Automated Microbial Identification: A Comparison of USP and EP Approaches

摘要

Microbial identification places an important role in pharmaceutical processing. Microbial identification can be defined as "microbial characterization by a limited spectrum of tests pre-chosen and appropriate to the problem being studied" [1]. Characterizing a microorganism can provide important information as to its origin and potential impact in relation to a product or in relation to the environment in which it was isolated. Microbiologists should understand the quantity and the types of microorganisms present in pharmaceutical ingredients, water for pharmaceutical use, in-process materials, final product and the manufacturing environment.