Industry-wide Study Research Articles

Viral contamination in biologic manufacture and implications for emerging therapies.

Recombinant protein therapeutics, vaccines, and plasma products have a long record of safety. However, the use of cell culture to produce recombinant proteins is still susceptible to contamination with viruses. These contaminations cost millions of dollars to recover from, can lead to patients not receiving therapies, and are very rare, which makes learning from past events difficult. A consortium of biotech companies, together with the Massachusetts Institute of Technology, has convened to collect data on these events. This industry-wide study provides insights into the most common viral contaminants, the source of those contaminants, the cell lines affected, corrective actions, as well as the impact of such events. These results have implications for the safe and effective production of not just current products, but also emerging cell and gene therapies which have shown much therapeutic promise.

Competitive Benchmarking with FM Customer and Occupant Satisfaction Surveys

ABSTRACT Customer satisfaction is arguably one of the most important key performance indicators (KPIs) in the business world. Facilities management (FM) researchers and practitioners have begun to examine this KPI and adapt it for use in facility services. Most of the adaptations have regarded internal benchmarks and use in quality management. Though research demonstrates the effectiveness of competitive benchmarking and, more specifically, the effectiveness of customer satisfaction as a competitive benchmark, there is little research on how to use customer satisfaction as a competitive benchmark in FM. Researchers have focused on determining the appropriate content for customer service surveys but have not documented how and to what extent the surveys are currently being used. To help fill this gap in the research, an industry-wide study on operations and maintenance (O&M) was conducted for an FM organization in 2017. Approximately 700 respondents in the United States completed the survey, and the responses were analyzed to examine the use of customer/occupant satisfaction surveys in the nation's FM industry. The results indicate that two-thirds of the industry uses these surveys at varying frequencies; the frequency differs somewhat according to the size of the facility in Rentable Square Feet (RSF), as there is a positive linear correlation between RSF and survey frequency. Future research on the use of these surveys as a competitive benchmarking tool needs to focus on standardizing these surveys to enable more equitable comparisons and engaging in in-depth interviews to evaluate the process by which FM departments manage their occupant satisfaction for continual improvement.

Chronic upper airway inflammation and systemic oxidative stress from nanoparticles in photocopier operators: Mechanistic insights

BackgroundSeveral recent studies have linked emissions from printing equipment with upper airway inflammation and systemic oxidative stress in healthy humans, lung inflammation in mice, and cytotoxicity, induction of inflammatory markers and epigenetic changes in human cell lines. Acute exposures have lead to upper airway inflammation and systemic oxidative stress, which for certain markers took longer than 24–36 h post-exposure to clear. ObjectiveIn this follow-up work, we determined: i) whether chronic exposures to nanoparticles from copiers lead to chronic upper airway inflammation and systemic oxidative stress; and ii) whether expression patterns of biomarkers for such stresses change during transition from acute to chronic exposures. MethodsSix permanent employees from three copy centers and eleven controls participated in the study. Nasal lavage and urine samples were collected on Monday morning (pre-shift, Mo-AM) and evening (post-shift, Mo-PM), as well as at the end of the workweek (Fr-PM), over three random weeks. The matched controls were sampled over one week. Nasal lavage samples were analyzed for a panel of 14 pro-inflammatory cytokines/chemokines, inflammatory cells, and total protein. Urine samples were analyzed for 8-OH-dG, a biomarker of systemic oxidative stress. Detailed quantitative exposure assessment to airborne nanoparticles was conducted for a whole week, and included size distribution, size-fractionated aerosol collection, extensive chemical analysis, and lung burden estimates. ResultsThe daily geometric mean total particle number concentration varied between 14,600–21,860particles/cm3, 1.7–12.1 times greater than background, with maxima up to 143,000particles/cm3. Mass concentration of the nanoscale fraction was in the 1–10μg/m3 range. Chemical composition of the nanoparticle fraction was comprised mostly of organic compounds, mixed with several engineered nanoparticles, which contributed a metal content ranging from 2 to 8% of the total particulate mass.Five out of the 14 inflammatory cytokines, namely IL-6, IL-8, TNFα, IL-1β and Eotaxin, were significantly elevated in the nasal lavage samples of the chronically exposed copier operators (p<0.0001) relative to controls. One cytokine, G-CSF, was significantly down regulated (p<0.0001) in copier operators (p<0.05). The level of all six cytokines did not change significantly across days (i.e. Mo-AM vs. Mo-PM, and Mo-AM vs. Fr-PM) and across weeks in chronically exposed individuals. In addition, there were significant (p<0.0001) increases in inflammatory cell infiltration (2.7 fold) in nasal lavage samples and 8-OH-dG in (4.3 fold) in urine samples. ConclusionChronic upper airway inflammation and systemic oxidative stress were documented in photocopier operators chronically exposed to nanoparticles. These findings agree with the recent toxicological literature on printer-emitted particles and medical case reports, and call for an industry-wide study of the health effects resulting from exposure to printer-emitted particles in chronically exposed workers. Inflammatory markers point to possible involvement of toll-like receptors, particularly TLR-4, oxidative stress, and the Nf-kB pathway in mediating airway tissue inflammation.

