EP0698481B2 - Fuzzy control for quality assurance in the manufacture of tablets - Google Patents

Fuzzy control for quality assurance in the manufacture of tablets Download PDF

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Publication number
EP0698481B2
EP0698481B2 EP94250211A EP94250211A EP0698481B2 EP 0698481 B2 EP0698481 B2 EP 0698481B2 EP 94250211 A EP94250211 A EP 94250211A EP 94250211 A EP94250211 A EP 94250211A EP 0698481 B2 EP0698481 B2 EP 0698481B2
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Prior art keywords
control
height
pressing force
weight
hardness
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German (de)
French (fr)
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EP0698481A1 (en
EP0698481B1 (en
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Wolfgang Dr. Linke
Walter Hegel
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Korsch AG
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Korsch Pressen GmbH
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Priority to DE4315680A priority Critical patent/DE4315680C2/en
Application filed by Korsch Pressen GmbH filed Critical Korsch Pressen GmbH
Priority to EP94250211A priority patent/EP0698481B2/en
Priority to DE59407774T priority patent/DE59407774D1/en
Priority to ES94250211T priority patent/ES2130350T5/en
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    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B30—PRESSES
    • B30B—PRESSES IN GENERAL
    • B30B11/00—Presses specially adapted for forming shaped articles from material in particulate or plastic state, e.g. briquetting presses, tabletting presses
    • B30B11/005—Control arrangements

Definitions

  • the invention relates to a method for quality assurance in tablet manufacture by pressing according to the preamble of the claim 1.
  • An important quality parameter for tablet production is compliance with the given Tablet weight, which with sufficient mixing quality compliance with the limits on the salary Active ingredients guaranteed.
  • the basis for any automatic The control of a tableting machine is the Relationship between measured maximum Pressing force of a tablet and the mass of the Matrix filled goods (tablet weight). It exists thereby a direct connection between the Tablet weight and the one used to manufacture the controlled Tablet necessary pressing force. This connection is used for automatic Monitoring and control devices on rotary presses exploited Depending on the material to be pressed Material is one by the weight of each tablet Pressing tools given tablet shape and one set tablet height a certain pressing force assigned. Now fluctuates with constant tablet height the filling quantity and thus the tablet weight, this results in a direct dependence on a change in the pressing force.
  • EP-0.261.358 B1 describes a method for Quality assurance in the manufacture of tablets described. After that, during manufacturing The tablets are sampled from a variety consist of tablets, their common actual weight value is compared with the target weight value, and where the tabletting machine corresponds to the The deviation between the actual value and the target value is readjusted the tablet weight to the TARGET value bring to. Before readjusting the tablet machine are the weights of each tablet measured and compared the sample. When determining one or more in the weight of the TARGET value the significantly different tablets of the sample Statistics corrected by correction calculation and the corrected value is used for readjustment.
  • the invention is therefore the object based on a quality assurance procedure at To develop tablet manufacture by pressing which all the necessary regulatory mechanisms for Keeping the tablet weight and the tablet height constant and hardness run so that a quick adjustment of deviations is guaranteed and after where the limit values are also automatically optimized can.
  • the weight, the height and the hardness of the tablets is made to fluctuate due to different filling ratios on the Matrices of the press not only after the determination of the Average values from a larger sample can be recorded and only then does a regulation take place, but that tendencies are one in the same direction changing value in time or earlier than can be recorded so far.
  • the invention is based on a the drawing shown exemplary embodiment of the Quality assurance process in tablet manufacturing thanks to a modern high-performance rotary press explained in more detail.
  • the only figure shows a controller model for simultaneous Regulation of tablet parameters weight, height and hardness.
  • the control system is divided into control circuits R1 to R5, which are connected to one another in such a way that they run parallel and nested one inside the other.
  • the first control circuit R1 maintains the actual pressing force PK IST constant at the value of the target pressing force PK target by a change in dosage ⁇ D.
  • the actual pressing force PK IST is the rigid or sliding average of several individual pressing forces at the stamp stations of the press.
  • the first input to the first control circuit R1 is the value of Preßkraftabweichung ⁇ PK between the target pressing force PK SOLL and the actual pressing force PK IST.
  • the control circuit R1 is acted upon by a second input variable, which is formed by the sensitivity of the pressing force dosing dPK / dD.
  • the sensitivity dPK / dD determines the accuracy of the pressing force control as a function of the change in dosage ⁇ D and is adjusted to the control during operation of the press, ie the sensitivity dPK / dD
  • the weight G, the height T and the hardness H of the tablets are measured continuously and a moving average is calculated.
  • a new value for the SET pressing force PK SOLL is calculated in the second control circuit R2, which in turn generates a dosage change ⁇ D in the first control circuit R1, whereby the weight deviation ⁇ G is compensated.
  • the variation of the target pressing force PK SOLL is determined by the value ⁇ PK SOLL.
  • a sensitivity weight dG / dPK is applied as the second input variable, which determines the accuracy of the weight control as a function of the change in pressing force ⁇ PK SHOULD .
  • This sensitivity dG / dPK is also adaptive and is adapted to the regulation during the tablet production process.
  • a deviation between the SET pressing force web height PK SOLLST and the ACTUAL pressing force PK IST is corrected by adjusting the web height by the value ⁇ ST.
  • the second input variable on the fifth control circuit R5 is the sensitivity-compression force web height dPK / ie with adaptive properties.
  • control loops R1 and R5 work alternatively.
  • All control loops R1 to R5 work each continuously. By a preferably sliding Averaging the individual control variables current values are always available.
  • the Control loops R1 to R5 can also each in several sub-circles are divided, e.g. depending on Control deviation different characteristics exhibit.
  • the limit values for the pressing force PK, at whose Reached the press stopped and / or tablets sorted out are determined adaptively by the data measured during operation of the Relationship between the pressing force PK and the Weight G, height T and hardness H is determined. This determination can also be made on a stamp basis. With given limits for the weight G, the Height T and hardness H can be deduced from this connection determine the associated press force limits.
  • variables of the controller model are fuzzified, by being translated into linguistic variables e.g. Weight deviation, sensitivity-weight, Height deviation, etc.
  • This linguistic Variables are assigned terms, e.g. "low, medium, high ", these terms being blurred Represent quantities.
  • the terms get membership functions, with the help of which it is possible for any value the linguistic variable the degree of affiliation to determine the individual terms. For example, one Weight deviation of 5mg the condition "medium Deviation "to grade 0.2, the condition” high Deviation "to grade 0.7.
  • the variables are linked using FUZZY operators, such as "Minimum operator, maximum Operator, gamma operator "or the like.
  • Processing the fuzzy information takes place by means of production rules, through methods of the FUZZY inference are processed, e.g. MAX-MIN / MAX-PROD inference or FAM / inference and other.
  • the output variables which are now called “FUZZY values” are defuzzified, i.e. into the "sharp” "Dosage change” and "Web height change” manipulated variables converted.
  • a defuzzification method is preferably the area center of gravity applied, but also other methods such as maximum average method, Maximum gravity method and others are possible.

