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By certification 
Description
30kd ultrafiltration cassettes scale-up easily and reliably from the laboratory to the production plant. By ensuring every flow channel has the same length, height and turbulence promoter as well as flow direction and materials of construction, we maintain the same 30kd ultrafiltration cassettes performance at all scales. Thus, rapid and reliable translation of processes from lab to manufacturing scale is easily achieved.
30kd ultrafiltration cassettes are ideal for development, pilot, and production-scale TFF applications in diverse biological and biopharmaceutical processes. They are especially useful in separation and purification.
2.Regulatory Information
| Component Material Toxicity | Component materials were tested and meet the criteria of the USP <88> Biological Reactivity Tests for Class VI Plastics. |
Good Manufacturing Practices |
These products are manufactured in a facility which adheres to CFDA Good Manufacturing Practices. |
ISO® 9001 Quality Standard: |
This product was manufactured in a facility whose Quality Management System is approved by an accredited registering body to the appropriate ISO® 9001 Quality Systems Standard |
100% Integrity Tested |
Each unit must pass an integrity test based on air flow through the fully-wetted membranes of the filter. |
Validated Production Process: |
This product was fabricated using a validated manufacturing process. Principles of statistical process control and determinations of process capability have been applied to critical variables in the device fabrication process. In-process controls are used to assure stability of the process. |
3. Typical Applications
Clarification: such as separate cell /cell debris
Concentration: protein concentration
Desalination: desalting of nucleic acid, nano microspheres and peptides
Buffer replacement: buffer system change before and after chromatography
Depyrogenation: pyrogen removal of culture medium and TCM injection
Ultrafiltration (UF) can be introduced to the intermediate phase of the downstream process, preceding or following purification chromatography. Here, UF is an effective method for protein concentration and buffer exchange prior to the polishing chromatography phase. Ultrafiltration separates macro-molecules ranging from 0.001 to 0.1 μm in size.
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