Something about Cleanroom System Design and Technical Requirements
To meet the specific needs of different industries, cleanroom designs must be tailored based on universal standards.
- Core Environmental Parameter Standards
This section provides a common foundation for all cleanroom designs and is not limited by industry.
- Air cleanliness: Classified according to ISO standards, from the highest ISO Class 5 to ISO Class 9, to meet the suspended particulate control requirements of different processes.
- Temperature and Humidity: The basic temperature range is 18-26°C, with humidity adjusted based on industry requirements (e.g., the food industry requires ≤75% to prevent condensation).
- Noise: The indoor noise level should not exceed 65 dB(A).
- Lighting: The average illuminance should not be less than 500 lx.
- Ventilation and Pressure Differential:
Fresh air volume: Ensure at least 40 m³ per person per hour to maintain positive pressure and compensate for exhaust airflow.
Airflow Distribution: Ensure an orderly flow of air from clean areas to less clean areas through rational supply, return, and exhaust air design.
II. Detailed Explanation of Industry-Specific Configurations
In addition to general standards, each industry requires the following specific technologies and designs.
- Biomedical: Focus on biosafety and sterility assurance
Linking levels and safety: Class A (ISO 5) filling areas and Class B (ISO 6) cell manipulation areas are fundamental. Operations involving high-risk pathogens must integrate BSL-2/3 biosafety laboratory designs, centered around negative pressure environments, airtight structures, double-door interlocks, and emergency showers.
Key Units: The sterilization room must be independent, constructed of fire-resistant and high-temperature resistant materials, and equipped with a double-door sterilizer or VHP atomizer disinfection equipment.
Isolation Principles: Different functional areas must be physically isolated, with personnel and logistics strictly separated.
- Food Industry: Focuses on microbial control and contamination prevention.
Zoning Control: Strictly adhere to a "clean to dirty" process layout. Clean work areas (such as the inner packaging room, ISO Class 8) must be located upwind, creating a pressure gradient with semi-clean areas (such as the raw material processing area, ISO Class 9).
Environmental Suppression: Strictly control low temperatures (18-26°C) and low humidity (≤75%) to inhibit microbial growth.
Hygienic Design: The ventilation system primarily utilizes primary and secondary filtration, emphasizing regular filter replacement and cleaning.
- Cosmetics Industry: Focuses on chemical contamination control and material compatibility.
Local Protection: Within the ISO Class 8 emulsification and filling rooms, Class 100 clean benches are installed to provide an ultra-clean environment for core operations.
Corrosion-Resistant Materials: Anti-mold and corrosion-resistant materials are preferred for interior decoration, such as anti-mold paint, color-coated steel plates, and epoxy self-leveling flooring. All joints must be sealed. Exhaust Gas Treatment: The exhaust system must be integrated with an activated carbon adsorption device to effectively remove volatile organic compounds (VOCs) generated during the production process.
Suzhou Pharma Machinery Co.,Ltd.
2025/10/29
Tia
