EP3939896A1 - Functional module for bringing to a dosing station positioned in a processing chamber of a containment and method for same - Google Patents

Abstract

The designed functional module (2) is intended to be brought to a dosing station (3) positioned in a process space (93) of a containment (9) and there for the aseptic filling of vessels with a liquid. The containment (9) is intended for placement in an installation room (8), the containment (9) and process room (93) being enclosed by a housing (90). The functional module (2) comprises an element carrier (23), functional elements (230) intended for installation on the element carrier (23), and medium lines (231) which are connected to the functional elements (230). The assembly as a module, consisting of element carrier (23), functional elements (230) accommodated by it and medium lines (231) connected to it, can be moved from a retracted initial position through a transfer port (260) leading into the process space (93) to an extended working position the dosing station (3) is movable. The function module (2) serves to aseptically fill a plurality of vessels, which are combined in a container, with a pharmacological or toxic liquid. In a second embodiment, the functional module (2) has a gas-tight container (28) with a sterilized interior (29) in which an assembled and sterilized assembly consisting of the element carrier (23), the functional elements (230) and connected to it medium lines (231) is housed. Finally, a method for bringing the functional module (2) to the dosing station (3) positioned in the process space (93) is proposed.

Description

Field of application of the invention

The invention relates to a functional module for leading to a dosing station positioned in a process space of a containment and is provided there for the aseptic filling of vessels with a liquid. The containment is intended for placement in an installation room, with the containment and process room being enclosed in a housing. The functional module comprises an element carrier, functional elements intended for installation on the element carrier and medium lines intended for connection to the functional elements. Furthermore, the subject matter of the invention is a method for bringing the conceived functional module to the dosing station.

State of the art

Until now, the components of functional modules for dosing stations on filling machines for the aseptic filling of liquids in containers, in particular vials for pharmaceuticals, first had to be introduced into the process space of containments using Rapid Transfer Ports (RTP). The components are then assembled in the process room, so that manual intervention in the process room is necessary. This workflow is time-consuming, involves risk with regard to incorrect manipulations and the entry of contamination, and is expensive in terms of plant technology.

object of the invention

In view of the hitherto incomplete solution in the technical field outlined according to the prior art above, the invention is based on the object of at least reducing manual activities in the process room and thereby making the workflow more efficient in terms of time expenditure, less error-prone, higher quality and with little outlay on equipment. In particular, there is a risk of contamination from manual activities in the process room rule out. For this purpose, a special device has to be developed and a method using the device has to be proposed.

Overview of the invention

The designed functional module is intended for the introduction to a dosing station positioned in a process room of a containment and there for the aseptic filling of vessels with a liquid. The containment is intended for placement in an installation room, with the containment and process room being enclosed in a housing. The functional module includes an element carrier, functional elements that are intended for installation on the element carrier, and medium lines that are connected to the functional elements. The assembly as an assembly, consisting of element carrier, functional elements accommodated by this and medium lines connected to it, can be moved from a retracted initial position through a transfer port leading into the process space into an extended working position at the dosing station.

Particularly advantageous details of the function module are given below: The function module is used for the aseptic filling of a plurality of vessels, which are combined in a container, with a pharmacological or toxic liquid. When handling liquids that are sensitive to oxygen, they are overlaid with an inert gas, e.g. nitrogen. The containment housing has a rear wall that delimits the process space as a component. The transfer port is formed by an opening provided in a molding of a flanged joint installed in the back panel.

1. a) eine Transfer-Armatur, vorzugsweise als Rapid Transfer Port (RTP) ausgebildet, bestimmt zum geschützten Einschleusen der vorsterilisierten Funktionselemente und Mediumsleitungen in die Transferzelle; und
2. b) Handschuheingriffe, in der Regel paarweise, um unter Wahrung der sterilen Atmosphäre in der Transferzelle Tätigkeiten auszuführen, insbesondere Montagearbeiten, nämlich die Bestückung des Elementeträgers mit Funktionselementen und daran anzuschliessende Mediumsleitungen.

Especially in the case of the first version of the function module, the element carrier has a front piece that is fixed at the front and an end piece that is fixed at the rear. The front piece comes to rest in the retracted initial position in the transfer port. The end piece, on the other hand, is designed to hit the transfer port in the extended working position and to allow passage for the medium lines leading to the functional module. The function module installed at the transfer port protrudes into a retracted initial position transfer cell adjacent to the process space. The transfer port forms an interface between the process room and the transfer cell. In an outer wall belonging to the containment housing, which delimits the transfer cell to the installation room, the following are provided:

1. a) a transfer fitting, preferably designed as a rapid transfer port (RTP), intended for the protected introduction of the pre-sterilized functional elements and medium lines into the transfer cell; and
2. b) Glove handles, usually in pairs, in order to carry out activities while maintaining the sterile atmosphere in the transfer cell, in particular assembly work, namely equipping the element carrier with functional elements and medium lines to be connected to it.

1. a) ein gasdichtes Behältnis mit einem sterilisierten Innenraum; und
2. b) eine im Behältnis montierte und sterilisierte Baugruppe, bestehend aus dem Elementeträger, von diesem aufgenommenen Funktionselementen und daran angeschlossenen Mediumsleitungen, die zu einem externen Anschluss bzw. zu externen Anschlüssen führen, sowie dem zuvorderst am Elementeträger fest angeordneten Frontstück.

