What is an ISO-6 Cleanroom Classification?

What is an ISO-6 CleanRoom Classification?

ISO-6 cleanroom classification is defined by the International Organization for Standardization (ISO) under the ISO 14644-1 standard, which categorizes cleanrooms based on the allowable levels of airborne particulate contamination. 

Key Features of ISO-6 Cleanrooms

1. Particle Count Limits

ISO-6 cleanrooms have a maximum allowable particle count of 1,000 particles per cubic meter for particles that are 0.5 micrometers or larger. This level of cleanliness is crucial for protecting sensitive processes and products from contamination.

2. Air Filtration Systems

To achieve the required cleanliness levels, ISO-6 cleanrooms utilize High-Efficiency Particulate Air (HEPA) filters. These filters are designed to trap a significant percentage of airborne particles, ensuring that the air circulating within the cleanroom is as clean as possible.

3. Temperature and Humidity Control

Maintaining specific environmental conditions, including temperature and humidity, is vital in ISO-6 cleanrooms. These conditions are monitored and controlled to ensure optimal performance of processes and equipment.

4. Operational Protocols

Stringent operational protocols are enforced in ISO-6 cleanrooms. Personnel are required to wear specialized clothing, such as gowns, gloves, and masks, to minimize particle shedding and contamination. Additionally, entry and exit procedures are strictly regulated.

5. monitoring and Validation

Regular monitoring of particle levels, temperature, and humidity is essential. Cleanrooms are subject to validation processes to ensure compliance with ISO-6 standards, involving periodic testing and maintenance of equipment.

ISO 6 Class 1000 Overview

ISO6 cleanrooms, with a limit of 1,000 particles of 0.5 micrometers or larger per cubic meter, are crucial for industries like pharmaceuticals, biotechnology, and electronics, where contamination risks are high. HEPA filtration and strict protocols ensure cleanliness and product integrity in these environments.

ISO 6 Cleanroom Temperature Requirements

1. Temperature Control: The recommended temperature range for ISO6 cleanrooms is typically between 20-24 °C (68-75 °F). This range is established to ensure the comfort of personnel working in the cleanroom and to maintain the stability of sensitive materials and processes.

2. Impact on Processes: Fluctuations in temperature can adversely affect the quality of products and processes. For example, excessive heat can alter the viscosity of certain substances or lead to the degradation of temperature-sensitive materials. Therefore, maintaining a consistent temperature is critical for operational efficiency.

3. Monitoring and Compliance: Continuous monitoring of temperature is essential to ensure compliance with ISO standards. Automated systems often provide real-time data and alerts for any deviations from the set temperature range. In addition, regular maintenance of HVAC systems is crucial to ensure they function effectively, providing stable and controlled conditions within the cleanroom.

What is the Particle Count for ISO6 Cleanroom?

• Stringent Particle Count Limits

ISO6 cleanrooms have strict particle count limits, allowing a maximum of 1,000 particles per cubic meter for particles 0.5 micrometers or larger. This regulation is essential for industries like pharmaceuticals and microelectronics, where contamination can cause significant defects.

• Continuous Monitoring

Specialized equipment, such as laser particle counters, is used for continuous monitoring of particle counts within cleanrooms. These devices provide real-time data to ensure compliance with ISO standards and maintain a controlled environment.

• Strict Compliance Protocols

Cleanroom operators must enforce strict gowning and behavior protocols to maintain ISO6 compliance. Rigorous training on contamination control and regular audits ensure personnel follow established procedures, minimizing particle introduction and maintaining air quality.

What is the ACPH for ISO 6?

Definition of ACPH：

Air Changes Per Hour (ACPH) refers to the number of times the air within A CleanRoom is replaced with fresh air in one hour. For ISO ISO 6 Cleanrooms, the typical range of ACPH is between 30 to 60. This means that the air is completely exchanged 30 to 60 times within an hour, ensuring that any airborne contaminants are effectively removed.

Importance of High ACPH：

Maintaining a high ACPH is crucial for achieving the cleanliness standards required by ISO6. A higher rate of air exchange helps to dilute and remove contaminants that may be introduced by personnel, equipment, or processes. This is particularly important in environments where sensitive products are handled, as any airborne particles can lead to contamination and product failure.

Factors Affecting ACPH：

Several factors influence the required ACPH for a cleanroom, including the size of the cleanroom, the number of personnel present, and the nature of the processes being conducted. For instance, cleanrooms with more complex processes or higher volumes of personnel may require a higher ACPH to maintain cleanliness. 

ISO 5 Cleanroom Requirements

1. Particle Count Limits: According to ISO5 standards, the maximum allowable particle count is 3,520 particles per cubic meter for particles that are 0.5 micrometers or larger. This stringent limit ensures that the environment is suitable for handling sensitive materials and processes without contamination risks.

2. Air Filtration System: To achieve the required cleanliness, ISO5 cleanrooms must be equipped with HEPA or ULPA filters. These filters must be capable of capturing at least 99.97% of particles that are 0.3 micrometers in diameter. The filtration system is critical in maintaining Clean air and minimizing contamination.

3. Environmental Control: Besides particle count, ISO5 cleanrooms require strict control over temperature and humidity levels. The ideal temperature range is generally maintained between 20-24 °C (68-75 °F), and humidity is often kept below 60% to prevent moisture-related contamination.

4. Operational Protocols: Personnel must adhere to stringent gowning procedures that include wearing cleanroom suits, gloves, masks, and shoe covers to minimize particle shedding. Access to the cleanroom is typically controlled, with airlocks or pass-through chambers used to reduce the introduction of contaminants.

5. Monitoring and Maintenance: Continuous monitoring of air quality, particle counts, temperature, and humidity is essential to ensure compliance with ISO ISO 5 standards. Regular audits and maintenance of the cleanroom environment, including filter changes and equipment checks, are necessary to uphold cleanliness and operational integrity.

In conclusion, ISO6 cleanrooms play an essential role in various high-tech and sensitive industries, ensuring contamination control through strict adherence to particle count limits, air change rates, and environmental conditions. Adhering to these standards is crucial for maintaining product quality and safety.