0.2µm AseptiCap® KSO-γ Small
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 |
|
||||
| Effective Filtration Area (Nominal) |
|
||||
| Dimension (End to End) – ½” Hose Barb I/O |
|
||||
| Dimension (End to End) – 1½” Sanitary Flange Inlet ½” Single Step Hose Barb Outlet |
|
||||
| Dimensions (End to End) – ¾” Sanitary Flange I/O |
|
||||
| Dimension (End to End) – 1½” Sanitary Flange I/O |
|
||||
| Dimension (End to End) – ½” Single Step Hose Barb I/O |
|
||||
| Operational Radius (with Vent/ Drain) |
|
||||
| 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 Irradiation | Gamma Irradiatiable up to 50 kGy. These filters should not be autoclaved or in-line steam sterilized. | ||||
| Shelf Life | 2 years after gamma 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> | ||||
|
|
|
|
|
|
|
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
*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
a: Gamma irradiated capsule filters cannot be gamma sterilized again
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 | 52 | 01 | EE | R | X | 1 | 01 |
Example for Non Sterile: DKOX5701EERX101 Example for Gamma Sterile: DKOX5701EEXX301
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.