Takeda Ireland introduces digital pharma operations

PAS-X operator.

Successful transformation to paperless factory brings huge benefits in quality, regulatory compliance, operations and data availability.

“With the help of Werum’s PAS-X MES we were able to successfully transform our Grange Castle site into a paperless factory,” says Paul Keogh, Plant Director at Takeda Ireland Limited Grange Castle. “The new digital operations provide huge quality, regulatory, operational, and data availability benefits. Example benefits include work standardization, human error avoidance, data entry reduction, batch review by exception, manufacturing decision support, material management, data visualization, etc. Moreover, the MES-based Level 2-4 integration architecture provides a solid platform for digital innovation and operational expansion.”

Werum’s PAS-X MES automatically pulls manufacturing data from the shop floor by integrating Takeda’s Process Control System via OSIsoft PI Historian. Thus, approximately 94% of all parameters in each batch record are automatically entered to the batch record. MES is configured to download recipes to the process control layer and to synchronize Electronic Batch Recording (EBR) with process controls in real-time to ensure batch data entry is contemporaneous and original as production progresses. In addition to the basic data integrity benefits, PAS-X EBR enforces additional operator confirmations and electronic signatures where required based on GxP and safety risks. Through EBR the manufacturing process is highly standardized, and batch review by exception is supported.

In addition to the shop floor integration, new PAS-X SAP interfaces were developed during the Takeda Ireland project as part of a global SAP template rollout across Takeda. These interfaces enable a seamless exchange between the global supply chain and the local manufacturing execution process.

The integrated MES template provides a basis for MES expansion to support operations for two new innovative manufacturing plants currently under construction at the Takeda Ireland Grange Castle campus. The new plants are solid oral dose and liquid vial based drug products employing high containment and cell culture technologies respectively.