BioPro® KS Large
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
- High flow rates
- High throughput
- Low protein binding
- No media migration
- Biologically inert
- Easy installation
- 100% integrity tested
- 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 autoclaving or Ethylene Oxide
- 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” 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” Single Step Hose Barb I/O |
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| Dimension (End to End) – 1″ Hose Barb I/O |
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| Operational Radius (with Vent/ Drain) |
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| Dimension (End to End) – 3/8″ Hose Barb I/O |
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| Vent and Drain | ¼” Hose Barb with Silicone “O” rings | ||||
| Integrity Testing / Retention | |||||
| Bacterial Retention |
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| Bubble Point |
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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 cycles and it cannot be In-line steam sterilized | ||||
| Shelf Life | 3 years after EO sterilization | ||||
| Assurance | |||||
| Toxicity | Passes Biological Reactivity Tests, In vivo, as per USP <88> for Class VI plastics | ||||
| Bacterial Endotoxin | Aqueous extracts exhibit < 0.25 EU/ml as established by Limulus Amebocyte Lysate (LAL) Test as per USP <85> | ||||
| 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 particulate matter in injections | ||||
| Indirect Food Additive | Passes as per USFDA 21 CFR 177.1520 | ||||
| Extractables with WFI | Passes NVR test as per USP <661> | ||||
| Good Manufacturing Practice | These products are manufactured in a facility which adheres to Good Manufacturing Practices. | ||||
| Oxidizable Substances | Passes test aas per USP <1231> | ||||
| Quality Management System | ISO-9001 Certified | ||||
| USFDA | DMF No. 015554 | ||||
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*T-line is not available in 5″ Capsule filter
**T-line Capsule filter are available with 1½” Sanitary Flange I/O only
***3/4″ Sanitary Flange end connection is available only in 5″ and 10″ capsule filters
****1″ Hose Barb is not available in 5″ capsule filters
| LBKS | 56 | 01 | X | X | 1 | 01 |
Example for Non Sterile: LBKS5601QQXX101 Example for EO Sterile: LBKS5601QQXX201
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