Cleanroom Technology for medical devices

Cleanroom technology covers everything that creates and maintains the controlled environment: planning and construction, ventilation and filtration, airlocks and pressure cascades, monitoring, qualification — and day-to-day operation with cleaning, garments and training. Classification to ISO 14644-1 is only the result; it is produced by air changes, airflow management and discipline.

The greatest lever is rarely the technology. People are the dominant particle source, and most deviations arise at airlocks, during material transfer, and from habits that creep in. A room built and qualified as class 7 delivers class 7 in operation only if garments, cleaning schedule and rules of conduct are followed and monitored.

For buyers it is worth distinguishing construction from operation. The providers listed here range from planners and system builders through suppliers of filters, benches and airlocks to service providers for qualification to ISO 14644-3, particle measurement and cleanroom cleaning. Anyone building new needs different partners than anyone requalifying an existing room.