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In-depth survey report: control technology assessment of enzyme fermentation processes at Miles Laboratories, Inc., Elkhart, Indiana.
Sheehy JW; Martinez KF
Cincinnati, OH: U.S. Department of Health and Human Services, Public Health Service, Centers for Disease Control, National Institute for Occupational Safety and Health, ECTB 16-16b, 1986 Oct; :1-34
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. The operation is a continuous one, which involves less than 100 workers involved. The facility also produces glucoamylase (9032080). Aspergillus-niger is used for the production of the latter enzyme and Bacillus-licheniformis is used for the production of alpha-amylase. When samples of microbial concentrations were taken around selected locations and compared against background concentrations, the centrifuge 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/m3.
NIOSH-Author; NIOSH-Survey; Field-Study; Region-5; Enzymes; Antibiotics-industry; Drugs; Pharmaceutical-industry
Field Studies; Control Technology
NTIS Accession No.
National Institute for Occupational Safety and Health
Page last reviewed: September 2, 2020
Content source: National Institute for Occupational Safety and Health Education and Information Division