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A cleanroom technician wearing full sterile attire selects a white coverall from a stainless steel garment rack in a brightly lit gowning room.

Optimizing Cleanroom Operations: SOPs for Gowning Protocols

This is Chapter 2 of Valutek's Technical Paper Series:
Standard Operating Procedures for Controlled Environments
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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.”

 

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Continue deepening your understanding of SOPs for controlled environments:
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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