Occupational Exposure Limit Values Research Articles

Evaluation of noise levels and noise sources in an Irish neonatal intensive care unit.

This study: (i) quantified the typical noise levels in an Irish neonatal intensive care unit (NICU) and compared the values to recommendations by the American Academy of Paediatrics (AAP) and the European Standards for Care for Newborn Health (EFCNI) and to occupational exposure limit value and exposure action values; and (ii) qualified the perception of noise levels and the sources of noise across the various stakeholders within a typical NICU. A noise survey was conducted in an Irish NICU. Observations identified practices and behaviours in the NICU that potentially had an impact on noise levels. Noise levels were compared to occupational exposure limits and AAP and EFCNI standards. A noise perception survey was conducted to identify noise sources and awareness of noise levels in the NICU. Results were analysed using SPSS Statistics to determine statistical significance. Noise levels recorded were consistent with previous similar studies and in all cases, the average noise levels recorded exceeded the 45 dBA as recommended by the AAP and EFCNI. There was a statistically significant difference (P < 0.01) between noise levels recorded on the day shift compared to the night shift. The perception of noise levels reported by nurses versus parents was found to be statistically significant (P = 0.001). 38.3% of all respondents reported having received no information or training with regard to noise in the NICU. There was a statistically significant difference in the perception of who is most likely to be affected by noise in the NICU, with nurses reporting those most likely to be affected by noise were patients, and parents reporting those most likely to be affected were staff (P = 0.003). This study supports the hypothesis that noise levels within the NICU are of concern and require regular assessment and monitoring. Training and awareness programmes are an important component to ensuring all persons in the NICU recognise their potential impact on noise levels in the NICU and in reducing the risk for patients and staff.

Bioaerosol Exposure during Sorting of Municipal Solid, Commercial and Industrial Waste: Concentration Levels, Size Distribution, and Biodiversity of Airborne Fungal

A study was carried out in a waste sorting plant (WSP) located in France, treating dry recyclable household waste (DRHW) as well as dry recyclable commercial and industrial waste (DRCIW). Stationary and personal inhalable samples were collected in the WSP in order to investigate bioaerosols (sampling on a filter; 2 L/min and 10 L/min) and airborne dust (CIP; 10 L/min). The aim of the study was to assess the extent to which the measurement of concentration, species composition, and particle size distribution contributes to a better assessment of the biological risks associated with exposure. The results confirmed that waste and waste sorting activities are sources of airborne fungi. Indeed, ambient concentrations ranged from 7.3 × 103 to 8.5 × 105 colony-forming units (CFU)/m3 for culturable fungi and up to 4 mg/m3 for dust. Personal exposure to inhalable dust was found up to 3 mg/m3 for dust and ranged from 8.6 × 103 to 1.5 × 106 CFU/m3 for fungi. Airborne fungal communities were found to be dominated by the Penicillium genera in both bioaerosols and settled dust samples, followed by the Aspergillus, Cladosporium, Wallemia, Mucor, and Rhizopus genera. Fungi were carried by particles of aerodynamic diameters, mainly between around 2.0 and 10.0 µm. The findings dealing with size distribution and biodiversity of bioaerosols suggest that employees are exposed to complex bioaerosols during their work and help to make a finer diagnosis of the risks involved, which is often difficult in the absence of any occupational exposure limit (OEL) value for bioaerosols in general.

Assessment of NOx Levels in an Underground Hospital Car Park: Implications for Occupational and Environmental Health

Environmental air pollution poses a significant threat to human health, with nitrogen oxides (NOx) identified as contributors to respiratory and cardiovascular diseases. This study evaluates NOx levels in an underground car park of a hospital complex, where vulnerable patients frequently visit. NOx levels were assessed using direct-reading devices with high-resolution electrochemical sensors measuring NO and NO2 concentrations. Measurements consistently remained below the legal occupational exposure limit values for car park employees, averaging around 10% of the limit. However, approximately 75% of days recorded NO2 concentrations exceeding 70% of the World Health Organization’s (WHO) recommendations, with about 20% surpassing the 0.1 ppm limit set by the WHO. The highest recorded one-hour NO2 level reached 0.165 ppm, typically around 11:00 h. The study recommends that vulnerable patients, especially asthmatics, utilize outdoor parking, while all users should avoid using the car park as a waiting area. Employees are advised to spend more time in enclosed spaces with fresh air. Although occupational levels are generally within limits, environmental levels during peak hours could pose risks to vulnerable populations. Mitigation measures, such as increased ventilation during peak hours and restricted access based on emission levels, are suggested to minimize exposure and protect public health.

