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Sanitary napkins are technical textile products that women use to hygienically collect menstrual fluids when they are menstruating. Because sanitary napkins must simultaneously fulfil a number of end-use requirements, they have layered constructions. Through the Unnat Bharat Abhiyan, Surat, India, this study explores the eco-friendly (organic material) sanitary napkin production facility in the village of Bhatlai in the Gujarat province of India and identifies an issue. With eco-friendly organic sanitary products, bioburdens are a big problem. The Unnat Bharat Abhiyan accepts recommendations and improvements relating to sterility in a sanitary manufacturing unit after bioburden testing is conducted using various approaches outlined by Sanitary Napkins - Specification (IS 5405:2019). This study seeks to develop sanitary napkins that are sterilized and have no bioburden to replace SAPs (super absorbent polymer) with an ecologically friendly biopolymer that provides competent performance and characteristics to rural women of India living near or below poverty line. [ABSTRACT FROM AUTHOR]

The recent FDA approvals of Rebyota™ and Vowst™ represent landmark milestones within the burgeoning field of live microbiota-based products. Future microbiota-based treatment approaches also hold significant promise for treating patients with a myriad of diseases and disorders, yet substantial hurdles hinder their development and utilization. Foremost, existing regulatory frameworks governing live biotherapeutic product (LBP) manufacturing development have notable gaps, requiring comprehensive expansion and refinement. Along with regulatory challenges, hurdles remain in the optimization and validation of analytical methodologies essential for characterizing LBPs, including for microbial identification, potency, and bioburden. To address these challenges, Microbiome Therapeutics Innovation Group (MTIG) spearheaded collaborative efforts, engaging industry leaders and the FDA in discussions aimed at catalyzing improvements in LBP analytics and refining the current regulatory landscape. Extrapolating on feedback from these discussions, this review highlights challenges and identifies critical gaps. Specific recommendations for future regulatory guidance are proposed, as are recommendations for interactions that developers can take now with regulatory agencies to support the development of maturing guidance. Key analytical factors to consider in LBP development are reviewed, highlighting strengths and weaknesses of various methodologies. Collaboration among regulatory and government agencies, industry, and academia, facilitated by coalitions like MTIG, will be instrumental in ushering the microbiota-based therapeutics field into the next phase of approvals and advancements, ultimately benefiting patients. [ABSTRACT FROM AUTHOR]

Negative Pressure Wound Therapy (NPWT) has been widely adopted in wound healing strategies due to its multimodal mechanism of action. While NPWT’s positive impression on wound healing is well-established, its effect on bacterial load reduction remains equivocal. This study investigates NPWT’s efficacy in reducing bioburden using an in vitro porcine skin model, focusing on the impact of Staphylococcus aureus and Staphylococcus epidermidis. Custom-made negative pressure chambers were employed to apply varying negative pressures. Porcine skin was cut into 5 × 5 cm squares and three standardized wounds of 6 mm each were created using a biopsy punch. Then, wounds were infected with S. aureus and S. epidermidis bacterial suspensions diluted 1:10,000 to obtain a final concentration of 1.5 × 104 CFU/ml and were placed in negative pressure chambers. After incubation, bacterial counts were expressed as colony-forming units (CFU) per ml. For S. aureus at 120 hours, the median CFU, mean area per colony, and total growth area were notably lower at −80 mmHg when compared to −250 mmHg and −50 mmHg, suggesting an optimal negative pressure for the pressure-dependent inhibition of the bacterial proliferation. While analyzing S. epidermidis at 120 hours, the response to the negative pressure was similar but less clear, with the minor CFU at −100 mmHg. The influence of intermittent negative pressure on the S. epidermidis growth showed notably lower median CFU with the interval therapy every hour compared to the S. aureus control group. This study contributes valuable insights into NPWT’s influence on the bacterial load, emphasizing the need for further research to reformulate its role in managing contaminated wounds.

Bioburden detection is crucial for food, water, and biopharmaceutical applications as it can directly impact public health. The objective of this study is to develop and validate an assay and protocol for detecting bioburden on solid surfaces, as well as in water, with high sensitivity and accuracy in a rapid manner. Henceforth, a resazurin‐based assay optimized for detecting bioburden has been integrated with a previously developed portable multichannel fluorometer. The microbes were isolated from solid surfaces in different laboratory settings by swabbing technique, and stream water was collected for contamination analysis. Based on the results, the assay and protocol can successfully detect bioburden as low as 20 CFU/cm2 and 10 CFU/mL present in both surface and water samples, respectively. [ABSTRACT FROM AUTHOR]

The suspension wet media milling manufacturing process is a complex multi-unit operation, resulting in drug substance comminution to a target particle size. As a result of this complexity, microbial contamination is of paramount concern, particularly for suspensions dosed for parenteral use. This perspective sought to review the influence of (4) critical manufacturing unit operations using a quality risk management approach to better identify and articulate impact of each unit operation on bioburden viability. The manufacturing unit operations in scope included slurry compounding, deaeration, milling, and filling. Bow tie risk analysis was used as a visual gap analysis tool to evaluate if conventional controls were appropriate to detect and mitigate potential for microbial contamination. A deep dive into these unit operations clarified that mechanisms such as turbohypobiosis, cavitation during deaeration, high energy milling, and inert overlay may have an appreciable influence on bioburden viability and proliferation. The resultant analysis also explicated that endotoxin oversight must be closely monitored through barriers (input material controls, water quality controls) to minimize impact to the product and patient. The identified manufacturing unit operations were not appropriate as mitigating controls for endotoxin. The output of this article relates risk intersections for microbial contamination during wet media milling and offers insights in critical areas for intervention. [ABSTRACT FROM AUTHOR]

The microbiological quality of municipal water is of prime importance for public health and represents a prominent concern for authorities to maintain and control the bioburden level within safe limits. An appropriately functioning network must ensure the biological stability of the water distribution system throughout the way of water from the processing and purification station until reaching the ultimate consumers. The study examines methodologies used to evaluate different segments from a local distribution system of city water by examining short-term results of the total microbial count obtained from several available points of use through a one-year period. Microbial variations observed in city's water system. Autumn has the highest bioburden. Locations exceeding 10,000 CFU/100 mL threshold warrant investigation. Non-uniform distribution across the system suggests potential influence of distance, pipe type, and biofilms. Early warning system established to monitor bioburden surges. Descriptive analysis showed that six lines from 19 examined sections from the distribution system had lower dispersion in the microbiological data between minimum and maximum results than the remaining parts of the distribution pipes. Moreover, multiple comparison test outputs returned significant differences in microbiological density datasets between high-count and low-count use points. Thus, surveying the layout design of the municipal water distribution infrastructure would be crucial to restate its impact on the sanitary distribution of water. In conclusion, this refined study provides a nuanced examination of microbiological stability in municipal water distribution, offering targeted insights for effective public health management. By implementing the present assessment, public health authorities can spot and identify defective areas in the distribution system and take necessary actions to prevent or mitigate potential risks of waterborne diseases. [ABSTRACT FROM AUTHOR]

