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.
- 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 | ||||
| Prefilter Pore Size | 0.45µm | ||||
| Support Layers | Polypropylene | ||||
| Housing | Polypropylene | ||||
| Size | |||||
| Size |
|
||||
| Effective Filtration Area (Nominal) |
|
||||
| Dimension (End to End) – 1½” Sanitary Flange Inlet ½” Hose Barb Outlet |
|
||||
| Dimension (End to End) – ¾” Sanitary Flange I/O |
|
||||
| Dimension (End to End) – 1½” Sanitary Flange I/O |
|
||||
| Dimensions (End to End) – ½” Single Step Hose Barb I/O |
|
||||
| Dimension (End to End) – 1″ Hose Barb I/O |
|
||||
| Dimension (End to End) – 3/8″ Hose Barb I/O |
|
||||
| Integrity Testing / Retention | |||||
| Bubble Point | > 50psi (3.52Kg/cm²) with Water | ||||
| Max. Air Diffusion Flows (10″) |
|
||||
| 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 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 | ||||
| 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> | ||||
|
|
|
|
|
|
|
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
*T-Line Capsule filters are with 1½” Sanitary Flange only
** 5″ Capsule Filter is available in in-line capsule filters only
***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 | 2 | 01 |
Example for Non Sterile: LKO55601EEXX101 Example for EO Sterile: LKO55601EEXX201
Have questions or need assistance?
Our team is here to help! Contact us today, and we’ll get back to you as soon as possible.