Mikrobiologische Untersuchungen und Umgebungsmonitoring bei Media Fills
Originale
Key Words Aseptische Abfüllung | Validierung | Umgebungskontrollen | Nährmedienabfüllungen | Media Fill
Abstract
Microbiological Examinations and Environmental Monitoring During Media Fills
Media fills should be adequate representatives of the conditions which actual manufacturing operations are conducted under. If media fills are carried out under extraordinary air particulate and microbial quality, or under special precautions taken for the process simulation, an inaccurate assessment may result. In such case the media fill is invalid.
This publication is embedded in the previously described context, and the environmental controls during media fills are described in detail. The following items are discussed: extended monitoring vs. routine monitoring, sampling locations, methods, limits.
Further, the growth promotion test of the filled medium is an important microbiological examination. The test serves as evidence that the selected medium promotes the growth of a wide range of microorganisms and ensures recovering of a low number of microorganisms.
Any contaminated media filled unit should be considered objectionable and, therefore, be investigated.
In case of contaminated units, all potential causes of contamination should be investigated. This paper describes bioburden tests for media, liquid for moistening of membrane filters, liquid of water bath for ultrasonic use and container/closures.
Finally, the microorganisms from contaminated units have to be identified. The biochemical profile of contaminants can be compared with the results received from the monitoring program to detect the possible sources of contamination.
Korrespondenz:
Dr. Hanfried Seyfarth, Kirschenweg 12, 88400 Biberach (Germany),
e-mail: seyfarth-bc@t-online.de
Zusammenfassung
Nährmedienabfüllungen (Media Fills) müssen unter den Bedingungen durchgeführt werden, unter denen die tatsächlichen Herstellvorgänge erfolgen. Werden Nährmedienabfüllungen unter außergewöhnlich hoher Reinheit der Luft (partikulär oder mikrobiell) oder unter speziell für die Prozess-Simulation ergriffenen Vorsichtsmaßnahmen durchgeführt, so kann der Herstellprozess dadurch fälschlich bewertet werden. In solchem Fall ist der Media Fill-Lauf ungültig.
In diesem Kontext werden die Umgebungskontrollen bei