In der eingefahrenen Ausgangsstellung steht die Baugruppe innerhalb des Behältnisses und dabei schliesst das Frontstück eine Passage am Behältnis gasdicht ab. Zum Erreichen der Arbeitsstellung ist die Baugruppe, mit dem Frontstück voran, aus dem Behältnis heraus durch den Transferport in den Prozessraum an die Dosierstation bewegbar.Especially with the second version of the function module, this shows:

1. a) a gas-tight container with a sterilized interior; and
2. b) an assembly assembled and sterilized in the container, consisting of the element carrier, functional elements accommodated by it and medium lines connected to it, which lead to an external connection or to external connections, as well as the front piece firmly arranged at the element carrier.

In the retracted initial position, the assembly is within the container and the front piece closes a passage on the container in a gas-tight manner. To reach the working position, the assembly can be moved, with the front piece first, out of the container through the transfer port into the process space at the dosing station.

1. a) ein oder mehrere aussen am Behältnis sitzende Anschlüsse, mit denen die Mediumsleitungen aus dem Inneren des Behältnisses verbunden sind, wobei der bzw. die Anschlüsse zum Verbinden mit zumindest einer Versorgungsleitung bestimmt sind; und
2. b) ein aussen am Behältnis vorhandenes Stellorgan für das Bewegen der Baugruppe, bestehend aus Elementeträger mit Frontstück, vom Elementeträger aufgenommenen Funktionselementen und daran angeschlossenen Mediumsleitungen.

The function module has:

1. a) one or more connections located on the outside of the container, with which the medium lines from the interior of the container are connected, the connection(s) being intended for connection to at least one supply line; and
2. b) an actuator on the outside of the container for moving the assembly, consisting of an element carrier with a front piece, functional elements accommodated by the element carrier and medium lines connected to it.

The function module is installed at the transfer port in such a way that it protrudes into a transfer cell adjacent to the process room and can extend into the installation room, or the function module extends completely freely into the installation room. The external connection or the external connections and an actuator for moving the assembly, consisting of an element carrier with a front piece, functional elements accommodated by the element carrier and medium lines connected to them, are accessible from the installation room. The transfer cell can be open to the installation room, e.g. due to a wall opening in the outer wall.

1. a) ausserhalb des Prozessraums Bereitstellung des Elementeträgers mit den bestückten Funktionselementen und den daran angeschlossenen Mediumsleitungen; und
2. b) Heranführen der montierten Baugruppe, bestehend aus Elementeträger, von diesem aufgenommenen Funktionselementen und daran angeschlossenen Mediumsleitungen, im dekontaminierten bzw. sterilisierten Zustand, aus der eingefahrenen Ausgangsstellung, durch den in der den Prozessraum begrenzenden Gehäusewand vorgesehenen abgedichteten Transferport in die ausgefahrene Arbeitsstellung an die Dosierstation.

Especially when using the first version of the function module, the following essential procedural steps are carried out:

1. a) Outside of the process room, provision of the element carrier with the equipped functional elements and the medium lines connected to it; and
2. b) Bringing the assembled assembly, consisting of element carrier, functional elements accommodated by it and medium lines connected to it, in the decontaminated or sterilized state, from the retracted starting position through the sealed transfer port provided in the housing wall delimiting the process space into the extended working position at the dosing station .

Particularly advantageous details of the method when using the first version of the function module are given below: In a transfer cell adjacent to the process room and hermetically sealable from the installation room, the provision and assembly of element carriers with function elements and medium lines takes place while maintaining aseptic conditions. When the element carrier is partially extended into the process space, the front piece that is firmly attached to the element carrier opens the transfer port between the process space and the transfer cell. In this position, the process space, transfer cell is decontaminated by introducing decontamination means, preferably from the process space and at the same time from the transfer cell and element carrier. The pre-sterilized functional elements and medium lines are then introduced into the transfer cell through the transfer fitting, while maintaining aseptic conditions. Finally, using the glove ports while maintaining the sterile atmosphere in the transfer cell, the element carrier is equipped with functional elements and the medium lines are connected to them.

In the initial position, the assembled subassembly, comprising the element carrier, the functional elements held by it and the medium lines connected to it, is in the transfer cell, and a front piece sitting at the forefront on the element carrier is positioned in the transfer port. To reach the working position, this assembled assembly is guided like a sled or supported and moved out of the transfer cell to the dosing station until the end piece on the rear of the element carrier hits the transfer port. The assembly is moved out into the working position by pushing it out from the transfer cell or by pulling it out from the process room, e.g. by means of a robot installed in the process room.

