Process automation “Collection of the fermentation broth” in Lek plant in Lendava: solution for monitoring, control and management of the process by which the company Lek increased production of antibiotics.

The situation

Lek, a Sandoz company, develops, manufactures and markets efficient, safe and high quality medicines from standard to modern biosimilars. Their goal is to become a leader in the generic pharmaceutical industry, while set new standards for quality. They advocate the introduction of innovative technologies and distribution methods in the generics market.

Business challenge

In order to increase the volume of production of antibiotics, which the company produces for the global market, it was necessary to extend the fermentation process and shorten the production cycle, so they needed to increase the capacity of the fermentation process and build the collection of the fermentation broth.

The main challenge of the project was the process construction in a short period of time, without significant shutdowns of the production and at the same time meeting the quality requirements of the pharmaceutical industry and the verification of the works carried out.

Since they do not have the capabilities to carry out such a project, they decided to select an external system integrator.

Capabilities and solutions

LEK needed an innovative solution that enables:

• shortening the production cycle,
• a system deployed in an existing (limited) space,
• it does not require additional staff for the operation.

Implementation and verification of the project was to be carried out in accordance with GAMP Directive. The project should be completed in a short time during the annual outage.

By automating the process “Collection of the fermentation broth” in the plant Lek Lendava, Inea established solution for monitoring, control and management of the process by which the company Lek increased production of antibiotics.

Results

• shortened production cycle for the production of antibiotics,
• improved quality of the final product due to provision of additional process parameters,
• improved control of process parameters with the introduction of a central control system.

Gordan Cizar, project manager of Lek d. d. said:
Engineers from the company Inea successfully carried out work of automating the production process at the plant in Lendava. They showed a professional approach to the execution of the project itself, work was carried out in quality and before deadline. Successfully and timely completed project was vital for us because the start of the production depends directly on the process, which was the subject of automation.