Quantitative and qualitative evaluation of microorganism profile identified in bioburden analysis in a biopharmaceutical facility in Brazil: Criteria for classification and management of results.

Microbiological contamination may cause microbial proliferation and consequently additional problems for pharmaceutical companies through production stoppage, product contamination, investigations of process deviations, out-of-specification results and product disposal. This is one of the major concerns of the regulatory health agencies. Microbiological load (bioburden) may represent a potential risk for patients if the sterilization process is not effective and/or due to the production of toxins. Although bioburden can be eliminated by terminal sterilization or filtration processes, it is important to monitor the amount and determine the identity and characteristics of the microorganisms present prior to final processing. The application of microorganism identification systems is crucial for identifying the type of contamination, which can be extremely useful for investigating. The aim of this study was to evaluate the profiles of microorganisms identified in bioburden assays from solutions, culture medias, and products (SCP) from a pharmaceutical industry facility. From 2018-2020, a total of 1,078 samples from 857 different lots of SCP were analyzed and isolated microorganisms were identified. A prefiltering step was included after March 2020, in order to reduce the bioburden before sterilizing filtration. Criteria for the definition and management of microorganisms identified were evaluated after an integrative bibliographic review, and three groups were proposed (critical, objectionable, and nonobjectionable microorganisms). For the samples that did not include prefiltering (n=636), 227 (35.7%) presented microbial growth. For those that included prefiltering, before prefiltering (n=221), 60.6% presented microbial growth, and after prefiltering, this value was reduced to 4.1%, which can be attributed to a contamination during the sampling or a wrong filtering. From the samples that presented microbial growth, 678 microorganisms were identified as bacteria and 59 as molds and yeasts. A total of 120 microorganisms (56 and 27 Gram-positive and negative bacteria, respectively, 31 yeasts, and six filamentous molds) could not be identified, and the remaining microorganisms were classified as objectionable (n=507; 82.2%), nonobjectionable (n=103; 16.7%) and critical (n=7; 1.1%). Most of the bioburden species (>80.0%) were considered objectionable microorganisms. A process for classification and management of bioburden analysis results based on a literature review of pathogenic and physiological characteristics of the microorganisms was proposed.

Development and Implementation of an Ultraviolet-Dye-Based Qualification Procedure for Hand Washing and Disinfection to Improve Quality Assurance of Pharmacy Preparations and Compounding, Especially in Cleanrooms: A Pilot Study.

Even though, nowadays, most medicines are manufactured industrially, patients may have medical needs that can only be met by a tailor-made approach. This requires the availability of pharmacy preparations made under Good Manufacturing Practice (GMP) conditions. An efficient hand hygiene practice is essential herewith, especially if sterile products that are prepared in a cleanroom are concerned. The effectiveness of hand washing and hand disinfection procedures greatly relies on adequate training. We carried out an observational cross-sectional pilot study aimed at optimizing hand hygiene training with objective and measurable quality assessments using an ultraviolet (UV) dye. Practical acceptance criteria for qualifying personnel through this method were set and evaluated. In total, 25 GMP-qualified cleanroom operators washed and disinfected their hands with UV dye hand wash lotion and UV dye hand alcohol, respectively. To obtain a proof-of-concept, the results were judged based on adherence to the WHO six-step protocol and associated acceptance criteria. Commonly missed areas were brought to light, and the influence of procedure duration was investigated. UV-dye-based assessments appeared to be more valuable in hand disinfection than in hand washing. In both procedures, the back of the hands and the thumbs were frequently missed. This underpins the need for enhanced and repeated education on hand washing and disinfection. Additionally, a dry skin gave rise to extra cleaning challenges. From this pharmacy practice pilot study with a focus on pharmaceutical product care, it may be concluded that the application of UV-dye-based assessments offers valuable insights for pharmacists to optimize hand hygiene, thereby increasing the safety of tailor-made medicines and on-site preparations.

Occurrence, Risk Implications, Prevention and Control of CIT in Monascus Cheese: A Review.

