Architectures and design patterns for functional design of logic control and diagnostics in industrial automation

Recently in most of the industrial automation process an ever increasing degree of automation has been observed. This increasing is motivated by the higher requirement of systems with great performance in terms of quality of products/services generated, productivity, efficiency and low costs in the design, realization and maintenance. This trend in the growth of complex automation systems is rapidly spreading over automated manufacturing systems (AMS), where the integration of the mechanical and electronic technology, typical of the Mechatronics, is merging with other technologies such as Informatics and the communication networks. An AMS is a very complex system that can be thought constituted by a set of flexible working stations, one or more transportation systems. To understand how this machine are important in our society let considerate that every day most of us use bottles of water or soda, buy product in box like food or cigarets and so on. Another important consideration from its complexity derive from the fact that the the consortium of machine producers has estimated around 350 types of manufacturing machine. A large number of manufacturing machine industry are presented in Italy and notably packaging machine industry,in particular a great concentration of this kind of industry is located in Bologna area; for this reason the Bologna area is called “packaging valley”. Usually, the various parts of the AMS interact among them in a concurrent and asynchronous way, and coordinate the parts of the machine to obtain a desiderated overall behaviour is an hard task. Often, this is the case in large scale systems, organized in a modular and distributed manner. Even if the success of a modern AMS from a functional and behavioural point of view is still to attribute to the design choices operated in the definition of the mechanical structure and electrical electronic architecture, the system that governs the control of the plant is becoming crucial, because of the large number of duties associated to it. Apart from the activity inherent to the automation of themachine cycles, the supervisory system is called to perform other main functions such as: emulating the behaviour of traditional mechanical members thus allowing a drastic constructive simplification of the machine and a crucial functional flexibility; dynamically adapting the control strategies according to the different productive needs and to the different operational scenarios; obtaining a high quality of the final product through the verification of the correctness of the processing; addressing the operator devoted to themachine to promptly and carefully take the actions devoted to establish or restore the optimal operating conditions; managing in real time information on diagnostics, as a support of the maintenance operations of the machine. The kind of facilities that designers can directly find on themarket, in terms of software component libraries provides in fact an adequate support as regard the implementation of either top-level or bottom-level functionalities, typically pertaining to the domains of user-friendly HMIs, closed-loop regulation and motion control, fieldbus-based interconnection of remote smart devices. What is still lacking is a reference framework comprising a comprehensive set of highly reusable logic control components that, focussing on the cross-cutting functionalities characterizing the automation domain, may help the designers in the process of modelling and structuring their applications according to the specific needs. Historically, the design and verification process for complex automated industrial systems is performed in empirical way, without a clear distinction between functional and technological-implementation concepts and without a systematic method to organically deal with the complete system. Traditionally, in the field of analog and digital control design and verification through formal and simulation tools have been adopted since a long time ago, at least for multivariable and/or nonlinear controllers for complex time-driven dynamics as in the fields of vehicles, aircrafts, robots, electric drives and complex power electronics equipments. Moving to the field of logic control, typical for industrial manufacturing automation, the design and verification process is approached in a completely different way, usually very “unstructured”. No clear distinction between functions and implementations, between functional architectures and technological architectures and platforms is considered. Probably this difference is due to the different “dynamical framework”of logic control with respect to analog/digital control. As a matter of facts, in logic control discrete-events dynamics replace time-driven dynamics; hence most of the formal and mathematical tools of analog/digital control cannot be directly migrated to logic control to enlighten the distinction between functions and implementations. In addition, in the common view of application technicians, logic control design is strictly connected to the adopted implementation technology (relays in the past, software nowadays), leading again to a deep confusion among functional view and technological view. In Industrial automation software engineering, concepts as modularity, encapsulation, composability and reusability are strongly emphasized and profitably realized in the so-calledobject-oriented methodologies. Industrial automation is receiving lately this approach, as testified by some IEC standards IEC 611313, IEC 61499 which have been considered in commercial products only recently. On the other hand, in the scientific and technical literature many contributions have been already proposed to establish a suitable modelling framework for industrial automation. During last years it was possible to note a considerable growth in the exploitation of innovative concepts and technologies from ICT world in industrial automation systems. For what concerns the logic control design, Model Based Design (MBD) is being imported in industrial automation from software engineering field. Another key-point in industrial automated systems is the growth of requirements in terms of availability, reliability and safety for technological systems. In other words, the control system should not only deal with the nominal behaviour, but should also deal with other important duties, such as diagnosis and faults isolations, recovery and safety management. Indeed, together with high performance, in complex systems fault occurrences increase. This is a consequence of the fact that, as it typically occurs in reliable mechatronic systems, in complex systems such as AMS, together with reliable mechanical elements, an increasing number of electronic devices are also present, that are more vulnerable by their own nature. The diagnosis problem and the faults isolation in a generic dynamical system consists in the design of an elaboration unit that, appropriately processing the inputs and outputs of the dynamical system, is also capable of detecting incipient faults on the plant devices, reconfiguring the control system so as to guarantee satisfactory performance. The designer should be able to formally verify the product, certifying that, in its final implementation, it will perform itsrequired function guarantying the desired level of reliability and safety; the next step is that of preventing faults and eventually reconfiguring the control system so that faults are tolerated. On this topic an important improvement to formal verification of logic control, fault diagnosis and fault tolerant control results derive from Discrete Event Systems theory. The aimof this work is to define a design pattern and a control architecture to help the designer of control logic in industrial automated systems. The work starts with a brief discussion on main characteristics and description of industrial automated systems on Chapter 1. In Chapter 2 a survey on the state of the software engineering paradigm applied to industrial automation is discussed. Chapter 3 presentes a architecture for industrial automated systems based on the new concept of Generalized Actuator showing its benefits, while in Chapter 4 this architecture is refined using a novel entity, the Generalized Device in order to have a better reusability and modularity of the control logic. In Chapter 5 a new approach will be present based on Discrete Event Systems for the problemof software formal verification and an active fault tolerant control architecture using online diagnostic. Finally conclusive remarks and some ideas on new directions to explore are given. In Appendix A are briefly reported some concepts and results about Discrete Event Systems which should help the reader in understanding some crucial points in chapter 5; while in Appendix B an overview on the experimental testbed of the Laboratory of Automation of University of Bologna, is reported to validated the approach presented in chapter 3, chapter 4 and chapter 5. In Appendix C some components model used in chapter 5 for formal verification are reported.

