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Moving towards a (microbiological) environmental monitoring programme that can be used to release aseptically produced pharmaceuticals: a hypothesis, a practical programme, and some results.

We present, in detail, the (microbiological) environmental monitoring programme for cleanrooms that is in use at the RIVM. The parameters that are measured are: Total airborne particles of 0.5 micron and larger, airborne colony forming units (cfu's), cfu's on surfaces, cfu's on fingertips of gloves and settling cfu's. Most attention is paid to areas where critical handling is performed (class A areas). In these areas sampling is performed continuously during work. The areas surrounding class A areas are seen as a necessary environment to create a class A area and are called supporting areas. Changes in these supporting areas that will adversely effect the quality of the class A area, will be detected in the continuous sampling of the class A area. Sampling the supporting areas should only bring forward whether the measured parameters of these areas are consistent. The frequency of sampling, either weekly, monthly or three monthly, is based on the data obtained in previous sampling. In addition to the programme some data are presented. These data indicate that the values of the earlier mentioned parameters are not particularly dependent upon the lay-out or classification of areas, but rather on the use of the areas, and how the operators behave in them. The results support the concept of our sampling schedule, that relevant information about the production areas can be gathered with relatively little effort. Evaluating the programme, we conclude that the main missing element is a known relation between the results of environmental monitoring and contamination of products. We strongly advocate research that could result in establishing such a relation.

Drug Industry↗

Environmental monitoring and assessment of short-term exposures to hazardous chemicals of a sterilization process in hospital working environments.

In order to assess short-term exposures to ethylene oxide, formaldehyde and glutaraldehyde in a sterilization process, the authors conducted continuous environmental monitoring of these chemicals in the breathing zone of workers in 2 hospitals. The arithmetic mean of ethylene oxide was 1.2 ppm near unventilated cabinets housing sterilizing materials, and environmental concentrations of ethylene oxide could not be reduced under threshold limit values time weighted average by only managing general ventilation. Environmental concentration of formaldehyde was lower in a properly ventilated pathology division in which no large specimens were stored (0.3 ppm) than in the pathology division where large specimens were stored (2.3 ppm). Although environmental concentrations of glutaraldehyde in an endoscopy unit with proper general ventilation were not detectable, environmental concentration levels in an endoscopy unit without general ventilation system were 0.2 and 0.5 ppm. According to the results of environmental monitoring in the breathing zone of workers, extremely high concentrations were observed in some work practices (ethylene oxide, 300 ppm; formaldehyde, 8.6 ppm; glutaraldehyde, 2.6 ppm). In order to avoid occupational exposures to these chemicals and prevent potential chronic and acute health hazards, good communications with these chemicals, good work practices, appropriate personal protective equipment, and engineering controls should be required.

Disinfectants↗

CaSO4:Dy and LiF:Mg, Cu, P thermoluminescent dosimeters for environmental monitoring in ambient areas of a nuclear power plant.

This paper describes CaSO4:Dy and LiF:Mg, Cu, P which were used for ambient environmental monitoring before the nuclear power plant operation in Guangdong Daya Bay, China, in 1991. Since LiF:Mg, Cu, P was first used as an environmental dosimeter in this laboratory, the intercomparison of both thermoluminescent dosimeters, including laboratory irradiation and environmental exposure in Beijing reference spots, was conducted in cooperation with National Institute of Metrology and Laboratory of Industrial Hygiene, measured values of both thermoluminescent dosimeters were in agreement with the error being less than +or- 2% for the laboratory irradiation. The results of measurement by both thermoluminescent dosimeters were quite in agreement with environmental reference exposure rates measured by a pressurized ionization chamber. The largest error of CaSO4:Dy environmental monitoring results in Daya Bay also showed that the differences of measurement results between two thermoluminescent dosimeters were not significant. The experiment results indicated that LiF:Mg, Cu, P was a good environmental dosimeter.

Calcium Sulfate↗

Methodological approach for an integrated environmental monitoring system relative to heavy metals from an incineration plant.

The use of an Integrated Environmental Monitoring System is an innovative and very important approach for the determination of environmental impacts due to a contamination source. In the present work, the methodological approach is described and applied to the case study of a MSW incineration plant. Heavy metals were chosen as Environmental Indicators. Gaseous emissions were measured and correlated to wet and dry depositions, soil and vegetation samples. Results show a good correlation between stack emissions and atmospheric depositions; less with soil and vegetation, but these results are important in order to design a standard procedure for an Integrated Monitoring System.

Air Pollutants↗

A novel system for environmental monitoring through a cooperative/synergistic scheme between bioindicators and biosensors.

