Batch control helps at Irish pharmaceutical plant

Active pharmaceutical ingredient plant designed to be multipurpose, allowing a large number of products to be manufactured, necessitated the use of a comprehensive batch control system,

Yokogawa has supplied an advanced batch control system to Takeda Pharma Ireland, a subsidiary of Takeda Pharmaceutical, for its active pharmaceutical ingredient (API) plant in Dublin.

This is Takeda's first API facility to be constructed outside Japan.

The 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).

The system has been 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 system also complies with FDA requirements for the use of electronic records and electronic signatures (as specified in FDA 21 CFR Part 11), which is important 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.

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