Rompa Group's Czech cleanroom officially certified to ISO Class 7

Rompa Group’s new cleanroom at our facility in Vyškov, Czech Republic, has officially achieved ISO Class 7 classification, following independent testing conducted in September 2026. The milestone further strengthens the company's manufacturing capabilities for the Life Sciences industry. 

The facility began operations earlier this year and was officially opened at a ceremony in June, marking a significant investment in Rompa's ability to support customers in the healthcare, medical devices and diagnostics sectors. 

The new assessment provides independent confirmation that the cleanroom meets the stringent airborne particle concentration limits defined by EN ISO 14644-1:2015. 

The certification was carried out by MERTEX Laboratory, an authorised testing body in the Czech Republic. Importantly, testing was conducted while the cleanroom was fully operational, with multiple employees present, production activities underway, and all ventilation and filtration systems running under normal working conditions. 

Measurements were taken at 25 locations throughout the main production area, covering approximately 414 m². All measurement points met the required ISO Class 7 limits.  

The cleanroom supports injection moulding and assembly of medical devices and healthcare components, including highly automated production lines for advanced diagnostic products. 

Its design also reflects Rompa's commitment to combining manufacturing quality with operational efficiency. 

High-efficiency HEPA filtration and an optimised airflow design help maintain the required particle control levels without relying on unnecessarily high air circulation volumes. This approach is designed to reduce energy demand while maintaining the controlled conditions required for sensitive manufacturing processes. 

The result is a production environment that balances strict cleanliness requirements, manufacturing efficiency, and responsible energy use. 

Achieving ISO Class 7 classification is another step in Rompa Group's long-term strategy to expand its capabilities in highly regulated manufacturing environments. 

For existing and prospective Life Sciences customers, the independently verified cleanroom provides additional assurance that Rompa can support demanding manufacturing requirements. 

Learn more about Rompa’s Life Sciences capabilities here.