With the recent advances in computer-aided technologies and their breach into the medical field, there can be seen more and more successful outcomes, especially in the files of reconstructive prosthetic surgery. With the application of advanced tools for reconstruction of complex shape such as human anatomy, it allowed accurate and fast design of complex implants as a substitution for deformed or damaged regions in the field of maxillofacial surgery. Design, in compliance with application of additive manufacturing (AM) technologies, is starting to gain more recognition as a tool for fast and accurate delivery of patient-specific 3D implants. This paper present a case study where such 3D technologies are used to design and fabricate a patient-specific mandibular implant. Tools for design of complex anatomical surfaces, such as mandible are presented and demonstrated in this paper. As the verification stage, AM technologies are used for visual inspection and surgical procedure planning of the designed 3D model of the mandibular implant.

• MeSH
• 3D tisk MeSH
• design s pomocí počítače * MeSH
• implantace protézy metody   přístrojové vybavení   MeSH
• lidé MeSH
• mandibula - implantace protéz * MeSH
• mandibula - protézy * MeSH
• mandibula MeSH
• nemoci mandibuly terapie   MeSH
• zobrazování trojrozměrné MeSH
• Check Tag
• lidé MeSH

Additive Manufacturing (AM) is a name of a group of technologies that build 3D objects by adding layer-upon-layer of material. There are many technologies, including Rapid Prototyping (RP), Direct Digital Manufacturing (DDM), layered manufacturing and additive fabrication. Many types of materials can be used for AM technology. Biodegradable polymers such as polylactic acid (PLA) and polyhydroxybutyrate (PHB), are currently the subject of intensive research in the field of additive manufacturing and regenerative medicine. A number of biodegradable and bioresorbable materials, as well as scaffold designs, have been experimentally and clinically studied in many research facilities around the world. For effective using of bioprinting technologies in tissue and biomedical engineering, the knowledge of material and technological parameters in the process of printing is necessary. In this study the 3D printer Bioplotter EnvisionTEC (the printer with ability to print different materials from hydrogel to plastic materials) was used. Scaffolds for the purpose of the experiment were prepared via extrusion-based bioprinting. Experimental part of this study was focused on defining the influence of printing parameters and technological pre-processing of the material on quality and mechanical and geometrical properties of printed parts. Testing of printed samples showed high influence of pre-processing of material, mainly drying process, on mechanical and geometric quality of samples. Drying of material before printing process makes the material more stable and allows it to maintain defined material properties for a longer time than non-dried material. Time of heating of the material in printing cartridge has also high impact on material behaviour. Test results showed that if the time of heating of the material in the high temperature cartridge exceeds defined time limit, the material starts to degrade and is no more usable.

• MeSH
• 3D tisk * MeSH
• biokompatibilní materiály * chemie   MeSH
• biomedicínské technologie MeSH
• kyselina polyglykolová chemie   MeSH
• lidé MeSH
• polymery * MeSH
• pružnost MeSH
• testování materiálů MeSH
• tkáňové inženýrství * MeSH
• tkáňové podpůrné struktury MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• práce podpořená grantem MeSH

Like all production areas the production of dental replacements, either prosthetic or aesthetic, has recently undergone great advancement due to computer-aided design of dental parts and their computer aided manufacturing. CNC milling, which belongs to the group of subtractive production methods, is very well established in dental production. For the last several years, methods of additive manufacturing, such as Selective Laser Melting (SLM), Selective Laser Sintering (SLS) and Direct Metal Laser Sintering (DMLS), have gone mainstream. In general, both additive and subtractive methods have their technological pros and cons; therefore, the aim of this paper is to determine how accurate in terms of tolerance of production of ± 50 μm both technologies are and afterwards to determine which of the technologies is more accurate. Given that nowadays the most commonly used material in the dental area is cobaltchromium (Co-Cr) alloy, this alloy was chosen for the experiment. Thirty Co-Cr dental crowns were manufactured for analysis according to the referential CAD model, 15 by CNC milling and 15 by SLM. The crowns were subsequently scanned using a dental 3D scanner, and their inner areas were extracted and compared to the nominal CAD model. The percentage agreement of production is on the level of approximately 94% with both devices, and the average value of agreement as well as the standard deviation and range variation are better with additive production.

• MeSH
• dentální technologie MeSH
• design s pomocí počítače MeSH
• klinická studie jako téma MeSH
• lidé MeSH
• návrh zubní protézy MeSH
• zubní korunky - technika post and core MeSH
• zubní korunky * MeSH
• zubní marginální adaptace MeSH
• zubní náhrady částečné fixní * MeSH
• Check Tag
• lidé MeSH

As is the case with batch-based tableting processes, continuous tablet manufacturing can be conducted by direct compression or with a granulation step such as dry or wet granulation included in the production procedure. In this work, continuous manufacturing tests were performed with a commercial tablet formulation, while maintaining its original material composition. Challenges were encountered with the feeding performance of the API during initial tests which required designing different powder pre-blend compositions. After the pre-blend optimization phase, granules were prepared with a roller compactor. Tableting was conducted with the granules and an additional brief continuous direct compression run was completed with some ungranulated mixture. The tablets were assessed with off-line tests, applying the quality requirements demanded for the batch-manufactured product. Chemical maps were obtained by Raman mapping and elemental maps by scanning electron microscopy with energy-dispersive X-ray spectroscopy. Large variations in both tablet weights and breaking forces were observed in all tested samples, resulting in significant quality complications. It was suspected that the API tended to adhere to the process equipment, accounting for the low API content in the powder mixture and tablets. These results suggest that this API or the tablet composition was unsuitable for manufacturing in a continuous line; further testing could be continued with different materials and changes in the process.

