A Semantic-driven Approach for Maintenance Digitalization in the Pharmaceutical Industry

The digital transformation of pharmaceutical industry is a challenging task due to the high complexity of involved elements and the strict regulatory compliance. Maintenance activities in the pharmaceutical industry play an essential role in ensuring product quality and integral functioning of equipment and premises. This paper first identifies the key challenges of digitalization in pharmaceutical industry and creates the corresponding problem space for key involved elements. A literature review is conducted to investigate the mainstream maintenance strategies, digitalization models, tools and official guidance from authorities in pharmaceutical industry. Based on the review result, a semantic-driven digitalization framework is proposed aiming to improve the digital continuity and cohesion of digital resources and technologies for maintenance activities in the pharmaceutical industry. A case study is conducted to verify the feasibility of the proposed framework based on the water sampling activities in Merck Serono facility in Switzerland. A tool-chain is presented to enable the functional modules of the framework. Some of the key functional modules within the framework are implemented and have demonstrated satisfactory performance. As one of the outcomes, a digital sampling assistant with web-based services is created to support the automated workflow of water sampling activities. The implementation result proves the potential of the proposed framework to solve the identified problems of maintenance digitalization in the pharmaceutical industry

An Edge-Cloud based Reference Architecture to support cognitive solutions in Process Industry

Process Industry is one of the leading sectors of the world economy, characterized however by intense environmental impact, and very high-energy consumption. Despite a traditional low innovation pace in PI, in the recent years a strong push at worldwide level towards the dual objective of improving the efficiency of plants and the quality of products, significantly reducing the consumption of electricity and CO2 emissions has taken momentum. Digital Technologies (namely Smart Embedded Systems, IoT, Data, AI and Edge-to-Cloud Technologies) are enabling drivers for a Twin Digital-Green Transition, as well as foundations for human centric, safe, comfortable and inclusive workplaces. Currently, digital sensors in plants produce a large amount of data, which in most cases constitutes just a potential and not a real value for Process Industry, often locked-in in close proprietary systems and seldomly exploited. Digital technologies, with process modelling-simulation via digital twins, can build a bridge between the physical and the virtual worlds, bringing innovation with great efficiency and drastic reduction of waste. In accordance with the guidelines of Industrie 4.0 this work proposes a modular and scalable Reference Architecture, based on open source software, which can be implemented both in brownfield and greenfield scenarios. The ability to distribute processing between the edge, where the data have been created, and the cloud, where the greatest computational resources are available, facilitates the development of integrated digital solutions with cognitive capabilities. The reference architecture is being validated in the three pilot plants, paving the way to the development of integrated planning solutions, with scheduling and control of the plants, optimizing the efficiency and reliability of the supply chain, and balancing energy efficiency

Revolutionizing Pharmaceutical Cold Chain Competency Framework with Reference Process Model and Reference Architecture

The utilization of the reference process model (RPM) and reference architecture (RA) as disruptive information and communication technologies (ICT) in the pharmaceutical cold chain (PCC) industry has enabled the management of tasks through a model-architecture-based approach. This research presents an innovative method for competency development in the cold chain sector, leveraging RPM and RA. By introducing a comprehensive conceptual framework encompassing RPM and RA design and workflow into cold chain competency development, this study outlines the key areas for incorporating RPM and RA into the PCC field. The framework elucidates the functioning of RPM and RA concerning occupational standards (OS) and units of competencies (UOC) within the industry. The study generates a research framework for the PCC industry by systematically implementing RPM and RA using a proposed method. The primary outcomes and empirical evidence are UOC and OS derived from RPM and RA implementation and integration, substantiating the conceptual framework's validity. The research highlights the evolutionary aspects and the significance of the conceptual framework in guiding the research framework and proposes a method for competency development. Furthermore, recommendations are provided for future research endeavors. Doi: 10.28991/HIJ-2023-04-02-011 Full Text: PD

Potentials of Traceability Systems - A Cross-Industry Perspective

Recently, traceability systems have become more common, but their prevalence and design vary significantly depending on the industry. Different law and customer-based requirements for traceability systems have led to diverse standards. This contribution offers a framework to compare the state of traceability systems in different industries. A comparison of industry characteristics, motivations for traceability system implementation, common data management, and identification systems are offered. Upon that analysis, the potential of cross-industry traceability systems and approaches is identified. This extended usage of traceability systems supports the quality assurance, process management and counterfeit protection and thus expands customer value

