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
| Construction | |||||
| Membrane | Polyethersulfone | ||||
| Final Filter Pore Size | 0.2µm | ||||
| Filter Media | Polyethersulfone Membrane | ||||
| 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 | > 50psi (3.52Kg/cm²) with Water | ||||
| 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 Irradiation | Gamma Irradiatiable up to 50 kGy. These filters should not be autoclaved or in-line steam sterilized. | ||||
| Shelf Life | 3 years after gamma sterilization | ||||
| Bacterial Retention | LRV > 7 for B. diminuta ATCC 19146 per cm² of filter area | ||||
| 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
**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
****Gamma irradiated capsule filters cannot be gamma sterilized again
Example :
| DKOX | 52 | 01 | EE | R | X | 1 | 01 |
Example for Non Sterile: DKOX5701EERX101 Example for Gamma Sterile: DKOX5701EEXX301
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