Through in‑depth research and engineering experience in various industries' cleanrooms, Berbson understands the critical points of cleanroom environmental control. We comprehensively build advanced dust‑free cleanroom spaces from the aspects of standards, professionalism, system integration, energy saving, intelligence, and convenience. We provide comprehensive cleanroom turnkey services including cleanroom planning and design, personnel and material flow purification solutions, cleanroom building decoration systems, air purification systems, HVAC systems, pure water systems, specialty gas systems, electrical systems, plumbing systems, automatic control systems, compressed air systems, wastewater and exhaust gas systems, etc.

Sterile Medical Devices Cleanroom Air Cleanliness Classes
Class ≥0.5 μm (particles/m³) ≥5 μm (particles/m³) Sedimentation bacteria (CFU/plate) Airborne bacteria (CFU/m³)
1003,500015
10,000350,0002,0003100
100,0003,500,00020,00010500
300,00010,500,000≤60,00015

* Based on relevant standards for sterile medical device manufacturing.

Pharmaceutical Cleanroom Air Cleanliness Classes
Class At rest In operation
≥0.5 μm ≥5.0 μm ≥0.5 μm ≥5.0 μm
A3,520203,52020
B3,52029352,0002,900
C352,0002,0003,520,00020,000
D3,520,00029,000Not specifiedNot specified
Medical Device Cleanroom Engineering

According to relevant regulations, Class I, II, and III sterile medical device production workshops, pharmaceutical production workshops, medical biology laboratories, operating rooms, etc., are all required to construct GMP cleanrooms that meet applicable standards.

Referenced Standards & Codes
  • ISO/DIS 14644 – International standard for cleanrooms
  • GB50073-2001 – Cleanroom plant design code
  • GMP-97 – Cleanroom specification for medical device packaging workshops
  • GMP-98 – Good Manufacturing Practice for Pharmaceutical Products
  • JGJ71-90 – Cleanroom construction and acceptance code
  • GB50243-2002 – Ventilation and air conditioning construction and acceptance code
  • FS209E-92 – US Federal Standard (cleanroom classes)