A cleanroom is not just about "looking clean," but about achieving a truly "dust-free and sterile" environment through scientific design, engineering technology, and standardized procedures, ensuring the smooth conduct of precision experiments and biosafety.
I. What is a Cleanroom?
A cleanroom, also known as a dust-free room or clean space, is a professional space that controls the concentration of particles, bacteria, and contaminants to extremely low levels through air purification, differential pressure control, material restriction, and personnel and material flow management.
Suitable for the following scenarios:
▶ Biological laboratories (P2, P3 level)
▶ Pharmaceutical workshops (such as GMP sterile preparation rooms)
▶ Precision manufacturing (chips, medical devices)
▶ PCR laboratories, cell culture rooms
II. How to Achieve "Dust-Free and Sterile"? Six Systems Working Together for Guarantee
◆ Cleanroom Air Conditioning System (HVAC)
This is the "lungs" of the cleanroom. It performs core functions such as filtration, temperature and humidity control, airflow organization, and differential pressure management.
HEPA high-efficiency filters (99.99%) are standard equipment in clean laboratories.
◆ Cleanroom Construction Materials
The outer casing material must be dust-free, dust-free, easy to clean, and non-corrosive.
Avoid using materials such as plasterboard and wood, which are prone to powdering, moisture absorption, and microbial growth.
◆ Cleanroom Conduct Guidelines
Humans are the biggest source of contamination in clean laboratories. All personnel must strictly adhere to the following operating procedures:
Gown Changing Procedure: Outerwear → First Gown → Second Gown → Cleanroom Gown
Pre-Entry Air Shower: Dust removal in the air shower for 10–20 seconds.
Cosmetics, paper, and fibrous items are prohibited.
Strictly control the number of personnel and their stay time according to the cleanliness level of the area.
◆ Zoning and Pressure Differential Management
Clean laboratories are divided into "dirty-clean-cleaning" zones according to cleanliness level, and "unidirectional airflow" is achieved through pressure differential:
Generally, a pressure differential of ≥10Pa is required.
High-cleanliness areas (e.g., Class B) maintain positive pressure externally.
Areas with contamination risk (e.g., inside biosafety cabinets) maintain negative pressure.
◆ Local Purification Devices
For critical operating locations, such as PCR amplification areas, cell inoculation stations, and aseptic packaging areas, the following additional devices will be installed:
Biosafety cabinets (BSC), laminar flow operating tables, clean benches, and local Class 100/Class 1000 air supply outlets to ensure that the local cleanliness level reaches ISO 5 (Class 100) or higher.
◆ Maintenance and Monitoring Mechanisms
Regular testing of air cleanliness (suspended particles); monitoring of microbial settling bacteria; online recording of pressure differential, temperature, and humidity; regular replacement of HEPA filters; annual cleanliness certification (such as GMP verification).
Special Note: Even the highest level of cleanroom design cannot truly achieve "dust-free and sterile" conditions if subsequent maintenance is inadequate.
The "cleanliness" of a cleanroom is the systematic result of design, materials, equipment, and management.
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