1. a) Bereitstellung des Funktionsmoduls, umfassend:
   • aa) ein gasdichtes Behältnis mit einem sterilisierten Innenraum; und
   • ab) die im Behältnis montierte und sterilisierte Baugruppe, bestehend aus einem Elementeträger mit Frontstück, vom Elementeträger aufgenommenen Funktionselementen und daran angeschlossenen Mediumsleitungen, die zu einem gemeinsamen externen Anschluss oder jeweiligen Anschlüssen führen, wobei die Baugruppe in der Ausgangsstellung eingefahren innerhalb des Behältnisses steht und dabei das Frontstück eine Passage am Behältnis gasdicht abschliesst, und zum Erreichen der Arbeitsstellung, die Baugruppe mit dem Frontstück voran, sich schlittenartig geführt aus dem Behältnis an die Dosierstation ausfahren lässt;
2. b) Installation des Funktionsmoduls in der Ausgangsstellung abgedichtet am Transferport, so dass die Aussenfläche des Frontstücks in den Prozessraum weist;
3. c) Dekontamination des Prozessraums und zeitgleich der Aussenfläche des Frontstücks;
4. d) Vorschub der Baugruppe an die Dosierstation zwecks Erreichen der Arbeitsstellung; und zuletzt
5. e) Verbinden von Versorgungsleitungen mit dem externen Anschluss bzw. den externen Anschlüssen, wobei
6. f) der Verfahrensschritt e) alternativ zwischen den Verfahrensschritten c) und d) oder zwischen den Verfahrensschritten b) und c) erfolgen kann.

Especially when using the second version of the function module, the following essential procedural steps are carried out:

1. a) Provision of the functional module, comprising:
   • aa) a gas-tight container with a sterilized interior; and
   • ab) the assembly assembled and sterilized in the container, consisting of an element carrier with a front piece, functional elements accommodated by the element carrier and medium lines connected to it, which lead to a common external connection or to respective connections, with the assembly being retracted in the initial position and standing within the container the front piece closes off a passage on the container in a gas-tight manner, and to reach the working position, the module can be moved out of the container to the dosing station, guided like a sled, with the front piece first;
2. b) Installation of the functional module in the initial position sealed at the transfer port, so that the outer surface of the front piece into the process space points;
3. c) Decontamination of the process space and at the same time the outer surface of the front piece;
4. d) advancing the assembly to the dosing station in order to reach the working position; and last
5. e) connecting supply lines to the external connection or the external connections, wherein
6. f) process step e) can alternatively take place between process steps c) and d) or between process steps b) and c).

1. a) das Funktionsmodul in eine zum Prozessraum benachbarte Transferzelle hineinragt und sich bis in den Aufstellraum erstrecken kann oder sich das Funktionsmodul in Gänze frei in den Aufstellraum erstreckt; und
2. b) der externe Anschluss bzw. die externen Anschlüsse und ein Stellorgan für das Bewegen der Baugruppe, bestehend aus dem Elementeträger mit Frontstück, vom Elementeträger aufgenommenen Funktionselementen und daran angeschlossenen Mediumsleitungen, vom Aufstellraum und/oder von der Transferzelle zugänglich sind.

Particularly advantageous details on the procedure when using the second version of the function module are given below: The function module is installed at the transfer port in such a way that:

1. a) the function module protrudes into a transfer cell adjacent to the process room and can extend into the installation room or the function module extends freely into the installation room in its entirety; and
2. b) the external connection or the external connections and an actuator for moving the assembly, consisting of the element carrier with front piece, functional elements accommodated by the element carrier and medium lines connected to them, are accessible from the installation room and/or from the transfer cell.

Brief description of the attached drawings

Figur 1A -

ein Containment mit Blick in den Prozessraum und in diesen in die Arbeitsstellung ausgefahrenem Funktionsmodul erster Version, in Perspektivansicht;

Figur 1B -

den Aufbau gemäss Figur 1A, in transparenter Seitenansicht;

Figur 2A

- das Funktionsmodul aus Figur 1A, in perspektivischer Explosivansicht;

Figur 2B -

die Darstellung gemäss Figur 2A, in gewechselter perspektivischer Explosivansicht;

Figur 3A -

das unbestückte Funktionsmodul aus Figur 1A in die Arbeitsstellung in den Prozessraum ausgefahren, in Perspektivansicht;

Figur 3B

- die Darstellung gemäss Figur 3A, in gewechselter Perspektivansicht;

Figur 4A -

die Darstellung gemäss Figur 3B, mit in das Funktionsmodul eingesetzten Funktionselementen, in Perspektivansicht;

Figur 4B -

die Darstellung gemäss Figur 4A, in gewechselter Perspektivansicht;

Figur 5

- die Darstellung gemäss Figur 4A, mit in das Funktionsmodul eingesetzten Funktionselementen und angeschlossenen Mediumsleitungen, in Perspektivansicht;

Figur 6 -

das Containment gemäss Figur 1A mit in der Transferzelle eingebautem Funktionsmodul zweiter Version, Baugruppe bestehend aus Elementeträger, Funktionselementen und Mediumsleitungen, in eingefahrener Ausgangsstellung, im Behältnis ruhend, in transparenter Seitenansicht;

Figur 7A -

das Funktionsmodul aus Figur 6, in der eingefahrenen Ausgangsstellung, in Perspektivansicht;

Figur 7B -

die Darstellung gemäss Figur 7A, in der ausgefahrenen Arbeitsstellung, in Perspektivansicht;

Figur 7C -

das Funktionsmodul aus Figur 6, in perspektivischer Explosivansicht;

Figur 8A -

einen vergrösserten Ausschnitt aus Figur 6, mit dem Funktionsmodul in transparenter Ansicht;

Figur 8B -

die Darstellung gemäss Figur 8A, mit dem Funktionsmodul in ausgefahrener Arbeitsstellung; und

Figur 8C -

das vergrösserte Detail X1 aus Figur 8B.

