Life Sciences Facility Engineering

What we deliver

• GMP Facility Design Package: process-driven layout, personnel and material flows, classified area strategy and cross-contamination control
• HVAC Design for Controlled Environments: pressure regime, air change rates, filtration, and temperature and humidity control for classified zones
• Containment Engineering: containment strategy for potent compounds and biological agents, including biosafety level considerations and pressure control
• Clean Utilities Design Input: water for injection, purified water, clean steam and process gas distribution requirements
• URS and Design Documentation: user requirement specifications, design qualification input and traceability to GMP expectations
• Regulatory Readiness Support: alignment of design and documentation with MHRA and EMA inspection expectations

Who it is for

• Pharmaceutical and biotech companies building or upgrading manufacturing capacity
• Contract manufacturers and CDMOs expanding regulated production
• Project and engineering leads needing GMP-literate facility design

Standards & regulations

Design driven by process and flow

Good GMP facilities start with process. We map material and personnel flows, define classified area boundaries, and design segregation that prevents mix-up and cross-contamination. Layout, pressure cascade and airlock strategy are developed together so that quality risk is engineered out rather than managed later.

Containment and controlled environments

For potent compounds, sensitising agents and biological material, we develop containment strategies that protect product, operator and environment. HVAC is designed for the required pressure regime, filtration and recovery, with controlled environments held to the temperature, humidity and cleanliness parameters the process demands.

Aligned to ISPE and inspection expectations

Using ISPE baseline principles and a clear URS-to-design trail, we align facility engineering with MHRA and EMA expectations. The result is a design that supports qualification and inspection, reducing rework and accelerating the path to licensed production.

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