What are the standard-setting organizations for cleanrooms and controlled environments?

An Overview of ISO Cleanroom Standards, Supporting Government Agencies and Independent Standards Organizations

Evolution of Cleanrooms and Standards

Cleanrooms have evolved as industry and consumer needs and technological advancements have changed the process and product requirements of the work performed there.

In 1962, thousands of “clean rooms” were being built for NASA’s space program. The United States government needed to establish a standard to distinguish a cleanroom that controlled airborne viable and non-viable particles from a “clean room.”

Federal Standard 209, Airborne Particulate Cleanliness Classes in Cleanrooms and Clean Zones, was the original standard that all industries adopted to distinguish their cleanrooms from a “clean room.”

The Institute of Environmental Sciences and Technology (IEST) led the development of the Federal Standard 209 (i.e., Class 1, 10, 100, 1,000, 10,000, 100,000 nomenclature).

Later, as the number of cleanrooms increased internationally, the International Organization for Standardization (ISO) established the technical committee (ISO/TC 209) to define the standards (i.e., ISO 3, 4, 5, 6, 7, 8 nomenclature).

In regulated industries, (i.e., pharmaceutical, medical design manufacturing) compliance with the standards is mandatory to receive the required government agency product approval.

In advanced material segments (i.e., SEMI, optics) the standards are in place to improve yields and reduce rework. Compliance with the standards in a non-regulated industry is at the discretion of each specific user. Market forces determine to what extent a non-regulated industry complies.

Today, ISO 14644-1:2015 and 14644-2:2015 are the international standards that distinguish a cleanroom from a generic room that is a clean, controlled environment.

ISO 14644-1 replaced the U.S. Federal Standard 209 in 2001.

What’s the purpose of cleanroom standards?

• To give operators of cleanrooms a common vocabulary and reproducible testing methodologies to ensure compliance with a specific standard.
• To provide external standards for reference in the development of specific internal Standard Operating Procedures (SOPs).
• To provide common ground for product and service performance requirements for third-party service and product providers who will be engaged as a vendor to operate and maintain your controlled environment.

Who’s involved in creating cleanroom standards?

Many organizations are involved with the development of cleanroom standards. Their spheres of influence are based on the specific activity performed and whether it is regulated or non-regulated.

General Standards Organizations

These organizations participate in the creation of standards for all cleanrooms.

ISO

ISO is an independent, non-governmental international organization with a membership of 167 national standards bodies. Through its members, it brings together subject matter experts to share knowledge and develop voluntary, consensus-based, market-relevant international standards that support innovation and provide solutions to global challenges.

The ISO 14644 series of international standards are specifically established for cleanrooms and associated controlled environments. You can find a list of the standards here.

IEST

IEST is the leading technical, nonprofit membership association that connects professionals in the controlled environment industry. IEST gives technical guidance through international standards, recommended practices, and education programs developed by experts in the fields of contamination control, environmental test and reliability, and nanotechnology facilities.

IEST collaborated with the International Cleanroom and Contamination Control Society (ICCCS) to write the ISO 14644 standards under the auspices of ISO/TC 209. IEST is the Secretariat to ISO/TC 209 and Administrator of ANSI-accredited U.S. TAG to ISO/TC 209. Therefore, all ISO 14644 standards for cleanrooms and associated controlled environments are published by the IEST (see “ISO Cleanroom Standards Summary” at the conclusion of the article).

International Cleanroom and Contamination Control Society (ICCCS)

ICCCS is a member organization for national member societies that helps facilitate international cooperation in the development, application, education and standardization of cleanroom technology and contamination control best practices. Delegates meet semi-annually to share and disseminate current information on cleanrooms and contamination control. The IEST is also a member of the ICCCS.

U.S. Technical Advisory Group to ISO

U.S. TAG is an independent, non-governmental international organization of nominated industry experts that represent the U.S. interests in ISO standards. U.S. members of ISO/TC 209 represent the U.S. federal government, U.S. cleanroom industries, organizations such as the International Society for Pharmaceutical Engineers, Cleanroom Environmental Testing Association as well as members of IEST.

National Institute of Standards and Technology (NIST)

NIST is a non-regulatory government agency of the U.S. Department of Commerce whose mission is to promote American innovation and industrial competitiveness.

Equipment used to monitor and evaluate the cleanroom integrity (air particle cleanliness, filter velocity, temperature, relative humidity, and room pressure) is calibrated to NIST standards.

American Society for Testing and Materials (ASTM International)

ASTM International is a globally recognized leader in the development and delivery of voluntary consensus standards. Three major cleanroom applications that subscribe to ASTM standards are automotive, aerospace, and plastics manufacturing. The woven cleanroom fabrics used in cleanroom garments are tested and evaluated using ASTM standards for textiles. ASTM F-51 test method is used to determine cleanroom garment particle cleanliness after cleanroom garment laundering.

American National Standards Institute (ANSI)

ANSI administers and coordinates the U.S. voluntary standards and conformity assessment system. ANSI facilitates the development of American National Standards (ANS) by accrediting the procedures of standards-developing organizations and approving their documents as ANS.

ANSI is the sole U.S. representative to ISO, and, through the U.S. National Committee to the International Electrotechnical Commission.

National Environmental Building Bureau (NEBB)

NEBB is an international association certifying firms and qualifying supervisors and technicians in the following disciplines: testing, adjusting, and balancing of HVAC systems; building systems commissioning; sound and vibration measurement; retro-commissioning; fume hood testing; and cleanroom performance testing.

