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Abstract: Compared to other nano polymers, dendrimers have novel three-dimensional, synthetic hyperbranched, nano-polymeric structures. These supramolecular dendritic structures have a high degree of significant surface and core functionality in the transportation of drugs for targeted therapy, specifically in host-guest response, gene transfer therapy, and imaging of biological systems. However, there are conflicting shreds of evidence regarding biological safety and dendrimers toxicity due to their positive charge at the surface. It includes cytotoxicity, hemolytic toxicity, haematological toxicity, immunogenicity, and in vivo toxicity. Surface modification of the dendrimer group is one of the methods to resolve these issues. This review aimed at investigating different strategies that can reduce toxicity and improve the biocompatibility of different dendrimers. From that viewpoint, we broaden the structural and safe characteristics of the dendrimers in the biomedical and pharmaceutical fields.

Purpose The unifying characteristic of dry eye is the loss of tear film homeostasis, and the tear lipid layer is a key component for maintaining film stability. The detection of tear lipid is of great significance for the diagnosis of dry eye. In this study, we explored a new test strip for the detection of tear lipid. Methods The tear lipid test strip was prepared by coating the strip material with hydrophobic nano-silica. We tested its physical properties with iodine vapor chromogenic and cobalt chloride test methods. Its biosafety was evaluated by an ocular irritation test in rabbits. Finally, we established a rabbit meibomian gland dysfunction model and measured both eyes with the tear lipid test strip at the first, third, seventh, 14th, 16th, and 21st day after surgery. Results The tear lipid test strip had fine lipophilicity and hydrophobicity. It can extract lipid from tear, and the tear lipid can be quantified by measuring the length of lipid infiltration. In the ocular irritation test, the test strip had no obvious eye irritation. The length of lipid infiltration between experimental and control rabbit eyes began to show statistical difference since the third day after surgery. Conclusions The novel tear lipid test strip has great lipophilicity, hydrophobicity, and biological safety. It might be effectively applied in diagnosis of dry eye.

Background COVID-19 disease has had a profound impact worldwide since it was discovered in Wuhan, China, in December 2019. Laboratory testing is crucial to prompt identification of positive cases, initiation of treatment and management strategies. However, medical scientists are vulnerable to infection due to the risk of exposure in the laboratory and the community. This study sought to determine the awareness of laboratory safety measures, assess the personal efforts of medical scientists in creating a safe laboratory environment for testing and examine the laboratory safety enabling factors. Methods The data used for the study were generated among medical scientists in Nigeria through an internet-broadcasted questionnaire and were analyzed using IBM SPSS Statistics (version 25). Results The majority of the respondents had a high awareness of laboratory safety measures (60.3%) and demonstrated good personal efforts in creating a safe laboratory testing environment (63%). The level of awareness of laboratory safety measures was significantly associated with respondents’ level of education (χ2 = 6.143; p = 0.046) and influences respondents’ efforts in creating a safe laboratory testing environment (p = 0.007). However, just a few respondents could convincingly attest to the availability of adequate and appropriate PPE with proper utilization training (45.1%), adequate rest and other welfare packages (45.8%) as well as access to appropriate Biological Safety Cabinets (BSCs) and other essential equipment in their laboratories (48.8%). Furthermore, a significant association existed between the availability of laboratory safety enabling factors and respondents’ efforts in creating a safe environment for testing with the p-value ranging between Conclusion This study revealed that despite the high awareness of safety measures and good personal efforts of the study participants in creating a safe laboratory-testing environment, there was poor availability of safety facilities, equipment, support and welfare packages required to enhance their safety. It is, therefore, crucial to provide necessary laboratory biosafety equipment and PPE in order not to compromise medical scientists’ safety as they perform their duties in COVID-19 pandemic response.

Excessive hemorrhage is a leading cause of death to trauma patients, especially in combat and civilian accidents. The main priority in the medical treatment of trauma patients is to reduce excessive blood loss by applying an appropriate hemostat. However, some issues concerning biological safety, hemostatic efficacy, and the high cost of commercial products limit their adequate applications. Thus, the hemostats that are easily portable and effectively applied at the injury site must be used in military and critical care situations. The development of hemostatic products from polysaccharides for their promising application in wound healing is of immense academic and biomedical interest. This comprehensive review presents the most significant advancements in polysaccharide-based hemostats in the decade regarding their hemostatic mechanisms, the advantages and limitations, and the factors influencing the efficacy. The primary focus is on the progress in naturally derived polysaccharides such as cellulose, chitosan, starch, alginate, dextran, and hyaluronic acid and their derivatives for its hemostasis in wound healing. Future trends towards developing the polysaccharide-based hemostats and novel fabrication techniques such as electrospinning and 3D printing have been proposed with the challenges and promising opportunities in the wound healing hemostasis research. This review may serve as a guideline for future work to develop a hemostat with the rapid and efficient treatment of severe hemorrhage.

The paper presents the results of a study and analysis of the problematic situation when handling potentially infectious public waste during the spread of the new coronavirus infection caused by the SARS-CoV-2 virus. The population around the world is forced to comply with special prevention rules recommended by supervisory medical and executive authorities. These include the use of personal protective equipment by citizens. To date, sanitary legislation, as well as municipal solid waste management standards and regulations, does not include a fraction of medical waste containing potentially hazardous substances personal protective equipment waste generated beyond healthcare facilities. The situation under study, in our opinion, determines the particular relevance of the setting and solving of the problem of scientific substantiation of the functional model of an integrated method for ensuring biological safety of the population. To develop a separate stream of potentially infectious public waste in the system of municipal solid waste handling in cities and settlements. The article analyzes and proposes new approaches to solving a number of tasks for the management of potentially infectious public waste generated beyond healthcare facilities. We invite stakeholders to jointly research and discuss all aspects of the management of medical and biological waste, as well as municipal solid waste, taking into account the continued spread of the new coronavirus infection caused by the SARS-CoV-2 virus, to develop proposals for improving sanitary and environmental legislation.