Monascus is a filamentous fungus that has been used in the food and pharmaceutical industries. When used as an auxiliary fermenting agent in the manufacturing of cheese, Monascus cheese is obtained. Citrinin (CIT) is a well-known hepatorenal toxin produced by Monascus that can harm the kidneys structurally and functionally and is frequently found in foods. However, CIT contamination in Monascus cheese is exacerbated by the metabolic ability of Monascus to product CIT, which is not lost during fermentation, and by the threat of contamination by Penicillium spp. that may be introduced during production and processing. Considering the safety of consumption and subsequent industrial development, the CIT contamination of Monascus cheese products needs to be addressed. This review aimed to examine its occurrence in Monascus cheese, risk implications, traditional control strategies, and new research advances in prevention and control to guide the application of biotechnology in the control of CIT contamination, providing more possibilities for the application of Monascus in the cheese industry.

The Molecular Profile of Soil Microbial Communities Inhabiting a Cambrian Host Rock.

The process of soil genesis unfolds as pioneering microbial communities colonize mineral substrates, enriching them with biomolecules released from bedrock. The resultant intricate surface units emerge from a complex interplay among microbiota and plant communities. Under these conditions, host rocks undergo initial weathering through microbial activity, rendering them far from pristine and challenging the quest for biomarkers in ancient sedimentary rocks. In addressing this challenge, a comprehensive analysis utilizing Gas Chromatography Mass Spectrometry (GC-MS) and Time-of-Flight Secondary Ion Mass Spectrometry (ToF-SIMS) was conducted on a 520-Ma-old Cambrian rock. This investigation revealed a diverse molecular assemblage with comprising alkanols, sterols, fatty acids, glycerolipids, wax esters, and nitrogen-bearing compounds. Notably, elevated levels of bacterial C16, C18 and C14 fatty acids, iso and anteiso methyl-branched fatty acids, as well as fungal sterols, long-chained fatty acids, and alcohols, consistently align with a consortium of bacteria and fungi accessing complex organic matter within a soil-type ecosystem. The prominence of bacterial and fungal lipids alongside maturity indicators denotes derivation from heterotrophic activity rather than ancient preservation or marine sources. Moreover, the identification of long-chain (>C22) n-alkanols, even-carbon-numbered long chain (>C20) fatty acids, and campesterol, as well as stigmastanol, provides confirmation of plant residue inputs. Furthermore, findings highlight the ability of contemporary soil microbiota to inhabit rocky substrates actively, requiring strict contamination controls when evaluating ancient molecular biosignatures or extraterrestrial materials collected.

Metal-free sampling methods for dust, rainwater, surface water, plants, and sediments: A selection of unique tools from the SWAMP laboratory.

Contamination control remains one of the greatest challenges for the reliable determination of many trace elements in environmental samples. Here we describe a series of metal-free sampling devices and tools designed and constructed specifically to minimize the risk of contamination by trace elements during sampling of dust, rainwater, surface water, plants, and sediments. Plastic components fabricated using 3-D printing include polylactic acid (PLA), polyethylene terephthalate (PET), polyethylene terephthalate glycol (PETG), polypropylene (PP), polycarbonate (PC) and PC with carbon fibre. When additional strength is needed (e.g. supporting structural components), carbon fibre, aluminum (Al), or 316 stainless steel (SS) is used. Other plastics employed include acrylic and vinyl. Epoxy glue or SS may be used for joining components, but do not come into contact with the samples. Ceramic (zirconium dioxide) cutting blades are used where needed. Each plastic material was evaluated for contaminant trace elements by leaching with high purity nitric acid in the metal-free, ultraclean SWAMP laboratory. The devices were tested in the field to evaluate their performance and durability. When combined with appropriate cleaning procedures, the equipment enables ultraclean collection for trace element analysis of environmental media.•Plastic sampling devices were designed and constructed using 3D printing of PLA, PET, PETG or PP.•Leaching characteristics of plastic components were evaluated using high purity nitric acid in a metal-free, ultraclean laboratory.•Each sampling device was successfully field-tested in industrial settings (near open pit bitumen mines and upgraders), and in remote locations of northern Alberta, Canada.

Identifying laboratory sources of microplastic and nanoplastic contamination from the air, water, and consumables.

