Task
A pharmaceutical company needed to replace its aging packaging line with a new one that should meet the highest standards in terms of quality, automation, and efficiency. The company therefore sought expert support in planning the automation technology. Complete project support was required: from supplier testing and acceptance, commissioning, qualifications, and processing any open issues, right through to handover.
Solution
Lehmann Engineering took over the entire automation project from planning to commissioning and defined the requirements in a specification sheet. We coordinated the system suppliers and all interfaces between the individual businesses. In addition, we carried out the entire qualification process in accordance with DQ, IQ, OQ, and PQ. For this, we set up and processed all relevant documents, including URS, GxP risk analysis, plans for FAT/SAT (Factory Acceptance Test / Side Acceptance Test), and qualification plans. After completion, the customer was able to immediately put the the new packaging line into operation.
Customer benefits
- Everything from a single source – one contact person throughout the entire project
- Processing of automation issues in accordance with factory standards
- Complete documentation and qualification from a single source
- Efficient supplier coordination and smooth, on-time commissioning
- Establishment of batch traceability forwards and backwards