Objectives The aims of the study were to evaluate the external contamination of hazardous drug vials used in Chinese hospitals and to compare environmental contamination generated by a robotic intelligent dispensing system (WEINAS) and a manual compounding procedure using a biological safety cabinet (BSC). Methods Cyclophosphamide, fluorouracil, and gemcitabine were selected as the representative hazardous drugs to monitor surface contamination of vials. In the comparative analysis of environmental contamination from manual and robotic compounding, wipe samples were taken from infusion bags, gloves, and the different locations of the BSC and the WEINAS robotic system. In this study, high-performance liquid chromatography coupled with double mass spectrometer (HPLC-MS/MS) was employed for sample analysis. Results (1) External contamination was measured on vials of all three hazardous drugs. The contamination detected on fluorouracil vials was the highest with an average amount up to 904.33 ng/vial, followed by cyclophosphamide (43.51 ng/vial), and gemcitabine (unprotected vials of 5.92 ng/vial, protected vials of 0.66 ng/vial); (2) overall, the environmental contamination induced by WEINAS robotic compounding was significantly reduced compared to that by manual compounding inside the BSC. Particularly, compared with manual compounding, the surface contamination on the infusion bags during robotic compounding was nearly nine times lower for cyclophosphamide (10.62 ng/cm2 vs 90.43 ng/cm2), two times lower for fluorouracil (3.47 vs 7.52 ng/cm2), and more than 23 times lower for gemcitabine (2.61 ng/cm2 vs 62.28 ng/cm2). Conclusions The external contamination occurred extensively on some hazardous drug vials that commonly used in Chinese hospitals. Comparison analysis for both compounding procedures revealed that robotic compounding can remarkably reduce environmental contamination.

Blood cultures are among the most important specimen types received and processed by the microbiology laboratory. Several publications list which variables should be measured to ensure quality. We undertook a qualitative structured questionnaire of Australian and New Zealand clinical microbiology laboratories to document current blood culture practices and to determine whether expected quality standards are being met. Questions included a wide range of pre-analytical, analytical, and post-analytical aspects of blood cultures from adults. The responses from 71 laboratories were analysed. Compliance was high for use of a biological safety cabinet (90%), incubating for 5 days (86%), and commenting on likely contaminants (85%). While Gram stains were reported within 2 hours during normal hours (93%), reporting was slower after hours (59%), p0.001. The volume of blood collected for a clinical episode was poorly monitored with only 11% (n=8) of laboratories regularly auditing the number of blood culture sets and 3% (n=2) monitoring adequacy of fill. Most laboratories received blood cultures from off-site with just 34% (n=21) meeting guidance for loading bottles onto the analyser within 4 hours. More laboratories met standards for loading bottles onto the analyser during working hours than after hours: 87% vs 56%, p0.001. Most laboratories did not monitor the contamination rate, 56% (n=40), and only 27% (n=19) knew their rate was below the guidance threshold of less than -3%. Considerable opportunities exist to improve quality assurance of blood culture practice in Australia and New Zealand, especially for the most critical aspect affecting culture sensitivity, the volume of blood collected.

3D-printing technology has become very popular the last 10 years, and their advantages have been widely proved. However, its safety in the operating room after sterilization has not been evaluated. Thus, the use of 3D printing is still questioned. The aim of this work is to evaluate the security of polylactic acid (PLA) to print surgical models after its sterilization. One hundred and eighty-six PLA plates and 6 negative controls without microorganisms were seeded. After 10 days of culture, the PLA plates were randomized into three groups: A, B, and C. Group A underwent a sterilization process using an autoclave program at 134 °C. Group B was seeded in different culture media and group C was used to make crystal violet stains on the biofilms formed on the PLA. Mechanical properties of PLA after autoclave sterilization including, the breaking load, deformation and breaking load per surface were calculated. Hundred percent of the group B showed monomicrobial growth. Stains performed on group C PLA showed biofilms in all PLA pieces. After sterilization, no pathogen growth was observed in group A during the culture observation period showing 100% sterilization effectiveness. A filling percentage of 5% obtained a breaking load of 6.36 MPa, and its elastic limit occurred after an elongation of 167.4%. A 10% infill was mechanically safe. Autoclave sterilization of PLA-printed pieces is safe for the patient and mechanically strong for the surgeon. This is the first 3D-printing protocol described and evaluated to implement 3D-printing technology safely in the operating room. This is the first 3D-printing protocol described to print and sterilize 3D biomodels using an autoclave showing its biological safety and its mechanical resistance.

The article presents materials on the toxicological and biological safety of livestock products: contaminants of various natures that contaminate raw materials and food products (microorganisms, viruses, mycotoxins, parasites, heavy metals, etc.) are presented. To ensure biological and toxicological safety of livestock products and public health, the implementation of legislation, as well as decisions of the President of the Russian Federation, it is proposed to provide the development of a national innovative system for protecting animal health from the negative effects of pathogens and toxicants, including: conducting research on the development of fundamental foundations for the protection of animal health from the negative impact of ecotoxicants and veterinary and sanitary welfare, improvement of regulatory and legislative documents on the organization of quality control and safety of raw materials and food products; restoration of the procedure for state registration of diagnostic test systems, disinfectants, insectoacaricides and rodenticides; creation of the State Veterinary Pharmacological and Biological «State Veterinary Pharmaceutical Commission». For the implementation of these measures, provide federal state budgetary funding.

Hydrogels are commonly used in wound dressing, as they retain moisture, accelerate healing, and break down necrotic tissue. This process enhances patient comfort levels while simultaneously reducing pain caused by dead tissue. The purpose of this study was to investigate the in vivo toxicity of a dual hydrogel consisting of type I atelocollagen cross-linked with sodium hyaluronate hydrogel used for wound dressing. Porcine type I atelocollagen was cross-linked with sodium hyaluronate to form the hydrogel. For subcutaneous implantation, 0.5 ml of dual hydrogel was injected into two different sites of twenty rats per group. High density polyethylene rods were implanted subcutaneously to serve as a control material. Hematological assessment, blood biochemistry, histopathological, and histological evaluations were scored and graded after 4 weeks. A bioreactivity rating was used for evaluation of subacute toxicity. Differences observed in blood chemical analysis and hematological analysis between control and test groups were within normal variations and considered unrelated to the test article implantation. No significant implantation-related lesions were observed in any of the major organs of all test animals. The overall histopathological index of the test article implantation sites was evaluated as 0. The bioreactivity rating was evaluated as non-irritant after 4-week subcutaneous implantation. Overall, these results indicate that the dual hydrogel of type I atelocollagen and sodium hyaluronate is biologically and chemically safe for clinical application as a wound dressing.

