Clean Room Classifications & ISO Standards

Clean Room Classifications & ISO Standards

Clean rooms are specialized environments designed to maintain extremely low levels of particulate contamination. They are classified according to ISO standards that define permissible particle counts per cubic meter of air across various sizes. The most widely recognized standard for clean rooms is ISO 14644, which provides a framework for classifying clean rooms based on their cleanliness levels. Each class, from ISO1 to ISO9, represents a different level of air cleanliness, with ISO1 being the cleanest, allowing fewer than 12 particles of 0.1 micrometers or larger per cubic meter.

ISO5 clean rooms, for example, permit a maximum of 3,520 particles of 0.5 micrometers or larger per cubic meter. These environments are commonly used in industries requiring aseptic conditions, such as pharmaceuticals and biotechnology. The standards dictate not only the acceptable particle levels but also the necessary airflow and filtration systems, typically utilizing HEPA or ULPA filters to ensure air cleanliness is maintained.

In contrast, ISO8 allows for up to 3,520,000 particles of 0.5 micrometers or larger per cubic meter, which is suitable for less sensitive applications. Understanding these classifications is essential for industries that rely on cleanroom environments to produce high-quality products while minimizing contamination risks. Compliance with ISO standards is crucial to meeting regulatory requirements and ensuring product integrity.

Relevant Standards and Specifications

• iso 14644-1: Classification of air cleanliness by particle concentration.

• iso 14644-2: Monitoring to provide evidence of cleanroom performance.

• ISO 14644-3: Test methods for measuring the cleanroom performance.

• ISO 14644-4: Design, construction, and start-up of a cleanroom.

• iso 14644-5: Operations and management of cleanrooms.

What is ISO Cleanliness Spec?

ISO cleanliness specifications define the acceptable levels of particulate contamination in controlled environments, critical for industries such as pharmaceuticals, aerospace, and electronics. The specifications are outlined in ISO 14644-1, which categorizes cleanrooms into different classes based on the maximum allowable number of particles per cubic meter of air at specified sizes. 

What is ISO 14644-1 Cleanroom Standards?

Overview of ISO 14644-1

ISO 14644-1 is an international standard that specifies the classification of air cleanliness in cleanrooms and controlled environments. This standard is crucial for industries that need to maintain stringent cleanliness levels to ensure product integrity and compliance with regulatory requirements.

Classification System

The classification system in ISO 14644-1 ranges from ISO1 to ISO9, with Class 1 being the cleanest. Each class has specific particle count limits for particulates of sizes 0.1 micrometers and 0.5 micrometers. For instance, ISO5 allows a maximum of 3,520 particles of size 0.5µm per cubic meter, while ISO7 permits 352,000 particles of the same size.

Testing and Monitoring Requirements

ISO 14644-1 emphasizes the importance of regular monitoring and testing to maintain cleanliness levels. This includes employing validated methods for measuring airborne particle concentration, ensuring that cleanrooms consistently meet the specified class requirements. 

What Are the Guidelines for ISO 5 Cleanroom?

General Requirements:

ISO5 cleanrooms are designed to maintain stringent cleanliness standards, allowing for a maximum of 3,520 particles of size 0.5 micrometers or larger per cubic meter. To achieve this, the cleanroom must utilize high-efficiency particulate air (HEPA) filters or ultra-low penetration air (ULPA) filters to ensure effective filtration of airborne particles. 

Operational Protocols:

Personnel entering an ISO5 cleanroom must adhere to strict gowning procedures, which include wearing gloves, masks, and coveralls to minimize the introduction of contaminants. It is essential to limit the number of personnel in the cleanroom at any given time. Training for cleanroom personnel is crucial to ensure adherence to protocols that maintain the required cleanliness level. 

Monitoring and Validation:

To maintain ISO5 standards, regular monitoring of airborne particles is mandatory. This involves using calibrated particle counters that can detect particles of 0.5 micrometers and smaller. Validation of the cleanroom's performance must be conducted periodically to ensure compliance with ISO 14644-1 specifications. 

What is ISO 8 Used For?

1. Applications of ISO 8 Cleanroom

ISO 8 cleanrooms are designed for less stringent contamination control compared to higher classes. They are often used in industries such as electronics, food processing, and some pharmaceutical applications where the risk of contamination is lower. In these environments, the maximum allowable particles of size 0.5 micrometers is 3,520,000 per cubic meter, making them suitable for processes that don't require the extreme cleanliness of ISO5 or lower.

2. Operational Flexibility

The operational flexibility of ISO 8 cleanrooms allows for a broader range of activities, including assembly and packaging of products that are less sensitive to particulate contamination. While these cleanrooms still employ HEPA filtration systems, the less stringent requirements mean they can accommodate a wider variety of manufacturing processes without compromising product quality.

3. Construction and Maintenance

Constructing an ISO 8 cleanroom involves ensuring proper airflow and filtration systems tailored to the specific requirements of the manufacturing processes. 

What is the Difference Between ISO 7 and ISO 8?

1. Cleanliness Levels: The primary difference between ISO7 and ISO ISO 8 cleanrooms lies in their cleanliness levels. ISO7 allows a maximum of 352,000 particles of size 0.5 micrometers per cubic meter, while ISO ISO 8 permits up to 3,520,000 particles of the same size. This significant difference means that ISO7 environments are suited for more sensitive operations that require stricter contamination control.

2. Applications and Uses: ISO 7 cleanrooms are commonly used in the pharmaceutical and biotechnology industries for aseptic processing and manufacturing sterile products. In contrast, ISO 8 cleanrooms are often used for production processes that are less sensitive, such as electronics assembly and some food processing applications. The choice between these classes often depends on the specific requirements of the product being manufactured.

3. Operational Protocols: Due to the differing cleanliness requirements, operational protocols in ISO 7 cleanrooms are typically more stringent. Personnel must follow rigorous gowning procedures, and particle monitoring is conducted more frequently. In ISO 8 cleanrooms, while cleanliness is still crucial, the protocols may be more relaxed, allowing for a slightly higher level of contamination.

What is the Difference Between ISO 9001 and ISO 9000?

ISO 9001 and ISO 9000 are both part of the ISO 9000 family of quality management standards, but they serve different purposes. ISO 9000 provides the fundamental concepts and vocabulary that underpin quality management systems, establishing the framework for understanding quality principles.