EP2291244B1 - Method for conveying an object into a clean room - Google Patents

Abstract

A method of transferring at least one object, sterilised and packed into a bag, into a clean room, where the bag is connected with an inner liner connecting the clean room with an outer room and on this is opened at an area open towards the inner liner so that a tube-like connection, closed towards the outer room, is formed between the interior of the bag and the inner liner, through which the at least one object is transferred into the clean room.

Description

The invention relates to a method for introducing at least one article packed and sterilized in a bag into a clean room.

From the DE 10 044 117 A1 a method of the type mentioned has become known. The known method is based on the object to inject objects, in particular of medical items in a sterile condition in a clean room. Here, the objects, such as syringes, are arranged in a container made of plastic, which is open at its top and is covered there with a gas-permeable but germ-proof material. The cover of germ-proof material is sealed with a sealed seam to the container. The so sealed container is repackaged by means of a bag, which in turn is wholly or partly made of the same or a similar material as the cover, and again the container germ-tight, but gas-permeable closes. After the objects have been introduced into the container, the container is sealed and the container has been bagged into the bag, the whole is now sterilized in a sterilization chamber. After removal from the sterilization chamber, the packaged items including and also the complete container are sterile. The same applies to the space between the bag and the container. The outer packaging by means of the bag avoids recontamination of the container. The thus packed container with the objects is then brought to its destination. There, the container is removed from the bag and passed through a lock in a sterile clean room.

A disadvantage of the known method, it is especially the danger of contamination of the surface of the container is given by the required removal of the outer packaging prior to introduction of the container into the clean room. Another disadvantage is also in the relatively complex and time-consuming packaging process.

It is therefore an object of the invention to provide a method in which a complete avoidance of contamination is ensured in an introduction of already sterilized objects from a transport bag into a clean room.

This object is achieved by a method of the type mentioned in the present invention, that the bag is connected to an inner liner connecting the clean room with an outer space and then opened on a region facing the inner liner, so that closed to the Ausseuraum, hose-like connection between the interior the bag and the inner liner is formed, through which the at least one object in the clean room is transferred.

Due to the closed system of inner liner and bag during the Einschleusvorganges contamination of the or in the bag items, such as spare parts, manufacturing accessories, bottles, closures, containers, syringes, pistons, tools, etc., can be avoided. The inner liner is tubular in this case. Thus, it can be formed, for example, from an internally and externally weldable and peelable on its inside after welding endless tubular film.

According to an advantageous variant of the invention, the bag is made of a continuous film tube which is weldable on its outside and inside, wherein the inside of the endless film tube is peelable after welding and the bag closed after filling with the at least one object by welding and then the at least one object is sterilized.

For introducing the at least one article into the clean room, an inlet of the inner liner around the outside of the bag can be arranged such that the side edge of the inlet comes to lie above a weld seam closing the bag, whereupon the bag is welded to the inlet, so that between its existing weld and the inlet side edge of the inlet at least one continuous new second weld arises, on the one hand connects the inside of the inlet to the outside of the bag and on the other hand at the same point the inside of the bag, whereupon the peelable inside of the bag and dissolved the bag is opened in the direction of the clean room for transferring the at least one article.

An alternative variant of the invention provides that the bag has an inlet and the inner liner is also formed from a continuous film tube which is closed with a weld, wherein the inlet is arranged so that the edge of the inlet comes to rest above the weld, whereupon the endless film tube is welded to the inlet, so that between the existing weld and the edge of the inlet at least one continuous new second weld arises, on the one hand connects the inside of the inlet to the outside of the continuous film tube and on the other hand at the same point the inside of the continuous film tube, whereupon the peelable inside of the endless film tube (1a) is released and the bag is peeled open and opened in the direction of the clean room for transferring the at least one article.

A further variant of the invention, which is characterized in that it can be very efficiently avoided with her contaminations Umzufüllender objects, provides that a sterilized bag is welded to the inlet of the inner liner, the sterilized bag has a tubular transition foil, the inside not but outside already weldable and connected with its side facing away from the inlet with a bag-shaped sealing film, the bag bottom is within the transition foil and the sack edge connected to the inlet facing away from the side of the transition foil, for example welded, for the sealing film, a plastic is chosen, the good weldable and the bag-shaped sealing film is arranged around the outside of the bag containing the at least one article such that the weld closing this bag comes to lie within the bag, wherein the bag containing the at least one article is welded to the sealing film so that between the existing weld seam of the bag containing the at least one article and the free edge of the sealing film, at least one continuous new weld seam, preferably a double-seam seam, which on the one hand forms the inside of the sealing film with the outside of the at least a sachet containing the article and, on the other hand, at the same point joining the inside of the pouch containing the at least one article, during which welding a dividing seam is placed in the middle of the weld, preferably between the double welds, so that the part of the pouch containing the article is facing the inner liner in the form of a material including a token is separated together with the sealing film surrounding it, whereupon the peelable inside of the bag containing the at least one object is released at its second welded point, so that the at least one object can be transferred into the clean room.