• MeSH
• atorvastatin MeSH
• farmaceutická technologie * metody   MeSH
• prášky, zásypy, pudry chemie   MeSH
• příprava léků metody   MeSH
• tablety chemie   MeSH
• tlak MeSH
• velikost částic MeSH
• Publikační typ
• časopisecké články MeSH

Práce popisuje metodu separace plné krve filtrem z dutých vláken a výrobu deleukotizovaných erytrocytů a plazmy za použití pouhé gravitace a hodnotí parametry kvality vyrobených přípravků. Filtr z dutých vláken je integrální součástí jednorázové odběrové soupravy ErySep? (LMB GmbH, SRN) se zařazeným deleukotizačním filtrem na filtraci plné krve. Prezentovány jsou výsledky dvou validačních studií: první srovnává vybrané parametry kvality vyrobených přípravků filtrem z dutých vláken soupravou ErySep? s konvenční metodou výroby transfuzních přípravků centrifugací a separací odebraných do soupravy se zařazeným filtrem pro deleukotizaci erytrocytů (Macopharma, Francie), druhá studie byla zaměřena na kvalitativní parametry erytrocytů a plazmy vyrobených novou generací soupravy ErySep?. Výsledky potvrzují, že přípravky vyrobené odběrem a následnou separací v soupravě s filtrem z dutých vláken vykazují srovnatelné hodnoty s přípravky vyrobené standardním způsobem, výtěžnost erytrocytů je dokonce vyšší. Lze konstatovat, že testovaná souprava je vhodná pro výrobu kvalitních transfuzních přípravků, a to zejména v případech a zdravotnických zařízeních, kde není k dispozici technické výrobní zařízení, např. v polních nemocnicích nebo v zemích či místech bez potřebné moderní zdravotnické infrastruktury.

The article describes the method of whole blood separation using hollow-fibre filters and the manufacture of leukodepleted red blood cells and plasma using only the force of gravity. It also evaluates the parameters of manufactured blood product quality. The hollow-fibre filter is an integral part of the disposable ErySep? (LMB GmbH, Germany) set, which includes a leukodepletion filter for whole blood filtration. Results from two validation studies are presented. The first study compared the quality parameters of products manufactured using the disposable ErySep? set with the conventional method for manufacturing leukodepleted RBCs and plasma using the classical centrifugation method (Macopharma disposable set Leucoflex with in-line RBCs leukofilter). The second study focused on the quality parameters of blood products manufactured by the new generation of ErySep? disposable set. The results confirm that blood components manufactured using the ErySep? hollow-fibre system have comparable parameters to products manufactured using the standard method. Red cell recovery is even higher. The tested disposable set is suitable for manufacturing high-quality blood products without the additional need for any expensive machines, such as centrifuges, blood separators, etc. This set could be most beneficial for medical facilities where appropriate technical equipment is not available such as field hospitals and in places (or countries) lacking modern infrastructure.

• Klíčová slova
• filtr z dutých vláken,
• MeSH
• design vybavení MeSH
• erytrocyty MeSH
• faktor VIII MeSH
• filtrace MeSH
• gravitace MeSH
• hematokrit statistika a číselné údaje   MeSH
• hemoglobiny analýza   MeSH
• hemolýza MeSH
• konzervace krve MeSH
• krevní plazma MeSH
• krevní transfuze MeSH
• osmolární koncentrace MeSH
• počet erytrocytů statistika a číselné údaje   MeSH
• počet leukocytů statistika a číselné údaje   MeSH
• proteiny analýza   MeSH
• separace krevních složek * normy   přístrojové vybavení   statistika a číselné údaje   MeSH
• validační studie jako téma MeSH
• zdravotnické prostředky normy   MeSH

INTRODUCTION: The process of fabricating physical medical skull models requires many steps, each of which is a potential source of geometric error. The aim of this study was to demonstrate inaccuracies and differences caused by DICOM to STL conversion in additively manufactured medical skull models. MATERIAL AND METHODS: Three different institutes were requested to perform an automatic reconstruction from an identical DICOM data set of a patients undergoing tumour surgery into an STL file format using their software of preference. The acquired digitized STL data sets were assessed and compared and subsequently used to fabricate physical medical skull models. The three fabricated skull models were then scanned, and differences in the model geometries were assessed using established CAD inspection software methods. RESULTS: A large variation was noted in size and anatomical geometries of the three physical skull models fabricated from an identical (or "a single") DICOM data set. CONCLUSIONS: A medical skull model of the same individual can vary markedly depending on the DICOM to STL conversion software and the technical parameters used. Clinicians should be aware of this inaccuracy in certain applications.