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  • Medical Preparation Storing Or Oral Administration Devices (AREA)
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Description

Die Erfindung bezieht sich auf ein Verfahren zur Qualitätssicherung bei der Tablettenherstellung durch Pressen gemäß dem Oberbegriff des Anspruches 1.The invention relates to a method for quality assurance in tablet manufacture by pressing according to the preamble of the claim 1.

Ein wichtiger Qualitätsparameter für die Tablettenherstellung ist die Einhaltung des vorgegebenen Tablettengewichts, welches bei hinreichender Mischgüte die Einhaltung der Grenzen für den Gehalt an Wirkstoffen gewährleistet. Die Grundlage für jede automatische Steuerung einer Tablettiermaschine ist der Zusammenhang zwischen gemessener maximaler Preßkraft einer Tablette und der Masse des in die Matrize gefüllten Gutes (Tablettengewicht). Es besteht dabei ein direkter Zusammenhang zwischen dem Tablettengewicht und der für die Fertigung der kontrollierten Tablette notwendigen Preßkraft. Dieser Zusammenhang wird zum Einsatz von automatischen Überwachungs- und Steuergeräten an Rundlaufpressen ausgenutzt In Abhängigkeit vom zu verpressenden Material ist jedem Tablettengewicht bei einer durch die Preßwerkzeuge vorgegebenen Tablettenform und einer eingestellten Tablettenhöhe eine bestimmte Preßkraft zugeordnet. Schwankt nun bei konstanter Tablettenhöhe die Füllmenge und damit das Tablettengewicht, resultiert daraus in direkter Abhängigkeit eine Preßkraftänderung.An important quality parameter for tablet production is compliance with the given Tablet weight, which with sufficient mixing quality compliance with the limits on the salary Active ingredients guaranteed. The basis for any automatic The control of a tableting machine is the Relationship between measured maximum Pressing force of a tablet and the mass of the Matrix filled goods (tablet weight). It exists thereby a direct connection between the Tablet weight and the one used to manufacture the controlled Tablet necessary pressing force. This connection is used for automatic Monitoring and control devices on rotary presses exploited Depending on the material to be pressed Material is one by the weight of each tablet Pressing tools given tablet shape and one set tablet height a certain pressing force assigned. Now fluctuates with constant tablet height the filling quantity and thus the tablet weight, this results in a direct dependence on a change in the pressing force.

