Design, simulate and optimize clean rooms to meet rigorous regulatory demands in pharma

Pharmaceutical clean rooms are expensive to operate, difficult to validate and increasingly subject to regulatory pressure. EU GMP Annex 1 now mandates a contamination control strategy that spans facility design, equipment integration and particle behavior management. Traditional design methods, built on oversized HVAC systems and physical trial-and-error, can no longer meet these demands at speed or cost.

This white paper shows how a comprehensive Digital Twin, combining infrastructure simulation and smart building systems, gives pharmaceutical manufacturers a proactive path to compliance, lower operational costs and faster time-to-market.

What pharma manufacturing leaders face today

• High operational costs driven by continuous HVAC operation regardless of production status
• Costly validation failures from reactive, experimental design methods
• Regulatory complexity as EU GMP Annex 1 requires documented contamination control strategies covering facility design, equipment and process behavior
• Slow adaptation to product changes, with a typical 25% annual product modification rate

How digital simulation solves it

Siemens software enables pharmaceutical manufacturers to build and verify a Digital Twin of the clean room before physical construction or modification begins. This means:

• Design verification using existing computer-aided design (CAD) and building information management (BIM data) converted into parametric models in NX™ software or Solid Edge® software
• Equipment placement and material flow optimization using Plant Simulation in the Tecnomatix® portfolio
• Precise airflow, particle and temperature modeling using Simcenter™ STAR-CCM+™ software computational fluid dynamics (CFD) simulation to meet Annex 1 contamination control requirements
• System-level HVAC sizing using Simcenter Amesim™ software and multi-disciplinary optimization using Simcenter HEEDS™
• Real-time monitoring and predictive control through Building X, Siemens' cloud-based smart infrastructure platform, which identifies contamination sources, reduces unplanned standstills and supports demand-controlled ventilation for energy savings

Key takeaways

• How to build an executable Digital Twin (xDT) that enables real-time response to changing clean room conditions
• How CFD simulation accelerates validation and reduces physical smoke testing
• How Building X integrates with control systems to maintain Annex 1 compliance and cut energy consumption
• How to reduce documentation burden and accelerate time-to-market for new and modified pharmaceutical products

Download the white paper to learn how Siemens' integrated Digital Twin approach transforms clean room design from a reactive cost center into a proactive competitive advantage.