Show it:

Figure 1A -

a containment with a view into the process space and into the first version of the functional module extended into the working position, in a perspective view;

Figure 1B -

according to the structure Figure 1A , in transparent side view;

Figure 2A

- the function module off Figure 1A , in exploded perspective view;

Figure 2B -

the representation according to Figure 2A , in alternate perspective exploded view;

Figure 3A -

the unequipped function module Figure 1A extended into the working position in the process room, in perspective view;

Figure 3B

- according to the illustration Figure 3A , in alternate perspective view;

Figure 4A -

the representation according to Figure 3B , with functional elements used in the functional module, in a perspective view;

Figure 4B -

the representation according to Figure 4A , in alternate perspective view;

figure 5

- according to the illustration Figure 4A , with functional elements used in the functional module and connected medium lines, in a perspective view;

Figure 6 -

the containment according to Figure 1A with second version function module installed in the transfer cell, assembly consisting of element carrier, function elements and medium lines, in retracted starting position, resting in the container, transparent side view;

Figure 7A -

the function module figure 6 , in the retracted starting position, in perspective view;

Figure 7B -

the representation according to Figure 7A , in the extended working position, in perspective view;

Figure 7C -

the function module figure 6 , in exploded perspective view;

Figure 8A -

an enlarged section figure 6 , with the functional module in transparent view;

Figure 8B -

the representation according to Figure 8A , with the functional module in the extended working position; and

Figure 8C -

the enlarged detail X1 Figure 8B .

examples

With reference to the accompanying drawings, the functional module according to the invention is described in detail below in two different versions and as a method of the assembly process, the preparation of operational readiness and the use of the functional module.

The following definition applies to the entire further description: Are in a figure contain reference numbers for the purpose of clarity in the drawing, but are not explained in the directly associated description text, reference is made to their mention in the preceding or following descriptions of the figures.

Figures 1A and 1B

The containment 9 surrounded by a housing 90 , here in the form of an isolator standing in the installation room 8 , is shown in its basic structure for the purpose of explaining the internal division of space, the existing walls and the equipment. A transparent pane 911 is usually seated in the front wall 910 , while an interchangeable unit 95 is inserted in the rear wall 912 . The housing 90 further includes the upper roof surface 91 , the lower floor surface 92 , the rear outer wall 900 with the transfer fitting 903 installed therein and the first and second side surfaces 916 , 918 , which together with the front and rear walls 910 , 912 the containment 9 demarcate to the outside. The passage 917 on the inlet side is located in the first side surface 916 , while the second side surface 916 has the passage 919 on the outlet side. From the lower section of the front wall 910 located below the pane 911 , the porch 913 extends into the installation space 8, as well as an inclined, downward-sloping intermediate floor 914 towards the lowest area of the rear wall 912 . In addition, the horizontal space divider 915 runs from the upper section of the front wall 910 to the rear wall 912 and from there each horizontally, the upper cell wall 901 and the lower cell wall 902 to the rear outer wall 900 .

The front area 94 and the rear area 99 are thus formed by the housing 90 and existing walls. The front area 94 is structured into the roof space 98 divided above the space divider 915 , the floor space 97 present below the intermediate floor 914 , and the process space 93 located between the roof space 98 and the floor space 97 . The transfer cell 96 is formed in the rear space 99 between the upper cell wall 901 and the lower cell wall 902 . A transfer fitting 903 , advantageously designed as a rapid transfer port (RTP), in the rear outer wall 900 serves to introduce pre-sterilized components into the transfer cell 96 in a protected manner. Furthermore, in the outer wall 900 glove ports 905 are provided, usually in pairs, to perform 96 activities while maintaining the sterile atmosphere in the transfer cell.

The equipment of the containment 9 includes a dosing station 3 set up in the process space 93 to which the functional module 2 - here in the first version - is brought from the transfer cell 96 through a transfer port 260 into the working position. The first version of the function module 2 is the subject of the sequence of figures 1A to 5, after their detailed description the practical assembly process and the application of the device are explained. A flange connection 20 installed in a recess in the exchange unit 95 has the transfer port 260 . The function module 2 is fixed but installed on the flange connection 20 so that it can be extended. An essential part of the function module 2 is the element carrier 23 . In order to approach the dosing station 3 , a robot 1 has the manipulation element 12 guided by its pivotable arm 11 , for example in the form of a gripper. The robot 1 can advantageously be anchored with its foot 10 below the exchangeable unit 95 on the rear wall 912 .

Figures 2A and 2B

1. a) die Flanschverbindung 20, welche aus einer ersten Dichtung 21, einer im Durchmesser kleineren zweiten Dichtung 21', einer dritten Dichtung 27, dem Deckring 22 und dem Formteil 26 mit seinem Transferport 260 besteht;
2. b) das Frontstück 24 mit dem daran zu befestigenden Griff 240;
3. c) das Endstück 25 mit dem daran zu befestigenden Griff 250; und
4. d) der Elementeträger 23, der zur Bestückung mit den Funktionselementen 230 bestimmt ist.

