Leading biotech company Genzyme has deployed the Manufacturing Executions System (MES) PAS-X from the software specialist Werum Software & Systems at its production site in Waterford, Ireland.
The facility has an annual capacity to produce and pack 800 batches and is one of the primary tableting and bottling centres for the successful kidney dialysis drug Renagel.
Genzyme has made its Waterford site a state-of-the-art manufacturing facility that sets new standards of excellence in quality, compliance and efficiency. The implementation of an MES has been an essential step towards reaching this status. Werum's PAS-X drives Genzyme's right-first-time and real-time-release strategy in manufacturing by introducing paperless electronic batch recording.
PAS-X is an off-the-shelf product specifically designed for the pharmaceutical and biopharmaceutical industries. It helps in streamlining manufacturing processes, improving product quality, decreasing product cycle times, increasing equipment efficiency and assuring compliance within GMP- and FDA-regulated production and packaging environments.
Genzyme's use of the software modules from the PAS-X portfolio enables the coverage of a broad spectrum of functionality. The core functions include recipe creation (MBR), weighing (WD), electronic batch recording (EBR), warehouse management (WMS), material tracking (MT), and deviation management (DM). The MES system is a central building block in the IT infrastructure of the facility and links the enterprise administration with the equipment level. PAS-X exchanges data with the business level through an ERP interface and also integrates the shop floor equipment.
In parallel with the implementation, Genzyme has started to build a further expansion of the pharmaceutical site. The Renal Expansion building is occupying 7,500m2 and will provide Genzyme Waterford with a 100% increase in tableting capacity by implementing the latest state-of-the-art tablet manufacturing process.