Microplastic and nanoplastic research has proliferated in recent years in response to the escalating plastic pollution crisis. However, a lack of optimised methods for sampling and sample processing has potential implications for contaminating samples resulting in an overestimation of the quantity of microplastics and nanoplastics present in environmental samples. In response, a series of recommendations have been made, but most have not been quantified or validated sources of contamination. In the present study, we investigated sources of plastic contamination in common laboratory procedures including water sources (e.g., Milli-Q), consumables (e.g., unburnt glassware), airflow (e.g., fume hood) and dust. Using flow cytometry, we identified water, air flow and dust as sources of significant contamination. Milli-Q and reverse osmosis were the least contaminated sources when compared with tap water. Interestingly, current recommendations are to use glass consumables in replacement of plastic consumables, however, we have identified glassware and glass consumables as a significant source of contamination. Current best practice is to cover the glass tube with aluminium foil to reduce airborne contamination, but we found fresh aluminium foil to be a significant source of contamination, bringing light to the limitations foil has as a contamination control measure. Lastly, we identified significant quantities of microplastics and nanoplastics present in dust collected within the laboratory, suggesting this is a widespread and underestimated source of contamination. We have provided validated sources of contamination for both consumables and common laboratory procedures and provided mitigation strategies based on these. Additional recommendations include the appropriate design of experimental controls to quantify levels of introduced contamination based on methods and the detection techniques utilised. The application of these mitigation strategies and appropriate experimental design will allow for more accurate estimations on the level of microplastic and nanoplastic contamination within environmental samples.

Risk assessment for biopharmaceutical single-use manufacturing: A case study of upstream continuous processing.

In the current transition to intensified upstream processing, the risks of adopting traditional single-use systems for high-titer, long-duration perfusion cultures, have thus far not been considered. This case study uses the Failure Modes and Effects Analysis (FMEA) method to evaluate the risks associated with implementing upstream single-use technology. The simulated model process was used to compare the risk level of single-use technology for a traditional fed-batch cell culture with that for perfusion culture, under the same annual protein production conditions. To provide a reasonable source of potential risk for FMEA, all single-use upstream operations for both fed-batch and perfusion processes were investigated using an analytical method developed to quantify the impact of process parameters and operating conditions on single-use system specifications and to ensure objectivity. Many of the risks and their levels, were similar in long-duration perfusion cultures and fed-batch cultures. However, differences were observed for high-risk components such as daily sampling and installation. The result of this analysis indicates that the reasons for risk are different for fed-batch cultures and perfusion cultures such as larger bioreactors in fed-batch and longer runs in perfusion, respectively. This risk assessment method could identify additional control measures and be part of a holistic contamination control strategy and help visualize their effectiveness.

Mars 2020 Mission Biological Return Sample Contamination Control Approach and Verification.

The Mars 2020 Perseverance rover is equipped with a Sample Caching System (SCS) designed to collect and cache martian core and regolith samples for potential return to Earth. To ensure the integrity of these samples, the mission requirements for each encapsulated sample for return is less than one Earth-sourced viable organism (VO) and more than a 99.9% probability of being free of any Earth-sourced VO. To satisfy the stringent biological contamination requirements in support of return sample science investigations, special bioburden mitigation and reduction approaches were developed and implemented for SCS hardware that would directly contact or be in close proximity to the martian samples. In this study, we describe the implemented approaches for microbiological contamination reduction and mitigation, detail the processes of the SCS aseptic assembly, and report the estimated VO for each returned sample. We found that our conservative estimate of the computed probability of a single VO in the returned sample is more than one order of magnitude lower than the biological contamination requirement while the best estimate exceeds two orders of magnitude.

Setup of a Contamination Control Strategy Using the Hazard Analysis Critical Control Point (HACCP) Methodology.

A Contamination Control Strategy (CCS) is a document that focuses on how to prevent contaminations with microorganisms, particles, and pyrogens within sterile and/or aseptic and preferably also in nonsterile manufacturing facilities. This document determines to what extent measures and controls in place are efficient in preventing contamination. In order to efficiently evaluate and control all potential hazards associated with sources of contamination within a CCS, the Hazard Analysis Critical Control Point (HACCP) methodology could be a useful tool to monitor all Critical Control Points (CCPs) related to various sources of contamination. This article describes a way to set up the CCS within a pharmaceutical sterile and aseptic manufacturing facility (GE HealthCare Pharmaceutical Diagnostics) by applying the HACCP methodology. In 2021, a global CCS procedure and a general HACCP template became effective for the GE HealthCare Pharmaceutical Diagnostics sites having sterile and/or aseptic manufacturing processes. This procedure guides the sites through the setup of the CCS by applying the HACCP methodology and helps each site to evaluate whether the CCS is still effective taking all (proactive and retrospective) data following the CCS into account. A summary of setting up a CCS using the HACCP methodology, specifically for the pharmaceutical company GE HealthCare Pharmaceutical Diagnostics Eindhoven site, is provided in this article. Use of the HACCP methodology enables a company to include proactive data within the CCS, making use of all identified sources of contamination, associated hazards, and/or control measures and CCPs. The constructed CCS allows the manufacturer to identify whether all included sources of contamination are under control and, if not, which mitigatory actions need to be performed. All current states are reflected by a traffic light color to reflect the level of residual risk, thereby providing a simple and clear visual representation of the current contamination control and microbial state of the manufacturing site.

