EP2307837B1 - Method for producing a multilayer compound on a cip-capable coating installation - Google Patents

Method for producing a multilayer compound on a cip-capable coating installation Download PDF

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Publication number
EP2307837B1
EP2307837B1 EP09777292.5A EP09777292A EP2307837B1 EP 2307837 B1 EP2307837 B1 EP 2307837B1 EP 09777292 A EP09777292 A EP 09777292A EP 2307837 B1 EP2307837 B1 EP 2307837B1
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Prior art keywords
drying oven
drying
cleaning
substrate
multilayer composite
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EP09777292.5A
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German (de)
French (fr)
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EP2307837A2 (en
Inventor
Rudi Brathuhn
Peter Schwarz
Wolfgang Schäfer
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LTS Lohmann Therapie Systeme AG
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LTS Lohmann Therapie Systeme AG
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    • FMECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F26DRYING
    • F26BDRYING SOLID MATERIALS OR OBJECTS BY REMOVING LIQUID THEREFROM
    • F26B13/00Machines and apparatus for drying fabrics, fibres, yarns, or other materials in long lengths, with progressive movement
    • FMECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F26DRYING
    • F26BDRYING SOLID MATERIALS OR OBJECTS BY REMOVING LIQUID THEREFROM
    • F26B13/00Machines and apparatus for drying fabrics, fibres, yarns, or other materials in long lengths, with progressive movement
    • F26B13/10Arrangements for feeding, heating or supporting materials; Controlling movement, tension or position of materials
    • F26B13/14Rollers, drums, cylinders; Arrangement of drives, supports, bearings, cleaning
    • FMECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F26DRYING
    • F26BDRYING SOLID MATERIALS OR OBJECTS BY REMOVING LIQUID THEREFROM
    • F26B21/00Arrangements or duct systems, e.g. in combination with pallet boxes, for supplying and controlling air or gases for drying solid materials or objects
    • F26B21/02Circulating air or gases in closed cycles, e.g. wholly within the drying enclosure
    • FMECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F26DRYING
    • F26BDRYING SOLID MATERIALS OR OBJECTS BY REMOVING LIQUID THEREFROM
    • F26B21/00Arrangements or duct systems, e.g. in combination with pallet boxes, for supplying and controlling air or gases for drying solid materials or objects
    • F26B21/02Circulating air or gases in closed cycles, e.g. wholly within the drying enclosure
    • F26B21/022Circulating air or gases in closed cycles, e.g. wholly within the drying enclosure with provisions for changing the drying gas flow pattern, e.g. by reversing gas flow, by moving the materials or objects through subsequent compartments, at least two of which have a different direction of gas flow
    • FMECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F26DRYING
    • F26BDRYING SOLID MATERIALS OR OBJECTS BY REMOVING LIQUID THEREFROM
    • F26B25/00Details of general application not covered by group F26B21/00 or F26B23/00
    • FMECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F26DRYING
    • F26BDRYING SOLID MATERIALS OR OBJECTS BY REMOVING LIQUID THEREFROM
    • F26B25/00Details of general application not covered by group F26B21/00 or F26B23/00
    • F26B25/06Chambers, containers, or receptacles

Definitions

  • FIG. 2 Shown is a single furnace segment Tn of a suitable for the process according to the invention drying oven 5.
  • the furnace segment Tn has an upper housing part 11 which is movable in the direction of arrow up and down, and a lower housing part 12 which is tapered downwards and over has a flow 15. Exactly between the upper housing part 11 and the lower housing part 12 moves to be dried in the furnace segment Tn multilayer composite 14 in the arrow direction from left to right.
  • the air supply 6 can be seen, while the exhaust air 7 exits laterally downwards.

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  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • General Engineering & Computer Science (AREA)
  • Textile Engineering (AREA)
  • Application Of Or Painting With Fluid Materials (AREA)
  • Medicinal Preparation (AREA)
  • Cosmetics (AREA)
  • Cleaning In General (AREA)
  • Cleaning By Liquid Or Steam (AREA)

Description

Die vorliegende Erfindung betrifft ein Herstellverfahren für einen Mehrschichtenverbund, bei dem zuerst eine oder mehrere Schichten auf einem Trägermaterial durch Beschichten mit einer flüssigen Komponente aufgebracht werden, danach der beschichtete Mehrschichtenverbund getrocknet wird und danach der getrocknete Mehrschichtenverbund aufgerollt wird. Der letzte Arbeitsschritt im Verfahren ist das Reinigen der Anlage, das erfindungsgemäß mittels eines CIP-Systems durchgeführt wird, d.h. eines in die Anlage integrierten Systems, das ein "Cleaning-In-Place" ermöglicht.
Ein derartiges Verfahren ist aus der DE 20 2007 016 425 U1 bekannt. Außerdem weist die Vorrichtung aus DE 20 2007 016 425 U1 zum Behandeln einer Substratbahn auf:

