METALPLAST’s ISO 8 cleanroom is a highly specialized manufacturing environment, designed to ensure the highest levels of cleanliness, safety, and control in the production of plastic components for the medical, biomedical, and pharmaceutical sectors.
Classified as ISO 8 in accordance with ISO 14644-1, the cleanroom guarantees stable environmental conditions through advanced air filtration systems and precise control of pressure, temperature, and humidity. This significantly reduces the risk of contamination from dust and micro-particles, ensuring process reliability, production repeatability, and full regulatory compliance.
The cleanroom houses four injection molding machines ranging from 60 to 240 tons, dedicated to the processing of plastic materials in a controlled environment. The entire department is fully integrated into an Industry 4.0 production process, managed via an MES system that enables continuous monitoring of every production phase, comprehensive process data collection, and complete product traceability.
This advanced technological approach allows for precise control of production parameters, consistently high quality standards, and efficient process management—essential requirements for supplying highly regulated industries where precision, safety, and quality are non-negotiable.
Thanks to its ISO 8 cleanroom, METALPLAST is able to provide reliable, regulation-compliant solutions for the manufacture of medical-grade plastic components, meeting the needs of customers who demand high standards and fully certifiable processes.