Radionuclides have been widely used for multimodal imaging and radioisotope therapy of cancer. Various nanomaterials have been developed as excellent nanocarriers of radionuclides for the targeted delivery into tumors, in order to minimize the unnecessary side effect and enhance the therapeutic efficacy of radiotherapy. Among those nanomaterials, gold nanomaterials with tunable morphologies, easy modification, good biological safety, and radiation sensitization capability are excellent candidates for cancer theranostics. Given the superior performance of gold-based nanomaterials in biomedicine, we summary the recent advance of radionuclide labeled/doped gold-based nanomaterials for cancer theranostics. In this review article, we will discuss the methods for labelling or doping radionuclides onto gold nanomaterials, their applications for nuclear imaging and Cerenkov luminescence (CL) imaging, as well as the radioisotope therapy of cancer, and finally the toxicity evaluation of radionuclide labeled/doped gold-based nanomaterials. We hope that our review article would provide guidance for non-experts to design the radiolabeled nanomaterials for cancer imaging guided therapy.

Introduction Past incidences have been recorded relating to mishandling of hazardous material either due to insufficient knowledge or inappropriate equipment resulting in the indirect transfer of infectious agents. It is necessary to identify gaps that inhibit proper protection of healthcare professionals from being inadvertently exposed to biological risks. Methods A cross sectional study was conducted at multiple laboratories across Karachi, Pakistan from January to August 2018. Descriptive questionnaire was used to record data about types and usage of Biological Safety Cabinets (BSCs), along with policies and practices adapted for its certification. Results A total of 30 laboratories were visited which included Clinical/Biomedical, University hospital, R&D and animal laboratories. Among these 60% always used BSCs, 30% periodically used BSCs while 10% did not have any BSCs. Among these facilities 63.6% had BSC class II-A2, 39.9% had BSC class II-B2, 4.5% had BSC class III and only 0.9% had BSC class I cabinet. No protocols for field certification of BSCs were available. Conclusion Establishment of biosafety training sessions, implementation and development of protocol for field certification for proper and safe use of BSCs on a local basis accompanied by continuous monitoring is required, for creating a safe environment for all laboratory staff.

Objective of the study was to select the criteria and methodological approaches to reclassify avirulent strains of plague agent from pathogenicity (hazard) group I into pathogenicity group III. Materials and methods . We have reviewed domestic and foreign normative, methodological documents, scientific publications in the field of laboratory diagnostics of plague and biosafety provision while working with pathogenic biological agents. Results and discussion. A complex of criteria for reclassification of Y. pestis strains from hazard group I into hazard group III has been substantiated; the methods for their assessment identified. Validation has revealed the grounds for reassignment of a number of avirulent Y. pestis strains included into the training kit which is compiled for mastering the training module “Microbiology and laboratory diagnostics of plague” into pathogenicity group III. We have demonstrated the feasibility of combining the structured methods of assessment of pathogenic properties in plague microbe with additional informative ones; in particular, evaluation of cytotoxicity of Y. pestis strains in relation to leucocytes of whole human blood in vitro. Analysis of a strain virulence should be built on complex characterization of major pathogenicity factors using advanced molecular-genetic research methods, the data on phenotypic manifestations of their functioning, as well as the level of pathogenicity for sensitive laboratory animals. The review of the utilized quantitative indicators for differentiation of plague microbe strains by virulence taking into account LD50 values for Y. pestis EV NIIEG strain is a relevant task. It is practical to supplement the complex approach with informative research methods, notably, characterization of strain cytotoxicity which shows high correlation with virulence criterion LD50.

is a Gram-negative, facultative anaerobic, rod-shaped coliform bacterium which is widely used as an indicator of biological safety of water. Currently, ‘gold’ standard for the detection of E. coli ...

La pandemia del síndrome respiratorio agudo conocido como COVID-19 y causada por el virus SARS-CoV-2, ha obligado a diversos laboratorios alrededor del mundo a rediseñar y reforzar sus programas de bioseguridad con la finalidad de facilitar el diagnóstico de la enfermedad y colaborar con datos epidemiológicos para la toma de decisiones asociadas a mitigación y control. Una combinación de buenas prácticas de laboratorio y procedimientos claramente definidos, apoyados en la adecuación de la infraestructura, son necesarios para proteger al personal de laboratorio y asegurar la reproducibilidad de los resultados generados. En esta revisión se muestran los lineamientos de bioseguridad fundamentales a implementar en los laboratorios de diagnóstico de la COVID-19, basados en RT-qPCR. El establecimiento del nivel de seguridad biológica a adoptar, así como de los procedimientos operativos estándar, dependerán de la evaluación de riesgo derivada de las actividades intrínsecas del laboratorio. Hasta la fecha, la OMS ha recomendado un nivel 2 de seguridad biológica NBS-2 (BSL-2), con medidas intensificadas de nivel 3 NBS-3 (BSL-3), para actividades de diagnóstico, con prácticas y equipos de protección personal que minimicen la generación de aerosoles y reduzcan la probabilidad de infecciones adquiridas en laboratorio. De igual forma, se ha hecho énfasis en un flujo de trabajo que tome en cuenta el transporte de la muestra bajo reglamentos internacionales y procedimientos para la inactivación del virus, compatibles con la prueba diagnóstica o con los protocolos para la descontaminación de superficies. A pesar del reto que conlleva la adecuación de programas de mitigación ante un patógeno relativamente desconocido como el SARS-CoV-2, es importante destacar que la cultura de bioseguridad permite reducir los riesgos del personal y del medio ambiente y asegurar la calidad de los resultados generados, que permitan contribuir significativamente a lograr el control de la enfermedad.