An Accounting of Contamination Control Requirements, Implementation, and Verification of the Sample Tubes for the Mars 2020 Mission and Future Return Sample Science.

The Sample Tubes on the Mars 2020 Perseverance rover were required to meet strict cleanliness standards for possible organic and inorganic contamination introduction to collected samples. There were also strict planetary protection cleanliness standards required to limit possible biological contamination. Together, these sets of standards also applied to associated hardware, like the Sample Tube hermetic seals. This created unique challenges to manufacturing, cleaning, and verifying the final cleanliness state of the Sample Tubes, which are the main focus of this publication. Documenting the final cleanliness state of the Sample Tubes is critical for future analysis of collected martian samples, of significant interest to the scientific community, and will have implications for possible future missions like Mars Sample Return. An accounting of events that led to the final delivered state of the Sample Tubes on Earth with regard to contamination control cleanliness requirements, precision cleaning, processing, and verification are provided.

Solid-Phase Microextraction for Organic Contamination Control Throughout Assembly and Operational Phases of Space Missions.

Space missions concerned with life detection contain highly sensitive instruments for the detection of organics. Terrestrial contamination can interfere with signals of indigenous organics in samples and has the potential to cause false-positive biosignature detections, which may lead to incorrect suggestions of the presence of life elsewhere in the solar system. This study assessed the capability of solid-phase microextraction (SPME) as a method for monitoring organic contamination encountered by spacecraft hardware during assembly and operation. SPME-gas chromatography-mass spectrometry (SPME-GC-MS) analysis was performed on potential contaminant source materials, which are commonly used in spacecraft construction. The sensitivity of SPME-GC-MS to organics was assessed in the context of contaminants identified in molecular wipes taken from hardware surfaces on the ExoMars Rosalind Franklin rover. SPME was found to be effective at detecting a wide range of common organic contaminants that include aromatic hydrocarbons, aliphatic hydrocarbons, nitrogen-containing compounds, alcohols, and carbonyls. A notable example of correlation of contaminant with source material was the detection of benzenamine compounds in an epoxy adhesive analyzed by SPME-GC-MS and in the ExoMars rover surface wipe samples. The current form of SPME-GC-MS does not enable quantitative evaluation of contaminants, nor is it suitable for the detection of every group of organic molecules relevant to astrobiological contamination concerns, namely large and/or polar molecules such as amino acids. However, it nonetheless represents an effective new monitoring method for rapid, easy identification of organic contaminants commonly present on spacecraft hardware and could thus be utilized in future space missions as part of their contamination control and mitigation protocols.

Levels, origins and probabilistic health risk appraisal for trace elements in drinking water from Lhasa, Tibet.

Due to the lack of monitoring systems and water purification facilities, residents in western China may face the risk of drinking water pollution. Therefore, 673 samples were collected from Lhasa's agricultural and pastoral areas to reveal the status quo of drinking water. We used inductively coupled plasma-mass spectrometry to determine trace elements concentrations for water quality appraisal, source apportionment, and health risk assessment. The results indicate that concentrations of V, Cr, Mn, Fe, Co, Ni, Cu, Zn, Cd, Ba, and Pb are below the guidelines, while As concentrations in a few samples exceed the standard. All samples were classified into "excellent water" for drinking purpose based on Entropy-weighted water quality index. Thereafter by principal component analysis, three potential sources of trace elements were extracted, including natural, anthropogenic, and mining activities. It is worth noting that geotherm and mining exploitation does not threaten drinking water safety. Finally, health risks were assessed using Monte Carlo technique. We found that the 95th percentiles of hazard index are 1.80, 0.80, and 0.79 for children, teenagers, and adults, indicating a non-carcinogenic risk for children, but no risks for the latter two age groups. In contrast, the probabilities of unacceptable cautionary risk are 7.15, 2.95 and 0.69% through exposure to Cr, Ni, As, and Cd for adults, children, and teenagers. Sensitivity analyses reveal As concentration and ingestion rate are most influential factors to health risk. Hence, local governments should pay more attention to monitoring and removal of As in the drinking water.

