2 IntroductionThis training provides a brief overview of the clean room gowning requirements to be applied by pharmaceutical manufacturing sites, in compliance with Good Manufacturing Practices.
3 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‐contaminationProvide adequate Gowning FacilitiesEstablish the position “Environment Hygiene Safety Manager”, who must approve personal protective equipmentProvide local procedures to document the gowning requirements,including a respective training programOnly use audited, qualified and approved suppliers, if laundry services are outsourced.
4 Gowning Requirements for Zones A and B Sterile hood that totally encloses hair and, whererelevant, beard and moustacheSterile face‐maskComplete protective sterile suit (with minimum skinvisible)Sterile over boots or footwear integral with sterile suitSterile or sanitized goggles to avoid shedding of droplets, eyelashes, browsNon‐powdered sterile rubber or plastic gloves.
5 Gowning Requirements for Zone C Hair and, where relevant, beard and moustache must be coveredA single or two‐piece trouser suit, gathered at the wrists and with high neckAppropriate shoes or overshoesWhere relevant, gloves*Where relevant, face mask*Where relevant, protective glasses* e.g. when working with exposed product or product contact items
6 Gowning Requirements for Zone D Hair and, where relevant, beard and moustache must be coveredA protective suit must be wornAppropriate shoes or overshoesWhere relevant, protective glassesWhere relevant, a face‐mask*Where relevant, gloves** e.g. when working with exposed product or product contact items
7 Gowning Requirements for Zones 2 and 3 One or two piece uniform or lab coat, depending onthe operations performedAppropriate shoes or overshoesWhere relevant, protective glassesWhere relevant, a face‐mask*Hair and, where relevant, beard and moustachemust be coveredWhere relevant, gloves** e.g. when working with exposed product or product contact items
8 Gowning Requirements for Zone 1 Personnel should wear clean clothingsuitable for the activity with which theyare involved and this clothing should bechanged when appropriate.