Selection of Containment System for Handling Cytotoxic Drugs in Pharmaceutical Industry

This article covers the topic of choosing the right containment system based on the occupational Exposure Limit (OEL) value to handle the cytotoxic drugs or waste generated in the pharmaceutical industry based on manufacturing steps/stages/activities associated with the pharma Industry. A safe and dedicated means of containment is essential for protecting both the person and their environment. The hazards in pharmaceutical industry workers or operators who handle, manufacture or dispose of cytotoxic drugs or waste are mainly caused by its toxicity and the extent and duration of exposure. Exposure to cytotoxic substances in pharma industry occurs during the production, testing &amp; cleaning activity. It is occurring through inhalation of dust or aerosols, absorption through the skin, ingestion owing to unsafe practices, or from waste items.

Accurate low-dose exposure assessment of benzene and monoaromatic compounds by diffusive sampling: sampling and analytical method validation according to ISO 23320 for radiello® samplers packed with activated charcoal.

The research study aimed at providing an accurate low-dose benzene exposure assessment method, by validating diffusive monitoring techniques for benzene personal exposure measurements at workplaces where benzene concentrations are expected in the low ppb range, such as in the present-day chemical, petrochemical, foundry, and pharmaceutical industry. The project was aimed at addressing the need for a robust and fully validated method to perform personal exposure measurements considering that the occupational exposure limit value for benzene is going to be significantly lowered in the next few years. Diffusive sampling offers a reliable alternative to pumped sampling methods, intrinsic safety in potentially explosive atmospheres, lightness, and ease of use. In this study, the radiello® diffusive sampler, with the packed activated charcoal RAD130 adsorbing substrate [suitable for solvent desorption and analysis by high-resolution gas chromatography-flame ionization detection (HRGC-FID)], was used. The experiments have been conducted following the ISO 23320 standard in the range from 0.005 to 0.1 ppm (16 to 320 μg/m3), yielding a full validation of the sampling and analytical method. The sampler performances have fulfilled all requisites of the ISO 23320 standard, in particular: bias due to the selection of a non-ideal sorbent is lower than 10% (no significant back diffusion of benzene due to concentration change in the atmosphere); bias due to storage of samples for up to 2 months is lower than 10%; nominal uptake rate for benzene on RAD130 is 74.65 mL/min; and expanded uncertainty of the sampling and analytical method is 20.6%. The sampling and analytical method is therefore fit-for-purpose for the personal exposure measurements aimed at testing compliance with occupational exposure limit values for benzene. The method is also fit for short-duration exposure monitoring related to specific tasks, and other volatile organic compounds, usually found in the same workplaces, such as aliphatic and aromatic hydrocarbons and some oxygenated compounds, have also been studied. In particular, n-hexane and isopropyl benzene, whose classification is currently under revision, can be efficiently monitored by this technique.

114 Development of High Volume Personal Aerosol Samplers

Abstract The tendency for decreasing a series of occupational exposure limit values is seen the last years. Especially metal species are linked to a larger health effect in latest toxicological assessments. These changes imply further reductions of the limits of quantification for both the sampling and analysis methods. The personal sampling methods (as a set of sampler, filter and pump) used today comprise air flows up to 10 l/min. In order to achieve higher amounts of sampled aerosols an airflow of 20 l/min is aimed for a new set of samplers for the inhalable and respirable dust fraction. This also enables shorter sampling times than a full shift, e.g. task based exposure assessment. A small set of prototypes was designed to go into testing. A filter size of 47 mm was chosen to realise a higher dust load and an acceptable pressure drop for a personal air sampling pump. Such a pump was recently developed and is now available. Samplers for the inhalable fraction with different numbers and orientation of orifices are tested in a calm air dust chamber and a wind tunnel according to the test standard EN 13205 in the particle size range up to 100 µm. A cyclone design according to the GK family of cyclones (Mesalabs) was chosen to meet the respirable convention. First test results will be shown, either in comparison with validated samplers or in terms of the sampling efficiency in dependence of the aerodynamic diameter.

