What is an ISO class 8 cleanroom?

In an ISO 8 Cleanroom, personnel must adhere to strict gowning procedures to minimize contamination risks. Gowning includes full-body coverage, gloves, face protection, and appropriate footwear to ensure that no particles from the person’s clothing or skin enter the clean environment.

What is an ISO Class 8 Cleanroom?

1. High cleanliness control

The concentration of particles greater than or equal to 0.5 microns in the air of ISO 8 cleanrooms shall not exceed 352,000/m³. This means that although its cleanliness is not as high as that of ISO 5 or ISO 7 Cleanrooms, it can still effectively control the source of pollution and is suitable for some production or experimental environments that require lower pollution levels. For fields such as biopharmaceuticals and medical device production, ISO 8 cleanrooms provide a basic clean environment that meets the standards.

2. HEPA/ULPA filtration system

ISO 8 cleanrooms are usually equipped with high-efficiency particulate air filters (HEPA) or ultra-low penetration air filters (ULPA). These filtration systems can efficiently filter tiny particles in the air to ensure that the air quality in the cleanroom meets the standard requirements. HEPA filters can capture particles as small as 0.3 microns, while ULPA filters have higher filtration efficiency and are suitable for environments with extremely high cleanliness requirements.

3. Precise temperature and humidity control

ISO 8 cleanrooms are usually equipped with precise temperature and humidity control systems to maintain stable environmental conditions. The temperature is generally controlled between 18°C and 24°C, and the humidity is controlled between 40% and 60%. This environmental condition is critical for many sensitive products and processes, especially in industries such as biopharmaceuticals and Semiconductor manufacturing. 

4. Strict contamination control measures

In ISO 8 cleanrooms, strict contamination control measures are essential. People in the cleanroom must follow strict  gowning (wearing)  procedures, such as wearing dust-proof clothing, masks, gloves, etc., to prevent particles on the skin or other contaminants from entering the clean environment. 

5. Compliance with international and national standards

The design, construction and operation of ISO 8 cleanrooms need to comply with ISO 14644-1 and other relevant standards, such as GMP (Good Manufacturing Practice). These standards specify the classification, test methods and verification process of cleanrooms to ensure that the cleanrooms continue to meet the specified cleanliness requirements during operation.

6. Applicable industries and applications

ISO 8 cleanrooms are widely used in biopharmaceuticals, pharmaceutical products, electronic products, optical instruments and other fields. It is usually used in production or R&D environments that require air cleanliness but do not require extremely high cleanliness. 

ISO 8 Cleanroom Air Changes

Air Changes Per Hour (ACH)

ISO 8 cleanrooms typically require 20–40 ACH to ensure proper air circulation and minimize particulate contamination. 

Airflow Requirements

The air exchange rate ensures that airborne particles are removed and replaced with clean, filtered air. This maintains the desired environmental conditions.

Airflow and Filtration

To meet ISO8 standards, the HVAC system should be capable of at least 20 ACH and utilize HEPA filters to maintain cleanliness. The airflow should be uniform and designed to prevent contamination build-up in the cleanroom.

ISO 8 Cleanroom Specifications and Requirements

ISO 8 cleanrooms are designed to control particulate contamination in environments with moderate sensitivity, such as research or industrial settings. Key specifications include air cleanliness, temperature, humidity, and gowning procedures, all aimed at reducing contamination risks.

1. Air Cleanliness Requirements

The cleanroom must maintain an airborne particle count of fewer than 3,520,000 particles per cubic meter for particles of 0.5 microns or larger.

To meet this, cleanrooms use HEPA filters and maintain consistent airflow and air pressure. Regular monitoring and maintenance are required to ensure compliance with iso 14644-1.

2. Temperature and Humidity Control

Temperature must be maintained within 18°C to 24°C (64°F to 75°F), while humidity should be controlled between 30%-60% to prevent static buildup and material degradation.

This control is essential for both the comfort of personnel and the integrity of sensitive equipment. Specialized HVAC systems help regulate these conditions in real-time.

3. Personnel and Gowning Procedures

ISO 8 cleanrooms require specific gowning procedures to prevent contamination from personnel. This includes wearing cleanroom suits, gloves, and footwear.

Gowning is essential for ensuring that personnel do not introduce particulates. It includes sterile suits, face coverings, and the use of airlocks to prevent contamination during entry and exit.

What is ISO 8 CleanRoom Classification?

1.High Cleanliness Control：ISO 8 cleanrooms limit particles ≥0.5 microns to a maximum of 352,000 particles per cubic meter, ensuring a controlled environment suitable for moderately sensitive manufacturing and research processes.

2. HEPA/ULPA Filtration：HEPA (High-Efficiency Particulate Air) or ULPA (Ultra-Low Penetration Air) filters are standard in ISO 8 cleanrooms. These filters efficiently capture fine particles, maintaining the purity of the air and meeting stringent cleanliness standards.

3. Precise Temperature and Humidity Control：ISO 8 cleanrooms are equipped with temperature and humidity control systems to maintain optimal conditions, typically 18-24°C and 40-60% relative humidity, ensuring stable environmental conditions for sensitive operations.

4. Strict Contamination Control Measures：Strict protocols for gowning, air circulation, and surface cleaning are followed to minimize contamination risks. These measures help prevent cross-contamination and ensure the cleanroom environment remains uncontaminated.

5. Compliance with Standards：ISO 8 cleanrooms are designed and operated in accordance with international standards such as ISO 14644 and GMP (Good Manufacturing Practice). Compliance ensures consistent air quality and operational efficiency within regulated industries.

What is the difference between ISO 7 and ISO 8?

ISO 7 vs. ISO 8 Cleanrooms

ISO 7 and ISO 8 are cleanroom standards by the International Organization for Standardization (ISO). ISO 7 Cleanrooms have stricter air cleanliness requirements, suitable for industries like pharmaceuticals and semiconductors, while ISO 8 allows more particles for less critical environments.

Application Considerations

Choosing between ISO 7 and ISO 8 cleanrooms depends on specific production needs and product characteristics. Companies must consider cleanliness requirements, production processes, and regulations to ensure compliance with industry standards and maintain product quality.

What is the microbial limit of ISO 8?

The microbial limit of ISO 8 refers to the maximum allowable levels of microbial contamination in controlled environments, particularly in cleanrooms and controlled areas. According to ISO standards, ISO 8 environments are typically used for processes that require a moderate level of cleanliness. Maintaining microbial limits is crucial for ensuring product quality and safety in various industries, including pharmaceuticals and biotechnology. 

This information is essential for organizations aiming to comply with industry standards and ensure a safe working environment.

Relevant Domestic and International Standards

• ISO 14644-1: Defines cleanroom classifications and provides guidelines for particle count levels and air cleanliness.

• iso 14644-2: Outlines testing and monitoring requirements for cleanroom operations.

• GMP (Good Manufacturing Practice): Provides industry-specific guidelines, including gowning and environmental control for pharmaceutical and medical device manufacturing.

• ASHRAE Standard 170: Sets ventilation standards for healthcare and cleanroom environments.