Spacers, such as FORMA (Edwards Lifescience) or Mitraspacer, are used to treat mitral regurgitation or tricuspid regurgitations. However, they require external therapeutic liquid filler injection into the spacer device. This should be leak-tight over the time of implantation, which is a major limitation in device design. Here, we propose a self-expandable spacer with a nitinol inner mesh and expanded poly (tetrafluoroethylene) (ePTFE) coating that also functions as a spacer. We designed nitinol 3D mesh templates, coated with a commercially available low and high durometer ePTFE membrane. Finally, we implanted the spacer into a swine pulmonary artery and right atrium (superior vena cava) as an intervention technique. Twenty-four swine were used, except in two cases suspected of procedural infection. The results were analyzed in the remaining 22 cases and all devices were easily delivered and had good function in self-expansion and implantation. After eight weeks, all individuals were examined for gross and pathological analysis to determine the biological safety of the device. There was no evidence of damage or other abnormalities and increased postoperative endothelialization outside of ePTFE coatings. In conclusion, this study suggests using a self-expandable spacer to complement the medical limitations of the existing filling-type spacer devices.

X-ray computed tomography (CT) has been widely used in clinical practice, and contrast agents such as Iohexol are often used to enhance the contrast of CT imaging between normal and diseased tissue. However, such contrast agents can have some toxicity. Thus, new CT contrast agents are urgently needed. Owing to the high atomic number (Z = 83), low cost, good biological safety, and great X-ray attenuation property (5.74 cm2 kg−1 at 100 keV), bismuth has gained great interest from researchers in the field of nano-sized CT contrast agents. Here, we synthesized BiF3: Ln@PVP nanoparticles (NPs) with an average particle size of about 380 nm. After coating them with polyvinylpyrrolidone (PVP), the BiF3: Ln@PVP NPs possessed good stability and great biocompatibility. Meanwhile, compared with the clinical contrast agent Iohexol, BiF3: Ln@PVP NPs showed superior in vitro CT imaging contrast. Subsequently, after in situ injection with BiF3: Ln@PVP NPs, the CT value of the tumor site after the injection was significantly higher than that before the injection (the CT value of the pre-injection and post-injection was 48.9 HU and 194.58 HU, respectively). The morphology of the gastrointestinal (GI) tract can be clearly observed over time after oral administration of BiF3: Ln@PVP NPs. Finally, the BiF3: Ln@PVP NPs were completely discharged from the GI tract of mice within 48 h of oral administration with no obvious damage to the GI tract. In summary, our easily synthesized BiF3: Ln@PVP NPs can be used as a potential clinical contrast agent and may have broad application prospects in CT imaging.

Results from monitoring biological safety in veterinary microbiological laboratories of various levels of protection are under consideration. An algorithm to monitor compliance with biological safety requirements for working conditions, engineering and technical support and protection of the laboratory employee health is adapted. Violations of biological safety requirements identified during the monitoring of veterinary laboratories of various levels of protection, where employees work with microorganisms of Groups II–IV pathogenicity (danger), are studied. Measures to improve the biological safety status are available. Keywords: veterinary laboratory, monitoring, analysis, biological safety

As an injectable anticancer drug delivery system, the biological safety of nanocarriers is the most important prerequisite for their clinical application. The objective of our study was to synthesize special ultrasound-responsive highly biocompatible chitosan nanodroplets (BCNDs), observe their spatiotemporally control the delivery of doxorubicin (DOX) in vivo. The experimental results showed that the BCNDs were successfully prepared with high biosafety in vivo and great ultrasound imaging ability. DOX-BCNDs promoted the anticancer effects of DOX in vivo and inhibited the development of tumors. They also reduced the side effects to the heart and kidneys. In conclusion, BCNDs are a new type of smart nanocarrier with high biocompatibility and efficacy have great potential to be used in the clinic.

Хорошо известно, что свиноводство является одной из самых рентабельных отраслей животноводства и способна в короткие сроки увеличить производство мяса при низких затратах кормов на производство единицы продукции. Именно поэтому создаются и функционируют промышленные комплексы и мелкие товарные хозяйства по выращиванию свиней. Однако наличие тканевых гельминтозов в организме живых животных и свинине существенно влияет на эффективность откорма, качество мяса и биологическую безопасность продукции. Примерно от 2 до 5% туш свиней регистрируются, как пораженные тканевыми паразитами. В Российской Федерации содержится около 25 млн. свиней, потому можно предположить, что свыше 1 млн. свиней являются больными, т.е они неэффективно откармливаются и являются источником возбудителей, опасных для здоровья человека. Вместе с тем существуют методы прижизненной диагностики паразитозов свиней и их применение могло бы существенно повысить экономическую эффективность свиноводческой отрасли улучшить эпидемическую ситуацию по гельминтозам во всех регионах страны. Целью исследования являлось разработка тест-системы на основе ELISA и оценка ее эффективности на убойных животных в некоторых регионах Центрального Федерального Округа. Параметры тест системы отрабатывали на 96 луночных планшетах, в качестве антигена использовали полные экстракты водно-солевых растворов паразитов – E.granulosus, T.spiralis, C.cellulosae, Sarcocystis spp. Сыворотки крови доставлялись с мясокомбинатов на которых производился убой свиней и сопровождались протоколом ветеринарно-санитарной экспертизы. Из 550 проверенных сывороток крови 43 имели антитела т.е. дали положительный ответ в мультиантигенном тесте. По протоколу экспертизы были зарегистрированы 25 туш, пораженных тканевыми паразитами.

Background Electroacupuncture (EA) is often used in clinical settings due to its analgesic effect, but its safety has not been verified due to the lack of clear criteria. This study examined the critical range of the corrosion of stainless steel types STS304 and STS316, which have been used clinically, and the relationship between needle corrosion and cell necrosis. Method The critical point of corrosion for STS304 and STS316 was identified by varying the time, frequency, and stimulation intensity. In a tissue necrosis experiment, EA stimulation was applied to rats using STS316 needles with different thicknesses at maximum intensity for 60 min, and the presence of corrosion and tissue necrosis was determined. A cytotoxicity experiment was also conducted and assessed the needles and tissue necrosis. Results The results showed that STS316 was more stable than STS304 and that only coated needles corroded. Furthermore, tissue necrosis was observed regardless of corrosion, and slight cell necrosis was associated with needles with corrosion. Conclusions This study demonstrated that non-coated STS316 was the most stable for EA stimulation and that corrosion byproducts and cell necrosis were not directly related.

