Dr. Michael Pikal, Ph.D.
Professor and Distinguished Chair, Pharmaceutical Technology
University of Connecticut
It is well known that freeze drying processes developed in the laboratory that perform well in the laboratory often encounter problems in manufacturing. Perhaps the most common problem is collapse in a small fraction of the product, but instability issues may also arise.This webinar will focus on identifying potential scale-up problems and their possible solutions. Successful scale-up depends on a systematic approach to “Operational Qualification” on both the laboratory dryer involved and the production dryers likely to be used in manufacture of the product. Thus, meaningful operational qualification testing will also be discussed.