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 ID: 491939
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Slide1
Pharmaceutical Manufacturing Clean
Room Gowning RequirementsSlide2
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.Slide3
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.Slide4
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.Slide5
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 itemsSlide6
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 itemsSlide7
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 itemsSlide8
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.Slide9
Thank You
Any Questions