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All Journal Mesin Proceeding of International Conference Health, Science And Technology (ICOHETECH)
Pitoyo Amrih
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Computer Science & IT Decision Sciences, Operations Research & Management Health Professions Industrial & Manufacturing Engineering Mechanical Engineering Medicine & Pharmacology

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Validating Pharma Machinery: A Journey To Find a Line Somewhere Above Baseline with Science and Risk Consideration for Cost Efficient Facility Requirement Pitoyo Amrih
Mesin Vol. 27 No. 2 (2018)
Publisher : Mesin

Show Abstract | Download Original | Original Source | Check in Google Scholar

Abstract

Every industries should be aware about how their product quality are build. It began with the end in mind about a detail specification of the product, a quality atribut designed to the product profile, process and technology choice. Then it will initiate a requirement of the facility for those need. Pharmaceutical product is one in many manufacturing industries that need to be carefully manage in term of product quality and the consideration that it can be harm to the consumer. The impact can also come from a requirement specification of its facility1. To protect the drugs consumer, we can use the term 'patient safety' then, authority made a regulation that became a coridor to lead the industry on how the good manufacturing pratices should be conducted. Regulator put it in the terminology: GMP (Good Manufacturing Practices). But they give only general statement about what a 'good manufacturing' is. Most of the time it needs detail technical explanation. Especially for the engineers perspective.  Some pharmaceutical engineering professional organization try to describe the minimum requirement should be designed for pharmaceutical facility purpose. A Baseline. But the baseline sometimes is not a clear bold line, Most of the time, in very detail technical decision, it can be a wide grey area. How high we put our requirement level above baseline corelate with how expensive the cost will be.
Discrete Event Simulation Approach for Pharmaceutical Industry Calibration Laboratory Service Digital Twin Model Amrih, Pitoyo; Widyo Laksono, Pringgo
Proceeding of the International Conference Health, Science And Technology (ICOHETECH) 2024: Proceeding of the 5th International Conference Health, Science And Technology (ICOHETECH)
Publisher : LPPM Universitas Duta Bangsa Surakarta

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.47701/icohetech.v5i1.4230

Abstract

This research aims to develop a simulation theory using discrete event simulation as a convincing tool for building a digital twin models in the pharmaceutical industry calibration department as part of the supporting components enabler for industry 4.0. The Methodology used are define the Calibration Laboratory service model, then analyze the big data collected from the service performance parameters. The analyzed data will be used to continue the development of discrete event simulation models for calibration laboratory service systems using ProModel2016 software. The simulation output data will be verified with real event data to ensure similarity. The study finds that the Discrete Event Simulation approach can be used as a convincing tool to develop digital twin models as virtual replicas of Calibration Laboratory Services in the Pharmaceutical Industry so that improvement planning can be analyzed efficiently. There is a limitation of this research that the digital twin model can only be verified for the Pharmaceutical Industry Calibration Laboratory Services as a case study object. Further research needs to be carried out to expand the possibilities of using this discrete event simulation approach for Digital Twin Model in every aspect of industrial activities.
Discrete Event Simulation Approach for Pharmaceutical Industry Calibration Laboratory Service Digital Twin Model Amrih, Pitoyo; Widyo Laksono, Pringgo
Proceeding of the International Conference Health, Science And Technology (ICOHETECH) 2024: Proceeding of the 5th International Conference Health, Science And Technology (ICOHETECH)
Publisher : LPPM Universitas Duta Bangsa Surakarta

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.47701/icohetech.v5i1.4230

Abstract

This research aims to develop a simulation theory using discrete event simulation as a convincing tool for building a digital twin models in the pharmaceutical industry calibration department as part of the supporting components enabler for industry 4.0. The Methodology used are define the Calibration Laboratory service model, then analyze the big data collected from the service performance parameters. The analyzed data will be used to continue the development of discrete event simulation models for calibration laboratory service systems using ProModel2016 software. The simulation output data will be verified with real event data to ensure similarity. The study finds that the Discrete Event Simulation approach can be used as a convincing tool to develop digital twin models as virtual replicas of Calibration Laboratory Services in the Pharmaceutical Industry so that improvement planning can be analyzed efficiently. There is a limitation of this research that the digital twin model can only be verified for the Pharmaceutical Industry Calibration Laboratory Services as a case study object. Further research needs to be carried out to expand the possibilities of using this discrete event simulation approach for Digital Twin Model in every aspect of industrial activities.
Co-Authors Widyo Laksono, Pringgo