Application of ISO/IEC Guide 51 to COVID-19 infection control for the occupational safety.

COVID-19 is around the world. We attempt to apply three-step method in ISO/IEC Guide 51: 2014 to COVID-19 infection control in the workplace. The results show that the COVID-19 infection control measures include the eradication of the virus, the destruction of infectivity, the detoxification and weakening and the elimination of opportunities for infection as "Inherently Safe Design Measures", the avoidance of contact as "Safeguarding and Complementary Protective Measures" and the reduction of contact and the avoidance of seriousness as "Information for Use". Among these specific measures, the New Normal, especially in the manufacturing industries, would be "telecommuting" and "unmanned workplaces", which are part of the elimination of opportunities for infection, and "changes in flow lines" and "changes in airflow", which are part of the avoidance of contact. Where "telecommuting" and "unmanned workplaces" are feasible, they should be implemented as much as possible, and where they are not, attempts should be made to minimize human-to-human contact by "changes in flow lines". In addition, in the area of "changes in airflow", there are high expectations for future research on how to establish a ventilation design for COVID-19, in which but also the source would be workers themselves, not only combustible gases and toxic gases.

Reverberation time recommendations for noisy industrial workshops.

Industrial workshops or any other industrial premises where noisy machines are operated should be as acoustically absorbent as possible. On the other hand, acoustic treatments are expensive (especially when correcting existing premises), messy, and not always compatible with the implemented production processes. Therefore, there is a need for acoustic specifications to find the best compromise between cost and efficiency. In France, for noisy industrial workshops to be compliant, the regulation requires the rate of decay of sound per distance doubling (DL2) to exceed compulsory limit values, unless this does not have a significant impact on workers' exposure to noise. However, that rate of decay is difficult and time consuming to evaluate. The purpose of this paper is to provide recommendations based on reverberation time (RT), which is not only easier to measure but is also widely used. The D2L values are conventionally measured in industrial workshops together with RT values and thus a database compiling both RT and DL2 values was available. It has been used to draw up reference limits for RT values consistent with the DL2 regulation limits. These reference limits were validated by comparison with the literature and with a new set of data collected specially for the purposes of performing that comparison. The final limits are divided into four categories: compliant/non-compliant, for furnished/empty industrial workshops, using a 95/99% confidence interval. They are intended to enable the acoustic treatment of a workshop to be evaluated using a simple metric, either at the design stage or for monitoring or occupational inspection purposes.

The Rise of Shop Floor Ergonomics: A Personal Perspective.

OCCUPATIONAL APPLICATIONS Based on a 45-year career as a practitioner in industrial ergonomics, I offer in this paper a personal memoir on how ergonomics came to the shop floor in North America, involving ordinary workers in an early effort to prevent what was at the time an unknown problem - work-related Musculoskeletal Disorders. The actions included the beginning of a low-tech, practical improvement process that is still effective today. In total, the experience can provide encouragement to everybody to be confident in their ability when trying new endeavors and to remember that small initial steps can eventually lead to major change.

Urinary symptoms and infections among female garment factory workers in Bangladesh.

BACKGROUND: The prevalence of urinary symptoms and infections among female garment factory workers in Bangladesh - a large developing country - is largely unknown. Garment sector is this country's main economic growth engine. OBJECTIVES: This paper focuses on garment industry workers and compares the findings with another group of low socioeconomic status working women. METHODS: Urinary tract symptoms (UTS) were determined by self-reported survey including International Consultation on Incontinence Modular Questionnaire-Female Lower Urinary Tract Symptoms (ICIQ-FLUTS) and urinary tract infection (UTI) was determined among a subset population by urine dipstick tests. RESULTS: Data were collected from 310 garment workers and 297 comparison workers. About one third of garment workers (31.94%) and comparison workers (29.97%) could take up to 3 toilet breaks in a day. Garment workers reported to be more sexually active and menstruation was more common among them compared to comparison workers. They reported a significantly higher prevalence of malodorous urine and vaginal discharge. Garment workers were found to have a significantly higher ICIQ-FLUTS score of voiding than comparison workers (0.44 vs. 0.27; p-value = 0.0167).Among the study respondents, 148 garment workers and 134 other workers provided urine samples and 21 (7.45%) were found to have UTI. After considering all the risk factors in multivariate model, garment work had a significant impact on the probability of having UTI with Odds Ratio of 5.46 (p-value = 0.0374; 95% CI = 1.10, 26.97) compared to other workers. CONCLUSIONS: This study highlights the prevalence and burden of urinary symptoms and infections among female worker populations in Bangladesh.

