Clean environments are critical in various industries, such as hospital operating rooms, health food GMP workshops, animal laboratories, and production environments for disposable hygiene products. Conducting clean environment testing is essential for ensuring personnel health, food safety, product quality and reliability, and compliance with legal and regulatory requirements.
Medical Device Industry:
Cleanrooms play a vital role in the production of medical devices. YY/T 0033-2000 Good Manufacturing Practices for Sterile Medical Devices specifies that the cleanliness of medical device production workshops must meet certain levels, and parameters such as settling bacteria, airborne bacteria, air exchange rate, static pressure difference, temperature, and relative humidity must also comply with requirements.
Pharmaceutical Industry:
Cleanrooms are crucial in pharmaceutical production. Ensuring the proper operation of cleanrooms is a prerequisite for drug manufacturing. China's Good Manufacturing Practices for Pharmaceutical Products (2010 Revision) classifies pharmaceutical workshops into four grades (A, B, C, D) and sets clear requirements for cleanliness and microbial levels.
Veterinary Drug Industry:
The Good Manufacturing Practices for Veterinary Drugs (2020 Revision) also classifies workshops into four grades (A, B, C, D) and specifies requirements for cleanliness and microbial levels.
Electronics Industry:
Cleanrooms for semiconductor materials, chip manufacturing, and other electronic industries have strict requirements for parameters such as cleanliness, static electricity, and vibration.
Cosmetics Industry:
The Good Manufacturing Practices for Cosmetics sets clear requirements for the cleanliness, pressure difference, and microbial levels of cosmetics production workshops.
Clean Benches, Medical Clean Benches, and Biosafety Cabinets:
Testing parameters such as air velocity, cleanliness, airflow pattern, and HEPA filters is crucial for ensuring the safety of samples, personnel, and the environment.
No. | Testing Objects |
1 | Clean Zones (Rooms) and Related Controlled Environments |
2 | Cleanrooms for the Electronics Industry |
3 | Laboratory Animal Environments and Facilities |
4 | Biosafety Laboratories |
5 | Cleanrooms (Zones) for Pharmaceutical Packaging Material Production |
6 | Hospital Clean Controlled Areas/Operating Rooms |
7 | Ventilation and Air Conditioning Systems |
8 | Clean Benches |
9 | Medical Clean Benches |
10 | Biosafety Cabinets |
11 | Ultraviolet Germicidal Lamps |