Bestimmung der Partikelbelastung von Oberflächen und Equipment in der aseptischen Abfüllung
Originale
Key Words Partikelmessung | Reinraum | Aseptische Abfüllung | Messsysteme | ISO-Klassifizierung | Wischtücher
Abstract
Examination of the pollution of surfaces and equipment by particles within aseptic production
Cleanrooms and associated controlled environments are categorized by the level of airborne particles, which is controlled by well-established measurement systems. Not only can containers for parenterals – like vials or syringes – be contaminated by airborne particles but also by loose surface adhesive particles.
In the course of several experiments, a measuring method was developed that allows an analysis of particle generation during routine operations like wipe disinfection of surfaces or via opening of overwraps of disposables or sterilized equipment and to assess particulate contamination of cleanroom surfaces.
By means of this measuring method, the authors have tested if ISO 14644-9 is practically applicable and if measuring results can be compared to the normative values to categorize pharmaceutical cleanroom surfaces.
The results indicate a significant influence of the wiping technique and the material composition on the particle generation of cleaning wipes. For example, cleaning wipes consisting of cotton have a higher tendency to emit particles to surfaces.
The assessment showed that the measurement method can only determine particles on surfaces with small dimensions. A holistic determination of the particle concentration cannot be given and therefore the surfaces cannot be categorized according to ISO 144644-9.
Korrespondenz:
Tim Schärff, Boehringer Ingelheim Pharma GmbH & Co. KG, Birkendorfer Str. 65, 88397 Biberach/Riß, Germany, e-mail: tim.schaerff@boehringer-ingelheim.com
Zusammenfassung
Das Monitoring von in der Luft befindlichen Partikeln in Reinräumen ist ein etabliertes Vorgehen für das es standardisierte Messsysteme gibt. Die Kontamination von abgefüllten Einheiten mit Partikeln oder Fasern kann jedoch nicht nur durch luftgetragene Partikel verursacht werden. Die Belastung von Oberflächen in Maschinen oder auf Equipment stellt ebenfalls ein großes Risiko dar. Im