The essential components of the function module 2 are described on the basis of this pair of figures. This includes:

1. a) the flange connection 20 , which consists of a first seal 21 , a second seal 21 ' with a smaller diameter, a third seal 27 , the cover ring 22 and the molded part 26 with its transfer port 260 ;
2. b) the front piece 24 with the handle 240 to be attached thereto;
3. c) the end piece 25 with the handle 250 to be attached thereto; and
4. d) the element carrier 23 which is intended to be equipped with the functional elements 230 .

Figures 3A and 3B

Only for the sake of clarity, but not in the practical assembly process, this pair of figures illustrates the functional module 2 previously assembled without being equipped with the functional elements 230 and without connected medium lines 231 , which extends out of the transfer port 260 into the process space 93 has approached the dosing station 3 . In the working position shown, the front piece 24 fixed to the element carrier 23 is moved forward in the process space 93 and the end piece 25 fills the transfer port 260 , at least partially sealing it. From the flange connection 20 installed in the exchange unit 95 , the cover ring 26 rests against the exchange unit 95 on the side of the process space 93 .

Figures 4A and 4B

Again in the working position and for the sake of clarity, but still not in conformity with the practical assembly process, the assembled functional module 2 can now be seen equipped with the functional elements 230 , but still without the medium lines 231 connected .

figure 5

In order to complete the assembly of the functional module 2 equipped with the functional elements 230 , the medium lines 231 are now also connected to it, specifically in each case directly at the junction with the functional elements 230 . As in practice, the functional module 2 is in the real working position, ie pulled out of the transfer port 260 into the process chamber 93 at the dosing station 3 and standing with the end piece 25 in the transfer port 260 and at least partially sealing it.

Assembly process and application of the function module first version

1. 1. Der unbestückte Elementeträger 23, d.h. es sind noch keine Funktionselemente 230 eingesetzt und keine Mediumsleitungen 231 angeschlossen, wird aus der eingefahrenen Ausgangsstellung in eine Zwischenstellung bewegt, in welcher zwischen dem Prozessraum 93 und der Transferzelle 96 der partiell offene Transferport 260 Gasdurchlass ermöglicht.
2. 2. Während der Zwischenstellung erfolgt die Dekontamination des Prozessraums 93, welche sich somit den Elementeträger 23 umspülend durch den partiell offenen Transferport 260 auch in die Transferzelle 96 erstreckt.
3. 3. Nach der Dekontamination von Prozessraum 93, Elementeträger 23 und Transferzelle 96 werden unter Wahrung des Reinraumstatus' vorsterilisierte Funktionselemente 230 und Mediumsleitungen 231 in die Transferzelle 96 eingeschleust. Das geschützte Einschleusen der vorsterilisierten Bauteile in die Transferzelle 96 geschieht mittels der Transfer-Armatur 903.
4. 4. Der Elementeträger 23 wird in die eingefahrene Ausgangsstellung zurückgebracht, d.h. dieser steht in der Transferzelle 96, und nun erfolgt die Bestückung des Elementeträgers 23 mit den Funktionselementen 230 und der Anschluss der Mediumsleitungen 231 an die Funktionselemente 230. Diese Montagearbeiten werden von einem Bediener zur Wahrung der sterilen Atmosphäre in der Transferzelle 96 mittels der Handschuheingriffe 905 ausgeführt.
5. 5. Soweit behandelt und montiert, kann jetzt der komplett bestückte Elementeträger 23 aus der Transferzelle 96 heraus, in den Prozessraum 93 bis an die Dosierstation 3 vorgeschoben werden.
6. 6. Vorteilhaft werden mit dem Manipulierorgan 12 des Roboters 1, insbesondere mit pharmakologischer Flüssigkeit zu befüllende Gefässe, vorzugsweise oben offene Vials, an die Dosierstation 3 transportiert.
7. 7. Beim Füllvorgang wird die Flüssigkeit über die Mediumsleitungen 231 und die kanülenartigen Funktionselemente 230 zugeführt, welche in die Gefässe eintauchen.

Preparation and start of production take place in the following steps:

1. 1. The unequipped element carrier 23 , ie no functional elements 230 have been inserted and no medium lines 231 are connected, is moved from the retracted starting position to an intermediate position in which the partially open transfer port 260 allows gas passage between the process space 93 and the transfer cell 96.
2. 2. During the intermediate position, the decontamination of the process space 93 takes place, which thus extends around the element carrier 23 through the partially open transfer port 260 and also into the transfer cell 96 .
3. 3. After the decontamination of the process room 93 , element carrier 23 and transfer cell 96 are pre-sterilized while maintaining the clean room status Functional elements 230 and medium lines 231 introduced into the transfer cell 96 . The pre-sterilized components are introduced into the transfer cell 96 in a protected manner by means of the transfer fitting 903 .
4. 4. The element carrier 23 is returned to the retracted starting position, ie it is in the transfer cell 96 , and now the element carrier 23 is fitted with the functional elements 230 and the medium lines 231 are connected to the functional elements 230 . This assembly work is carried out by an operator using the glove ports 905 to maintain the sterile atmosphere in the transfer cell 96 .
5. 5. Insofar as it has been treated and assembled, the completely equipped element carrier 23 can now be pushed out of the transfer cell 96 into the process space 93 up to the dosing station 3.
6. 6. Advantageously, the manipulation organ 12 of the robot 1 is used to transport vessels to be filled, in particular with pharmacological liquid, preferably vials that are open at the top, to the dosing station 3 .
7. 7. During the filling process, the liquid is supplied via the medium lines 231 and the cannula-like functional elements 230 , which dip into the vessels.

