0.2μm AseptiPrime® KS Large
mdi AseptiPrime® KS are sterilizing grade PES membrane capsule filters specially designed for very high throughput.
The special asymmetric pre-filter membrane layer with high asymmetric proportion offers high loading and volume handling capacities to provide enhanced protection to the final membrane layer.
These are available in a wide range of sizes and end connections tosuit a multitude of sterilization applications in biopharmaceuticals for process development, pilot scale and production batch sizes.
AseptiPrime® KS filters meet key process requirements such as absolute retention, high protein recoveries and low extractables.
- 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 | Hydrophilic PES | ||||
| Final Filter Pore Size | 0.2 μm | ||||
| Prefilter Pore Size | 0.5μm | ||||
| Support Layers | Polyester | ||||
| Size | |||||
| Size |
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| Effective Filtration Area (Nominal) |
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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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| Dimensions (End to End) Inline Capsule Filters – 1½” Sanitary Flange Inlet ½” Single Step Hose Barb Outlet |
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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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| Integrity Testing / Retention | |||||
| Bubble Point | > 50psi (3.51Kg/cm²) with Water | ||||
| Max. Air Diffusion Flows (10″) | < 30 ml/min @ 37 psi (2.6 Kg/cm²) with water | ||||
| Microbial Retention | LRV >7 for B. diminuta (ATCC 19146) per cm² | ||||
| 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 1-10 | ||||
| Sterilization By Gas | Sterilization by Ethylene Oxide | ||||
| Sterilization By Autoclave | Autoclavable at 125°C for 30 minutes, 3 cycles and it cannot be in-line steam sterilized | ||||
| Shelf Life | 3 years after EO Sterilization | ||||
| Assurance | |||||
| Toxicity | Passes Bioreactivity test, In Vivo, as per USP <88> for Class VI plastics | ||||
| Cytotoxicity | Passes Biological Reactivity Tests, In vitro, USP <87> for Cytotoxicity | ||||
| Bacterial Endotoxin | Aqueous extracts exhibit < 0.25 EU/ml as established by Limulus Amebocyte Lysate (LAL) Test as per USP <85> | ||||
| Non Fiber Releasing | Passes test as per USP and comply with USFDA 21 CFR Part 210.3(b)(6) for fiber release | ||||
| TOC and Conductivity | Meets the WFI requirements of USP for TOC <643> and Conductivity <645> | ||||
| Indirect Food Additive | Comply with USFDA 21 CFR Part 177.1520 | ||||
| Extractables with WFI | Passes NVR test as per USP <661> | ||||
| Oxidizable Substances | Within limits as specified in USP <1231> | ||||
| Quality Management System | ISO-9001 Certified | ||||
| USFDA | DMF No. 015554 | ||||
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*1″ Hose Barb and T-line is not available in 5″ Capsule filter
*T-line Capsule Filters are available with 1½” Sanitary Flange I/O Connections Only
**3/4″ Sanitary Flange end connection is available only in 5″ and 10″ capsule filters
Example:
| LKX7 | 54 | 01 | EE | X | T | 1 | 01 |
Example for Non Sterile: LKX75301QQXX101 Example for EO Sterile: LKX75301QQXX201
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