There is an increasing use of non‐medicated wound dressing with claims of irreversible bacterial binding. Most of the data are from in vitro models which lack clinical relevance. This study employed a range of in vitro experiments to address this gap and we complemented our experimental designs with in vivo observations using dressings obtained from patients with diabetes‐related foot ulcers. A hydrophobic wound dressing was compared with a control silicone dressing in vitro. Test dressings were placed on top of a Pseudomonas aeruginosa challenge suspension with increasing concentrations of suspension inoculum in addition to supplementation with phosphate buffered saline (PBS) or increased protein content (IPC). Next, we used the challenge suspensions obtained at the end of the first experiment, where bacterial loads from the suspensions were enumerated following test dressing exposure. Further, the time‐dependent bacterial attachment was investigated over 1 and 24 h. Lastly, test dressings were exposed to a challenge suspension with IPC, with or without the addition of the bacteriostatic agent Deferiprone to assess the impacts of limiting bacterial growth in the experimental design. Lastly, two different wound dressings with claims of bacterial binding were obtained from patients with chronic diabetes‐related foot ulcers after 72 h of application and observed using scanning electron microscope (SEM). Bacteria were enumerated from each dressing after a 1‐h exposure time. There was no statistical difference in bacterial attachment between both test dressings when using different suspension inoculum concentrations or test mediums. Bacterial attachment to the two test dressings was significantly lower (p < 0.0001) when IPC was used instead of PBS. In the challenge suspension with PBS, only the hydrophobic dressing achieved a statistically significant reduction in bacterial loads (0.5 ± 0.05 log colony forming units; p = 0.001). In the presence of IPC, there was no significant reduction in bacterial loads for either test dressing. When bacterial growth was arrested, attachment to the test dressings did not increase over time, suggesting that the number of bacteria on the test dressings increases over time due to bacterial growth. SEM identified widespread adsorption of host fouling across the test dressings which occurred prior to microbial binding. Therein, microbial attachment occurred predominantly to host fouling and not directly to the dressings. Bacterial binding is not unique to dialkylcarbamoyl chloride (DACC) dressings and under clinically relevant in vitro conditions and in vivo observations, we demonstrate (in addition to previously published work) that the bacterial binding capabilities are not effective at reducing the number of bacteria in laboratory models or human wounds. [ABSTRACT FROM AUTHOR]

A commercial bacterial cellulose-monolaurin wound dressing was investigated for changes in the chemical structure, mechanical strength, thermal degradation, morphology, and functional swelling properties after exposure to gamma and electron beam radiations at doses 15-50 kGy. Radiation-induced oxidation occurred as seen in the FT-IR peaks at 1720-1750 cm−1. Degradation of the cellulosic network was observed in tensile strength reduction and shift in degradation temperature to lower values. The SEM cross-section images of the irradiated dressings revealed a less dense nanostructure network compared to the non-irradiated samples while the XRD diffractograms indicated a change in lattice direction/plane. Despite these changes, irradiation caused no significant effect on the functional properties especially at 15-25 kGy doses where most biomedical devices are sterilized. All irradiated wound dressings exhibited physical integrity, increased exudate absorption, and water vapor transmission rate - properties beneficial to wound-healing functionality. The pre-selected sterilization dose of 15 kGy for each ionizing radiation was successfully verified and substantiated following ISO 11137-2:2016, hence ionizing radiation is a suitable sterilization modality for the product. Graphical Abstract [ABSTRACT FROM AUTHOR]

Planetary protection is a discipline dedicated to preventing biological contamination between celestial bodies and Earth during space exploration to ensure the integrity of scientific research. National space agencies such as the National Aeronautics and Space Administration and the European Space Agency set biological cleanliness requirements for their missions based on the guidelines provided in The Committee on Space Research’s Planetary Protection Policy. Compliance with these requirements is often demonstrated by surface sampling of spacecraft hardware and associated surfaces to enumerate the number of microorganisms present and establish that they are below the required level. The discipline has employed a variety of tools to perform sampling; the recovery efficiency of which is a key parameter used to generate spacecraft level cleanliness estimates. In this study, we investigated how recovery efficiency differs by inoculum amount and species. This was analyzed across different sampling devices using a set of microorganisms applied to stainless steel surfaces (representative of spacecraft surfaces) and two processing methods. Data were analyzed by developing a probabilistic model of the experimental process, from stainless steel coupon inoculation through recovery of spores observed in the form of colony forming units. The model quantifies the probability that an individual spore is recovered, a key metric for predicting bioburden and statistically assessing bioburden requirements. A cost function was developed to identify those assay methods that provided optimal bioburden estimation capability. Results show the nylon-flocked swab and the TX3211 wipe yield the highest recovery efficiency of those tested. [ABSTRACT FROM AUTHOR]

Aim: In this article, we aim to raise awareness of some of the clinical concerns surrounding the management of oncology wounds, particularly malignant fungating wounds. We will also provide practical wound management recommendations for healthcare professionals to consider when managing this wound type. We aim to assess the potential of a 100% chitosan with bioactive microfibre gelling (BMG™) dressing (MaxioCel®), to support wound management and work in partnership with industry to deliver clinical education on the management of oncology wounds, including malignant fungating wounds. Method: A case study series was undertaken over four weeks, using the chitosan BMG dressing. Results: We recruited 10 patients during the study. The chitosan BMG dressing facilitated a significant improvement in wound tissue type, exudate levels, and periwound skin, as well as reduced malodour. A reduction in patient-reported pain levels was also noted throughout the evaluation process. Conclusion: The introduction of BMG fibre technology demonstrated good outcomes in this patient group, in a short period of time. Importantly for this patient group, the BMG dressing was able to remain in situ during radiotherapy treatment, allowing uninterrupted management of the wounds. [ABSTRACT FROM AUTHOR]

