Case Study.

Process Optimisation for the Market Launch of an API Product.

Process Optimization for an Animal Health API Product Launch at a global-oriented CDMO Site.

The Challenge.

As a superior issue the whole project team has been exchanged, the project budget has grown from 5 million EUR to approx. 25 million EUR and a limited batch validation process capacity has been detected. As a major bottlenecks the cleaning validation, including more than 5 percent of OOS batches, was determined. Moreover, streamlined communication management without clear communication paths and lacking transparency was present. Finally, no person in plant was installed to provide a single point of contact and to ensure the correct project coordination.

The Benefits.

  • Implementation of an optimized shift model with additional runs for bottlenecks, cleaning processes during night shifts and additional runs over the weekend
  • Usage of one tablet press for the highest possible volume to reduce change overs
  • Installation of an additional rotor for the tablet press and an increased size of ethanol vessels​
  • Hiring of a qualified person in plant to ensure correct and straight forward project coordination as well as the right expert involvement

The Outcome.


project management via qualified person in place. Responsible for communication, correct coordination and simple implementation ​


Process validation and batch production via improved cleaning procedures and re-organized shift models


involvement of the new project team to the already running process and sustainable continuous improvement processes​

The Result.

Reliable process validation and product launch within 4 months