Syntegon has launched a European roadshow to help pharmaceutical and biotechnology manufacturers address the requirements of EU GMP Annex 1, with live demonstrations of contamination control technologies and on-site consultations planned through April 2027.
The roadshow began at Syntegon’s largest site in Germany at the end of September, with a dedicated truck visiting customer sites across Europe, giving manufacturers opportunities to discuss regulatory requirements with the company’s engineering, sales and service teams and see selected technologies in operation.
Syntegon specialises in pharmaceutical processing and packaging equipment, including filling and closing systems for liquid medicines, alongside integrated production solutions and lifecycle services.
The company also supports manufacturers with equipment modernisation, software and field service.
The roadshow will showcase technologies including First Air solutions, an SPC settle plate changer for automated environmental monitoring, an integrated glove tester, a pre-use post-sterilisation integrity testing (PUPSIT) filter test rack and automated set-up tools.
The initiative comes as manufacturers continue adapting to the revised EU GMP Annex 1, which became fully applicable on 25 August 2024.
The guidance places strong emphasis on a comprehensive contamination control strategy (CCS), risk management and measures to prevent microbial, particulate and endotoxin contamination during sterile medicinal product manufacture.
For manufacturers, implementing these requirements can involve reviewing existing facilities, equipment, procedures and monitoring practices while maintaining production efficiency.
Automated systems can help reduce unnecessary operator intervention in critical areas and support more consistent contamination control.
“By listening closely to our customers, we continuously develop our portfolio; not only for Annex 1, but also across related areas of quality, performance and compliance,” said Stephan März, Executive Vice-President of Pharma Liquid at Syntegon.
With our Annex 1 Roadshow, we bring innovative technologies and expert advice directly to their sites. Together, we learn and co-create solutions that turn challenges into opportunities.
Syntegon said its approach covers the full equipment lifecycle, from initial compliance assessments and implementation through to modernisation and ongoing service support.
What is Annex 1?
EU GMP Annex 1 is the section of the European Union’s Good Manufacturing Practice guidelines covering the manufacture of sterile medicinal products.
Its revised version strengthens the emphasis on a documented, facility-wide contamination control strategy, quality risk management, environmental and process monitoring and the use of appropriate technologies to minimise contamination risks.
The guidance is particularly relevant to manufacturers of injectable medicines and other sterile products, where contamination can pose serious risks to patient safety.
It affects both new production lines and existing facilities that need to demonstrate appropriate controls and compliance.