The original definition of Biological started out as aset of preventive measures designed to reduce the risk of transmission of infectious diseases in crops and livestock, quarantined pests, invasive alien species, and living modified organisms [1]. To keep illness out of a facility, livestock producers are encouraged to maintain Biological standards in their operations. Biological (biological safety and well-being) is the set of management practices that prevent infectious diseases from being carried into a herd. The goal of a Biological program is to stop the transmission of disease-causing agents by preventing, minimizing or controlling cross-contamination of body fluids between and among animals, between animals and feed, or between animals and equipment that may directly or indirectly contact animals. Effective Biological management practices prevent the spread of disease by minimizing movement of biological organisms and their vectors onto and within the premises. These management practices are based on the principle that it is easier to prevent disease than it is to treat or react to a problem caused by disease. The outbreak of Foot and Mouth Disease in the United Kingdom in early 2001 caused many producers to reevaluate their own programs of Biological. The advantages of adopting a Biological program are numerous. An effective program can improve the cost-efficiency of the farm, improve the reputation of the producer, and allow the producer to better maintain the health status of the herd.

Division of infections into the constituting individual and population danger taking into account the territorial and seasonal risks of distribution at their drift is proved in article and the differentiation of the last on threat of emergence of emergency situation of biological character at epidemic manifestations that will allow to optimize algorithms of reaction and the organization of antiepidemic actions. The new relative criterion «orient number of infections from one source» reflecting potential ability of the activator to be transferred in human population is offered. Assessment of risk of distribution and threat of emergence of emergency situation at the drift on the territory of the Russian Federation of some diseases constituting population danger is carried out: plagues (in pulmonary and bubonic forms), cholera, hemorrhagic fevers with the leading contact mechanism of transfer of the activator, especially dangerous the ortopoxvirus and the coronavirus of infections, the Crimean hemorrhagic fever, poliomyelitis.

Herbal-based dietary supplements have become increasingly popular. The extract from milk thistle (Silybum marianum), is often used for the treatment of liver diseases. However, serious concerns exist regarding the efficacy, composition, as well as the safety of these over-the-counter preparations. Therefore, the aim of the present study was to investigate the composition as well as chemical and biological safety of 26 milk thistle-based dietary supplements purchased from both the U.S. and Czech markets between 2016 and 2017. The study was focused on a determination of the composition of active ingredients, as well as analyses of possible contaminants including: mycotoxins, plant alkaloids, and pesticide residues, as well as the microbial purity. High-throughput analyses were performed using advanced U-HPLC-HRMS techniques. Large differences in the silymarin content were observed among individual milk thistle preparations, often in contrast with the information provided by the manufacturers. In addition, substantial inter-batch differences in silymarin content were also demonstrated. In all milk thistle preparations tested, large numbers and high concentrations of mycotoxins and several pesticides, as well as the substantial presence of microbiological contamination were detected, pointing to serious safety issues. In conclusion, our results strongly indicate the need for strict controls of the composition, chemical contaminants, as well as the microbiological purity of commercial milk thistle extracts used for the treatment of liver diseases. Poor definition of these preparations together with contamination by biologically active substances may not only account for the inconsistency of clinical observations, but also be responsible for possible herbal-based dietary supplements-induced liver injury.

BACKGROUND: Biological safety of ultrasound is a complex and nuanced subject that is poorly understood by ultrasound users. Little is known about the acoustic output and thermal index levels during the routine use of modern ultrasound machines in prenatal scanning. METHODOLOGY: This study was a retrospective review of thermal index (TI) values encountered during 300 prenatal ultrasound examinations (100 in each trimester) performed on any one of 13 Philips Epiq 7 or Epiq 5 systems, representing approximately 106.5 h of real‐time scanning. The TI levels were compared to three international guidelines on the biological safety of ultrasound. RESULTS: The routine use of current Philips systems was associated with low TI levels. Of the 300 examinations reviewed, virtually all were compliant with the BMUS and Nelson safety guideline. Whether the examination was compliant with the WFUMB guideline is open to interpretation. The highest level of TI encountered was 1.1. In no instance did the TI level incur into the ‘not recommended’ range or into a range where specific user action was required to reduce the TI within 1 min. The most frequent action associated with TI > 0.7 was the use of M‐mode to document the fetal heart rate. In the four instances where TI peaked at 1.1, 3 were associated with the use of M‐mode and one with B‐mode. Spectral Doppler was not implicated in high TI levels. These results are surprising and open up a range of opportunities for future study.

The level of biogenic significance of chromium in animals is determined by a generous amount of vital pro­cesses it participates in. The trivalent form of chromium (III) has biological significance. Standard chromium level in diets for farm animals currently vary from 0.2 to 4.2 mg per 1 kg of dry matter, and chromium is represented mainly by compounds in the form of salts and chelates. A distinctive feature of microelement nanoparticles is the ability to activate physiological and biochemical processes when used in very small doses. The paper dwells on study of different doses and forms of chromium in diets for young pigs: in the form of sulphate (4.16 mg/kg of dry matter of feed) and in the form of nanoparticles (0.5, 0.083, 0.05, 0.02 mg/kg of dry matter of feed). Research showed that enrichment of diets with chromium in the form of nanoparticles © Голушко В. М., Кравченко А. В., Линкевич С. А., 2019 in the amount of 0.05 mg per 1 kg of dry matter was most effective. It was determined that use of chromium nanoparticles for feeding pigs by adding them to water, the feed was kneaded up to obtain loose porridge, was more efficient than spraying on wheat bran. The positive effect of feeding animals with chromium nanoparticles on meat traits of carcass was revealed. A high assessment of biological safety of slaughter products of experimental pigs using test organisms of Tetrahymena piri­formis and laboratory mice was determined. The data obtained in the course of research allow to recommend using chromium nanoparticles in the amount of 0.05 mg per 1 kg of dry matter of feed for young pigs during rearing and fattening periods in order to increase the average daily weight gain, reduce feed cost for its production, improve meat products quality and pro­duction economic efficiency.

