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Aseptic manufacturing environment for the production of a qu | 56122

微生物学および免疫学ジャーナル

概要

Aseptic manufacturing environment for the production of a quality product

Dr. Michelle Law

Clean rooms and other controlled environments are essential in the aseptic manufacturing environment for the production of a quality product. Monitoring microbial distribution and identifying the predominant isolates is part of any effective environmental monitoring program. Maintaining the integrity of a clean room or other controlled environment is a constant battle because of both the materials used as well as the activities that take place within the environment. Contaminated surfaces can and often do, adversely impact the quality of product manufactured. Identifying which method of application that would be most efficacious in reducing microbial numbers on surfaces is just as important as selecting the right disinfectant. To determine which method: spray or wipe, would prove more efficacious in the application of disinfectants on surfaces in the manufacturing environment, our laboratory conducted a comparison study. Using one surface (stainless steel) in order to focus the data on the application of the disinfectants and not variability of microbial attachment between different surfaces, we assessed the efficacy of application between: 5% Decon spore, Decon Quat, and 70% IPA. Our test organisms included S. aureus, P. chrysogenu, B. licheniformis, P. aeruginosa, and C. albicans. With acceptance criteria of 3-log reduction for vegetative cells and 2-log reduction for spore formers, our data showed that the use of Decon Spore, regardless of how it is applied, is effective on the most common classes of organisms tested for in manufacturing environments; gram positive, gram negative, spore formers, filamentous fungi and yeast. Gram negatives can be reduced by Decon spore, Decon Quat or 70% IPA; by either application method while spore formers are most reduced by wiping. Gram positives and yeast are most effectively reduced by spraying the disinfectant on the surface rather than wiping. The data suggest that knowing and identifying what types of organisms typically inhabit your manufacturing environment can help with not only selecting which disinfectant works best, but also which application enhances that effectiveness.

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