Abstract
“Japanese Guideline for Industry on sterile drug products produced by aseptic processing” was published in July 2006 by MHLW. The chapter of “PEST CONTROL OF PROCESSING AREAS” has newly been installed in the guideline.
Generally, it tends to have been thought that there are no insects or arthropods in APAs wherein a highly clean level is kept. However, many actual data obtained has clearly shown that there were very few facilities with no insects or arthropods but a specific fauna found in clean areas, as a result of our investigation. The author and coworkers have investigated insects and arthropods in Grade B areas for 11 years. The limited kinds of species of insects and arthropods detected in some clean rooms are so statistically indicated that 98.5% of the insects and arthropods captured by sticky traps are clearly found to be the species emerging from inside the facility. Most of them (94.7%) are fungivorous, wingless and other tiny species. These pests may be spreading some microbes or spores on their bodies. And if any fungivorous pest is found in a clean room, there is an unfavorable risk of infestation with the fungus in and/or outside the clean room. Therefore, a special notice is described hereupon “Identification of these pests is also important to maintain cleanliness, because such insects are available as an indicator of overall biological contamination” in the above-mentioned chapter.
All the other detailed back data relating to this report will be further supplementing the description in the chapter, though all of them was not provided herein. The data based on the results of our investigation in Grade B however, shows the insect fauna, population density, spatial distribution patterns, etc. Moreover, some key points of contamination due to such insects have also been discussed about their food chains, relationship between fungivorous insects and the fungi, and cause of their occurrence.
