BioPro® KS Small
The BioPro® KS is designed for protecting your critical and high value downstream systems.
It helps in significant reduction of bioburden and complete removal of particulate contamination. It is ideal for applications which do not require sterilization but where reduction in bio load in the process fluid is the objective.
It improves the process efficiency by reducing filter sizing and prolonging life of expensive sterilizing filters.
These filters provide easy scalability from process development labs to actual manufacturing processes.
- Validated for high bio-burden reduction
- High flow rates
- High throughput
- Low protein binding
- No media migration
- Biologically inert
- Easy installation
- Clarification of cell harvest
- Buffer filtration
- In process protein filtration
- Prefiltration to sterile filtration
- Prefiltration to virus filtration
| Construction | |||||
| Membrane | Hydrophilic PES | ||||
| Final Filter Pore Size (Nominal) | 0.1µm, 0.2µm, 0.45µm | ||||
| Support Layers | Polyester | ||||
| Body and Core | Polypropylene | ||||
| Size | |||||
| Size |
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| Effective Filtration Area (Nominal) |
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| Dimension (End to End) – 1½” Sanitary Flange Inlet ½” Single Step 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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| Dimension (End to End) – ½” Hose Barb 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 for 2″, 5″, and 8″ capsule filters | ||||
| Integrity Testing / Retention | |||||
| Bacterial Retention |
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| Bubble Point (with water) |
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| Operational | |||||
| Max. Operating Temperature | 80 °C @ < 30 psi (2 Kg/cm²) | ||||
| Max. Differential Pressure | < 60 psi (4 Kg/cm²) @ 30° C | ||||
| Sterilization By Gas | Sterilizable by Ethylene Oxide | ||||
| Sterilization By Autoclave | Autoclavable at 125°C for 30 minutes, 25 cycle and it cannot be In-line steam sterilized | ||||
| Shelf Life | 3 years after EO sterilization | ||||
| Assurance | |||||
| Toxicity | Passes Bioreactivity test, Invivo, as per USP <88> for Class VI plastics | ||||
| Bacterial Endotoxin | Aqueous extracts exhibit < 0.25 EU/ml as established by LAL Test | ||||
| Bioburden | Bioburden level is < 1000 cfu/filter device as per ISO 11737-1 : 2018 | ||||
| Non Fiber Releasing | Complies with USFDA CFR Title 21, 210.3 (b) (6) | ||||
| Particle Release | The filtrate complies with USP <788> test for particulatematter in injections | ||||
| Indirect Food Additive | Passes as per USFDA 21 CFR 177.1520 | ||||
| Extractables with WFI | Passes test as per USP | ||||
| Good Manufacturing Practice | These products are manufactured in a facility which adheres to Good Manufacturing Practices. | ||||
| Oxidizable Substances | Within limits as specified in USP | ||||
| Quality Management System | ISO-9001 Certified | ||||
| USFDA | DMF No. 015554 | ||||
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*1″ Capsule filters are not available with ½” Single Step Hose Barb
**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
Example :
| DBKS | 57 | 01 | EE | X | X | 1 | 01 |
Example for Non Sterile: DBKS5701EEXX101 Example for EO Sterile: DBKS5701EEXX201
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