ISO 14644 Standards Series on Airborne Particulate Cleanliness

Environmental pollution and global warming are some of the most concerning issues of the modern world. The indoor air quality is also affected by outdoor environmental issues. As a result, many standards have been devised globally to manage air pollution,  and ISO 14644 is one of them but it focuses on indoor air quality.

ISO 14644: A Brief History

ISO  14644 is a collective set of standards. The standard was first formulated as ISO 14644-1 in 1999 from the US Federal Standard 290E Airborne Particulate Cleanliness Classes in Cleanrooms and Clean zones. The following year, ISO 14644-2 was published, but it was later canceled and replaced by ISO 14644-1 and ISO 14644-2.

Composition of ISO 14644

ISO 14644 comprises of nine parts:

  1. Classification of Air Cleanliness
  2. Specifications for Testing and Monitoring to Prove Continued Compliance with ISO 14644-1
  3. Test Methods
  4. Design, Construction, and Start-up
  5. Operations
  6. Vocabulary
  7. Separative Devices (Clean Air Hoods, Gloveboxes, Isolators, and Minienvironments)
  8. Classification of Airborne Molecular Contamination
  9. Classification of Surface Particle Cleanliness.

Classification of Air Cleanliness-Part 1

This part discusses the classification of air cleanliness in cleanrooms and other associated cleanroom environments. This classification is specified and accomplished concerning the concentration of airborne particulates. After the cancellation of FED-STD-209E, this document was adopted as ANSI/IEST/ISO 14644-1 in the United States.

Specifications for Testing and Monitoring to Prove Continued Compliance with ISO 14644-1-Part 2

Requirement Specifications

This part specifies two requirements, i.e.,

  • Those for periodic testing of a cleanroom or a clean zone for proving its continued compliance with ISO 14644-1
  • Those for cleanroom monitoring and clean zone installation to prove its continued compliance with ISO 14644-1.

After FED-STD-290E’s cancellation in 2000, this became an international standard and was adopted in the US as ANSI/EST/ISO 14644-2:2000.

Test Methods-Part 3

Test Methods

This part contains the test methods for

  • Designated classification of airborne particulate cleanliness
  • Characterization of cleanrooms and clean zones performance.

These test methods are specified for two different cleanroom types and clean zones. They are

  • Unidirectional flow
  • Multidirectional flow.

Objectives of the Document

The objectives of this document are:

  • Providing an everyday international basis of cleanrooms measurement and evaluation
  • Not prevent the introduction of any new technologies.

Design, Construction, and Startup-Part 4

Requirement Specifications

In this part, there are specifications about requirements for:

  • Design and construction of cleanroom and clean air devices
  • Requirements for start-up qualification.

Although this part specifies design, construction, and startup qualification requirements, it does not identify any particular or technological means to comply with these requirements.

Uses of ISO 14644-1

The document is intended to be used by:

  • Purchasers
  • Suppliers
  • Designers of cleanroom installations.

Submission of the Document

The document was submitted in 2001 as an American National Standard.

Operations:-Part 5

Basic Requirements

This part contains basic requirements regarding the operation and maintenance of controlled environments associated with cleanrooms. In this standard, there are essential requirements for the operations of all cleanrooms without concerning their applications, and they include:

  • Correctly placed operational systems
  • Selecting and using appropriate cleanroom garments
  • Training and monitoring cleanroom activities and personnel
  • Installation and use of equipment
  • Requirements regarding materials used in the cleanroom
  • Maintenance of the cleanroom environment in a clean and usable condition that conforms to design standards.

Publication, Submission, and Adoption

This document was submitted and published in 2004 as an International Standard. It is now adopted as an American National Standard ANSI/IEST/ISO 14644-5:2004.

Vocabulary-Part 6

This document describes all the terms and conditions in ISO 14644 and ISO 14698 and is considered an essential document for contamination control professionals.

Adoption

The standard was adopted as an American National Standard in 2008.

Separative Devices (Clean Air Hoods, Gloveboxes, Isolators, and Minienvironments)-Part 7

Specifications of the Document

This part has specified the requirements for

  • Design
  • Construction
  • Installation
  • Testing
  • Approval of separative devices.

This document considers all of the above processes for the separative devices, such as they differ from cleanrooms described by Parts 4 ad 5.

Range of Separative Devices

The range of these separative devices is from open to closed systems.

Limitations of this Standard

The limitations of this standard are:

  • It does not address the application-specific requirements
  • User arguments are those agreed upon by the customer and supplier
  • Those specific processes requiring accommodation in the separative device installation are not specified
  • This standard’s scope does not include full-suits
  • Regulatory matters such as fire and safety, etc., are not considered.

Publication, Submission, and Adoption

This document was published in 2004 as an International Standard. It was submitted as an American National Standard and is now adopted as an American National Standard ANSI/IEST/ISO 14644-7:2004.

Classification of Airborne Molecular Contamination-Part 8

Scope of the Document

This part covers the classification of AMC (Airborne Molecular Contamination) in

  • Cleanrooms
  • Associated controlled environments.

This classification is per the airborne concentrations of specific chemical substances (either individual, group, or category). It provides a protocol to include:

  • Test methods
  • Analysis
  • Time-weighted factors within the specification of classification.

Development and Adoption of the Standard

Secretariat of ISO Technical Committee 209, IEST developed this document, becoming a standard in 2006.

Classification of Surface Particle Cleanliness-Part 9

This document describes how to classify the particle contamination levels on solid surfaces in

  • Cleanrooms
  • Other associated controlled environments application.

Informative Annexes

The informative annexes contain

  • Recommendations on testing and measuring methods
  • Information about surface characteristics.

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About the Author

Waqas Imam

S. M. Waqas Imam is associated with TS Quality as a Regional Partner. He is also an ambassador of Medical Device Community. He is an Industrial Engineer by qualification and served the manufacturing industry since 2011. He is also IRCA CQI Lead Auditor of ISO 9001 and other management system standards. He had served as Quality Assurance and Regulatory Affairs Manager in QSA Surgical Pvt. Ltd. and Ultimate Medical Products. He managed requirements of ISO 13485:2003, EU directives, CE marking and FDA. He also served as Expert Blog Writer for 13485Academy and wrote expert articles on various topics of ISO 13485:2016.