Variations of PCDD/Fs emissions from secondary nonferrous smelting plants and towards to their source emission reduction.

Polychlorinated dibenzo-p-dioxins and dibenzofurans (PCDD/Fs) are cancerogenic organic pollutants that priority controlled by Stockholm Convention with globally 183 signatories now. Secondary nonferrous smelting plants are confirmed to be important sources in China due to its large industrial activities and high emissions of PCDD/Fs. It is important to prioritize source to achieve source emission reduction by conducting field monitoring on typical case plants. Here, the emission profiles and levels of PCDD/Fs were investigated in 25 stack gas samples collected from three secondary copper production (SeCu), two secondary zinc production (SeZn) and two secondary lead production (SePb). Both average mass concentration and toxic equivalency quantity (TEQ) concentrations of PCDD/Fs all generally decreased in the order: SeCu > SeZn > SePb. It is noteworthy that the mean TEQ concentration in stack gas from SeCu with oxygen-enrich melting furnace technology, at 2.7 ng I-TEQ/Nm3, was much higher than the concentrations of other smelting processes. The average emission factors and annual release amounts of PCDD/Fs from SeCu, SePb and SeZn investigated were 28.4, 1.5, 10.4 µg I-TEQ/t and 1.03, 0.023, 0.17 g I-TEQ/year, respectively. The ratios of 2,3,7,8-TCDF to 1,2,3,7,8-PeCDF and OCDD to 1,2,3,7,8,9-HxCDD varied to large extent for three metal smelting, which could be used as diagnostic ratios of tracing specific PCDD/Fs sources. Addition of copper-containing sludge into the raw materials might lead to higher PCDD/Fs emissions. It is important to emphasize and reduce the PCDD/Fs emissions from oxygen-enrich melting furnace from secondary copper productions.

Optimal Decisions for Two Risk-Averse Competitive Manufacturers under the Cap-and-Trade Policy and Uncertain Demand.

With the increasingly serious problem of environmental pollution, reducing carbon emissions has become an urgent task for all countries. The cap-and-trade (C&T) policy has gained international recognition and has been adopted by several countries. In this paper, considering the uncertainty of market demand, we discuss the carbon emission reduction and price policies of two risk-averse competitive manufacturers under the C&T policy. The two manufacturers have two competitive behaviors: simultaneous decision making and sequential decision making. Two models were constructed for these behaviors. The optimal decisions, carbon emission reduction rate, and price were obtained from these two models. Furthermore, in this paper the effects of some key parameters on the optimal decision are discussed, and some managerial insights are obtained. The results show that the lower the manufacturers' risk aversion level is, the higher their carbon emission reduction rate and utilities. As the carbon quota increases, the manufacturers' optimal carbon reduction rate and utilities increase. Considering consumers' environmental awareness, it is more beneficial for the government to reduce the carbon quota and motivate manufacturers' internal enthusiasm for emission reduction. The government can, through macro control of the market, make carbon trading prices increase appropriately and encourage manufacturers to reduce carbon emissions.

Effective countermeasures for Salmonella contamination in actual oilmeal-manufacturing plant in India.

AIMS: Salmonella contamination in the manufacturing process of an overseas oilmeal plant was investigated and countermeasures for Salmonella contamination were evaluated. METHODS AND RESULTS: Salmonella was detected from deposits and adhered materials inside the main processing equipment. Specifically high contamination was observed in the equipment associated with the meal cooler, with several Salmonella serovars being detected. A number of Salmonella serovars were also detected in the equipment of the fine powder recovery process. To prevent Salmonella contamination of oilmeal products, effective countermeasures that have been employed in Japan were implemented. By removing residues from the equipment and disinfecting the interior of the equipment, a significant decrease in the contamination rate of oilmeal products was achieved compared to before sanitation (P < 0·05). CONCLUSIONS: Effective countermeasures to control Salmonella contamination in the overseas manufacturing process of oilmeal were established. SIGNIFICANCE AND IMPACT OF THE STUDY: This is the first report focusing on Salmonella countermeasures in an actual oilmeal-manufacturing plant overseas.

