Search Results (11)

The preparation of antiblastic and parental drugs should be carried out by ensuring an aseptic condition and minimizing exposure to toxic drugs. The aim of this study is to evaluate the quality and qualification of these features of an automated dispensing system, called PHARMODUCT^®, built by Bioduct s.r.l, part of the Dedalus group. Three antiblastic drugs (cyclophosphamide (powder), 5-fluorouracil and paclitaxel) were used and three preparation and dispensing sessions were carried out for each drug, using PHARMODUCT^®. Some of the infusion bags, prepared for each type of antiblastic, were sent to an external laboratory to perform the quantitative dosage analysis and compare it with the quantitative concentration, set on the automatic dispensing equipment, which was found to meet the acceptance criteria of 10%. In addition, to assess the safety of the process for operator exposure to toxic drugs, the differential pressure value between the main chamber and the clean room was measured to be ˂0 Pa, with an hourly leakage rate of ˂2.5 × 10⁻³ h⁻¹. Media fill tests showed no microbiological growth after a 14-day incubation period. The PHARMODUCT^® system meets the requirements of safety and repeatability for the dispensation of parenteral antiblastic drugs. Full article

Pear black spot disease, caused by Alternaria alternata, is a devastating disease in pears and leads to enormous economic losses worldwide. In this investigation, we isolated a Streptomyces odonnellii SZF-179 from the rhizosphere soil of pear plants in China. Indoor confrontation experiments results showed that both SZF-179 and its aseptic filtrate had excellent inhibitory effects against A. alternata. Afterwards, the main antifungal compound of SZF-179 was identified as polyene, with thermal and pH stability in the environment. A microscopic examination of A. alternata mycelium showed severe morphological abnormalities caused by SZF-179. Protective studies showed that SZF-179 fermentation broth could significantly reduce the diameter of the necrotic lesions on pear leaves by 42.25%. Furthermore, the potential of fermentation broth as a foliar treatment to control black leaf spot was also evaluated. Disease indexes of ‘Hosui’ and ‘Wonwhang’ pear plants treated with SZF-179 fermentation broth were lower than that of control plants. Overall, SZF-179 is expected to be developed into a safe and broad-spectrum biocontrol agent. No studies to date have evaluated the utility of S. odonnellii for the control of pear black spot disease; our study fills this research gap. Collectively, our findings provide new insights that will aid the control of pear black spot disease, as well as future studies of S. odonnellii strains. Full article

Patulin (PAT) is a toxic secondary metabolite produced by Aspergillus sp. and Penicillium sp., which acts as a contaminant of most apples and their products. The internationally recognized HACCP system is selected as the theoretical basis to more effectively reduce the PAT in apple juice concentrate (AJC). Through field investigation of apple juice concentrate (AJC) production enterprises, we collected 117 samples from 13 steps of AJC production, including whole apple, apple pulp, and apple juice. PAT contents were analyzed via high-performance liquid chromatography (HPLC) and compared with samples from the different production processes. The result demonstrated that the PAT content was significantly (p < 0.05) influenced by five processes, receipt of raw apples, sorting of raw apples, adsorption step, pasteurization, and aseptic filling. These processes were determined as the CCPs. Monitoring systems for maintaining CCPs within acceptable limits were established, and corrective actions were proposed in case a CCP was surpassed. Based on the above-identified CCPs, critical limits, and control methods (corrective actions), a HACCP plan related to the production process of AJC was established. This study provided important guidance for juice manufacturers wishing to effectively control the PAT content in their products. Full article

Cemented implant fixation in total joint arthroplasty has been proven to be safe and reliable with good long-term results. However, aseptic loosening is one of the main reasons for revision, potentially caused by poor cementation with low penetration depth in the cancellous bone. Aim of this prospective laboratory study was, to compare impact pressure and cleaning effects of pulsatile saline lavage to novel carbon dioxide lavage in a standardized carbon foam setup, to determine whether or not additional use of carbon dioxide lavage has any impact on cleaning volume or cleaning depth in cancellous bone. Carbon specimens simulating human cancellous bone were filled with industrial grease and then underwent a standardized cleaning procedure. Specimens underwent computed tomography pre- and post-cleaning. Regarding the impact pressure, isolated carbon dioxide lavage showed significant lower pressure compared to pulsatile saline lavage. Even though the combination of carbon dioxide lavage and pulsatile saline lavage had a positive cleaning effect compared to the isolated use of pulsatile saline lavage or carbon dioxide lavage, this was not significant in terms of cleaning volume or cleaning depth. Full article

The resistance formation of spores in general and of Bacillus atrophaeus in particular has long been the focus of science in the bio-defense, pharmaceutical and food industries. In the food industry, it is used as a biological indicator (BI) for the evaluation of the inactivation effects of hydrogen peroxide in processing and end packaging lines’ sterilization. Defined BI resistances are critical to avoid false positive and negative tests, which are salient problems due to the variable resistance of currently available commercial BIs. Although spores for use as BIs have been produced for years, little is known about the influence of sporulation conditions on the resistance as a potential source of random variability. This study therefore examines the dependence of spore resistance on the temperature, pH and partial oxygen saturation during submerged production in a bioreactor. For this purpose, spores were produced under different sporulation conditions and their resistance, defined by the D-value, was determined using a count reduction test in tempered 35% liquid hydrogen peroxide. The statistical analysis of the test results shows a quadratic dependence of the resistance on the pH, with the highest D-values at neutral pH. The sporulation temperature has a linear influence on the resistance. The higher the temperature, the higher the D-value. However, these factors interact with each other, which means that the temperature only influences the resistance when the pH is within a certain range. The oxygen partial pressure during sporulation has no significant influence. Based on the data obtained, a model could be developed enabling the resistance of BIs to be calculated, predicted and standardized depending on the sporulation conditions. BI manufacturers could thus produce BIs with defined resistances for the validation of sterilization effects in aseptic packaging/filling lines for the reliable manufacture of shelf-stable and safe food products. Full article