Many individuals worldwide are at risk of hearing loss due to unsafe acoustical exposure and chronic listening experience using personal audio devices. Assistive hearing devices(AHD), such as hearing-aids(HAs) and cochlear-implants(CIs) are a common choice for the restoration and rehabilitation of the auditory function. Audio sound processors in CIs and HAs operate within limits, prescribed by audiologists, not only for acceptable sound perception but also for safety reasons. Signal processing(SP) engineers follow best design practices to ensure reliable performance and incorporate necessary safety checks within the design of SP strategies to ensure safety limits are never exceeded irrespective of acoustic environments. This paper proposes a comprehensive testing and evaluation paradigm to investigate the behavior of audio devices that addresses the safety concerns in diverse acoustic conditions. This is achieved by characterizing the performance of devices with large amounts of acoustic inputs and monitoring the output behavior. The CCi-MOBILE Research-Interface(RI) (used for CI/HA research) is used in this study as the testing paradigm. Factors such as pulse-width(PW), inter-phase gap(IPG) and a number of other parameters are estimated to evaluate the impact of AHDs on hearing comfort, subjective sound quality and characterize audio devices in terms of listening perception and biological safety.

ViroStatics is a privately held small pharmaceutical company dedicated to discovering and developing novel compounds for a multifaceted treatment of cancers and viral diseases and focuses on novel, selective, host cell kinase targeted inhibitors in its state-of-the-art Biological Safety Level 3 Laboratory. The company has strong expertise in testing drugs, natural substances, disinfectants, or any material for activity against SARS-CoV-2, either in liquid suspension or aerosol.

Hyaluronic acid (HA) is a glycosaminoglycan that was first isolated and identified from the vitreous body of a bull’s eye. HA is ubiquitous in the soft connective tissues of animals and therefore has high tissue compatibility for use in medication. Because of HA’s biological safety and water retention properties, it has many ophthalmology-related applications, such as in intravitreal injection, dry eye treatment, and contact lenses. Due to its broad range of applications, the identification and quantification of HA is a critical topic. This review article discusses current methods for analyzing HA. Contact lenses have become a widely used medical device, with HA commonly used as an additive to their production material, surface coating, and multipurpose solution. HA molecules on contact lenses retain moisture and increase the wearer’s comfort. HA absorbed by contact lenses can also gradually release to the anterior segment of the eyes to treat dry eye. This review discusses applications of HA in ophthalmology.

Fused filament fabrication 3D printing with polylactic acid filaments is the most widely used method to generate biomodels at hospitals throughout the world. The main limitation of this manufacturing system is related to the biomodels’ temperature sensitivity, which all but prevents them to be sterilized using conventional methods. The purpose of this study is to define an autoclave temperature-resistant FFF-PLA 3D printing protocol to print 3D fractures biomodels during preoperative planning. Six different printing protocols were established, each with a different infill percentage. Ten distal radius biomodels were printed with each protocol and each biomodel was subject to 3D scanning. The biomodels were subsequently autoclave-sterilized at 134 °C and subjected to a new scanning process, which was followed by a calculation of changes in area, volume and deformity using the Hausdorff–Besicovitch method. Finally, 192 polylactic acid models were produced using the printing protocol offering the greatest resistance and were contaminated with 31 common nosocomial pathogens to evaluate the effectiveness of sterilizing the model printed using the said protocol. Sterilization resulted in a mean deformation of the biomodel of 0.14 mm, a maximum deformity of 0.75 mm, and a 1% area and a 3.6% volume reduction. Sterilization of the pieces printed using the analyzed protocol was 100% effective. The analyzed 3D printing protocol may be applied with any FFF-PLA 3D printer, it is safe and does not significantly alter the morphology of biomodels. These results indicate that 3D printing is associated with significant advantages for health centers as it increases their autonomy, allowing them to easily produce 3D biomodels that can be used for the treatment of fractures.

This paper describes a magnetic nanotechnology that locally enables hyperthermia treatment of hollow organ tumors by using polymer hybrid stents with incorporated magnetic nanoparticles (MNP). The hybrid stents are implanted and activated in an alternating magnetic field to generate therapeutically effective heat, thereby destroying the tumor. Here, we demonstrate the feasibility of nanomagnetic actuation of three prototype hybrid stents for hyperthermia treatment of hollow organ tumors. The results show that the heating efficiency of stent filaments increases with frequency from approximately 60 W/gFe (95 kHz) to approximately 250 W/gFe (270 kHz). The same trend is observed for the variation of magnetic field amplitude, however, heating efficiency saturates at approximately 30 kA/m. MNP immobilization strongly influences heating efficiency showing a relative difference in heating output of up to 60% compared to that of freely dispersed MNP. The stents showed uniformly distributed heat on their surface reaching therapeutically effective temperatures of 43 °C and were tested in an explanted pig bile duct for their biological safety. Nanomagnetic actuation of hybrid stents opens new possibilities in cancer treatment of hollow organ tumors.

Danofloxacin is a veterinary fluoroquinolone used to treat respiratory and gastrointestinal diseases of birds, pigs and cattle. The literature reviewed shows some analytical methods to quantify this fluoroquinolone, but microbiological and biological safety studies are limited. The analytical methods were validated by the Official Codes. The LC-DAD method was developed and validated using an RP-18 column, mobile phase containing a mixture of 0.3% triethylamine (pH 3.0) and acetonitrile (85:15, v/v). The microbiological assay was performed by agar diffusion method (3 x 3) and Staphylococcus epidermidis as a microorganism test. Forced degradation studies were performed in both methods. The minimum inhibitory concentration (MIC) was performed by test microdilution and toxicity studies were evaluated using in silico study, cell proliferation, cell viability test, micronuclei and comet assay. LC and a microbiological assay proved linear, accurate, precise, and robust to quantify danofloxacin, but only the LC method showed selectivity to quantify the drug in the presence of its degradation products. These results demonstrate that the LC method is suitable for stability studies of danofloxacin, but a microbiological assay cannot be used to quantify the drug due to the biological activity of the photoproducts. Ex-vivo cytotoxicity and theoretical and experimental genotoxicity were also observed.

