Grundlagen der Personalhygiene und -Schulung für den Reinraum
Der Mensch im Mittelpunkt
Fachthemen
Abstract
Basics on Personnel Hygiene and Training for Cleanrooms: Man in the Centre
A considerable source of contamination in the manufacture of high sensitivity products such as drugs, their active ingredients, and medical devices is man himself. To minimise the risks, manufacturing processes take place under conditions as clean as possible in controlled facilities. To maintain this state, elaborate hygiene requirements must be met by the personnel, like personal hygiene, hand disinfection measures and precisely specified processes of changing into appropriate hygiene clothing. Subsequently, there are specific rules of conduct which must also be followed during activities in cleanrooms, so as to minimise the risk of contamination by the personnel, e.g. no unnecessary movements, no unnecessary talking, etc. Extensive staff training is unavoidable in order to meet these requirements. In individual cases, e.g. during the changing procedures for sterile areas, even microbiological control, which means a validation of the process, might be necessary.
Zusammenfassung
Eine nicht zu unterschätzende Kontaminationsquelle bei der Herstellung sensibler Produkte, wie Arzneimittel, deren Wirkstoffe und Medizinprodukte, stellt der Mensch dar. Um die Risiken zu minimieren, erfolgt die Herstellung unter möglichst reinen Bedingungen in kontrollierten Räumlichkeiten. Um diesen Status aufrechtzuerhalten, sind umfassende Hygienevorgaben für das Personal zu erfüllen, die von der persönlichen Hygiene über spezielle Händedesinfektionsmaßnahmen bis hin zu genau festgelegten Umkleideprozessen in entsprechende Hygienekleidung
