Quality assurance of polyethylene liners

Quality assurance (QA) in pharmaceutical manufacturing is essential for ensuring drug safety, efficacy, and consistency. As global pharmaceutical markets expand and regulations become increasingly complex, there is a pressing need for a holistic approach to integrate regulations, supply chain resilience, and technological innovations to maintain high-quality standards. This paper explores the critical role of regulatory frameworks, such as the FDA, EMA, and GMP guidelines, in ensuring compliance across diverse markets, while addressing the challenges associated with evolving laws and documentation requirements. It delves into the vulnerabilities within the pharmaceutical supply chain, including risks related to raw material sourcing, counterfeit drugs, and cold chain logistics, and highlights strategies such as traceability, serialization, and real-time monitoring to mitigate these risks. The paper also examines how AI, automation, blockchain, and continuous manufacturing revolutionize the quality assurance landscape by improving process control, transparency, and predictive capabilities. Ultimately, this paper recommends harmonizing regulatory frameworks with emerging technologies, ensuring compliance through AI-driven systems, and fostering the next generation of automation in pharmaceutical manufacturing to ensure product integrity and safety in a rapidly evolving global market.

Machine learning for the intelligent analysis of 3D printing conditions using environmental sensor data to support quality assurance

PurposeDue to the complexity of and variations in additive manufacturing (AM) processes, there is a level of uncertainty that creates critical issues in quality assurance (QA), which must be addressed by time-consuming and cost-intensive tasks. This deteriorates the process repeatability, reliability and part reproducibility. So far, many AM efforts have been performed in an isolated and scattered way over several decades. In this paper, a systematically integrated holistic view is proposed to achieve QA for AM.Design/methodology/approachA systematically integrated view is presented to ensure the predefined part properties before/during/after the AM process. It consists of four stages, namely, QA plan, prospective validation, concurrent validation and retrospective validation. As a foundation for QA planning, a functional workflow and the required information flows are proposed by using functional design models: Icam DEFinition for Function Modeling.FindingsThe functional design model of the QA plan provides the systematically integrated view that can be the basis for inspection of AM processes for the repeatability and qualification of AM parts for reproducibility.Research limitations/implicationsA powder bed fusion process was used to validate the feasibility of this QA plan. Feasibility was demonstrated under many assumptions; real validation is not included in this study.Social implicationsThis study provides an innovative and transformative methodology that can lead to greater productivity and improved quality of AM parts across industries. Furthermore, the QA guidelines and functional design models provide the foundation for the development of a QA architecture and management system.Originality/valueThis systematically integrated view and the corresponding QA plan can pose fundamental questions to the AM community and initiate new research efforts in the in-situ digital inspection of AM processes and parts.

Quality Assurance has evolved from an essentially narrow, manufacturingbased discipline to one with much broader implications for management. Outside the confines of the manufacturing facility, quality has tremendous impact on the strategic direction, operations, and, profitability of whole industries. Quality assurance, as applied to the manufacture of products, focuses on three phases of the manufacturing activity: (1) control of raw materials and components; (2) process control; and (3) evaluation of outcomes. It is popular to think of the entire manufacturing and control process as a system.

BIRD CHERRY FRUIT - PROSPECTIVE RAW MATERIAL FOR THE PREPARATION OF UKRAINIAN PHARMACOPOEIA MONOGRAPH

These days the use of natural and technogenic raw materials is particularly relevant for the production of efficient construction composites, including the use of nature-like technologies. Successful development of efficient compositions of raw mixes using technogenic and natural raw materials of various genesis is only possible on the basis of in-depth and versatile study of physical, chemical and technological solidification. Thus, the use of nonconventional alumina-silicate raw materials during the production of construction composites provides for theoretical and experimental possibility of shifting from traditional raw materials to the production of composite materials on the basis of nonconventional natural and technogenic raw materials. The study resulted in scientific and theoretical fundamentals of alumina-silicate binding agent design on the basis of technogenic raw materials used to produce non-autoclaved silicate materials. It is suggested to use alumina-silicate rocks of incomplete stage of clay synthesis as an active component of non-autoclaved silicate materials, which structure differs with regard to their thermodynamically-unstable compounds, which, in turn, may result in the production of efficient energy-saving high-hollow silicate materials of a new generation with up to 32 MPa compression strength, F15-25 frost resistance and 1100-1200 kg/m3 average density.