Application of quantitative mineralogy to determine sources of airborne particles at a European copper smelter

Copper processing operations, such as smelters and refineries, can produce airborne particles that may impact the health of workers. At these operations, worker exposure to chemicals are regularly monitored to ensure that regulatory compliance with occupational exposure limit values (OELVs) are maintained. Determining the type of airborne particles present is important for characterizing the composition of dust exposures and better understanding the relationship between worker exposure and health. Routine methods of analysis (e.g., chemical assay) are unable to differentiate between phases containing the same elements and may result in ambiguity. A novel approach of a combination of Quantitative Evaluation of Materials by Scanning Electron Microscope (QEMSCAN) and chemical characterization was used here to evaluate airborne and settled dust collected at key locations throughout a copper smelter in Europe. The copper (Cu) phases present in the airborne dust are indicative of the activities performed at specific locations. In the batch preparation area where Cu concentrate is received, significant amounts of Cu were carried in sulfidic minerals (chalcocite, chalcopyrite/bornite, >40%), whereas near the anode and electric furnace, the majority of Cu in dust was carried in metallic and oxidic phases (60–70%). Particle size analysis of the settled dust indicates that the sulfidic and oxidic Cu minerals are more likely to become airborne over metallic Cu. Furthermore, overall Cu concentrations decreased with particle size where metallic and oxidic Cu dominate, which suggests that differences in the proportion of Cu forms present in the dust will impact how much Cu ends up in the respirable fraction. These results highlight the need to understand the characterization of Cu in dust in order to set better OELVs.

Temporal Trends in Variability of Respirable Dust and Respirable Quartz Concentrations in the European Industrial Minerals Sector.

While between- and within-worker variability have been studied quite extensively, hardly any research is available that examines long-term trends in the variability of occupational exposure. In this first study on trends in occupational exposure variability temporal changes in the variability of respirable dust and respirable quartz concentrations within the European industrial minerals sector were demonstrated. Since 2000 the European Industrial Minerals Association's Dust Monitoring Program (IMA-DMP) has systematically collected respirable dust and respirable quartz measurements. The resulting IMA-DMP occupational exposure database contains at present approximately 40 000 personal full-shift measurements, collected at 177 sites owned by 39 companies, located in 23 European countries. Repeated measurements of workers performing their duties within a specific site-job-campaign combination allowed estimation of within- and between-worker variability in exposure concentrations. Overall day-to-day variability predominated the between-worker variability for both respirable dust concentrations and quartz concentrations. The within-worker variability in concentrations by job was two to three times higher for respirable quartz than for respirable dust. The median between-worker variability in respirable dust concentrations was low and further reduced over time. For quartz concentrations the same phenomenon albeit somewhat less strong was observed. In contrast, for the within-worker variability in concentrations downward and upward temporal trends were apparent for both respirable dust and respirable quartz. The study shows that the (relative) size of temporal variability is large and unpredictable and therefore regular measurement campaigns are needed to ascertain compliance to occupational exposure limit values.

Real-Time Measurement of Personal Exposure to Airborne Nano-Objects with the DiSCminiPart 2 – Application Examples of the DiSCmini/Echtzeitmessung der persönlichen Exposition gegenüber luftgetragenen Nano-Objekten mit dem DiSCminiTeil 2 – Anwendungsbeispiele