Development of a Framework for Managing the Industry 4.0 Equipment Procurement Process for the Irish Life Sciences Sector

Industry 4.0 (I4.0) brings unprecedented opportunities for Manufacturing Corporations poised to implement Digital Business models; DigitALIZAtion. Industry Standards have been developed for the core technologies of the I4.0 Digital Supply Chains. Manufacturing equipment must now be procured to integrate seamlessly at any point in these novel supply chains. The aim of this study is to determine if an I4.0 Equipment Procurement Process (I4.0-EPP) can be developed which reduces the risk of equipment integration issues. It asks; Can the form of the equipment be specified, so that it correctly fits into the I4.0 Digital Supply Chain, to facilitate the desired I4.0 Digital Business function? An Agile Development Methodology was utilized to design the I4.0-EPP techniques and tools, for use by Technical and Business Users. Significant knowledge gaps were identified during User Acceptance Testing (UAT) by Technical Practitioners, over four equipment procurement case studies. Several iterations of UAT by MEng students, highlighted the requirement for Requirements Guides and specialized workbooks. These additional tools increased the understandability of the technical topics to an acceptable level and delivered very accurate results across a wide spectrum of users. This research demonstrates that techniques and tools can be developed for an I4.0-EPP which are accurate, feasible and viable, but, as with Six Sigma, will only become desirable, when mandated by Corporate Business Leaders. Future research should focus on implementing the ALIZA Matrix with Corporate Practitioners in the Business Domain. This approach will bring the ALIZA techniques and tools, developed during this study, to the attention of Corporate Business Leaders with the authority to sponsor them

The Digitalization of medicine supply chain: How to re-aim the shots in the dark?

ABSTRACT Healthcare expenses have been on the rise for decades. One of the key areas contributing to this ever-expanding growth is medicine expenses. Medicines are required to maintain a sustainable health system in a world of aging populations and pandemics. Novel medicines combat diseases previously considered incurable, and medicines help people with chronic conditions to live normal lives. Furthermore, in emerging economies, pharmacies are often the first and only interface to healthcare services, whereby other medical services are scarce or expensive. However, medicines are associated with costs. To maintain a sustainable health system, the growing expenses have to be managed. There are different ways of controlling medicine expenses. In this age of digitalization, when multiple sectors have been disrupted by digital technologies, it can be argued that digital technologies have a role to play in the medicine supply field. This intersection of medicine supply and information systems has been, however, sparsely studied. This thesis seeks to fill this research gap by exploring the medicine supply chain and discovering obstacles and bottlenecks across the chain. The study also intends to identify how information systems and digital technologies can be utilized to remediate the problems and facilitate an efficient medicine supply chain. The research approaches the medicine supply chain arena through the medicine supply chain concept. The supply chain is a highly complex world involving the pharmaceutical industry and the distribution, prescription and dispensing of medicines. This research examines this arena through cases from across the supply chain covered in four separate studies and related articles. The supply chain concept and the scene are set in one of the studies, followed by studies on the digitalization of pharmacies, medicine waste management in hospitals and the digitalization of the plasma derivatives supply chain. The results of this research illustrate that the main role of digital technology in the management of the medicine supply chain relates to managing several information asymmetries across the chain. The key is to increase transparency between various stakeholders in the chain through novel digital solutions. Currently, the supply chain processes are largely based on rules of thumb rather than facts and evidence, and this should be addressed to maintain a sustainable chain and, subsequently, a sustainable health system. TIIVISTELMÄ Terveydenhuollon kulut ovat nousseet vuosikymmenien ajan. Lääkekulut muodostavat merkittävän osan terveysmenoista. Lääkkeitä tarvitaan kestävän terveydenhuoltojärjestelmän ylläpitämiseksi: lääkkeillä voidaan hoitaa aiemmin parantumattomia sairauksia sekä tukea ikääntyvää väestöä. Kehittyvissä talouksissa apteekit ovat usein myös ensimmäinen ja ainoa yhteys terveyspalveluihin. Lääkkeillä ja niiden kehittämisellä on kuitenkin kulunsa ja kestävän terveydenhuollon järjestelmän ylläpitämiseksi onkin kyettävä ymmärtämään ja hallitsemaan lääkekuluja. Lääkekuluja voidaan hallita eri tavoin. Digitalisaatiolla voidaan ajatella olevan tässä myös roolinsa – useat toimialathan ovat muuttuneet merkittävästi digitaalisten ratkaisujen myötä. Digitalisaation ja tietojärjestelmien merkitystä lääkejakelussa ei olla kuitenkaan tutkittu laajasti. Tämän väitöskirjan tarkoituksena on täyttää tätä tutkimusaukkoa perehtyen lääkejakelun prosesseihin, niihin liittyviin esteisiin ja pullonkauloihin sekä digitaalisiin ratkaisuihin, joilla lääkejakelua voidaan tukea ja tehostaa. Tutkimus lähestyy aluetta mallintaen lääkejakeluketjua. Lääkejakeluketju on monimutkainen globaali systeemi, joka kattaa toimijoita mm. lääketeollisuudesta, jakelusta ja logistiikasta, terveydenhuollosta ja vähittäismyynnistä. Tässä tutkimuksessa jakeluketjua tarkastellaan neljän tutkimuksen kautta, jotka liittyvät lääkejakeluketjun eri osiin. Aluksi esitellään lääkejakeluketjukonsepti, jota seuraavat tutkimukset apteekkien digitalisoinnista, sairaalan lääkehuollosta ja veriplasmatuotteiden toimitusketjun digitalisoinnista. Tämän tutkimuksen tulokset havainnollistavat, että digitaalisten ratkaisujen päärooli lääkejakeluketjun hallinnassa liittyy varsinkin informaatiosymmetrioiden hallintaan sekä tiedon avoimuuden ja läpinäkyvyyden lisäämiseen ketjun eri sidosryhmien välillä. Nykyisin lääkejakeluketjun prosesseja leimaa epävarmuus ja faktoihin perustuva päätöksenteko on vaikeaa, mikä heikentää tehokkaan lääkejakelun ylläpitämistä