  • ein Gehäuse, das mindestens einen Behandlungsabschnitt für die Substratbahn, einen Zufluss und einen Abfluss für ein Medium umfasst,
  • wobei im Behandlungsabschnitt mindestens eine Leitwalze zum Transport der Substratbahn angeordnet ist,
  • wobei zur Beaufschlagung der Substratbahn mit Medium mindestens eine Düsenvorrichtung vorgesehen ist, durch welche das Medium in den Behandlungsabschnitt geleitet werden kann. Dabei ist mindestens eine Leitwalze mit mindestens einer Reinigungsdüse ausgerüstet, durch welche zu Reinigungszwecken flüssige und/oder gasförmige Reinigungssubstanzen in den Behandlungsabschnitt geleitet werden können,
  • wobei der Innenraum jeder Behandlungsabschnitt/ jede Trockenzone zur kontrollierten Reinigung mit Sprühdüsen zum Versprühen einer Reinigungsflüssigkeit ausgestaltet ist,
  • und wobei der Innenraum des Trockenofens totraumfrei ausgeführt ist,
  • wobei alle für die Ablagerung von eventuellen Verunreinigungen in Frage kommenden Ecken und Nischen entweder durch entsprechende technische Konstruktionen ausgeschlossen werden oder durch geeignete Abdeckelemente vor dem Eindringen von Verunreinigungen abgeschirmt sind,
  • wobei alle Transportwalzen, mit denen der beschichtete Mehrschichtverbund durch den Trockenofen und die einzelnen Behandlungsabschnitte / Trockenzonen hindurch bewegt wird, als Hohlwellen ausgestaltet und mit Sprühdüsen ausgerüstet sind,
  • und wobei die Reinigungsflüssigkeit in dem nach unten konisch zulaufend ausgestalteten unteren Gehäuseteil des Trockenofens zusammenfließt und dort über einen Ablauf abgelassen wird.
Neben den bekannten Applikationsformen von Arzneimitteln wie Tabletten, Kapseln, Dragees, Tropfen, Spritzen oder rektalen Applikationsformen gibt es auch die Darreichungsform mittels transdermaler Systeme oder Wafer. Transdermale Systeme und Wafer werden aus bahnförmigen Materialien hergestellt, wobei die Herstellung der bahnförmigen Materialien mehrere aufeinander folgende Schritte wie Beschichten, Trocknen und Aufwickeln auf rollen umfasst. Sie sind beispielsweise in der WO 03/61635 beschreiben. An den eigentlichen Vorgang der Herstellung schließt sich im Betrieb üblicherweise noch als letzter Arbeitsschritt die Reinigung der Anlage an. Die Anlage soll nämlich für die Herstellung einer anderen, neuen Rezeptur möglichst schnell wieder einsatzbereit sein, um unwirtschaftliche Stillstände zu vermeiden. Ferner soll der Reinigungsprozess sicher validierbar sein.
Bei dem Schritt des Beschichtens werden eine oder mehrere flüssige Komponenten mittels einer Beschichtungsanlage auf ein Trägermaterial aufgebracht. Der danach fertig beschichtete Mehrschichtenverbund enthält aber noch einen relativ hohen Anteil an Flüssigkeit, die normalerweise im nächstfolgenden Herstellschritt durch Hitze entfernt wird.
Der fertig beschichtete Mehrschichtenverbund wird daher zum Trocknen einem Trockenofen zugeführt, der vorzugsweise in kontinuierlicher Fahrweise betrieben wird. Der Trockenofen kann eine oder mehrere Trockenzonen umfassen. Die einzelnen Trockenzonen unterscheiden sich dabei durch ihre jeweils unterschiedlichen Temperaturen und Luftmengen. Daneben soll jede Trockenzone ihre eigene Luftregelung besitzen, in die üblicherweise auch noch Filter- und Heizelemente integriert sind. Durch die Einwirkung der Wärme im Trockenofen auf den beschichteten Mehrschichtverbund gelangt die Feuchtigkeit aus dem beschichteten Mehrschichtverbund in den Luftstrom. Um die Feuchtigkeit im Luftkreislauf stabil zu halten, muss trockene Frischluft zugeführt werden, mit der die verbrauchte feuchte Luft ersetzt wird. Schwankungen der Feuchtigkeit in der Frischluftzufuhr wirken sich unmittelbar aus auf die Effizienz der Trocknung und mittelbar auf die Qualitätseigenschaften des fertigen Produkts, das nicht zu feucht, aber auch nicht zu trocken sein soll.The present invention relates to a production method for a multi-layer composite, in which first one or more layers are applied to a carrier material by coating with a liquid component, after which the coated multilayer composite is dried and then the dried multilayer composite is rolled up. The last step in the process is the cleaning of the plant, which is carried out according to the invention by means of a CIP system, ie an integrated system in the system, which enables a "cleaning-in-place".
Such a method is known from DE 20 2007 016 425 U1 known. In addition, the device turns off DE 20 2007 016 425 U1 for treating a substrate web on:
  • a housing comprising at least a treatment section for the substrate web, an inflow and outflow for a medium,
  • wherein in the treatment section at least one guide roller for transporting the substrate web is arranged,
  • wherein for applying the substrate web with medium at least one nozzle device is provided, through which the medium can be passed into the treatment section. In this case, at least one guide roller is equipped with at least one cleaning nozzle, through which cleaning and / or gaseous cleaning substances can be conducted into the treatment section for cleaning purposes,
  • wherein the interior space of each treatment section / drying zone is designed for controlled cleaning with spray nozzles for spraying a cleaning liquid,
  • and wherein the interior of the drying oven is executed dead space free,
  • all the corners and niches which may be considered for the deposition of any impurities, either by appropriate technical Structures are excluded or shielded by suitable cover elements from the ingress of contaminants,
  • wherein all transport rollers with which the coated multi-layer composite is moved through the drying oven and the individual treatment sections / drying zones are designed as hollow shafts and equipped with spray nozzles,
  • and wherein the cleaning liquid flows together in the downward conically designed lower housing part of the drying oven and is discharged there via an outlet.
In addition to the known application forms of pharmaceuticals such as tablets, capsules, dragees, drops, syringes or rectal administration forms, there is also the dosage form by means of transdermal systems or wafers. Transdermal systems and wafers are made of sheet-like materials, and the manufacture of the sheet-like materials involves several sequential steps such as coating, drying and roll-winding. For example, you are in the WO 03/61635 describe. The actual process of production is usually followed by cleaning of the plant during operation as the last step. The plant should namely be ready for use as quickly as possible to produce another, new recipe to avoid uneconomic downtime. Furthermore, the cleaning process should be validatable safely.
In the coating step, one or more liquid components are applied to a substrate by means of a coater. However, the subsequently coated multilayer composite still contains a relatively high proportion of liquid, which is normally removed by heat in the next production step.
The finished coated multi-layer composite is therefore supplied for drying a drying oven, which is preferably operated in a continuous mode. The drying oven may comprise one or more drying zones. The individual drying zones differ in their different temperatures and air volumes. In addition, each drying zone should have its own air control, in which usually also filter and heating elements are integrated. Due to the action of heat in the Drying oven on the coated multi-layer composite passes the moisture from the coated multi-layer composite in the air flow. In order to keep the humidity in the air circulation stable, dry fresh air must be supplied, with which the used moist air is replaced. Fluctuations in the humidity in the fresh air supply have an immediate effect on the efficiency of the drying and indirectly on the quality characteristics of the finished product, which should not be too moist, but also not too dry.