78 The changing epidemiology of silicosis in South African gold mining - an industry wide study

ObjectivesAgainst the background of an epidemic of silicosis and related tuberculosis revealed by field and autopsy studies in recent decades, the South African gold mining industry has committed itself to...

365 Predictors of silicosis in an industry wide study in the South African gold mining industry

ObjectivesDespite the scale of the silicosis problem in the South African goldmining industry, studies in active miners are scarce. A large randomised cluster trial of isoniazid tuberculosis prophylaxis provided an...

Occupational Health and Safety Issues in Ontario Sawmills and Veneer/Plywood Plants: A Pilot Study

A pilot study was conducted within the Ontario sawmill and veneer/plywood manufacturing industry. Information was collected by postal questionnaire and observational walk-through surveys. Industrial hygiene walk-through surveys were conducted at 22 work sites, and measurements for wood dust, noise, and bioaerosol were taken. The aim of the study was to obtain data on the current status regarding health and safety characteristics and an estimate of wood dust, noise, and bioaerosol exposures. The occupational exposure to wood dust and noise are similar to what has been reported in this industry in Canada and elsewhere. Airborne wood dust concentration ranged between 0.001 mg/m3 and 4.87 mg/m3 as total dust and noise exposure ranged between 55 and 117 dB(A). The study indicates the need for a more comprehensive industry-wide study of wood dust, noise, and bioaersols.

What drives innovation? Inferences from an industry-wide survey in Nigeria

This paper seeks to make some contributions to the literature on firm-level innovation in Africa by attempting to identify the significant factors that explain the capability of firms in Nigeria to innovate using the results of an industry-wide study. We focused on the product and process innovation activities of firms between 2003 and 2006 and found differences in the factors that drive them at the firm level. Our results further show that interactions matter more than most innovation-related variables and that the most important actors that influence a firm's innovation efforts are its customers and suppliers. We conclude that product and process innovations are not mutually exclusive and that a major key to successful innovation is how and with whom a firm collaborates. The implication of this for firms and policymakers is that an effectively wired innovation system where all stakeholders are active is critical for firm-level innovation capability.

Implementing a Buildability Assessment Model for Buildability Improvement

In view of the need to improve the buildability of building designs pursuant to an industry-wide study, a Buildability Assessment Model (BAM) has been developed for use in Hong Kong by adapting the Buildable Design Appraisal System of Singapore. This paper is aimed at evaluating the practicalities of implementing the BAM, and identifying any possible resistance and corresponding improvement strategies based on a questionnaire survey with industry practitioners. Results showed that the BAM is a useful tool for assessing the buildability of completed designs. There is, however, inherent resistance hindering the smooth implementation of the BAM, such as designers valuing aesthetics more than buildability and the lack of incentive conducive to buildability improvement. Measures for enhancing buildability are suggested, including the establishment of formal channels for coordination and communication between contractors and designers. Independent survey results indicate that consultants and contractors have the consensus that the BAM would help to improve buildability in the longer term. Together with other pull and push factors, the benefits to be brought about by such measures and the feasibility of possible legislation are analysed.

