Modular Cleanrooms

1. Temperature: 20–24 °C with control accuracy of ±0.5 °C, ±1 °C, or ±2 °C

2. Humidity: 45–60% RH with control accuracy of ±2% RH or ±5% RH

3. Our modular cleanrooms are designed to comply with international standards, including ISO 14644, FED-STD-209E, and GMP guidelines (EU GMP Annex 1, FDA cGMP). They can be flexibly configured to meet different cleanliness levels:

• Class 10 (ISO Class 4) – GMP Grade A

  Ultra-clean environments for aseptic filling, critical semiconductor and nanotechnology processes.

• Class 100 (ISO Class 5) – GMP Grade A/B

 Widely used in sterile pharmaceutical manufacturing (Grade A: laminar airflow zones, Grade B: clean background),        precision electronics, and medical device production.

• Class 1,000 (ISO Class 6) – GMP Grade C

  Suitable for optical instruments, high-precision assembly, and secondary pharmaceutical manufacturing steps.

• Class 10,000 (ISO Class 7) – GMP Grade C/D

 Commonly used in pharmaceutical packaging, clean laboratories, and electronics assembly lines.

• Class 100,000 (ISO Class 8) – GMP Grade D

 Applied in general industrial cleanrooms, non-sterile pharmaceutical manufacturing, and controlled industrial spaces.

 Note: FED-STD-209E has been replaced by ISO 14644, but the Class terminology (e.g., Class 100, Class 1,000) is still widely used in the cleanroom industry. GMP guidelines apply specifically to pharmaceutical and biotechnology cleanrooms.

Please refer to the official ISO website for details: https://www.iso.org/standard/53394.html [ISO 14644-1:2015 – Cleanrooms and associated controlled environments – Part 1: Classification of air cleanliness by particle concentration]