A multiscale simulation framework for the manufacturing facility and supply chain of autologous cell therapies.

BACKGROUND AIMS: Autologous cell therapy (AuCT) is an emerging therapeutic treatment that is undergoing transformation from laboratory- to industry-scale manufacturing with recent regulatory approvals. Various challenges facing the complex AuCT manufacturing and supply chain process hinder the scale out and broader application of this highly potent treatment. METHODS: We present a multiscale logistics simulation framework, AuCT-Sim, that integrates novel supply chain system modeling algorithms, methods, and tools. AuCT-Sim includes a single facility model and a system-wide network model. Unique challenges of the AuCT industry are analyzed and addressed in AuCT-Sim. Decision-supporting tools can be developed based on this framework to explore "what-if" manufacturing and supply chain scenarios of importance to various cell therapy stakeholder groups. RESULTS: Two case studies demonstrate the decision-supporting capability of AuCT-Sim where one investigates the optimal reagent base stocking level, and the other one simulates a reagent supply disruption event. These case studies serve as guidelines for designing computational experiments with AuCT-Sim to solve specific problems in AuCT manufacturing and supply chain. DISCUSSION: This simulation framework will be useful in understanding the impact of possible manufacturing and supply chain strategies, policies, regulations, and standards informing strategies to increase patient access to AuCT.

Comparison of accident characteristics between manual materials handling (MMH) and non-MMH works in the automobile parts manufacturing industry: Based on South Korea and the US.

BACKGROUND: Despite ergonomic improvements in the workplace of automobile parts manufacturing industry, many jobs still require workers to perform repetitive tasks or manual material handling. OBJECTIVE: This study compares the characteristics of occupational injuries between MMH and non-MMH in the automobile parts manufacturing industry based in South Korea and the US. METHODS: Occupational injuries were analyzed by age, work experience, company size, employment type, injury severity, work type, type of accident, agency of accident, injured part of body, and injury type. RESULTS: Among 1,530 injuries, 271 people (17.7%) were MMH injuries, and 1,259 people (82.3%) were non-MMH injuries. The rate of MMH injury was higher in the logistics process, in the work experience with more than 10 years, and in the company size with more than 100 employees than that of the non-MMH injury. Also, the rate of MMH injury was higher in the types of sprain and herniated discs, and in the injured part of trunk/back, leg/foot, and shoulder than that of the non-MMH injury. CONCLUSIONS: The results of this study can be used as essential data for establishing a systematic preventive policy for industrial accidents in the automobile parts manufacturing industry.

The impact of theory-based educational intervention on improving helmet use behavior among workers of cement factory, Iran.

BACKGROUND: The occurrence of occupational accidents is a serious public health issue in industrial workers and may impose life jeopardizing complications. The aim of the study was to assess the effect of a training intervention based on the theory of planned behavior (TPB) on helmet use of workers in cement factories in Khoy and Urmia, Northwest of Iran. MATERIALS AND METHODS: This study was a controlled quasi-experimental investigation (before and after) which was conducted on 170 workers employed in Khoy and Urmia cement factories, Northwest of Iran. Eighty-five eligible subjects from Khoy (as intervention group) and 85 similar samples from Urmia (as control group) were selected and recruited. A valid and reliable four-part questionnaire was used to collect the data including socio demographic information, awareness, the theory constructs, and the behavior. After completing the study questionnaire and needs assessment, a specific educational program was implemented on the intervention group only. The effects of education were compared between the groups before and after intervention. The posttest was applied 1 month after educational intervention. RESULTS: The mean age of workers in the intervention and control groups was 34.32 ± 8.19 and 33.62 ± 6.17 years, respectively. Before education, the mean score of awareness and helmet use behavior of intervention group was 6.15 ± 3.4 and 5.35 ± 2.8, but after education, those changed into 13.61 ± 3.10 and 9.15 ± 1.65, and the differences were significant (p < 0.01). In addition, before education, the mean score of attitude, subjective norm, behavioral control, and behavioral intention of intervention group was 27 ± 5.17, 37.74 ± 6.92, 29.56 ± 6.17, and 17.65 ± 4.90, respectively. After education, the mean score of those changed into 37.26 ± 4.76, 48.34 ± 5.64, 42 ± 8.07, and 24.79 ± 5.33, respectively, and changes were statistically significant (p < 0.01), while no statistically significant differences were observed in awareness, the behavior, and the theory constructs in the control group after the intervention. CONCLUSION AND RECOMMENDATIONS: The TPB-based educational approach had a remarkable effect on helmet use of workers. Applying this theory to improve workers' personal protective behaviors is recommended and emphasized.