Es ist bereits bekannt, mittels einer rechnergeführten, vollelektronisch arbeitenden PID-Regelung (Proportional-Integral-Differential-Regelung) über den Mittelwert der Preßkräfte, der aus aufeinanderfolgenden Einzelpressungen ermittelt wird, das eingestellte Tablettengewicht zu überwachen (Korsch, Wolfgang: "Pharmakontroll -die neue rechnergeführte Preßkraftüberwachungseinrichtung für die voltautomatische Tablettengewichtsregulierung an Rundlaufpressen" in Zeitschrift: "Swiss Pharma" 2 (1980) Nr.4, Seiten 28 bis 33). Während der automatischen Tablettenproduktion vergleicht die PID-Regelung kontinuierlich die gemessene Preßkraft mit der gewünschten Preßkraft. Ergibt sich eine Abweichung zwischen diesen beiden Werten, dann ermittelt der Rechner selbsttätig die Differenz und betätigt die Dosiereinrichtung, damit die gewünschte Preßkraft, und somit das vorgeschriebene Tablettengewicht, erreicht wird. Zusätzlich werden diskontinuierlich die Parameter Gewicht, Höhe und Härte der Tablette gemessen, wobei Abweichungen von den Sollwerten zur Vorgabe eines neuen Preßkraftsollwertes führen. Bei Höhen- oder Härteabweichungen wird der neue Preßkraftsollwert durch eine Steghöhenverstellung eingeregelt.It is already known to use a computer-controlled, fully electronic PID control (Proportional-integral-differential control) via the Average of the pressing forces, that of successive Individual pressures is determined, the set Monitor tablet weight (Korsch, Wolfgang: "Pharmaceutical control - the new computer-controlled press force monitoring device for the fully automatic Tablet weight regulation on rotary presses "in Journal: "Swiss Pharma" 2 (1980) No. 4, pages 28 to 33). During automatic tablet production the PID control continuously compares the measured Pressing force with the desired pressing force. results there is a discrepancy between these two values, then the computer automatically determines the difference and actuates the dosing device so that the desired one Pressing force, and thus the prescribed tablet weight, is achieved. In addition, be discontinuous the parameters of weight, height and hardness of the tablet measured, with deviations from the target values lead to the specification of a new pressing force setpoint. If there are deviations in height or hardness, the new one Press force setpoint adjusted by means of a web height adjustment.

In der EP-0.261.358 B1 ist ein Verfahren zur Qualitätssicherung bei der Herstellung von Tabletten beschrieben. Danach werden während der Herstellung der Tabletten Proben gezogen, die aus einer Vielzahl von Tabletten bestehen, deren gemeinsamer Gewichts-IST-Wert mit dem Gewichts-SOLL-Wert verglichen wird, und bei dem die Tablettiermaschine entsprechend der Abweichung zwischen IST-Wert und SOLL-Wert nachgeregelt wird, um das Tablettengewicht auf den SOLL-Wert zu bringen. Vor einer Nachregelung der Tablettiermaschine werden die Gewichte der einzelnen Tabletten der Probe gemessen und verglichen. Bei Ermittlung einer oder mehrerer im Gewicht vom SOLL-Wert wesentlich abweichender Tabletten der Probe wird die Statistik durch Korrekturrechnung berichtigt und der berichtigte Wert wird zur Nachregelung benutzt.EP-0.261.358 B1 describes a method for Quality assurance in the manufacture of tablets described. After that, during manufacturing The tablets are sampled from a variety consist of tablets, their common actual weight value is compared with the target weight value, and where the tabletting machine corresponds to the The deviation between the actual value and the target value is readjusted the tablet weight to the TARGET value bring to. Before readjusting the tablet machine are the weights of each tablet measured and compared the sample. When determining one or more in the weight of the TARGET value the significantly different tablets of the sample Statistics corrected by correction calculation and the corrected value is used for readjustment.