Estudo, projeto e desenvolvimento de uma máquina para montar e vincar sacos de papel

Dissertação de mestrado integrado em Engenharia Mecânica

Racionalização e redução de custos das TIC na Administração Pública: o caso da PSP

Dissertação de mestrado integrado em Engenharia e Gestão de Sistemas de Informação

Towards automated specifications of scenarios in enhanced learning technology

Recent standardization efforts in e-learning technology have resulted in a number of specifications, however, the automation process that is considered essential in a learning management system (LMS) is a lessexplored one. As learning technology becomes more widespread and more heterogeneous, there is a growing need to specify processes that cross the boundaries of a single LMS or learning resource repository. This article proposes to obtain a specification orientated to automation that takes on board the heterogeneity of systems and formats and provides a language for specifying complex and generic interactions. Having this goal in mind, a technique based on three steps is suggested. The semantic conformance profiles, the business process management (BPM) diagram, and its translation into the business process execution language (BPEL) seem to be suitable for achieving it.

Development of capacitive sensor for measuring soil water content

The irrigation management based on the monitoring of the soil water content allows for the minimization of the amount of water applied, making its use more efficient. Taking into account these aspects, in this work, a sensor for measuring the soil water content was developed to allow real time automation of irrigation systems. This way, problems affecting crop yielding such as irregularities in the time to turn on or turn off the pump, and excess or deficit of water can be solved. To develop the sensors were used stainless steel rods, resin, and insulating varnish. The sensors measuring circuit was based on a microcontroller, which gives its output signal in the digital format. The sensors were calibrated using soil of the type “Quartzarenic Neosoil”. A third order polynomial model was fitted to the experimental data between the values of water content corresponding to the field capacity and the wilting point to correlate the soil water content obtained by the oven standard method with those measured by the electronic circuit, with a coefficient of determination of 93.17%, and an accuracy in the measures of ±0.010 kg kg-1. Based on the results, it was concluded that the sensor and its implemented measuring circuit can be used in the automation process of irrigation systems.

