Pharmaceutical Manufacturing

CleanRoom 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,

whererelevant, 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 clothingsuitable for the activity with which theyare involved and this clothing should bechanged when appropriate.

Thank You

Any Questions