Der aus dem Trockenofen austretende getrocknete Mehrschichtenverbund wird sofort auf Rollen aufgewickelt.The dried multilayer composite emerging from the drying oven is immediately wound on rolls.

Während der fertig getrocknete und aufgerollte Mehrschichtverbund wahlweise zwischengelagert oder abtransportiert wird, steht im Betrieb die vollständige Reinigung der Anlage an, die möglichst rasch, aber zugleich auch so gründlich durchgeführt werde soll, dass eine "Crosscontamination", d.h. eine Übertragung von Spuren von Inhaltsstoffen des im vorherigen Produktionsdurchlauf in der Anlage produzierten Materials auf das in der Anlage im nachfolgenden Produktionsdurchlauf produzierte Material, mit Sicherheit ausgeschlossen wird. Diese besonders gründliche Reinigungsmethode wird in der Fachsprache auch als GMP-gerecht bezeichnet (siehe dazu Wikipedia, freie Enzyklopädie im Internet). In Kombination damit soll die besonders unwirtschaftliche Stillstandszeit der Anlage auf eine möglichst kurze Zeitdauer verkürzt werden.While the ready-dried and rolled-up multi-layer composite is either temporarily stored or transported away, in the operation of the complete cleaning of the plant is to be performed as quickly as possible but at the same time so thoroughly that a "Cross Contamination", i. a transfer of traces of ingredients of the material produced in the previous production run in the plant to the material produced in the plant in the subsequent production run, is excluded with certainty. This particularly thorough cleaning method is referred to in the jargon as GMP-fair (see Wikipedia, free encyclopedia on the Internet). In combination, the particularly uneconomic downtime of the system should be shortened to a shortest possible duration.

