Journal of Chromatography & Separation Techniques
Open Access

Shintani H

Publications

• Research Article
  Rapid Assay of Bioburden, Endotoxin and Other Contaminnation
  Author(s): Shintani HShintani H
  
  Microbial testing performed in support of pharmaceutical and biopharmaceutical production falls into three main categories: detection (qualitative), enumeration (quantitative), and characterization/identification. Traditional microbiological methods listed in the compendia and discussed by using the conventional growth-based techniques, which are labor intensive and time consuming. In general, such tests require several days of incubation for microbial contamination (bioburden) to be detected, and therefore management seldom is able to take proactive corrective measures. In addition, microbial growth is limited by the growth medium used and incubation conditions, thus impacting testing sensitivity, accuracy, and reproducibility. For more than 20 years various technology platforms for Rapid Microbiological Methods (RMM) have been developed, and many have been readily adopted by the foo.. View More»
  DOI: 10.4172/2157-7064.1000204

  Abstract PDF

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