WO2013004322A1

WO2013004322A1 - Device for aseptic connection and separation of connections between containers

Info

Publication number: WO2013004322A1
Application number: PCT/EP2012/002095
Authority: WO
Inventors: Oscar-Werner Reif; Shahmir Fatherazi; Ralf Lausch
Original assignee: Sartorius Stedim Biotech Gmbh
Priority date: 2011-07-05
Filing date: 2012-05-16
Publication date: 2013-01-10
Also published as: DE102011106852B4; EP2729211A1; DE102011106852A1

Abstract

Device (1) and method for aseptic connection and separation of connections between two containers (2, 3), wherein a coupling connector (4) has first and second connector parts (8, 9) which can be coupled to each other via corresponding coupling parts (10, 11), and the connector parts (8, 9), at their ends directed away from the coupling parts (10, 11), each communicate with a part (5) of a sterile connector (6), and the connector parts (8, 9), in the coupled state, are surrounded by a tubular film (7) which, at its ends directed towards the sterile connectors (6), is sealed off with respect to the connector parts (8, 9) or with respect to connection hoses (12) connected to the connector parts (8, 9) or with respect to the parts (5) of the sterile connectors (6) and, at the connection site (14) of the coupling parts (10, 11), forms a circumferential fold (15) which permits sealing of the coupling connector (4) when the connector parts (8, 9) are uncoupled and spaced apart.

Description

Device for aseptically connecting and disconnecting

Connections between containers

description

Field of the invention

The invention relates to a device for aseptically connecting and disconnecting connections between two

Containers.

The invention further relates to a method for

aseptic connection and disconnection between two containers.

State of the art

Sterile transfer of media is an important requirement in the field of pharmaceutical and medical technology. For example, the contents of bioreactors must be transferred to storage or further processing containers in a sterile condition. Also, for example, additives and buffer media for process control must be added sterile in bioreactors. This often happens through flexible hoses

Plastics. In the end, the transfer tubes should be separated in such a way that on the one hand the sterility of media is preserved and on the other hand the environment is not contaminated.

- l - Crushing and separating systems for flexible hoses have been known for years. For this purpose, a metal sleeve is pulled over the hose and with a tool in the middle

pressed together. Together with the metal sleeve and the tube is compressed and squeezed. Thereafter, the sleeve in the middle and thus also the hose is separated with a pair of cutting pliers.

A disadvantage of such a squeezing and separating system is that with increasing hose diameter, the dimensions of the tools increase accordingly and relatively large forces are required to operate the tools. In addition, such a device is only for separating and not for

Connect suitable.

From US 2008/0009833 AI is a device for

aseptic connection of two hose ends, the

For example, connected to a container, known. The free hose ends each have one

Cap made of a thermoplastic material, which is connected at one end tightly connected to the hose. In a corresponding device, the two ends to be joined together are squeezed together by pressing from opposite sides so that the lumen of the respective

Hose end is closed. Subsequently, the

End walls of the two caps to be joined together melted away and the two cap ends are welded together. After welding, the squeezing pressure on the hoses and caps is released so that the hoses including the now together

welded caps return to their original position and the lumen of the two now interconnected

Release hose ends again.

A disadvantage is that on the one hand, the process is relatively expensive and on the other hand, aseptic separation of the tubes with this method is not possible. Another disadvantage is that this method is only suitable for thermoplastic tubes.

Furthermore, from US 2008/0023135 AI a device for aseptically connecting connections between two

Containers known. Here are free, closed

Hose ends parallel side by side introduced into a device, the adjacent ends are on both sides of a designated interface by

squeezed corresponding clamping devices and cut between the clamping devices transversely to the longitudinal direction of the tubes. Subsequently, the ends of the

Hoses to be connected to each other so moved against each other that their faces are aligned with each other and can be welded together.

Again, it is disadvantageous that the device must be designed for a relatively complex and complex and the other is provided only for establishing a connection and not to their separation. Another disadvantage is that this method is only suitable for non-reinforced thermoplastic hoses. Furthermore, US Pat. No. 4,022,256 A discloses a device for aseptically connecting connections between two

Containers known. In this case, tube sections to be joined together have an insert made of a material that melts at a higher level in this area than the tube wall. In this case, the tube sections are placed against each other and pressed together with heating to a temperature which is lower than the melting temperature of the deposits to make a connection, so that the material of the

Hose sections in the deposits is pressed away and creates a passage between the two hose sections.