Automatisointiin ja monistettavuuteen perustuvan palvelumallin soveltaminen tietojärjestelmätoimituksissa

Ohjelmistotuotannon yleinen ongelma on se, että toimitusprojektien läpivientiajat pitkittyvät. Kilpailun kiristyessä ohjelmistoalalla on alettu kiinnittää erityistä huomiota projektien eri vaiheiden tehostamiseen. Process Vision Oy kehittää energiatietojärjestelmiä Suomen energia-alan yrityksille. Yrityksessä on kehitetty vuonna 2010 palvelumalli, jonka avulla pyritään nopeuttamaan toimitusprojektien eri vaiheita. Valtioneuvosto valmisteli vuonna 2009 tuntimittausasetuksen, joka määritti sääntöjä mittaustiedon hallintaan energia-alalla. Kyseisen asetuksen pohjalta Energiateollisuus julkaisi vuonna 2010 ohjeistuksen, joka selkeyttää asetuksen sisällön vaatimuksia jakeluverkonhaltijoille ja sähkön myyjille. Process Vision Oy on valmistellut ohjeistuksen pohjalta tuntimittauspaketin, joka sisältää ohjeistuksen mukaiset toiminnot GENERIS-järjestelmässä. Tässä diplomityössä määritellään Process Vision Oy:n palvelumallin mukaiset standardikomponentit tuntimittauspaketin toimitusprojekteja varten. Työn tavoitteena on kehittää mahdollisimman pitkälle tuotteistettu tuntimittauspaketin toimitus uusille ja vanhoille asiakkaille. Työn lopussa pohditaan miten hyvin palvelumalli soveltuu tuntimittauspaketin toimitusprojekteihin. Lisäksi työssä kartoitetaan yrityksessä käytössä olevien automatisointityökalujen kehitystarpeita. Työn tuloksena saatiin määriteltyä GENERIS-objektit ja konfiguraatiot, jotka toimitetaan tuntimittauspaketin mukana. Työn ohessa sisällytettiin yrityksen Suomen taseselvitysjärjestelmien asennusohjeeseen tuntimittauspaketin toiminnallisuuksien konfigurointi. Uusien vientimäärittelyjen avulla voidaan tuntimittauspaketin toiminnallisuudet toimittaa jatkossa tehokkaammin kuin aiemmin.

Virtuaalisen oppimisympäristön funktionaalisen käyttöliittymätestauksen automatisointi