The use of the DiSCmini has developed considerably in the context of evaluating inhalation exposure to nanoparticles. This article presents the results obtained during measurement campaigns at workplaces. A few examples describe the applicability of the DiSCmini to measure nano-objects in different metrics complementary to standard exposure measurement methods. This article is the follow up of the instrument’s working principle description and laboratory comparison [1], that showed its ability to determine personal exposure to ultrafine particles and nano-objects in the size range below approximately 700 nm. Besides the number concentration, also the surface area concentration as well as a mean diameter of the aerosol is determined. The DiSCmini is one of the few instruments allowing person mounted use to measure directly the personal exposure to ultrafine particles. For a more comprehensive exposure determination, other instruments can be useful like direct reading instruments for the size range above 700nm, in addition to conventional aerosol samplers for mass concentrations. Although occupational exposure limit values for a number concentration are not in use for ultrafine particles or nano-objects, number based reference values can be chosen for an assessment of the exposure [2]. Such easy to use instruments like the DiSCmini can also be used in a tiered approach for exposure determination of nano-objects as described in a European Standard [3]. The first two phases of the latter approach is a suitable application to get an overview of the concentrations. Another application for such direct reading instruments will be the assessment of protective measures at particle emitting processes, e.g. the application of local exhaust ventilation [4]. Further experience in using the DiSCmini in the laboratory and the field was described in [5, 6, 7], while a review on exposure measurement methods for nano-objects is given in [8]. The following part describes examples of use of the DiSCmini and should help the reader to plan such applications and show which data can be expected.

Contribution of toxicological pathology to occupational health: lung carcinogenicity of fibrous and particulate substances in rats.

In this review, we focus on the rat pulmonary carcinogenicity of two solid substances, fibrous multi-walled carbon nanotube (MWCNT) and particulate indium tin oxide (ITO). Inhalation exposure to MWNT-7, a type of MWCNTs, and ITO induced lung carcinogenicity in both male and female rats. Toxicity to the alveolar epithelium is induced by macrophages undergoing frustrated phagocytosis or frustrated degradation of engulfed particles (referred to as frustrated macrophages). Melted macrophage contents contribute significantly to development of hyperplasia of the alveolar epithelium, which eventually results in the induction of lung carcinoma. MWNT-7 and ITO induce secondary genotoxicity; consequently, a no-observed-adverse-effect level can be applied to these materials rather than benchmark doses that are used for non-threshold carcinogens. Thus, establishing occupational exposure limit values for MWNT-7 and ITO based on the existence of a carcinogenic threshold is reasonable.

Occupational Exposure to Halogenated Anaesthetic Gases in Hospitals: A Systematic Review of Methods and Techniques to Assess Air Concentration Levels

Objective During the induction of gaseous anaesthesia, waste anaesthetic gases (WAGs) can be released into workplace air. Occupational exposure to high levels of halogenated WAGs may lead to adverse health effects; hence, it is important to measure WAGs concentration levels to perform risk assessment and for health protection purposes. Methods A systematic review of the scientific literature was conducted on two different scientific databases (Scopus and PubMed). A total of 101 studies, focused on sevoflurane, desflurane and isoflurane exposures in hospitals, were included in this review. Key information was extracted to provide (1) a description of the study designs (e.g., monitoring methods, investigated occupational settings, anaesthetic gases in use); (2) an evaluation of time trends in the measured concentrations of considered WAGs; (3) a critical evaluation of the sampling strategies, monitoring methods and instruments used. Results Environmental monitoring was prevalent (68%) and mainly used for occupational exposure assessment during adult anaesthesia (84% of cases). Real-time techniques such as photoacoustic spectroscopy and infrared spectrophotometry were used in 58% of the studies, while off-line approaches such as active or passive sampling followed by GC-MS analysis were used less frequently (39%). Conclusions The combination of different instrumental techniques allowing the collection of data with different time resolutions was quite scarce (3%) despite the fact that this would give the opportunity to obtain reliable data for testing the compliance with 8 h occupational exposure limit values and at the same time to evaluate short-term exposures.

Collective Protection Measures for Occupational Exposure to Carcinogenic Chemicals in France: The Links between Regulations on Chemicals and Effective Implementation.

