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Ethylene oxide sterilization in the medical‐supply manufacturing industry: Assessment and control of worker exposure
Author(s) -
Chien YehChung,
Liu HungHsin,
Lin YiChang,
Su PoChi,
Li LienHsiung,
Chang ChengPing,
Tang DaToung,
Chen ChangYuh
Publication year - 2007
Publication title -
journal of biomedical materials research part b: applied biomaterials
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.665
H-Index - 108
eISSN - 1552-4981
pISSN - 1552-4973
DOI - 10.1002/jbm.b.30825
Subject(s) - respirator , occupational hygiene , environmental science , ethylene oxide , toxicology , occupational exposure , operations management , medicine , waste management , pulp and paper industry , environmental health , materials science , occupational safety and health , engineering , pathology , copolymer , composite material , biology , polymer
Objective : In 2005, the Taiwan Institute of Occupational Safety and Health started an on‐site consulting program for the medical supplies manufacturing industry, which use ethylene oxide (EO) as a sterilant, with the goal of enhancing occupational hygiene practices and controlling EO‐related risks. This study presents EO exposure assessment results and examines the effectiveness of control measures. Methods : Detailed surveys, including exposure monitoring, were conducted at 10 factories. Airborne EO was collected using an HBr‐coated charcoal tube and analyzed using GC/MS. Results : Sterilizer operators had an average short‐term EO exposure level of 27.61 ppm during unloading; mean time‐weighted average workshift exposure was 7.35 ppm. High EO concentrations were also present throughout the facilities. Specifically, mean EO concentrations in the aeration area, near the sterilizer and in the warehouse were 10.19, 5.75, and 8.78 ppm, respectively. These findings indicate that immediate controls are needed, and that EO emissions from sterilized products during storage cannot be overlooked. Worker short‐term exposures during unloading was inversely correlated ( p < 0.05) with the numbers of poststerilization purge cycle applied. The specific controls implemented and their usefulness is discussed. Conclusion : Increasing the number of poststerilization purge cycles is a simple approach to eliminating extremely high exposure during unloading. Improvements to ventilation, particularly in the aeration area and warehouse, were also effective in minimizing worker exposures. Use of effective respirator is recommended until the EO exposure levels, averaging 3.41 ppm after the controls, fall below the permissible exposure limit. © 2007 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater, 2007