Manufacturing chimeric antigen receptor T cells: issues and challenges.

Clinical trials of adoptively transferred CD19 chimeric antigen receptor (CAR) T cells have delivered unprecedented responses in patients with relapsed refractory B-cell malignancy. These results have prompted Food and Drug Administration (FDA) approval of two CAR T-cell products in this high-risk patient population. The widening range of indications for CAR T-cell therapy and increasing patient numbers present a significant logistical challenge to manufacturers aiming for reproducible delivery systems for high-quality clinical CAR T-cell products. This review discusses current and novel CAR T-cell processing methodologies and the quality control systems needed to meet the increasing clinical demand for these exciting new therapies.

Listeria monocytogenes colonization in a newly established dairy processing facility.

The presence and colonization of Listeria monocytogenes were investigated in a newly established dairy processing plant during a one-year period. A total of 250 non-food contact surfaces, 163 food contact surfaces, 46 personnel and 77 food samples were analyzed in two different buildings according to the cheese production chain. Initial steps, including salting, are performed in building I (old facility), while the final steps, including ripening, cutting and packaging, are performed in building II (new facility). Overall, 218 samples were collected from building I and 318 from building II. L. monocytogenes isolates were subtyped by PFGE and MLST, and a questionnaire about quality measures was completed. The overall prevalence of L. monocytogenes was 8.40%, and while the presence of the pathogen was observed just during the first sampling in building I, L. monocytogenes was found in building II at the third sampling event. The salting area in building I had the highest proportion of positive samples with the highest diversity of PFGE types. Moreover, L. monocytogenes PFGE type 3 (sequence type -ST- 204) was first detected in building II in the third visit, and spread through this building until the end of the study. The answers to the questionnaire implied that lack of hygienic barriers in specific parts of the facilities and uncontrolled personnel flow were the critical factors for the spread of L. monocytogenes within and between buildings. Knowledge of the patterns of L. monocytogenes colonization can help a more rational design of new cheesemaking facilities, and improve the food safety within current facilities.

Heat stress in rice vermicelli manufacturing factories.

OBJECTIVE: This study provides an assessment of heat stress in indoor rice vermicelli manufacturing factories. METHODS: Worker interviews and heat stress assessments were conducted in food manufacturing factories in Singapore. The Wet Bulb Globe Temperature (WBGT) and Heat Stress Index (HSI) were used as heat stress indicators. RESULTS: The highest WBGT and HSI levels recorded in the rice vermicelli manufacturing factories were 36.68°C and 3777 in the drying and steaming process respectively. These levels were above the recommended permissible HSI and WBGT action limit for heat exposure and considered to be high risk. CONCLUSION: Workers in indoor rice vermicelli manufacturing factories can be exposed to heat stress, and the current measures in place may not be sufficient to protect workers against heat stress injuries. Preventive measures such as engineering controls and heat acclimatization programs are important.

Characterization and cost-benefit analysis of automated bioreactor-expanded mesenchymal stem cells for clinical applications.