Nachteilig ist es bei den bekannten Verfahren, daß aufgrund der großen gegenseitigen Abhängigkeiten und des sehr komplexen Systems die Parameter Gewicht, Höhe und Härte der Tabletten nacheinander eingeregelt werden. Eine Dosierungsänderung bewirkt nicht nur eine Gewichtsänderung, sondern hat Auswirkungen auf die Härte und die Dichte der Tabletten. Aufgrund der systembedingten in großen Zeitintervallen nacheinander ablaufenden Einzelregelungen entsteht eine große Trägheit bei der Ausregelung von Abweichungen. Die SOLL- und Grenzwerte für die Parameter müssen vom Systembenutzer fest vorgegeben werden, was gegebenenfalls zum fehlerbehafteten Aussortieren oder Akzeptieren von Tabletten führen kann, wenn diese Werte nicht optimal den Bedingungen entsprechen.It is a disadvantage of the known methods that that because of the large interdependencies and the parameters of the very complex system Weight, height and hardness of the tablets one after the other be regulated. A change in dosage causes not just a change in weight, but has an impact on the hardness and density of the tablets. by virtue of the system-related in large time intervals successive individual regulations arise a great sluggishness in the correction of deviations. The SET and limit values for the parameters must be specified by the system user what if necessary for faulty rejection or accepting tablets if these values do not optimally correspond to the conditions.

Der Erfindung liegt von daher die Aufgabe zugrunde, ein Verfahren zur Qualitätssicherung bei der Tablettenherstellung durch Pressen zu entwickeln, nach dem alle erforderlichen Regelungsmechanismen zur Konstanthaltung des Tablettengewichts, der Tablettenhöhe und -härte so ablaufen, daß eine schnelle Ausregelung von Abweichungen gewährleistet wird und nach dem die Grenzwerte auch automatisch optimiert werden können.The invention is therefore the object based on a quality assurance procedure at To develop tablet manufacture by pressing which all the necessary regulatory mechanisms for Keeping the tablet weight and the tablet height constant and hardness run so that a quick adjustment of deviations is guaranteed and after where the limit values are also automatically optimized can.

Die Lösung dieser Aufgabe ergibt sich aus den kennzeichnenden Merkmalen des Anspruches 1.The solution to this problem results from the characterizing features of claim 1.

Durch die Möglichkeit der gleitenden Mittelwertbildung für die Preßkraft, das Gewicht, die Höhe und die Härte der Tabletten wird erreicht, daß Schwankungen durch unterschiedliche Füllverhältnisse an den Matrizen der Presse nicht erst nach der Ermittlung des Mittelwertes aus einer größeren Stichprobe erfaßt werden und erst zu diesem Zeitpunkt eine Regelung erfolgt, sondern daß Tendenzen eines sich in gleicher Richtung verändernden Wertes rechtzeitig oder frühzeitiger als bisher erfaßt werden können.Due to the possibility of moving averages for the pressing force, the weight, the height and the hardness of the tablets is made to fluctuate due to different filling ratios on the Matrices of the press not only after the determination of the Average values from a larger sample can be recorded and only then does a regulation take place, but that tendencies are one in the same direction changing value in time or earlier than can be recorded so far.

Die Herstellung einer Korrelation zwischen Preßkraft und Gewicht für jede Preßstation erlaubt es, jeder einzelnen Stempelstation ihre maximale und minimale Preßkraftgrenze zuzuordnen. Damit wird sichergestellt, daß Stempelvariationen nicht zu Fehlentscheidungen bei der Tablettensortierung führen.Establishing a correlation between Press force and weight for each press station allows each individual stamp station its maximum and minimum Allocate pressing force limit. This ensures that stamp variations are not too Make wrong decisions when sorting tablets.

Durch den Einsatz eines FUZZY-Reglers wird eine gute Übersichtlichkeit des Regelungsprozesses erreicht. Das sehr komplexe System kann vollständig beschrieben und dadurch beherrschbar gemacht werden. Es ist leicht modifizierbar und übersichtlich. Das Systemverhalten wird optimal an alle Randbedingungen angepaßt. Die Regelungseigenschaften von Tablettenpressen werden wesentlich verbessert, es gibt u.a. kein Überschwingen des Reglers, und eine Regelungsabweichung gegen Null wird schon nach wenigen Tischumdrehungen erreicht. Inkonsistenz des Preßmaterials, Temperaturschwankungen, stochastische Schwankungen aller Einflußgrößen werden mühelos durch die adaptiven Eigenschaften des FUZZY-Reglers ausgeregelt.By using a FUZZY controller a good overview of the control process reached. The very complex system can be complete described and thereby made controllable. It is easily modifiable and clear. The System behavior is optimal to all boundary conditions customized. The regulatory properties of tablet presses are significantly improved, there are no overshoot of the controller and a control deviation becomes zero after a few Table rotations reached. Inconsistency of the press material, Temperature fluctuations, stochastic Fluctuations of all influencing factors become effortless through the adaptive properties of the FUZZY controller corrected.

Weitere vorteilhafte Ausgestaltungen der Erfindung ergeben sich aus den Unteransprüchen.Further advantageous embodiments of the invention result from the subclaims.