A 12-year experience with prehospital cricothyrotomies

Introduction: Maintaining cricothyrotomy skills is difficult for air medical crewmembers because the procedure is performed infrequently. The purposes of this study were to review our program's experience with cricothyrotomies and use this pilot study to guide an industry-wide study. Methods: We conducted a retrospective review of all cricothyrotomies performed by our flight crew during the past 12 years. The flight logs were reviewed for patient demographics, scene information, clinical data, and procedure data. Results: During this period, 8833 patients were transported: 1589 required intubation (18%), and eight of the 1589 required a cricothyrotomy (0.5%). Five nurses (14% of the total employed during the study) and one physician attempted this procedure. All patients had at least one intubation attempt before the cricothyrotomy (average 3.6, range 1-6 attempts). Six (75%) patients had airway edema, four (50%) had an unstable trachea, and one patient (12.5%) had an airway obstruction. Five (62.5%) of the cricothyrotomy attempts were successful. The remaining three patients were managed with bag-valve mask ventilation. Three patients arrived at the receiving hospital with a perfusing rhythm. Conclusion: Cricothyrotomy, rarely performed by our flight crews, is successful in 62.5% of cases. These preliminary data suggest current training practices should be re-evaluated. An industrywide survey is planned to determine the optimal training program.

Electron microscopy study of refractory ceramic fibers.

In epidemiological studies designed to identify potential health risks of exposures to synthetic vitreous fibers, the characterization of airborne fiber dimensions may be essential for assessing mechanisms of fiber toxicity. Toward this end, air sampling was conducted as part of an industry-wide study of workers potentially exposed to airborne fibrous dusts during the manufacture of refractory ceramic fibers (RCF) and RCF products. Analyses of a subset of samples obtained on the sample filter as well as on the conductive sampling cowl were performed using both scanning electron microscopy (SEM) and transmission electron microscopy (TEM) to characterize dimensions of airborne fibers. Comparison was made of bivariate fiber size distributions (length and diameter) from air samples analyzed by SEM and by TEM techniques. Results of the analyses indicate that RCF size distributions include fibers small enough in diameter (< 0.25 microm) to be unresolved by SEM. However, longer fibers (> 60 microm) may go undetected by TEM, as evidenced by the proportion of fibers in this category for TEM and SEM analyses (1% and 5%, respectively). Limitations of the microscopic techniques and differences in fiber-sizing rules for each method are believed to have contributed to the variation among fiber-sizing results. It was concluded from these data that further attempts to characterize RCF exposure in manufacturing and related operations should include analysis by TEM and SEM, since the smallest diameter fibers are not resolved with SEM and the fibers of longer length are not sized by TEM.

Industry-wide study of mortality of pulp and paper mill workers.

A study of pulp and paper mill workers indicated low risks of death from all causes (standardized mortality ratio (SMR) = 0.74) and all cancers (SMR = 0.81) compared with U.S. rates. The leukemia death rate in workers was not higher than the U.S. rate but was higher than the rate in county populations surrounding mills. Workers whose last jobs were in the finishing areas of the mills had an elevated SMR for liver cancer. An internal comparison of occupational characteristics indicated that workers employed in mills using other chemical pulping operations had significantly elevated mortality from all causes, all cancers, heart disease, lymphomas, and brain cancers. Lung cancer mortality was elevated in mills using kraft pulping. The internal comparisons confirmed the association between work in finishing and the risk of liver cancer. This study was designed to investigate whether pulp and paper mill workers have any risks that would indicate the need for studies detailing exposures.

New Developments in Measuring the Resistivity of Paper

The importance of the resistivity of the paper used in toner-based printers and copiers has now been well established and accepted by the paper industry. In the '70s, studies were made of the relationship between resistivity and the runnability, imaging, and release properties. Most of this work was done with the first generation of Keithley Instruments test fixtures, electrometers, and picoammeters, using a DC test voltage.A newly available system has two major changes: The test fixture applies much higher pressure to the test sample, and an alternating polarity test voltage is used to eliminate offset errors.Preliminary test data is presented. An industry-wide study is proposed to verify the procedure for correlating new data with existing results.