This paper addresses environmental monitoring through a robust dynamic integration between biomonitor and biosensor systems, a strategy that has not been attempted before. The two systems are conceptually interrelated and methodologically correlated to a cooperative/synergistic scheme (CSS) with a view to minimise uncertainty and monitoring costs and increase reliability of pollution control and abatement. The structures and operations of the biosensor component (in terms of sensitivity, device and method versatility, nature-mimicking physicochemical mechanisms, prospects and technological input) are such that they reinforce or promote the structures and operations of the natural component (in terms of bio-surveillance, impact assessment, environmental quality indexing, stress responses, metabolic pathways, etc.) and vice versa. The bioindicator ontology presented herein, including concepts, relations and controlled vocabulary aiming at establishing an integrated methodology for mapping/assessing negative environmental externalities, provides a useful tool for the design/development/implementation of an environmental network for the monitoring of a variety of pollutants over time and space and the assessment of environmental quality; the collection of the available information and its classification into taxonomic and partonomic relations allows the construction of a database that links pollutants with organisms' response, at a phenomenological and in-depth level, considering ecological parameters, relations and geomorphologic characteristics. As a result, a computer program has been designed/developed as a decision support system and has been successfully tested on a representative population of species indigenous to southern Greece. Significantly, a novel system in the form of a rational framework at the conceptual design level has been developed, that actually contributes towards achieving a cost-effective long-term monitoring program, with the flexibility to counter on-course any (anticipated or not) variations/modifications of the surveillance environment. This novel and pioneering approach will further offer a dynamic system utilised in (a) environmental impact studies and risk assessment (positive/analytic approach), (b) decision-making in the short-run (normative/tactic approach), and (c) policy-making in the long-run (normative/strategic approach). The proposed CSS, based on the integration of multiple data sources, can establish a local area network, incorporated into/expanding to a wide area network, thus offering the potential of better predictive ability and greater lead-time warning at alarm conditions than that provided by separate, stand-alone surveillance modalities.

Biosensing Techniques↗

Identifying and closing gaps in environmental monitoring by means of metadata, ecological regionalization and geostatistics using the UNESCO biosphere reserve Rhoen (Germany) as an example.

In Germany, environmental monitoring is intended to provide a holistic view of the environmental condition. To this end the monitoring operated by the federal states must use harmonized, resp., standardized methods. In addition, the monitoring sites should cover the ecoregions without any geographical gaps, the monitoring design should have no gaps in terms of ecologically relevant measurement parameters, and the sample data should be spatially without any gaps. This article outlines the extent to which the Rhoen Biosphere Reserve, occupying a part of the German federal states of Bavaria, Hesse and Thuringia, fulfills the listed requirements. The investigation considered collection, data banking and analysis of monitoring data and metadata, ecological regionalization and geostatistics. Metadata on the monitoring networks were collected by questionnaires and provided a complete inventory and description of the monitoring activities in the reserve and its surroundings. The analysis of these metadata reveals that most of the monitoring methods are harmonized across the boundaries of the three federal states the Rhoen is part of. The monitoring networks that measure precipitation, surface water levels, and groundwater quality are particularly overrepresented in the central ecoregions of the biosphere reserve. Soil monitoring sites are more equally distributed within the ecoregions of the Rhoen. The number of sites for the monitoring of air pollutants is not sufficient to draw spatially valid conclusions. To fill these spatial gaps, additional data on the annual average values of the concentrations of air pollutants from monitoring sites outside of the biosphere reserve had therefore been subject to geostatistical analysis and estimation. This yields valid information on the spatial patterns and temporal trends of air quality. The approach illustrated is applicable to similar cases, as, for example, the harmonization of international monitoring networks.

Ecology↗

Biosensors for environmental monitoring.

In this article we will outline several biosensor applications which may fill existing technology gaps in the area of environmental monitoring. The requirements for these environmental biosensors, as well as difficulties in commercialization, are also addressed.

Biosensing Techniques↗

Evaluation of 20 years of environmental monitoring data around Swedish nuclear installations.

Twenty years of environmental monitoring data around the Swedish nuclear power plants and the Studsvik research facilities have been evaluated. In the marine environment, Fucus vesiculosus generally has high activity concentrations and the presence of a large variety of radionuclides in comparison with other bioindicators. However, for single nuclides the detection frequency was higher for 110mAg in Littorina spp and for 152Eu in Macoma baltica in comparison with other bioindicators. Close to the discharge point the activity concentration of 60Co in F. vesiculosus and in the discharge water were correlated. In the terrestrial environment, few radionuclides were detected and the activity concentrations were generally low. Of the terrestrial indicators, mosses had the highest activity concentrations and also comprised the largest variety of radionuclides. The radiation doses to humans based on measurements of released activity were small. Based on the results from the evaluation, alternative sampling strategies for the monitoring program are discussed.