Assembly process and application of the second version function module figure 6

The internal division of space, the existing walls and the equipment of the containment 9 shown are in principle unchanged compared to the pair of figures 1A+1B, so that reference is made thereto. Now, however, a second version of the functional module 2 is used, which is dealt with using the sequence of figures 6 to 8C. Furthermore, instead of the transfer device 903 installed in the rear outer wall 900 , access to the transfer cell 96 is now possible via a simple wall opening 904 or the wall section at least along the transfer cell 96 is completely open.

The function module 2 according to the second version - currently in the retracted initial position - is not permanently installed on the flange connection 20 , in contrast to the first version , but can be pushed into this dock through wall opening 904 to flanged joint 20 with access through its open transfer port 260. The functional module 2 has a container 28 that is sealed off from the outside, in whose sterile interior 29 the completely equipped element carrier 23 is accommodated in the retracted initial position, pre-sterilized. In the container 28 there is a passage 280 which is closed almost automatically in the initial position and through which the equipped element carrier 23 can be moved out into the extended working position.

Figures 7A to 7C

1. a) das gasdichte Behältnis 28 mit den äusseren Montageelementen 282, dem sterilen Innenraum 29 und der von einem frontseitig vorhandenen Fensterstück 281 umrandeten verschliessbaren Passage 280;
2. b) der Elementeträger 23 mit den darin eingesetzten Funktionselementen 230, dem Frontstück 24 und dem Endstück 25 sowie den hier nicht sichtbaren Mediumsleitungen 231 (s. Figur 8A-8C);
3. c) der Deckel 285 für den hinteren Verschluss des Behältnisses 28; und
4. d) das Vorschubteil 286, z.B. als Spindel ausgebildet, und das Stellorgan 287, hier in Form eines Drehrades.

The essential components of the function module 2, second version, are described on the basis of this sequence of figures. This includes:

1. a) the gas-tight container 28 with the outer assembly elements 282 , the sterile interior 29 and the closable passage 280 bordered by a window piece 281 present on the front;
2. b) the element carrier 23 with the functional elements 230 inserted therein, the front piece 24 and the end piece 25 as well as the medium lines 231 (not visible here) (see Fig. Figure 8A-8C );
3. c) the lid 285 for the rear closure of the container 28 ; and
4. d) the feed part 286 , for example designed as a spindle, and the actuator 287 , here in the form of a rotary wheel.

Figure 8A

In the retracted starting position, the element carrier 23 fitted with the functional elements 230 rests in the container 28 and is therefore not at the dosing station 3 . The front piece 24 closes the passage 280 in a gas-tight manner. The excess length of the medium lines 231 connected to the functional elements 230 lie in the interior 29 of the container 28 and lead to the connection 232 . As an example of the structure of the medium lines 231 , a medium line 231 exiting from the connection 232 could advantageously be divided into the individual functional elements 230 by branching. However, a separate medium line 231 with excess length to a respective connection 232 will preferably extend to each functional element 230 .

Before the start of production, ie the functional module 2 is still in the retracted starting position, it is necessary to decontaminate the process space 93 and at the same time the outer surface of the front piece 24 which currently hermetically seals the interior 29 .

Figures 8B and 8C

When the actuator 287 is actuated, the feed part 286 is driven, which means that the front piece 24 is gradually removed from the passage 280 and at the same time the element carrier 23, together with its equipment, moves out of the container 28 , into the processing space 93 , up to the extended working position the dosing station 3 approach. The end piece 25 abuts inside the container 28 in its front area. With the extension of the element carrier 23 , the previously existing excess length of the medium line 231 is stretched. In the production process, the liquid to be processed at the dosing station 3 is fed from the outside to the connection 232 , conveyed into the medium line 231 and via it into the functional elements 230 .

For the use of the function module 2 first version ( Figures 1A-5 ) and second version ( Figures 6-8C ) it applies that vessels to be filled, for example a container with four vials, are advantageously transported to the dosing station 3 with the manipulation element 12 of the robot 1 . The vials are filled, for example with a pharmacological liquid, by means of the functional elements 230 , which are now also in the dosing station 3 and are held by the element carrier 23 . During the filling process, the cannula-like functional elements 230 dip into the vials, which are open at the top. When handling liquids that are sensitive to oxygen, filling is carried out with an overlay of an inert gas, eg nitrogen.

Claims (16)

