Preparing for and Implementing the Scale-up Run

There are two key objectives for effectively scaling up a process: to anticipate and solve processing problems in the laboratory, and to thoroughly execute the scale-up operation. The detailed method for developing a process and carrying it out on scale varies according to the phase of development of the final product, time pressures to prepare the final product, and the protocols favored by both the group who developed the process and the group carrying out the scale-up run. There are several categories of processing problems encountered on scale. Most arise from nonhomogeneous operating conditions (physically derived impurities), extended processing (chemically derived impurities), and processing outside normal ranges (physically or chemically derived impurities). There are several categories of processing problems encountered on scale. The focus of the scale-up run determines how the operations are approached during the run. Good teamwork is essential for efficient operations on scale. The team may be composed of chemists, engineers, operators, analysts, and others. It is important to appreciate the experience of other team members, especially the operators, who are most familiar with the scale-up equipment.