Manufacturing Practices Research Articles

A comparative analysis between backpropagation and general regression neural networks to predict the tensile properties of fused filament fabricated parts

The Fused Filament Fabrication (FFF) process comprises a large number of process parameters that affect the resultant mechanical properties of the parts, generating uncertainties during the Design for Additive Manufacturing (DfAM) practice. Several studies have used Artificial Neural Networks (ANN) based on classification machine learning techniques such as Backpropagation Neural Network (BPNN), to evaluate the dimensional accuracy, surface roughness, compressive, flexural and tensile strength of FFF parts. As an alternative, in this paper a new General Regression Neural Network (GRNN) approach, based on a regression machine learning technique, is proposed to estimate the tensile structural properties of polylactic acid (PLA)-FFF parts using variable process parameters. The performance of the new proposed GRNN is compared with the performance of a BPNN. The comparison and evaluation are based on their capability to accurately predict the experimental Ultimate Tensile Stress (UTS) and the Elastic Modulus ( E) of FFF parts. The outcomes of this evaluation have shown that although the GRNN and the BPNN are able to estimate with high accuracy the structural behaviour of FFF parts, the performance of the proposed GRNN is superior (0.001 Mean Square Error, MSE) than the BPNN (0.0031 MSE). Moreover, the new proposed GRNN fits the experimental test values with a minimal average error of 0.62%. Thus, the proposed GRNN can be used during the design of components intended to be manufacture by FFF.

Characterizing the manufacturing practices of Late Bronze Age White slip ware from Bamboula-Kourion, Cyprus

White Slip Ware (WS) is one of the most recognizable Late Cypriot pottery types and was traded around the Mediterranean in the Late Bronze Age. This study examines the specific methods used to create the WS pots deposited in tombs at Bamboula-Kourion by considering the ware’s chaîne opératoire. Using a combination of ceramic petrography, x-radiography, infrared spectroscopy and electron microscopy, we reconstruct the production technology of WS I, II, and IIA vessels and add this fabric-based evidence to discussions of typology. This characterization of the production of WS ware vessels contributes to an understanding of community-level interaction at Bamboula and in the region around the Troodos and opens new questions about the continuities and changes in technical production knowledge that accompanied stylistic and typological shifts in LC pottery.

A Study on Artificial Intelligence – Driven Inventory Solutions and Enhancing Manufacturing Efficiency

Artificial Intelligence is pivotal in transforming Manufacturing and Inventory management practices and maintaining this delicate inventory balance. AI-driven predictive forecasting, for instance, considers historical data, seasonality, and market dynamics to provide exceptionally accurate demand forecasts. Managing inventory has become a complex puzzle in today’s fast-paced business world. As companies expand their reach and cater to a global audience, tracking inventory and maintaining an accurate “available-to-promise” status in real time has become a challenge. In the current competitive landscape, retailers prioritise a seamless approach to inventory management, especially with the growing importance of omnichannel fulfilment. The art of balancing supply and demand while keeping costs in check has become a high-stakes game where every piece of the inventory puzzle must fit perfectly. In this article, we explore the remarkable role of Artificial intelligence in Manufacturing and Inventory management. We will discuss how businesses can harness the power of AI to optimize their efficiency in Manufacturing and Inventory processes.

Production of antiviral “OP7 chimera” defective interfering particles free of infectious virus

Defective interfering particles (DIPs) of influenza A virus (IAV) are suggested for use as broad-spectrum antivirals. We discovered a new type of IAV DIP named “OP7” that carries point mutations in its genome segment (Seg) 7 instead of a deletion as in conventional DIPs (cDIPs). Recently, using genetic engineering tools, we generated “OP7 chimera DIPs” that carry point mutations in Seg 7 plus a deletion in Seg 1. Together with cDIPs, OP7 chimera DIPs were produced in shake flasks in the absence of infectious standard virus (STV), rendering UV inactivation unnecessary. However, only part of the virions harvested were OP7 chimera DIPs (78.7%) and total virus titers were relatively low. Here, we describe the establishment of an OP7 chimera DIP production process applicable for large-scale production. To increase total virus titers, we reduced temperature from 37 to 32 °C during virus replication. Production of almost pure OP7 chimera DIP preparations (99.7%) was achieved with a high titer of 3.24 log10(HAU/100 µL). This corresponded to an 11-fold increase relative to the initial process. Next, this process was transferred to a stirred tank bioreactor resulting in comparable yields. Moreover, DIP harvests purified and concentrated by steric exclusion chromatography displayed an increased interfering efficacy in vitro. Finally, a perfusion process with perfusion rate control was established, resulting in a 79-fold increase in total virus yields compared to the original batch process in shake flasks. Again, a very high purity of OP7 chimera DIPs was obtained. This process could thus be an excellent starting point for good manufacturing practice production of DIPs for use as antivirals.Key points• Scalable cell culture-based process for highly effective antiviral OP7 chimera DIPs• Production of almost pure OP7 chimera DIPs in the absence of infectious virus• Perfusion mode production and purification train results in very high titers

