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Delivering PAT
Today
The PAT
Initiative desires to change the mindset of the
pharmaceutical industry to replace
“test after each
manufacturing step to find out what was made”
with
“test and
correct during each manufacturing step to ensure that what
is made is only what is wanted”.
This is
possible with GPC whereas previously there has been no
solution.
Now the
drugs are delivered to the consumer with the same safety but
much less effort and cost for the manufacturer.
Not only can
manufacturers now predict the consequences of how they are
operating but they can do this before the product shows any
change. This means any impending deviations can be corrected
by altering the process variables responsible. The
responsible variable and magnitude of the alteration is
information given by GPC.
Geometric
Process Control (GPC) technology is based on multidimensional
geometry and offers a single solution to the PAT Initiative,
which requires no mathematical knowledge to
implement or maintain. It models and utilises the geometric
envelopes of multi-dimensional
operating points from past process history where the desired
result was achieved.
The process operating objective is
converted to a geometric intention of being an interior
point in the envelope. The usable space inside the envelope
is easily found from the present operating points. It is shown
to the process operator in an understandable
visualisation in terms of only the existing process and
predicted quality variables.
Violations of
the envelope are immediately apparent and Corrective Advice
easily and automatically generated by GPC. The
envelope model has a dual response to timebased events. This
allows it to give very early indication with Avoidance
Advice for potential deviations.
GPC is THE only complete
solution to the PAT Initiative - available now!
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