Exposure Risks and Potential Control Measures for a Fire Behavior Lab Training Structure: Part B. Chemical Gas Concentrations.

Firefighters' or instructors' exposure to airborne chemicals during live-fire training may depend on fuels being burned, fuel orientation and participants' location within the structure. This study was designed to evaluate the impact of different control measures on exposure risk to combustion byproducts during fire dynamics training where fuel packages are mounted at or near the ceiling. These measures included substitution of training fuels (low density wood fiberboard, oriented strand board (OSB), pallets, particle board, plywood) and adoption of engineering controls such as changing the location of the instructor and students using the structure. Experiments were conducted for two different training durations: the typical six ventilation cycle (6-cycle) and a shorter three ventilation cycle (3-cycle) with a subset of training fuels. In Part A of this series, we characterized the fire dynamics within the structure, including the ability of each fuel to provide an environment that achieves the training objectives. Here, in Part B, airborne chemical concentrations are reported at the location where fire instructors would typically be operating. We hypothesized that utilizing a training fuel package with solid wood pallets would result in lower concentrations of airborne contaminants at the rear instructor location than wood-based sheet products containing additional resins and/or waxes. In the 6-cycle experiments (at the rear instructor location), OSB-fueled fires produced the highest median concentrations of benzene and 1,3 butadiene, plywood-fueled fires produced the highest total polycyclic aromatic hydrocarbon (PAH) concentrations, particle board-fueled fires produced the highest methyl isocyanate concentrations, and pallet-fueled fires produced the highest hydrogen chloride concentrations. All fuels other than particle board produced similarly high levels of formaldehyde at the rear instructor location. The OSB fuel package created the most consistent fire dynamics over 6-cycles, while fiberboard resulted in consistent fire dynamics only for the first three cycles. In the follow-on 3-cycle experiment, PAH, benzene, and aldehyde concentrations were similar for the OSB and fiberboard-fueled fires. Air sampling did not identify any clear differences between training fires from burning solid wood pallets and those that incorporate wood-based sheet products for this commonly employed fuel arrangement with fuels mounted high in the compartment. However, it was found that exposure can be reduced by moving firefighters and instructors lower in the compartment and/or by moving the instructor in charge of ventilation from the rear of the structure (where highest concentrations were consistently measured) to an outside position.

Influence of the Internal Structure Type of a Large-Area Lower Exhaust Workbench on Its Surface Air Distribution.

Local exhaust ventilation is an important method of contamination control, and the type of exhaust hood and the air distribution at the hood face have an important influence on the contamination control effect. When the hood face is large, it is difficult to create a uniform airflow distribution at the hood face, which if achieved, could improve the effect of contamination control. To that end, the large-area workbench used in the process of vaccine purification was taken as the research subject prototype for this study. According to the methods for generating a uniform airflow distribution at the hood face, the lower exhaust workbenches of four structures were established using CAD and simulated using Ansys Fluent. The best uniformity of workbench surface air distribution was with Structure-4, while the worst was with Structure-1. The workbench surface airflow distribution could not achieve uniformity when only an inclined bottom was used for the large-area lower exhaust workbench with one side outlet. The more internal slits there were, the greater the air distribution area and the more uniform the air distribution. The width of the area of workbench surface airflow distribution was determined by the width of the slits. The numerical simulation results were verified by experiments, which showed them to be credible.

Hierarchy of contamination control in the fire service: Review of exposure control options to reduce cancer risk.

The international fire service community is actively engaged in a wide range of activities focused on development, testing, and implementation of effective approaches to reduce exposure to contaminants and the related cancer risk. However, these activities are often viewed independent of each other and in the absence of the larger overall effort of occupational health risk mitigation. This narrative review synthesizes the current research on fire service contamination control in the context of the National Institute for Occupational Safety and Health (NIOSH) Hierarchy of Controls, a framework that supports decision making around implementing feasible and effective control solutions in occupational settings. Using this approach, we identify evidence-based measures that have been investigated and that can be implemented to protect firefighters during an emergency response, in the fire apparatus and at the fire station, and identify several knowledge gaps that remain. While a great deal of research and development has been focused on improving personal protective equipment for the various risks faced by the fire service, these measures are considered less effective. Administrative and engineering controls that can be used during and after the firefight have also received increased research interest in recent years. However, less research and development have been focused on higher level control measures such as engineering, substitution, and elimination, which may be the most effective, but are challenging to implement. A comprehensive approach that considers each level of control and how it can be implemented, and that is mindful of the need to balance contamination risk reduction against the fire service mission to save lives and protect property, is likely to be the most effective.