The disadvantage here is that the necessary

Litigation is relatively complicated and expensive.

A further disadvantage is that the production of

Special hoses with refractory feed is relatively expensive.

The known devices have the disadvantage that the special hoses and devices in the

Manufacture of the containers must be planned and pre-assembled, with a subsequent contribution is either not possible or associated with greater effort and risk, and that on the other devices can indeed be used for connecting and transferring dangerous fluids, a separation after the transfer but relatively risky is. After separation, parts of the hazardous fluid may come into contact with the environment and, for example, contamination of employees and work areas

cause. task

Object of the present invention is therefore, a

Apparatus and method for aseptically connecting and disconnecting connections between two containers

to provide, at any time

Aseptically, liquids can be transferred between the containers without environmental contamination.

Presentation of the invention

The object concerning the device is achieved in conjunction with the preamble of claim 1, characterized in that a coupling connector has a first and a second connector part, which are verkuppelbar via corresponding coupling parts with each other, that the connector parts at their the

Dome-facing ends are each in communication with a first part of a sterile connector and that the connector parts in the coupled state of a

Tubular film are surrounded by theirs

Sterilinknektoren facing ends opposite to the

Connector parts or opposite to the connector parts connected connecting tubes or against the parts of the sterile connectors is sealed and at the

Junction of the dome parts forms a circumferential fold, which allows a seal of the coupling connector with uncoupled and spaced connector parts.

The device, consisting essentially of the

Coupling connector, the sterile connectors or their first parts and surrounding the connector parts tubular film can be delivered sterile packaged and connected without tools with corresponding to the containers associated second parts of sterile connectors. Due to the circumferential fold of the tubular film of the coupling connector or

its dome parts are easily decoupled, with the

Tubular film reliably prevents the environment from being contaminated with undesirable substances. The tubular film can be folded, welded and separated between the dome parts, so that the separate dome parts or connector parts are each reliably sealed from the environment by the welding of the tubular film. This is a connection device available, the simple and at any time for aseptic

Transferring liquids can be used. After transferring the liquid, a simple and completely aseptic separation without environmental contamination is made possible.

According to a preferred embodiment of the invention, the connector parts are connected via hoses to the first parts of the sterile connectors. In principle, however, it is also possible to connect the connector parts directly to a first part of a sterile connector. The connection of

Connector parts via hoses with the first parts of the

Sterile connectors allows for a certain

Flexibility and on the other hand can conventional

Coupling connectors and sterile connectors are used with appropriate hose connections.

According to a further preferred embodiment of the invention are associated with the first parts of the second parts of the sterile connectors via hoses with them associated containers in connection. Again, it is true that the sterile connectors or their second parts can be arranged directly on the associated containers.

According to a further preferred embodiment of the

Invention is one of the containers as a bioreactor

educated. Especially for bioreactors and downstream or upstream container, the aseptic compound of the invention proves to be advantageous.

According to another preferred embodiment of the invention, a welding and cutting device is provided for welding and cutting through the tubular film in the space formed by the decoupled connector parts. Here too, a simple welding and cutting device known per se to the person skilled in the art can be used. In principle, a welding tool or welding device and a separate cutting tool or cutting device can also be used.

When welding the protective film are all possible

dangerous cells, bacteria and the like by the welding temperature, which is for example about 160 ° C, under the weld or between them

welded areas of the protective film killed.

According to a further preferred embodiment of the

Invention, the tubular film is formed as a multi-layer film. The formation of the tubular film as a multilayer film, the impermeability or

Tear strength and weldability are improved. According to a further preferred embodiment of the

Invention is the inner layer of the tubular film

Polyethylene or ethylene vinyl acetate formed.

Inner layers of these materials also contribute to better protection and weldability.

According to a further preferred embodiment of the invention, the coupling connector is designed as a quick coupling

trained, which is locked in a coupling and can be uncoupled by pressing a button. The person skilled in a variety of suitable quick couplings are known, which can be used as a coupling connectors.