As an alternative to the just mentioned variant of the invention, the bag can have an inlet, with which a sterilized bag is welded, wherein the sterilized bag has a tubular transitional film, the inside but not already outside and already welded with its side facing away from the inlet with a bag-shaped sealing film is connected, the sack bottom is within the transition foil and the sack edge connected to the inlet side facing away from the transition foil, for example welded, for the sealing film, a plastic is chosen, which is well weldable, and the bag-shaped sealing film around the outside of the inner liner around is arranged so that a weld closing the inner liner comes to lie within the bag, wherein the inner liner is welded to the sealing film, so that between the existing weld innerliner and the free edge of the sealing film at least one continuous new e weld seam preferably double weld arises, on the one hand connects the inside of the sealing film with the outside of the inner liner and on the other hand at the same point the inside of the inner liner, wherein during this welding process the center of the weld, preferably between the double welds a Trennaht is set, so that the bag facing part of the inner liner is separated in the form of a material including token including the sealing film surrounding it, whereupon the peelable inside of the inner liner is released at its second welded point, so that the at least one object can be transferred after Aufpeelen of the bag in the clean room.

The formation of a severed token can be avoided in that the bag has a bag-shaped receptacle for a welded end portion of the inner liner, wherein the receptacle is double-walled and made of an externally weldable and internally non-weldable plastic, and two separate from the walls of the receptacle , Areas are bounded, one of which is closed to the bag, and the other area is in communication with the interior of the bag, for refilling the bag contents, the portion of the end portion of the inner liner in the receptacle is arranged so that the weld within the Recording comes to rest, whereupon the recording and the section of the inlet located therein are welded, so that between the edge of the receptacle and the existing weld of the inner liner, a further weld is formed, a Trennaht is set, preferably in the middle of the other weld, so in that after loosening the separating seam between the interior of the bag and the inner liner, a tubular connection for transferring the at least one article into the clean room and the separated section of the inner liner in a region closed from the bottom of the receptacle and an outer side wall of the bag closed area and a space formed by a separated portion of an outer side wall of the area open to the bag. After the at least one article has been transferred to the clean room, the tube-like connection between the bag and the inner liner is interrupted by attaching a weld and then the inner liner is separated from the bag. In this context, it has been found to be particularly advantageous that the inner liner is formed by an endless film tube mounted axially around an inlet of the clean room.

Fig. 1 a, b, c

Herstellung und Sterilisation von Gegenständen sowie der Verpackung in Beutel;

Fig. 2

eine Ansicht auf eine verschweisste Endlosschlauchfolie oberhalb eines Einlaufs eines zu befüllenden Innenliners;

Fig. 3

eine Seitenansicht auf die Darstellung von Fig.2;

Fig. 4

eine Ansicht auf die verschweisste Endlosschlauchfolie von Fig.2 nach dem Einstecken in den Einlauf des zu befüllenden Innenliners;

Fig. 5

eine Seitenansicht auf die Darstellung von Fig. 4;

Fig. 6

die Ansicht von Fig.4 mit angebrachter Schweissnaht;

Fig. 7

eine Seitenansicht auf die Darstellung von Fig.6; 30

Fig. 8

eine Ansicht auf eine verschweisste und anschliessend gepeelte Endlosschlauchfolie nach Fig.6;

Fig. 9

eine Seitenansicht auf die Darstellung von Fig.8; 35

Fig. 10

eine Ansicht auf eine gepeelte und anschliessend an einer dritten Stelle wieder verschweissten Endlosschlauchfolie gemäss Fig.8;

Fig. 11

eine Seitenansicht auf die Darstellung von Fig.10;

Fig. 12

eine Ansicht der an der Dritten Stelle wieder verschweissten und dort getrennten Endlosschlauchfolie oberhalb des Einlaufs gemäss Fig.10, wobei die freistehenden Enden des Innenliners verschweisst sind;

Fig. 13

eine Seitenansicht auf die Darstellung von Fig.12;

Fig. 14

eine Ansicht auf eine Endlosschlauchfolie gem. Fig.2 oberhalb eines erfmdungsgemässen Beutels an einem Einlauf;