A COMPARISON OF EXPOSURES TO REFRACTORY CERAMIC FIBRES OVER MULTIPLE WORK SHIFTS

As part of an ongoing, industry-wide study in the manufacture of refractory ceramic fibres (RCF), time weighted average (TWA) exposures have been collected at five facilities according to a standardised protocol. Work activities were grouped into dust zones (DZs). Persons to be sampled were randomly selected according to a protocol designed to assure that at least one sample was collected annually from each DZ; each work shift is also sampled at least annually. TWA exposures calculated over a sampling period of at least 360 min were included in the data set. DZs were combined into one of three groups (DZGs): fibre production; vacuum processes; other. The data were analysed to identify any differences by DZG between airborne fibre exposures, by the shift worked at each facility, and across all facilities. There were no statistically significant shift-related differences detected between airborne fibre exposures across the five RCF facilities when analysed as a group. Within four of the facilities, no shift-related differences were detected between airborne fibre exposures; however, at one facility, first and third shift exposures were statistically different. No documentation related to job activities was found to account for the observation. The data generally support the use of a single exposure estimate for each DZG in each of these facilities, regardless of shift worked. Researchers reconstructing exposure and not able to determine the shift worked by study subjects may find these results useful, but are cautioned that substantial differences in exposure across shifts may exist in other types of manufacturing. © 1997 Published by Elsevier Science Ltd.

A comparison of exposures to refractory ceramic fibres over multiple work shifts

As part of an ongoing, industry-wide study in the manufacture of refractory ceramic fibres (RCF), time weighted average (TWA) exposures have been collected at five facilities according to a standardised protocol. Work activities were grouped into dust zones (DZs). Persons to be sampled were randomly selected according to a protocol designed to assure that at least one sample was collected annually from each DZ; each work shift is also sampled at least annually. TWA exposures calculated over a sampling period of at least 360 min were included in the data set. DZs were combined into one of three groups (DZGs): fibre production; vacuum processes; other. The data were analysed to identify any differences by DZG between airborne fibre exposures, by the shift worked at each facility, and across all facilities. There were no statistically significant shift-related differences detected between airborne fibre exposures across the five RCF facilities when analysed as a group. Within four of the facilities, no shift-related differences were detected between airborne fibre exposures; however, at one facility, first and third shift exposures were statistically different. No documentation related to job activities was found to account for the observation. The data generally support the use of a single exposure estimate for each DZG in each of these facilities, regardless of shift worked. Researchers reconstructing exposure and not able to determine the shift worked by study subjects may find these results useful, but are cautioned that substantial differences in exposure across shifts may exist in other types of manufacturing.

Analysis of Distribution Strategies in the Industrial Paper and Plastics Industry

The costs, benefits and strategic role of intermediate echelons in distribution networks are not well understood in many industries. This paper describes a study of such multilevel systems in the industrial paper and plastics industry. We quantify the impact of redistributors, who buy products from manufacturers and sell them exclusively to other distributors. The methodology was applied to an industry-wide study. We derived statistics based on optimal distributor policies for channel choice and stock control. Based on our analysis, we found that effective use of redistribution, in conjunction with these policies, has the potential to generate savings of $446 million for the industry.

Case Studies

The National Institute for Occupational Safety and Health (NIOSH) publishes the NIOSH Manual of Analytical Methods (NMAM), a collection of analytical methods for characterizing exposures to environmental chemicals. When an industrial hygienist selects a method to monitor worker exposure, it is important to remember that not all the methods in the NMAM have undergone the same level of evaluation, as the following case demonstrates. As part of an industrywide study of the health effects resulting from methyl bromide exposure in structural and agricultural applicators, NIOSH researchers conducted industrial hygiene monitoring for methyl bromide in Florida during July 1990. NIOSH method 2520 was used. This method recommends use of two charcoal tubes (400 mg/100 mg) in series, desorption with carbon disulfide, and analysis by gas chromatography with a flame ionization detector. Sampling results from these surveys indicated a capacity problem. A project was then initiated to determine the reason for the methyl bromide breakthrough that occurred during industrial hygiene monitoring. While conducting research to define and solve this problem, several other problems were identified: reduced adsorption capacity caused by high humidity, difficulty in preparing standard solutions, sample instability, change in recovery with loading, and insufficiently low quantitation limit. The addition ofmore » a drying tube to the sampling train, as well as changes to the analytical technique, to the desorption solvent, and to the time till analysis, resulted in an improved method for methyl bromide. This case study demonstrates the importance of noting the conditions under which a method was evaluated and the benefit of testing method performance under conditions likely to exist at a field site. 5 refs.« less