Die Erfindung ist nachfolgend anhand eines in der Zeichnung dargestellten Austührungsbeispieles des Verfahrens zur Qualitätssicherung bei der Tablettenherstellung durch eine moderne Hochleistungs-Rundlaufpresse näher erläutert. In der zugehörigen Zeichnung zeigt die einzige Figur ein Reglermodell zur gleichzeitigen Regelung der Tablettenparameter Gewicht, Höhe und Härte.The invention is based on a the drawing shown exemplary embodiment of the Quality assurance process in tablet manufacturing thanks to a modern high-performance rotary press explained in more detail. In the accompanying drawing the only figure shows a controller model for simultaneous Regulation of tablet parameters weight, height and hardness.

Das Regelungssystem ist in Regelungskreise R1 bis R5 aufgeteilt, welche so miteinander verbunden sind, daß sie ineinandergeschachtelt parallel ablaufen. Der erste Regelungskreis R1 bewirkt eine Konstanthaltung der IST-Preßkraft PKIST auf den Wert der SOLL-Preßkraft PKSOLL durch eine Dosierungsänderung ΔD. Die IST-Preßkraft PKIST ist der starre oder gleitende Mittelwert aus mehreren Einzelpreßkräften an den Stempelstationen der Presse. Die erste Eingangsgröße am ersten Regelungskreis R1 ist der Wert der Preßkraftabweichung ΔPK zwischen der SOLL- Preßkraft PKSOLL und der IST-Preßkraft PKIST. Der Regelungskreis R1 wird mit einer zweiten Eingangsgröße beaufschlagt, die durch die Empfindlichkeit Preßkraft-Dosierung dPK/dD gebildet wird. Die Empfindlichkeit dPK/dD bestimmt die Genauigkeit der Preßkraftregelung in Abhängigkeit von der Dosierungsänderung ΔD und wird während des Betriebes der Presse der Regelung angepaßt, d.h. die Empfindlichkeit dPK/dD ist adaptiv.The control system is divided into control circuits R1 to R5, which are connected to one another in such a way that they run parallel and nested one inside the other. The first control circuit R1 maintains the actual pressing force PK IST constant at the value of the target pressing force PK target by a change in dosage ΔD. The actual pressing force PK IST is the rigid or sliding average of several individual pressing forces at the stamp stations of the press. The first input to the first control circuit R1 is the value of Preßkraftabweichung ΔPK between the target pressing force PK SOLL and the actual pressing force PK IST. The control circuit R1 is acted upon by a second input variable, which is formed by the sensitivity of the pressing force dosing dPK / dD. The sensitivity dPK / dD determines the accuracy of the pressing force control as a function of the change in dosage ΔD and is adjusted to the control during operation of the press, ie the sensitivity dPK / dD is adaptive.

Parallel dazu werden kontinuierlich das Gewicht G, die Höhe T und die Härte H der Tabletten gemessen und je ein gleitender Mittelwert berechnet. Entsprechend der gemessenen Gewichtsabweichung ΔG wird im zweiten Regelungskreis R2 ein neuer Wert für die SOLL-Preßkraft PKSOLL errechnet, der im ersten Regelungskreis R1 wiederum eine Dosierungsänderung ΔD erzeugt, wodurch die Gewichtsabweichung ΔG ausgeglichen wird. Die Veränderung der SOLL-Preßkraft PKSOLL wird durch den Wert ΔPKSOLL bestimmt. Auch im zweiten Regelungskreis R2 wird als zweite Eingangsgröße eine Empfindlichkeit-Gewicht dG/dPK angelegt, welche die Genauigkeit der Gewichtsregelung in Abhängigkeit von der Preßkraftänderung ΔPKSOLL bestimmt. Auch diese Empfindlichkeit dG/dPK ist adaptiv und wird während des Tablettenherstellungsprozesses der Regelung angepaßt.At the same time, the weight G, the height T and the hardness H of the tablets are measured continuously and a moving average is calculated. Corresponding to the measured weight deviation ΔG, a new value for the SET pressing force PK SOLL is calculated in the second control circuit R2, which in turn generates a dosage change ΔD in the first control circuit R1, whereby the weight deviation ΔG is compensated. The variation of the target pressing force PK SOLL is determined by the value ΔPK SOLL. Also in the second control circuit R2, a sensitivity weight dG / dPK is applied as the second input variable, which determines the accuracy of the weight control as a function of the change in pressing force ΔPK SHOULD . This sensitivity dG / dPK is also adaptive and is adapted to the regulation during the tablet production process.

