Top themes medical technology

„Das Uniklinikum Regensburg unterhält Reinräume unter anderem im Bereich der Apotheke, im Jose-Carreras Centrum zur Herstellung von Zelltherapeutika und Arzneimitteln für neuartige Therapien (ATMP) sowie in der Transfusionsmedizin.“ (Nikolaus Ferstl, technischer Leiter an der Uniklinik Regensburg) / “University Hospital Regensburg operates cleanrooms in various areas, including the pharmacy, in the José-Carreras Centre for Somatic Cell Therapy, where it is used for the production of cell therapies and pharmaceuticals for Advanced Therapy Medicinal Products (ATMP), and in transfusion medicine.” (Nikolaus Ferstl, Technical Director at University Hospital Regensburg)

Nikolaus Ferstl, Technical Director at University Hospital Regensburg, will be discussing ‘Innovations in the field of cleanroom technology’ and their importance for hospital operations at the Cleanzone Conference. He offers a preview of his presentation here in our interview.

In what areas does University Hospital Regensburg operate cleanrooms?

“University Hospital Regensburg operates cleanrooms in various areas, including the pharmacy, in the José-Carreras Centre for Somatic Cell Therapy, where it is used for the production of cell therapies and pharmaceuticals for Advanced Therapy Medicinal Products (ATMP), and in transfusion medicine.”

What sort of investments are planned in cleanrooms over the next few years?

“In the field of cleanroom technology, we are investing in renewing our ventilation and air-conditioning systems, including the measurement and control technology, to satisfy hygiene requirements and reduce energy costs. We have also begun implementing a CATO project, and are in the process of creating the technical framework in which this can proceed. cato® is a comprehensive software solution for chemotherapy that supports the entire process, from long-term therapy planning and therapy support to the actual production of the cytotoxic drugs. State-of-the-art database technology allows for its utilisation both as a standalone application in smaller pharmacies, as well as in networks for large hospitals with station integration.”

With the growing number of multi-resistant germs in hospitals, what is the importance of cleanroom technology?

“Cleanroom technology has a huge role to play here. We are trying to deliver the necessary improvements in every area. These include the aforementioned new systems engineering capabilities, systematically structured quality improvements within the framework of re-validation and re-qualification activities / requirements, additional training for employees, and achievement of GMP production certification in all areas, including in production in pharmacies.”

Your presentation at the Cleanzone Congress is entitled ‘Innovations in the field of cleanroom technology’. Which innovations are particularly important for hospital operations, and what are some of the other factors that you will be addressing in your talk?

“The following innovations are particularly important for hospital operations: Hygienic and germicidal surfaces and materials, due to the high footfall, and the CATO solution I discussed, because it offers the potential for tremendous cost savings. Medications that have been opened do not have to be disposed of immediately, and can potentially be used for the preparation of medications for other customers. Other aspects of my presentation including current requirements mandated by law and GMP guidelines, while I will also be addressing the topics of digitisation, cleanroom technology 4.0 and BIM.”