Fig. 15

eine Seitenansicht auf die Darstellung gemäss Fig.14;

Fig. 16

eine Ansicht auf den Aufbau nach Fig.14, wobei die Endlosschlauchfolie in den Beutel eingesteckt wurde;

Fig. 17

eine Seitenansicht auf die Darstellung gemäss Fig.16;

Fig. 18

eine Ansicht auf die Darstellung gemäss Fig.16 jedoch mit zusätzlich angebrachter Schweissnaht an einer zweiten Stelle; 25

Fig. 19

eine Seitenansicht auf die Darstellung gemäss Fig.18;

Fig. 20

eine Ansicht auf die Darstellung gemäss Fig.18 jedoch mit einem abgetrennten Token;

Fig. 21

eine Seitenansicht auf die Darstellung von Fig.20;

Fig. 22

eine Ansicht auf den Aufbau gemäss Fig.20, wobei die Endlosschlauchfolie an Ihrer ersten Schweissstelle aufgepeelt (geöffnet) wurde;

Fig.23

eine Seitenansicht auf die Darstellung gemäss Fig.22;

Fig.24 und 25

den Aufbau von Fig.22, nachdem an der Endlosschlauchfolie an einer dritten Stelle wieder eine Trennschweissung angebracht wurde;

Fig. 26

eine Seitenansicht auf einen Beutel mit einer sackförmigen Aufnahme für einen Endabschnitt eines Innenliners, wobei der Endabschnitt in die Aufnahme eingesteckt ist;

Fig. 27

eine Seitenansicht auf die Anordnung aus Fig. 19 wobei der Endabschnitt des Innenliners mit Seitenwänden der Aufnahme mit einer Schweissnaht verbunden ist,

Fig. 28

eine Seitenansicht auf die Anordnung aus Fig. 26 nach Trennen der Schweissnaht und nach aufpeelen des Endlosschlauches

Fig. 29

einen schematischen Querschnitt durch eine Schleuse für einen Reinraum.

The invention together with further advantages is explained below with reference to some non-limiting embodiments, which is shown in the drawing. In this show schematically:

Fig. 1 a, b, c

Manufacture and sterilization of articles and packaging in bags;

Fig. 2

a view of a welded endless tubular film above an inlet of an inner liner to be filled;

Fig. 3

a side view on the representation of Fig.2 ;

Fig. 4

a view of the welded endless tube of Fig.2 after insertion into the inlet of the inner liner to be filled;

Fig. 5

a side view on the representation of Fig. 4 ;

Fig. 6

the view of Figure 4 with attached weld seam;

Fig. 7

a side view on the representation of Figure 6 ; 30

Fig. 8

a view of a welded and then peeled endless tubular film after Figure 6 ;

Fig. 9

a side view on the representation of Figure 8 ; 35

Fig. 10

a view of a peeled and then re-welded at a third point endless tubular film according to Figure 8 ;

Fig. 11

a side view on the representation of Figure 10 ;

Fig. 12

a view of the rewelded at the third place and there separated endless tubular film above the inlet according to Figure 10 wherein the freestanding ends of the innerliner are welded;

Fig. 13

a side view on the representation of Figure 12 ;

Fig. 14

a view of an endless tube film acc. Fig.2 above a bag according to the invention at an inlet;

Fig. 15

a side view of the illustration according to Figure 14 ;

Fig. 16

a view on the structure after Figure 14 , with the endless tubular film in the bag was inserted;

Fig. 17

a side view of the illustration according to Figure 16 ;

Fig. 18

a view on the representation according to Figure 16 but with additionally attached weld at a second location; 25

Fig. 19

a side view of the illustration according to Figure 18 ;

Fig. 20

a view on the representation according to Figure 18 however, with a severed token;

Fig. 21

a side view on the representation of fig.20 ;

Fig. 22

a view of the structure according to fig.20 where the endless tubular film was peeled (opened) at your first welding site;

Figure 23

a side view of the illustration according to Figure 22 ;

Fig.24 and 25th

the construction of Figure 22 after a separation weld has been re-attached to the continuous tube film at a third location;

Fig. 26

a side view of a bag with a bag-shaped receptacle for an end portion of an inner liner, wherein the end portion is inserted into the receptacle;

Fig. 27

a side view of the arrangement Fig. 19 wherein the end portion of the inner liner is connected to side walls of the receptacle with a weld,

Fig. 28

a side view of the arrangement Fig. 26 after separating the weld and after aufpeelen the endless hose

Fig. 29

a schematic cross section through a lock for a clean room.