BACKGROUND: Expanding quantities of mesenchymal stem cells (MSCs) sufficient to treat large numbers of patients in cellular therapy and regenerative medicine clinical trials is an ongoing challenge for cell manufacturing facilities. STUDY DESIGN AND METHODS: We evaluated options for scaling up large quantities of bone marrow-derived MSCs (BM-MSCs) using methods that can be performed in compliance with Good Manufacturing Practices (GMP). We expanded BM-MSCs from fresh marrow aspirate in αMEM supplemented with 5% human platelet lysate using both an automated cell expansion system (Quantum, Terumo BCT) and a manual flask-based method using multilayer flasks. We compared MSCs expanded using both methods and assessed their differentiation to adipogenic and osteogenic tissue, capacity to suppress T-cell proliferation, cytokines, and growth factor secretion profile and cost-effectiveness of manufacturing enough BM-MSCs to administer a single dose of 100 × 106 cells per subject in a clinical trial of 100 subjects. RESULTS: We have established that large quantities of clinical-grade BM-MSCs manufactured with an automated hollow-fiber bioreactor were phenotypically (CD73, CD90, CD105) and functionally (adipogenic and osteogenic differentiation and cytokine and growth factor secretion) similar to manually expanded BM-MSCs. In addition, MSC manufacturing costs significantly less and required less time and effort when using the Quantum automated cell expansion system over the manual multilayer flasks method. CONCLUSION: MSCs manufactured by an automated bioreactor are physically and functionally equivalent to the MSCs manufactured by the manual flask method and have met the standards required for clinical application.

Crane cabins' interior space multivariate anthropometric modeling.

BACKGROUND: Previous research has shown that today's crane cabins fail to meet the needs of a large proportion of operators. Performance and financial losses and effects on safety should not be overlooked as well. OBJECTIVE: The first aim of this survey is to model the crane cabin interior space using up-to-date crane operator anthropometric data and to compare the multivariate and univariate method anthropometric models. The second aim of the paper is to define the crane cabin interior space dimensions that enable anthropometric convenience. METHODS: To facilitate the cabin design, the anthropometric dimensions of 64 crane operators in the first sample and 19 more in the second sample were collected in Serbia. The multivariate anthropometric models, spanning 95% of the population on the basis of a set of 8 anthropometric dimensions, have been developed. The percentile method was also used on the same set of data. RESULTS: The dimensions of the interior space, necessary for the accommodation of the crane operator, are 1174×1080×1865 mm. The percentiles results for the 5th and 95th model are within the obtained dimensions. CONCLUSIONS: The results of this study may prove useful to crane cabin designers in eliminating anthropometric inconsistencies and improving the health of operators, but can also aid in improving the safety, performance and financial results of the companies where crane cabins operate.

Topical otic drugs in a multi-purpose manufacturing facility: a guide on determination and application of permitted daily exposure (PDE).

Due to newly introduced EU GMP (Good Manufacturing Practice) guideline for Medicinal Products for Human and Veterinary use, product specific permitted daily exposure (PDE) for toxicological evaluation in multi-purpose facilities are required within a documented process for risk assessment. European Medicines Agency (EMA) guidance on setting PDE limits so far focused on systemic administration routes such as intravenous (IV), oral or inhalation. This article provides guidance on setting PDE values for risk management purposes in multi-purpose facilities for active pharmaceutical ingredients (APIs) applied as topical otic drugs to the outer ear canal. The therewith determined PDE otic, is used for the calculation of maximum safe carry-over (MSC) in manufacturing scenarios where a topical otic product is manufactured followed by another topical otic product.

Determination and application of the permitted daily exposure (PDE) for topical ocular drugs in multipurpose manufacturing facilities.

Limits for the carry-over of product residues should be based on toxicological evaluation such as described in the "Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities". The toxicological evaluation should be performed also for locally administered drugs to ensure patient safety. Currently, there is no guidance on setting PDE for ocular drug substances in particular. The purpose of this investigation was to identify and describe a method for calculating a PDE value for topical ocular drugs (PDEocular). As an alternative method, extrapolation of a PDE for systemically administered drugs to a PDEocular is presented. These methods may be applied in cross-contamination risk assessments for manufacturing of topical ocular drugs. Similarly, the methods apply to systemically administered drugs, if their production precedes manufacturing of a topical ocular drug. We have examined pharmacokinetic (PK) properties of topical ocular drugs and compared them to the PK parameters of systemically administered drugs. Furthermore, we examined possible adverse effects of the carry-over in topical ocular drugs at therapeutic doses.