Ultrafiltration/diafiltration (UF/DF) is typically the final step in downstream processing of recombinant monoclonal antibody (mAb) products, which serves for protein concentration and buffer exchange. For UF/DF membranes composed of regenerated cellulose (RC), sanitization with 0.1 M sodium hydroxide is generally recommended by the supplier, but it may not be sufficient for reducing bioburden during large scale manufacturing. Therefore, more stringent sanitization methods for RC membranes are required. However, chemicals used in such sanitization step may disrupt membrane integrity, while the corresponding residuals may reduce product quality. Previous work has shown that high concentration of sodium hydroxide or addition of peracetic acid (PAA) can effectively reduce bioburden, but their effects on the RC membranes remain unknown. In this work, we assessed the impact of two sanitization methods, 0.5 M sodium hydroxide and 30 mM PAA in combination with 0.5 M sodium hydroxide, on membrane integrity and protein quality of Millipore and pall corporation (PALL) membranes. Both methods showed a similar impact as the control after performing 15 cycles. However, the addition of PAA may cause residual chemical concerns, therefore, 0.5 M sodium hydroxide was recommended as an effective and safe sanitization method for RC UF/DF membranes. Three different sanitization methods, including 0.1 M sodium hydroxide, 0.5 M sodium hydroxide, and 30 mM PAA in combination with 0.5 M sodium hydroxide, have different ability to control bioburden. The former has the weakest control ability, while the latter has the strongest control ability. In this study, the impact of these methods on the integrity of RC UF/DF membrane and product quality was evaluated. Finally, 0.5 M sodium hydroxide is recommended as an effective and safe sanitization method. [ABSTRACT FROM AUTHOR]

Responsible space exploration is a cornerstone of planetary protection, particularly at sites in the Solar System with a high potential for the existence of extant life. To limit bioburden, spacecraft assembly occurs in cleanroom facilities. Cleanroom levels are established through air particulate counters that can assess particle size distribution and concentration but cannot detect bioaerosols. Additionally, these devices do not detect in real-time, which poses a risk to critical flight hardware assemblies or even mission timelines. A first-of-its-kind study was conducted to simultaneously detect bioaerosols, inert particles, and their size distribution in real-time in operational spacecraft assembly cleanrooms at NASA's Jet Propulsion Laboratory in Pasadena, CA, USA, using the BioVigilant IMD-A® 350 (Azbil Corporation, Tucson, AZ, USA). The IMD-350A continuously sampled during operations and no-operation 6 h intervals in two facilities per cleanroom class: ISO 6, ISO 7, and ISO 8. A positive correlation was established between human presence in the cleanroom and elevated bioaerosol counts. Smaller particles of sizes 0.5 and 1 μm constituted an average ∼91% of the total bioaerosols detected in At Work intervals across all ISO classes observed. The results of this study were used to establish bioburden particulate thresholds for the most stringent JPL cleanrooms used in the assembly of the Sample Caching System for the Mars 2020 Perseverance rover. [ABSTRACT FROM AUTHOR]

The Mars 2020 Flight System comprises a Cruise Stage; Aeroshell; Entry, Descent, and Landing system; Perseverance rover; and the Ingenuity helicopter. The Perseverance rover was successfully delivered to Jezero Crater on February 18, 2021. Among its science objectives, Perseverance is meant to search for rocks that are capable of preserving chemical traces of ancient life, if it existed, and to core and cache rock and regolith samples. The Perseverance rover is gathering samples for potential return to Earth as part of a Mars Sample Return campaign. Thus, controlling the presence of Earth-sourced biological contamination is important to protect the integrity of the scientific results as well as to comply with international treaty and NASA requirements governing Planetary Protection prior to launch. An unprecedented campaign of sampling and environmental monitoring occurred, which resulted in over 16,000 biological samples collected throughout spacecraft assembly. Engineering design, microbial reduction measures, monitoring, and process controls enabled the mission to limit the total spore bioburden to 3.73 × 105 spores, which provided 25.4% margin against the required limit. Furthermore, the total spore bioburden of all landed hardware was 3.86 × 104, which provided 87% margin against the required limit. This manuscript outlines the Planetary Protection implementation approach and verification methodologies applied to the Mars 2020 flight system and its surrounding environments. [ABSTRACT FROM AUTHOR]

Rapid and sensitive bioburden detection is of paramount importance in different applications including public health, and food and water safety. To overcome the traditional limitations of bacterial detection i.e., lengthy culture time, and complicated procedure, a low-cost, portable multichannel fluorometer coupled with machine learning (ML) has been implemented in this study. Five different strains of bacterial samples were tested along with the negative control for time-series fluorescence data collection and analysis. We applied different conventional unsupervised and supervised machine learning techniques with extracted features followed by preprocessing of the data. Initially, machine learning algorithms were applied for the qualitative detection of bacteria by binary classification followed by regression analysis to predict the level of contamination for E. coli. The multiclass classification was used to identify gram-positive, and gram-negative bacterial strains and differentiate all the bacterial strains tested. Our results show that around 97.9% accuracy can be achieved for bacterial contamination detection for as low as 1 CFU/mL while 92.1% accuracy can be achieved for differentiating the gram-positive and gram-negative strains. Additionally, with 1 minute of data, high accuracy is obtained for detecting bioburden, proving the multichannel fluorometer’s rapid detection capability. The multichannel fluorometer integrated with ML analytics is capable of automating data analysis and determining accurate and rapid bacterial detection on-site with the prediction of bioburden levels and differentiating bacterial strains and the protocol can be applied to the biosensors with a similar data type.

Microbial contamination in the hospital environment is a major concern for public health, since it significantly contributes to the onset of healthcare-associated infections (HAIs), which are further complicated by the alarming level of antimicrobial resistance (AMR) of HAI-associated pathogens. Chemical disinfection to control bioburden has a temporary effect and can favor the selection of resistant pathogens, as observed during the COVID-19 pandemic. Instead, probiotic-based sanitation (probiotic cleaning hygiene system, PCHS) was reported to stably abate pathogens, AMR, and HAIs. PCHS action is not rapid nor specific, being based on competitive exclusion, but the addition of lytic bacteriophages that quickly and specifically kill selected bacteria was shown to improve PCHS effectiveness. This study aimed to investigate the effect of such combined probiotic–phage sanitation (PCHSφ) in two Italian hospitals, targeting staphylococcal contamination. The results showed that PCHSφ could provide a significantly higher removal of staphylococci, including resistant strains, compared with disinfectants (−76%, p < 0.05) and PCHS alone (−50%, p < 0.05). Extraordinary sporadic chlorine disinfection appeared compatible with PCHSφ, while frequent routine chlorine usage inactivated the probiotic/phage components, preventing PCHSφ action. The collected data highlight the potential of a biological sanitation for better control of the infectious risk in healthcare facilities, without worsening pollution and AMR concerns. [ABSTRACT FROM AUTHOR]

Background: The microbial contamination of a respirator can be evaluated through a count of the number of bacteria living on a non-sterilized surface (bioburden). This preliminary study investigated the external contamination of two different FFP2s over time by studying the bioburden values in increasing exposure times. Methods: FFP2 respirators of two different brands were used during routine clinical settings and examined through the bioburden test; for each brand, three devices were tested at 8, 16, and 30 h. Results: No significant differences were observed between mask brands (p = 0.113). There were only significant CFU differences between each mask and its control (p = 0.027 and p = 0.004). Conclusions: Both brands of respirators were found to be contaminated and this contamination increased with the increase in exposure time. Further studies are needed to investigate the exact amount of contamination that could be considered acceptable before discarding each used mask. [ABSTRACT FROM AUTHOR]

