ABSTRACT
The International Organization for Standardization (ISO) was founded in 1946 by 25 national standards associations. It is the largest of the international voluntary groups involved in technical cooperation within industries in every area of technology. The processes, programs, and procedures relative to aseptic processing described within ISO-TC 198 WG-9's document pertain to such products. The aseptic processing document contains many requirement statements and describes guidelines for aseptic processing from the product batch stage to the filling of the finished product. The ISO-TC 198 document includes location of aseptic processing area, and facility design review, as requirements. The fact that the Food and Drug Administration (FDA) representatives participated on the US SubTAG to ISO-TC 198 WG-9 suggests that the FDA may, consider adapting portions of the ISO document into validation guidelines for aseptic processing. The results of each day’s environmental monitoring shall be reviewed in a timely manner against the alert and action levels established for the facility.
