0.2µm AseptiCap® KSO-γ Large
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.
- 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, 0.65μm or 0.45 μm Hydrophilic PES | ||||
| Support Layers | Polypropylene | ||||
| Plastic Parts | Gamma Stable 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″) | <30 ml/min @ 37 psi (2.6 Kg/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 | Gamma Irradiatiable up to 50 kGy. These filters should not be autoclaved or in-line steam sterilized. | ||||
| 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 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 available with 1½” Sanitary Flange only
**T-Line and 1″ Hose Barb are not available in 5″ capsule filters
***3/4″ Sanitary Flange end connection is available only in 5″ and 10″ capsule filters
a: Gamma irradiated Capsule Filters cannot be gamma sterilized again
Example :
| LKO5 | 56 | 01 | EE | X | X | 3 | 01 |
Example for Non Sterile: LKOX5401EERX101 Example for EO Sterile: LKOX5401EEXX301
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