Module 3 - Strategic case studies in practice

Pharmaceutical Development

Example 3: The design space for a drying operation that is dependent upon the path of temperature and/or pressure over time. The end point for moisture content is 1-2%. Operating above the upper limit of the design space can cause excessive impurity formation, while operating below the lower limit of the design space can result in excessive particle attrition.

35%

30%

Excessive impurity formation

Design space upper limit

25%

20%

15%

Design space lower limit

10% MoistureContent

Excessive particle attrition

5%

Endpoint criterion

{

0%

0

2

4

6

8

10

12

time (hr)

24