cleanrooms

Cleanrooms are controlled environments designed to minimize the introduction, generation, and retention of airborne particles and other contaminants. They are used in industries and research areas where even tiny amounts of dust, microbes, or chemical vapors can compromise product quality, reliability, or safety. Typical controls include restricted access, controlled temperature and humidity, high-efficiency filtration, and specialized cleaning protocols.

Airflow and filtration are central features. Most cleanrooms use unidirectional or turbulent airflow paired with HEPA or ULPA filters to maintain low particle levels. Positive or negative pressure relative to adjacent spaces helps prevent ingress of contaminants. Personnel and equipment enter through gowning and air showers, and workers wear cleanroom garments and procedures to minimize contamination. Surfaces are finished for easy cleaning, and cleaning is performed with validated methods.

Standards and classifications are defined by ISO 14644. Cleanliness is classified by particle concentration in the air for specified particle sizes, with tighter classes indicating cleaner environments. The ISO 14644 series also provides methods for testing, monitoring, and validating cleanroom performance. GMP and other regulatory frameworks in pharmaceuticals and medical devices often require cleanroom classifications and validation appropriate to the intended use.

Applications are broad and include semiconductor fabrication, pharmaceutical manufacturing, biotechnology, medical device production, hospital sterile rooms, and analytic laboratories. Operational considerations include energy use, maintenance of filtration systems, environmental monitoring, and ongoing qualification and certification.

Maintenance and validation involve IQ, OQ, and PQ, along with regular particle counts, filter integrity testing, pressure differential checks, surface sampling, and routine cleaning. Continuous monitoring and periodic re-qualification ensure sustained compliance.

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