European directives stipulate that French employers take all available measures to reduce the use of carcinogenic agents. Our study explores the links between regulations on chemicals and the effective implementation of collective protection measures in France to occupational exposure to carcinogenic chemicals. Individual data from the French national cross-sectional survey of occupational hazards, conducted in 2017, were analysed. We investigated whether stricter regulations and longer exposures were associated with a higher level of collective protection using multivariate logistic regressions. In 2017, any collective protection measures were implemented for 35% of occupational situations involving exposure to a carcinogen. A total of 21% of exposure situations benefited from source-based controls (e.g., isolation chamber and local exhaust ventilation) and 26% from general ventilation, for which the effect is limited as collective protection. Our regressions showed that longer exposure durations were associated with more collective protection. Exposure situations to chemicals classified as proven carcinogens by the European Union (category 1A) benefited more from collective protections, which is not the case for products only classified as suspected carcinogens (category 1B). Exposures to products with a Binding Occupational Exposure Limit Value benefited more from source-based controls. Nonetheless, the time spent on the IARC list of carcinogens did not appear to influence the implementation of collective protection measures, except for local exhaust ventilation. At a time when efforts to improve the implementation of protective measures in order to drastically reduce the risks of occupational cancers are still necessary, stricter European and national regulations, but above all, better coordination with the work of the IARC and its classification, are avenues to pursue.

The utility of hERG channel inhibition data in the derivation of occupational exposure limits

Inhibition of the human ether-à-go-go (hERG) channel may lead to QT prolongation and fatal arrhythmia. While pharmaceutical drug candidates that exhibit potent hERG channel inhibition often fail early in development, many drugs with both cardiac and non-cardiac indications proceed to market. In this study, the relationship between in vitro hERG channel inhibition and published occupational exposure limit (OEL) was evaluated. A total of 23 cardiac drugs and 44 drugs with non-cardiac indications with published hERG channel IC50 and published OELs were identified. There was an apparent relationship between hERG IC50 potency and the OEL for cardiac and non-cardiac drugs. Twenty cardiac and non-cardiac drugs were identified that had a potent hERG IC50 (≤25 μM) and a contrastingly large OEL value (≥100 μg/m3). OELs or hazard banding corresponding to ≤100 μg/m3 should be sufficiently protective of effects following occupational exposure to the majority of APIs with hERG IC50 values ≤ 100 μM. It is important to consider hERG IC50 values and possible cardiac effects when deriving OEL values for drugs, regardless of indication. These considerations may be particularly important early in the drug development process for establishing exposure control bands for drugs that do not yet have full clinical safety data.

Nanosized titanium dioxide particle emission potential from a commercial indoor air purifier photocatalytic surface: A case study.

Background: Photocatalytic air purifiers based on nano-titanium dioxide (TiO 2) visible light activation provide an efficient solution for removing and degrading contaminants in air. The potential detachment of TiO 2 particles from the air purifier to indoor air could cause a safety concern. A TiO 2 release potential was measured for one commercially available photocatalytic air purifier "Gearbox Wivactive" to ensure a successful implementation of the photocatalytic air purifying technology. Methods: In this study, the TiO 2 release was studied under laboratory-simulated conditions from a Gearbox Wivactive consisting of ceramic honeycombs coated with photocatalytic nitrogen doped TiO 2 particles. The TiO 2 particle release factor was measured in scalable units according to the photoactive surface area and volume flow (TiO 2-ng/m 2×m 3). The impact of Gearbox Wivactive on indoor concentration level under reasonable worst-case conditions was predicted by using the release factor and a well-mixed indoor aerosol model. Results: The instrumentation and experimental setup was not sufficiently sensitive to quantify the emissions from the photoactive surfaces. The upper limit for TiO 2 mass release was <185×10 -3 TiO 2-ng/m 2×m 3. Under realistic conditions the TiO 2 concentration level in a 20 m 3 room ventilated at rate of 0.5 1/h and containing two Gearbox Wivactive units resulted <20×10 -3 TiO 2-ng/m 3. Conclusions: The release potential was quantified for a photocatalytic surface in generalized units that can be used to calculate the emission potential for different photocatalytic surfaces used in various operational conditions. This study shows that the TiO 2 nanoparticle release potential was low in this case and the release does not cause relevant exposure as compared to proposed occupational exposure limit values for nanosized TiO 2. The TiO 2 release risk was adequately controlled under reasonable worst-case operational conditions.

