The difference between ISO 4 and ISO 5 cleanrooms

The Difference Between ISO 4 and ISO 5 Cleanrooms

• Cleanliness Levels

ISO4 cleanrooms are significantly cleaner than ISO 5 environments. According to ISO 14644-1, an ISO4 cleanroom allows a maximum of 10 particles ≥0.1 µm and 2 particles ≥0.2 µm per cubic meter of air. In contrast, an ISO5 cleanroom permits up to 3,520 particles ≥0.5 µm per cubic meter. This stark difference in allowable particle counts highlights the stringent requirements for ISO4 environments, making them suitable for highly sensitive processes.

• Applications in Industry

The applications for ISO4 and ISO 5 cleanrooms vary widely. ISO4 cleanrooms are typically used in pharmaceutical manufacturing, Semiconductor fabrication, and biotechnology where the control of particulate contamination is crucial. Conversely, ISO5 cleanrooms are often sufficient for less sensitive operations, such as assembly of electronic components and certain laboratory environments. Understanding these applications is essential for selecting the appropriate cleanroom class based on industry requirements.

• Design and Construction

Design considerations for ISO4 cleanrooms are more rigorous than those for ISO 5. ISO 14644-4 outlines that Class 4 cleanrooms require advanced filtration systems, including High-Efficiency Particulate Air (HEPA) filters, to maintain the low particle levels. Additionally, airflow patterns must be designed to minimize turbulence and ensure uniform distribution. In contrast, ISO5 cleanrooms may employ less stringent HVAC requirements, allowing for a broader range of construction materials and designs.

• Operational Protocols

Operational protocols also differ significantly between ISO4 and ISO 5 Cleanrooms. Class 4 environments require more frequent monitoring of particulate levels, typically on an hourly basis, to ensure compliance with stringent cleanliness standards. This includes continuous monitoring systems for real-time data. In comparison, ISO5 cleanrooms may conduct monitoring less frequently, often on a weekly or monthly basis, depending on the specific operational requirements. These differences in monitoring frequency reflect the varying levels of risk associated with each cleanroom class.

Relevant Standards

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

• iso 14644-4: Design, construction, and startup of cleanrooms and controlled environments.

• iso 14644-2: Monitoring cleanroom performance.

• ISO 14698: Biocontamination control in cleanrooms and controlled environments.

Requirements for ISO4 Cleanroom

1. Air Cleanliness

ISO4 cleanrooms must maintain an air cleanliness level of 10 particles ≥0.1 µm and 2 particles ≥0.2 µm per cubic meter. This stringent requirement ensures minimal contamination for sensitive processes.

2. Filtration Systems

Advanced filtration systems, such as High-Efficiency Particulate Air (HEPA) filters, are essential for ISO4 cleanrooms. These systems effectively capture airborne particles, ensuring that the environment meets strict cleanliness standards.

3. airflow design

Proper airflow design is crucial in ISO4 cleanrooms. Unidirectional airflow minimizes turbulence and ensures uniform distribution of clean air, significantly reducing the risk of contamination during operations.

Particle Count for ISO5 Cleanroom

1. Particle Count Limits: ISO5 cleanrooms permit a maximum of 3,520 particles ≥0.5 µm per cubic meter. This limit allows for a controlled environment but is less stringent than that of ISO4 cleanrooms.

2. Air Quality Assessment: Regular assessments of air quality are necessary in ISO5 cleanrooms. Monitoring particle counts ensures that the environment remains within acceptable limits, promoting operational efficiency and product quality.

3. Application Suitability: ISO5 cleanrooms are suitable for various applications, including electronics assembly and pharmaceutical processes. The established particle count limits make this class effective for industries requiring moderate cleanliness.

4. Compliance Requirements: Compliance with ISO 14644-1 is essential for ISO ISO 5 Cleanrooms. Facilities must adhere to monitoring and reporting protocols to ensure that air cleanliness is consistently maintained.

The Requirements for ISO 5 Cleanroom Gowning

Gowning Protocol

Proper gowning protocols are critical in ISO5 cleanrooms. Personnel must wear cleanroom-approved garments, including coveralls, gloves, and masks, to minimize contamination risks during operations.

Material Selection

Gowning materials must be non-linting and resistant to particle shedding. Common materials include polyester and Tyvek, which provide effective barriers against contaminants while ensuring comfort for personnel.

Gowning Procedure

A strict gowning procedure should be followed in ISO ISO 5 cleanrooms. This includes donning garments in a specific order, ensuring that no contaminants are introduced during the process.

Footwear Requirements

Footwear in ISO5 cleanrooms must be cleanroom-compatible, often including latex or disposable shoe covers. This requirement prevents dirt and particles from being tracked into the controlled environment, maintaining cleanliness.

What is the Particle Count Limit as per ISO 14644?

1. ISO 5 Particle Count Limit

According to ISO 14644-1, ISO5 cleanrooms can have a maximum of 3,520 particles ≥0.5 µm per cubic meter. This establishes a baseline for cleanliness, suitable for various industrial applications.

2. Class 4 Particle Count Limit

ISO4 cleanrooms are more stringent, allowing only 10 particles ≥0.1 µm and 2 particles ≥0.2 µm per cubic meter. This strict limit is essential for environments requiring extreme cleanliness.

The Cleanest ISO Cleanroom

Applications of ISO1

ISO1 cleanrooms are essential in sectors like semiconductor manufacturing and aerospace. These environments support processes that require the highest levels of cleanliness to prevent contamination.

Design Specifications

The design of ISO1 cleanrooms includes advanced filtration systems and unidirectional airflow. These features are crucial for maintaining the ultra-low particle levels necessary for compliance with cleanliness standards.

Stringent Personnel Protocols

Personnel in ISO1 cleanrooms must follow extremely rigorous gowning and entry protocols. This includes specialized clothing and strict adherence to cleanliness practices to protect the environment from contamination.