Client & Project Overview
Teleflex Medical is a global provider of medical technologies with a long-established manufacturing presence in Limerick. To support business continuity and growth, Teleflex urgently required the delivery of a new cleanroom facility within an existing, fully operational medical device manufacturing campus. The project involved the fast-tracked design, installation, commissioning, and qualification of a new ISO Class 8 cleanroom, delivered under strict regulatory and operational constraints.
The cleanroom had to meet all relevant medical device regulatory standards, including GMP and GEP requirements, while also satisfying Irish planning, fire safety, Disability Access Certificate (DAC), and building control obligations. A key challenge was delivering the retrofit works without interrupting the site’s 24-7 manufacturing operations. The work area was surrounded by other occupied production and business zones, with neighbouring operations required to remain live at all times. Maintaining safety, access, and good communication with adjacent users was essential throughout the project.
PEMCAS was appointed to provide a fully integrated service, including engineering, architectural, and health and safety consultancy. From the outset, the approach was to “design in compliance,” ensuring that regulatory, statutory, and quality requirements were embedded into the design rather than addressed retrospectively. This enabled approvals, procurement, and construction planning to progress in parallel, significantly reducing programme risk.
Through close collaboration with Teleflex and a clear understanding of both operational and regulatory drivers, the new cleanroom was delivered, commissioned, and qualified on time and within budget, while the wider facility continued to operate safely and efficiently.
Key Insights
In regulated environments such as medical device manufacturing, early and proactive compliance is critical to programme certainty. Designing with regulatory standards, statutory permissions, and certification requirements embedded from the outset allowed approvals for planning, fire safety, and DAC to progress smoothly alongside design and procurement.
Equally important was understanding the realities of a live site. Careful sequencing, clear communication with neighbouring business areas, and strong health and safety management allowed construction works to proceed without disrupting round-the-clock production. The project demonstrates how a coordinated, compliant, and practical approach—supported by a fully in-house multidisciplinary team—can deliver complex retrofit projects successfully while maintaining operational continuity and client confidence.
