Effect of process conditions on generation of hydrochloric acid and lithium hydroxide from simulated lithium chloride solution using bipolar membrane electrodialysis

A feasibility study was carried out on generation of hydrochloric acid and lithium hydroxide from the simulated lithium chloride solution using EX3B model bipolar membrane electrodialysis (BMED). The influence of a series of process parameters, such as feed concentration, initial acid and base concentration in device component, feed solution volume, and current density were investigated. In addition, the maximum achievable concentrations of HCl and LiOH, the average current efficiency, and specific energy consumption were also studied and compared in this paper to the existing literature. Higher LiCl concentrations in the feed solution were found to be beneficial in increasing the final concentrations of HCl and LiOH, as well as improving current efficiency while decreasing specific energy consumption. However, when its concentration was less than 4 g/L, the membrane stack voltage curve of BMED increased rapidly, attributed to the higher solution resistance. Also low initial concentration of acid and base employed in device component can improve the current efficiency. Increasing of the initial concentration of acid and base solution lowered energy consumption. Moreover, a high current density could rapidly increase HCl and LiOH concentration and enhance water movements of BMED process, but reduced the current efficiency. The maximum achievable concentration of HCl and LiOH generated from 130 g/L LiCl solution were close to 3.24 mol/L and 3.57 mol/L, respectively. In summary, the present study confirmed the feasible application for the generation of HCl and LiOH from simulated lithium chloride solution with BMED.

New Visualization Models of Designation Pathway and Group Categorization of Device–Drug and Device–Biologic Combination Products Classification in the United States: Analysis of FDA Capsular Decisions

Objective The developer and sponsor of new combination products in US needs to forecast which classification and designation to the regulatory scheme of drug, biological product, or device would be required for the new products by the Food and Drug Administration (FDA). To improve the predictability and acceptability of the designation of new combination products for innovators, developers, and sponsors, and to encourage the development and early access of new combination products, we proposed new visualization models of the designation pathway and group categorization. Method We searched the website of the FDA on 15 November, 2020 to identify the regulatory scheme of the FDA’s 129 capsular decision cases of device–drug and device–biologics combination products and other publicly available cases the FDA designated to the drug/biologic or device regulatory scheme. Results By introducing a new definition for primary intended use (PIU) by developers and sponsors extracted from the classification factors of primary mode of action (PMOA), we developed new visualization models of the designation pathway and two-dimensional group categorization. And applying these models to the cases the FDA designated, we proposed a new group categorization of combination products while focusing on the device component function. Conclusions The new visualization models with PIU and PMOA and the new group categorization focusing on the device component function proposed in this study may increase predictability and acceptability of the classification of newly developed combination products into the regulatory scheme of drug, biological product, and device, for innovators, developers, and sponsors.

Testing of Selected Accuracy Parameters for the Single Axis Positioner at the Automated Workplace

Although some authors realized various measurement techniques and relevant standards in the experimental verification, the existing contributions still did not mention more complex automated workplaces with industrial robotic arm participation. To solve this, we provide a different view of the interconnection between individual devices (positioner, robot, etc.) controlled by third-party methods (Siemens products). Also, to obtain the necessary effectiveness, we tested and verified selected accuracy parameters for the participating device component (positioner). The proposed work tries to fulfill expectations for a precise welding technology (to ensure simultaneous movements of both the industrial robotic arm and positioner) to achieve higher quality and productivity. However, the components are from different manufacturers.

Acceptability of Information Technology Systems Developed for Distant Philippine Communities among Local Health Providers

Introduction. The National Telehealth Service Program (NTSP) has developed Information Technology (IT) systems aimed at improving health services primarily in isolated Philippine communities. These included two electronic health records modalities (Community Health Information Tracking System, or CHITS, and Real-time Regular Routine Reporting for Health, or R4Health), a referral system (Telemedicine), and a remote diagnostic device (RxBox).Objectives. This study was undertaken to describe the utilization and cost patterns as well as the perceptions of the local health personnel regarding the use of the various NTSP systems. The implications of the end-user perceptions on the acceptability and expanded use of the IT interventions were inferred, from which corresponding policy recommendations were made.Methods. Twelve NTSP sites, including far-flung and economically depressed communities, where the systems were concurrently available over a defined six month period, were selected. The frequency of respective system transactions for these sites was collected from NTSP files. Interviews and focus group discussions were conducted at the communities, involving physicians, nurses, midwives, and other health workers. Associated costs, and perceptions related to the adoption, operation, and sustained use of the IT systems were elucidated.Results. Telemedicine, though the least costly modality, was the least utilized of the systems. While both R4Health and CHITS facilitated health data management, CHITS provided more locally-relevant information. The RxBox system, due to its clinical diagnostic device component, was widely accepted and also increased health center consultations, especially among pregnant patients. Technical malfunctions, as well as system failures following natural calamities, were recurrent problems.Conclusions. The RxBox system, with its bundled health records and specialist consultation functions, is highly accepted by health providers and other community stakeholders. The technology can be expected to be similarly well-regarded in other settings. The stand-alone IT modalities that do not directly or significantly benefit the actual implementers are not as sustainable.

System Accuracy Assessment of a Combined Invasive and Noninvasive Glucometer

Background: The pain associated with pricking the fingertip for blood glucose self-testing is considered to be a major burden in diabetes treatment. This study was performed to evaluate the system accuracy of the invasive TensorTip Combo Glucometer (CoG) device component in accordance with ISO15197:2015 requirements and to explore the accuracy of the noninvasive tissue glucose prediction component. Methods: One hundred samples were obtained from people with type 1 and type 2 diabetes and healthy volunteers (43 females, 57 males; age: 53 ± 16 years), with glucose distribution as requested by the ISO standard. Three strip lots were tested twice by healthcare professionals in comparison to YSI 2300 Stat Plus reference method followed by a noninvasive tissue glucose reading (NI-CoG). Mean Absolute (Relative) Difference (MARD) was calculated and a consensus error grid (CEG) analysis was performed. Results: The ISO system accuracy criteria were met with the invasive strip technology by 586/600 of the data points (97.1%) and for each strip lot separately. All invasive results (100%) were within CEG-zone A and total MARD was calculated to be 7.1%. With the noninvasive reading, 99% of raw data points were in A + B (91.1% and 7.8%), and the total MARD was calculated to be 18.1%. Discussion: The invasive component of the CoG device was shown to be in full compliance with the current ISO15197 criteria. Good results were also obtained with the NI-CoG tissue glucose prediction. This noninvasive technology would potentially be suitable for frequent pain-free glucose monitoring in many people with diabetes.