Aufgabe der vorliegenden Erfindung war es daher, ein einfaches, gleichzeitig aber auch garantiert sicheres Reinigungsverfahren für den Trockenofen in der Beschichtungsanlage anzugeben, das unter wirtschaftlichen Bedingungen großtechnisch durchgeführt werden kann. Gleichzeitig soll damit die Trocknung des beschichteten Mehrschichtverbundes optimal auf die Anforderungen transdermaler Applikationssysteme oder Wafer einzustellen sein, dazu gehört, dass der Trockenofen mehrere Trockenzonen mit kontrollierter Luftführung besitzt, wobei in den einzelnen Trockenzonen eine präzise und individuelle Regelung der Luftfeuchtigkeit jederzeit gewährleistet sein muss.Object of the present invention was therefore to provide a simple, but also guaranteed safe cleaning process for the drying oven in the coating plant, which can be carried out on an industrial scale under economic conditions. At the same time the drying of the coated multi-layer composite should be optimally adjusted to the requirements of transdermal application systems or wafers, including that the drying oven has several drying zones with controlled air flow, in the individual drying zones a precise and individual control of humidity must be ensured at all times.

Gelöst wird diese Aufgabe durch ein Verfahren der eingangs genannten Gattung, dessen Kennzeichenmerkmale darin zu sehen sind, dass während der Trocknung des beschichteten Mehrschichtenverbundes im Trockenofen mit mindestens zwei Trockenzonen der Luftkreislauf jeder Trockenzone vollständig auf Frischluftzufuhr eingestellt wird und jede individuelle Trockenzone über eine unabhängig von allen anderen Trockenzonen regulierbare Konditionierung des zugeführten Frischluftstromes verfügt, wobei die durch eine Luftzufuhr eintretende Luft über ein kombiniertes Heiz-Düsen-System auf den zu trocknenden Mehrschichtenverbund appliziert wird.This object is achieved by a method of the type mentioned, whose characteristics are to be seen in that during the Drying of the coated multi-layer composite in a drying oven with at least two drying zones of the air cycle of each drying zone is completely adjusted to fresh air supply and each individual drying zone via an independent of all other drying zones regulatable conditioning of the supplied fresh air flow, wherein the air entering through an air supply via a combined heating nozzles -System is applied to the multi-layer composite to be dried.

Als Trägermaterial für den Mehrschichtenverbund eignen sich bahnförmige Materialien wie Papierbahnen oder Textilbahnen in Form von Geweben oder Vliesen aus natürlichen oder künstlichen Fasern, es können aber auch Folien aus Kunststoff eingesetzt werden, die ggf. mit Löchern versehen sein können.As a carrier material for the multilayer composite are web-like materials such as paper webs or textile webs in the form of woven or nonwoven fabrics of natural or artificial fibers, but it can also be used plastic films, which may optionally be provided with holes.

Als flüssige Komponente für die Beschichtung des Trägermaterials kommen für das erfindungsgemäße Verfahren im wesentlichen organische Rohstoffe in Mischung mit Wasser und/oder organischen Lösemitteln in Frage. Auch Mischungen organischer Rohstoffe, die wasserlöslich oder in Wasser suspendierbar sind, eignen sich bestens. Beispiele solcher organischer Rohstoffe sind Polymere wie Polyvinylalkohol, Polyvinylpyrrolidon, Cellulosederivate, Polyvinylacetat, Polyethylenglykol, Alginate, Xanthate, Gelatine und andere mehr oder weniger wasserlösliche Polymere, die der Fachmann kennt. Falls gewünscht, können die flüssigen Komponenten noch weitere Füllstoffe enthalten wie Mannitol, Lactose, Kalziumphosphate, Glucose oder Sorbinsäurederivate. Ferner eigenen sich Zusätze von aktiven Substanzen wie Arzneimittel, Aromastoffe, Menthol, Glutamat und andere Zusatzstoffe, teilweise auch flüchtiger Art.Suitable liquid components for the coating of the support material for the process according to the invention are essentially organic raw materials mixed with water and / or organic solvents. Even mixtures of organic raw materials that are water-soluble or suspendable in water, are ideal. Examples of such organic raw materials are polymers such as polyvinyl alcohol, polyvinylpyrrolidone, cellulose derivatives, polyvinyl acetate, polyethylene glycol, alginates, xanthates, gelatin and other more or less water-soluble polymers known to those skilled in the art. If desired, the liquid components may contain other fillers such as mannitol, lactose, calcium phosphates, glucose or sorbic acid derivatives. Furthermore, additions of active substances are appropriate Substances such as medicines, flavors, menthol, glutamate and other additives, sometimes volatile.

