Technical Information
Comparison Of Cleanroom Standards
The Comparison of Cleanroom Standards table provides a detailed analysis of various international cleanroom standards, including U.S.209E 1992, ISO 14644-1 1997, EEC GGMP 1989, VDI 2083 1990, BS 5295 1989, and JACA B 9920 1989. These standards are essential for maintaining controlled environments in industries where contamination control is critical, such as pharmaceuticals, biotechnology, and microelectronics.
Overview of Standards
- U.S.209E 1992:
- This standard specifies the allowable number of particles per cubic meter or cubic foot for various particle sizes (0.1 µm, 0.2 µm, 0.3 µm, 0.5 µm, 5 µm).
- It includes classifications based on the maximum allowable concentration of airborne particles.
- ISO 14644-1 1997:
- The ISO standard is widely recognized and specifies the classification of air cleanliness by particle concentration.
- It includes nine classes (ISO 1 to ISO 9), with ISO 1 being the cleanest and ISO 9 being the least stringent.
- EEC GGMP 1989:
- The European Economic Community (EEC) Good Manufacturing Practice (GMP) guidelines outline the requirements for manufacturing environments, particularly in the pharmaceutical industry.
- These guidelines are designed to ensure that products are consistently produced and controlled according to quality standards.
- VDI 2083 1990:
- The VDI (Association of German Engineers) guideline focuses on the requirements for cleanrooms, particularly in terms of air cleanliness and particle count.
- It provides detailed classifications and requirements for maintaining clean environments.
- BS 5295 1989:
- The British Standard BS 5295 outlines the specifications for cleanrooms and controlled environments, providing guidance on particle counts and cleanroom classification.
- It includes multiple classes and specific requirements for different levels of cleanliness.
- JACA B 9920 1989:
- The Japanese Air Cleaning Association (JACA) standard provides classifications for cleanrooms based on particle counts and other criteria specific to Japanese industry needs.
Detailed Analysis
- The table compares the allowable number of particles per cubic meter or cubic foot across different standards and classes.
- It specifies the minimum pressure differential (ΔP) required between fields and between neighboring high and low classes, ensuring proper airflow and contamination control.
- Each standard and class is detailed with specific particle count limits for various particle sizes (0.1 µm, 0.2 µm, 0.3 µm, 0.5 µm, 5 µm), reflecting the stringent requirements for maintaining cleanroom environments.
This comprehensive comparison highlights the critical aspects of cleanroom standards, enabling industry professionals to understand and implement the appropriate standards for their specific needs. By adhering to these standards, industries can ensure high levels of contamination control, product quality, and regulatory compliance.