Standard dental procedures, when using a water coolant and rotary instruments, generate aerosols with a significantly higher number of various dangerous pathogens (viruses, bacteria, and fungi). Reducing the amount of aerosols to a minimum is mandatory, especially during the new coronavirus disease, COVID-19. The study aimed to evaluate the amount of aerosol generated during standard dental procedures such as caries removal (using dental bur on a high and low-speed handpiece and Er:YAG laser), ultrasonic scaling, and tooth polishing (using silicon rubber on low-speed handpiece) combined with various suction systems. The airborne aerosols containing particles in a range of 0.3&ndash, 10.0 &mu, m were measured using the PC200 laser particle counter (Trotec GmbH, Schwerin, Germany) at three following sites, manikin, operator, and assistant mouth, respectively. The following suction systems were used to remove aerosols: saliva ejector, high volume evacuator, saliva ejector with extraoral vacuum, high volume evacuator with extraoral vacuum, Zirc&reg, evacuator (Mr.Thirsty One-Step&reg, ), and two customized high volume evacuators (white and black). The study results showed that caries removal with a high-speed handpiece and saliva ejector generates the highest amount of spray particles at each measured site. The aerosol measurement at the manikin mouth showed the highest particle amount during caries removal with the low and high-speed handpiece. The results for the new high volume evacuator (black) and the Zirc&reg, evacuator showed the lowest increase in aerosol level during caries removal with a high-speed handpiece. The Er:YAG laser used for caries removal produced the lowest aerosol amount at the manikin mouth level compared to conventional dental handpieces. Furthermore, ultrasonic scaling caused a minimal aerosol rise in terms of the caries removal with bur. The Er:YAG laser and the new wider high volume evacuators improved significantly suction efficiency during dental treatment. The use of new suction systems and the Er:YAG laser allows for the improvement of biological safety in the dental office, which is especially crucial during the COVID-19 pandemic.

The analysis of scientific publication, dedicated to human pathogenic orthopoxviruses over the past 40 years is generalizated. The essential activation of focies of monkeypox in Central Africa, cowpox in Europe, buffalopox in South-East Asia, camelpox in South-West and Central Asia and vaccinia-like viruses in Southern America is marked on the background of the apperance of three novel representatives of orthopoxviruses in North America (agents of volepox, raccoonpox and skunpox) and two representatives of African orthopoxviruses (agents of Uasingishu, named self-titled province of Kenya and taterpox). It is concluded, that this is facilitated by almost complete absence of anti-smallpox immunity after the elimination of smallpox and stopping immunization in the world on the background of active human intervention in the nature. Expert do not exclude, that as a result of a mutation of one of orthopoxviruses of animal, similar to smallpox virus agent will exist. Whereat the world will face a threat, much more serious that swine flu or avian flu. It is concluded that modern scientific and methodological approachesto study of orthopoxvirus infections evolution allow to predict threats, related on biological safety of Russian Federation.

The formation of mucosal ulcers is an end result of epithelial damage, and it occurs due to some specific causes, such as trauma, aphthous stomatitis, lichen planus and lichenoid reactions, cytotoxic effects of chemotherapy and radiation, and drug-induced hypersensitivity reactions and malignant settings. This study focused on films for target drug delivery with respect to the treatment of the diseases of the oral mucosa, specifically mucositis. The results of a single clinical study as a pre-experimental design was performed and followed up to the outcome until 30 days. The polymeric film was prepared in a mucoadhesive bilayer structure: the basal layer with lidocaine HCl had a faster release than the apical layer with benzydamine HCl and N-acetyl-cysteine. Fourier Transform Infrared Spectroscopy (FTIR), Differential Scanning Calorimetry (DSC), and SEM characterized the physical–chemical and morphological properties. The cell viability and cytotoxicity were evaluated in cell line MCF7. The transport mechanism of the solvent (swelling) and the drugs in the basal or apical layer (drug release) was explained with mathematical models. To evaluate the effect of movement inside the mouth, the folding endurance was determined. The mucoadhesive bilayer film is biologically safe and stimulates cellular proliferation. A single study in vivo demonstrated the therapeutic effect of the mucoadhesive bilayer film in buccal mucositis., The authors express their gratitude to financial support from CAPES/PROSUP-Brazil; Sao Paulo Research Foundation 2011/21219-5; Sao Paulo Research Foundation. 2018/13432-0; Sao Paulo Research Foundation. 2018/11350-6; National Council for Scientific and Technological Development (CNPq) 425271/2016-1., info:eu-repo/semantics/publishedVersion

This article presents data from an analysis of the epidemiological and epizootological situation in the Republic of Tajikistan, for various infectious diseases circulating both in the territory of the republic and in neighboring countries. The factors affecting the occurrence of additional risks of the introduction of pathogens of highly infectious diseases, both for humans and animals, are identified. The risks of the spread of highly infectious diseases during laboratory research are determined. The role of food additives used in animal feed and their impact on the health of animals and humans was studied; the risk of biological safety when using medicine drugs was assessed, and ways to counter increasing biological hazards were identified, recommendations for reducing the risks of biological safety in Tajikistan were given.

The effect of unmodified chitosan nanoparticles with a size of ~100 nm and a weakly positive charge on blood coagulation, metabolic activity of cultured cardiomyocytes, general toxicity, biodistribution, and reactive changes in rat organs in response to their single intravenous administration at doses of 1, 2, and 4 mg/kg was studied. Chitosan nanoparticles (CNPs) have a small cytotoxic effect and have a weak antiplatelet and anticoagulant effect. Intravenous administration of CNPs does not cause significant hemodynamic changes, and 30 min after the CNPs administration, they mainly accumulate in the liver and lungs, without causing hemolysis and leukocytosis. The toxicity of chitosan nanoparticles was manifested in a dose-dependent short-term delay in weight gain with subsequent recovery, while in the 2-week observation period no signs of pain and distress were observed in rats. Granulomas found in the lungs and liver indicate slow biodegradation of chitosan nanoparticles. In general, the obtained results indicate a good tolerance of intravenous administration of an unmodified chitosan suspension in the studied dose range.

