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General Standards Organizations for Controlled Environments: An Overview

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Overview

Cleanrooms are critical environments designed to control contamination for industries ranging from pharmaceuticals to aerospace. In this chapter, you’ll learn about the key organizations that develop and maintain standards ensuring cleanrooms meet consistent, measurable requirements worldwide.

By the end of Chapter 1, you will understand how:

  • International and national bodies collaborate to define cleanroom standards.
  • Standards like ISO 14644 replace older frameworks such as Federal Standard 209.
  • Organizations like IEST, ASTM, ANSI, and NEBB contribute technical guidance.
  • Electrostatic discharge control is managed by groups like the EOS/ESD Association.

 

“The ISO 14644 series of standards has replaced Federal Standard 209 and serves as the global framework for cleanroom classification and operation.”
– Jan Eudy, Cleanroom Expert

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Jan Eudy is a cleanroom/contamination control and microbiological subject matter expert with more than 30 years of industry experience in semiconductor, microelectronics, pharmaceutical, biopharmaceutical, medical device, food manufacturing, compounding pharmacies, aerospace, and automotive. As the corporate quality assurance manager for Cintas Corp., Jan oversaw research and development, directed the quality system and ISO registration at all cleanroom locations, and supported validation and sterile services. During her time with the company, Jan also implemented and maintained the HACCP risk management program at all Cintas industrial laundries. She is also a Past President and Fellow of the Institute for Environmental Sciences and Technology (IEST).

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