Animals↗

Environmental monitoring in stem cell banks.

The processing of stem cell lines for application in human therapy requires a physical environment in which air quality (i.e., the number of airborne particles) is controlled to minimize risk of contamination. The processing facility should be constructed and operated to minimise the introduction, generation and retention of particles and microorganisms. A formal program of environmental monitoring should be maintained in each stem cell bank to specify and assess key factors and their influence on the microbiological quality of the process and product. This program should assure the manipulation of cells involved in the derivation of stem cell lines and their culture under established limits for airborne particles and for microbial contamination of the air and surfaces. Environmental monitoring should also address the regulatory requirements in the countries in which the cells will be used. The monitoring programme will depend on local conditions in each processing centre or cell bank. Each centre will need to evaluate its specific needs and establish appropriate monitoring procedures which should not become intrusive to the extent that they might compromise the quality of the cell banks or products.

Biological Specimen Banks↗

Environmental monitoring and research at the John F. Kennedy Space Center.

The Biomedical Operations and Research Office at the NASA John F. Kennedy Space Center has been supporting environmental monitoring and research since the mid-1970s. Program elements include monitoring of baseline conditions to document natural variability in the ecosystem, assessments of operations and construction of new facilities, and ecological research focusing on wildlife habitat associations. Information management is centered around development of a computerized geographic information system that incorporates remote sensing and digital image processing technologies along with traditional relational data base management capabilities. The proactive program is one in which the initiative is to anticipate potential environmental concerns before they occur and, by utilizing in-house expertise, develop impact minimization or mitigation strategies to reduce environmental risk.

Aerospace Medicine↗

Environmental monitoring for a low-level radioactive waste management facility: incinerator operations.

An environmental monitoring program has been developed for Harvard University, Southborough campus, to assess the local environmental concentrations of radionuclides released in incinerator effluents. The campus is host to the University's low-level radioactive waste management facility, which consists of 6,000 drum capacity decay-storage buildings; a 250 drum capacity decay-storage freezer; and a controlled-air incinerator. Developmental considerations were based on the characteristics and use of the incinerator, which has a capacity of 8 tons per day and is operated 5% of the time for the volume reduction of Type 0 and Type 4 wastes contaminated with a variety of radionuclides used in biomedical research-some in microsphere form. Monitoring was established for air, leafy vegetation, leaf-litter, and surface soil media. Field sampling was optimized regarding location and time based on the action of atmospheric, terrestrial, and biotic transport mechanisms. Preliminary results indicate transient concentrations of 3H and 125I in vegetation directly exposed to the dispersing plume. Measurable particulate depositions have not been observed.

Environmental Monitoring↗

Models of human exposure based on environmental monitoring.

The relevant exposure to environmental pollutants or relevant confounders can virtually never be measured directly in sufficient detail in a sufficient number of people included in an epidemiological study. Instead, surrogate indicators of exposure are used that are implicitly or explicitly linked by (conceptual) models to the 'relevant exposure'. Using specified indices (e.g., the coefficient of alienation and forecasting efficiency), the models of different forms can be compared and tested in special investigations. This can evaluate the criterion validity of the model through analysis of the agreement between the model estimates, based on measured surrogate indicators of the exposure, and the actual exposure. The perspective on the construct under study may further change the validity of the exposure indicator. Therefore, sub-studies evaluating the quality of exposure indicators should be considered as integral part of any study in environmental epidemiology, preferably as a pre-study or pilot study.

Environmental Exposure↗

Radiostrontium analytical method using crown-ether compound and Cerenkov counting and its applications in environmental monitoring.

The radiostrontium content in environmental samples was determined by chemical analysis by means of the fuming nitric acid method and ion exchange method with low-level beta counting and the newly developed method using crown-ether compound. Counting was performed with a low-background counter and a liquid scintillation counter together; the latter was the Cerenkov counting method. All results obtained by these three methods were in good agreement. The time for chemical separation of radiostrontium, using crown-ether compound, is much faster than fuming nitric acid and ion exchange methods. However, due to the high background of the liquid scintillation counter, the detection limit for Cerenkov counting is about two times higher than that for low-background counting.

Chromatography, Ion Exchange↗

Ensuring quality in long term environmental monitoring for chemical speciation.

The awareness regarding quality assurance (QA) and quality control (QC) for environmental monitoring has considerably increased in the past few years, especially with respect to the determination of chemical species, since errors occurring at various levels may considerably affect the interpretation of results (e.g. studies of toxic impact, geochemical pathways, etc.). QA for environmental analysis covers a broad range of activities from sample collection to laboratory work and the approach for ensuring quality data should be considered in a global context. However, whereas great emphasis has been placed on QA within the laboratory, there have been few systematic attempts to evaluate risks of discrepancies related, for example, to field manipulations. The situation is even worse when monitoring is applied to relatively new fields such as chemical speciation. This paper outlines some of the main aspects of quality control of environmental analysis, including the validation of methods, sampling and sample handling, storage, etc., with special emphasis on the monitoring of chemical forms of elements (e.g. species of tin, mercury, lead and selenium).

