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ISO 8 is one of the classifications in the ISO 14644-1 standard which classifies cleanrooms and associated controlled environments by the concentration of particles floating in the air. Here's a detailed explanation of the ISO 8 standard:
ISO 8 Clean Room is defined as an area of the community where environmental control is introduced and maintained to carry out clean tasks or other specialized operations which may generate contaminants that could affect the health of those interested in the area. An SO 8 Clean Room is a developed enclosed environment in which microorganisms are at a density controlled to an accepted limit. ISO 8 is not as clean as ISO 5 or ISO 4, however, it is cleaner than other conditions as ISO 5 or ISO 4 means ultra clean areas or clean rooms.
The primary requirement of ISO 8 is based on the concentration of airborne particles in the room. The maximum allowable particle counts are as follows:
Particle Size (µm) | Maximum Allowable Concentration (particles/m³) |
≥0.1 µm | Not specified |
≥0.2 µm | Not specified |
≥0.3 µm | Not specified |
≥0.5 µm | 3,520,000 particles/m³ |
≥1.0 µm | 832,000 particles/m³ |
≥5.0 µm | 29,300 particles/m³ |
Typically, ISO 8 clean rooms need an ACH between 10 to 25, and this depends on the process to be conducted or the siting of the actual facility in question. They are realized with the help of the HVAC system and HEPA filtration.
· HEPA Filters: High-Efficiency Particulate Air filters are used to remove airborne particles. These filters can remove up to 99.97% of particles ≥0.3 µm in size.
· Airflow Design: The airflow is typically turbulent flow while higher grade clean room like the ISO 5 use laminar flow.
ISO 8 clean rooms are applied in industries or processes where the degree of cleanness is not very high but must be controlled. Common applications include:
· Pharmaceutical manufacturing (e.g., secondary packing areas).
· Food production (specific stages requiring reduced contamination).
· Electronics assembly.
· Medical device manufacturing.
· Aerospace component assembly.
· Particle Monitoring: Regular monitoring is required to ensure particle counts stay within acceptable limits.
· Personnel Behavior: Workers must follow cleanroom protocols, such as wearing proper attire (e.g., gowns, hairnets) and limiting activities that generate particles.
· Cleaning Frequency: ISO 8 rooms require regular cleaning to maintain particle counts, but the cleaning schedule is less frequent compared to higher-class cleanrooms.
ISO 8 is the least stringent classification for cleanrooms under ISO 14644-1. Here’s how it compares:
ISO Class | 0.5 µm particles/m³ | Air Changes per Hour (ACH) | Applications |
ISO 5 | 3,520 | 240-600 (Laminar Flow) | Sterile pharmaceutical filling, surgeries |
ISO 6 | 35,200 | 90-180 | Microelectronics manufacturing |
ISO 7 | 352,000 | 30-60 | Pharmaceutical mixing/compounding |
ISO 8 | 3,520,000 | 10-25 | Less critical processes (e.g., packaging) |
To achieve ISO 8 certification, the cleanroom must pass the following tests:
1. Airborne Particle Count Test: Checks that the number of particles in the air complies with the ISO 8 requirements.
2. Airflow Test: Air Velocity probes reveals, measures and monitors the air velocity to assure appropriate air flow patterns.
3. Filter Integrity Test: Assertions that it is possible to confirm HEPA filters are trapping particles.
4. Pressure Differential Test: Ensures that pressure gradients between cleanroom zones prevent contamination.
· Regular Cleaning: Floors, walls and other surfaces require washing with sanitizers to avoid a build up of dust and other debris.
· Filter Replacement: HEPA filters should be inspected and replaced periodically.
· Environmental Monitoring: There are different suggestions on how often the counts of particles, temperature, humidity, and pressure must be monitored to meet the regulation’s requirements regularly or constantly
· Personnel Training: People working in the cleanroom should also be taught proper conduct gowns, movement and handling of items to avoid contamination.
· Provides a cost-effective controlled environment.
· Suitable for less stringent processes.
· Reduces contamination risks compared to unclassified environments.
· Not suitable for highly sensitive processes (e.g., sterile drug manufacturing).
· Limited particle size control for sub-micron particles.