Tämän tutkimuksen kohteena on Turun yliopistossa kehitetyn www-pohjaisen ViLLE-oppimisjärjestelmän funktionaalisen käyttöliittymätestauksen automatisointityö. Tutkimusta varten olen kerännyt kattavasti aineistoa aihetta käsittelevästä yleisestä kirjallisuudesta ja artikkeleista sekä toteutuksen kannalta spesifistä tietoa tarjoavista Internet-lähteistä. Tutkimuksessa olen tehnyt myös pienehkön määrän testausalan asiantuntijahaastatteluja. Tutkimuksen empiirisessä osuudessa olen valinnut testaukseen käytettävän testaustyökalun sekä toteuttanut valitulla testaustyökalulla ViLLE-oppimisjärjestelmän testauksen automatisointityön soveltamalla käytäntöön tutkimuksen teoriaosuudessa esitettyä tietoa hyvistä käytänteistä funktionaalisen käyttöliittymätestauksen automatisoinnissa. Tutkimuksen toteutuksessa olen käyttänyt kvalitatiivista tutkimusmenetelmää. Tutkimuksen empiirisen osuuden pohjalta kerätyn havaintoaineiston perusteella olen selvittänyt vastaukset seuraaviin tutkimuksessa esitettyihin tutkimuskysymyksiin: • Miten käytetty testaustyökalu on valittu ja mitkä olivat valintaan vaikuttaneet tärkeimmät kriteerit? • Miten käytetty testaustyökalu soveltuu ViLLE-oppimisjärjestelmän funktionaalisen käyttöliittymätestauksen automatisointiin? • Millä eri tavoin käytäntöön viety hyvien testiautomaation laatimistapojen mukainen toteutus vaikuttaa nyt laadittuun testiautomaatioon? • Esiintyikö toteutetussa testiautomaatiossa tutkimuksen teoreettisessa viitekehyksessä kuvattuja funktionaalisen käyttöliittymätestauksen automatisoinnille tyypillisiä ongelmia ja miten ongelmat saatiin ratkaistua? Tutkimuksen tulokset osoittavat melko selvästi, että ViLLE-oppimisympäristön funktionaalisen käyttöliittymätestauksen automatisointityön toteutukseen valittu Vaadin TestBench -testaustyökalu, joka on valittu tutkimuksen alkuvaiheessa suoritetun evaluoinnin perusteella, soveltuu käyttötarkoitukseensa hyvin. Lisäksi pystyin luotettavasti havainnoimaan, että testiautomaation ylläpidon tarve sekä testien laatimiseen kuluva aika vähenevät merkittävästi, kun testit laaditaan heti alusta lähtien rakenteeltaan modulaariseksi sekä tietyin teknisin keinoin mahdollisimman vähän käyttöliittymän rakennetta huomioonottavaksi. Ongelmia testiautomaation laatimisessa voivat aiheuttaa käytetty työkalu itsessään, testattavan järjestelmän toteutus sekä testien suoritusympäristö. Huolimatta kirjallisuuskatsauksen perusteella tehdystä varautumisesta tyypillisiin testiautomaation laatimisessa esiintyviin ongelmiin, myös joitakin sellaisia ongelmia esiintyi, joihin en ollut osannut varautua. Mahdollisiin ongelmiin etukäteen varautuminen kuitenkin selvästi auttoi suurimpaan osaan testiautomaation laatimisessa esiintyneistä ongelmista.

Planejamento de informática nas administrações públicas municipais do Estado de São Paulo

O trabalho mostra a utilização do Plano Diretor de Informática no setor público, através de estudos realizados junto às Administrações Públicas Municipais do Estado de São Paulo. Para tanto, tomou-se como base os modelos, as recomendações e diretrizes de estudos realizados para o setor privado destacando algumas características que diferenciam os dois setores. A partir dessa diferenciação. realizamos uma pesquisa em duas fases: a primeira: através de um questionário, enviado para 199 Municípios do Estado de São Paulo, para identificação daqueles que elaboraram Plano Diretor de Informática; a segunda, através de visita e entrevista a 4 dos 22 Municípios, os quais possuern Plano Diretor de Informática, para examiná-los e analisar a utilização prática destes. Depois de analisados os dados pudemos verificar que a diferenciação deve ser feita e recomendamos um modelo, o PSI - Planejamento Setorial de Informática, para a condução do processo de informatização das Administrações Públicas Municipais, o qual deve ser realizado de maneira setorial e não global como o proposto para o setor privado.

Trabalho e educação da classe operaria: a perspectiva politica da escola tecnica do Sindicato dos Metalurgicos - RJ

Esta dissertação procura refletir os pressupostos teóricos da relação trabalho-educação, a partir da vida real da classe operária, bem como a partir da prática político-pedagógica da escola técnica do Sindicato dos Metalúrgicos do Rio de Janeiro. Contextualizando o nexo entre a escola e a entidade de trabalhadores nos diferentes momentos do movimento sindical, procura resgatar a lógica da educação promovida pelos próprios operários-metalúrgicos. Ao tomar o trabalho como princípio educativo, analisa a experiência vivida por professores, operários-estudantes, dirigentes e ativistas sindicais na reconstrução do processo de produção pedagógica. Reflete então, a formação dos trabalhadores tendo como perspectiva o encontro entre o saber escolar e o saber prático do operariado adquirido no cotidiano da fábrica. Analisando a dicotomia trabalho manual/trabalho intelectual, o processo de automação da produção, a condição de classe do técnico industrial, entre outras questões, enfatiza a necessidade de se resgatar a unidade entre educação técnica e educação política da classe operária.

