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What is ISO 8, ISO 7, ISO 6, ISO 5 Cleanroom?
1. ISO 8 Cleanroom
An ISO 8 cleanroom is one of the less stringent classifications, allowing up to 3,520,000 particles (≥0.5 microns) per cubic meter. These cleanrooms are typically used for less sensitive manufacturing processes, such as:
Aseptic packaging: Ensuring that packaging materials and products are free from large contaminants.
Automotive industry: Assembly of critical components requiring moderate contamination control.
The air change rate in an ISO 8 cleanroom is relatively low, usually around 20 air changes per hour.
2. ISO 7 Cleanroom
An ISO 7 cleanroom allows up to 352,000 particles (≥0.5 microns) per cubic meter. This level is suitable for more sensitive processes, including:
Medical device manufacturing: Production of non-implantable medical devices.
Electronics: Assembly of components that are somewhat sensitive to contamination.
The air change rate in an ISO 7 cleanroom is typically around 60 air changes per hour.
3. ISO 6 Cleanroom
An ISO 6 cleanroom permits up to 35,200 particles (≥0.5 microns) per cubic meter. These cleanrooms are used in industries with higher cleanliness requirements, such as:
Pharmaceutical production: Manufacturing of non-sterile medicinal products.
Biotechnology: Research and production of certain biological materials.
The air change rate here is generally around 90-180 air changes per hour.
4. ISO 5 Cleanroom
An ISO 5 cleanroom is one of the cleanest classifications, allowing only 3520 particles (≥0.5 microns) per cubic meter. This environment is essential for:
Semiconductor manufacturing: Production of microchips and other highly sensitive electronic components.
Sterile pharmaceutical production: Manufacturing of injectable drugs and other sterile products.
The air change rate in an ISO 5 cleanroom is typically ≥240 air changes per hour.
| ISO Class | Particles (≥0.5 microns) per m³ | Common Applications | Air Changes per Hour |
| ISO 8 | 3,520,000 | Aseptic packaging, automotive industry | 20 |
| ISO 7 | 352,000 | Medical device manufacturing, electronics | 60 |
| ISO 6 | 35,200 | Pharmaceutical production, biotechnology | 90-180 |
| ISO 5 | 3,520 | Semiconductor manufacturing, sterile pharmaceuticals | ≥240 |
Clean Room Classifications & ISO Standards
CleanRoom Classifications are governed by the ISO 14644-1 standards, which define the maximum allowable concentrations of particles in the air. These classifications range from ISO 1 (the cleanest) to ISO 9 (the least stringent). The standards ensure that cleanrooms meet specific cleanliness levels required for various industries, protecting products from contamination and ensuring quality and safety.
| ISO Class | Particles (≥0.5 microns) per m³ |
| ISO 1 | 10 |
| ISO 2 | 100 |
| ISO 3 | 1,000 |
| ISO 4 | 10,000 |
| ISO 5 | 100,000 |
| ISO 6 | 1,000,000 |
| ISO 7 | 10,000,000 |
| ISO 8 | 100,000,000 |
| ISO 9 | 1,000,000,000 |
GMP Cleanroom Classifications: Understand Class A, B, C, and D
Class A
Class A cleanrooms are the highest level of cleanliness under Good Manufacturing Practice (GMP) guidelines. They are used for critical operations such as aseptic filling and compounding. The environment must have a very low level of particulate and microbial contamination.
Class B
Class B environments are used for less critical stages of sterile product manufacturing. They typically surround Class A zones and support operations like background environments for aseptic preparation.
Class C
Class c CleanRooms are used for the preparation of less critical sterile products. These environments have moderate cleanliness requirements, suitable for preparation and filling of products prior to final sterilization.
Class D
Class D cleanrooms are the least stringent under GMP. They are used for stages of manufacturing where the product is less susceptible to contamination, such as handling of bulk starting materials.
How do Cleanrooms differ in their cleanliness?
Cleanrooms vary in cleanliness based on the number of particles allowed per cubic meter of air. ISO 5 Cleanrooms have the fewest allowable particles, making them suitable for sensitive manufacturing processes. ISO 8 cleanrooms allow more particles, thus they are used for less critical processes. The design and maintenance of each cleanroom type ensure they meet the specific cleanliness requirements for their intended use.
Cleanroom Classification Requirements Industry Standards
Cleanrooms are classified according to industry standards like ISO 14644-1, which specifies the maximum allowable particle concentration for different classes. Each class supports specific industrial applications, requiring varying levels of air filtration, airflow patterns, and environmental controls to meet the cleanliness standards.
| ISO Class | Particles (≥0.5 microns) per m³ |
| ISO 5 | 3,520 |
| ISO 6 | 35,200 |
| ISO 7 | 352,000 |
| ISO 8 | 3,520,000 |
How classification impacts the design of a cleanroom
1. Air Filtration and Flow: The classification determines the type of air filtration (HEPA or ULPA) and the airflow pattern (laminar or turbulent) required to achieve the desired cleanliness level.
2. Environmental Control Systems: Higher-class cleanrooms require more stringent control of environmental factors such as temperature, humidity, and pressure to maintain the necessary cleanliness.
3. Personnel and Protocols: Cleanroom classification impacts the protocols for personnel, including gowning procedures and movement restrictions, to minimize contamination risks.
What is ISO 8 used for?
An ISO 8 cleanroom is used for processes that require a controlled environment but do not demand the stringent cleanliness levels of higher-class cleanrooms. It is suitable for applications like automotive component assembly, cosmetic manufacturing, and certain pharmaceutical processes where moderate contamination control is adequate. These environments ensure quality and safety without the higher costs associated with more stringent cleanroom classes.