Abstract Introduction Infections due to extended spectrum beta-lactamase producing organisms (ESBL) have emerged as the leading cause of sepsis among hospitalized neonates in Botswana and much of sub-Saharan Africa and south Asia. Yet, ESBL reservoirs and transmission dynamics within the neonatal intensive care unit (NICU) environment are not well-understood. This study aimed to assess the efficiency and feasibility of a chromogenic-culture-media-based environmental sampling approach to characterize the ESBL bioburden within a NICU. Methods A series of four point-prevalence surveys were conducted at a 36-bed NICU at a public tertiary referral hospital in Botswana from January-June 2021. Samples were collected on 4 occasions under semi-sterile technique using 1) flocked swabs & templates (flat surfaces); 2) sterile syringe & tubing (water aspiration); and 3) structured swabbing techniques (hands & equipment). Swabs were transported in physiological saline-containing tubes, vortexed, and 10 µL was inoculated onto chromogenic-agar that was selective and differential for ESBL (CHROMagar™ ESBL, Paris, France), and streaking plates to isolate individual colonies. Bacterial colonies were quantified and phenotypically characterized using biochemical identification tests. Results In total, 567 samples were collected, 248 (44%) of which grew ESBL. Dense and consistent ESBL contamination was detected in and around sinks and certain high-touch surfaces, while transient contamination was demonstrated on medical equipment, caregivers/healthcare worker hands, insects, and feeding stations (including formula powder). Results were available within 24–72 h of collection. To collect, plate, and analyse 50 samples, we estimated a total expenditure of $269.40 USD for materials and 13.5 cumulative work hours among all personnel. Conclusions Using basic environmental sampling and laboratory techniques aided by chromogenic culture media, we identified ESBL reservoirs (sinks) and plausible transmission vehicles (medical equipment, infant formula, hands of caregivers/healthcare workers, & insects) in this NICU environment. This strategy was a simple and cost-efficient method to assess ESBL bioburden and may be feasible for use in other settings to support ongoing infection control assessments and outbreak investigations.

Objective: Endotoxin causes inflammation and can impair wound healing. Conventional methods that reduce bioburden in wounds by killing microorganisms using antibiotics, topical antimicrobials or antimicrobial dressings may induce endotoxin release from Gram-negative bacteria. Another approach is to reduce bioburden by adsorbing microorganisms, without killing them, using dialkylcarbamoyl chloride (DACC)-coated wound dressings. This study evaluated the endotoxin-binding ability of a DACC-coated wound dressing (Sorbact Compress, Abigo Medical AB, Sweden) in vitro, including its effect on the level of natural endotoxin released from Gram-negative bacteria. Method: Different concentrations of purified Pseudomonas aeruginosa endotoxin and a DACC-coated dressing were incubated at 37°C for various durations. After incubation, the dressing was removed and endotoxin concentration in the solution was quantified using a Limulus amebocyte lysate (LAL) assay. The DACC-coated dressing was also incubated with Pseudomonas aeruginosa cells for one hour at 37°C. After incubation, the dressing and bacterial cells were removed and shed endotoxin remaining in the solution was quantified. Results: Overnight incubation of the DACC-coated wound dressing with various concentrations of purified Pseudomonas aeruginosa endotoxin (96–11000 EU/ml) consistently and significantly reduced levels of free endotoxin by 93–99% (p<0.0001). A significant endotoxin reduction of 39% (p<0.001) was observed after five minutes. The DACC-coated dressing incubated with clinically relevant Pseudomonas aeruginosa cells also reduced shed endotoxin by >99.95% (p<0.0001). Conclusion: In this study, we showed that a DACC-coated wound dressing efficiently and rapidly binds both purified and shed endotoxin from Pseudomonas aeruginosa in vitro. This ability to remove both endotoxin and bacterial cells could promote the wound healing process. [ABSTRACT FROM AUTHOR]

Microbial contamination in the hospital environment is a major concern for public health, since it significantly contributes to the onset of healthcare-associated infections (HAIs), which are further complicated by the alarming level of antimicrobial resistance (AMR) of HAI-associated pathogens. Chemical disinfection to control bioburden has a temporary effect and can favor the selection of resistant pathogens, as observed during the COVID-19 pandemic. Instead, probiotic-based sanitation (probiotic cleaning hygiene system, PCHS) was reported to stably abate pathogens, AMR, and HAIs. PCHS action is not rapid nor specific, being based on competitive exclusion, but the addition of lytic bacteriophages that quickly and specifically kill selected bacteria was shown to improve PCHS effectiveness. This study aimed to investigate the effect of such combined probiotic–phage sanitation (PCHSφ) in two Italian hospitals, targeting staphylococcal contamination. The results showed that PCHSφ could provide a significantly higher removal of staphylococci, including resistant strains, compared with disinfectants (−76%, p < 0.05) and PCHS alone (−50%, p < 0.05). Extraordinary sporadic chlorine disinfection appeared compatible with PCHSφ, while frequent routine chlorine usage inactivated the probiotic/phage components, preventing PCHSφ action. The collected data highlight the potential of a biological sanitation for better control of the infectious risk in healthcare facilities, without worsening pollution and AMR concerns.

Purpose: The management of severe soft tissue injuries to the extremities with full-thickness wounds poses a challenge to the patient and surgeon. Dermal substitutes are used increasingly in these defects. The aim of this study was to investigate the impact of the type of injury on the success rate of Matriderm® (MD)-augmented split-thickness skin grafting, as well as the role of negative pressure wound therapy (NPWT) in preconditioning of the wounds, with a special focus on the reduction of the bioburden. Methods: In this study, 45 wounds (44 affecting lower extremities (97.7%)), resulting from different types of injuries: soft tissue (ST), soft tissue complications from closed fracture (F), and open fracture (OF) in 43 patients (age 55.0 ± 18.2 years, 46.7% female), were treated with the simultaneous application of MD and split-thickness skin grafting. The study was designed as a retrospective cohort study from March 2013 to March 2020. Patients were stratified into three groups: ST, F, and OF. Outcome variables were defined as the recurrence of treated wound defects, which required revision surgery, and the reduction of bioburden in terms of reduction of number of different bacterial strains. For statistical analysis, Student's t-test, analysis of variance (ANOVA), Mann–Whitney U test, and Pearson's chi-squared test were used. Results: There was no significant difference in the rate of recurrence in the different groups (F: 0%; OF: 11.1%; ST: 9.5%). The duration of VAC therapy significantly differed between the groups (F: 10.8 days; OF: 22.7 days; ST: 12.6 days (p < 0.05)). A clinically significant reduction of bioburden was achieved with NPWT (bacterial shift (mean (SD), F: − 2.25 (1.89); OF: − 1.9 (1.37); ST: − 2.6 (2.2)). Conclusion: MD-augmented split-thickness skin grafting is an appropriate treatment option for full-thickness wounds with take rates of about 90%. The complexity of an injury significantly impacts the duration of the soft tissue treatment but does not have an influence on the take rate. NPWT leads to a relevant reduction of bioburden and is therefore an important part in the preconditioning of full-thickness wounds. [ABSTRACT FROM AUTHOR]

