Regulations and Standards for Cleanrooms: U.S. Government Agencies

Overview

Cleanrooms used in regulated industries must comply with specific government standards to ensure safety, quality, and efficacy. This chapter highlights the primary U.S. agencies that regulate cleanroom environments, the scope of their regulations, and how these influence contamination control practices.

By the end of Chapter 3, you will understand:

• The roles of the Food and Drug Administration (FDA), United States Department of Agriculture (USDA), National Aeronautics and Space Administration (NASA), and Department of Defense (DOD) in cleanroom regulation.
• Key regulations such as the FDA’s 21 CFR parts relevant to pharmaceuticals and medical devices.
• How standards like MIL-STD-810(H) shape testing requirements for aerospace and defense.
• The impact of these agencies’ regulations on cleanroom SOPs and compliance strategies.
  
  

“Government agency regulations form the backbone of compliance strategies for cleanroom operations in regulated industries.”
– Jan Eudy, Cleanroom Subject Matter Expert

EXPLORE MORE RESOURCES

• Chapter 1: General Standards Organizations for Cleanrooms and Controlled Environments

• Chapter 2: Controlled Environment Focused Standards Organizations

• Chapter 4: Introduction to Life Sciences Associations

• Chapter 5: Introduction to Advanced Material Associations