Clean area classification is a system used to categorize environments based on the level of cleanliness required for specific activities or processes. It is a critical aspect of industries such as pharmaceuticals, biotechnology, electronics manufacturing, and healthcare, where the presence of contaminants can have significant consequences on product quality and safety. The classification standards are defined by international organizations such as the International Organization for Standardization (ISO) and other regulatory bodies.
1. International Organization for Standardization (ISO) Cleanroom Standards:
ISO 14644-1: This standard specifies the maximum allowable levels of airborne particulate contamination in cleanrooms and controlled environments. Cleanrooms are classified based on the number of particles present in the air per cubic meter at specified particle sizes.
ISO 14644-2: Provides guidelines for monitoring cleanrooms and clean zones to verify their continued compliance with ISO 14644-1.
2. United States Federal Standard 209E (FS 209E):
FS 209E: Though now obsolete and replaced by ISO standards, FS 209E was widely used in the United States. It classified cleanrooms based on the number of particles per cubic foot.
Clean Area Classification Levels:
Clean areas are classified into different levels based on the allowable particle count in the air. The lower the classification number, the cleaner the environment. The two commonly used classification systems are ISO and FS:
ISO Cleanroom Classification (ISO 14644-1):
– ISO Class 1: ≤ 10 particles per cubic meter (at 0.1 micrometers)
– ISO Class 2: ≤ 100 particles per cubic meter (at 0.1 micrometers)
– ISO Class 3: ≤ 1,000 particles per cubic meter (at 0.1 micrometers)
– ISO Class 4: ≤ 10,000 particles per cubic meter (at 0.1 micrometers)
– ISO Class 5: ≤ 100,000 particles per cubic meter (at 0.1 micrometers)
FS Cleanroom Classification (FS 209E):
– Class 1: ≤ 1 particle per cubic foot (at 0.5 micrometers)
– Class 10: ≤ 10 particles per cubic foot (at 0.5 micrometers)
– Class 100: ≤ 100 particles per cubic foot (at 0.5 micrometers)
– Class 1,000: ≤ 1,000 particles per cubic foot (at 0.5 micrometers)
– Class 10,000: ≤ 10,000 particles per cubic foot (at 0.5 micrometers)
– Class 100,000: ≤ 100,000 particles per cubic foot (at 0.5 micrometers)
Clean Area Classification Considerations:
1. Process Requirements: The classification of a clean area is often determined by the specific requirements of the processes conducted within it. For example, pharmaceutical manufacturing may demand a cleaner environment compared to some electronic assembly processes.
2. Risk of Contamination: The nature of the product and the potential impact of contaminants on product quality and safety influence the clean area classification.
3. Airflow and Filtration: The design of the ventilation system, including the type and efficiency of filters, plays a crucial role in maintaining the cleanliness of the area.
4. Personnel Activities: Clean areas may have different classifications for different activities. For instance, gowning rooms or airlocks may have a higher classification than the main manufacturing area.
5. Equipment and Furnishings: The materials and design of equipment and furnishings in the clean area can contribute to or reduce particle generation.
Maintaining Clean Area Classification:
1. Regular Monitoring: Implement continuous monitoring of particle counts and other environmental parameters to ensure compliance with the specified clean area classification.
2. Proper Gowning Procedures: Strict gowning procedures for personnel entering clean areas are essential to prevent contamination from clothing and body.
3. Effective Cleaning and Disinfection: Regular and thorough cleaning of surfaces, equipment, and facilities is crucial to maintaining the cleanliness of the environment.
4. Controlled Access: Limit and control the entry of personnel and materials to minimize the introduction of contaminants.
5. Well-designed HVAC Systems: Implement efficient Heating, Ventilation, and Air Conditioning (HVAC) systems with appropriate filters to ensure the desired level of air cleanliness.
6. Training and Awareness: Ensure that personnel are well-trained in cleanroom procedures and are aware of the impact their actions can have on the clean area.
7. Periodic Validation: Conduct periodic validation studies to verify that the clean area continues to meet the specified classification requirements.
Clean area classification is a fundamental aspect of quality control in industries where the control of airborne contaminants is critical. Adhering to these classifications and implementing effective contamination control measures ensures the production of high-quality products and compliance with regulatory standards.
