Cleanroom Standards: What You Need to Know (and Why)

By Jan E. Eudy

More than 30 years ago, the International Organization for Standardization (ISO) launched a program to develop global cleanroom standards. Since 1990, ISO has published 14 of them. Why are cleanroom and contamination control management standards important? Who, exactly, creates them? Who uses them? Here is a brief overview of cleanroom standards.

Jan Eudy
Jan Eudy

First, an overview of cleanrooms

Before we dive into cleanroom standards, it’s important to understand the purpose of cleanroom and where they are used. Cleanrooms are rooms in which the concentration of airborne particles is controlled by air filtration and contains at least one “clean zone.” They are designed to control molecular, particulate, electrostatic and microbial contamination. Cleanrooms are found in a variety of industries: pharmaceutical, medical devices and microelectronics/semiconductor manufacturing; aerospace; automotive paint-spray applications; biotechnology and biopharmaceutical research; and compounding pharmacies.

Guidelines and best practices

Because of the nature of cleanrooms, it’s imperative that there are standards for determining and managing the risk of contamination in these facilities. Contaminants like excessive moisture, bacteria, radiation, even sound and vibration can compromise the products being manufactured in cleanrooms. Equipment defects and faulty or ill-maintained structures are some common sources of contamination in cleanrooms. But the main source of cleanroom contamination is people. People who are working in and cleaning the cleanroom must adhere to cleanroom clothing and hygiene standards. It’s also imperative that there are standards for materials, equipment, and even how to “clean the cleanroom.”

ISO Technical Committee 209, made up of subject matter experts who represent 22 nations, create cleanroom standards. These international standards have also been approved by the American National Standards Institute (ANSI) as U.S. national standards. IEST is administrator of the ANSI-accredited U.S. Technical Advisory Group to ISO/TC 209.

The initial five ISO 14644 cleanroom standards established airborne particulate cleanliness classes for particle sizes ranging from 0.1 µm to 5 µm, monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration, testing, design and validation of cleanrooms and cleanroom operations.

How can I learn more?

Next week, the IEST will offer a training course series that covers essential cleanroom standards, the latest revisions, and general implementation guidelines. I encourage you to participate in IEST’s entire ISO 14644 Learning Path Bootcamp course series, March 9-11, and earn your IEST ISO 14644 Fundamentals Learning Path Certificate. However, you can easily register for any combination of classes. The courses are:

  • Essential Cleanroom Standards ISO 14644-1 and ISO 14644-2: The Foundations of Contamination Control, March 9 International cleanroom standards ISO 14644 Parts 1 and 2 are an essential part of any discussion related to cleanrooms and maintaining contamination control. This course will provide technical information and provide case histories related to the understanding and implementation of these important cleanroom standards.International cleanroom standards ISO 14644 Parts 1 and 2 are an essential part of any discussion related to cleanrooms and maintaining contamination control. This course will provide technical information and provide case histories related to the understanding and implementation of these important cleanroom standards.
  • New ISO 14644-3:2019 Basic Information and How to Implement, March 10 This course will provide detailed information about revisions and general implementation for existing cleanroom testing procedures. You will learn the differences between the 2005 and 2019 versions, key terms and definitions, test procedures, supporting test explanations, test apparatus, proper reporting, application examples, and more.
  • Universal Cleanroom Operations Guidelines with ISO 14644-5, March 11 The ISO 14644-5 Cleanrooms and Associated Controlled Environments – Operations standard specifies the basic requirements for cleanroom operations. I will teach this course and discuss in detail standards for operational systems, cleanroom clothing, personnel, stationary equipment, materials and portable equipment, cleanroom cleaning. I will also reference IEST Recommended Practices (garments, wipers, gloves, testing, design, housekeeping, operations, personnel) where applicable. The ISO 14644-5 standard states what should be done. The IEST Recommended Practices outline how to comply with the standard.

Registration closes next week for the course series, so be sure to sign up quickly. I look forward to introducing you to key cleanroom standards and discussing how to help you manage risk to cleanroom products and processes.

Jan E. Eudy is a cleanroom and contamination control consultant with more than 30 years of industry experience. Jan is a technical resource for cleanroom, food and healthcare reusable garments and consumable products. She holds numerous certifications and credentials, including: Registered Medical Technologist and Specialist in Microbiology with the American Society of Clinical Pathologists, Registered Microbiologist with the National Registry of Certified Microbiologists in Consumer Product Testing and Quality Assurance, and Certified Quality Auditor with the American Society for Quality.

Registration closes March 3 for ISO 14644 Learning Path Bootcamp, taking place March 9-11. Sign up today!

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