Driving Manufacturing Companies toward Industry 5.0: A Strategic Framework for Process Technological Sustainability Assessment (P-TSA)

This study explores the complex nexus between technological innovation, Industry 4.0′s transformative paradigm, and the emerging concept of Industry 5.0, highlighting the critical role of integrating sustainability into factories to enhance organizational competitiveness. In this context, confusion arises between the terms “sustainable technologies” and “technological sustainability” due to two factors: the misuse of the terms as synonyms and the misattribution of conceptual meaning to each term. To clarify this ambiguity, this study validates a conceptual framework for technological sustainability by examining the processes of a ceramic manufacturing company. This assessment highlights the potential of technological sustainability and its associated measurement model to facilitate the transition from Industry 4.0 to Industry 5.0. This research provides fundamental insights into technological sustainability and serves as a guide for future empirical efforts aimed at achieving a balanced and sustainable integration of technology into manufacturing practices.

Transforming Object Design and Creation: Biomaterials and Contemporary Manufacturing Leading the Way.

In the field of three-dimensional object design and fabrication, this paper explores the transformative potential at the intersection of biomaterials, biopolymers, and additive manufacturing. Drawing inspiration from the intricate designs found in the natural world, this study contributes to the evolving landscape of manufacturing and design paradigms. Biomimicry, rooted in emulating nature's sophisticated solutions, serves as the foundational framework for developing materials endowed with remarkable characteristics, including adaptability, responsiveness, and self-transformation. These advanced engineered biomimetic materials, featuring attributes such as shape memory and self-healing properties, undergo rigorous synthesis and characterization procedures, with the overarching goal of seamless integration into the field of additive manufacturing. The resulting synergy between advanced manufacturing techniques and nature-inspired materials promises to revolutionize the production of objects capable of dynamic responses to environmental stimuli. Extending beyond the confines of laboratory experimentation, these self-transforming objects hold significant potential across diverse industries, showcasing innovative applications with profound implications for object design and fabrication. Through the reduction of waste generation, minimization of energy consumption, and the reduction of environmental footprint, the integration of biomaterials, biopolymers, and additive manufacturing signifies a pivotal step towards fostering ecologically conscious design and manufacturing practices. Within this context, inanimate three-dimensional objects will possess the ability to transcend their static nature and emerge as dynamic entities capable of evolution, self-repair, and adaptive responses in harmony with their surroundings. The confluence of biomimicry and additive manufacturing techniques establishes a seminal precedent for a profound reconfiguration of contemporary approaches to design, manufacturing, and ecological stewardship, thereby decisively shaping a more resilient and innovative global milieu.

Large scale controlled Fab exchange GMP process to prepare bispecific antibodies.

Objective: Bispecific antibodies (BsAbs) have demonstrated significant therapeutic impacts for the treatment of a broad spectrum of diseases that include oncology, auto-immune, and infectious diseases. However, the large-scale production of clinical batches of bispecific antibodies still has many challenges that include having low yield, poor stability, and laborious downstream purification processes. To address such challenges, we describe the optimization of the controlled Fab arm exchange (cFAE) process for the efficient generation of BsAbs. Methods: The process optimization of a large-scale good manufacturing practice (GMP) cFAE strategy to prepare BsAbs was based on screening the parameters of temperature, reduction, oxidation, and buffer exchange. We include critical quality standards for the reducing agent cysteamine hydrochloride. Results: This large-scale production protocol enabled the generation of bispecific antibodies with >90% exchange yield and at >95% purity. The subsequent downstream processing could use typical mAb procedures. Furthermore, we demonstrated that the bispecific generation protocol can be scaled up to ∼60L reaction scale using parental monoclonal antibodies that were expressed in a 200L bioreactor. Conclusion: We presented a robust development strategy for the cFAE process that can be used for a larger scale GMP BsAb production.

