Biomedical Engineering Reference
In-Depth Information
deemed safe and effi cacious, it is a candidate for commercial
manufacture and marketing. The question is: how does the
company move from the scale of laboratory production,
perhaps several ounces of product in total, to the commercial
scale of thousands or millions of units of product? This is
where the pilot project fi ts in.
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The company pilots the manufacture of the product, as a
transition from the laboratory scale to the commercial scale.
The pilot has a number of outcomes, four of which are
particularly important:
1. It demonstrates the feasibility of the scale-up in general.
2. It demonstrates the validity and reliability of the
particular process selected for the pilot.
3. It generates parametric product and process data for
commercial manufacturing.
4. It provides data for budgeting, planning, and scheduling
of subsequent manufacturing.
Each of these outcomes may prove positive or negative for
the future of the product. As examples of negative outcomes:
the scale-up process may not prove technically feasible, the
particular process may be unreliable, there may be off-spec
fi ndings during scale-up, and the process may not be
economically feasible.
The relationship between the (Pilot) Implementation phase
and the rest of the program improvement model is similar.
When a pharmaceutical company has discovered a promising
solution to a training gap, it goes into a development phase.
The company assigns an instructional design team to take
the promising solution and develop it into a draft training
module. If the training module seems to be effi cacious, in
terms of face validity and peer review, for example, it
becomes a candidate for department-wide, site-wide, or even
