Assessment of degree of risk from sources of microbial contamination in cleanrooms; 3:udOverall application

摘要

A method of calculating the degree of risk of sources of microbial contamination to productsudmanufactured in cleanrooms has been described in two previous articles. The degree of risk wasudascertained by calculating the number of microbes deposited (NMD) onto, or into, a product fromudeach source of contamination. The first article considered airborne sources, the second articleudconsidered surface and liquid sources, and this final article considers all three sources. The NMDudmethod can be applied to various manufacturing methods and designs of cleanrooms but wasudillustrated by a vial-filling process in a unidirectional airflow (UDAF) workstation located in a non-udUDAF cleanroom. The same example was used in this article to demonstrate how to control theudmicrobial risk, and included the use of a restricted access barrier system.udThe risk to a patient is not only dependent on microbial contamination of pharmaceuticaludproducts during manufacture in cleanrooms and controlled zones but the chance that any microbesuddeposited in the product will survive and multiply during its shelf life, and this aspect of patient riskudis considered.