Standard Operating Procedure for Gowning Procedure

1) Purpose

This SOP outlines the gowning procedures to be followed by personnel entering controlled environments, such as cleanrooms, to prevent contamination of pharmaceutical products.

2) Scope

This SOP applies to all personnel who are required to gown and enter controlled environments within the pharmaceutical manufacturing facility.

3) Responsibilities

Personnel entering controlled environments are responsible for following the gowning procedures outlined in this SOP. Quality Assurance (QA) oversees compliance with this SOP and regulatory requirements.

4) Procedure

4.1 Gowning Requirements

1. Ensure personnel are trained on gowning procedures and hygiene practices before entering controlled environments.
2. Verify that cleanroom garments (e.g., coveralls, hoods, boots) are correctly sized and in good condition.

4.2 Gowning Sequence

1. Perform hand hygiene using approved methods (e.g., hand washing, sanitization).
2. Don gowning attire in a designated gowning area according to the gowning sequence specified for the cleanroom class.
3. Ensure proper donning of garments to prevent skin and hair exposure.

4.3 Entry Procedure

1. Proceed to the entry point of the controlled environment after completing gowning.
2. Undergo a visual inspection by a trained observer to ensure compliance with gowning requirements.

4.4 Behavior in Cleanrooms

1. Maintain appropriate behavior and movements within the cleanroom to minimize particle generation and contamination risks.
2. Report any breaches in gowning integrity or observed