Avaliação da exposição e do risco toxicológico ocupacional na fabricação de medicamento

Abstract

Environmental occupational exposure limits are established based on information from industry experience, human or animal studies and, where possible, a combination of these three experiences. When establishing limits, only data referring to health science (and not technical and economic feasibility) are taken into account. The objective is to establish monitoring for the occupational exposure limit (OEL) to active pharmaceutical ingredients (API) in the drug manufacturing facilities of a company in the western region of Paraná. Through a literature review on occupational exposure to chemical substances, referring to: risk conceptualization; toxicology; exhibition concepts; occupational monitoring. A health-based toxicological assessment report has been prepared to determine the Occupational Exposure Limit (OEL) for the active pharmaceutical ingredient of interest Amoxicillin. The objective of this report is to evaluate pharmacological and toxicological data of the active substance Amoxicillin to determine its specific OEL, that is, the occupational exposure limit by a worker exposed (respiratory route) for 8 hours (average of 10 m3 of air breathed/8h) in a 40-hour workweek to the said substance (Amoxicillin), which are unlikely to cause adverse effects, considering that OELs protect healthy workers, aged between 18 and 65 years and exposed oer 40 years of working life. The OEL limit set out in this report 0.28 mg/m3 or 280 µg/m3 will be used as a risk management that is to ensure that a worker's exposure from direct contact/inhalation is kept below the health-based acceptable limit. The ideal scenario for having a safe work environment would be the sum of actions: obtaining the occupational exposure limit (OEL), implementing current and mandatory regulatory standards, applying qualitative and quantitative assessments and standard operating procedures, and, finally, investment in the development of sampling and analytical methodology are necessary actions to have a safe work environment.