Bei Höhen- und Härteabweichungen der Tabletten werden in den Regelungskreisen R3,R4 jeweils neue Werte für die SOLL-Preßkraft-Steghöhe PKSOLLST berechnet. An den dritten Regelungskreis R3 sind dazu als Eingangsgrößen die Werte für die Höhenabweichung ΔT und für die Empfindlichkeit-Höhe dT/dh angelegt, an den Eingang des vierten Regelungskreises R4 sind die Werte für die Härteabweichung ΔH und die Empfindlichkeit-Härte dH/dh angelegt. Die Empfindlichkeiten dT/dh und dH/dh sind wiederum adaptiv.If there are deviations in the height and hardness of the tablets, new values are calculated in the control loops R3, R4 for the TARGET pressing force web height PK TARGET . For this purpose, the values for the height deviation ΔT and for the sensitivity height dT / dh are applied as input variables to the third control circuit R3, the values for the hardness deviation ΔH and the sensitivity hardness dH / dh are applied to the input of the fourth control circuit R4. The sensitivities dT / dh and dH / dh are again adaptive.

In dem fünften Regelungskreis R5 wird eine Abweichung zwischen der SOLL-Preßkraft-Steghöhe PKSOLLST und der IST-Preßkraft PKIST ist durch eine Steghöhenverstellung um den Wert ΔST ausgeregelt. Die zweite Eingangsgröße am fünften Regelungskreis R5 ist die Empfindlichkeit-Preßkraft-Steghöhe dPK/dh mit adaptiven Eigenschaften.In the fifth control circuit R5, a deviation between the SET pressing force web height PK SOLLST and the ACTUAL pressing force PK IST is corrected by adjusting the web height by the value ΔST. The second input variable on the fifth control circuit R5 is the sensitivity-compression force web height dPK / ie with adaptive properties.

Die Regelungskreise R1 und R5 arbeiten alternativ.The control loops R1 and R5 work alternatively.

Alle Regelungskreise R1 bis R5 arbeiten jeweils kontinuierlich. Durch eine vorzugsweise gleitende Mittelwertbildung der einzelnen Regelungsgrößen stehen ständig aktuelle Werte zur Verfügung. Die Regelungskreise R1 bis R5 können auch jeweils in mehrere Teilkreise unterteilt werden, die z.B. je nach Regelabweichung unterschiedliche Charakteristiken aufweisen.All control loops R1 to R5 work each continuously. By a preferably sliding Averaging the individual control variables current values are always available. The Control loops R1 to R5 can also each in several sub-circles are divided, e.g. depending on Control deviation different characteristics exhibit.

Die Grenzwerte für die Preßkraft PK, bei deren Erreichen die Presse gestoppt und/oder Tabletten aussortiert werden, werden adaptiv bestimmt, indem aus den im laufenden Betrieb gemessenen Daten der Zusammenhang zwischen der Preßkraft PK und dem Gewicht G, der Höhe T und der Härte H ermittelt wird. Diese Ermittlung kann auch stempelbezogen erfolgen. Bei vorgegebenen Grenzen für das Gewicht G, die Höhe T und die Härte H lassen sich aus diesem Zusammenhang die zugehörigen Preßkraftgrenzen ermitteln.The limit values for the pressing force PK, at whose Reached the press stopped and / or tablets sorted out are determined adaptively by the data measured during operation of the Relationship between the pressing force PK and the Weight G, height T and hardness H is determined. This determination can also be made on a stamp basis. With given limits for the weight G, the Height T and hardness H can be deduced from this connection determine the associated press force limits.

Die Beschreibung des Regelungssystems erfolgt aufgrund der großen Komplexität vorzugsweise durch Methoden der FUZZY-Set-Theorie. Die technischen Größen des Reglermodells werden dazu fuzzyfiziert, indem sie in linguistische Variable umgesetzt werden, z.B. Gewichtsabweichung, Empfindlichkeit-Gewicht, Höhenabweichung usw. Diesen linguistischen Variablen werden Terme zugeordnet, wie z.B. "niedrig, mittel, hoch", wobei diese Terme jeweils unscharfe Mengen darstellen. Die Terme erhalten Zugehörigkeitsfunktionen, mit deren Hilfe es möglich ist, für jeden Wert der linguistischen Variablen den Grad der Zugehörigkeit zu den einzelnen Termen zu bestimmen. Z.B erfüllt eine Gewichtsabweichung von 5mg die Bedingung "mittlere Abweichung" zum Grade 0,2, die Bedingung "hohe Abweichung" zum Grade 0,7.The description of the control system is preferred due to the great complexity through methods of the FUZZY set theory. The technical For this purpose, variables of the controller model are fuzzified, by being translated into linguistic variables e.g. Weight deviation, sensitivity-weight, Height deviation, etc. This linguistic Variables are assigned terms, e.g. "low, medium, high ", these terms being blurred Represent quantities. The terms get membership functions, with the help of which it is possible for any value the linguistic variable the degree of affiliation to determine the individual terms. For example, one Weight deviation of 5mg the condition "medium Deviation "to grade 0.2, the condition" high Deviation "to grade 0.7.

