(Process Analytical Technology) refers to the use of mid-stream
chemical analyses of parameters that are directly
related to product quality. PAT can be used as part of a Quality Management
program for improved quality control. Traditional monitoring methods generally result in more variable product quality. An example of the difference in parameter choice is measurement of cell density in-line during a fermentation
, as opposed to measuring CO2
and assuming a relationship between the concentration and cell growth.
Here are four reasons to use PAT in a bioprocessing facility:
1. Immediate Adjustments to Production Parameters
Real-time information is obtained, allowing in-line corrections
if the measurements indicate a parameter is out of range. Parameters such as oxygen levels, pH and stir-rates can be adjusted, or nutrients added. In-line monioring is useful, not only for monitoring natural variations in a biological system, but for catching obvious human errors, before it's too late and the batch is ruined. Building in-line measurements and batch adjustments into the production line is an easy way to achieve process intensification
2. More Predictable ResultsIn-line monitoring leads to less variability of end product quality. As a result, statistically speaking, the manufacturer can have more confidence in the quality of the product and the accuracy of end-point parameter measurements. This also results in less waste because less batches are discarded at the end of the process for not meeting specifications. Of course, the obvious side effect of this is cost savings because less raw materials and batch time go to waste.
3. Useful Data for Research and Development
A valuable sideline to using PAT is that the data collected during process monitoring can be incorporated into research and development programs. A large amount of data
is collected and, with proper organization and use of XML
or other IT solutions, it can be immediately organized for analysis by researchers who may use the informations to further improve product quality.
4. Time Saved
Time is saved in several ways: Reduced waste of QC time on non-value-added
protocols, less time in production for repeating batches or cycles, and the opportunity for real-time release of product because the quality has already been established mid-stream.