Impact of lean manufacturing practices on the performance of manufacturing industries

In this paper, we aim to check the impact of lean manufacturing practices on the performance of the manufacturing industry in Pakistan. The three practices involve customer involvement, supplier involvement, and 5s and their effect on the industry's performance. For this purpose, we used a random sampling technique with a sample of 20 questions, a question-based questionnaire designed under the supervision of expert supply chain specialists from different manufacturing industries and authentic research journals. The key finding of this research paper is that we have seen the positive significance of lean practice on the performance of Pakistan's manufacturing industry.

Engineered T cells from induced pluripotent stem cells: from research towards clinical implementation.

Induced pluripotent stem cell (iPSC)-derived T (iT) cells represent a groundbreaking frontier in adoptive cell therapies with engineered T cells, poised to overcome pivotal limitations associated with conventional manufacturing methods. iPSCs offer an off-the-shelf source of therapeutic T cells with the potential for infinite expansion and straightforward genetic manipulation to ensure hypo-immunogenicity and introduce specific therapeutic functions, such as antigen specificity through a chimeric antigen receptor (CAR). Importantly, genetic engineering of iPSC offers the benefit of generating fully modified clonal lines that are amenable to rigorous safety assessments. Critical to harnessing the potential of iT cells is the development of a robust and clinically compatible production process. Current protocols for genetic engineering as well as differentiation protocols designed to mirror human hematopoiesis and T cell development, vary in efficiency and often contain non-compliant components, thereby rendering them unsuitable for clinical implementation. This comprehensive review centers on the remarkable progress made over the last decade in generating functional engineered T cells from iPSCs. Emphasis is placed on alignment with good manufacturing practice (GMP) standards, scalability, safety measures and quality controls, which constitute the fundamental prerequisites for clinical application. In conclusion, the focus on iPSC as a source promises standardized, scalable, clinically relevant, and potentially safer production of engineered T cells. This groundbreaking approach holds the potential to extend hope to a broader spectrum of patients and diseases, leading in a new era in adoptive T cell therapy.

Optimizing Smart Factories: A Data-Driven Approach

Since the first industrial revolution, the leading role of emerging technologies has been highlighted in modernizing the industry and developing the workforce. This study explores the impact of Industry 4.0 digital technologies on manufacturing competitiveness, focusing on Finnish SMEs within the EU with a sample (n = 123). It utilizes extensive 2022 European Manufacturing Survey (EMS22) data. Advanced statistical techniques reveal complex connections between automation, competitive edge on services, and innovation models, among other factors. Robust statistical methods, including component and reliability analyses, reinforced the findings. The conclusion offers critical insights and identifies areas for further research in combining innovative manufacturing practices with technology education.

Overcoming the obstacle of excess acetonitrile content in the final fluorine-18 radiotracers

Abstract Acetonitrile is widely used as a solvent in synthesizing various fluorine-18 positron emission tomography (PET) radiotracers. Acetonitrile is classified as a Class II residual solvent, and due to its inherent toxic properties, the quantity of residual acetonitrile in drug products has to be limited. When working under Good Manufacturing Practices (GMP) during the radiosynthesis of a radiotracer, the aim is to control all solvent concentrations contained in the ready-to-use product. All products must meet predetermined specifications. Rarely, these limits may be exceeded. To avoid eliminating the entire batch, applying a straightforward time-based technique would be desirable to allow the majority of the product to be safely used. This technique should be based on determining a specific time and volume for which the radiotracer can be utilized in the patients after completing quality control analysis. Here, we report a very simple Excel sheet program based on existing mathematical equations that calculates the exact time and volume at which the radiotracer product can be safely administered to a patient.