The assessment of particle selection and blank correction to enhance the analysis of microplastics with Raman microspectroscopy.

Although microplastics research has received enormous attention in the last decade, both the research practices and the quality of produced data should still be improved. In this study, the identification process of microplastics with Raman imaging microscope was improved by decreasing the time needed for the analysis. To do that, new features, including terrain mosaic and automatic particle selection, were utilized and various ways of handling the produced microplastics data were implemented and discussed. Furthermore, blank correction of microplastic concentrations was demonstrated and its effects on the recovery of spiked microplastics was assessed with aqueous and solid samples. Six types of microplastics, including fragments and fibers, were spiked in triplicates of ultra-pure water and reference sediment samples. The spiked samples were pretreated by a modified method of the universal enzymatic purification protocol. Microplastics were analyzed with Raman imaging microscope, using terrain mosaic combined with automatic particle selection. The microplastics data were subjected to different identification steps to estimate the potential overestimation and underestimation of microplastics counts. With the complete correction of Raman-based data, the average recovery rates of fragments (77-80%) were higher than fibers (20-33%). The decrease in recovery rates of spiked microplastics (49-57%) were observed when blank correction was applied (28-47%). The impact of the blank correction depended on the polymer, causing exclusion of PE, PET, and PP from sediment samples. For the completely corrected Raman-based data, the average recovery rates of microplastics were higher for water than sediment samples both with and without blank correction. The results demonstrated the impact of blank correction on the microplastics recovery rates. To our knowledge, this is the first study to explore the use of automatic particle selection of Raman imaging microscope for microplastics analysis. Hence, potential drawbacks and advantages of the new features of Raman imaging microscope were explicitly discussed.

Ocorrência de bromato em águas destinadas ao consumo humano / Occurrence of bromate in water intended for human consumption

Introdução: Bromato é mutagênico e um provável carcinogênico em seres humanos. Normalmente não ocorre em águas para consumo humano, mas a contaminação pode ocorrer por águas residuárias industriais e pela desinfecção por ozonização (se brometo estiver presente) ou pelo uso de solução de hipoclorito de qualidade insatisfatória. Objetivo: Descrever as concentrações de bromato nas águas de abastecimento de 89 municípios do estado de São Paulo (Brasil), os perfis físico-químicos das águas nas quais o contaminante ocorre e uma ação conjunta entre Laboratório de Saúde Pública, Grupo de Vigilância Sanitária e de duas Vigilâncias Sanitárias dos municípios onde foram encontrados níveis importantes de bromato. Método: Foram analisadas 4.853 amostras em 21 parâmetros físico-químicos (incluindo concentração de bromato) e dois microbiológicos. Para análise multivariada foram incluídos quatro parâmetros demográficos. Resultados: O bromato foi encontrado em 224 amostras (4,6% do total) de 17 municípios. As concentrações variaram entre 3 e 199 µg L-1 e 56 amostras (1,1% do total) apresentaram teores acima do valor máximo permitido. A Análise de Componentes Principais nesses 17 municípios indicou KBrO3 como a forma predominante de contaminação. Os índices de contaminação de dois municípios diminuíram a partir da disponibilização para as Vigilâncias Sanitárias de laudos que incluíram os resultados de bromato. Conclusões: Os dados sugerem que o monitoramento das concentrações de bromato deveria ser incluído na rotina do Programa de Vigilância da Água para Consumo Humano do estado de São Paulo. As notificações das Vigilâncias Sanitárias junto aos responsáveis pelo abastecimento de água de dois municípios foram importantes para a melhoria da qualidade da água fornecida à população em relação à contaminação.