Not shown is the separation of the endless tubular film after attaching the Trennschweissung at the third point of the endless tubular film. This will be on FIGS. 12 and 13 referenced, here the welding of freely projecting remnants of the inlet can be omitted, since the separated lower part of the endless tubular film already serves as a closure of the inner liner or inlet

The figures are described coherently and comprehensively. Same components carry the same Reference numerals. Similar components or functionally similar components bear the same reference numerals with different indices.

As in the FIG. 1a The objects 1 'to be transported into a clean room are produced at a location outside the clean room. In Fig. 29 this clean room is provided with the reference numeral 15.

Then the articles 1 'are packed in bag 1 ( Fig. 1b ) and sterilized by the manufacturer ( Fig. 1c ), preferably with gamma radiation, ETO fumigation or steam or the like. 1b. A bag 1 may contain, depending on the size of the articles 1 ', a single article 1' or even a large number of articles 1 ', for example of the order of ten thousand. Plastic bags 1 are used, which ensure the sterility of the contents during transport and which are also compatible with an inner liner. Thereafter, these sterilized and packaged items 1 'are transported to a clean room and introduced there. By virtue of the method according to the invention, these articles 1 'can be introduced from the bags 1 sterile into the clean room by means of the inner liner connecting the clean room to the outer space, and thus pass from the interior of the bag 1 into the clean room without further on-site sterilization being necessary is.

According to Fig. 2 is the bag 1 is made of an endless film tube 1 a, which is weldable on its outside and inside. The inside of the endless film tube 1a is peelable after welding and the bag 1 is closed by welding after its filling.

Fig.2 and 3 further show the initial situation before the introduction of the objects 1 'in the clean room: According to the invention, the bag 1 is connected to an inner liner 4a connecting the clean room with an outer space and is then opened on a region facing the inner liner 4a, so that an outer space is closed, hose-like connection between the interior of the bag 1 and the inner liner 4a is formed, through which a discharge of the bag can be made in the clean room. The inner liner 4a is thus part of a lock for the clean room or acts as such.

The bag 1 faces with a free end, which is closed with a sealing weld 3a in an inlet 2a. The inlet 2a is part of the inner liner 4a and is internally weldable. It is open in this embodiment and therefore may not be sterile.

4 and 5 show the next step for introducing the articles 1 ', in which the free welded end 3a of the endless tubular film 1a or of the bag 1 is inserted into the inner liner 4a or its inlet 2a to be filled.

6 and 7 indicate the process of the welding according to the invention: With a conventional welding apparatus, the endless tubular film 1a and the inlet 2a of the innerliner 4a to be filled are welded together continuously (second weld seam 6a). The broad side of the endless tubular film 1a superior part 5a is also welded through. This results in complete protection against contamination, since so no material can escape between endless tubular film 1a of the bag 1 and the inlet 2a. Apart from that, between the outside of the endless tubular film 1a of the bag 1 and the inside of the inlet 2a a dense, non-peelable weld seam has been created. The endless tubular film 1a itself is welded to itself on its inside.

8 and 9 now show the process of opening the hose connection to allow the Umfüllvorgangs: the first weld 3a and the second weld 6a are peeled, ie from the outside detects an operator, the endless tubular film 1a and pulls them apart, wherein the internal welds 3a and 6a aufpeelen. The opening or the Aufpeelen can optionally also be achieved by the optionally slightly increased inerting pressure of the article 1 '. The welding between the outside of the endless tubular film 1a and the inlet 2a remains. As a result, the innerliner 4a is tightly connected to the bag 1. In this state, the counter sand 1 'is transferred via the inner liner 4a in the clean room.

10 and 11 show the process of completing the filling process. After filling, the endless tubular film 1 is preferably separated with a separating weld seam 3b. A separating weld 3b is a weld which, after the welding operation, allows separation of the two parts which abut the weld. The two parts remain welded at the ends facing each other. The transfer process of the article 1 'from the bag 1 in the clean room is thus closed, since the dividing seam, as mentioned, forms an edge weld. The weld seam 3b corresponds to the weld seam 3a in a new cycle.

FIGS. 12 and 13 show the next step, in which preferably the inner liner 4a is closed again at its upper end by the free ends of the inlet 2a are welded tight at a fourth point 7. In advance, the welded-off (3b ") remainder of the endless tubular film 1 is placed or inserted in the inlet 2a.

This creates a closed transfer process. Both endless tubular film 1a or bag 1 as well as the inner liner 4a do not come into contact with the objects 1 'to be transposed on their outer sides.

