45SCALE‐UP DO'S AND DON'TS

Francis X. McConville

Impact Technology Development, Lincoln, MA, USA

45.1 INTRODUCTION

One of the chemical engineer's primary responsibilities in the pharmaceutical industry is to assist in scaling up laboratory or development‐stage processes to commercialization. An unfortunate fact is that so much of the really practical information that can make scale‐up more efficient and ultimately more successful is generally acquired in the workplace only through years of on‐the‐job training. Most university engineering curricula are simply not geared toward teaching students about the many real‐world issues that can complicate scale‐up or lead to unexpected results, unsuccessful campaigns, and potentially dangerous situations.

45.2 LEARNING THE HARD WAY

Many of the most important things I know about technology transfer and process scale‐up were learned throughout my career, on the floor of the pilot plant long after I left school. And suffice it to say that some of these lessons were hard won, sometimes at the cost of out‐of‐spec batches, close calls, and unnecessary delays. Lucky is the new graduate in a position to be mentored by someone who has learned about scale‐up through experience by putting time in “in the trenches.”

It sometimes seems that scale‐up is simply a lesson in learning to expect the unexpected. But over time, one realizes that many of the surprises encountered during scale‐up could have been anticipated and often prevented by paying ...

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