018 clean room gowning requirements

8/12/2019 018 Clean Room Gowning Requirements

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Pharmaceutical

Manufacturing Clean

Room Gowning

Requirements



Introduction

This training provides a brief overview ofthe clean room gowning requirements to

be applied by pharmaceuticalmanufacturing sites, in compliance withGood Manufacturing Practices.



The Manufacturing Site Must....• Provide an assessment for each facility, taking into

considerationProtection against contamination from the personProtection against contamination of the personProtection 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 laundryservices 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 ofdroplets, eyelashes, brows• Non‐powdered sterile rubber or plastic gloves.



Gowning Requirements forZone C

• Hair and, where relevant, beard and moustachemust 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 forZone D

• Hair and, where relevant, beard and moustachemust 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 Zones2 and 3

• One or two piece uniform or lab coat, depending onthe 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 forZone 1

• Personnel should wear clean clothingsuitable for the activity with which theyare involved and this clothing should bechanged when appropriate.



Thank You

Any Questions

018 clean room gowning requirements

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