Life Sciences Fill Finish Facility Ireland

Linesight collaborated with this client on a large scale project aimed at enhancing production of a prescription medicine for a number of cancers. The goal was to implement a flexible product line with a Level 5 exposure category design within a modular cleanroom, ensuring scalability and optimised output.

Key site challenges were addressed, including potential space limitations for expansion, managing logistics and site access during construction, and ensuring compliance with local environmental regulations. Additionally, the client targeted and worked towards achieving LEED certification at either the “Certified” or “Silver” level, reflecting its commitment to sustainability.

Linesight implemented a stringent Quantitative Risk Analysis (QRA) of the project throughout it’s development, offering valuable insights into the project’s risks and uncertainties. This enabled the client to make well-informed decisions and prioritise risk mitigation efforts. This proactive strategy played a significant role in the project’s success. By identifying and quantifying the risks, Linesight helped the client prioritise their efforts and by implementing these controls, the client met this project milestone.

The project had a base estimate of approximately €500 million, but there was uncertainty about potential cost overruns due to various risks. Linesight’s QRA provided a risk-adjusted cost estimate, giving the client a clearer picture of the potential cost outcomes. This allowed for better cost management and contingency planning.

The project was exposed to new and complex proccesses and the risk mitigation effort involved controls on exposure levels from the design and modular manufacturing point of view, and on the seamless introduction of the new flexible line into exisiting operational processes. The QRA identified process-related risks as major drivers of both schedule and cost uncertainty. By highlighting these process uncertainties, the QRA helped the client focus on areas where process optimisation and control were critical. This involved refining procedures, improving training, and implementing stricter quality control measures.