What is ISO 14644 clean room classification?

ISO 6 Cleanroom Regulations

ISO6 cleanrooms are governed by specific regulations designed to maintain exceptionally low levels of airborne particulate contamination. These regulations are crucial in industries such as pharmaceuticals, biotechnology, and semiconductor manufacturing, where product purity is vital. The following sections outline key aspects of ISO6 regulations, including limits, requirements, and comparisons with other cleanroom classes.

1. Definition and Purpose

ISO6 is defined by specific limits on airborne particles. According to the ISO 14644-1 standard, an ISO6 cleanroom can have a maximum of 3,520 particles of size 0.5 micrometers (µm) or larger per cubic meter of air. The primary purpose of these regulations is to protect sensitive processes and products from contamination, ensuring that they meet safety and efficacy standards.

2. CleanRoom Classification

Cleanrooms are classified based on the maximum allowable concentration of airborne particles. The ISO classification system ranges from ISO1, which has the strictest limits, to ISO9, which has the least stringent requirements. ISO6 falls on the higher end of the cleanliness spectrum, making it suitable for processes that require moderate levels of control over particulate contamination.

3. Key Requirements

To maintain ISO6 standards, several operational requirements must be adhered to:

a. Air Cleanliness

Compliance with iso 14644-1, allowing a maximum of 3,520 particles ≥0.5 µm per cubic meter.

b. Air Change Rate

Typically, a minimum of 20 to 60 air changes per hour (ACPH) is required to ensure proper ventilation and contamination control.

c. Filtration Systems

High-Efficiency Particulate Air (HEPA) filters must be used, with an efficiency rating of at least 99.97% for particles ≥0.3 µm.

d. Temperature and Humidity Control

Cleanrooms should maintain a temperature of 20°C ± 2°C and relative humidity levels between 30% and 60% to ensure optimal operational conditions.

e. Personnel Training

Staff must undergo training in cleanroom protocols, including gowning procedures and contamination control measures.

4. Monitoring and Validation

Regular monitoring and validation are crucial for maintaining ISO6 cleanroom conditions. Continuous air quality monitoring systems should be in place to track particle counts and other environmental parameters. Routine audits and validation processes are necessary to ensure compliance with the established standards, helping to identify potential contamination sources and implement corrective actions when needed.

5. Importance in Industry

ISO6 cleanrooms play a vital role in various industries. In the pharmaceutical sector, for example, they are essential for the production of sterile products, such as injectables and vaccines. In microelectronics, they are necessary for manufacturing semiconductors, where even minute levels of contamination can lead to product defects. Therefore, adherence to ISO6 regulations is not just a matter of compliance; it is critical for ensuring product safety, quality, and reliability.

ISO 6 Limit

This table shows the permissible particle concentration for ISO 6 Cleanrooms, which allows up to 35,200 particles per cubic meter for particles that are 0.5 microns or larger.

ISO Requirement for Clean Rooms

ISO requirements for cleanrooms include several key standards designed to ensure air quality and environmental control. These requirements are as follows:

Air Cleanliness Class: Must comply with ISO 14644-1 standards.

Particle Count Limits: Maximum of 3,520 particles per cubic meter (≥0.5 µm).

Air Change Rate: Minimum of 20 to 60 air changes per hour (ACPH).Filtration: Use of HEPA filters with a minimum efficiency of 99.97% for particles ≥0.3 µm.

Temperature Control: Typically maintained at 20°C ± 2°C.

Humidity Control: Relative humidity should be kept between 30% and 60%.

Personnel Training: Staff must receive training in cleanroom protocols and contamination control.

Is ISO 5 or 7 Cleaner?

• ISO 5 vs ISO 7 Cleanrooms

• ISO 5 Cleanrooms are cleaner than ISO 7, with a limit of 3,520 particles per cubic meter (≥0.5 µm), while ISO 7 allows 352,000 particles.

• Cleanliness Level

• ISO 5 is ideal for processes requiring higher cleanliness, such as sterile pharmaceutical production, where contamination risk must be minimized.

• Air Filtration and Change Rates

• ISO 5 Cleanrooms use stricter air change rates and advanced filtration to maintain air quality, essential for high-stakes applications.

• ISO 7 Cleanrooms

• ISO 7 cleanrooms are suitable for less critical processes, with lower contamination risk, such as certain manufacturing or research environments.

ISO Standard for Air Cleanliness

ISO Standard for Air Cleanliness：

The ISO 14644-1 standard defines cleanroom classifications based on allowable airborne particle concentrations, from ISO1 (cleanest) to ISO9 (least clean).

Cleanroom Classifications and Particle Limits：

Each cleanroom class has specific particle limits for various sizes. For example, ISO6 allows 3,520 particles per cubic meter (≥0.5 µm).

Importance of ISO Classifications：

ISO classifications help ensure product integrity, guiding cleanroom design, operations, and monitoring for different industries requiring controlled environments.

Compliance and Monitoring：

Compliance with ISO standards is crucial for maintaining product quality and safety. Regular monitoring and validation ensure cleanrooms meet the required classification.

Air Quality Management Systems：

Robust air quality management systems are necessary to ensure continuous compliance with ISO 14644-1, keeping cleanrooms within their designated class limits.

ISO standard for air quality

Cleanroom Environmental Monitoring Parameters

Monitoring and Validation Frequency