Standard Operating Procedure (SOP)

1. Purpose

To establish a standardized method for qualifying personnel in proper gowning procedures to ensure compliance with cleanliness and contamination control requirements in controlled environments (e.g., cleanrooms, sterile areas).

2. Scope

This SOP applies to all employees, contractors, and visitors who are required to enter controlled or classified areas at [Facility/Organization Name].

3. Responsibilities

• Training Coordinator: Organize and document gowning training and qualification activities.

• Area Supervisor/QA Officer: Verify that personnel comply with gowning standards during routine operations.

• Personnel: Successfully complete gowning qualification and maintain proper gowning practices.

4. Definitions

• Gowning: The process of donning (putting on) and doffing (removing) approved garments to minimize contamination risks.

• Qualification: Demonstration that an individual can correctly perform gowning procedures according to SOPs without assistance.

5. Procedure

5.1 Initial Training

• Provide theoretical training covering:

  • Importance of gowning

  • Types of garments and personal protective equipment (PPE)

  • Steps for correct gowning and de-gowning

  • Contamination control principles

• Conduct practical demonstration by a qualified trainer.

5.2 Gowning Practice

• Personnel must practice gowning under supervision in a non-classified area before qualification.

• Emphasis on critical aspects like hand hygiene, sequential gowning, and avoiding contamination of sterile surfaces.

5.3 Qualification Assessment

• Conduct practical evaluation in a simulated or actual gowning area.

• Personnel must:

  • Perform hand washing or sanitization properly.

  • Correctly don gowning attire (e.g., coverall, boots, mask, gloves, hood) in the correct sequence without touching contaminated surfaces.

  • Doff garments correctly to avoid contamination spread.

5.4 Monitoring and Verification

• Perform a visual inspection by a QA Officer or Supervisor.

• Optional: Conduct microbiological monitoring (e.g., contact plates or swabs from gown surfaces) after gowning to confirm adequacy.

• Record the outcome in the Gowning Qualification Record.

5.5 Requalification

• Requalification is required:

  • Annually (or as per internal policy).

  • After long absence (e.g., >30 days).

  • After failure to comply during routine operations.

  • Following updates to gowning procedures.

6. Acceptance Criteria

• No observed errors during gowning or de-gowning.

• No contamination of critical surfaces.

• If microbiological monitoring is performed, results must be within acceptable limits.

7. Documentation

• Training Attendance Sheet

• Gowning Qualification Checklist

• Gowning Requalification Records

• Deviation and Re-Training Records (if applicable)

8. Safety and Compliance

• Follow facility hygiene protocols at all times.

• Report any damaged gowning materials immediately.

• Maintain personal hygiene standards (e.g., trimmed nails, no makeup or jewelry) before gowning.

9. References

• [ISO 14644 Cleanroom Standards]

• [EU GMP Annex 1: Manufacture of Sterile Medicinal Products]

• [Facility Gowning Procedure Manual]

10. Annexures

• Gowning Qualification Checklist (Sample)

• Hand Washing Procedure Diagram

• Cleanroom Classification Chart.

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