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Classification and Control of Contaminants in Clean Rooms
2026/5/13
I. Classification of Contaminants (reduced by nature + form)
1. Main types of contaminants

2. Key classification dimensions
By particle size: ≥ 0.5 μm (for routine monitoring), ≥ 0.1 μm (for high-grade clean rooms, such as Class 1-10)
According to the hazards: lethal pollutants (toxic gases, pathogenic bacteria), functional pollutants (particles that affect product performance)
II. Core Control Measures (Derived from Different Aspects)
1. Source Control (Most Critical)
Personnel: Wear clean suits (covering from head to toe), pass-through shower for dust removal, prohibit bringing in cosmetics / Materials: Clean incoming materials, sealed transportation, go through transfer window / air lock chamber purification equipment: Select low-dust equipment, regular maintenance to avoid wear, exhaust and filtration treatment of equipment 2. Process Control (Dynamic Maintenance)
Air Purification: HEPA/ULPA filters (filtration efficiency ≥ 99.97% @ 0.3 μm), laminar air supply (vertical / horizontal)
Pressure control: Positive pressure in the clean room (to prevent external contamination from entering), pressure difference ≥ 10 Pa
Humidity and temperature control: Temperature 20-24℃, humidity 45-65% (to inhibit microorganisms + reduce static electricity)
Cleaning Management: Use lint-free cloths and dedicated cleaning agents. Do not use dry sweeping (to prevent dust).
3. Terminal Monitoring and Emergency Response
Real-time monitoring: Particle counter (particle concentration), microbial sampler, temperature and humidity / pressure difference sensor
Emergency handling: Increase the ventilation frequency when the standard is exceeded, isolate the contaminated area, and investigate the source of contamination (personnel / equipment / materials)
III. Key Indicators (Core Parameters)
Cleanliness level: ISO 14644-1 (Class 1 to 9), with a particular focus on ≥ 0.5 μm particle count
Air exchange frequency: ≥360 times/h for Class 100 grade, ≥200 times/h for Class 10,000 grade (adjust as needed)
Microbial limit: Pharmaceutical industry (GMP) ≤ 10 CFU/m³ (critical areas)