Introduction: Bromate is mutagenic and a probable carcinogen in humans. It usually does not occur in water for human consumption, but contamination can occur by industrial wastewater and in the disinfection process by ozonization (if bromide is present) or by the use of hypochlorite solution of unsatisfactory quality. Objective: Describe bromate concentrations in the water supply of 89 municipalities in the state of São Paulo (Brazil), the physicochemical profiles of the waters in which the contaminant occurs, and a joint action between the Public Health Laboratory, the Sanitary Surveillance Regional Group and two Sanitary Surveillance of municipalities where important levels of bromate were found. Method: 4,853 samples were analyzed in 21 physicochemical parameters (including bromate concentration) and 2 microbiological parameters. For multivariate analysis, 4 demographic parameters were included. Results: Bromato was found in 224 samples (4.6% of the total) from 17 municipalities. The concentrations ranged between 3 and 199 µg L-1 and 56 samples (1.1% of the total) presented levels above the Maximum Allowed Value. Principal  Component Analysis in these 17 municipalities indicated KBrO3 as the predominant form of contamination. The contamination rates of two municipalities decreased from the availability to the Sanitary Surveillance of reports that included bromate results. Conclusions: The data suggest that the monitoring of bromate concentrations should be included in the routine of the Water Surveillance Program for Human Consumption in the state of São Paulo. The notifications of the Sanitary Surveillance with those responsible for the water supply of two municipalities were important to improve the quality of the water supplied to the population in relation to contamination.

Are we contaminating our samples? A preliminary study to investigate procedural contamination during field sampling and processing for microplastic and anthropogenic microparticles.

Methods for sampling, analysis and interpretation of fresh and saltwater microplastics and anthropogenic microfibers have improved since 2004, but techniques for reducing and monitoring procedural contamination are still limited. Quantifying the amount of procedural contamination introduced to samples improves the robustness of counts of microplastics and anthropogenic microfibers in the environment. This pilot study investigates procedural contamination introduced into water samples when rigorous QA/QC anti-contamination protocols are used and removed. Procedural contamination accounted for 33.8% of the total microfibers and microplastics found in samples when protocols were used (n = 81), but 70.7% when they were not (n = 8). With the use of extensive control sampling and full characterization of samples (morphological, optical and chemical) it was possible to identify the predominant sources of contamination (crew clothing) and make recommendations for anti-contamination and procedural contamination identification/reduction protocols for shoreline and small/medium sized vessel sampling for microplastics and anthropogenic microfibers.

Cultivation processes to select microorganisms with high accumulation ability.

The microbial ability to accumulate biomolecules is fundamental for different biotechnological applications aiming at the production of biofuels, food and bioplastics. However, high accumulation is a selective advantage only under certain stressful conditions, such as nutrient depletion, characterized by lower growth rate. Conventional bioprocesses maintain an optimal and stable environment for large part of the cultivation, that doesn't reward cells for their accumulation ability, raising the risk of selection of contaminant strains with higher growth rate, but lower accumulation of products. Here in this work the physiological responses of different microorganisms (microalgae, bacteria, yeasts) under N-starvation and energy starvation are reviewed, with the aim to furnish relevant insights exploitable to develop tailored bioprocesses to select specific strains for their higher accumulation ability. Microorganism responses to starvation are reviewed focusing on cell cycle, biomass production and variations in biochemical composition. Then, the work describes different innovative bioprocess configurations exploiting uncoupled nutrient feeding strategies (feast-famine), tailored to maintain a selective pressure to reward the strains with higher accumulation ability in mixed microbial populations. Finally, the main models developed in recent studies to describe and predict microbial growth and intracellular accumulation upon N-starvation and feast-famine conditions have been reviewed.

Contamination Control Strategy: Implementation Road Map.

The article proposes an implementation road map of a contamination control strategy (CCS) in a facility. The CCS is the culmination of an exercise to identify activities designed to prevent microorganism, pyrogen, and particulate contamination in the product, the facility, and the supporting processes used to manufacture the product. Manufacturers can formulate their contamination control strategy based on information in the quality target product profile or in the critical quality attributes, in the facility, and in the processes used to manufacture and transport the product. The strategy implementation involves executing the strategic plan and managing the implementation by priority overtime should it be deployed. The evaluation of the efficiency and effectiveness of the contamination control strategy implemented is confirmed by analyzing and trending the various quality performance parameters related to contamination control. The strategy evaluation allows the manufacturer to identify a new strategic plan to support improvement goals or new measures and/or controls to achieve the desired result, minimizing the contamination risk.