Introduction: Infections due to extended spectrum beta-lactamase producing organisms (ESBL) have emerged as the leading cause of sepsis among hospitalized neonates in Botswana and much of sub-Saharan Africa and south Asia. Yet, ESBL reservoirs and transmission dynamics within the neonatal intensive care unit (NICU) environment are not well-understood. This study aimed to assess the efficiency and feasibility of a chromogenic-culture-media-based environmental sampling approach to characterize the ESBL bioburden within a NICU. Methods: A series of four point-prevalence surveys were conducted at a 36-bed NICU at a public tertiary referral hospital in Botswana from January-June 2021. Samples were collected on 4 occasions under semi-sterile technique using 1) flocked swabs & templates (flat surfaces); 2) sterile syringe & tubing (water aspiration); and 3) structured swabbing techniques (hands & equipment). Swabs were transported in physiological saline-containing tubes, vortexed, and 10 µL was inoculated onto chromogenic-agar that was selective and differential for ESBL (CHROMagar™ ESBL, Paris, France), and streaking plates to isolate individual colonies. Bacterial colonies were quantified and phenotypically characterized using biochemical identification tests. Results: In total, 567 samples were collected, 248 (44%) of which grew ESBL. Dense and consistent ESBL contamination was detected in and around sinks and certain high-touch surfaces, while transient contamination was demonstrated on medical equipment, caregivers/healthcare worker hands, insects, and feeding stations (including formula powder). Results were available within 24–72 h of collection. To collect, plate, and analyse 50 samples, we estimated a total expenditure of $269.40 USD for materials and 13.5 cumulative work hours among all personnel. Conclusions: Using basic environmental sampling and laboratory techniques aided by chromogenic culture media, we identified ESBL reservoirs (sinks) and plausible transmission vehicles (medical equipment, infant formula, hands of caregivers/healthcare workers, & insects) in this NICU environment. This strategy was a simple and cost-efficient method to assess ESBL bioburden and may be feasible for use in other settings to support ongoing infection control assessments and outbreak investigations. [ABSTRACT FROM AUTHOR]

Purpose To explore the level of bioburden and the effectiveness of the manufacturers' recommended cleaning methods on lead apparel in a radiology department. Methods A 2-phase experiment at a level II trauma center during a 2-year period assessed the level of bioburden on radiology lead apparel. Adenosine triphosphate swabs and a luminometer were used to measure cleanliness of high-touch areas. Cleanliness was measured before and after 3 cleaning methods were used: cleaning with a mild detergent and water; cleaning with a mild detergent, water, and then a disinfectant; and scrubbing with cleaning wipes. Results Average bioburden levels exceeded facility thresholds for all areas and types of lead apparel examined. All tested cleaning methods significantly reduced bioburden. Discussion Monthly cleaning of lead apparel provides improved cleanliness when compared with quarterly cleaning. Daily cleaning of lead apparel that will be used in a sterile environment is recommended. Future research might include examining other patient care and ancillary equipment found in the imaging department for potential bioburden and surveying technologists to examine practices for routine removal of bioburden from equipment. Conclusion Health care professionals must be aware of the potential bioburden on clinical equipment and maintain an effective cleaning practice and schedule to reduce the possibility of spreading infection. [ABSTRACT FROM AUTHOR]

The current communication seeks to provide an updated narrative review on latest methods of reducing implant contaminations used during spine surgery. Recent literature review has shown that both preoperative reprocessing and intraoperative handling of implants seem to contaminate implants. In brief, during preoperative phase, the implants undergo repeated bulk cleaning with dirty instruments from the OR, leading to residue buildup at the interfaces and possibly on the surfaces too. This, due to its concealed nature, remains unnoticed by the SPD (sterile processing department) or other hospital staff. Nevertheless, these can be avoided by using individually prepackaged presterilized implants. In the intraoperative phase, the implants (in the sterile field) are directly touched by the scrub tech with soiled (assisting the surgeon dispose the tissues from the instruments in use) gloves for loading onto an insertion device. It is then kept exposed on the working table (either separately or next to the used instruments as the pedicles hole are being prepared). Latest investigation has shown that by the time it is implanted in the patient, it can harbor up to 10e7 bacterial colony-forming units. The same implants were devoid of such colony-forming units, when sheathed by an impermeable sterile sheath around the sterile implant.

Historically, fuel microbiology studies have relied on culture data. Potentially relevant but unculturable bacteria were not detected. Although ATP can quantify total microbial bioburdens in fuels, it cannot differentiate among the taxa present. Quantitative PCR (qPCR) testing promises to fill this gap by quantifying targeted amplicon sequences thereby detecting both culturable and non-culturable taxa and quantifying specifically targeted taxa. In this study, fluid samples drawn from the fuel, interface and water phases of fuel over water microcosms were tested for cellular ATP concentration ([cATP]) and qPCR bioburdens. Additionally, surface swab samples from steel corrosion coupon surfaces exposed to each of these three phases were collected and tested for total ATP concentration ([tATP]) and qPCR bioburdens. Statistical relationships between ATP and qPCR bioburdens were examined. Correlation coefficients between the two variables were matrix dependent and ranged from negligible (| r |=0.2) to strong (| r |=0.7). When results were categorized into negligible, moderate and heavy bioburdens, parameter agreement was again matrix dependent. Percentage agreement between [ATP] and qPCR gene copies ranged from 11 % to 89 % - with qPCR-bioburden ratings typically being greater than ATP-bioburden ratings., Competing Interests: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 The Authors.)

Background: The microbial contamination of a respirator can be evaluated through a count of the number of bacteria living on a non-sterilized surface (bioburden). This preliminary study investigated the external contamination of two different FFP2s over time by studying the bioburden values in increasing exposure times. Methods: FFP2 respirators of two different brands were used during routine clinical settings and examined through the bioburden test; for each brand, three devices were tested at 8, 16, and 30 h. Results: No significant differences were observed between mask brands (p = 0.113). There were only significant CFU differences between each mask and its control (p = 0.027 and p = 0.004). Conclusions: Both brands of respirators were found to be contaminated and this contamination increased with the increase in exposure time. Further studies are needed to investigate the exact amount of contamination that could be considered acceptable before discarding each used mask.

