Environmental Monitoring and Media Fill Observation

Microbiological monitoring is a potential source of contamination that must be simulated in media fills, as one of the best ways of diagnosing the source of contamination arising in media fills. It should always be assumed that management is anxious to know what, where and why media fill contamination has arisen, in order to decide on appropriate corrective and preventive actions and improve their processes.

For this reason it is advisable to have intensive microbiological monitoring over the period of the media fill. The potential advantages outweigh the disadvantages. Microbiological environmental monitoring should be intensive. Where intensive microbiological monitoring may be routine practice, applied over a number of locations on a matrix basis, the practice during media fills should be for all locations to be monitored.

It is also advisable that the media fill is observed by a person who has been trained in asepsis and is familiar with the filling process. Detailed notes should be taken describing what and when is happening, particularly anything unusual. The observer may provide an independent verification that the listed contaminating events have been simulated. It is useful if the "traying" of filled units can be related to the times of filling.

Some regulatory agencies indicate a preference for media fills to be recorded on videotape. This is the best way of proving that fraudulent claims regarding the conduct of the media fill are not being made. Conversely the video camera rarely has the peripheral vision and the variability of focus of the human observer. For information purposes the video recording has to be done intelligently, but the risk is that regulatory investigators may become more interested in what the camera person may not have recorded, than what they have focused on. A fixed camera focused at point-of-fill gives no information about the risks attendant upon, for example, unloading autoclaves, replenishing stopper bowls, etc. After all, although contamination of the product unit may only happen at point-of-fill, who is to say that the contamination did not come from a stopper that was itself contaminated by an operator unloading an autoclave?

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