Do talão de nota fiscal ao cupom fiscal: a implantação do ECF no estado do Rio Grande do Norte e sua repercussão na arrecadação do ICMS

The present paper has aimed the analysis of a real instrument which offers great impact in the ICMS revenue: The Fiscal Voucher Emitting Equipment (ECF). In this sense, the effects of the commercial automation process in Rio Grande do Norte s ICMS revenue between 2000 and 2006 were investigated. Based on this goal, the methodology adopted was characterized as a study of quantitative, exploratory-qualitative nature, through the collecting of secondary data, provided by the State Taxation Bureau (SET). In the absence of a statistic model in the existing literature about the approached theme, we decided for the elaboration of a suitable model, with tables and graphics. As a way to observe the effects of these programs on the revenue, the comparison between the ECF users and non users, in the same period, has proved to be of great importance. We reached the conclusion that even though the growth rates amongst the activities that use the ECF had ascended in tributary revenue in the related years, from 2004 on, with the introduction of TEF, this participation presented a higher growth, which leads us to suppose that the use of this recent instrument provides a significant impact in the State effective revenue. We stand out that the collected amounts could have been even higher, if the level of adhesion to the instrument had not been so low, mainly amongst the minor entrepreneurs, which may mean a rooted defraudation in the system. In short, through the set of data obtained, it is possible to conclude that the ECF and the recent TEF have significantly influenced the ICMS revenue in the entire State all over the period that was analyzed

Protocolo multiciclos para automação hospitalar sobre Multicast com IEEE 802.3 utilizando

The concepts of the industrial automation are being incorporated in the medical area, in other words, they also pass to be applied in the hospital automation. In this sense, researches have been developed and have usually been approached several of the problems that are pertinent to the processes that can be automated in the hospital environment. Considering that in the automation processes, an imperative factor is the communication, because the systems are usually distributed, the network for data transference becomes itself an important point in these processes. Because this network should be capable to provide the exchange of data and to guarantee the demands that are imposed by the automation process. In this context, this doctorate thesis proposed, specified, analyzed and validated the Multicycles Protocol for Hospital Automation (MP-HA), which is customized to assist the demands in these automation processes, seeking to guarantee the determinism in the communications and to optimize the factor of use of the mean of transmission

Ambiente para desenvolvimento de aplicações fuzzy industriais

This paper describes the design, implementation and enforcement of a system for industrial process control based on fuzzy logic and developed using Java, with support for industrial communication protocol through the OPC (Ole for Process Control). Besides the java framework, the software is completely independent from other platforms. It provides friendly and functional tools for modeling, construction and editing of complex fuzzy inference systems, and uses these logical systems in control of a wide variety of industrial processes. The main requirements of the developed system should be flexibility, robustness, reliability and ease of expansion

A multi-agent architecture for intelligent data analysis

The present study introduces a multi-agent architecture designed for doing automation process of data integration and intelligent data analysis. Different from other approaches the multi-agent architecture was designed using a multi-agent based methodology. Tropos, an agent based methodology was used for design. Based on the proposed architecture, we describe a Web based application where the agents are responsible to analyse petroleum well drilling data to identify possible abnormalities occurrence. The intelligent data analysis methods used was the Neural Network.