One of the most important problems of total hip replacement is aseptic loosening of the femoral component, which is related to the changes of the stress distribution pattern after implantation of the prosthesis. Stress shielding of the femur is recognized as a primary factor in aseptic loosening of hip replacements. Utilizing different materials is one of the ordinary solutions for that problem, but using functionally graded materials (FGMs) could be better than the conventional solutions. This research work aims at investigating different porous FGM implants and a real femoral bone by a 3D finite element method. The results show that a neutral functionally graded prosthesis cannot extraordinarily make changes in the stress pattern of bone and prosthesis, but an increasing functionally graded prosthesis leads a lower level of stress in the prosthesis, and a decreasing functionally graded prosthesis can properly reduce the stress shielding among these three architectures. Due to the absence of similar results in the specialized literature, this paper is likely to fill a gap in the state-of-the-art bio-implants, and provide pertinent results that are instrumental in the design of porous femoral prostheses under normal walking loading conditions. Full article

Objective: The objective of the study was to examine the knowledge of Polish physicians and medical students about the role of hand hygiene (HH) in healthcare-associated infection (HAI) prevention. Study design: A survey was conducted using an author-prepared questionnaire, which was filled out on the first day of hospital work (or internship) by newly admitted physicians who had worked in other hospitals and students of different medical schools in Poland. Methods: 100 respondents participated in the study: 28 students, 18 medical interns and 54 physicians. Results: As many as 3/4 of physicians and students did not use the HH techniques correctly. The respondents declared that they perform HH in the following situations: 74.4% of respondents before an aseptic task; 60.8% before patient contact; 57.0% after patient contact; 11.5% after body fluid exposure risk, and only two respondents (1.1%) after contact with patient surroundings. 64% of respondents declared that their supervisor checked their knowledge of the HH technique when they were touching patients, but their supervisors checked the five instances for HH only in the case of 27 respondents (27%). Students experienced any control of HH in the workplace less often. Interns and physicians mentioned that the most important preventive action in HAI is HH, but for students it is the use of gloves. Conclusions: The level of knowledge and skills of physicians and students in the field of HH is insufficient. Deficiencies in skills and knowledge of HH were identified as early as at the level of the first internship. Full article

Sterilization of packages prior to product filling is a key step in aseptic filling machines. Chemical sterilization is one of the main conventional techniques in many packaging industries. To monitor the effect of sterilization on test microorganisms (Bacillus atrophaeus spores), an impedimetric sensor approach was developed based on a planar interdigitated electrode (IDE) design. In this work, sensor measurements were conducted to prove sensor functionality at different hydrogen peroxide concentrations. Full article

To mimic in vivo vibration of vocal fold cells, we studied the controllability and range of frequency, acceleration, duration, and shear stress in a new bioreactor attachment. The custom multiwell disc appliance fits into a commercially built rheometer, together termed a torsional rheometer bioreactor (TRB). Previous attachments to the TRB were capable of 50–100 Hz vibrations at relatively high strains but were limited to single-sample experiments. The TRB-multiwell disc system accommodates 20 samples in partially fluid-filled wells in an aseptic environment delivering three different acceleration conditions to different samples simultaneously. Frequency and amplitude used to calculate acceleration along with duration and shear stress were controllable and quantifiable using a combination of built-in rheometer sensors, manufacturer software, and smooth particle hydrodynamics (SPH) simulations. Computed shear stresses at the well bottom using SPH in two and three dimensions were verified with analytical approximations. Results demonstrate capabilities of the TRB-multiwell disc system that, when combined with computational modeling, provide quantifiable vibration parameters covering frequencies 0.01–250 Hz, accelerations of 0.02–300 m/s², and shear stresses of 0.01–1.4 Pa. It is well-suited for studying cell function underlying vocal fold lamina propria homeostasis, inflammation, and wound healing under differential vibration conditions. Full article

A completely extruded talus without any remaining soft tissue attachments is extremely rare. The present report describes treatment of a 45-year-old man who sustained a completely extruded talus injury following a rockclimbing fall. Upon admission, the extruded talus was deep-frozen in our bone bank. The open ankle joint underwent massive wound debridement and irrigation for 3 days. Four days later we performed a primary subtalar fusion between the extruded talus and the calcaneus, anticipating revascularization from the calcaneus. However, aseptic loosening and osteolysis developed around the screw and talus. At 12 months post-trauma we performed a tibiocalcaneal ankle fusion with a femoral head allograft to fill the talar defect. Follow-up at 24 months post-trauma showed the patient had midfoot motion, tibio-talar-calcaneal fusion, and was able partake in 4-hour physical activity twice per week. Full article