Comparison of ConsExpo estimated exposure levels to glycol ethers during professional cleaning work to existing regulatory occupational exposure limit values

Objectives. Researchers have shown that cleaning workers have an increased risk of asthma and rhinitis, mainly due to exposure to chemical substances present in the cleaning products they use. Among the important substances are glycol ethers, increasingly used as components in cleaning products. This study aimed to assess exposure levels of glycol ether in professional cleaning products and compare them to existing regulatory exposure limit values. Methods. Information from safety data sheets of the products is used to identify the glycol ethers present in the cleaning products and their respective concentrations. Other sources were used to obtain the relevant data required for use in the tool to generate exposure assessments. Exposure levels for various cleaning work exposure scenarios were estimated using the ConsExpo Web tool. Results. The estimated exposure values are significantly lower than the existing regulatory occupational exposure limit (OEL) values for the different glycol ethers. Conclusions . The study showed that the risk of exposure to glycol ethers by inhalation from professional cleaning products is minimal as exposure estimates were much below the regulatory OEL values.

Occupational Exposure of Hairdressers to Airborne Hazardous Chemicals: A Scoping Review.

Introduction: Exposure to hazardous chemicals released during hairdressing activities from hair care products puts hairdressers at risk of adverse health effects. Safety assessments of hair products are mainly focused on consumers, but exposure for professional hairdressers might be substantially higher. Objective: To identify and assess available research data on inhalation exposures of professional hairdressers. Methods: A systematic search of studies between 1 January 2000 and 30 April 2021 was performed in Medline, Embase, Web of Science and in Cochrane registry, toxicological dossiers of the Scientific Committee on Consumer Safety (SCCS) of the European Commission as well as the German MAK Commission. Studies reporting quantitative data on airborne concentrations of chemicals in the hairdresser’s workplace were considered. The outcome was an airborne concentration of chemicals in the working environment, which was compared, when possible, with current occupational exposure limits (OEL) or guidance levels. Results: In total, 23 studies performed in 14 countries were included. The average number of hairdressing salons per study was 22 (range 1–62). Chemicals most frequently measured were formaldehyde (n = 8), ammonia (n = 5), total volatile organic compounds (TVOC) (n = 5), and toluene (n = 4). More than fifty other chemicals were measured in one to three studies, including various aromatic and aliphatic organic solvents, hydrogen peroxide, persulfate, and particulate matter. Most studies reported environmental air concentrations, while personal exposure was measured only in seven studies. The measured air concentrations of formaldehyde, ammonia, and TVOC exceeded OEL or guidance values in some studies. There was large variability in measuring conditions and reported air concentrations differed strongly within and between studies. Conclusion: Hairdressers are exposed to a wide spectrum of hazardous chemicals, often simultaneously. Airborne concentrations of pollutants depend on salon characteristics such as ventilation and the number of customers but also on used products that are often country- or client-specific. For exposure to formaldehyde, ammonia, and TVOC exceeding OELs or guidance values for indoor air was observed. Therefore, occupational exposure should be taken into account by safety regulations for hair care products.

Transpozycja dyrektywy 2019/1831/UE z dnia 24 października 2019 r. ustanawiającej piąty wykaz wskaźnikowych dopuszczalnych wartości narażenia zawodowego do prawa krajowego

The issue of the regulations amending the Regulation of the Minister of Family, Labour and Social Policy on the maximum admissible concentrations and intensities of agents harmful to health in the working environment resulted from the requirement to implement into national law the provisions of Commission Directive (EU) 2019/1831 of 24 October 2019 establishing a fifth list of indicative occupational exposure limit values pursuant to Council Directive 98/24/EC, and amending Commission Directive 2000/39/EC, the provisions of which Member States had to introduce by 20 May August 2021. The Regulation takes into account 3 motions submitted by the Interdepartmental Commission for Maximum Admissible Concentrations and Intensities for Agents Harmful to Health in the Working Environment to the minister of labour in the years 2017-2020. The Commission was appointed by the Regulation of the Prime Minister of December 15, 2008 (Journal of Laws of 2015, item 1772, with amendments), and its tasks include submitting to the minister of labour motions on the value of the maximum admissible concentrations and intensities for agents harmful to health in the working environment. Med Pr. 2022;73(1):43-50.

