The Journal of the IEST presents the first in a series of outreach articles by ISO/TC 209 Working Group Convenors to foster promotion and education of the expanding body of ISO/TC 209 Standards

Abstract

Within the International Organization for Standardization (ISO), Technical Committee (TC) 209 is chartered with standardization of cleanrooms and associated controlled environments. A series of 15 international standards (thirteen parts under ISO 14644 and ISO 14698 Parts 1–2) has been established for controlling contamination by means of cleanroom technology. The documents address design, classification, and support operation of cleanrooms.

The recently published standard ISO 14644-15:2017 specifies assessment of the suitability of equipment and materials with respect to airborne chemical concentration. Three sampling procedures are described as well as calculation procedures for emission rate and specific emission rate in g/s for equipment or g/(m2s) for material. The emission rate and specific emission rate and proscribed inspection result are used for the cleanroom suitability assessment.

The specific emission rate can be used by designers, suppliers, and users for acceptance or impact evaluation of equipment and materials considered for use in existing or future applications of cleanroom technology.

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About the author

Dr. Berthold Düthorn is a pharmacist by education and received a PhD from the faculty of natural sciences of University Erlangen-Nürnberg. He is a vice president of Robert Bosch Technology GmbH and Managing Director of Valicare GmbH. His responsibilities are product area qualification and validation services, plant design, and industry 4.0.

For more than 20 years, Düthorn has been engaged in national and international standardization activities for cleanrooms and associated controlled environments as a nominated expert, Convenor of ISO/TC 209 WG 11 and the German mirror group, and head of the German delegation to ISO/TC 209 and CEN/TC 243.