The same property, but moreover even more sterile working conditions, ie that no substances, germs or the like can come into contact with the articles to be filled during the introduction, are realized by the further developed method described below, according to which the inner sides of the films are filled during the process never completely with the Environment come into contact, while in the method described above, the insides do not come into contact with the environment until they had come into contact with the objects to be filled.

Fig.14 and 15 show the initial situation for the sterile and contamination-free introduction of objects into a clean room according to the further development of the invention:

The inner liner 4b to be filled has a short inlet 2b, which is welded to a special tubular transition foil 5. The transition foil 5 is internally not weldable and externally weldable. At the transition foil 5, the side facing away from the inlet 2b is welded edge-tight with a bag-like sealing foil 6. The sealing film 6 is made of pure PE and good weldability on all sides. The inner liner 4b is tightly welded to the transition foil 5 and can be gas or gamma sterilized. The entire package can thus be delivered, for example, in sterile packaging and placed on site (e.g., in the clean room) in the facility.

FIGS. 16 and 17 show how the bag 1 is inserted with a section in the special inlet structure consisting of transition foil 5 and sealing film 6 and welded to the inlet formed as a bag 7: The endless tubular film 1a and the bag 1 is in the bag-shaped recess of the sealing film 6 to filling inner liner 4b inserted. The outer sides of the sealing film 6 thus touch the outer sides of the endless tubular film 1a of the bag 1. The outer side in this case is the side which comes into contact with the environment. From the point of view of the bag 7, however, it is rather an inner side due to the bag formation of the sealing film 6. For linguistic clarification 10, however, the external side always speaks in the above sense.

Fig.18 and 19 now show the process in which the nested endless tubular film 1a of the bag 1 and the sealing film 6 are welded: - With a welder (not shown, because conventional per se), the endless tubular film 1a and the sealing film are welded together, so that two tight welds 8a , 8b arise between the endless film tube 1a and the bag 7. In this process, the endless tubular film 1a is also welded together. During the welding process, a separating seam 9 is set between the welding seams 8a and 8b. This separates the non-sterile part in the form of a token 10. The welding and separation is done from the outside through the transition foil 5 through. Since the inner layer is not weldable, there is no connection of the inside of the transition foil 5 with the inside of the sealing foil 6 or with the endless tubular foil 1a.

FIGS. 20 and 21 show the process of separation of the token 10: The token falls down into the inner liner 4b and is taken from the clean room side.

Fig.22 and 23rd show the process of peeling, in which the endless tubular film 1a and with it the sealing film 16 is opened. The welding between the endless tubular film 1a and the sealing film 16, however, remains. As a result, the innerliner 4b is tightly connected to the bag 1. In this state, the inner liner 4b is filled or emptied sterile.

It should be noted at this point that the introduction of the articles 1 'into the clean room can be both a horizontal and a vertical conveying process. Preferably, however, a horizontal sluice is realized because it can be used to ensure better protection against contamination.

With the in FIGS. 24 and 25 shown steps, the cycle closes. There is a separation welding: After filling the endless tubular film 1a can be separated with a separation weld 3b. The process in the plant as well as the inner liner 4b are thus closed and sterile, since the separating seam 3b triggers an edge weld.

For a renewed transfer operation, the separating seam 3b would correspond with its edge welding to the weld seam 3a on the endless tubular film 1.

Fig. 26 - 28 show a further variant of the inventive method. According to this variant, the bag 1 has a bag-shaped receptacle 12 for an end section 13 of the inner liner 4c which is closed with a welded seam 11. The receptacle 12 is double-walled and made of an externally weldable and internally non-weldable plastic. Of the walls of the receptacle, two separate regions 12a, 12b are delimited, one of which is closed to the bag 1 and the other is in communication with the interior of the bag 1.

For transferring the bag contents, the end portion 13 of the inner liner 4c is arranged in the receptacle 12 so that the weld seam 11 comes to lie within the receptacle 12, whereupon the receptacle 12 and the portion 13 of the inner liner 4c therein are welded, so that between the edge the receptacle 12 and the existing weld seam 11 of the inner liner 4c, a further weld seam 11 a is formed. Then a dividing seam can be set to separate the weld seam 11 a. Then, the further weld seam 11a is separated so that a weld portion 11 of the closed end portion 13 of the inner liner 4c containing portion 13 'of the inner liner 4c is separated and contained in a space 13a. The space 13a is formed by the bottom of the receptacle 12 and an inner side wall 12b 'of the bag 12 closed portion 12b and a separated side wall portion 12a "of an inner side wall 12a' of the bag (1) open area 12a.

