Designing clean rooms for operational excellence in pharma

Clean room operations bring significant challenges: high operational costs, unexpected downtime and delays in product introduction. A comprehensive digital twin, integrating infrastructure simulation and smart systems, directly addresses these issues. This approach facilitates contamination control strategies mandated by EU GMP Annex 1, minimizes physical experimentation, predicts contamination sources and accelerates time-to-market for new or modified pharmaceutical products.

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