Die Verknüpfung der Variablen erfolgt mittels FUZZY-Operatoren, wie z.B. "Minimum Operator, Maximum Operator, Gamma Operator" oder ähnliche.The variables are linked using FUZZY operators, such as "Minimum operator, maximum Operator, gamma operator "or the like.

Die Verarbeitung der unscharfen Informationen erfolgt mittels Produktionsregeln, die durch Methoden der FUZZY-Inferenz abgearbeitet werden, z.B. MAX-MIN/MAX-PROD-Inferenz oder FAM/Inferenz und andere. Nach Ausführung aller Inferenzvorgänge werden die Ausgangsvariablen, welche jetzt als "FUZZY-Werte" vorliegen defuzzyfiziert, d.h. in die "scharfen" Stellgrößen "Dosierungsänderung" und "Steghöhenänderung" umgewandelt. Als Defuzzyfikationsmethode wird vorzugsweise das Flächenschwerpunktsverfahren angewandt, aber auch andere Methoden wie Maximumsmittelwertverfahren, Maximumsschwerpunktverfahren und andere sind möglich.Processing the fuzzy information takes place by means of production rules, through methods of the FUZZY inference are processed, e.g. MAX-MIN / MAX-PROD inference or FAM / inference and other. After all inference operations are completed the output variables, which are now called "FUZZY values" are defuzzified, i.e. into the "sharp" "Dosage change" and "Web height change" manipulated variables converted. As a defuzzification method is preferably the area center of gravity applied, but also other methods such as maximum average method, Maximum gravity method and others are possible.

Claims (10)

  1. Method for the quality assurance for tablet production by means of pressing by way of influential action on the pressing force, on the weight, on the hardness and the height of the tablets with the use of control elements where the control system is subdivided into control loops (R1 to R4), which influence each other and which are essentially parallel in sequence, for the purpose of simultaneous control of the pressing force (PF) and the tablet parameters weight (W) and hardness (H),
    wherein for the interactively influencing and essentially parallel sequence-arranged control loops of the control system a further control loop (R5) for the simultaneous control of the tablet parameter height (T) is envisaged, in a first control loop (R1) the ACTUAL-pressing force (PFactual) is kept constant to the value of the required pressing force (PFrequired) by means of the dosage change (ΔD) and in a second control loop (R2) in parallel sequence thereto the tablet weight (W) is measured and, in accordance with the weight deviation (ΔW), a new value is calculated for the required pressing force (PFrequired), and in the first control loop (R1) a dosage change (ΔD) is produced and the weight deviation (ΔW) is balanced, in a third control loop (R3) the height deviation (ΔT) is measured and in a fourth control loop (R4) the hardness deviation (ΔH) is measured, and for the existing deviations (ΔT, ΔH) new values are calculated in each case for the required pressing force ligament height (PFrequired lig. height), and in a fifth control loop (R5) a deviation between the value of the required pressing force ligament height (PFrequired lig. height) and the value of the ACTUAL-pressing force (PFactual) is balanced-controlled by means of a ligament height adjustment (ΔST).
  2. Method according to Claim 1, wherein the ACTUAL-pressing force (PFactual) is formed from the rigid or floating mean value of several single pressing forces.
  3. Method according to Claims 1 and 2, wherein, parallel to the pressing force measurement, the weight (W), the height (T) and the hardness (H) of the tablets are continually measured, and are each calculated to a floating value.
  4. Method according to Claim 3, wherein the measuring values of the height (T), the hardness (H) and the weight (W) of the tablets are allocated to the individual stamp stations.
  5. Method according to Claims 1 to 4, wherein the first control loop (R1) and the fifth control loop (R5) work alternatively.
  6. Method according to Claims 1 to 5, wherein, onto the inlets of the control loops (R1 to R5) and in addition to the individual control deviations (ΔPF, ΔW, ΔT, ΔH, PFrequired lig. height), the sensitivities (dG/dPF), (dT/dh), dH/dh, dPF/dh, dPF/dD) of the control are also placed in each case.
  7. Method according to Claim 6, wherein, the sensitivities (dG/dPF, dT/dh, dH/dh, dPF/dh, dPF/dD) are adapted to the controls during operation.
  8. Method according to Claims 1 to 7, wherein, the control loops (R1 to R5) are each subdivided into several partial control units.
  9. Method according to Claims 1 to 8, wherein, the limit values for the pressing force (PF) are adaptively determined to the values measured during operation and to the pre-specified limit values for the weight (W), the height (T) and the hardness (H) of the tablets.
  10. Method according to Claim 1, wherein, the methods of the FUZZY logic are applied for the description, the draft, the realisation and the optimisation of the control loops (R1 to R5).
EP94250211A 1993-05-05 1994-08-24 Fuzzy control for quality assurance in the manufacture of tablets Expired - Lifetime EP0698481B2 (en)