Chemistry Techniques, Analytical↗

Decreasing lead levels in Swedish biota revealed by 36 years (1969-2004) of environmental monitoring.

Since the 1980s, lead levels decreased significantly in most marine biota from the Baltic Sea, the Kattegatt and the Skagerrack and in terrestrial biota from south and central Sweden, analysed in the National Swedish Environmental Monitoring Programme. In herring and cod liver, the decrease was 4.2-7.1% annually 1981-2003 and in perch liver and guillemot eggs analysed since the middle of the 1990s the decrease was 10-13%. In kidneys of young starlings from south and central Sweden, lead levels decreased 6.2-12% annually and the annual decrease in liver and kidney from young moose was 8.8% and 6.5%, respectively. In northern Sweden, lead levels decreased in pike liver by 2.8% between 1969 and 1994 and in reindeer liver by 3.5% annually while a significant increase (5% annually 1981-1994) has been detected in arctic char. In some marine biota, there were indications of a larger decrease during the last ten years compared to the whole period. The large decline in lead emission to the atmosphere during the last twenty years, mainly because of decreasing use of leaded gasoline has obviously resulted in decreasing lead levels in biota.

Animals↗

Aquaculture-related trace metals in sediments and lobsters and relevance to environmental monitoring program ratings for near-field effects.

The study was undertaken to assess the marine environmental effects from feed and waste associated with aquaculture activities. Metal compositions of sediment, lobster, and feed were used to evaluate the extent of detectable effects at 0 m (under the cage) and 50 m distance. Sediments that were collected under the cages and were characterised as hypoxic or anoxic, showed elevated levels of Cu, Zn, organic carbon, and % <63 microm particles, and low Mn and Fe. At 50 m there was a major reduction in waste chemical impact. Using lobster, a bioindicator species, as a tool for detecting near-field impacts, showed accumulations of high Cu associated with active aquaculture sites. Chemical compositions and metal ratios normalised with organic carbon, were used to assess the sediment conditions associated with environmental monitoring program ratings (EMP--normal, hypoxic, and anoxic). Principal component analysis (PCA) was used to explore chemical data at all sites for differentiating normal, hypoxic and anoxic sediment conditions. Selected variables (Cu, Zn, Fe, Mn, organic carbon, and particles <63 microm) were sufficient for the PCA approach with >90% explainable variance of first two components. The groupings based on PCA and cluster analysis were similar to EMP classifications with some exceptions of mis-identification by EMP. The sediment chemistry components were valid indicators for evaluating marine environmental conditions and for assessing aquaculture operating sites. The developed techniques, using chemical variables in combination with EMP and the statistical approach should be useful to predict the effects of aquaculture practices and the suitability of aquaculture operations.

Animal Feed↗

Environmental monitoring: a correlation study between viable and nonviable particles in clean rooms.

This article describes an environmental monitoring data study for clean rooms. Two parameters were compared in order to investigate the possibility of correlation between them: (1) total airborne nonviable (0.5 and 5 microm) and viable (CFU) particulates, and (2) surface contamination (Rodac). The investigation took into account A, B, and C classified areas, in operational moment or status, which involved "at rest" (just equipment working) and "dynamic" (equipment and operators working) conditions. Available data in the literature indicates that the parameters are not particularly dependent upon the layout or classification of areas, but rather on the use of the areas and operator behaviour. Our results showed a correlation around 0.6 between different sampling places for nonviable 0.5- and 5-microm particles. There was no correlation between nonviable 0.5- and 5-microm particles in places with laminar flow.

Air Pollutants↗

Methods of removing external metal contamination from hair samples for environmental monitoring.

Human exposure to trace elements has become a major environmental issue with the growing industrialization and urbanization around the world. Hair samples are the most conveniently obtainable biopsy material and they have been identified as good indicators of the metal pollution in an environment. For their effective use, however, it is necessary to exclude the effect of external contamination of the hair surface by metals. The present investigation compares the different methods of washing hair samples prior to further treatment for elemental analysis. Deionized water, solvents (acetone, ether and carbon tetrachloride), non-ionic detergent, ionic detergent (sodium lauryl sulfate), chelating agent (EDTA-2Na), ultrasonics and combinations of these agents were used in the experiments. EDTA was found to be the most suitable of these washing agents for removing external contaminant metals. Further elucidation, however, is needed before a standard method of hair washing can be established.

Copper↗