Ergonomic Evaluation of Checkstand Designs in the Retail Food Industry: A Report Based on Expert Assessment

Abstract Increasing evidence suggests that musculoskeletal disorders are common in the U.S. retail food industry. Cashiers who use electronic scanners appear to be at especially high risk for upper extremity cumulative trauma disorders (CTDs). One potential source of biomechanical stress is the checkstand design. Checkstand design can greatly influence the cashier's posture and movement patterns during grocery checking tasks. It is hypothesized that designs which expose cashiers to stressful postures and unnatural movements may be associated with increased musculoskeletal complaints. The National Institute for Occupational Safety and Health (NIOSH) is conducting an industrywide study to evaluate the prevalence and possible causes of musculoskeletal disorders among retail food workers. An objective of this research is to evaluate the relationship between CTDs and different checkstand designs. This article describes initial activities to identify ergonomic stressors associated with five common checkstand ty...

Numerical aperture of multimode fibers by several methods: resolving differences

An industrywide study among members of the Electronic Industries Association was conducted to document differences among three numerical aperture measurement methods. Results on 12 multimode graded index fibers indicate systematic differences exist among commonly used far-field and index profile techniques. Differences can be explained by a wavelength-dependent factor and choice of definitions. Conversion factors can be used to relate the various methods. >

A strategy for merging and analyzing work history data in industry-wide occupational epidemiological studies.

Study populations examined in epidemiologic investigations of occupational disease risks often are assembled by the pooling of employee data from several workplaces that share common exposure factors. The primary objectives of this approach are to enhance the representativeness of the overall study population and to obtain sufficient employee sample sizes in exposure subgroups of interest. Among the many epidemiologic aspects that must be considered carefully in such industry-wide studies is the inter- and intra-company or plant comparability of employee work history data. Currently, the literature is void of articles that specifically address the fundamental data reduction and statistical analysis issues related to merging work history data from several distinct cohorts. This paper describes the basic methodologic problems associated with the pooling of work history data and proposes a joint job title/job exposure-based uniform coding scheme (UCS) that facilitates the aggregation of data from similar or diverse cohorts in a variety of epidemiologic study settings. The utility of the UCS as both an efficient data coding structure and a flexible basis for statistical analysis is described within the context of a popular computer software program for analyzing occupational cohort data. The fundamental features of the UCS are illustrated using data from a recent industry-wide study of copper and zinc smelter workers.

A Strategy for Merging and Analyzing Work History Data in Industry-Wide Occupational Epidemiological Studies

Study populations examined in epidemiologic investigations of occupational disease risks often are assembled by the pooling of employee data from several workplaces that share common exposure factors. The primary objectives of this approach are to enhance the representativeness of the overall study population and to obtain sufficient employee sample sizes in exposure subgroups of interest. Among the many epidemiologic aspects that must be considered carefully in such industry-wide studies is the inter- and intra-company or plant comparability of employee work history data. Currently, the literature is void of articles that specifically address the fundamental data reduction and statistical analysis issues related to merging work history data from several distinct cohorts. This paper describes the basic methodologic problems associated with the pooling of work history data and proposes a joint job title/job exposure-based uniform coding scheme (UCS) that facilitates the aggregation of data from similar or diverse cohorts in a variety of epidemiologic study settings. The utility of the UCS as both an efficient data coding structure and a flexible basis for statistical analysis is described within the context of a popular computer software program for analyzing occupational cohort data. The fundamental features of the UCS are illustrated using data from a recent industry-wide study of copper and zinc smelter workers.