• MeSH
• algoritmy MeSH
• anatomické modely * MeSH
• design s pomocí počítače statistika a číselné údaje   MeSH
• kefalometrie statistika a číselné údaje   MeSH
• lebka anatomie a histologie   MeSH
• lidé MeSH
• mandibula anatomie a histologie   MeSH
• nosní dutina anatomie a histologie   MeSH
• orbita anatomie a histologie   MeSH
• počítačová tomografie s kuželovým svazkem statistika a číselné údaje   MeSH
• počítačové zpracování obrazu statistika a číselné údaje   MeSH
• povrchové vlastnosti MeSH
• radiologické informační systémy statistika a číselné údaje   MeSH
• sinus maxillaris anatomie a histologie   MeSH
• software MeSH
• zobrazování trojrozměrné statistika a číselné údaje   MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• časopisecké články MeSH
• práce podpořená grantem MeSH
• srovnávací studie MeSH

• MeSH
• chuťové esence analýza   toxicita   MeSH
• hodnocení rizik MeSH
• kontaminace potravin analýza   MeSH
• potravinářské přísady analýza   toxicita   MeSH

• Konspekt
• Potravinářský průmysl
• NLK Obory
• zemědělství a potravinářství
• NLK Publikační typ
• publikace WHO

Pressure pads are small hand-made corset components used for scoliotic curve correction by applying pressure to the body segment. The design and accuracy of these pads can be increased by using modern approaches like CAD modeling and additive manufacturing. The aim of this research was to apply these methods in the pressure pad development process and evaluate the suitability of the designed prototypes. A CAD software SOLIDWORKS was used for the pad design and 2 manufacturing technologies have been selected, specifically FDM and MJF, for the pad production. As for the material of which the pads could be manufactured, PLA, PETG and PA12 have been selected. Abaqus software, using the finite element method, has been chose for the 9 pad prototypes strength calculation, from which 6 have passed the test. It would be appropriate to expand the given research with CAD pressure pads of various optimized designs with different types and densities of infills.

• MeSH
• 3D tisk MeSH
• design s pomocí počítače MeSH
• lidé MeSH
• protetické prostředky MeSH
• skolióza terapie   MeSH
• výztuhy * MeSH
• Check Tag
• lidé MeSH

Pharmacovigilance is the science of monitoring the effects of medicinal products to identify and evaluate potential adverse reactions and provide necessary and timely risk mitigation measures. Intelligent automation technologies have a strong potential to automate routine work and to balance resource use across safety risk management and other pharmacovigilance activities. While emerging technologies such as artificial intelligence (AI) show great promise for improving pharmacovigilance with their capability to learn based on data inputs, existing validation guidelines should be augmented to verify intelligent automation systems. While the underlying validation requirements largely remain the same, additional activities tailored to intelligent automation are needed to document evidence that the system is fit for purpose. We propose three categories of intelligent automation systems, ranging from rule-based systems to dynamic AI-based systems, and each category needs a unique validation approach. We expand on the existing good automated manufacturing practices, which outline a risk-based approach to artificially intelligent static systems. Our framework provides pharmacovigilance professionals with the knowledge to lead technology implementations within their organizations with considerations given to the building, implementation, validation, and maintenance of assistive technology systems. Successful pharmacovigilance professionals will play an increasingly active role in bridging the gap between business operations and technical advancements to ensure inspection readiness and compliance with global regulatory authorities.

• MeSH
• automatizace MeSH
• farmakovigilance * MeSH
• lidé MeSH
• řízení rizik MeSH
• technologie MeSH
• umělá inteligence * MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• časopisecké články MeSH
• práce podpořená grantem MeSH

This study focuses on the fabrication and analysis of a total of 90 dental structures (metal parts of dental prostheses – coping, bridges) of 3 types made of cobalt-chromium alloy through different fabrication technologies which include casting, additive manufacturing by selective laser melting (SLM) and subtraction technology by CNC milling. The manufacturing accuracy analysis was carried out by comparing the nominal model and the actual model obtained by 3D scanning of the fabricated dental structures in GOM Inspect software. Density measurements were performed by helium-based gas pycnometry. The data obtained were statistically analysed and a statistically significant difference was confirmed between the subtraction and additive technology. Based on the available manufacturing technologies, materials and equipment used to fabricate the samples for this study, it can be concluded that dentures fabricated by 3D printing are more accurate than dental structures fabricated by milling or casting technology.

• MeSH
• 3D tisk MeSH
• dentální technologie * MeSH
• lidé MeSH
• přesnost dimenzionálního měření * MeSH
• výzkumný projekt MeSH
• záchovná stomatologie metody   MeSH
• zubní materiály klasifikace   terapeutické užití   MeSH
• zubní náhrady částečné fixní * MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• práce podpořená grantem MeSH