In-Depth Survey Report: Control Technology Assessment of Enzyme Fermentation Processes at Miles Laboratories, Inc., Elkhart, Indiana

摘要

The controls and containment capabilities of the carbohydrase enzyme manufacturing process were evaluated at the Miles Laboratories, Inc. (SIC-2869) facility located in Elkhart, Indiana. The enzyme alpha-amylase (9000902) has been produced at this facility since March of 1982. One specific unit process showed results significantly above the background levels, that being the centrifuge. At the vacuum filter knife edge the viable levels were higher than background, but even within a few feet of the vacuum filter belt they were reduced below background levels. Levels were not significantly above background at the fermentor agitator shaft, seed fermentor agitator shaft, and fermentor sample port. The clean room had background levels significantly below the levels in the laboratory. Apparently the overall effective containment of the production organisms used is very good. Measures of total dust levels indicated these were far below the threshold limit value of 10mg/cu m.