Advancing zero defect manufacturing: A state-of-the-art perspective and future research directions

Zero Defect Manufacturing is a disruptive concept that has the potential to entirely reshape the manufacturing ideology. Building on the same quality management philosophy that underpins both lean production and Six Sigma, the Zero Defect Manufacturing paradigm has in recent years developed significantly, given the onset of Industry 4.0 and the increasing maturity of its digital technologies. In this paper, we review contemporary advances in Zero Defect Manufacturing using structured literature review. We explore emergent themes and present important directions for future development in this continuously emerging field of research and practice. We highlight two specific Zero Defect Manufacturing strategy types: defect prevention, and defect compensation; as well as identify two important themes for future ZDM research, namely advancing ZDM research (particularly with a view to progressing from zero-defect processes to zero-waste value chain strategies) and overcoming the global application challenges of ZDM (with emphasis on cyber-security and the extension of defect prevention and compensation strategies to less explored manufacturing processes).publishedVersio

Green IT towards Digitalizing India

Digital India is an initiative by government of India which will prove as a blessing for Indian citizens and will also assist in connecting dots between past, present projects in India. Over the years biggest challenge for India has been to communicate information to this gigantic population. Digital Platform is one of the most efficient ways of communicating information to 1.2 billon citizens of India. Green Computing and Green technology are adopted by developed countries to reduce the impact of growing usage of computing equipments. Apache Hadoop is one of the best upcoming technologies to maintain and analyze Big Data. Hadoop can be implemented on with normal computing and also with cloud computing. Efficient use of Green technology and moving towards virtualization will trigger reduction in environmental impact of the growing use of computing

Digital Twins applied to the implementation of Safe-by-Design strategies in nano-processes for the reduction of airborne emission and occupational exposure to nano-forms

Digital Twins (DTs) are one of the most promising enabling technologies for the deployment of the factory of the future and the Industry 4.0 framework. DTs could be labelled as an inherently Safe-by-Design (SbD) strategy and can be applied at different stages in the life cycle of a process. The EU-funded project ASINA has the ambition to promote coherent, applicable and scientifically sound SbD nano-practices. In particular, in the field of nanomanufacturing, ASINA intends to deliver innovative SbD solutions applied to process (P-SbD). In this context, ASINA will investigate the use of DTs as a disruptive digital technology for the prevention, prediction and control of nano-forms airborne emission and worker exposure. This paper introduces the concept of DT in the field of nano-processes SbD and outlines the preliminary architecture of ASINA-DT, that will be developed and implemented by ASINA in one industrial scenario.The project ASINA received funding from the European Union’s Horizon 2020 research and innovation programme, under grant agreement Nº 862444. This paper reflects only the authors’ views, and the Commission is not responsible for any use that may be made of the information contained therein