Das Beschichten des Trägermaterials mit einer oder mit mehreren flüssigen Komponenten erfolgt erfindungsgemäß nach üblichen Auftragstechniken. Die flüssigen Komponenten können auf das Trägermaterial z. B. aufgegossen, mit Hilfe von Walzen oder mit anderen, dem Fachmann einschlägig bekannten Verfahren aufgetragen werden.The coating of the carrier material with one or more liquid components is carried out according to the invention by conventional application techniques. The liquid components can be applied to the substrate z. B. poured, with the help of rollers or with other, the expert known in the art processes are applied.

Für das Reinigen der Beschichtungsanlage werden alle mit dem Trägermaterial und/oder mit der oder den flüssigen Komponenten in Berührung kommenden Anlagenteile mit einer CIP (= Cleaning-In-Place)-Technik gründlich gereinigt. Ferner besteht Reinigungsbedarf für die restlichen Anlagenteile insbesondere dann, wenn sich das Beschichtungsgut während des Beschichtungsvorganges auch nur im geringsten Maße vom Trägermaterial gelöst hat und/oder Inhaltsstoffe des Beschichtungsgutes beim Beschichtungsvorgang verdampfen und sich in der Beschichtungsanlage niederschlagen.For cleaning the coating system, all parts of the system which come into contact with the carrier material and / or with the liquid component (s) are thoroughly cleaned with a CIP (= Cleaning-In-Place) technique. Furthermore, there is a need for cleaning the remaining parts of the system, in particular when the coating material has dissolved even during the coating process even the slightest extent from the carrier material and / or evaporate the ingredients of the coating material during the coating process and precipitate in the coating system.

Der Trockenofen, der für das erfindungsgemäße Verfahren eingesetzt wird, besitzt vorzugsweise mindestens zwei, besonders bevorzugt bis zu vierzehn Trockenzonen, in denen der Luftkreislauf vollständig auf Frischluftzufuhr eingestellt ist. Die Zuluftdüsen sind dabei so ausgestaltet, dass sie in jeder Trockenzone eine gleichmäßige Belüftung der gesamten Oberfläche des in der jeweiligen Trockenzone befindlichen beschichteten Mehrschichtverbundes mit dem konditionierten Frischluftstrom ermöglichen. Dabei verfügt jede individuelle Trockenzone in dem Trockenofen über eine unabhängig von allen anderen Trockenzonen regulierbare Konditionierung des zugeführten Frischluftstromes. So ist gewährleistet, dass in jeder Trockenzone die optimalen Trockenbedingungen über die Luftmenge, die Lufttemperatur und die Luftfeuchtigkeit genau eingestellt werden können.The drying oven used for the process according to the invention preferably has at least two, more preferably up to fourteen, drying zones in which the air circuit is completely set to fresh air supply. The supply air nozzles are designed so that they allow uniform ventilation of the entire surface of the present in the respective drying zone coated multi-layer composite with the conditioned fresh air flow in each drying zone. Each individual drying zone in the drying oven has a conditioning of the supplied fresh air flow which can be regulated independently of all other drying zones. This ensures that the optimum drying conditions can be precisely set in each drying zone via the air volume, the air temperature and the humidity.

Der Trockenofen, der für das erfindungsgemäße Verfahren eingesetzt wird, ist vorzugsweise so konstruiert, dass sein gesamter Innenraum kontrolliert reinigbar und leicht zugänglich ist. Das bedeutet insbesondere, dass alle Bauteile des Trockenofens, die mit dem darin produzierten Produkt in Berührung kommen können, zum Zweck der Reinigung nicht ausgebaut werden müssen, sondern mit Hilfe des in den Trockenofen integrierten Systems in CIP-Technik gereinigt werden können. Das äußere Gehäuse des Trockenofens ist dabei so ausgestaltet, dass der obere Teil des Trockenofens nach oben abgehoben werden kann, um so die einfache Zugänglichkeit für den oberen und unteren Teil des Trockenofens zu gewährleisten. Das dient dazu, den Reinigungserfolg der CIP-Technik zu kontrollieren. Alle Einbauteile im Innern des Trockenofens sind so ausgestaltet, dass eine Demontage zu Reinigungszwecken nicht notwendig ist. Darüber hinaus ist der Innenraum des Trockenofens totraumfrei ausgeführt. Das bedeutet, dass alle für die Ablagerung von eventuellen Verunreinigungen in Frage kommenden Ecken und Nischen durch entsprechende technische Konstruktion nicht auftreten oder, wenn doch, dann durch geeignete Abdeckelemente vor dem Eindringen von Verunreinigungen abgeschirmt sind.The drying oven used for the process according to the invention is preferably designed so that its entire interior can be cleaned in a controlled manner and easily accessible. This means in particular that all components of the drying oven, which can come into contact with the product produced therein, need not be removed for the purpose of cleaning, but can be cleaned with the help of integrated in the drying oven system in CIP technology. The outer housing of the drying oven is designed so that the upper part of the drying oven can be lifted upwards, so as to ensure easy accessibility for the upper and lower part of the drying oven. This serves to control the cleaning success of the CIP technique. All built-in parts inside the drying oven are designed in such a way that disassembly for cleaning purposes is not necessary. In addition, the interior of the drying oven is executed dead space free. This means that all corners and niches that may be considered for the deposition of possible impurities do not occur through appropriate technical construction or, if so, are then shielded from the ingress of contaminants by suitable cover elements.