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., (Copyright © 2024, Parenteral Drug Association.)

In the execution of its legislated responsibilities, the United States Food and Drug Administration commonly refers to standard test methods detailed in the United States Pharmacopeia (USP). Microbiological test methods (contained in general chapters) are listed in chapters <51> to <80> with details regarded as enforceable where referenced as a test method. USP <61> "Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests" is a globally harmonized chapter that has been successfully employed for the enumeration of microorganisms recoverable from nonsterile finished drug products. The content of USP <61> is not always scientifically principled nor emphatically understood by all pharmaceutical microbiologists. Consequently, misunderstanding and misapplication of USP <61> may result in analyses and assessments of microbiological quality that are flawed or erroneous. In this article, clarification is provided to assist the pharmaceutical microbiologist in the appropriate and intended use of USP <61>, including provision of details not always commonly known or understood., (© PDA, Inc. 2024.)

Background: Surgical templates are classified as noncritical devices, and they do not need to be sterile. Aim: Primary aim of this study was to assess the microbiological burden present on the surgical templates without metallic sleeves after disinfection. Furthermore, to evaluate trueness after disinfection and steam sterilization at 121°C/15 min, and over a 8‐week storage period. Finally, to assess their accuracy after in vitro implant placement simulation. Materials and methods: Forty surgical templates were printed and divided in five groups of eight templates each. Groups A to C were disinfected with 0.5% Chlorhexidine Gluconate and 70% ethyl alcohol base solution for 15 min. Templates in the group D were steam sterilized at 121°C for 15 min, while, the templates in the group E were used as control. Implant simulation was performed in the group A. Outcome measures were determination of bioburden, trueness assessment using GOM Inspect Professional software, and accuracy evaluated thought the mean angular deviation of simulated implants. Results: Total microbic charge measured as colony forming units (CFU) for sample, was 24.40 in the control group (group E; n = 8), and <4.40 in the test group (group C; n = 8), with a reduction of 84%. Colored representation from GOM inspection showed no differences after disinfection and implant simulation, disinfection alone, and steam sterilization, compared to the control group. A very small difference in the surface and volume dimensions was reported 1 month after templates fabrication. The mean roundness tolerances of the tested templates improved of 0.96 ± 0.56° (95% CI 0.57–1.35). Conclusion: Surgical templates without metallic sleeves can be safely used after disinfection, demonstrating high level of accuracy, even when the surgical procedures should be postponed within a couple of weeks. Further in vivo study are needed to confirm these preliminary results. [ABSTRACT FROM AUTHOR]

The collection and analysis of settled dust samples from indoor environments has become one of several environmental sampling methods used to assess bioburden indoors. The aim of the study was to characterize the bioburden in vacuumed settled dust from 10 Primary Health Care Centers by culture based and molecular methods. Results for bacterial load ranged from 1 to 12 CFU.g−1 of dust and Gram-negative bacteria ranged between 1 to 344 CFU.g−1 of dust. Fungal load ranged from 0 CFU.g−1 of dust to uncountable. Aspergillus section Fumigati was detected in 4 sampling sites where culture base-methods could not identify this section. Mucorales (Rhizopus sp.) was observed on 1 mg/L voriconazole. Three out of 10 settled dust samples were contaminated by mycotoxins. Settled dust sampling coupled with air sampling in a routine way might provide useful information about bioburden exposure. [ABSTRACT FROM AUTHOR]

Caroline E Fife,1 Raphael A Yaakov,2 Thomas E Serena2 1CHI St. Luke’s Health, Wound Care Clinic, The Woodlands, TX, USA; 2SerenaGroup, Clinical Research, Cambridge, MA, USA Abstract: Epidermolysis bullosa (EB), often referred to as the butterfly disease, is a group of rare genetic conditions characterized by skin that is delicate and fragile as butterfly wings. The skin blisters in response to friction, minor injury, or trauma. In certain types of EB, other organs, such as the esophagus, can also be affected, and secondary complications may require multiple interventions. While there has been significant progress in classifying the disease – identifying genes and proteins involved – there have been few advances in the treatment of the disease. The care of the EB patient focuses on management of symptoms, protecting the skin, and preventing complications. In this case report, the use of a multivalent wound-healing ointment (Terrasil®) was evaluated in a 60-year-old patient with a history of junctional EB. A polymerase chain reaction-based culturing was utilized to quantitatively test for bacteria and fungi at baseline and follow-up visits. Pain assessment and wound area were also documented at each visit. Following the application of the wound care ointment, there was a reduction in wound surface area on central (96%) and distal mid-back (92%) by treatment visit three, and there was a 96% reduction on the left shoulder blade ulcer by treatment visit four. Moreover, there was a noticeable drop in the percentage of bacteria detected by polymerase chain reaction. The wound care ointment was also effective in eliminating the fungal species and reducing pain, itching, blistering, and cracking around the wound. Keywords: mechanobullous disorders, adjunctive therapy, bioburden, therapeutic management

Abstract Background Expressed human milk (EHM) feed preparation areas represent a potential source of unintentional nosocomial infection. Daily disinfection of environmental surfaces remains an essential intervention to mitigate nosocomial infections. The inefficiency of conventional cleaning and disinfection contributes to an increased risk for the acquisition of multi-drug resistant pathogens. “Non touch” technologies such as the pulsed xenon ultraviolet (PX-UVD) light device have documented sustained reduction in surface bacterial colonization and reduced cross contamination. Methods The impact of a PX-UVD on surface colony forming units per square centimeter (cfu/cm2) in feed preparation areas was evaluated following its implementation as standard care. A quasi-experimental study was performed documenting bacterial colonization from 6 high risk feed preparation areas in a community care hospital in South Africa. Pre and post conventional cleaning neutralizing rinse swabs were collected fortnightly over a 16 week control period prior to the introduction of the PX-UVD and compared to a matching set of samples for the PX-UVD period. Results A 90% reduction in total surface bioburden was noted from the control period (544 cfu/cm2) compared to the corresponding PX-UVD period (50 cfu/cm2). Sub -analysis of both the Pre-clean Control: Pre-clean PX-UVD counts as well as the Post-clean Control: Post-clean PX-UVD counts noted significant improvements (p

