ABSTRACT
Abstract For places where non-sterile drug production occurs, regulatory bodies recommend monitoring of the environmental bioburden. This procedure provides information regarding possible microbiological risks to which the products may be exposed, so that subsequent action measures may be implemented. The aim of the present work was to quantify and characterize the microorganisms present in Grade D (ISO 8) cleanrooms of a Brazilian pharmaceutical industry, identifying any possible seasonal climatic influences on these environments. Sampling was performed by surface and air monitoring, over 12 months during the year 2019, in rooms that were in operation. For both sampling methods, no statistically significant differences in bacteria and fungi counts were found between months or seasonal periods. Microorganisms that presented higher incidence included Staphylococcus epidermidis (15%) and Micrococcus spp. (13%), common to the human microbiota, and the fungi Cladosporium sp. (23%) and Penicillium sp. (21%), typical of the external environment. The results showed that microbial contamination in the Grade D cleanrooms was within the permissible maximum levels and remained similar throughout the year. Microbiological quality control in the clean areas of the pharmaceutical industry investigated was considered effective, with regular maintenance being necessary to keep bioburden levels controlled.
ABSTRACT
BACKGROUND: Cleanroom air is extremely dry, as it is maintained within 1 % of relative humidity. Few studies have assessed the dermatologic life quality of workers in ultralow-humidity environments. Therefore, we aimed to evaluate the dermatologic life quality of cleanroom workers using the Skindex-29, compared to those of non-cleanroom workers. METHODS: Study participants were 501 cleanroom workers and 157 non-cleanroom workers from a secondary battery factory, who underwent an employee health examination at a single university hospital from September 2014 to September 2015. Results of the self-administered Skindex-29, and McMonnies questionnaire were analyzed. Other information and disease history were also collected during physician's medical examination. Descriptive and multivariate logistic regression analysis were performed. RESULTS: The Skindex-29 score was significantly higher in cleanroom workers than in non-cleanroom workers for all domains, Symptom (16.0 ± 15.9 vs. 6.3 ± 10.2, p < 0.001), Emotion (11.3 ± 17.4 vs. 2.5 ± 7.4, p < 0.001), Function (5.2 ± 11.1 vs. 1.6 ± 4.0, p < 0.001), and Overall (10.8 ± 13.4 vs. 3.5 ± 6.2, p < 0.001). The Skindex-29 score of cleanroom workers was similar to that of patients with skin diseases such as psoriasis, other dermatitis, corns, alopecia etc. Among the cleanroom workers, 37 workers had one or more skin diseases. Among the risk factors, ‘working at cleanroom’, ‘possessing skin disease’ and ‘McMonnies score’ had significant strong correlations with Skindex-29 score, meanwhile age, sex, smoking, drinking and exercise had weak correlations with it.‘Working at cleanroom’ and ‘possessing skin disease’ had highest odds ratios with overall 14.0 (C.I.: 5.9–33.1) and 13.4 (C.I.: 4.5–29.2), and the lowest odds ratios with function domain 3.5(C.I.: 1.7–7.1) and 4.5(C.I.: 2.1–9.5), respectively. The McMonnies score had the highest odds ratio with overall, 6.9(C.I.: 4.5–10.8) and lowest odd ratio with emotion domain 4.2 (C.I.: 2.7–6.4). CONCLUSIONS: Dermatologic life quality among cleanroom workers in the secondary battery factory is shown to be lower than that among non-cleanroom workers in this study. The study suggests that the Skindex-29 may provide helpful information on the dermatologic life quality of cleanroom workers. Therefore, regarding evaluation of dermatologic life quality using Skindex-29, preventive care is necessary for cleanroom workers in ultralow humidity environment.
Subject(s)
Humans , Alopecia , Callosities , Dermatitis , Drinking , Humidity , Logistic Models , Occupational Health , Odds Ratio , Psoriasis , Quality of Life , Risk Factors , Skin , Skin Diseases , Smoke , Smoking , Zea maysABSTRACT
We report 2 cases of hepatotoxicity in cleanroom workers due to high retained chloroform air concentrations. The women, aged 34 and 41 years, who had been working in a medical endoscopic device manufacturer as cleanroom workers for approximately 40-45 days suffered severe liver damage. Two measured time-weighted averages of the chloroform concentration in the air in the cleanroom were 82.74 and 64.24 ppm, which are more than 6 times the legal occupational exposure limit in Korea. Only 7% of the cleanroom air was newly introduced from outside. The clinical courses of these cases and workplace inspection, led us to conclude that both cases of hepatotoxicity were caused by chloroform exposure.