Algorithms for UAS insertion in civil air space

One of the most interesting challenge of the next years will be the Air Space Systems automation. This process will involve different aspects as the Air Traffic Management, the Aircrafts and Airport Operations and the Guidance and Navigation Systems. The use of UAS (Uninhabited Aerial System) for civil mission will be one of the most important steps in this automation process. In civil air space, Air Traffic Controllers (ATC) manage the air traffic ensuring that a minimum separation between the controlled aircrafts is always provided. For this purpose ATCs use several operative avoidance techniques like holding patterns or rerouting. The use of UAS in these context will require the definition of strategies for a common management of piloted and piloted air traffic that allow the UAS to self separate. As a first employment in civil air space we consider a UAS surveillance mission that consists in departing from a ground base, taking pictures over a set of mission targets and coming back to the same ground base. During all mission a set of piloted aircrafts fly in the same airspace and thus the UAS has to self separate using the ATC avoidance as anticipated. We consider two objective, the first consists in the minimization of the air traffic impact over the mission, the second consists in the minimization of the impact of the mission over the air traffic. A particular version of the well known Travelling Salesman Problem (TSP) called Time-Dependant-TSP has been studied to deal with traffic problems in big urban areas. Its basic idea consists in a cost of the route between two clients depending on the period of the day in which it is crossed. Our thesis supports that such idea can be applied to the air traffic too using a convenient time horizon compatible with aircrafts operations. The cost of a UAS sub-route will depend on the air traffic that it will meet starting such route in a specific moment and consequently on the avoidance maneuver that it will use to avoid that conflict. The conflict avoidance is a topic that has been hardly developed in past years using different approaches. In this thesis we purpose a new approach based on the use of ATC operative techniques that makes it possible both to model the UAS problem using a TDTSP framework both to use an Air Traffic Management perspective. Starting from this kind of mission, the problem of the UAS insertion in civil air space is formalized as the UAS Routing Problem (URP). For this reason we introduce a new structure called Conflict Graph that makes it possible to model the avoidance maneuvers and to define the arc cost function of the departing time. Two Integer Linear Programming formulations of the problem are proposed. The first is based on a TDTSP formulation that, unfortunately, is weaker then the TSP formulation. Thus a new formulation based on a TSP variation that uses specific penalty to model the holdings is proposed. Different algorithms are presented: exact algorithms, simple heuristics used as Upper Bounds on the number of time steps used, and metaheuristic algorithms as Genetic Algorithm and Simulated Annealing. Finally an air traffic scenario has been simulated using real air traffic data in order to test our algorithms. Graphic Tools have been used to represent the Milano Linate air space and its air traffic during different days. Such data have been provided by ENAV S.p.A (Italian Agency for Air Navigation Services).

Prozessanalytische Technologien "PAT" zur Optimierung von Wirbelschichtgranulationsprozessen