Good manufacturing practice production of human corneal limbus-derived stromal stem cells and in vitro quality screening for therapeutic inhibition of corneal scarring

BackgroundMesenchymal stem cells in the adult corneal stroma (named corneal stromal stem cells, CSSCs) inhibit corneal inflammation and scarring and restore corneal clarity in pre-clinical corneal injury models. This cell therapy could alleviate the heavy reliance on donor materials for corneal transplantation to treat corneal opacities. Herein, we established Good Manufacturing Practice (GMP) protocols for CSSC isolation, propagation, and cryostorage, and developed in vitro quality control (QC) metric for in vivo anti-scarring potency of CSSCs in treating corneal opacities.MethodsA total of 24 donor corneal rims with informed consent were used—18 were processed for the GMP optimization of CSSC culture and QC assay development, while CSSCs from the remaining 6 were raised under GMP-optimized conditions and used for QC validation. The cell viability, growth, substrate adhesion, stem cell phenotypes, and differentiation into stromal keratocytes were assayed by monitoring the electric impedance changes using xCELLigence real-time cell analyzer, quantitative PCR, and immunofluorescence. CSSC’s conditioned media were tested for the anti-inflammatory activity using an osteoclastogenesis assay with mouse macrophage RAW264.7 cells. In vivo scar inhibitory outcomes were verified using a mouse model of anterior stromal injury caused by mechanical ablation using an Algerbrush burring.ResultsBy comparatively assessing various GMP-compliant reagents with the corresponding non-GMP research-grade chemicals used in the laboratory-based protocols, we finalized GMP protocols covering donor limbal stromal tissue processing, enzymatic digestion, primary CSSC culture, and cryopreservation. In establishing the in vitro QC metric, two parameters—stemness stability of ABCG2 and nestin and anti-inflammatory ability (rate of inflammation)—were factored into a novel formula to calculate a Scarring Index (SI) for each CSSC batch. Correlating with the in vivo scar inhibitory outcomes, the CSSC batches with SI < 10 had a predicted 50% scar reduction potency, whereas cells with SI > 10 were ineffective to inhibit scarring.ConclusionsWe established a full GMP-compliant protocol for donor CSSC cultivation, which is essential toward clinical-grade cell manufacturing. A novel in vitro QC–in vivo potency correlation was developed to predict the anti-scarring efficacy of donor CSSCs in treating corneal opacities. This method is applicable to other cell-based therapies and pharmacological treatments.

Bacteriological Analysis of Cow Milk (Nono) Sold Within Gusau Metropolis, Zamfara State

Fresh cow milk popularly called Nono was collected from ten (10) different sellers at different areas within Gusau metropolis and one control was collected directly from a lactating cow and transported immediately to Microbiology Laboratory of Federal University Gusau where they wereassessed for their bacteriological quality. The total bacteria viable count of the ten Nono samples ranged between 6.6 x105 to 2.7 x106 cfu/ml, the total coliforms count ranged between 4.2x105 to 2.2x106cfu/ml, the range of the total Staphylococcal count and total lactic acid bacterial count were 2.5x105 to 4.0x106 cfu/ml and 5.9x105 to 1.7x106 cfu/ml respectively. The control sample had total viable count of 5.6 x 103 cfu/ml, total staphylococcal count of 3.2 x 103 cfu/ml, total lactic acid bacteria count of 4.2 x 103 cfu/ml whereas the coliform count gotten was too few to count (TFTC). The isolates were identified based on their morphological characteristics, Gram's reactions and biochemical profiles and a total of seventy-four (74) bacterial isolates belonging to the genus Lactobacillus, Leuconostoc, Streptococcus, Micrococcus, Pediococcus, Escherichia coli, Pseudomonas, Proteus, Klebsiella, Enterobacter and Staphylococcus spp. were identified from the eleven samples analyzed. The presence of Lactic Acid Bacteria in Nono is very good as they are one of the most significant groups of probiotic which not only enhance lactose digestion but also stimulate the immune system, However, the presence of E. coli and the other enterobacteriaceae and Staphylococcus sp. is of public health concern because they can cause several diseases therefore it was concluded that the bacterial loads of the Nono samples were not satisfactory with the exception of the control which had organisms within the acceptable limit of 30,000/ml for raw milk. The presence of potential pathogenic bacteria in all of the Nono samples is an indication that the samples were contaminated and this can potentially cause diseases to the consumers, Hence the need for public enlightenment for handlers and producers of Nono to observe good manufacturing practices in production and storage of the product to avoid outbreak of infections associated with the organisms encountered in this study.

