0.2μm AseptiCap® KSO Large
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 | 0.2 μm Hydrophilic PES | ||||
| Upstream Membrane | 0.8 μm or 0.45 μm Hydrophilic PES | ||||
| 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 | > 50psi (3.52Kg/cm²) with Water | ||||
| Max. Air Diffusion Flows (10″) |
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| Operational | |||||
| Max. Operating Temperature | 80 °C @ ≤ 2 Kg/cm2 | ||||
| Max. Differential Pressure | 60 psi (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 | LRV> 7 for B. diminuta (ATCC 19146) per cm² of filter area as per ASTM F 838 | ||||
| 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 10 liter flush for 5” capsule filters and 20 liter flush for 10” capsule filters | ||||
| Particle Release | The filtrate complies with USP <788> test for particulate matter in injections | ||||
| Oxidizable Substances | Within limits as specified in 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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*T-Line Capsule filters are with 1½” Sanitary Flange only
**1″ Hose Barb and T-Line are not available in 5″ Capsule Filter
***3/4″ Sanitary Flange end connection is available only in 5″ and 10″ capsule filters
Example :
| LKO5 | 56 | 01 | EE | X | X | 2 | 01 |
Example for Non Sterile: LKO55601EEXX101 Example for EO Sterile: LKO55601EEXX201
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