In der Herstellung fester Darreichungsformen umfasst die Granulierung einen komplexen Teilprozess mit hoher Relevanz für die Qualität des pharmazeutischen Produktes. Die Wirbelschichtgranulierung ist ein spezielles Granulierverfahren, welches die Teilprozesse Mischen, Agglomerieren und Trocknen in einem Gerät vereint. Durch die Kombination mehrerer Prozessstufen unterliegt gerade dieses Verfahren besonderen Anforderungen an ein umfassendes Prozessverständnis. Durch die konsequente Verfolgung des PAT- Ansatzes, welcher im Jahre 2004 durch die amerikanische Zulassungsbehörde (FDA) als Guideline veröffentlicht wurde, wurde der Grundstein für eine kontinuierliche Prozessverbesserung durch erhöhtes Prozessverständnis, für Qualitätserhöhung und Kostenreduktion gegeben. Die vorliegende Arbeit befasste sich mit der Optimierung der Wirbelschicht-Granulationsprozesse von zwei prozesssensiblen Arzneistoffformulierungen, unter Verwendung von PAT. rnFür die Enalapril- Formulierung, einer niedrig dosierten und hochaktiven Arzneistoffrezeptur, wurde herausgefunden, dass durch eine feinere Zerstäubung der Granulierflüssigkeit deutlich größere Granulatkörnchen erhalten werden. Eine Erhöhung der MassRatio verringert die Tröpfchengröße, dies führt zu größeren Granulaten. Sollen Enalapril- Granulate mit einem gewünschten D50-Kornverteilung zwischen 100 und 140 um hergestellt werden, dann muss die MassRatio auf hohem Niveau eingestellt werden. Sollen Enalapril- Granulate mit einem D50- Wert zwischen 80 und 120µm erhalten werden, so muss die MassRatio auf niedrigem Niveau eingestellt sein. Anhand der durchgeführten Untersuchungen konnte gezeigt werden, dass die MassRatio ein wichtiger Parameter ist und zur Steuerung der Partikelgröße der Enalapril- Granulate eingesetzt werden kann; unter der Voraussetzung dass alle anderen Prozessparameter konstant gehalten werden.rnDie Betrachtung der Schnittmengenplots gibt die Möglichkeit geeignete Einstellungen der Prozessparameter bzw. Einflussgrößen zu bestimmen, welche dann zu den gewünschten Granulat- und Tabletteneigenschaften führen. Anhand der Lage und der Größe der Schnittmenge können die Grenzen der Prozessparameter zur Herstellung der Enalapril- Granulate bestimmt werden. Werden die Grenzen bzw. der „Design Space“ der Prozessparameter eingehalten, kann eine hochwertige Produktqualität garantiert werden. rnUm qualitativ hochwertige Enalapril Tabletten mit der gewählten Formulierung herzustellen, sollte die Enalapril- Granulation mit folgenden Prozessparametern durchgeführt werden: niedrige Sprührate, hoher MassRatio, einer Zulufttemperatur von mindestens > 50 °C und einer effektiven Zuluftmenge < 180 Nm³/h. Wird hingegen eine Sprührate von 45 g/min und eine mittlere MassRatio von 4.54 eingestellt, so muss die effektive Zuluftmenge mindestens 200 Nm³/h und die Zulufttemperatur mindestens 60 °C betragen, um eine vorhersagbar hohe Tablettenqualität zu erhalten. Qualität wird in das Arzneimittel bereits während der Herstellung implementiert, indem die Prozessparameter bei der Enalapril- Granulierung innerhalb des „Design Space“ gehalten werden.rnFür die Metformin- Formulierung, einer hoch dosierten aber wenig aktiven Arzneistoffrezeptur wurde herausgefunden, dass sich der Wachstumsmechanismus des Feinanteils der Metformin- Granulate von dem Wachstumsmechanismus der D50- und D90- Kornverteilung unterscheidet. Der Wachstumsmechanismus der Granulate ist abhängig von der Partikelbenetzung durch die versprühten Flüssigkeitströpfchen und vom Größenverhältnis von Partikel zu Sprühtröpfchen. Der Einfluss der MassRatio ist für die D10- Kornverteilung der Granulate vernachlässigbar klein. rnMit Hilfe der Störgrößen- Untersuchungen konnte eine Regeleffizienz der Prozessparameter für eine niedrig dosierte (Enalapril)- und eine hoch dosierte (Metformin) Arzneistoffformulierung erarbeitet werden, wodurch eine weitgehende Automatisierung zur Verringerung von Fehlerquellen durch Nachregelung der Störgrößen ermöglicht wird. Es ergibt sich für die gesamte Prozesskette ein in sich geschlossener PAT- Ansatz. Die Prozessparameter Sprührate und Zuluftmenge erwiesen sich als am besten geeignet. Die Nachregelung mit dem Parameter Zulufttemperatur erwies sich als träge. rnFerner wurden in der Arbeit Herstellverfahren für Granulate und Tabletten für zwei prozesssensible Wirkstoffe entwickelt. Die Robustheit der Herstellverfahren gegenüber Störgrößen konnte demonstriert werden, wodurch die Voraussetzungen für eine Echtzeitfreigabe gemäß dem PAT- Gedanken geschaffen sind. Die Kontrolle der Qualität des Produkts findet nicht am Ende der Produktions- Prozesskette statt, sondern die Kontrolle wird bereits während des Prozesses durchgeführt und basiert auf einem besseren Verständnis des Produktes und des Prozesses. Außerdem wurde durch die konsequente Verfolgung des PAT- Ansatzes die Möglichkeit zur kontinuierlichen Prozessverbesserung, zur Qualitätserhöhung und Kostenreduktion gegeben und damit das ganzheitliche Ziel des PAT- Gedankens erreicht und verwirklicht.rn