Prediction Of Raw Material Batches For The Production Of Clinker By Means Of Artificial Neural Networks -Analysis Of Behaviour

Additive manufacturing (AM) has revolutionized the manufacturing industry by offering flexibility, customization, and rapid prototyping capabilities. Complex geometries and low volume parts can be produced via AM in much lower lead time and cost compared to traditional manufacturing methods. However, ensuring the quality and reliability of AM parts remains a significant challenge due to variations in material properties and process parameters. Traditional material property analysis methods, that require experimental testing and computational modeling, are often costly and time-consuming and often not applicable to the complex geometries of AM components. These challenges are further magnified when repetitive sampling is required. To address these challenges, this paper presents a novel approach that combines experimental findings with Finite Element Modeling (FEM) to construct a digital twin (DT) model of AM parts. The DT model will serve as a virtual representation along with real-time monitoring, simulation, and optimization capabilities. Numerical simulations are conducted to correlate the resonance frequency of parts at different process conditions with their material characteristics, represented as RF Z-score values. Hence, the results suggest that such an approach provides manufacturers with cost-effective and efficient means of analyzing material properties and optimizing AM processes. Moreover, by leveraging digital twin technology, manufacturers can achieve greater process control and quality assurance in additive manufacturing. The findings of this study contribute to advancing the understanding and implementation of digital twin technology in AM; therefore, paving the way for enhanced productivity and reliability in additive manufacturing processes.

SUMMARY This is the first in a two-part report on control engineering considerations in quality assurance. This paper introduces some basic concepts in the measurement of the ‘loss’ due to poor product quality, and approaches the issue of parameter optimization of the control system through the modem of manipulating the ‘proportional-integral-and-derivative controller’ (PID) constants, using an experimental approach coupled with simulation as the methodology to achieve the desired objective. The second paper (forthcoming) approaches the problem from the point of view of parameter optimization via mathematical programming, and then addresses the issue of setting the standard of system performance through Markov decision processes.

Introduction. The rapid development of industry in recent decades has caused global pollution, including heavy metals. Of particular danger is the accumulation of heavy metals in plantswidely cultivated in crop production practices, such as wheat.Among growth-promoting and remedying drugs, compounds of natural origin -humic substances -deserve special attention.Currently, around the world there is an increased interest in humic substances, the technologies for their production are being improved, and the raw material base is expanding, in which all new types of raw materials are involved.Of particular interest are synthetic humic substances, which are obtained from low molecular weight phenolic precursors.Strict control of the synthesis conditions allows obtaining a product with standardized properties, which is one of the advantages over natural humic substances.In addition, it is assumed that the nature of the low molecular weight phenolic precursor affects the biological activity of the final product.Purpose.The aim of our study was to study the effect of humic substances of various origins (a complex preparation of natural humic substances and synthetic fulvic acids from catechol) on the germination and morphological characteristics of wheat under the influence of heavy metals (Cu 2+ ).Methods.During the study, laboratory, accounting, analytical and mathematical-statistical methods were used.Result.A comparative study of the effect of a complex preparation of natural humic substances and synthetic fulvic acids from catechol on the germination of wheat seeds shows their stimulating effect compared to the control by 11.2% and 8.2%, respectively.The presence in the nutrient solution of Cu 2+ ions at the levels of 0.5, 1 and 5 MPC contributed to the increase of germination energy and germination of seeds in all experiments.The types of humic substances investigated intensify the growth processes in green shoots of wheat.Compared to the control, their

The article is devoted to the formation of strategic directions for the development of foreign economic activity of Ukrainian agricultural enterprises in terms of the European integration, based on the inductive method. As a case study, the domestic vertically integrated agricultural holding Astarta was selected. The company specializes in growing grain and oilseed crops (including organic), sugar production, dairy farming, soybean processing, and bioenergy. It was found the high economic performance of Astarta’s is largely due to its strong integration into the European and international agri-food markets. Approximately half of the company’s foreign currency revenues are generated from the export of agricultural raw materials - grain and oilseeds. One of the key success factors of Astarta in foreign markets is its responsible and consistent compliance with international quality standards for final products. Some of the opportunities and threats for Ukrainian agricultural enterprises in terms of the EU intergration were summarized. Through a SWOT-analysis, the main strengths and weaknesses of Astarta in domestic and foreign markets were identified, along with the systematization of opportunities and threats facing the enterprise under conditions of European integration and martial law. The TOWS-analysis method made it possible to formulate and justify key strategic directions for the development of Astarta’s foreign economic activity. To leverage opportunities through its strengths, the company is advised to focus on scaling up production and entering new markets, particularly in EU member states, with organic food products. To counteract the threats arising from the European integration, several strategic directions were proposed based on the enterprise’s strengths: deepening soybean processing to the stage of soybean protein concentrate production for further export, developing compound feed production and gradually entering export markets using the enterprise’s own raw material base, launching export-oriented bioethanol production, fully aligned with the principles of the EU Green Deal. Moreover, it was established that Astarta’s weaknesses can be mitigated by using available opportunities, such as expanding the production and export of ISCC-certified soybean oil. Finally, reducing exports of raw agricultural materials (grain and oilseeds) and optimizing production chains to enhance flexibility during wartime disruptions was determined to be a justified strategic step to eliminate Astarta’s weaknesses amid external threats. As a result of the study, universal principles were proposed for developing strategic directions for the foreign economic activity of domestic agricultural enterprises in terms of the EU integration – resilience, sustainability, and a focus on deep processing of agricultural raw materials.