Development of Good Manufacturing Practice-Compatible Isolation and Culture Methods for Human Olfactory Mucosa-Derived Mesenchymal Stromal Cells.

Demyelination in the central nervous system (CNS) resulting from injury or disease can cause loss of nerve function and paralysis. Cell therapies intended to promote remyelination of axons are a promising avenue of treatment, with mesenchymal stromal cells (MSCs) a prominent candidate. We have previously demonstrated that MSCs derived from human olfactory mucosa (hOM-MSCs) promote myelination to a greater extent than bone marrow-derived MSCs (hBM-MSCs). However, hOM-MSCs were developed using methods and materials that were not good manufacturing practice (GMP)-compliant. Before considering these cells for clinical use, it is necessary to develop a method for their isolation and expansion that is readily adaptable to a GMP-compliant environment. We demonstrate here that hOM-MSCs can be derived without enzymatic tissue digestion or cell sorting and without culture antibiotics. They grow readily in GMP-compliant media and express typical MSC surface markers. They robustly produce CXCL12 (a key secretory factor in promoting myelination) and are pro-myelinating in in vitro rodent CNS cultures. GMP-compliant hOM-MSCs are comparable in this respect to those grown in non-GMP conditions. However, when assessed in an in vivo model of demyelinating disease (experimental autoimmune encephalitis, EAE), they do not significantly improve disease scores compared with controls, indicating further pre-clinical evaluation is necessary before their advancement to clinical trials.

Processing Practices and Quality of Dairy Products in Burkina Faso

Dairy industry is playing an increasing role in food security and economics of West African countries. However there is a need for more information on the quality and history of the dairy products found on the local markets in order to guide necessary reformations in this sector. The objective of this study was to provide data on the quality and processing practices of dairy products, including some locally manufactured dairy products and imported powder milk commercialised in Burkina Faso. Specifically, a survey was carried out first, to identify the locally manufactured dairy products as well as the manufacturing practices, particularly the malpractices not yet reported in the literature. Then, locally manufactured dairy products (excluding the traditionally fermented milk lait caillé and pasteurised milk), imported powder milk from brands frequently used for processing milk products and fraudulent practices identified during the survey were evaluated through laboratory analyses. Physico-chemical parameters such as pH, acidity and moisture content were determined. In addition microbiological parameters such as aerobic mesophilic flora, yeast and mold, thermotolerant coliforms or enterobactria, were also determined. &#x0D; Results from the survey showed that good manufacturing practices were not strictly observed. In addition it was reported use of salt and a popular street medicine “toupaϊ” (supposedly an antibiotic) for delaying the spoilage/fermentation of the raw milk. Six types of locally manufactured milk products were identified while seven brands of powder milk were frequently used, after repackaging, for processing milk products. Most samples of locally manufactured products were unsatisfactory for fungal and thermotolerant coliforms loads. Powder milk samples showed absence of enterobacteria. Sensory analyses showed that locally manufactured products from powder milk were more appreciated than those made from raw milk. Attempts to reproduce the malpractices of using salt or “toupaϊ” did not lead to significant results compared to the control, suggesting that some respondents did not fully open up about the malpractices. These data are useful since they would give tools to policy makers for quality control and regulation in the sector of dairy products.

Digital Product Passport: A Pathway to Circularity and Sustainability in Modern Manufacturing

The primary aim of this study is to explore and understand the potential benefits and applications of the Digital Product Passport (DPP) system within the modern manufacturing industry. To achieve this, we developed a unique methodology, model, and a template for creating a DPP, identifying the key characteristics essential for effective implementation. Our approach involved an analysis of the literature and the formulation of a unified DPP framework, tailored to enhance supply chain transparency and support sustainable manufacturing practices. The empirical findings from our research demonstrate the DPP’s impact on supply chain transparency, providing crucial product lifecycle information that bolsters decision-making and facilitates optimal resource management. Additionally, our study suggests that the DPP model, when applied to sectors such as electronics manufacturing, promises transformative results. This research underpins the pivotal role of DPPs in the future of manufacturing, highlighting their potential to catalyze a shift towards greater transparency and sustainability. Actionable guidelines are provided for manufacturers considering the adoption of this innovative system.

