What is the Latest Version of ISO 14644?

ISO 14644 is a series of international standards that provide guidelines for the design, operation, and performance of cleanrooms and controlled environments. These standards are essential across industries such as pharmaceuticals, biotechnology, electronics, and aerospace, where contamination control is critical. The most recent updates in the series reflect advancements in cleanroom technology, monitoring, and operational procedures to ensure environments remain contamination-free.

ISO 14644-1: 2015 Classification of Airborne Particles

The latest version of ISO 14644-1** was published in **2015**, which establishes the classification system for cleanrooms based on the concentration of airborne particles. This standard defines the maximum allowable number of particles per cubic meter for each class of cleanroom, with particle sizes measured at **0.5 microns**. For example, **ISO5** allows up to **3,520 particles per cubic meter

at 0.5 microns, and this class is used for highly sensitive processes such as aseptic filling in pharmaceuticals.

iso 14644-2: 2015 Monitoring and Maintenance

ISO 14644-2:2015 focuses on the ongoing monitoring, testing, and maintenance required to ensure that cleanrooms continue to meet the modular classification standards set in ISO 14644-1

. The standard specifies how to assess factors like particle counts, airflow, and pressure differentials to maintain consistent air quality. Regular monitoring and validation of these factors ensure that cleanrooms meet strict cleanliness requirements over time.

ISO 14644-3: 2019 Testing and Measurement Methods

The ISO 14644-3** standard, updated in **2019, provides methods for testing and measuring the performance of cleanrooms. It clarifies how to evaluate the effectiveness of air cleanliness, filtration systems, and overall cleanroom performance. The standard outlines protocols for particle counting and the measurement of other factors like airflow velocity, ensuring that cleanrooms maintain the desired level of cleanliness and air quality.

ISO 14644-4: 2001 Design and Construction

iso 14644-4:2001 outlines guidelines for the design and construction of cleanrooms and associated controlled environments. Although this standard is not as frequently updated as others in the series, it remains crucial for ensuring that cleanrooms are properly built to meet strict cleanliness requirements. This version covers aspects such as airflow design, materials selection, and space layout.

iso 14644-5: 2004 Operation and Performance

ISO 14644-5:2004 details operational and performance requirements for cleanrooms. It addresses the need for proper procedures, training, and operational protocols to maintain cleanliness standards. It emphasizes the importance of consistent performance in maintaining the integrity of cleanrooms during day-to-day operations.

ISO 14644-7: 2004 CleanRoom Classification in Non-Pharmaceutical Sectors

ISO 14644-7:2004 focuses on modular cleanroom classifications and standards for non-pharmaceutical applications

such as electronics and aerospace. It provides guidelines for evaluating cleanroom performance and maintaining cleanliness standards specific to these industries.

ISO 14644-8: 2009 Measurement of Air Cleanliness by Particle Concentration

ISO 14644-8:2009 introduces guidelines for measuring air cleanliness by particle concentration. This standard provides detailed methods for measuring airborne particles, focusing on particle size and distribution. It serves as a crucial reference for validating cleanroom performance and confirming that environments meet specified cleanliness levels.

Related ISO 14644 Standards

• ISO 14644-1:2015

  Classification of cleanrooms based on airborne particle concentrations.

• ISO 14644-2:2015

  Monitoring and maintenance guidelines to ensure ongoing cleanroom performance.

• ISO 14644-3:2019

  Testing and measurement methods for assessing cleanroom performance.

• ISO 14644-4:2001

  Design and construction guidelines for cleanrooms and controlled environments.

• ISO 14644-5:2004

  Operational and performance requirements for maintaining cleanroom standards.

• ISO 14644-7:2004

  Cleanroom classification for non-pharmaceutical sectors.

• ISO 14644-8:2009

  Measurement standards for determining air cleanliness by particle concentration.

The latest versions of ISO 14644 standards are essential for ensuring that cleanrooms maintain the highest levels of air cleanliness and operational efficiency. By following these updated guidelines, industries can ensure compliance with global standards, improve product quality, and minimize contamination risks in critical manufacturing environments.