Industry 4.0 at Bachem
Author: Elodie Decuypere, Specialist Marketing at Bachem AG
Innovation and operational excellence are two important pillars of Bachem’s success. Thus, to keep technological leadership and high-quality services, it was essential to start our digital transformation and to enter the Industry 4.0 area. This will benefit our customers, as we will be able to increase our capacity.
Innovation and operational excellence are two important pillars of Bachem’s success. Thus, to keep technological leadership and high-quality services, it was essential to start our digital transformation and to enter the Industry 4.0 area. This will benefit our customers, as we will be able to increase our capacity with a more agile and flexible production, simplify and improve our GMP documentation, and provide a safe, reliable, and scalable manufacturing process delivering consistently high-quality API.
WHY ARE WE AUTOMATING AND DIGITALIZING SPPS AT BACHEM?
Optimizing production is crucial to us to help and support our customers in their drug development and manufacturing processes. We have started our journey to Industry 4.0 by automating and digitalizing one of our core business processes, solid-phase peptide synthesis (SPPS).
We have automated our SPPS process so that operations can be carried out with minimal human intervention, thus improving the reliability of the process, reproducibility of results, and safety, while significantly increasing the cost-effectiveness of operations. Thanks to automation, we are able to optimize equipment utilization and reduce operating times and personnel time down to a fraction. This reduction enables a higher capacity, efficiency, and agility of production and brings more flexibility to take on new projects. Bachem has also invested in digitalization of the production process so that documentation can be conducted in a paper-free way. Furthermore, we can attain improved first-time-right (FTR) rates, data analytics by implementing a plant information (PI) system, and higher data safety and integrity.
As first steps towards our “smart factory, we have introduced some major innovations. The first Bachem robot operator, BALU, was designed and programmed to support the commercial scale of SPPS. BALU handles the containers with the amino acid powders and is able to perform the powder transfer into the activator vessels for our 150L SPPS reactors. And the robot does so without the involvement of an operator. BALU can perform other critical tasks, such as cleaning the amino acid transfer port to prevent cross-contamination. A barcode scanner that reads the labels placed on the amino acid containers ensures correct handling.
Another innovative feature of this new fully automated SPPS process is Process Analytical Technology (PAT), which performs inline analytics after key steps. PAT removes the need for manual in-process controls (IPC) and provides better control of critical process parameters (CPP). Additionally, this automated process enables data recording and analytics as well as paper-free cGMP documentation. Implementing PAT to our process control decreases human contributions and cost of goods. Indeed, manual tasks are no longer required and free resources for other tasks and projects. Furthermore, PAT leads to higher reproducibility with minimized chemical side reactions. Ultimately, we utilize our assets more efficiently and streamline our production scheduling for a higher capacity and flexibility.
Dicover more: https://www.pharmafocusasia.com/articles/industry-40-at-bachem