Functional module ( 2 ), which is intended to be brought to a dosing station ( 3 ) positioned in a process space ( 93 ) of a containment ( 9 ) and there for the aseptic filling of vessels with a liquid, wherein: a) the containment ( 9 ) is provided for placement in an installation room ( 8 ); b) the containment ( 9 ) and the process space ( 93 ) are enclosed by a housing ( 90); and c) the functional module ( 2 ) has: ca) an element carrier ( 23 ); cb) functional elements (230 ) intended for installation on the element carrier ( 23 ); and cc) medium lines ( 231 ), provided for connection to the functional elements (230 ), characterized in that d) the assembly as a module, consisting of element carrier ( 23 ), functional elements ( 230 ) accommodated by this and medium lines ( 231 ) connected to it, from a retracted initial position through a transfer port ( 260 ) leading into the process space ( 93 ) into an extended working position can be moved to the dosing station ( 3 ). Functional module ( 2 ) according to claim 1, characterized in that a) the functional module ( 2 ) is used for the aseptic filling of a plurality of vessels, which are combined in a container, with a pharmacological or toxic liquid; and b) when handling liquids that are sensitive to oxygen, an inert gas, eg nitrogen, is superimposed. Functional module ( 2 ) according to at least one of claims 1 and 2, characterized in that a) the housing ( 90 ) of the containment ( 9 ) has a rear wall ( 912 ) delimiting the process space ( 93 ) as a component; and b) the transfer port (260 ) is formed by an opening provided in a molding ( 26 ) of a flange connection ( 20 ) installed in the rear wall ( 912). will. Functional module ( 2 ) according to at least one of claims 1 to 3, characterized in that a) the element carrier ( 23 ) has a front piece ( 24 ) fixed at the front and an end piece ( 25 ) fixed at the rear; whereby: b) the front piece ( 24 ) comes to rest in the retracted starting position in the transfer port ( 260); and c) the end piece ( 25 ) is intended to hit the transfer port ( 260 ) in the extended working position and forms a passage for the medium lines ( 231 ) leading to the functional module ( 2 ). Functional module ( 2 ) according to at least one of claims 1 to 3, characterized in that a) the functional module ( 2 ) installed at the transfer port ( 260 ) in the retracted starting position protrudes into a transfer cell ( 96 ) adjacent to the process space ( 93 ); and b) the transfer port (260 ) forms an interface between the process space ( 93 ) and the transfer cell ( 96 ). Functional module ( 2 ) according to Claim 5, characterized in that in an outer wall ( 900 ) belonging to the housing ( 90 ) of the containment ( 9 ) and delimiting the transfer cell ( 96 ) towards the installation space (8 ), the following are provided: a) a transfer fitting ( 903 ), preferably designed as a rapid transfer port (RTP), intended for the protected introduction of the pre-sterilized functional elements (230 ) and medium lines ( 231 ) into the transfer cell (96 ); and b) glove ports ( 905 ), usually in pairs, in order to carry out activities while maintaining the sterile atmosphere in the transfer cell ( 96 ), in particular assembly work, namely equipping the element carrier ( 23 ) with functional elements ( 230 ) and medium lines ( 231 ) to be connected thereto . Functional module ( 2 ) according to at least one of claims 1 to 3, characterized in that a) the functional module ( 2 ) has: aa) a gas-tight container ( 28 ) with a sterilized interior ( 29 ); and ab) an assembly assembled and sterilized in the container ( 28 ), consisting of the element carrier ( 23 ), functional elements ( 230 ) accommodated by it and medium lines ( 231 ) connected thereto, which lead to an external connection ( 232 ) or to external connections ( 232 ) as well as the front piece ( 24 ) firmly arranged at the foremost on the element carrier (23 ); whereby: b) the subassembly is retracted in the starting position within the container ( 28 ) and the front piece ( 24 ) closes off a passage ( 280 ) on the container ( 28 ) in a gas-tight manner; and c) to reach the working position, the assembly, with the front piece ( 24 ) first, can be moved out of the container ( 28 ) through the transfer port ( 260 ) into the process space ( 93 ) at the dosing station ( 3 ). Functional module ( 2 ) according to claim 7, characterized in that there are: a) one or more connections ( 232 ) on the outside of the container ( 28 ) to which the medium lines ( 231 ) from the interior of the container ( 28 ) are connected, the connection(s ) (232 ) for connection to at least one supply line are determined; and b) an actuator ( 287 ) on the outside of the container ( 28 ) for moving the assembly, consisting of an element carrier (23 ) with a front piece ( 24 ), functional elements (230 ) accommodated by the element carrier ( 23 ) and medium lines (231 ) connected thereto. Functional module ( 2 ) according to at least one of claims 7 and 8, characterized in that a) this is installed at the transfer port ( 260 ) in such a way that it protrudes into a transfer cell ( 96 ) adjacent to the process room ( 93 ) and can extend into the installation room ( 8 ) or the functional module ( 2 ) is completely free extends into the installation room ( 8 ); and b) the external terminal (232) or the external terminals (232) and an actuator (287) for moving the assembly consisting of the element carrier (23) with a front piece (24), the element carrier functional elements received (23) (230 ) and medium lines ( 231 ) connected thereto, are accessible from the installation room (8); whereby c) the transfer cell ( 96 ) can be open to the installation room ( 8 ), for example due to a wall opening ( 904 ) in the outer wall (900 ). Method for bringing the functional module ( 2 ) according to one or more of claims 1 to 6 to a dosing station ( 3 ) positioned in a process space (93 ) of a containment ( 9 ) and intended there for the aseptic filling of vessels with a liquid, wherein: a) the containment ( 9 ) is intended for placement in an installation room ( 8 ); b) the containment ( 9 ) and the process space ( 93 ) are enclosed by a housing ( 90); and c) the functional