ISO Clean Room Engineering International Standard

Clean Room Engineering Overview‌

Clean room engineering systematically controls airborne particles, bacteria, temperature, humidity, and pressure to provide ultra-clean environments for precision manufacturing (e.g., semiconductors, biopharmaceuticals). Its core objective is to maintain specific cleanliness levels (e.g., ISO Class 1 to 9) for pollution-sensitive production processes.

‌Key Technologies & Components‌

1. ‌Air Filtration System‌

   • Uses HEPA (99.97% @ 0.3μm) or ULPA (99.9995% @ 0.12μm) filters with three-stage filtration (pre-filter, medium filter, high-efficiency filter).
   • Unidirectional airflow design (vertical/horizontal) ensures uniform air distribution and prevents particle accumulation.

2. ‌Building Structure & Materials‌

   • ‌Walls:‌ Seamless welded stainless steel or color steel panels with rounded corners to eliminate cleaning dead zones.
   • ‌Floor:‌ Epoxy self-leveling or anti-static PVC flooring; raised floors for concealed piping.
   • ‌Ceiling:‌ Integrated FFU (Fan Filter Unit) with high-efficiency air supply.

3. ‌Pressure & Environmental Control‌

   • Maintains positive pressure (e.g., >15Pa) to prevent external contamination.
   • Temperature and humidity control within ±1°C and ±5% RH for semiconductor or pharmaceutical needs.

‌Cleanliness Classifications & Applications‌

‌Construction & Maintenance Key Points‌

1. ‌Cleanroom Construction Process‌

   • phased construction with cleaning/testing after each stage.
   • 3D modeling for optimized piping layout to avoid cross-contamination.

2. ‌Personnel & Material Management‌

   • Air showers for personnel; separate clean/dirty material pathways.
   • Cleanroom tools and anti-static packaging minimize secondary contamination.

3. ‌Regular Maintenance‌

   • Real-time particle monitoring; filter replacement as needed.
   • Sterilization and cleanroom cleaning (e.g., lint-free wipes, liquid-sealed drains).

‌Industry Trends & Challenges‌

• ‌Market Size:‌ Global market exceeds $300 billion in 2024, driven by semiconductors and biopharma.
• ‌Technical Challenges:‌ Corrosion-resistant design in coastal areas (e.g., Qingdao); energy-saving solutions (e.g., variable-speed FFU).