What is Cleanroom Engineering?
Simply put, cleanroom engineering is a systematic project that uses air filtration, airflow control, and environmental monitoring to control pollutants such as dust, microorganisms, and harmful gases within specific standards in a cleanroom, while maintaining stable parameters such as temperature, humidity, and pressure differential.
From ISO 14644 cleanliness levels (Class 1 to Class 9) to GMP pharmaceutical workshop standards, the requirements for cleanliness levels vary significantly across industries—the electronics industry may require Class 5 (≤352 0.5μm particles per cubic meter), while food workshops typically only require Class 8.
Why must factories prioritize cleanroom engineering?
1. Maintaining the Bottom Line of Product Quality
In precision manufacturing fields such as semiconductors and optical instruments, even particles 1/200th the size of a human hair can cause short circuits and decreased precision; in the biopharmaceutical industry, excessive microbial levels directly violate GMP regulations, posing a risk of production stoppage. 1. Cleanroom engineering controls pollution at its source, reducing product defect rates by over 30%.
2. Compliance is a prerequisite for production.
Industries such as pharmaceuticals, medical devices, and food contact materials are subject to mandatory national cleanliness standards for production environments. Even with advanced technology, workshops that fail cleanroom engineering acceptance cannot obtain production licenses.
3. Reduce hidden production costs.
Uncleaned workshops may increase costs due to frequent rework, batch scrapping, and accelerated equipment wear. A well-designed cleanroom system, while requiring initial investment, can recoup costs in the long run through stable production efficiency.
4. Protect occupational health.
In industries such as chemicals and spray painting, untreated volatile organic compounds (VOCs) and dust in workshops can harm employee health. Cleanroom engineering's waste gas treatment and fresh air systems can simultaneously achieve "clean production" and "healthy work."
What are the core systems included in cleanroom engineering?
A complete cleanroom system is not a single piece of equipment, but the result of multiple systems working together:
Air Purification System: The core components are high-efficiency particulate air (HEPA) filters and ultra-high-efficiency particulate air (ULPA) filters, working in conjunction with pre- and medium-efficiency filters to form a three-stage filtration system capable of intercepting over 99.97% of particles as small as 0.3μm.
Envelope Structure: Utilizing dust-proof, mildew-proof, and easy-to-clean materials (such as stainless steel and PVC roll materials), the junctions between walls, floors, and ceilings are rounded to prevent dust accumulation.
Ventilation and Differential Pressure Control: Maintaining positive pressure in the clean area by ensuring the supply air volume exceeds the exhaust air volume to prevent external contaminants from entering; a pressure gradient (typically 5-10 Pa) is established between areas of different cleanliness levels.
Cleanroom Auxiliary Systems: These include air showers for personnel entry, pass-through windows for material transfer, and clean benches, minimizing the introduction of contaminants through meticulous attention to detail.
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