Ensuring the quality of 3D printed medicines: Integrating a balance into a pharmaceutical printer for in-line uniformity of mass testing

Semi-solid extrusion (SSE) 3D printing has great potential to be integrated in a clinical setting, with the use of pre-filled and disposable pharma-ink syringes meeting regulatory good manufacturing practice (GMP) requirements. Uniformity of mass testing is a critical quality attribute and is carried out by weighing a specific amount of dosage units in a single batch and finding the average mass to evaluate any deviations. However, this test for small batches of 3D printed medicines may require weighing the entire manufactured batch. To overcome this limitation, an in-line analytical balance was implemented inside a GMP pharmaceutical 3D printer, with a specialised software-controlled weighing system for the automated mass uniformity testing of the entire printed batch. Three different dose batches (n = 28) of hydrocortisone pharma-ink were 3D printed and subjected to in-line mass uniformity testing. The developed software was capable of registering the weights of all individual printlets and accurately detecting any deviations within the accepted limits. Only one printlet was outside the accepted weight range, a result of the first print often being imperfect due to the semi-solid nature of the pharma-ink. The weight results were compared against an external analytical balance, and no significant differences were found. This study is the first to integrate an analytical balance inside a pharmaceutical printer, automating the dosage form mass uniformity testing which can save time, labour, and resources, whilst improving the quality control testing of 3D printed pharmaceuticals.

Safety Assessment of Butyrospermum parkii (Shea)-Derived Ingredients as Used in Cosmetics.

The Expert Panel for Cosmetic Ingredient Safety (Panel) assessed the safety of 13 Butyrospermum parkii (shea)-derived ingredients, which are most frequently reported to function in cosmetics as skin and hair conditioning agents. The Panel reviewed the available data to determine the safety of these ingredients. Because final product formulations may contain multiple botanicals, each containing similar constituents of concern, formulators are advised to be aware of these constituents and to avoid reaching levels that may be hazardous to consumers. Industry should use good manufacturing practices to limit impurities that could be present in botanical ingredients. The Panel concluded that these ingredients are safe in the present practices of use and concentration when formulated to be non-sensitizing.

Green entrepreneurship: A review of sustainable business practices in manufacturing and high-tech industries

This paper aims to examine sustainable practices within the manufacturing and high-tech industries, highlighting how green entrepreneurship and sustainable business practices are reshaping these sectors. As global pressures to address climate change intensify, these sectors are increasingly adopting sustainable strategies that not only reduce environmental impact but also drive economic growth. The paper discusses key sustainable practices, including energy management, advanced manufacturing technologies, and supply chain optimization, highlighting their significance in reducing carbon emissions and enhancing operational efficiency. Case studies from leading companies, such as Toyota, Google, and Apple, illustrate how innovations in renewable energy, automation, and ethical sourcing are being integrated into business models to support long-term sustainability goals. Additionally, the paper examines the challenges faced by organizations, particularly smaller enterprises, in implementing these practices, and the critical role of international regulatory frameworks in ensuring global sustainability standards. The analysis underscores the importance of the “triple bottom line” approach – profit, people, and planet – as a strategic framework for businesses aiming to achieve resilience and leadership in the emerging green economy. The findings suggest that while the transition to sustainable practices presents significant challenges, it also offers substantial opportunities for long-term economic and environmental benefits.

Lean green practices in Automotive Components Manufacturing

In response to the global surge in industrial competition, organizations have increasingly embraced lean green practices as an approach to identify and eliminate non-value-added waste in manufacturing processes, while ensuring sustainable practices. This research extends current literature on lean green practices in manufacturing by a) exploring current implementation of lean green practices in the automotive components manufacturing industry and b) examining the challenges encountered within its supply chain processes when implementing the practices. The evaluation utilizes the SCOR model, and a focus group of automotive components manufacturing professionals in the UK. The findings reveal that an average level of implementation of lean green practices, offering benefits such as enhanced productivity, cost reduction, and improved competitive advantage. Implementation challenges were found to be particularly faced in the sourcing and manufacturing (MAKE) processes of the supply chain, due largely to component outsourcing issues, and inefficiencies in the conversion of raw materials into finished products to meet supply chain demands.