Alle Transportwalzen, mit denen der beschichtete Mehrschichtverbund durch den Trockenofen und die verschiedenen Trockenzonen hindurch bewegt wird, sind vorzugsweise als Hohlwellen ausgestaltet und mit Sprühdüsen ausgerüstet. Wenn sie an eine Hochdruckpumpe angeschlossen sind, ermöglicht das eine sehr schnelle Reinigung dieser Transportwalzen von innen heraus sowie gleichzeitig auch die Reinigung ihrer unmittelbaren Umgebung innerhalb des Trockenofens, ohne dass dazu ein Ausbau dieser Teile des Trockenofens notwendig wird. Die Sprühdüsen sind erfindungsgemäß so angeordnet, dass alle Bereiche des Innenraums des Trockenofens mittels der CIP-Technik erreicht werden und so kontrolliert reinigbar sind. Die Transportwalzen drehen sich vorzugsweise während des Reinigungsprozesses langsam, was die Reinigungswirkung im gesamten Innenraum des Trockenofens optimiert. Die für die Reinigung benötigte Reinigungsflüssigkeit sammelt sich in dem nach unten konisch ausgebildeten Boden des Trockenofens und kann dort entweder der Hochdruckpumpe wieder zugeführt oder einfach abgelassen oder mit Hilfe einer Pumpe entfernt werden. Somit kann ein Reinigungsverfahren eindeutig charakterisiert und validiert werden.All transport rollers with which the coated multi-layer composite is moved through the drying oven and the various drying zones are preferably designed as hollow shafts and equipped with spray nozzles. When connected to a high-pressure pump, this enables very fast cleaning of these transport rollers from the inside as well as the cleaning of their immediate environment within the drying oven, without the need to dismantle these parts of the drying oven. The spray nozzles are arranged according to the invention so that all areas of the interior of the drying oven are achieved by means of the CIP technique and are controlled so cleanable. The transport rollers preferably rotate slowly during the cleaning process, which optimizes the cleaning effect in the entire interior of the drying oven. The cleaning fluid needed for the cleaning collects in the downwardly conical bottom of the drying oven and can either be fed back to the high pressure pump or simply drained or removed by means of a pump. Thus, a purification process can be uniquely characterized and validated.

Der nach dem erfindungsgemäßen Verfahren hergestellte Mehrschichtenverbund eignet sich insbesondere zur Verwendung als transdermales System zur Applikation von Arzneimitteln oder Kosmetika oder für die Applikation in Körperhöhlen.The multilayer composite produced by the process according to the invention is particularly suitable for use as a transdermal system for the application of medicaments or cosmetics or for application in body cavities.

Die Erfindung soll beispielhaft für den Fachmann durch die beigefügten Zeichnungen gemäß Figur 1 und Figur 2 noch deutlicher erläutert werden.

  • Figur 1 zeigt schematisch, wie ein Mehrschichtenverbund erfindungsgemäß in einem Mehrstufenverfahren hergestellt wird.
  • Figur 2 zeigt in schematischer Darstellung einen senkrechten Schnitt durch ein Segment eines für das erfindungsgemäße Verfahren geeigneten Trockenofens in seitlicher Ansicht.
The invention will be described by way of example by those skilled in the art by the accompanying drawings FIG. 1 and FIG. 2 be explained more clearly.
  • FIG. 1 shows schematically how a multi-layer composite according to the invention is prepared in a multi-stage process.
  • FIG. 2 shows a schematic representation of a vertical section through a segment of a suitable for the process according to the invention drying oven in a side view.

Mit Hilfe von Bezugszeichen ist in Figur 1 die Abwicklung 1 des Trägermaterials 2 dargestellt. Das abgewickelte Trägermaterial 2 wird in der nachgeschalteten Beschichtungsstation 3 mit einer oder mit mehreren flüssigen Komponenten beschichtet. Danach wird das beschichtete Trägermaterial 4 dem Trockenofen 5 zugeführt, der in der Ausführungsform nach Figur 1 mehrere Trockenzonen T1, T2, T3, Tx-1 und Tx umfasst. Am oberen Teil des Trockenofens 5 ist die Luftzufuhr 6 dargestellt, während die Abluft 7 im unteren Teil des Trockenofens 5 gesammelt und seitlich abgeführt wird. Der an der Trockenstation Tx den Trockenofen 5 verlassende, getrocknete Mehrschichtverbund 8 wird über eine Ablenkrolle 9 der Aufrollstation 10 zugeleitet und dort aufgerollt.With the help of reference numerals is in FIG. 1 the settlement 1 of the carrier material 2 shown. The unwound substrate 2 is coated in the downstream coating station 3 with one or more liquid components. Thereafter, the coated substrate 4 is fed to the drying oven 5, which in the embodiment according to FIG. 1 several drying zones T1, T2, T3, Tx-1 and Tx. At the upper part of the drying oven 5, the air supply 6 is shown, while the exhaust air 7 is collected in the lower part of the drying oven 5 and discharged laterally. The dried multi-layer composite 8 leaving the drying oven 5 at the drying station Tx is fed via a deflection roller 9 to the reeling station 10 and rolled up there.