Concerns regarding the quality and number of Occupational Exposure Limit Values

Concerns regarding the quality and number of Occupational Exposure Limit Values

Exposure of cleaning workers to chemical agents and physical conditions in swimming pools and spas

Swimming pools and spas require a high hygiene level, and therefore constant cleaning. In this study, cleaning workers’ exposure to volatile organic compounds (VOCs), trichloramine (TCA), and particulate matter (PM) in the swimming pools and spas were evaluated. Also, statistical methods were employed to determine what activities affect the exposure to disinfection byproducts (DBPs). The study was conducted in 32 swimming pools and spas. The measurement locations were pool areas, bathrooms, and locker rooms, both during cleaning and opening hours. During the cleaning, the total volatile organic compound (TVOC) concentrations were low, on average 96, 251, and 91 µg/m3 for locker rooms, bathrooms, and pool areas, respectively. Similarly, during the opening hours, the TVOC concentrations were on average 78, 125, and 83 µg/m3, for locker rooms, bathrooms, and pool areas, respectively. This is in line with previous studies investigating cleaning work in other environments. The most prevalent compounds during the cleaning were 2-(2-butoxyethoxy)ethanol (DEGBE), 2-(2-ethoxyethoxy)ethanol (DEGEE), 2-butyl-1-octanol, trichloromethane (chloroform), decamethylcyclopentasiloxane (D5), and carbon tetrachloride. The most prevalent compounds during the opening hours were D5, D-limonene, carbon tetrachloride (bathrooms and pool areas), and trichloromethane (bathrooms and pool areas). The TCA concentrations during the cleaning in the bathrooms and pool areas were on average 60 and 67 µg/m3, respectively, and during the opening hours, 28 and 122 µg/m3, respectively. The use of disinfectants was found to increase the TCA concentration in the bathrooms, while the other cleaning products did not. Even though the TCA concentrations were below the WHO’s guideline and the Finnish occupational exposure limit value of 500 µg/m3, the measured TCA levels were occasionally high enough to pose a risk of irritative symptoms. The PM concentrations were low, both in the real-time monitoring (aerodynamic diameter, Dae ≤ 15 µm) and inhalable dust samples (Dae ≤ 100 µm). Highest measured inhalable dust concentration was 350 µg/m3, well below the Finnish occupational limit value of 5,000 µg/m3 for organic inhalable dust.

Approaches for setting occupational exposure limits in the pharmaceutical industry.

The use of pharmaceutical drugs has provided a cure for many diseases. However, unintended exposure to drugs in the manufacturing workplace can cause significant health hazards to workers. It is important to protect the workforce from these deleterious effects by limiting exposure to an acceptable level, the occupational exposure limit (OEL). OEL is defined as airborne concentrations (expressed as a time-weighted average for a conventional 8-h workday and a 40-h work week) of a substance to which nearly all workers may be repeatedly exposed (for a working lifetime) without adverse effects. Determination of OELs has become very challenging over time, requiring an overall assessment of the preclinical and clinical data of the drug being manufactured. Previously, to derive OEL values, toxicologists used animal no-observed-adverse-effect level (NOAEL) data, which have been replaced with the overall assessment of animal and human data, placing a higher emphasis on human health-based data. A major advantage of working with human pharmaceuticals is that sufficient clinical data are available for them in most cases. The present manuscript reviews the latest knowledge regarding the derivation of occupational exposure limits as health-based exposure limits (HBELs) for pharmaceuticals. We have provided examples of OEL calculations for various drugs including levofloxacin (CAS No. 100986-85-4), dienogest (CAS no. 65928-58-7), and acetylsalicylic acid (ASA, CAS no. 50-78-2) using human data. This report will benefit professionals in the OEL domain in understanding this highly important, growing, and challenging field.