The object with respect to the method is achieved in conjunction with the preamble of claim 9, characterized in that a device having a two via corresponding dome parts verkuppelbare connector parts

Coupling connector, which has at opposite ends in each case a first part of a sterile connector and that of a sealed at their ends tubular film. surrounded, which has a circumferential fold, for connecting the

Container over the first parts of the sterile connectors with second parts of the sterile connectors, which are in communication with the containers, and that for separating the connection between the containers in a first step

Connector parts are separated and pulled apart, in a second step, the tubular film in the space between the connector parts juxtaposed and welded, and in a third step, the tubular film is severed in the welded area. The method has the advantages described with respect to the device. Both the connection and the disconnection between two containers is relatively simple, inexpensive and also safe.

According to a preferred embodiment of the invention, before disconnecting the connection between the containers, the connections associated with the containers are interrupted by means of clamping valves. By the clamping valves, it is reliably avoided that the separate connector parts are pressurized from the inside.

Further details of the invention will become apparent from the following detailed description and the accompanying drawings in which preferred embodiments of

Invention are exemplified.

Brief description of the drawings

In the drawings show:

Figure 1: a side view of a device with a

Coupling connector, with sterile connectors and with a tubular film partially in section;

Figure 2: the device of Figure 1 as a connection

between two containers;

FIG. 3 shows a side view of the device of FIG. 1 in the decoupled state; FIG. 4 shows a side view of the device of FIG. 3 with the tubular film juxtaposed between the connector parts with the welding tool in the unwelded state;

Figure 5 is a side view of the device of Figure 4 with welded between the connector parts foil with welding tool;

FIG. 6 shows a side view of the device of FIG. 5 with a severed weld;

FIG. 7 shows a second part of a first connector part in FIG

Side view in an enlarged view and

FIG. 8 shows a first part of a second connector part in FIG

Side view in an enlarged view.

Description of the embodiments

A device 1 for the aseptic connection and disconnection of connections between containers 2, 3 consists essentially of a coupling connector 4, two first parts 5 of sterile connectors 6 and a tubular film 7.

The coupling connector 4 consists of a first

Connector part 8 and a second connector part 9, which are interconnected via mutually corresponding coupling parts 10, 11. The connector parts 8, 9 are at their the dome parts 10, 11 facing away from each one ends Hose 12 with the first part 5 of a sterile connector 6 in conjunction.

The coupling connector 4 is in the embodiment of

Figures 1 to 6 surrounded by the tubular film, which is sealed at the first parts 5 of the sterile connectors 6 adjacent ends 13 of the tubes 12. The seal can be done via cable ties, not shown, by welding, by gluing or by jamming. In the area of the dome 14 formed by the dome parts 10, 11, the tubular film 7 has a circumferential fold 15 which, even with uncoupled connector parts 8, 9 den

Clutch connector 4 seals against the environment.

The first parts 5 of the Sterilkonnektoren 6 are with

corresponding second parts 16 of the sterile connectors 6 connectable, which in turn via hoses 17, 18 are connected to the containers 2, 3.

The coupling connector 4 is referred to as a so-called

Quick coupling formed, which can be uncoupled by pressing a button 19. The coupling connector 4 consists of the first connector part 8, which has a first coupling part 10 and is formed, for example, as a male dome part. The second dome part 11 of the second connector part 9 corresponding to the first dome part 10 is correspondingly designed as a female dome part which receives the first dome part 10. By nesting the dome parts 10, 11 engage with each other, wherein by pressing the button 19 is a unlatching. At their the dome parts 10, 11 facing away from the ends Connector parts 8, 9 hose connections 20, 21, via which they are connected to the hoses 12.

As coupling connectors 4, for example, NS6 couplings can be used, as described by the company Colder

Products Company offered.

The device 1 has at its two free ends connected to the hoses 12 first parts 5 of

Sterile connectors 6 on. The with the first parts 5

Corresponding second parts 16 of the sterile connectors 6 are arranged at the free ends of the tubes 17, 18, which in turn are connected to the containers 2, 3. While the first parts 5 are formed, for example, as a male receiving part, the second parts 16 as

formed corresponding female parts.

Of course, the device 1 may also have at one end a first part 5 designed as a female part and at the other end have a first part 5 designed as a male part.

As Sterilkonnektoren 6 can, for example

Sterile connectors used as the Fa.

Sartorius Stedim Biotech GmbH under the name OPTA SFT.

