Controlled Environment Gowning Procedure

The Controlled Environment Gowning Procedure sets out personal hygiene, dress and gowning rules for personnel entering a controlled manufacturing area. It describes the entry sequence and prohibited items that help reduce contamination during work.

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Editable Microsoft Word procedure supplied as a digital download. Adapt responsibilities and workflows to your organization before approval and implementation.

Personnel entry, hygiene and gowning

The source instructions address the practical sequence for entering and working in a controlled manufacturing area. They distinguish ordinary dress and personal hygiene from the required gown and its fit, and identify exposed jewelry and other items that must be excluded. They also instruct personnel to alert production management about illness that could affect the work area. Supervisors can use these details during training and routine observation of gowning practices.

The revised procedure references ISO 13485:2016 and the FDA Quality Management System Regulation (QMSR), 21 CFR Part 820.

For the facility's routine conditions, see the Environmental Controls Procedure; for cleaning schedules and records, see the Controlled Environment Cleaning Procedure. Those procedures are included in the Cleanroom Procedure Bundle. This gowning procedure is sold separately and is not included in that bundle.

Using an eQMS? These editable Microsoft Office files can be imported into any electronic quality management system (eQMS) that manages Word and Excel documents, or used in a paper-based system. Adapt the approval, signature and record steps to your system’s workflow, and validate the eQMS software under your own QMS. See how to use A.P. Lyon procedures in an eQMS.

Practical guide

Read Medical Device Cleanrooms: Qualification, Monitoring, Cleaning and Gowning for workflow guidance, a checklist and common mistakes.