ISO 14644-5

ISO 14644-5 is a part of the ISO 14644 series that provides guidelines for the design, installation, and operational requirements for cleanroom equipment and systems in controlled environments. This standard focuses on the equipment necessary to achieve and maintain the cleanliness standards set in other parts of the ISO 14644 series, particularly regarding air handling systems, monitoring systems, and filtration systems. ISO 14644-5 outlines best practices for selecting, installing, and maintaining equipment such as air filtration units (e.g., HEPA filters), particle counters, and HVAC systems to ensure they perform effectively and maintain the required cleanroom conditions. It also includes recommendations for verifying and calibrating equipment to ensure reliability and accuracy in maintaining air cleanliness, temperature, humidity, and pressure within the cleanroom. The goal of ISO 14644-5 is to support industries like pharmaceuticals, biotechnology, and semiconductor manufacturing in creating and maintaining environments that meet stringent contamination control standards, ensuring the equipment functions optimally throughout the cleanroom's lifecycle.

ISO-14644-5-2004.pdf

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Foreword

International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.

The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote.

Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights.

ISO 14644-5 was prepared by Technical Committee ISO/TC 209, Cleanrooms and associated controlled environments.

ISO 14644 consists of the following parts, under the general title Cleanrooms and associated controlled environments:

Part 1: Classification of air cleanliness
Part 2: Specifications for testing and monitoring to prove continued compliance with ISO 14644-1
Part 3: Test methods
Part 4: Design, construction and start-up
Part 5: Operations
Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments)
Part 8: Classification of airborne molecular contamination
The following part is under preparation:
Part 6: Terms and definitions

Introduction

Industries and organizations of all kinds utilize cleanrooms. Operational procedures have a profound effect on the cleanliness levels achieved during the operation of the cleanroom and equipment. Consistent quality is cleanliness dependent. Operational cleanliness can only be attained and maintained through a deliberate programme established to specify, measure and enforce defined operational procedures. Regulatory agencies that have authority over processes and products produced in the cleanroom may require additional procedures and measures of cleanliness not covered in this general operating standard.

This part of ISO 14644 addresses normative and informative operational requirements related to:

providing a system that defines policies and operational procedures;
clothing used to isolate human-generated contamination from the cleanroom environment;
training of personnel inside the cleanroom and monitoring their compliance to specified procedures and disciplines;
transfer, installation and maintenance of stationary equipment (selection criteria is not discussed);
selection and use of materials and portable equipment in the cleanroom;
maintaining the cleanliness of the cleanroom through systematic cleaning and monitoring procedures.

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ISO 14644-5:2004(EN) Video Introduction

FAQ

Q: What is ISO 14644-5?

A: ISO 14644-5 is a standard within the ISO 14644 series that provides guidelines for the classification, testing, and maintenance of cleanrooms with respect to environmental conditions, specifically focusing on the installation and operation of cleanroom equipment such as air handling systems, HVAC systems, and particle monitoring devices. It covers the requirements for the verification and monitoring of cleanroom systems to ensure they meet the necessary cleanliness standards, and it includes recommendations for maintaining air cleanliness, proper airflow, temperature control, and humidity levels. This standard helps ensure the cleanroom meets the required environmental conditions for its intended use.

Q: What is the current version of ISO 14644?

A: The current version of ISO 14644 consists of several parts, including the most recent revisions of ISO 14644-1:2015, ISO 14644-2:2015, ISO 14644-3:2019, ISO 14644-4:2018, and ISO 14644-5:2020. These updates reflect the latest best practices for cleanroom classification, testing, performance monitoring, and environmental control systems. ISO 14644-1:2015 provides the criteria for classifying cleanrooms based on particle concentration, ISO 14644-2:2015 outlines the procedures for monitoring cleanroom performance, ISO 14644-3:2019 deals with testing methods, ISO 14644-4:2018 focuses on airflow and air change rates, and ISO 14644-5:2020 covers cleanroom equipment and installation.

Q: What is the difference between ISO 4 and ISO 5 cleanroom?

A: The primary difference between an ISO Class 4 and ISO Class 5 cleanroom is the level of cleanliness, specifically the allowable concentration of airborne particles. ISO Class 4 cleanrooms allow no more than 352 particles of 0.5 microns or larger per cubic meter of air, whereas ISO Class 5 cleanrooms allow up to 3,520 particles of the same size. This makes ISO Class 4 cleanrooms much cleaner and more suitable for extremely sensitive processes, such as the manufacturing of microelectronics or pharmaceuticals, where contamination control is critical. In contrast, ISO Class 5 cleanrooms, while still maintaining stringent cleanliness standards, are often used in less sensitive operations, such as assembly or packaging in medical device manufacturing.

Q: What is ISO 14644-4 cleanroom standards?

A: ISO 14644-4 outlines the cleanroom standards specifically related to the design, installation, and operation of HVAC systems and airflow patterns within cleanrooms. It provides guidelines for air change rates, airflow direction, and the distribution of clean air to ensure that the environment remains free from contamination. This part of the ISO 14644 series also offers recommendations for the configuration and testing of air handling systems to maintain the required cleanliness levels, ensuring that the cleanroom meets the necessary particle concentration standards. It also includes suggestions for monitoring environmental conditions such as temperature, humidity, and pressure to achieve optimal cleanroom performance.

Q: What is the latest version of ISO 14644?

A: The latest version of ISO 14644 includes revisions across several parts, with the most current versions being ISO 14644-1:2015, ISO 14644-2:2015, ISO 14644-3:2019, ISO 14644-4:2018, and ISO 14644-5:2020. These revisions provide updated guidelines on cleanroom classification, performance monitoring, testing, and system design. The changes incorporate advancements in cleanroom technology and practices, focusing on improving energy efficiency, enhancing contamination control, and updating testing methodologies. The most recent updates are designed to ensure cleanrooms maintain high standards of air cleanliness and operational performance in industries such as pharmaceuticals, semiconductors, and biotechnology.