Cleanroom monitoring refers to the systematic inspection, measurement and recording of environmental parameters in cleanrooms to ensure compliance with specified cleanliness and contamination control standards. This process is of crucial importance in industries where strict requirements regarding environment purity have a direct impact on product quality and process safety, e.g. in the pharmaceutical, biotechnology, microelectronics, food, and cosmetics industries.

The most important aspects of cleanroom monitoring (German translation: Reinraumüberwachung) include:

• Particle concentration: Measurement of the number and size of particles in the air to determine the cleanliness class of a room. Particle counters and other purpose-built devices are used for this.
• Microbiological monitoring: Regular sampling to assess the microbiological contamination of surfaces, equipment and air. Cultivation methods, PCR and other biological tests are used.
• Temperature and humidity: Maintaining and monitoring optimum temperature and humidity conditions that are crucial for many manufacturing and research processes.
• Air pressure: In many cleanrooms, excess pressure (translation into German: Überdruck) is maintained in order to prevent the ingress of particles from less clean areas. These types of cleanrooms are known as positive-pressure cleanrooms.
• Ventilation and filtration: Monitoring of ventilation and air filtration systems, including inspection of HEPA filters to ensure proper air purification of particles and contaminants.
• Documentation and reporting: Complete and uninterrupted documentation of monitoring results and measures to control and improve cleanroom conditions.

Cleanroom monitoring is primarily used to ensure product quality as part of aseptic manufacturing (German translation: aseptische Herstellung). This process minimizes the risk of products, processes and research being contaminated. Of course, compliance with the legal regulations is also a must. Cleanroom monitoring is an integral part of quality management in companies and research facilities where cleanroom requirements are of crucial importance.

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