Clean Area Classification based on the permissible levels of particulate and microbial contamination.
The classification is typically done according to ISO 14644-1 standards or GMP (Good Manufacturing Practices) guidelines.
ISO 14644-1 Cleanroom Standards
ISO Class 1: Max 10 particles (≥0.1 µm) per m³.
ISO Class 2: Max 100 particles (≥0.1 µm) per m³.
ISO Class 3: Max 1,000 particles (≥0.1 µm) per m³.
ISO Class 4: Max 10,000 particles (≥0.1 µm) per m³.
ISO Class 5: Max 100,000 particles (≥0.1 µm) per m³.
ISO Class 6: Max 1,000,000 particles (≥0.1 µm) per m³.
ISO Class 7: Max 352,000 particles (≥0.5 µm) per m³.
ISO Class 8: Max 3,520,000 particles (≥0.5 µm) per m³.
ISO Class 9: Max 35,200,000 particles (≥0.5 µm) per m³.
GMP Cleanroom Grades
1. Grade A:
Highest level of cleanliness, for high-risk operations like filling and aseptic connections.
2. Grade B:
Background environment for Grade A activities, such as the background for aseptic preparation and filling.
3. Grade C:
Clean areas for less critical stages in sterile product manufacturing.
4. Grade D:
Clean areas for less critical processes, such as handling of components after final cleaning.