Standard Operating Procedure for Gowning Procedures in Cleanroom Environment
1) Purpose
The purpose of this SOP is to define the procedures for gowning in a cleanroom environment to prevent contamination of pharmaceutical products and ensure compliance with cleanliness standards.
2) Scope
This SOP applies to all personnel entering cleanrooms within the pharmaceutical manufacturing facility.
3) Responsibilities
3.1 Cleanroom Personnel
- Follow gowning procedures accurately and consistently.
- Report any deviations or issues related to gowning to supervisors.
3.2 Cleanroom Supervisor
- Monitor gowning practices and ensure compliance with gowning SOP.
- Provide training and guidance to personnel on gowning procedures.
4) Procedure
4.1 Gowning Sequence
- Perform hand hygiene according to handwashing protocols.
- Don cleanroom garments in the designated gowning area.
4.2 Gowning Steps
- Wear hair covers, beard covers (if applicable), and face masks as required.
- Put on cleanroom coveralls or gowns following proper technique.
- Don gloves and ensure proper fit and coverage.
4.3 Cleanroom Entry
- Proceed to the designated entry point of the cleanroom.
- Perform final visual inspection of gowning attire to ensure integrity.
4.4 Exiting the Cleanroom
- Remove gloves and dispose of them in designated waste containers.
- Remove gown and other PPE items in the designated doffing area.
5) Abbreviations, if any
SOP: Standard Operating Procedure
6) Documents, if any
- Gowning SOP Training Records
- Cleanroom Gowning Log
- Procedure for Cleanroom Gowning
7) Reference, if any
ISO 14644-5: Cleanrooms and associated controlled environments – Part 5: Operations
USP General Chapter <797>: Pharmaceutical Compounding – Sterile Preparations
8) SOP Version
Version 1.0