The InSight (Interior Exploration using Seismic Investigations, Geodesy and Heat Transport) Mars mission launched from Vandenberg Air Force Base on an Atlas V 401 rocket on May 5, 2018. Prior to launch, the InSight spacecraft, associated launch vehicle hardware, and ground support equipment were required to satisfy Planetary Protection requirements to comply with international treaty obligations and demonstrate compliance with National Aeronautics and Space Administration (NASA) levied bioburden requirements. InSight was the first bioburden-controlled mission to launch from Vandenberg Air Force Base and required mission-unique policies and procedures to ensure Planetary Protection requirements were satisfied. All the launch vehicle hardware and associated ground support equipment with direct contact or line of sight to flight hardware were required to demonstrate a bioburden density of less than 1,000 spores/m2. Additionally, the environmental control system air ducts were required to demonstrate more stringent bioburden limits on internal duct surfaces (<100 spore/m2) and on air passing through the ducts (88 colony-forming units/m3). Although conservative approaches were used with the data analysis and launch recontamination analysis, InSight, the launch vehicle hardware, and ground support equipment were able to demonstrate compliance with the Planetary Protection requirements needed for launch approval. Here we detail the biological practices implemented on the launch vehicle hardware and ground support equipment that resulted in biologically clean hardware and the satisfaction of Planetary Protection. [ABSTRACT FROM AUTHOR]

The InSight (Interior Exploration using Seismic Investigations, Geodesy and Heat Transport) Mars flight system is made up of a cruise stage, an aeroshell, and a Phoenix heritage-based lander that successfully landed in the Elysium Planitia on November 26, 2018. InSight has primary science objectives that are aimed at understanding more about the interior of Mars and the formation and evolution of terrestrial planets. As with previous Mars missions, InSight was obligated to satisfy bioburden requirements and verify compliance with international treaty obligations and National Aeronautics and Space Administration requirements before launch. InSight implemented a series of policies and procedures to minimize biological risk and comply with all applicable requirements for a Planetary Protection Category IVa mission. At launch, InSight had an estimated total bacterial spore burden of 1.50 × 105 spores on the entire spacecraft, including the cruise stage, satisfying the requirement of 5 × 105 spores. The landed hardware components required <3 × 105 spores and a bioburden density of <300 spores/m2. At launch, the landed hardware of InSight contained an estimated total spore bioburden of 1.35 × 105 spores and an estimated bioburden density of 129 spores/m2. [ABSTRACT FROM AUTHOR]

Bone allografts are the preferred method for bone augmentation in over 500,000 orthopedic surgical procedures in the US. Sterilization by ionizing radiation is the most effective method of minimizing the bioburden of bone allografts; however, radiation causes chain scission of collagen, resulting in the reduction of the allografts' mechanical strength. In this study, we doped bone allografts with vitamin E as radioprotectant using a novel two‐step process to protect the collagen architecture against radiation damage and to preserve the mechanical strength of the construct. In addition, combining the radioprotectant with a cross‐linking agent further minimized collagen degradation and further preserved the mechanical strength of the allografts. Both vitamin E and combined vitamin E/genipin‐treated allograft were less cytotoxic to both osteoblasts and osteoclasts when compared to irradiated‐only allografts. Host bone‐allograft unionization was faster in a rat calvaria defect model with vitamin E‐treated and combined vitamin E and genipin‐treated allograft when compare to irradiated‐only allografts. This method can enable the efficient and uniform radioprotective treatment of bone allograft of desired shapes for sterilization with improved mechanical strength and biointegration. [ABSTRACT FROM AUTHOR]

• Filtering Respiratory Protective Devices (FRPD) presented high levels of bioburden. • Several Aspergillus sections exhibited reduced susceptibility to the tested azoles. • Toxigenic fungal strains were detected on FRPD. • Workers with more waste contact showed increased bioburden on FRPD. • FRPD can be used as passive sampling methods to assess occupational exposure. One of the solutions for decreasing the workers' exposure to bioburden is the use of Filtering Respiratory Protective Devices (FRPD). As such it is important to determine whether these devices are fulfilling their protective role. This is the basis of the current study, aimed at characterizing bioburden retained by 120 FRPD (both in interior layers and in exhalation valves) through culture based-methods and molecular tools and also via analysis of antifungal resistance and mycotoxins profile. Our results show that Gram – Bacteria are present at a higher prevalence than total bacteria in both matrixes. Regarding fungal identification, Chrysonilia sitophila presented the highest prevalence on interior layers (55.1% on malt extract agar (MEA) supplemented with chloramphenicol (0.05%); 59.6% on dichloran-glycerol agar (DG18)), whereas on exhalation valves Aspergillus sp. presented the highest prevalence on MEA (6.8%) and C. sitophila on DG18 (36.3%). Among Aspergillus genera, section Fumigati was the one with the highest prevalence in both matrices. Aspergillus sp. was the most prevalent on exhalation valves (75.0% ITRA) in the screening of azole resistance. Fumigati section was the most abundant Aspergillus sp. detected on the interior layers (33.33%, 40 samples out of 120) and on the exhalation valves (1.66%, 2 samples out of 120). The interior layers and exhalation valves from workers with more waste contact showed an increased exposure to bioburden. This study showed that FRPD can have high levels of bioburden, toxigenic fungal strains and Aspergillus sections with reduced susceptibility to the tested azoles and can be used as a passive sampling method since it mimics the results obtained by active methods in previous studies. The gathered information will be useful to prioritize multiple interventions on workers' education or even on FRPD replacement frequency. [ABSTRACT FROM AUTHOR]

Perioperative and sterile processing department personnel commonly use visual inspection to validate surgical instrument cleanliness. This validation process does not detect microbes (eg, bacteria, viruses) and the resultant inadequately decontaminated instruments can put patients at risk for developing surgical site infections. Sterile processing department personnel should use a rapid, straightforward method to validate surgical instrument cleanliness objectively. During a quality improvement project at a military treatment facility, staff members found that adenosine triphosphate (ATP)–based technology was a viable and affordable solution for detecting bioburden and validating cleaning practices. The project design compared manually and mechanically cleaned cannulated instruments (59 of each) and identified 16 contaminated instruments, 14 of which had been manually cleaned. The contamination rate after mechanical cleaning was significantly lower (P =.0022) compared with manual cleaning. As a result of this quality improvement project, this facility fully implemented the technology to validate instrument cleaning. [ABSTRACT FROM AUTHOR]

