Pharmaceutical Manufacturing Clean Room Gowning Requirements Introduction This

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 Ø Protection against contamination from the person Ø Protection against contamination of the person Ø 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