NEBB also establishes and maintains industry standards, procedures, and work specifications for these disciplines. The test methods for certifying cleanroom air particle cleanliness to ISO 14644-1 and 2 were established by NEBB. Many industries using cleanroom testing companies require the technicians to be NEBB certified.

EOS/ESD Association, Inc.

EOS/ESD Association is a professional voluntary association dedicated to advancing the understanding of EOS and the theory and practice of electrostatic discharge (ESD) avoidance. Initially focusing on ESD on electronic components, the Association has broadened its horizons to include areas such as textiles, plastics, web processing, cleanrooms, and graphic arts.

To meet the needs of a continually changing environment, it is chartered to expand ESD awareness through standards, development, education programs, local chapters, publications, tutorials, certification, and symposia. It is the only organization accredited by ANSI to write and produce standards on electrostatics. Several ESD standards are referenced in IEST-RP-CC052, Understanding, Identifying, and Controlling Electrostatic Charge in Cleanrooms and Other Controlled Environments.

ISO Cleanroom Standards Summary

• ISO 14644-1:2015 Cleanrooms and Associated Controlled Environments Part 1: Classification of air cleanliness by particle concentration covers the classification of air cleanliness in cleanrooms and associated controlled environments.
• ISO 14644-2:2015 Cleanrooms and Associated Controlled Environments Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration specifies the requirement for monitoring and periodic testing of a cleanroom or clean zone to prove its continued compliance to ISO 14644-1.
• ISO 14644-3:2005 Cleanrooms and Associated Controlled Environments Part 3: Test Methods specifies test methods for designated classification of airborne particulate cleanliness for characterizing the performance of cleanrooms and clean zones.
• ISO 14644-4:2022 Cleanrooms and Associated Controlled Environments Part 4: Design, Construction, and Start-up specifies requirements for the design and construction of cleanroom installations.
• ISO 14644-5:2004 Cleanrooms and Associated Controlled Environments Part 5: Operations specifies basic requirements for cleanroom operations.
• ISO 14644-7: 2004 Cleanrooms and Associated Controlled Environments Part 7: Separative devices (clean air hoods, glove boxes, isolators, mini environments specify the minimum requirements for the design, construction, installation, testing and approval of separative devices.
• ISO 14644-8:2022 Cleanrooms and Associated Controlled Environments Part 8: Assessment of air cleanliness for chemical concentration establishes assessment processes to determine grading levels of air chemical cleanliness (ACC).
• ISO 14644-9:2022 Cleanrooms and Associated Controlled Environments Part 9: Assessment of surface cleanliness for particle concentration establishes a procedure for the assessment of particle cleanliness levels on solid surfaces.
• ISO 14644-10:2022 Cleanrooms and Associated Controlled Environments Part 10: Assessment of surface cleanliness for chemical contamination establishes appropriate testing processes to determine the cleanliness of surfaces regarding the presence of chemical compounds or elements.
• ISO 14644-12:2018 Cleanrooms and Associated Controlled Environments Part 12: Specifications for monitoring air cleanliness by nanoscale particle concentration covers the monitoring of air cleanliness by a particle in terms of concentration of airborne nanoscale particles.
• ISO 14644-13:2017 Cleanrooms and Associated Controlled Environments Part 13: Cleaning of surfaces to achieve a defined level of cleanliness in terms of particle and chemical classifications addresses the cleaning to a specified degree on cleanroom surfaces, surfaces of equipment in a cleanroom and surfaces of materials in a cleanroom.
• ISO 14644-14:2016 Cleanrooms and Associated Controlled Environments Part 14: Assessment of suitability for use of equipment by airborne particle concentration specifies a methodology to assess the suitability of equipment for use in cleanrooms and associated controlled environments.
• ISO 14644-15:2017 Cleanrooms and Associated Controlled Environments Part 15: Assessment of suitability of equipment and materials by airborne chemical concentration provides requirements and guidance for assessing the chemical airborne cleanliness of equipment and materials that are foreseen to be used in cleanrooms and associated controlled environments.
• ISO 14644-16:2019 Cleanrooms and Associated Controlled Environments Part 16: Energy efficiency in cleanrooms and separative devices provides guidance and recommendations for optimizing energy usage and maintaining energy efficiency in new and existing cleanrooms, clean zones, and separative devices.
• ISO 14644-17:2021 Cleanrooms and Associated Controlled Environments Part 17: Particle deposition rate applications provide guidance on the interpretation and application of the results of measurement of Particle Deposition Rate (DPR) on one or more vulnerable surfaces in a cleanroom as part of a contamination control program.
• ISO/DIS 14644-18 Cleanrooms and Associated Controlled Environments Part 18: Assessment of suitability of consumables provides guidance for assessing personal and non-personal consumables for their appropriate use in cleanrooms, clean zones or controlled zones based on product and process requirements, cleanliness attributes, and functional performance properties.

ISO 14644 standards under development are:

• ISO/AWI TS 14644-19 Cleanrooms and Associated Controlled Environments Part 19: General technical requirements of modular isolation units for emergency medical use.
• ISO/AWI 14644-20 Cleanrooms and Associated Controlled Environments Part 20: Microbiological contamination control.
• ISO/DTR 14644-21 Cleanrooms and Associated Controlled Environments Part 21: Airborne Particle Sampling Techniques
  
  

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