Optimizing Cleanroom Operations: SOPs for Gowning Protocols

In cleanroom environments, the operator represents one of the most significant sources of particulate contamination. To mitigate this risk, well-structured SOPs for gowning protocols are essential. This chapter explores the development of gowning SOPs that govern garment selection, donning sequence, personnel behavior, and cleanroom zoning — all aligned with environmental classification and process-specific risks.

Drawing on standards such as IEST-RP-CC003, USP 797, and Annex 1, this chapter offers a comprehensive approach to documenting gowning procedures that are both compliant and operationally efficient.

By the end of Chapter 2, readers will understand how to:

• Define gowning zones and structure operator flow for contamination control
• Select appropriate cleanroom garment systems based on ISO classification and use case
• Incorporate testing methods like Helmke drum and body box validation
• Document gowning SOPs using illustrated step-by-step procedures
• Ensure operator compliance through clear SOP training and performance checks
  
  

“The specific methods and intentional order of operations for donning cleanroom garments controls the particulate integrity of the environment.”

Explore More Resources

Continue deepening your understanding of SOPs for controlled environments:

• Chapter 1: Introduction to Writing Internal SOPs for Controlled Environments

• Chapter 3: SOPs for Cleanroom Operator Requirements and Training

• Chapter 4: SOPs for Cleaning and Sanitization

• Chapter 5: SOPs for Critical Cleaning