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Hideharu Shintani
Hideharu Shintani
School of Science, 1-13-27, Kasuga Bunkyo 112-0003 Tokyo
Japan
Publications
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Review Article
Rapid Assay of Airborne Microorganisms and Bioburden using Several Procedures
Author(s): Hideharu ShintaniHideharu Shintani
In 2004, FDA Guidance for Industry Pat-A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance was issued to urge pharmaceutical makers to advance and enable successful and productive imaginative methodologies in giving quality pharmaceuticals to general society. The linkage of fast microbiological techniques (Rmms) to Process Analytical Technology (Pat) is substantially dependent upon continuous discharge, which is the capability to assess and guarantee the worthy nature of in-technique or last item on the foundation of the accumulation and examination of in-procedure information. As stated in the FDA aide, the Pat segment of ongoing discharge normally incorporates a good blending of evaluated material characteristics and process controls. Material traits for example bioburden, endotoxin content, and sterility could be surveyed utilizing control or.. View More»
DOI: 10.4172/2153-2435.1000246