module ( 2 ) has: ca) an element carrier ( 23 ); cb) functional elements (230 ) intended for installation on the element carrier ( 23 ); and cc) medium lines ( 231 ), intended for connection to the functional elements ( 230 ), characterized by the sequence of the method steps: d) outside the process space (93 ), providing the element carrier (23 ) with the equipped functional elements (230 ) and the medium lines ( 231 ) connected thereto; and e) Bringing the assembled assembly, consisting of element carrier ( 23 ), functional elements ( 230 ) received by it and medium lines ( 231 ) connected to it, in the decontaminated or sterilized state, from a retracted initial position, through a process chamber ( 93 ) into a sealed transfer port ( 913 ) provided on the delimiting housing wall ( 912 ) into an extended working position on the dosing station ( 3 ). Method according to Claim 10, characterized in that in a transfer cell (96 ) which is adjacent to the process space ( 93 ) and can be hermetically sealed off from the installation space (8), the provision and assembly of the element carrier (23 ) with functional elements (230 ) and medium lines ( 231 ) be carried out under aseptic conditions. Method according to at least one of claims 10 and 11, characterized in that a) when the element carrier ( 23 ) is partially extended into the process space ( 93 ), the front piece ( 24 ) that is first and foremost firmly seated on the element carrier ( 23 ) opens the transfer port ( 260 ) between the process space ( 93 ) and transfer cell ( 96 ) and in this position by introduction the decontamination of the process space ( 93 ), transfer cell ( 96 ) and element carrier ( 23 ) is carried out by decontamination means, preferably on the part of the process space ( 93 ) and at the same time on the part of the transfer cell ( 96); subsequently b) the pre-sterilized functional elements (230) and fluid lines (231) are introduced through the transfer valve (903) while maintaining aseptic conditions in the transfer cell (96); and finally c) using the glove ports ( 905 ) while maintaining the sterile atmosphere in the transfer cell ( 96 ), the element carrier (23 ) is fitted with functional elements (230 ) and the medium lines ( 231 ) are connected thereto. Method according to at least one of claims 10 to 12, characterized in that a) in the starting position, the mounted assembly consisting of element carrier (23) of this recorded function elements (230) and connected thereto, medium lines (231) is in the transfer cell (96) and a foremost seated on the element carrier (23) front piece (24 ) is positioned in the transfer port ( 260 ); while b) to reach the working position, this assembled assembly is moved out of the transfer cell ( 96 ) to the dosing station ( 3 ). Method according to at least one of claims 10 to 13, characterized in that a) to reach the working position, the assembled assembly, consisting of the element carrier (23 ) with front piece ( 24 ), the element carrier (23 ) accommodated functional elements (230 ), medium lines ( 231 ) connected to them, guided like a carriage or supported from the transfer cell (96 ) is moved out until the end piece (25 ) seated at the rear of the element carrier (23 ) strikes the transfer port ( 260); whereby b) the assembly is moved out into the working position by being pushed out by the transfer cell ( 96 ) or by being pulled out by the processing space ( 93 ), eg by means of a robot (1) installed in the processing space (93). Method for bringing the functional module ( 2 ) according to one or more of claims 1 to 3 and 7 to 9 to a dosing station ( 3 ) positioned in a process space ( 93 ) of a containment ( 9 ) and there for the aseptic filling of vessels with a liquid determined, where: a) the containment ( 9 ) is intended for placement in an installation room ( 8 ); b) the containment ( 9 ) and the process space ( 93 ) are enclosed by a housing ( 90 ), characterized by the sequence of the method steps: c) provision of the functional module ( 2 ), comprising: ca) a gas-tight container ( 28 ) with a sterilized interior ( 29 ); and cb) the in the container ( 28 ) mounted and sterilized assembly, consisting of an element carrier ( 23 ) with front piece ( 24 ), the element carrier ( 23 ) accommodated functional elements ( 230 ) and connected medium lines ( 231 ), which lead to a common external connection ( 232 ) or respective terminals ( 232 ), wherein: cc) the subassembly is retracted in the starting position within the container ( 28 ) and the front piece ( 24 ) closes off a passage ( 280 ) on the container ( 28 ) in a gas-tight manner; and cd) in order to reach the working position, the assembly with the front piece ( 24 ) in front, can be moved out of the container ( 28 ) to the dosing station ( 3 ) in a sled-like manner; d) installation of the functional module (2 ) in the initial position sealed at the transfer port ( 260 ) so that the outer surface of the front piece ( 24 ) points into the process space (93 ); e) decontamination of the processing space (93 ) and at the same time the outer surface of the front piece ( 24 ); f) advancing the assembly to the dosing station ( 3 ) in order to reach the working position; and last g) connecting supply lines to the external connection ( 232 ) or the external connections ( 232 ), wherein h) method step g) can alternatively take place between method steps e) and f) or between method steps d) and e). Method according to claim 15, characterized in that a) the function module ( 2 ) is installed at the transfer port ( 260 ) in such a way that the function module ( 2 ) protrudes into a transfer cell ( 96 ) adjacent to the process room ( 93 ) and can extend into the installation room ( 8 ) or the function module ( 2 ) extends freely into the installation space ( 8 ) in its entirety; and b) the external connection ( 232 ) or the external connections ( 232 ) and an actuator ( 287 ) for moving the assembly, consisting of the front piece ( 24 ) with element carrier ( 23 ), functional elements ( 230 ) accommodated by this and thereon connected medium lines ( 231 ), from the installation room ( 8 ) and/or from the transfer cell ( 96 ).

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