What is the particle count for ISO Class 5 cleanroom?

What is the Particle Count for ISO5 Cleanroom?

ISO5 cleanrooms are critical environments used in industries where air quality and contamination control are of utmost importance, such as pharmaceuticals, biotechnology, and Semiconductor manufacturing. The cleanliness of A CleanRoom is measured by the concentration of airborne particles. According to ISO 14644-1, an ISO5 cleanroom must maintain specific particle count limits to ensure product integrity and safety.

Particle Count Limits

In an ISO5 cleanroom, the maximum allowable particle count is defined as follows:

• 0.5 micrometers (µm) and larger:3,520 particles per cubic meter (m³)

• 1.0 micrometers (µm) and larger:29 particles per cubic meter (m³)

• 5.0 micrometers (µm) and larger:3 particles per cubic meter (m³)

These limits are crucial, as even a small number of particles can lead to contamination of sensitive products. Maintaining these levels requires rigorous monitoring and control of the cleanroom environment, including air filtration systems, regular maintenance, and strict operational procedures.

Maximum Particle Count Associated with ISO 5

The maximum particle count for ISO5 is defined based on the allowable concentration of particles of varying sizes in the air. For instance, the ISO5 cleanroom is permitted to have no more than 3,520 particles per cubic meter at 0.5 micrometers, 29 particles at 1.0 micrometer, and just 3 particles at 5.0 micrometers. These specifications are designed to minimize the risk of contamination during the manufacturing or handling of sensitive materials. 

Particle Count Limit for ISO 5 Non-Viable

The particle count limit for ISO5 non-viable particles mirrors the overall requirements of the class but focuses on non-living particles such as dust and aerosolized substances. The limits are:

• 0.5 micrometers (µm) and larger:3,520 particles/m³

• 1.0 micrometers (µm) and larger:29 particles/m³

• 5.0 micrometers (µm) and larger:3 particles/m³

Requirements for ISO 5 Cleanroom

1. Environmental Controls

To achieve ISO5 standards, cleanrooms must have effective environmental controls in place. This includes high-efficiency particulate air (HEPA) or ultra-low penetration air (ULPA) filters that remove particles from the air. The airflow must be carefully designed to minimize turbulence and maintain a unidirectional flow, ensuring that contaminants do not accumulate. 

2. Personnel and Procedures

Personnel working in ISO5 cleanrooms must adhere to strict gowning procedures to prevent contamination from skin, hair, and clothing. This includes wearing cleanroom suits, gloves, masks, and other protective gear. Training is crucial, as staff must understand the importance of contamination control and the methods used to maintain a clean environment. Regular audits and evaluations of personnel practices help ensure compliance and continual improvement.

3. Maintenance and Monitoring

Ongoing maintenance and monitoring are vital for sustaining ISO5 cleanliness. This includes routine cleaning of surfaces and equipment, as well as regular calibration and testing of monitoring equipment. Particle counters and other analytical tools are used to assess air quality continuously. 

What is the Particle Count of a Class 100000 Clean Room?

Class 100,000 cleanrooms are less stringent than ISO ISO 5 Cleanrooms and are suitable for environments where moderate cleanliness is acceptable. The particle count for a Class 100,000 cleanroom is defined by the maximum allowable number of particles per cubic meter of air. The standards for a Class 100,000 cleanroom are as follows:

• 0.5 micrometers (µm) and larger:100,000 particles per cubic meter (m³)

• 1.0 micrometers (µm) and larger:29,000 particles per cubic meter (m³)

• 5.0 micrometers (µm) and larger:3,000 particles per cubic meter (m³)

Particle Count Breakdown

Understanding the particle count breakdown helps in assessing the suitability of a Class 100,000 cleanroom for specific applications. The following points summarize the limits:

• 0.5 micrometers (µm) and larger:The cleanroom can have up to 100,000 particles/m³. This size is significant as it includes a wide range of potential contaminants such as dust and airborne microorganisms.

• 1.0 micrometers (µm) and larger:The allowable count decreases to 29,000 particles/m³. Particles of this size may include larger dust particles and droplets that could carry contaminants.

• 5.0 micrometers (µm) and larger:The limit stands at 3,000 particles/m³. Larger particles are often easier to filter and control, but they can still pose risks in sensitive environments.

Application Considerations

Class 100,000 cleanrooms are typically used in industries where the risk of contamination is lower than in sectors requiring stricter controls, such as Electronics and pharmaceuticals. Examples of applications include certain manufacturing processes, assembly areas for non-sensitive electronics, and laboratories conducting research that does not involve highly sensitive materials.

Compliance and Monitoring

To maintain compliance with Class 100,000 standards, regular monitoring and maintenance of the cleanroom environment are essential. This includes using particle counters to evaluate air quality and ensuring that the filtration systems are functioning correctly. Routine cleaning procedures and staff training also contribute to maintaining the required cleanliness levels.

How to Test Your CleanRoom Classification

1. Preparation: Before testing, ensure that the cleanroom is in operation and has been running under normal conditions for a sufficient period. This allows for an accurate assessment of the particle count in real operational conditions.

2. Use of Particle Counters: Employ calibrated particle counters to measure airborne particle concentrations at various locations within the cleanroom. The counters should be capable of detecting particles of different sizes, typically starting from 0.3 micrometers up to 5 micrometers and beyond.

3. Data Collection: Record the particle counts over a specified period and at different points in the cleanroom. It is important to take measurements during normal operations and under various conditions to ensure comprehensive data collection.

4. Analysis and Reporting: After collecting data, analyze the results against the ISOspecifications. Prepare a report that details the particle counts and identifies any areas that exceed the allowable limits. This report can be used to implement corrective actions if necessary.

Particle Counter for Classification of Clean Room

Operational Principles:

Particle counters work by drawing air through a sensing chamber where particles are illuminated by a laser or light source. As particles pass through, they scatter light, which is detected by a sensor. This scattering provides information about the size and number of particles, allowing for accurate measurement of particle concentrations in the air.

Types of Particle Counters:

There are various types of particle counters available, including portable handheld models and stationary units designed for continuous monitoring. Portable counters are useful for spot checks and validation, while stationary units provide ongoing data collection to ensure compliance with cleanliness standards.

Importance in Cleanroom Classification:

Regular use of particle counters is vital for cleanroom classification as they provide real-time data that informs operational decisions. By continuously monitoring particle levels, cleanroom managers can quickly identify contamination events and take corrective actions to maintain compliance with ISO standards. This proactive approach not only ensures adherence to regulations but also protects product integrity and safety.