According to the exemplary embodiment of FIG. 2, the connections designed as tubes 17, 18 belong to the

Containers 2, 3 each have a pinch valve 22. In order to connect the containers 2, 3 with each other, the first parts 5 of the sterile connectors 6 are connected to the second parts 16 of the sterile connectors 6, which are connected to the tubes 17, 18 associated with them container 2, 3. After connecting the first and second parts 5, 16 of the sterile connectors 6, the between them

arranged (not shown) sealing membranes removed so that the lumen of the sterile connectors 6

exposed. After establishing the connection between the containers 2, 3 via the device 1, the clamping valves 22 are opened, so that a fluid transfer between the containers 2, 3 can take place.

To disconnect the first clamping valves 22 are closed again.

By pressing the button 19, the connector parts 8, 9 of the coupling connector 4 are separated and pulled apart in a first step. In a second step, the tubular film in a space 24 between the

Connector parts 8, 9 laid together using a welding tool 23 and subsequently welded (see Figure 4 and 5). Finally, in a third step, the

Cut tube film 7 in the welded area.

Of course, those in the special description

discussed and shown in the figures embodiments only illustrative embodiments of the present

Invention is the expert in the light of the local

Revelation given a wide range of possible variations. Reference sign list

1 device

2 first container

3 second container

4 coupling connector

5 first part of 6

6 sterile connector

7 tubular film

8 first connector part of FIG. 4

9 second connector part of 4

10 first dome part of 8

11 second dome part of 9

12 hose

13 the end of 12

14 coupling point

15 circumferential fold of 7

16 second part of 6

17 hose

18 hose

19 button of 4

20 hose connection of 8

21 hose connection of 9

22 pinch valve

23 welding tool / welding u. cutter

24 space

Claims

claims

Device (1) for aseptically connecting and disconnecting connections between two containers (2, 3),

characterized,

in that a coupling connector (4) has a first and a second connector part (8, 9) which via

corresponding dome parts (10, 11) are verkuppelbar with each other,

in that the connector parts (8, 9) are in each case connected to a part (5) of a sterile connector (6) at their ends facing away from the dome parts (10, 11) and that the connector parts (8, 9) are in the coupled state by a tubular film (8). 7) are surrounded, which at their the sterile connectors (6) facing ends relative to the connector parts (8, 9) or opposite with the

Connector parts (8, 9) connected to the connecting tubes (12) or against the parts (5) of the Sterilkonnektoren (6) is sealed and at the junction (14) of the coupling parts (10, 11) forms a circumferential fold (15), which is a seal the coupling connector (4) at decoupled and spaced connector parts (8, 9) allows.

2. Apparatus according to claim 1,

characterized,

in that the connector parts (8, 9) are connected via the hoses (12) to the first parts (5) of the sterile connectors (6). Apparatus according to claim 1 or 2,

characterized,

that with the first parts (5) corresponding second parts (16) of the sterile connectors (6) via hoses (17, 18) with their associated containers (2, 3) in

Connection stand.

Device according to one of claims 1 to 3,

characterized,

that one of the containers (2, 3) as a bioreactor

is trained.

Device according to one of claims 1 to 4,

characterized,

a welding and cutting device (23) for

Welding and cutting through the tubular film (7) is provided in the intermediate space (24) formed by the decoupled connector parts (10, 11).

Device according to one of claims 1 to 5,

characterized,

the tubular film (7) is designed as a multilayer film.

Device according to claim 6,

characterized,

that the inner layer of the tubular film (7) made

Polyethylene or ethylene vinyl acetate is formed. Device according to one of claims 1 to 7,

characterized,

in that the coupling connector (4) is designed as a quick-action coupling which locks when coupled and can be decoupled by pressing a button (19).

Method for aseptically connecting and disconnecting

Connections between two containers (2, 3),

characterized,

that a device (1) with a two over

corresponding dome parts (10, 11) with each other verkuppelbare connector parts (8, 9)

Coupling connector (4) having at opposite ends in each case a first part (5) of a sterile connector (6) and which is surrounded by a tubular film (7) sealed at its ends, which has a circumferential fold (15),

for connecting the containers (2, 3) via the first parts (5) of the sterile connectors (6) to second parts (16) of the sterile connectors (6) which communicate with the containers (2, 3), and

in that the connector parts (8, 9) are separated and pulled apart in a first step in order to separate the connection between the containers (2, 3), in a second step the tubular film (7) in the intermediate space (24) between the connector parts (8, 9 ) and welded together, and in a third step the

Hose film (7) is severed in the welded area. Method according to claim 9,

characterized,

that before disconnecting the connection between the

Containers (2, 3), the containers (2, 3) associated connections are interrupted by clamping valves.