Biomedical Engineering Reference
In-Depth Information
(b)
12
10
System A
System B
8
6
4
2
0
0 500 1000 1500 2000 2500 3000
Elution Time (seconds)
Figure
13.6.
(Continued).
Some of the greatest benefits from a combined PAT/QbD approach can be realized
when processes are transferred from one site to the next, or one scale to the next, when
there will be unavoidable changes in equipment. If the process is described and
controlled in terms of process parameters and product quality attributes, and supported
by well-developed models, the process becomes scale transparent and the risk associated
with the transfer is understood and minimized (assuming that issues in scalability of
monitoring systems are also addressed).