After the separation of the weld seam 11a, the receptacle 12 and the inner liner 4c become a tubular one due to the region 12a of the receptacle 12 which is in communication with the interior of the bag 1 Connection for transferring the at least one object formed in the clean room.

It is not shown here that after a transfer of the at least one article 1 'into the clean room, the hose-like connection between the bag 1 and the inner liner 4c is interrupted by attaching a separating weld seam and a separation of the inner liner 4c from the bag can be made.

Fig. 29 shows a lock 14 for a clean room 15, to Verdanblidung the invention. The lock 14 has an inlet opening 14a for transferring the article 1 'into the clean room 15. The inlet opening 14a is penetrated by the inner liner 4c, which connects the clean room 15 with an outer space 16. Furthermore, welding means are provided to connect the inner liner 4c to the bag 1. The inner liner 4c formed from an endless tubular film is completely closed towards the outer space 16 before the transfer process. Wide, the inner liner 4c is axially supported around the inlet opening 14a in a chamber 14b annularly arranged around the inlet opening 14a of the clean room 15. After each insertion process, the inner liner is mirrored at its end portion located in the outer space 16 by attaching the weld seam 11 a by means of both sides of an imaginary extension of the axis of the inlet opening 14, per se conventional and therefore not shown welding equipment.

It should be noted that all the above-mentioned methods can also be carried out so that the embodiments of inner liner 4a, 4b, 4c and bag 1 are such that the bag 1 on a connecting wall for the inner liner 4a, 4b, 4c as the The innerliner 4a, 4b, 4c described above and shown in the figures is designed, wherein the inner liner 4a, 4b, 4c may be formed at its edge as the bag 1 described above. Essential to the invention here is merely that bag 1 and inner liner 4a, 4b, 4c are compatible with each other.

In the context of the invention, if appropriate, processes which replace the "welding" by a "gluing", provided that the bonds have the same properties with respect to the peelability, as indicated for the welding above. "Welding" is therefore to be understood in a very broad sense.

LIST OF REFERENCE NUMBERS

1

bag contents

1'

object

1a

Endless tubular film

1b

gamma radiation

2a, b

enema

3a, b

third weld on the endless tubular film 1

4a, b, c

Inner liner of the device to be transferred to. 10

5

Transition film

6

sealing film

6a

second weld seam contamination-free design

7

bag

8a, b

Second weld sterile version

9

dividing seam

10

Token (waste part)

11

Welded seam on inner liner 4c

11a

another weld

12

bag-shaped recording

12a

towards the bag open area

12b

closed to the bag area

12a '

Side wall of the recording

12a "

separated portion of the side wall 12a

12b '

Side wall of the recording

13

End portion of the inner liner 4c

13 '

severed end area

13a

Reception room for the end area

14

Lock for a clean room

14a

inlet port

14b

annular chamber

15

cleanroom

16

outer space

Claims (11)

