Cleanroomnormen

Cleanroomnormen describes standards and guidelines for the planning, construction, operation and monitoring of cleanrooms to minimize contamination by particles, microorganisms and other pollutants in sensitive processes. They are essential in industries such as pharmaceuticals, biotechnology, electronics, medical devices and laboratories, where even trace contaminants can impact product quality and process reliability.

The core framework is the ISO 14644 series. ISO 14644-1 defines the classification of air cleanliness by particle concentration; ISO 14644-2 deals with ongoing monitoring of the cleanroom environment; ISO 14644-3 outlines test methods; ISO 14644-4 covers design, construction and start-up; ISO 14644-5 addresses operation, qualification and ongoing verification. In addition, ISO 14698 focuses on biocontamination control. In practice, cleanrooms are commonly described by ISO classes (for example ISO 5, ISO 7, ISO 8) and, in European GMP, by Grade A, B, C and D designations depending on the required level of contamination control.

Implementation typically involves engineered airflow with HEPA or ULPA filtration, laminar or mixed-flow air distribution, suitable surface materials, and controlled gowning and cleaning procedures. A robust cleanroom program also includes qualification and validation activities (IQ, OQ, PQ), periodic performance checks, and environmental monitoring that covers particle counts, microbial testing, differential pressures, temperature and humidity.

Cleanroomnormen thus provide a coherent, internationally recognized basis for achieving and maintaining high levels of cleanliness and reproducibility across industries, while requiring regular audits and updates in response to revised standards.