Pharmaceutical

Manufacturing Clean
Room Gowning
Requirements

Introduction

This training provides a brief overview of
the clean room gowning requirements to
be applied by pharmaceutical
manufacturing sites, in compliance with
Good Manufacturing Practices.
The Manufacturing Site Must....
• Provide an assessment for each facility, taking into
consideration
Protection against contamination from the person
Protection against contamination of the person
Protection against cross‐contamination
• Provide adequate Gowning Facilities
• Establish the position “Environment Hygiene Safety Manager”,
who must approve personal protective equipment
• Provide local procedures to document the gowning
requirements,
including a respective training program
• Only use audited, qualified and approved suppliers, if laundry
services are outsourced.
Gowning Requirements for Zones
A and B
• Sterile hood that totally encloses hair and, where
relevant, beard and moustache
• Sterile face‐mask
• Complete protective sterile suit (with minimum skin
• visible)
• Sterile over boots or footwear integral with sterile
suit
• Sterile or sanitized goggles to avoid shedding of
droplets, eyelashes, brows
• Non‐powdered sterile rubber or plastic gloves.
Gowning Requirements for
Zone C
• Hair and, where relevant, beard and moustache
must be covered
• A single or two‐piece trouser suit, gathered at
the wrists and with high neck
• Appropriate shoes or overshoes
• Where relevant, gloves*
• Where relevant, face mask*
• Where relevant, protective glasses
* e.g. when working with exposed product or
product contact items
Gowning Requirements for
Zone D
• Hair and, where relevant, beard and moustache
must be covered
• A protective suit must be worn
• Appropriate shoes or overshoes
• Where relevant, protective glasses
• Where relevant, a face‐mask*
• Where relevant, gloves*
* e.g. when working with exposed product or
product contact items
Gowning Requirements for Zones
2 and 3

• One or two piece uniform or lab coat, depending on
the operations performed
• Appropriate shoes or overshoes
• Where relevant, protective glasses
• Where relevant, a face‐mask*
• Hair and, where relevant, beard and moustache
must be covered
• Where relevant, gloves*
* e.g. when working with exposed product or product
contact items
Gowning Requirements for
Zone 1
• Personnel should wear clean clothing
suitable for the activity with which they
are involved and this clothing should be
changed when appropriate.


Thank You

Any Questions