Yokogawa has supplied an advanced batch control system to Takeda Pharma Ireland (a subsidiary of Takeda Pharmaceutical) at the new active pharmaceutical ingredient (API) plant in Dublin
The new active pharmaceutical ingredient (API) plant in Dublin is Takeda's first API facility to be constructed outside Japan.
The new plant will be used to develop and produce APIs used in clinical trials through to launch and full commercialisation.
In addition, Takeda also plans to produce APIs for products such as the diabetes 'blockbuster' drug Pioglitazone (brand name Actos).
To meet these challenges, the system has been specifically designed to be multipurpose, allowing a large number of products to be manufactured.
This necessitated the use of a comprehensive batch control system, and Takeda decided to use Yokogawa's CS3000 DCS batch control system, which is based on the ISA S88.01 batch standard.
The CS3000 batch control system also complies with the current FDA requirements for the use of electronic records and electronic signatures (as specified in FDA 21 CFR Part 11): an issue of vital importance when supplying control and information systems to the pharmaceuticals industry.
The system comprises a Centum CS3000 R3 with eight operator stations, one audit trail server, five field control stations, 4500 conventional I/O points, and Profibus communications to the packaged equipment.
In addition to the batch control functions, it produces online batch and process reports.
