New Drug Approvals

Design, construction and start-up of a pilot plant for active pharmaceutical ingredients

June 12, 2014 6:31 am

: Linde-KCA-Dresden built a pilot plant 16 times the size of the laboratory apparatus for Novo Nordisk A/S
: The building layouts show different areas for the pilot plant, the utility systems and the technical rooms with hazardous and non-hazardous proof conditions (top). The engineering documents include

The construction of a pilot plant constitutes an important milestone in the development cycle of a new active pharmaceutical ingredient. Pilot plants are used to gain the technological experience needed for the scale-up process and are required for producing sufficient quantities of the active pharmaceutical ingredient for clinical trials and other types of tests. As a result, even these testing facilities must comply with GMP regulations.

http://www.cpp-net.com/pharma/-/article/5829537/15910929/Challenging+task/