AseptiCap® KSO-γ 5", 10", 20", 30"
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 advantages 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
- Minimum cleaning requirement and low installation cost
- Low hold up volume
- Very high flow rates
- 100% Integrity tested
- Total traceability
- Sterilization of buffers
- Sterilization of bio-pharmaceuticals such as vaccines and therapeutic proteins
- Sterilization of oncology drugs
Construction | |||||
Membrane | Polyethersulfone | ||||
Final Filter Pore Size |
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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) - 1½" Sanitary Flange Inlet ½" Hose Barb Outlet |
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Dimension (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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Dimensions (End to End) - ½" Single Step Hose Barb I/O |
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Dimension (End to End) - 1" Hose Barb I/O |
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Dimension (End to End) - 3/8" Hose Barb I/O |
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Integrity Testing / Retention | |||||
Bubble Point |
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Max. Air Diffusion Flows (10") |
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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 | Gamma Irradiatiable up to 50 kGy. These filters should not be autoclaved or 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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* T-Line Capsule filters are available with 1½” Sanitary Flange only
** 5" Capsule Filters are not available with T-Line
*** Gamma irradiated Capsule Filters cannot be gamma sterilized again
****1" Hose Barb is not available in 5" capsule filters
*****3/4" Sanitary Flange end connection is available only in 5" and 10" capsule filters
Example :
LKO5 | 56 | 01 | EE | X | X | 3 | 01 |