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 complete 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.
| Class | ≥0.5 μm (particles/m³) | ≥5 μm (particles/m³) | Sedimentation bacteria (CFU/plate) | Airborne bacteria (CFU/m³) |
|---|---|---|---|---|
| 100 | 3,500 | 0 | 1 | 5 |
| 10,000 | 350,000 | 2,000 | 3 | 100 |
| 100,000 | 3,500,000 | 20,000 | 10 | 500 |
| 300,000 | 10,500,000 | ≤60,000 | 15 | — |
* Based on relevant standards for sterile medical device manufacturing.
| Class | At rest | In operation | ||
|---|---|---|---|---|
| ≥0.5 μm | ≥5.0 μm | ≥0.5 μm | ≥5.0 μm | |
| A | 3,520 | 20 | 3,520 | 20 |
| B | 3,520 | 29 | 352,000 | 2,900 |
| C | 352,000 | 2,900 | 3,520,000 | 29,000 |
| D | 3,520,000 | 29,000 | Not specified | Not specified |
Biopharmaceutical aseptic workshops differ from traditional cleanrooms. Especially for biopharmaceutical workshops, requirements for internal facilities and personnel are extremely high. In this regard, GMP biopharmaceutical workshops differ from traditional cleanrooms: product quality compliance means not only that the product meets registered quality standards, but also that the entire process complies with Good Manufacturing Practice (GMP).
The goal of aseptic GMP for biopharmaceutical enterprises is to establish a scientific, rigorous system for the production environment, processes, operation, and management of sterile drugs, to minimize all possible and potential biological activity, dust, and pyrogens. Through in‑depth research and engineering experience in biopharmaceutical production environments, Berbson clearly understands the key points of environmental control in biopharmaceutical processes.
Energy saving and emission reduction services include: GMP plant planning and design – personnel/material flow purification solutions, clean air conditioning systems, clean decoration systems; plant energy saving retrofitting, water & electricity, ultra‑pure gas piping, cleanroom monitoring, maintenance systems, and comprehensive installation services.
Recommended personnel purification sequence for biopharmaceutical cleanrooms (zones).