Iest Rp-cc034.2

[Kassim Sin]

Sincelaunching its program to develop global cleanroom standards in 1990, ISO has published 10 ISO 14644 standards under the auspices of Technical Committee (ISO/TC) 209, Cleanrooms and associated controlled environments. The voting members of ISO/TC 209 represent 22 nations. The ISO 14644 cleanroom standards established airborne particulate cleanliness classes for particle sizes ranging from 0.1 μm to 5 μm. Nine of these international standards have also been approved by the American National Standards Institute (ANSI) as American national standards. IEST is Secretariat of ISO/TC 209 and Administrator of the ANSI-accredited US Technical Advisory Group (TAG) to ISO/TC 209.

Together, these non-profit organizations contribute a vast amount of knowledge and resources to the cleanroom and controlled environments industries. This article will provide an overview and summarize the key points of the full array of contamination control guidance documents produced by IEST and ISO and presented at ESTECH 2015.

ISO/TC 209 published two biocontamination control standards in 2000: ISO 14698-1 General principles and methods and ISO 14698-2 Evaluation and interpretation of biocontamination data. Associated RPs that assist cleanroom operators in achieving the principles in these ISO standards are IEST-RP-CC013: Calibration Procedures and Guidelines for Selecting Equipment Used in Testing Cleanrooms and other Controlled Environments, and IEST-RPCC023: Microorganisms in Cleanrooms.

ISO 14644-3: Test methods specifies metrology and test methods for characterizing the performance of cleanrooms and clean zones. Relatedly, IEST-RP-CC014: Calibration and Characterization of Optical Airborne Particle Counters and IEST-RP-CC034: HEPA and ULPA Filter Leak Tests provide test methods for compliance with ISO 14644-3.

Cleanroom design and construction ISO 14644-4: Design, construction and start-up provides guidance for cleanroom designers, contractors, purchasers, and suppliers. A useful tool for cleanroom installers is the construction protocol included in IEST-RP-CC012: Considerations in Cleanroom Design, which addresses the design and installation of cleanroom production equipment and includes a table on cleanroom classifications, airflow velocities, and recommended number of air changes per hour. IESTRP-CC024: Measuring and Reporting Vibration in Microelectronics Facilities provides guidance regarding the special vibration considerations for equipment in the cleanroom. IEST-RP-CC022, Electrostatic Charge in Cleanrooms and Other Controlled Environments addresses design aspects that enable control of static electricity in cleanrooms.

ISO 14644-4: Design, construction and start-up provides guidance for cleanroom designers, contractors, purchasers, and suppliers. A useful tool for cleanroom installers is the construction protocol included in IEST-RP-CC012: Considerations

in Cleanroom Design, which addresses the design and installation of cleanroom production equipment and includes a table on cleanroom classifications, airflow velocities, and recommended number of air changes per hour. IESTRP-CC024: Measuring and Reporting Vibration in Microelectronics Facilities provides guidance regarding the special vibration considerations for equipment in the cleanroom. IEST-RP-CC022, Electrostatic Charge in Cleanrooms and Other Controlled Environments addresses design aspects that enable control of static electricity in cleanrooms.

ISO 14644-7: Separative devices addresses enclosures such as barrier isolator systems, clean air hoods, gloveboxes, and minienvironments. IESTRP-CC028: Minienvironments provides guidance specifically for minienvironments in cleanrooms.

The primary concern for any product produced in a cleanroom environment is the potential impact of airborne molecular contamination (AMC) on the product. ISO 14644-8: Classification of air cleanliness by chemical concentration (ACC) addresses airborne concentrations of specific chemical substances and provides a protocol to include test methods, analysis, and time-weighted factors within the specification for classification.

The recommended practice IEST-RPCC035: Design Considerations for Airborne Molecular Contamination Filtration Systems in Cleanrooms covers HVAC system design, filter selection, and the materials used to build the cleanroom. IEST-RP-CC016: The Rate of Deposition of Nonvolatile Residue in Cleanrooms is a reference for cleanroom certification and monitoring of nonvolatile residue. IEST-RP-CC031: Method for Characterizing Outgassed Organic Compounds from Cleanroom Materials and Components provides guidance for selecting of compatible materials.

ISO 14644-9: Classification of surface cleanliness by particle concentration describes the classification of particle contamination levels on solid surfaces and recommends testing and measuring methods. ISO 14644-10: Classification of surface

cleanliness by chemical concentration defines the classification system for cleanliness of surfaces in cleanrooms with regard to the presence of chemical compounds or elements (including molecules, ions, atoms, and particles).

ISO/TC 209 also established a nanotechnology working group (WG) to develop contamination control standards for industries involved with nanoscale materials and devices. This WG is convened by the US under the leadership of IEST. The first document will be written to help nanotechnology professionals apply the existing series of ISO/TC 209 documents. Future standards are proposed to include classification of air cleanliness and metrology; design, construction, and start-up; operations; and nanobiotechnology. Another ISO technical committee, ISO/TC 229 Nanotechnologies, is addressing all aspects of this emerging discipline. IEST represents the environmental sciences as a voting member of the ANSI-accredited US TAG to ISO/TC 229.

IEST WGs are developing a series of RPs addressing nanotechnology topics. IEST-RPNANO200: Planning of Nanoscale Science and Technology Facilities: Guidelines for Design, Construction, and Start-up, was published in 2013. Also under development is IEST-RPNANO205: Nanotechnology Safety: Applying Prevention through Design Principles to Nanotechnology Facilities. At ESTECH 2015, two new working groups are being formed: Vibration and Acoustics in Nanotechnology, and Testing Aerosol-Nanomaterial Containment Devices.

IEST recently published IEST-RP-CC046: Controlled Environments (Aerospace, Noncleanroom) and IEST-RP-CC042: Sizing and Counting of Submicrometer Liquid-Borne Particles Using Optical Discrete-Particle Counters.

Several RPs are under development and revision. Interested professionals are invited to participate in the working groups at ESTECH and at the Fall Conference. Titles under development or revision include:

Details about each of the standards and RPs discussed in this article, along with information on how to participate in working groups, can be found in the Standards RPs area of the IEST website at www.iest.org. The documents, including both the original and revised versions of ISO 14644 parts 1 and 2, are available through the IEST Bookstore.

The popular ISO Certificate Series will provide insights on the ISO cleanroom standards and pending revisions. These two courses in the series may also be taken individually: Evolution and Revolution in the Cleanroom: New ISO 14644-1 and -2 Standards discusses the significant changes in the newly revised Draft International Standards, how they impact your cleanroom operations, and the rationale of the documents. Application of ISO 14644-3 discusses the practical application of the series that a certification contractor would use to certify a clean space, including an open discussion on how best to implement these standards.

A new Cleanroom Basics course is being offered as an overview of all the IEST recommended practices and ISO 14644 standards applicable to the design, construction, and operation of a controlled environment.

Jan Eudy is a Cleanroom/Contamination Control Consultant as well as a Fellow and Past President, Institute of Environmental Sciences and Technology. She is located in Carolina Beach, N.C. and can be reached at [email protected].

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