1. A method for channelling at least one object (1') which has been packed in a bag (1) and sterilised into a clean chamber (15), characterised in that the bag (1) is connected to an inner liner (4a, 4b, 4c) which connects the clean chamber (15) to an outer chamber (16) and is thereupon opened in a region facing the inner liner (4a, 4b, 4c) so that a tube-like connection is formed between the interior of the bag (1) and the inner liner (4a, 4b, 4c), which tube-like connection is closed off from the outer chamber (16) and through which the at least one object (1') is transferred into the clean chamber (15).
2. The method according to Claim 1, characterised in that the bag (1) is produced from an endless film tube, which can be fused at the outer and inner sides thereof, wherein the inner side of the endless film tube (1a) can be peeled after fusing, and the bag is closed by fusing after being filled with the at least one object and thereupon the at least one object is sterilised.
3. A method for channelling at least one object (1') which is packed in a bag (1) and sterilised into a clean chamber (15), characterised in that the bag (1) is connected by fusing to an inner liner (4a, 4b, 4c) which connects the clean chamber (15) to an outer chamber (16) and thereupon is opened in a region facing the inner liner (4a, 4b, 4c), so that a tube-like connection is formed between the interior of the bag (1) and the inner liner (4a, 4b, 4c), which tube-like connection is closed off from the outer chamber (16) and through which the at least one object (1') is transferred into the clean chamber (15), wherein the bag (1) is produced from an endless film tube which can be fused at the outer and inner sides thereof, wherein the inner side of the endless film tube (1a) can be peeled after fusing, and the bag is closed by fusing after being filled with the at least one object and thereupon the at least one object is sterilised.
4. The method according to Claim 2 or 3, characterised in that, in order to channel the at least one object (1') into the clean chamber (15), an inlet (2a) of the inner liner (4a) is arranged around the outer side of the bag (1) in such a manner that the bag-side edge of the inlet (2a) comes to lie above a fuse seam (3a) which seals the bag (1), whereupon the bag (1) is fused with the inlet (2a), so that at least one continuous new second fuse seam (6a) is produced between the existing fuse seam (3a) of the inlet and the inlet-side edge of the inlet (2), which second fuse seam connects the inner side of the inlet (2a) to the outer side of the bag (1) on one side and connects the inner side of the bag (1) at the same point on the other side, whereupon the peelable inner side of the bag (1) is detached and the bag (1) is opened in the direction of the clean chamber (15) to transfer the at least one object.
5. The method according to Claim 2 or 3, characterised in that the bag (1) has an inlet (2a) and the inner liner is likewise formed from an endless film tube (1a) which is sealed with a fuse seam (3a), wherein the inlet (2a) is arranged in such a manner that the edge of the inlet (2a) comes to lie above the fuse seam (3a), whereupon the endless film tube (1a) is fused with the inlet (2a), so that at least one continuous new second fuse seam (6a) is produced between the existing fuse seam (3a) and the edge of the inlet (2), which second fuse seam connects the inner side of the inlet (2a) to the outer side of the endless film tube (1a) on one side and connects the inner side of the endless film tube (1a) at the same point on the other side, whereupon the peelable inner side of the endless film tube (1a) is detached and the bag (1) is peeled open and opened in the direction of the clean chamber (15) to transfer the at least one object.
6. The method according to Claim 2 or 3, characterised in that a sterilised sack (7) is fused with an inlet (2b) of the inner liner (4b), wherein the sterilised sack (7) has a tube-shaped transition film (5) which can be fused on the inside rather than the outside and is connected with its side facing away from the inlet (2b) to a sack-shaped sealing film (6), the sack bottom of which lies inside the transition film (5) and the sack edge of which is connected, for example fused, to the side of the transition film (5) facing away from the inlet (2b), wherein a plastic is selected for the sealing film (6) which can easily be fused, and the sack-shaped sealing film (6) is arranged around the outer side of the bag (1) containing the at least one object in such a manner that the fuse seam (3a) sealing the said bag (1) comes to lie inside the sack, wherein the bag (1) containing the at least one object is fused with the sealing film (6) so that at least one continuous new fuse seam (8), preferably a double fuse seam (8a, 8b), is produced between the existing fuse seam (3a) of the bag (1) containing the at least one object and the free edge of the sealing film (6), which new fuse seam connects the inner side of the sealing film (6) to the outer side of the bag (1) containing the at least one object on one side and the inner side of the bag (1) containing the at least one object at the same point on the other side, wherein a separation seam (9) is placed in the centre of the fuse seam (8), preferably between the double fuse seams (8a, 8b) during the fusing process, so that the part of the bag (21) containing the object which faces the inner liner is detached along with the sealing film (6) surrounding it in the form of a token (10) including material, whereupon the peelable inner side of the bag (1) containing the at least one object is detached at its second fused point (8a), so that the at least one object (1') can be transferred into the clean chamber (15).
