DEVELOPMENT OF A BIOCONTAMINATION STRATEGY

摘要

Biocontamination refers to biological contamination of products by bacteria and/or fungi, as well as the toxic byproducts of these micro-organisms, such as endotoxin and mycotoxins from Gram-negative bacteria and fungi respectively. When designing a biocontamination control strategy, which is based on the manufacturing process, there are three components to consider, each of which requires risk assessment: 1) designing process systems to avoid contamination; 2) monitoring process systems to detect contamination; and 3) reacting to contamination events with proactive measures. Process systems design is where maximum effort should be placed.