Engineering Considerations for Facility Design
Most cleanroom facility failures happen long before construction begins, in the design phase where compliance gaps are hardest to spot.
Designing pharmaceutical and medical device facilities isn't just about building walls and installing HVAC systems. It's about engineering precision at the micron level where contamination control meets regulatory compliance.
Our latest guide breaks down the 6 critical considerations that determine whether your facility meets ISO 14644, EU GMP Annex 1, and FDA requirements:
Cleanroom Classification (ISO 5-8)HVAC Design (ACH rates, pressure differentials, HEPA filtration)Materials of Construction (seamless, cleanable, compliant)Environmental Monitoring SystemsStrategic Facility Layout & UtilitiesQualification Programs (V-Model approach
Enter your details below to download the full guide from Connected’s GMP Operations SME Monica Montanaro to see how proper engineering planning drives cost certainty, schedule confidence, and regulatory compliance.