Priority Applications (4)

Application Number Priority Date Filing Date Title
DE4315680A DE4315680C2 (en) 1993-05-05 1993-05-05 Regulation of tablet parameters during production on rotary presses
EP94250211A EP0698481B2 (en) 1993-05-05 1994-08-24 Fuzzy control for quality assurance in the manufacture of tablets
DE59407774T DE59407774D1 (en) 1993-05-05 1994-08-24 Fuzzy control process for quality assurance in tablet manufacturing
ES94250211T ES2130350T5 (en) 1993-05-05 1994-08-24 PROCEDURE TO ENSURE QUALITY IN THE MANUFACTURE OF TABLETS.

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE4315680A DE4315680C2 (en) 1993-05-05 1993-05-05 Regulation of tablet parameters during production on rotary presses
EP94250211A EP0698481B2 (en) 1993-05-05 1994-08-24 Fuzzy control for quality assurance in the manufacture of tablets

Publications (3)

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EP0698481A1 EP0698481A1 (en) 1996-02-28
EP0698481B1 EP0698481B1 (en) 1999-02-03
EP0698481B2 true EP0698481B2 (en) 2003-03-19

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE19828004B4 (en) * 1998-06-24 2005-10-13 Korsch Ag Method for achieving a constant pressing force in tableting machines
DE19955196A1 (en) * 1999-11-16 2001-05-23 Korsch Pressen Ag Method to maintain breaking resistance of e.g. washing powder tablets etc. with constant automatic adaptation of dosing resp. compacting rollers to compensate for charging variations
DE19958999A1 (en) * 1999-12-08 2001-04-26 Henkel Kgaa Quality regulation method for pharmaceutical tablet manufacture compares tablet press energy value with reference value for press energy correction
DE50300536D1 (en) 2003-02-10 2005-06-16 Korsch Ag Method and device for controlling a rotary tableting machine
DE102006017196B4 (en) * 2006-04-12 2008-09-11 Fette Gmbh Method of controlling the amount of active ingredient of tablets during production in a rotary tablet press
US8361360B2 (en) 2006-05-15 2013-01-29 Courtoy Nv Method for controlling a tablet press
DE102009004620A1 (en) * 2009-01-15 2010-07-22 Gkn Sinter Metals Holding Gmbh Method for operating a pressing device for the production of compacts of constant height from pulverulent materials, control device for such a pressing device and pressing device
BRPI0925048B8 (en) 2009-05-07 2021-06-22 Gea Pharma Systems Ltd module for tablet production and method for continuous tablet production
DE102017004803A1 (en) * 2017-05-18 2018-11-22 Cosateq Gmbh Method for operating a powder press with layer control and powder press for carrying out the method
DE102018113220A1 (en) * 2018-06-04 2019-12-05 Thilo Kraemer Method for automatically determining limit values of at least one parameter of small-volume bulk goods of a certain type

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Publication number Priority date Publication date Assignee Title
JPS5085661A (en) * 1973-11-30 1975-07-10
JPS61111799A (en) * 1984-11-02 1986-05-29 Hata Tekkosho:Kk Rotary type powder compression molding machine
DE3628757A1 (en) * 1986-08-23 1988-03-03 Fette Wilhelm Gmbh METHOD FOR QUALITY ASSURANCE IN THE PRODUCTION OF TABLETS
FR2607441B1 (en) * 1986-12-02 1992-01-24 Commissariat Energie Atomique INSTALLATION FOR THE MANUFACTURE OF TABLETS OF CONSTANT LINEAR MASS

Also Published As

Publication number Publication date
EP0698481A1 (en) 1996-02-28
ES2130350T5 (en) 2003-11-16
DE59407774D1 (en) 1999-03-18
DE4315680A1 (en) 1994-11-10
ES2130350T3 (en) 1999-07-01
EP0698481B1 (en) 1999-02-03
DE4315680C2 (en) 1996-02-29

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