In Figur 2 haben gleiche Bezugszeichen die gleiche Bedeutung wie in Figur 1. Dargestellt ist ein einzelnes Ofensegment Tn eines für das erfindungsgemäße Verfahren geeigneten Trockenofens 5. Das Ofensegment Tn besitzt ein oberes Gehäuseteil 11, das in Pfeilrichtung nach oben und nach unten beweglich ist, und ein unteres Gehäuseteil 12, das nach unten konisch zulaufend ausgebildet ist und über einen Ablauf 15 verfügt. Genau zwischen dem oberen Gehäuseteil 11 und dem unteren Gehäuseteil 12 bewegt sich der in dem Ofensegment Tn zu trocknende Mehrschichtenverbund 14 in Pfeilrichtung von links nach rechts. Im oberen Teil des Ofensegmentes Tn ist die Luftzufuhr 6 zu erkennen, während die Abluft 7 nach unten seitlich austritt. Die durch die Luftzufuhr 6 eintretende Luft wird über ein kombiniertes Heiz-Düsen-System 16 auf den zu trockenenden Mehrschichtenverbund 14 appliziert, welcher mit Hilfe von Leitrollen 17, die mit nicht dargestellten Sprühdüsen ausgerüstet sind, durch das Trockensegment Tn in Pfeilrichtung von links nach rechts bewegt wird.In FIG. 2 Like reference numerals have the same meaning as in FIG FIG. 1 , Shown is a single furnace segment Tn of a suitable for the process according to the invention drying oven 5. The furnace segment Tn has an upper housing part 11 which is movable in the direction of arrow up and down, and a lower housing part 12 which is tapered downwards and over has a flow 15. Exactly between the upper housing part 11 and the lower housing part 12 moves to be dried in the furnace segment Tn multilayer composite 14 in the arrow direction from left to right. In the upper part of the furnace segment Tn, the air supply 6 can be seen, while the exhaust air 7 exits laterally downwards. The air entering through the air supply 6 is applied via a combined heating nozzle system 16 to be dried multi-layer composite 14, which by means of guide rollers 17 which are equipped with spray nozzles, not shown, through the dry segment Tn in the arrow direction from left to right is moved.

Claims (8)