7. The method according to Claim 2 or 3, characterised in that the bag (1) has an inlet (2b), with which a sterilised sack (7) is fused, wherein the sterilised sack (7) has a tube-shaped transition film (5) which can be fused on the inside rather than the outside and is connected with its side facing away from the inlet (2b) to a sack-shaped sealing film (6), the sack bottom of which lies inside the transition film (5) and the sack edge of which is connected, for example fused, to the side of the transition film (5) facing away from the inlet (2b), wherein a plastic is selected for the sealing film (6) which can easily be fused, and the sack-shaped sealing film (6) is arranged around the outer side of the inner liner (4b) in such a manner that a fuse seam (3a) sealing the inner liner (4b) comes to lie inside the sack, wherein the inner liner (4b) is fused with the sealing film (6) so that at least one continuous new fuse seam (8), preferably a double fuse seam (8a, 8b), is produced between the existing fuse seam (3a) of the inner liner (4b) and the free edge of the sealing film (6), which new fuse seam connects the inner side of the sealing film (6) to the outer side of the inner liner (4b) on one side and the inner side of the inner liner (4b) at the same point on the other side, wherein a separation seam (9) is placed in the centre of the fuse seam (8), preferably between the double fuse seams (8a, 8b) during the fusing process, so that the part of the inner liner (4b) which faces the bag (1) is detached along with the sealing film (6) surrounding it in the form of a token (10) including material, whereupon the peelable inner side of the inner liner (4b) is detached at its second fused point (8a), so that the at least one object (1') can be transferred into the clean chamber (15) after the bag (1) has been peeled open.
8. The method according to Claim 1, characterised in that the bag (1) has a sack-shaped receptacle (12) for an end section (13) of the inner liner (4c), which end section is closed with a fuse seam (11), wherein the receptacle (12) is double-walled and is formed from a plastic which can be fused on the outside but cannot be fused on the inside, and two regions (12a, 12b) which are separated from each other are delimited by the walls of the receptacle, of which one region (12b) is closed off from the bag (1) and the other region (12a) is connected to the interior of the bag (1), wherein, in order to transfer the bag contents, the end section (13) of the inner liner (4c) is arranged in the receptacle (12) in such a manner that the fuse seam (11) comes to lie inside the receptacle (12), whereupon the receptacle (12) and the section (13) of the inner liner (4c) situated therein are fused, so that a further fuse seam (11a) is produced between the edge of the receptacle (12) and the already existing fuse seam (11) of the inner liner (4c), whereupon the further fuse seam (11a) is separated in such a manner that a section (13') of the inner liner (4c) which contains the fuse seam (11) of the closed end section (13) of the inner liner (4c) is detached and is contained in a chamber (13a) formed by the bottom of the receptacle (12) and an inner side wall (12b') of the region (12b) which is closed off from the bag (1) and by a detached side wall section (12a") of an inner side wall (12a') of the region (12a) which is open towards the bag (1), wherein, due to the region (12a) of the receptacle (12) which is connected to the interior of the bag (1) and the inner liner (4c), a tube-shaped connection is formed for transferring the at least one object into the clean chamber, wherein preferably after transfer of the at least one object (1') into the clean chamber (15), the tube-like connection between the bag (1) and the inner liner (4c) is disconnected by applying a fuse seam and the inner liner (4c) is separated from the bag.
9. The method according to one of Claims 1 to 8, characterised in that the inner liner (4a, 4b, 4c) is formed by an endless film tube mounted axially around an inlet of the clean chamber.
10. A method for channelling at least one object (1') which is packed in a bag (1) and sterilised into a clean chamber (15), characterised in that the bag (1) is connected by fusing to an inner liner (4a, 4b, 4c) which connects the clean chamber (15) to an outer chamber (16) and thereupon is opened in a region facing the inner liner (4a, 4b, 4c), so that a tube-like connection is formed between the interior of the bag (1) and the inner liner (4a, 4b, 4c), which tube-like connection is closed off from the outer chamber (16) and through which the at least one object (1') is transferred into the clean chamber (15), wherein the bag (1) has a sack-shaped receptacle (12) for an end section (13) of the inner liner (4c), which end section is closed with a fuse seam (11), wherein the receptacle (12) is double-walled and is formed from a plastic which can be fused on the outside but cannot be fused on the inside, and two regions (12a, 12b) which are separated from each other are delimited by the walls of the receptacle, of which one region (12b) is closed off from the bag (1) and the other region (12a) is connected to the interior of the bag (1), wherein, in order to transfer the bag contents, the end section (13) of the inner liner (4c) is arranged in the receptacle (12) in such a manner that the fuse seam (11) comes to lie inside the receptacle (12), whereupon the receptacle (12) and the section (13) of the inner liner (4c) situated therein are fused, so that a further fuse seam (11a) is produced between the edge of the receptacle (12) and the already existing fuse seam (11) of the inner liner (4c), whereupon the further fuse seam (11a) is separated in such a manner that a section (13') of the inner liner (4c) which contains the fuse seam (11) of the closed end section (13) of the inner liner (4c) is detached and is contained in a chamber (13a) formed by the bottom of the receptacle (12) and an inner side wall (12b') of the region (12b) which is closed off from the bag (1) and by a detached side wall section (12a") of an inner side wall (12a') of the region (12a) which is open towards the bag (1), wherein, due to the region (12a) of the receptacle (12) which is connected to the interior of the bag (1) and the inner liner (4c), a tube-shaped connection is formed for transferring the at least one object into the clean chamber.
11. The method according to Claim 10, characterised in that, after the at least one object (1') has been transferred into the clean chamber (15), the tube-like connection between the bag (1) and the inner liner (4c) is disconnected by applying a fuse seam and the inner liner (4c) is separated from the bag, wherein the inner liner (4a, 4b, 4c) is preferably formed by an endless film tube mounted axially around an inlet of the clean chamber.

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