Teams

Process Excellence

Process Excellence Team (from left): Han Quang Li, Gerhard Bättig, Michael Oelting, Alexandra Born

Our Mission

“We aim be an excellent service provider to the Zofingen production site delivering relevant experimental data and scientific guidance which serves to optimize and refine the processes of the established product portfolio. Our key success factor is a deep understanding of the underlying production processes and a seamless exchange with the production stakeholders.”

In close cooperation with production, the Process Excellence group carries out process improvements at the Zofingen site with the aim of reducing cycle times of production and amounts of waste. The final aim is to save costs without compromising on quality. In case of production problems, trouble shooting is performed in order to ensure that production interruptions remain at a minimum. Further tasks are laboratory tests of new raw materials, tests to verify the chemical resistance of materials in the plant against corrosive reaction media, and support in cleaning validation.

The group consists of experienced chemists and laboratory assistants. The assignments are carried out in close coordination with colleagues in production and program management and will be prioritized, if necessary. Consequently, assignments that avoid or help reduce production interruptions enjoy highest priority at all times. 

 

The main areas of our activity spectrum include:

Optimization of production costs

Our production processes for intermediates and drug substances are subject to continuous inspection cycles carried out by the responsible production chemist or program managers. Within the leeway available for registered processes and, where necessary, subject to the approval of our customers, the mode of ­operation of individual process steps can be improved in close cooperation with chemists, production staff, the quality department, SHE department and the process excellence laboratory. 

The biggest effects are achieved by means of improving the space-time yield. In this respect, the target API is to be produced in as low volume and as short production time as possible to make the most favorable use of raw materials, plant and staff. 

Many improvements can be implemented directly in production by implementing organizational or technical measures. Often, while fine-tuning production processes, laboratory data are required to evaluate and confirm the savings potential in advance. 

Important production support

Fast action is required when a process problem occurs in production in order to identify the root cause(s) and define effective measures. Often, when a root-cause analysis is carried out, production samples of the affected batch are sent to the process excellence laboratory for evaluation. In such a case, unexpected deviations in unit operations, such as phase separation, distillation, crystallization, centrifugation and drying can be adjusted in detail, discussed with production staff to initiate supporting measures that have been tested. If necessary, intermediate steps right up to final stage will be carried out in the process excellence laboratory in order to ascertain whether deviations in the intermediate step influence the quality of the final product.

Use tests of raw materials

When evaluating a new producer of a key raw material due to lower cost or because the present producer cannot cover demand, use tests are carried out in advance in the process excellence laboratory. This becomes necessary especially when the producers of the raw material apply different production processes resulting in a different impurity profile. Moreover, the certificates of analysis of raw materials are frequently rudimentary and the analytical method of the various suppliers are not directly comparable.