Three blended polyolefin (BPO) geomembranes (GMBs) with nominal thicknesses of 1.0 mm (BzSw10), 1.5 mm (BzSw15), and 2.0 mm (BzS20) were immersed for 9.3 years in highly acidic (L1-pH 0.5) and highly alkaline (L8-pH 13.5) heap leaching solutions, and water (pH 6.5–7.6), at 85, 75, and 65°C. The solutions simulated pregnant liquors from metal recovery processes. BzSw10 and BzSw15 shared the same resin and antioxidant package, while BzS20 had a different formulation. All three comprised around 90% linear low-density polyethylene (LLDPE) and 10% high-density polyethylene (HDPE) resin. Times to antioxidant depletion and nominal tensile failure generally increased from BzSw10 to BzSw15 to BzS20 across all media. Among the solutions, pH 13.5 was the most aggressive, causing faster antioxidant depletion and onset of degradation, followed by water (pH 6.5–7.6) and pH 0.5. In pH 13.5, melt index and break strength initially decreased but later stabilized at low values, reflecting the strong influence of solution chemistry. Compared to a HDPE GMB previously immersed in the same pH 13.5 and pH 0.5 solutions, the BPOs exhibited faster antioxidant depletion but generally outperformed the HDPE in terms of mechanical property degradation, including break strength and stress-crack resistance.

50 - Teaching Organic and Polymer Chemistry in an Industrial Context

Aerospace manufacturing SMEs are continuously facing the challenge on managing their supply chain and complying with the aerospace manufacturing quality standard requirement due to their lack of resources and the nature of business. In this paper, the ERP system based approach is presented to quality control and assurance work in light of seamless integration of in-process production data and information internally and therefore managing suppliers more effectively and efficiently. The Aerospace Manufacturing Quality Assurance Standard (BS/EN9100) is one of the most recognised and essential protocols for developing the industry-operated-and-driven quality assurance systems. The research investigates using the ERP based system as an enabler to implement BS/EN9100 quality management system at manufacturing SMEs and the associated implementation and application perspectives. An application case study on a manufacturing SME is presented by using the SAP based implementation, which helps further evaluate and validate the approach and application system development.

Contemporary challenges facing food manufacturing are shaped by the synergistic impact of multiple factors. Most significant among these is continuous technological advancement, unfolding within the context of supply chain globalization and increasingly complex value networks. These factors, compounded by the impact of significant socio-economic disruptions, have diminished the efficacy of traditional approaches to quality and safety assurance for processes and products in the food industry. Consequently, there is an imperative to refine these approaches to enhance their applicability within modern production environments, which are characterized by attributes such as modularity, technological sophistication, an extensive product range, and a high degree of product customization. The objective of this study was to establish the foundational core of manufacturing quality assurance for application within the production environments of modern food enterprises. This core constitutes a homologous, transversal, and additive subsystem that shapes the resultant developmental vector through functional integration into the production system, taking into account the interdisciplinary nature of contemporary complex value networks and stakeholder satisfaction. The study employed lexico-semantic alignment of international interdisciplinary normative documents and contemporary scientific models of quality control subsystems, alongside IDEF0 notation for systemic interconnections and ontological modeling. Based on the results, 10 foundational components were identified, comprising 102 structural and functional elements ensuring the systemic role of these components, and 6 types of interconnections, which collectively constituted the core architecture of the quality assurance subsystem. The proposed architecture is designed to meet contemporary requirements and optimize processes such as integration, monitoring, and regulation across all stages of the value chain through the establishment of a comprehensive technological infrastructure.