Scale-Up Background

In the aforementioned chapter in the First Edition Reference 1,1 mentioned, There is no such thing as a standard approach to solve compactor scale-up or compactor equipment changes in the pharmaceutical production process (1). At that time of the publication, it appeared that was very much the case history of roller compaction scale-up in the pharmaceutical industry. This understanding was based on the fact that there were no pharmaceutical industrial journal articles published at the time on the subject. On the other hand, it was also true that considerations, approaches, and examples presented in that chapter were experienced by others and were not all-inclusive. 

Some scaling factors that go beyond specific formulation technical aspects follow. What type of equipment manufacturer support is expected What are the reputation and reliability of the equipment manufacturer in the country where the start-up will occur What is the equipment manufacturer s customer service record worldwide How many days will it take to replace a broken or worn out part Does the equipment manufacturer carry a reliable stock parts inventory A survey evaluated industrial practices and preferences that addressed some of these questions (2). 

Additionally, what is a company s commitment to technology and engineering support before and after start-up Who provides the training costs Who pays what Are the in-process testing equipment and necessary analytical equipment operational, qualified, and ready when needed Who will perform the validation requirements (equipment and process) These are some of the key questions and concerns that go beyond the hardware issues and technology that must be addressed prior to the project start-up. 

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