0.2µm AseptiCap® KSO Small
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.
- Absolute retention
- 100% integrity tested
- Low protein binding
- Very low hold up volume in filters
- High flow rates
- Serial construction with prefilter for higher throughput with fouling streams
- Bioburden maintained below 1000 cfu/device
- Endotoxin level certified to be <0.25 EU/ml
- Widest range of end connections
- Products available for total scalability from a few ml to thousands of liters
- Total traceability through unique serial number for each filter
- Individual certificate of quality for each device
- Sterilizable by EO gas or autoclaving
Sterile Filtration of
- Cell culture media
- Cell culture media containing serum
- Media additives
- pH adjusters
- Final product concentrates
Bioburden Reduction/ Particulate Removal
- Buffers
- Centrifuge supernatants
- Clarified cell lysates
Construction | |||||
Membrane | Polyethersulfone | ||||
Upstream Membrane | 0.8 μm and 0.45 μm Hydrophilic PES | ||||
Support Layers | Polypropylene | ||||
Plastic Parts | 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 | ||||
Integrity Testing / Retention | |||||
Bubble Point | >50psi (3.52Kg/cm²) with Water | ||||
Operational | |||||
Max. Operating Temperature | 80 °C @ < 30 psi (2 Kg/cm²) | ||||
Max. Differential Pressure | 60 psi (4 Kg/cm²) @ 30 °C | ||||
pH Compatibility | Compatible with pH range of 1-14 | ||||
Sterilization By Autoclave | Autoclavable at 125° C for 30 minutes, 25 cycles, cannot be in-line steam sterilized | ||||
Shelf Life | 3 years after EO 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 for TOC <643> and Conductivity <645> after a 3 liter flush | ||||
Particle Release | The filtrate complies with USP <788> test for particulate matter in injections | ||||
Oxidizable Substances | Passes test as per USP <1231> | ||||
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 and ½” MNPT
**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
b: Bell and bell with cover is available with :
- ½” HB outlet connections in 1”, 2”, 5” and 8” capsule filters
- ¼” SHB outlet connection in 1” capsule filters only
Example :
DKOX | 57 | 01 | DD | X | X | 1 | 01 |
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