Task
An old filling line consisting of two process steps, filling and sealing, is in operation at a pharmaceutical company’s site. Due to the age of the system, future system availability, production reliability, and spare parts supply can no longer be guaranteed. To ensure long-term production capability, a new, modern, and GMP-compliant filling and sealing machine must be installed.
The main objective of the project is to provide comprehensive support to the customer in the field of automation – from the early planning phase to the handover of the plant ready for operation. Project support and coordination should cover all relevant phases, such as detailed requirements analysis and technical design, support in supplier selection, and technical coordination.
The goal is not just to deliver a new machine, but also to provide a process-reliable, GMP-qualified, and fully approved overall solution that can be seamlessly integrated into the existing production environment.
Solution
To ensure successful implementation, the Lehmann Engineering project team assumed a central interface function between customer and suppliers. This support includes, in particular, managing and coordinating automation requirements, actively liaising with suppliers, conducting GMP qualification processes, and ensuring that the system meets customer and GMP requirements.
This comprehensive support ensures that the new plant meets technical, qualitative, and
regulatory requirements and can be safely transferred to production.
Customer benefits
- Comprehensive handling of all automation issues from a single source
- Coordination and management of suppliers
- Ensuring GMP- and GAMP (Good Automated Manufacturing Practice)-compliant qualification of the entire system
- Support throughout the entire project, from specification to handover
