Cleanroom production

A cleanroom is a controlled environment in which the number of airborne particles and contaminants is minimised to ensure the quality and hygiene of manufactured components.

Cleanrooms are required for producing items that must meet the highest standards of cleanliness and precision, such as in medical engineering, the pharmaceutical industry and the optical sector.

Cleanroom classes range from ISO 1 to ISO 9 (according to DIN EN ISO 14644), with ISO 1 being the cleanest environment.

An ISO 8 cleanroom permits a maximum particle concentration of 3,520,000 particles per cubic metre for particles of 0.5 micrometres.

Air quality is monitored continuously by measuring particle concentration, temperature, humidity and air pressure. Specialised instruments capture these parameters in real time to ensure they comply with the relevant cleanroom class. Automatic alarms signal deviations, and regular calibration guarantees precise measurements.

A cleanroom offers controlled conditions for air purity, temperature and humidity – unlike conventional production areas. This prevents contamination and ensures product quality.

Industries such as medical engineering, pharmaceuticals, semiconductor manufacturing and optics rely on cleanroom production to meet strict requirements for precision and hygiene.

Components are produced using specially integrated machinery such as injection moulding systems positioned directly within the cleanroom to prevent contamination. Additional processes such as post-curing, assembly and packaging also take place under cleanroom conditions.

Personnel must undergo regular training to familiarise themselves with cleanroom procedures. Minimal movement and quiet communication are required, and protective equipment including hair nets, masks and gloves must be worn to avoid contamination.

HEPA or ULPA filters ensure air purification, laminar-flow systems maintain uniform air circulation and continuous monitoring controls air quality and temperature. Overpressure systems prevent contaminants from entering the cleanroom.

Cleanrooms must be cleaned regularly, sometimes several times a day depending on usage. The process uses special micro-porous cloths and disinfectants. Each cleaning cycle is documented to ensure compliance with cleanroom standards.

Quality control includes continuous air monitoring and regular sampling of air and surfaces. All measurement data and cleaning records are meticulously documented to verify compliance with cleanroom standards.