This study presented an evaluation of the impact of gamma irradiation as a decontaminating tool in improving microbial quality of dried cassava chips. Thirteen (13) month old white-flesh cassava roots were purchased from an experimental farm of the Council for Scientific and Industrial Research-Crops Research Institute (CSIR-CRI) at Pokuase in the Greater Accra Region of Ghana. The cassava roots were cleaned, peeled, washed and processed into chips, and then oven-dried. The dried cassava chips were gamma irradiated to target doses of 2.5, 5.0, 7.5 and 10.0 kGy at a dose rate of 0.75 kGy/h. Un-irradiated chips were used as controls. Total Viable Count (TVC), Total Coliform Count (TCC), Yeast and Mould Count (YMC), Staphylococcus aureus count (SAC), Bacillus species count (BSC) and Salmonella count (SC) of the dried cassava chips were determined using standard methods. Coliform, Staphylococcus aureus, Bacillus spp , yeast and moulds were detected in the dried cassava chips, except Salmonella. Gamma irradiation significantly reduced the microorganisms recorded on the surfaces of the dried cassava chips in dose-dependent manner. Radiation decontamination has the potential to improve microbial quality of dried cassava chips. • Irradiation reduced microbial bioburden on the surface of dried cassava chips. • Irradiation dose of 7.5 kGy completely eliminated all microorganisms on the chips. • Radiation decontamination can improve microbial quality of dried cassava chips. [ABSTRACT FROM AUTHOR]

Microbial contamination of medical devices during pilot production can be a significant barrier as the laboratory environment is a source of contamination. There is limited information on microbial contaminants in laser laboratories and environments involved in the pilot production of medical devices. This study aimed to determine the bioburden and microbial contaminants present in three laser laboratories - an ISO class 7 clean room, a pilot line facility and a standard laser laboratory. Microbiological air sampling was by passive air sampling using settle plates and the identity of isolates was confirmed by DNA sequencing. Particulate matter was analysed using a portable optical particle counter. Twenty bacterial and 16 fungal genera were isolated, with the genera Staphylococcus and Micrococcus being predominant. Most isolates are associated with skin, mouth, or upper respiratory tract. There was no significant correlation between microbial count and PM 2.5 concentration in the three laboratories. There were low levels but diverse microbial population in the laser-processing environments. Pathogenic bacteria such as Acinetobacter baumannii and Candida parapsilosis were isolated in those environments. These results provide data that will be useful for developing a contamination control plan for controlling microbial contamination and facilitating advanced manufacturing of laser-based pilot production of medical devices., Competing Interests: The authors declare that there are no conflicts of interest., (© 2023 The Authors.)

Sampling campaigns indoors have shown that occupants exposed to contaminated air generally exhibit diverse health outcomes. This study intends to assess the deposition rates of total settleable dust and bioburden in the indoor air of dwellings onto quartz fiber filters and electrostatic dust collectors (EDCs), respectively. EDC extracts were inoculated onto malt extract agar (MEA) and dichloran glycerol (DG18) agar-based media used for fungal contamination characterization, while tryptic soy agar (TSA) was applied for total bacteria assessment, and violet red bile agar (VRBA) for Gram-negative bacteria. Azole-resistance screening and molecular detection by qPCR was also performed. Dust loading rates ranged from 0.111 to 3.52, averaging 0.675 μg cm−2 day−1. Bacterial counts ranged from undetectable to 16.3 colony-forming units (CFU) m−2 day−1 and to 2.95 CFU m−2 day−1 in TSA and VRBA, respectively. Fungal contamination ranged from 1.97 to 35.4 CFU m−2 day−1 in MEA, and from undetectable to 48.8 CFU m−2 day−1 in DG18. Penicillium sp. presented the highest prevalence in MEA media (36.2%) and Cladosporium sp. in DG18 (39.2%). It was possible to observe: (a) settleable dust loadings and fungal contamination higher in dwellings with pets; (b) fungal species considered indicators of harmful fungal contamination; (c) Aspergillus section Candidi identified in supplemented media with voriconazole and posaconazole; (d) specific housing typologies and (e) specific housing characteristics influencing the microbial contamination.

• Surgical mask conservation practices may lead to increased operating room bioburden. • All sampled masks showed some colony manifestation. • Surgeons' masks contamination has been linked to conservation techniques. Evaluating the impact of surgical masks' conservation practices during the Coronavirus Disease pandemic in the bioburden of the operating room seems imperative, as they play a critical role against this pandemic. We demonstrate that surgeons' masks tend to be contaminated due to the conservation techniques to maximize protection equipment during the pandemic. Health institutions should highlight the importance of surgical mask exchange to avoid increments in surgical mask contamination. [ABSTRACT FROM AUTHOR]

Background: The spread of pathogens via the airborne route is often underestimated, and little is known about the extent to which airborne microbial contamination levels vary throughout the day and night in hospital facilities.Aims: To evaluate airborne contamination levels within intensive care unit (ICU) isolation rooms over 10-24-h periods in order to improve understanding of the variability of environmental aerial bioburden, and the extent to which ward activities may contribute.Methods: Environmental air monitoring was conducted within occupied and vacant inpatient isolation rooms. A sieve impactor sampler was used to collect 500-L air samples every 15 min over 10-h (08:00-18:00 h) and 24-h (08:00-08:00 h) periods. Samples were collected, room activity was logged, and bacterial contamination levels were recorded as colony-forming units (cfu)/m3 air.Findings: A high degree of variability in levels of airborne contamination was observed across all scenarios in the studied isolation rooms. Air bioburden increased as room occupancy increased, with air contamination levels highest in rooms occupied for the longest time during the study (10 days) (mean 104.4 cfu/m3, range 12-510 cfu/m3). Counts were lowest in unoccupied rooms (mean 20 cfu/m3) and during the night.Conclusion: Peaks in airborne contamination were directly associated with an increase in activity levels. This study provides the first clear evidence of the extent of variability in microbial airborne levels over 24-h periods in ICU isolation rooms, and found direct correlation between microbial load and ward activity. [ABSTRACT FROM AUTHOR]

Two ASTM standard test methods for determining microbial contamination in fuels and fuel-associated water were compared in a joint interlaboratory study. One method measured cellular adenosine triphosphate (cATP) and the other detected specific microbial antigens. The latter was a lateral flow device (LFD). The results illustrate the degree of agreement between the two methods. Representatives of eight organizations tested a total of 144 fuel and fuel-associated water samples by each of the two methods. Raw data were converted into negligible, moderate, and heavy, attribute scores (1, 3 and 5, respectively). The two methods' attribute scores agreed for 122 of the 144 samples (83%). This degree of agreement is a very strong indicator that the two methods provided an accurate indication of microbial contamination. • Bioburden heterogeneity in fuels presents unique test method precision evaluation challenges. • Eight participating labs tested single set of 144 fuel and fuel-associated water samples by two ASTM standard methods: D7687 and D8070. • There was 83% attribute score agreement between the two methods. • The 83 % agreement demonstrated that differences among replicate sample containers eclipsed test method variability. • The results of this two parameter study led to changes in the standard practice for ASTM fuel microbiology interlaboratory studies. [ABSTRACT FROM AUTHOR]