Siegfried, the world’s leading CDMO (Custom Development and Manufacturing Organization), produces active pharmaceutical ingredients, intermediates and finished products from a single source. Its core competence lies in the integration of complementary chemical and pharmaceutical competencies in a single business model.
In our hot-off-the-press user report, the focus is on the site in Hameln, where production has been optimized with FASTEC 4 PRO for over ten years. Siegfried Hameln primarily produces parenterals, i.e. liquid medicines that bypass the digestive tract and are administered intravenously or intramuscularly. Siegfried Hameln is also active as a contract manufacturer and produces pharmaceutical products (including anaesthetics, painkillers and drugs for intensive care) for other companies. The majority of the products manufactured are used internationally.
Previously, data acquisition at Siegfried Hameln was carried out exclusively via manual data entry and reports. When a new building for the sterile filling of parenterals was built in Hameln, Siegfried Hameln’s vision was clear: paperless production in the cleanroom area of the new building. After a 6-month test phase, the FASTEC 4 PRO software solution was gradually rolled out to all machines and Work centers.
Another important requirement for the introduction of digital data acquisition at Siegfried Hameln was the possibility of validation in accordance with GAMP 5. Its use now extends far beyond the production level. FASTEC meets all of Siegfried Hameln’s individual requirements for a software solution for digital production optimization. All managers have the FASTEC 4 PRO Office Client on their end devices. Large screens have been placed in the production area to provide visibility of the current production status at all times. Outside of production, departments such as controlling or quality analysis use the real-time data. The software also serves as a signal generator for quality control.
Conclusion:
Digitalization – at all levels.