Abstract

The objective of this article is to apply Statistical Process Control (SPC) to guarantee the safety in the operation of a sterilization chamber with ethylene oxide gas in thermo-sensitive material. One of the most used in Mexico; but at the same time, one of the most unfavorable methods due to the risks it presents to exposed workers. Environmental and personal measurements were carried out to control the exposure limits. Once the data was collected, SPC tools such as variable control charts (X bar-R chart) were applied to verify that the process was under statistical control. The results of the environmental and personal measurements of the sterilization process carried out by the manufacturer of surgical and healing material showed the process is within the permitted exposure limits. Recommendations are extended in relation to the use of personal protection equipment and working environment conditions, to fulfill with the requirements of national regulatory frameworks.

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