RESUMO
BACKGROUND: Psychosocial risks are among the significant risks at the workplace. This study aims to assess psychosocial risks for the first time in a metal processing plant in Istanbul, Turkey by applying Copenhagen Psychosocial Questionnaire (COPSOQ II) to maintenance workers, and comparing risks scores by Fine Kinney and Analytic Hierarchy Process (AHP) methods. METHOD: The COPSOQ II questionnaire was applied to all 120 maintenance workers. All items in COPSOQ II questionnaire were used as psychosocial hazards in risk assessments. Risk scores obtained by Fine Kinney and AHP methods are compared. RESULTS: AHP and Fine Kinney methods indicate that "demands at work" and "offensive behavior" domains in COPSOQ II have relatively higher priorities in the workplace. The most effective sub criteria in demands at work domain are: quantitative demands and work pace. Comparison of risk classes show that AHP scores are usually higher than those by Fine Kinney. CONCLUSION: Fine Kinney risk scores and classes are considered more realistic than AHP since they include actual responses of the maintenance workers to the COPSOQ II questionnaire. These results provide a useful tool for the management to implement psychosocial hazards in their risk assessment and a roadmap for action plans.
RESUMO
BACKGROUND: About 8 million healthcare workers in the USA are potentially exposed to hazardous drugs or their toxic metabolites over a long period of time despite the fact that both the Occupational Safety and Health Administration and the European Parliament recommend the monitoring of exposure among workers dealing with substances which have carcinogenic, mutagenic or toxic effects on the reproductive system. The objective of this study is to determine exposure to active pharmaceutical ingredients (APIs) among pharmaceutical industry workers, and to develop a methodology which promotes the accurate monitoring, evaluation and control of exposure to active pharmaceutical ingredients, also in compliance with good manufacturing practice. MATERIAL AND METHODS: The pilot study was designed in accordance with "Sterile Drug Products Produced by Aseptic Processing - Current Good Manufacturing Practice," issued by the U.S. Food and Drug Administration. The samples were collected with the swab technique which was recommended in the "Validation of Cleaning Processes (7/93)" guideline. The minimum numbers of locations (NL = 9) and sampling points (NL(T) = 63) were determined according to ISO 14644-1:2015 "Cleanrooms and Associated Controlled Environments" issued by the International Organization for Standardization. The samples were analyzed using an ultra performance liquid chromatography system, with an analytical method which was developed and validated according to "Q7A, Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients" issued by the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use. The low limit of quantification of the employed method (17 ng/ml) enables the determination of exposure at low concentrations. RESULTS: While contamination was detected in 43 (68.3%) of the 63 samples collected, 20 (31.7%) could not be detected. The environmental monitoring results ranged 0-15 000 ng/cm2 and the potential risk of exposure to API was considered to be >2 g. CONCLUSIONS: The results clearly prove and reveal the magnitude of the hazard, both objectively and scientifically, when compared to the research which suggests that 10 ng/cm2 should be considered the prohibitory risk level in quantitative terms. Med Pr. 2020;71(6):649-63.
