Technical Papers

Optimizing Cleanroom Operations: SOPs for Gowning Protocols

Written by Jan Eudy | May 15, 2025

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.

This article is Chapter 2 of Valutek’s Technical Paper Series:
Standard Operating Procedures for Controlled Environments

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 this chapter, 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.”

 

Components of a Gowning SOP

A well-developed gowning SOP should address:

  • Garment system selection – including reusable or single-use options based on the cleanroom class and application

  • Donning sequence and zones – specifying three-stage gowning areas (gray, blue, and white zones) to structure behavior and flow

  • Documentation and visuals – illustrated step-by-step instructions ensure operator adherence

  • Operator requirements – specifying PPE fit, hygiene expectations, and self-inspection practices

Reusable garments are typically constructed from ESD-safe polyester with high particle filtration efficiency, cleanroom-laundered per IEST-RP-CC003, and may include flame-retardant options for arc flash protection. Single-use garments, like those made from SMS or microporous films, are pre-sterilized for ISO 5+ cleanrooms and offer flexibility where laundering is impractical.

 

Technical Evaluation and Fit-for-Use

Gowning SOPs must go beyond compliance—they should be validated for actual performance. Testing methods such as the Helmke drum test and body box testing quantify particle release during movement. Additional garment properties—such as moisture vapor transmission rate (MVTR), bacterial filtration efficiency (BFE), and electrostatic dissipation—should be matched to application needs.

The SOP should ensure garments:

  • Are comfortable and breathable for the operator

  • Provide appropriate chemical resistance

  • Deliver required barrier protection for the cleanroom process

 

“Reusable and single-use cleanroom garment systems are evaluated for the specific cleanroom operation, classification, and fabric properties.”

 

Essential Considerations for Gowning SOP Development

  • Gowning SOPs must reflect cleanroom classification, process risk, and personnel protection needs.

  • Properly documented SOPs ensure repeatability through zone-based gowning and visual donning instructions.

  • Garment selection must be evaluated for particle control, comfort, and regulatory fit.

  • Performance should be validated through particle shedding and filtration efficiency tests.

 

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