Long-term stability and biological safety are crucial for translation of 3D-bioprinting technology into clinical applications. Here, we addressed the long-term safety and stability issues associated with 3D-bioprinted constructs comprising a cellulose scaffold and human cells (chondrocytes and stem cells) over a period of 10 months in nude mice. Our findings showed that increasing unconfined compression strength over time significantly improved the mechanical stability of the cell-containing constructs relative to cell-free scaffolds. Additionally, the cell-free constructs exhibited a mean compressive stress and stiffness (compressive modulus) of 0.04 +/- 0.05 MPa and 0.14 +/- 0.18 MPa, respectively, whereas these values for the cell-containing constructs were 0.11 +/- 0.08 MPa (p= .019) and 0.53 +/- 0.59 MPa (p= .012), respectively. Moreover, histomorphologic analysis revealed that cartilage formed from the cell-containing constructs harbored an abundance of proliferating chondrocytes in clusters, and after 10 months, resembled native cartilage. Furthermore, extension of the experiment over the complete lifecycle of the animal model revealed no signs of ossification, fibrosis, necrosis, or implant-related tumor development in the 3D-bioprinted constructs. These findings confirm the in vivo biological safety and mechanical stability of 3D-bioprinted cartilaginous tissues and support their potential translation into clinical applications.

Background and importance Ulcerative proctitis is associated with faecal incontinence, pain, itching, bleeding and purulent discharge, and is often managed with topical salicylates or steroids. However, treatment can be refractory in some patients. Rectal administration of tacrolimus may be effective in difficult to treat ulcerative proctitis1. Some patients find it difficult to retain rectal pharmaceutical forms, suppositories or enemas, which lead to painful administration and infradosification. Aim and objectives To develop a tacrolimus adhesive gel and its galenic validation, to improve and extend contact time of tacrolimus with rectal mucosal surfaces. Material and methods Tacrolimus 0.06% adhesive gel was compounded, in a biological safety cabinet with protection equipment for the manipulator, with tacrolimus 5 mg capsules (Prograf, Astellas Pharma), glycerin (Acofarma) and a lipophilic gel (Excipiente Acofar adhesivo oral, Acofarma). The compounded drug was packed on monodoses of 4.5 g with the aim of administering 2 mg of tacrolimus in 5 mL latex free luer lock syringes (Omnifix, B Braun). Each syringe was supplied with a rectal cannula (Jose Mestre, SA) for patient administration (1 g of gel is retained in the cannula). Tacrolimus gel was stored at room temperature, in a dry place and protected from light. Galenic characterisation was carried out, according to good manufacturing practices,2 testing for homogeneity and appearance, extensibility, pH and monodose mass extraction, weekly over 28 days. Determination of pH was made with pHmeter glp21. Results For 28 days at room temperature: tacrolimus gel kept the same appearance (granular, translucent and colourless), there were no quite different values for extensibility and pH (5.99) and monodose mass extraction (3.50 g) results differed minimally ( Conclusion and relevance This gel preparation is stable for 28 days at room temperature, maintaining its galenic characteristics and it can be useful in patients with difficult to treat ulcerative proctitis. References and/or acknowledgements 1. Jaeger SU, et al. Tacrolimus suppositories in therapy-resistant ulcerative proctitis. Inflamm Intest Dis 2018;3:116–124. doi:10.1159/000493979 2. Ministerio De Sanidad, Servicios Sociales e Igualdad. Guia de buenas practicas de preparacion de medicamentos en servicios de farmacia hospitalaria. Junio 2014. No conflict of interest.

Bioresorbable stents (BRS) are investigated and designed to revascularize occluded arteries. The iron-based bioresorbable stent is a promising device in interventional therapies, although it's corrosion and bioresorption rate remain challenging. In this work, we introduced a novel nitrided iron coronary stent (IBS) with enhanced degradation rate compared with pure iron stent. To evaluate the biosafety of this device, a sub-chronic systemic toxicity study was conducted and a stainless steel stent (Supporter™) served as a control. Here, the bioresorbable stent was first evaluated in rat abdominal aortic implantation model. When subjected to exaggerated exposure dose, no clinical signs of toxicity or mortality were observed in either, the IBS group or the control group. Histopathological examinations showed the corrosion particles of iron were encapsulated by fibrocytes and engulfed by macrophages, indicating that the degradation of iron was in the early stage. Our results demonstrated that the nitrided iron stent did not induce systemic toxicity under the experimental conditions.

Sterility is one of the key parameters of biological safety of immunobiological medicinal products. The article traces the history of the development of sterility test methods for immunobiological medicinal products from as far back as 1961 and up to the current requirements laid down in the State Pharmacopoeia of the Russian Federation, 13th edition. The article provides a detailed analysis of major approaches to the improvement of medicines quality evaluation based on this parameter, namely to the choice of: optimal growth media and methods of their evaluation, sensitive test strains, incubation conditions, the number of test samples (i.e., sample size) required for reliable demonstration of batch sterility; as well as approaches to the development of a test design that would accommodate specific aspects of production and use of immunobiological products. The article dwells upon the longstanding use of the sterility testing scheme developed in the national agency for control of immunobiological products — L.A. Tarasevich State Institute for Standardization and Control of Medicinal Immunobiological Products. The article analyses the current status of harmonisation of requirements for sterility testing of immunobiological products and other groups of medicines with those of the leading world pharmacopoeias, and prospects of using these requirements in the Eurasian Economic Union.

Microorganism resistance to medicinal products and disinfectants reduces the efficacy of prevention and treatment of human infectious diseases, increases the severity and duration of such diseases as well as the mortality rates, and is therefore regarded as a major global health issue. With a view to implementing the Russian National Security Strategy and the Principles of the National Policy in the Sphere of Chemical and Biological Safety of the Russian Federation up to 2025 and beyond, and with due regard to the Concept of the Long-Term Social and Economic Development of the Russian Federation until 2030 — the Government of the Russian Federation issued a resolution (in 2017) that approved the Strategy for Prevention and Combating the Resistance of Microorganisms and Plant Pests to Medicinal Products, Chemical and Biological Agents up to 2030 and beyond (hereinafter — Strategy). The Strategy is a federal document that defines the aim and objectives of controlling the biological threat coming from the spread of microorganism and plant pest resistance to medicines, chemical and biological agents. The article analyses the aim and objectives of the Strategy, dwells upon specific features of the document, summarises the main stages and expected results of measures outlined in the document, and describes some aspects of its implementation.