  1. A production process for a multilayer composite (14), in which one or more layers are firstly applied to a substrate by coating using a liquid component, the coated multilayer composite (14) is dried thereafter and the dried multilayer composite (14) is thereafter rolled up, wherein the installation is cleaned as a final step, wherein the air circulation of each drying zone (T1, T2) is set entirely to fresh air supply during the drying of the coated multilayer composite (14) in the drying oven (5) having at least two drying zones (T1, T2) and each individual drying zone has a conditioning of the supplied fresh air flow that can be controlled independently of all other drying zones, wherein the air entering through an air supply (6) is applied to the multilayer composite (14) to be dried via a combined heating-nozzle system (16) and wherein the interior of each drying zone (T1, T2) is embodied with spray nozzles for spraying a cleaning fluid for controlled cleaning purposes, and wherein the interior of the drying oven (5) does not have dead space, wherein all corners and nooks that are susceptible to the deposition of possible contaminants are either excluded by appropriate technical designs or screened from contaminants penetrating therein by suitable cover elements, wherein all transport rollers (17), by means of which the coated multilayer composite (14) is moved through the drying oven (5) and the individual drying zones (T1 to Tx), are embodied as hollow shafts and equipped with spray nozzles, wherein the transport rollers (17) embodied as hollow shafts and equipped with spray nozzles are connected to a high-pressure pump, which pumps the cleaning fluid through the transport rollers and into the spray nozzles integrated into the transport rollers, and wherein the cleaning fluid flows together in the lower housing part (12) of the drying oven (5), which lower housing part has a design that tapers in a conical fashion toward the bottom, from where said cleaning fluid is drained via an outflow (15) or returned to the high-pressure pump with the aid of a pump or removed.
  2. The process as claimed in claim 1, wherein web-shaped materials such as paper webs or textile webs in the form of fabrics or nonwovens from natural or artificial fibers are utilized as a substrate (2), but plastics films may also be utilized, which can optionally be provided with holes as well.
  3. The process as claimed in claim 1 or 2, wherein, as the liquid component for the coating of the substrate (2), use is substantially made of organic raw materials in a mixture with water, more particularly mixtures of organic raw materials, which are water-soluble or can be suspended in water, such as polyvinyl alcohol, polyvinyl pyrrolidone, cellulose derivatives, polyvinyl acetate, polyethylene glycol, alginates, xanthates, gelatins and other water-soluble polymers.
  4. The process as claimed in claim 3, wherein the liquid component for coating the substrate (2) additionally contains further fillers such as mannitol, lactose, calcium phosphates, glucose or sorbic-acid derivatives, and wherein it additionally contains additives of active substances such as active ingredients, flavorings, menthol, glutamate and other additives, partly also of a volatile type.
  5. The process as claimed in one or more of claims 1 to 4, wherein the substrate (2) is coated with one or more liquid components according to conventional application techniques, in which the liquid components are poured onto the substrate or applied with the aid of rollers.
  6. The process as claimed in one or more of claims 1 to 5, wherein the drying oven (5) for the process is constructed such that its entire interior is suitable for controlled cleaning and can be cleaned using the CIP technique with the aid of the system integrated into the drying oven (5).
  7. The process as claimed in one or more of claims 1 to 6, wherein the outer housing of the drying oven (5) is embodied such that the upper part (11) of the drying oven (5) can be lifted upward and wherein all fixtures inside the drying oven (5) are embodied such that cleaning does not require disassembly.
  8. The process as claimed in one or more of claims 1 to 7, wherein the transport rollers (17) rotate during the cleaning process.
EP09777292.5A 2008-07-24 2009-07-20 Method for producing a multilayer compound on a cip-capable coating installation Active EP2307837B1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102008034453A DE102008034453A1 (en) 2008-07-24 2008-07-24 Method for producing a multi-layer composite on a CIP-capable coating system and use of the multilayer composite produced therewith for transdermal application or application in body cavities
PCT/EP2009/005239 WO2010009848A2 (en) 2008-07-24 2009-07-20 Method for producing a multilayer compound on a cip-capable coating installation and use of the multilayer compound produced by said method for transdermal application or the application in body cavities

Publications (2)

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EP2307837A2 EP2307837A2 (en) 2011-04-13
EP2307837B1 true EP2307837B1 (en) 2018-09-05

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US (1) US8864047B2 (en)
EP (1) EP2307837B1 (en)
JP (2) JP2011528613A (en)
KR (1) KR101629527B1 (en)
CN (1) CN102099650B (en)
AU (1) AU2009273514B2 (en)
BR (1) BRPI0916291B1 (en)
CA (1) CA2731600C (en)
DE (1) DE102008034453A1 (en)
ES (1) ES2700654T3 (en)
HK (1) HK1158302A1 (en)
IL (1) IL210727A (en)
MX (1) MX2011000827A (en)
NZ (1) NZ590407A (en)
RU (1) RU2530120C2 (en)
WO (1) WO2010009848A2 (en)
ZA (1) ZA201100131B (en)

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CN110131983A (en) * 2018-02-02 2019-08-16 丹东金丸集团有限公司 A kind of capsule full automatic drying process and the drying unit for implementing this method
CN108469174B (en) * 2018-03-09 2020-07-24 河北陶菊农业科技有限公司 Automatic medicinal daisy stoving frame paves
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ZA201100131B (en) 2011-09-28
JP6498717B2 (en) 2019-04-10
CA2731600C (en) 2017-01-03
IL210727A0 (en) 2011-03-31
AU2009273514A1 (en) 2010-01-28
HK1158302A1 (en) 2012-07-13
RU2011102258A (en) 2012-07-27
EP2307837A2 (en) 2011-04-13
MX2011000827A (en) 2011-02-25
US8864047B2 (en) 2014-10-21
JP2017159299A (en) 2017-09-14
KR20110049776A (en) 2011-05-12
BRPI0916291B1 (en) 2020-04-28
NZ590407A (en) 2013-05-31
AU2009273514B2 (en) 2016-04-21
WO2010009848A3 (en) 2010-10-28
DE102008034453A1 (en) 2010-02-11
CN102099650A (en) 2011-06-15
JP2011528613A (en) 2011-11-24
CA2731600A1 (en) 2010-01-28
US20110117177A1 (en) 2011-05-19
ES2700654T3 (en) 2019-02-18
CN102099650B (en) 2016-03-16
RU2530120C2 (en) 2014-10-10
KR101629527B1 (en) 2016-06-10
WO2010009848A2 (en) 2010-01-28
IL210727A (en) 2015-07-30

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