[en] Pyronaridine tetraphosphate (1) is a well-known antimalarial drug. However, it required a carefully optimized production process for the manufacture of pyronaridine tetraphosphate. Each step of its manufacturing process was reinvestigated. For the cyclization of 4-chloro-2-(6-methoxy-pyridin-3-yl-amino)-benzoic acid 6 to 7,10-dichloro-2-methoxybenzo[b]-1,5-naphthyridine 5, an improved process was developed to eliminated critical process impurity (BIA). By the redesign of the formation of triphosphate salt, the purity as API grade was increased. Thus, a robust manufacturing process with an acceptable process performance has been developed to produce high quality pyronaridine tetraphosphate

[en] The purpose of this study was to retrospectively compare the technical success and reliability of the measurements made using two 2-dimensional (2D) shear wave elastography (SWE) systems using the comb-push technique from the same manufacturer and to assess the intersystem reproducibility of the resultant liver stiffness (LS) measurements. Ninety-four patients with suspected chronic liver diseases were included in this retrospective study. LS measurements were obtained using two 2D-SWE systems (LOGIQ E9 and LOGIQ S8) from the same manufacturer, with transient elastography (TE) serving as the reference standard, on the same day. The technical success rates and reliability of the measurements of the two 2D-SWE systems were compared. LS values measured using the two 2D-SWE systems and TE were correlated using Spearman correlation coefficients and 95% Bland-Altman limits of agreement. Thereafter, Bland-Altman limits of agreement and intraclass correlation coefficients (ICCs) were used to analyze the intersystem reproducibility of LS measurements. The two 2D-SWE systems showed similar technical success rates (98.9% for both) and reliability of LS measurements (92.3% for the LOGIQ E9, 91.2% for the LOGIQ S8; P=0.185). Despite the excellent correlation (ICC=0.92), the mean LS measurements obtained by the two 2D-SWE systems were significantly different (LOGIQ E9, 6.57±2.33 kPa; LOGIQ S8, 6.90±6.64 kPa; P=0.018). Significant intersystem variability was observed in the LS measurements made using the two 2D-SWE systems. Therefore, even 2D-SWE systems from the same manufacturer should not be used interchangeably in longitudinal follow-up

[en] This report on development and manufacture of the nuclear laboratory equipment contains the work scope and contents performed for supporting the researches and the developments projects efficiently. And also, the records for the principal production design, the manufacture contents, the working drawings are described in it. Most of works are to support the successful and convenient performance of the R and D projects by development and manufacturing the requested laboratory equipment.

[en] This paper describes steps followed by PETROBRAS to carry out technological cooperation agreements with new suppliers of Wet Christmas Trees (WCT) in order to motivate the technological development of the WCT market and to reduce the costs related to the equipment. It deals with the technical aspects of the WCT designed by PETROBRAS and with the general characteristics of the agreements that are being negotiated with prospective suppliers aiming at the transference of the developed technology

[en] PurposeThe purpose of the study is to quantify the variation in the metric equivalent of French size in a range of medical devices, from various manufacturers, used in interventional radiology.MethodsThe labelling of a range of catheters, introducers, drains, balloons, stents, and endografts was examined. Products were chosen to achieve a broad range of French sizes from several manufacturers. To assess manufacturing accuracy, eight devices were selected for measurement using a laser micrometer. The external diameters of three specimens of each device were measured at centimeter intervals along the length of the device to ensure uniformity.ResultsA total of 200 labels of interventional radiology equipment were scrutinized. The results demonstrate a wide variation in the metric equivalent of French sizing. Labelled products can vary in diameter across the product range by up to 0.79 mm.The devices selected for measurement with the non-contact laser micrometer demonstrate acceptable manufacturing consistency. The external diameter differed by 0.05 mm on average.ConclusionsOur results demonstrate wide variation in the interpretation of the French scale by different manufacturers of medical devices. This has the potential to lead to problems using coaxial systems especially when the products are from different manufacturers. It is recommended that standard labelling should be employed by all manufacturers conveying specific details of the equipment. Given the wide variation in the interpretation of the French scale, our opinion is that this scale either needs to be abandoned or be strictly defined and followed

[en] Little formal work has been undertaken on the subject of component supply. Garrad Hassan (GH) has provided consultancy services to the UK and international wind energy industry, including almost all European wind turbine manufacturers, for more than a decade. Most of this report is based on that experience. Over this period, a good understanding of the market for wind turbines and the associated components has developed. (author)

[en] Medical device manufacturers have recently began to study and implement in-line electron beam irradiators for device sterilization instead of relying heavily on centralized locations serving multiple manufacturing sites. Before deciding to install such a system, the sterilization needs should be systematically considered. The evaluation includes - Technical specifications for in-line systems, including energy requirements balanced against size and shielding requirements. - Economics of in-line systems, balancing capital expenditure and increased operational costs at a single location versus costs of transporting products to the central location and the operational costs, including institutional and quality assurance requirements on operating a system

[en] Additive manufacturing (AM) is taking the place of traditional methods of manufacturing such as casting, because of the many advantages of this new technique, e.g. freedom in design, cost and time effective, less waste, etc. However, AM metallic products present several defects in terms of pores and surface roughness. Despite the high potential of AM, reliable mechanical properties of the manufactured parts are a prerequisite for series production and thus a need to be more deeply investigated. Among metallic materials, a combination of high fracture toughness and light weight has made Ti-6Al-4V suitable for manufacturers in the biomedical and aerospace industry. Although the monotonic stress-strain behavior of Selective Laser Melted (SLM) Ti-6Al-4V is superior to conventionally manufactured parts, this is not the case when the component is subjected to cyclic loading. Therefore, researchers and manufacturers need to take a closer look into mechanical properties of AM parts under cyclic loading. The aim of this review is to provide the state of the art in this area for the researchers and manufacturers seeking information specifically about the fatigue behavior of SLM Ti-6Al-4V components and with the aim of improving the fatigue behavior of components manufactured from Ti-6Al-4V using the SLM manufacturing process. (topical review)

[en] The production process of the SSC CDM outer wire and cable was almost established through the successful Phase I production of highly uniform cable of about 4,000 kg in weight. However, some minor problems were found. For example, there was a small margin over the required wire critical current (Ic) because of low critical current density (Jc). And part of the wire did not survive the sharp bend test. In order to solve these problems, wire cross-sectional design was slightly changed in Phase II. This paper describes the R ampersand D results for those improvements, as well as the evaluation of the performance of the wire produced in Phase II

[en] The history of manufacture of nuclear components by SKODA JS from the 1970s till now is outlined with stress on the quality assurance and quality management systems aspects. (orig.)