Patent Application
20210354229
The present invention concerns a method and device for generating an environmentally sealed connection between two regions suited for transfer, which is not exposed to an external environment.
Several industry sectors, such as the pharmaceutical and biotech industry, chemical industry and medical device industry, regularly face the problem of how to join a volume or region of a defined environmental condition, such as a defined contamination status, with another volume or region of the same environmental condition without exposing either of the volumes of regions to an external environment with different environmental condition. In these industries, the consequences of contaminating the enclosed volumes or regions with the external environment may result in considerable financial consequences and potentially poses a severe risk for consumer or patient health.
The same technical problem, i.e. how to safely join two regions under exclusion of the environment, presents itself also in a medical setting, for example if sterile-packed consumables or tools, such as syringes, need to be transferred from their packaging into a sterile chamber or sterile room. Similarly, the sterile transfer of organs, uncontaminated biological tissue or samples from one containment to another also faces this problem.
Since this is a widely known technical challenge, it is not surprising that a number approached have been described to safely join packaging, containers or other volumes for the uncontaminated transfer of different objects and materials.
Document WO2018019785 discloses the extraction of a content of a bag for pharmaceutical and chemical sectors from a first environment into a second environment being separated form a third environment of a different contamination classes. The extraction assembly employs a separation wall comprised in an end mouth of the bag, which is formed by opposing flaps. The opening mechanism relies on grippers and jaws operating the flaps and on movable closing partitions.
Document EP2441692B1 a device and method to transfer a sterile object from a sterile bag from a non-sterile environment to a sterile environment through an inlet mouth of an inlet section of the sterile environment. The sterile bag is cut, and the product is expulsed from the bag by pushing on the outer face of the bag. This invention neither discloses superposition not welding of a bag or liner.
Document US2012085490A1 discloses a method for contamination-free docking of a first at least partially flexible receptacle to a second at least partially flexible receptacle. The receptacles include, at least in part, films having outer sides that can be solidly welded, and inner sides can be detachably welded. According to the described system, a solid connection between the receptacles is produced outside the detachably welded inner sides in order to create a channel between the receptacles. The channel is opened by loosening the connection between the inner sides.
Document US2011142574A1 discloses 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.
Document US2010012225A1 discloses a device and a method for decanting powders and solid substances or materials while avoiding contamination and a novel use of a weldable and peelable continuous tubular film. The transfer opening is generated by selective peeling of fused welding seams.
Document US2018369801 discloses a method for manufacturing a leak-tight assembly by providing a bag, a connection system including a connector adapted for mechanical connection to a complementary connector of a sterile chamber in order to establish sterile communication between the bag and the chamber. The connection system comprises and overmolding onto which the wall of the bag is molded for the sterile transfer.
Document US2014314527A1 discloses a discharge method for discharging a sterile good from an at least partially flexible container without contamination, through a liner into a receiving region employing a knife to create an aperture in the flexible container.
Document US2018078665A1 discloses a medical packaging bag having different thermal property zones. The invention does not disclose a method for transfer between different regions.
Document EP1918209B1 discloses a process to empty a package without contamination at a station where the package is wrapped in a tubular film inside the station. The wrapped package is opened in station and emptied by cutting a region. This invention neither discloses superposition not welding of a bag or liner.
Document U.S. Pat. No. 5,858,016A discloses the generation of an aseptic/sterile fluid connection between two containers by radiofrequency welding, wherein portions of adjacent container outer walls are fused and a fluid opening is subsequently formed due to squeezing action of the dies.
Based on the state of the art, the present invention sets out to find a solution for the reliable generation of a joining connection between two regions under exclusion of a third external region. Preferably, the solution should to be able to safeguard that the barriers between the external environment and the environment of the two regions are not breached during the process of joining the regions or during the operational steps thereafter. The solution should be simple to use and suited for repeated or serial use, for example to facilitate repeated transfer of items from several distinct first regions to one second region. The solution should also be highly reliable in its capacity to protect against contamination in order to be adequate for operations in sterile environments and to meet the high standards required for medical and pharmaceutical applications.
An aim of the present invention is the generation of a joining connection between two regions which meets the desired requirements of being simple to use, but secure in terms of maintaining the integrity of the barriers separating said two regions from an external environment.
Another aim of the invention is to provide a system for the transfer or objects, materials, biological matter and lifeforms between two regions of the same environmental conditions avoiding contamination of these regions by the external environment.
Another aim of the invention is the provision of a system which can be used repeatedly in quick succession without the need of extensive additional manipulation for serial use.
According to the invention, these aims are attained by providing a method and device for connecting the barriers of a first and a second region through a cut ‘n’ seal welding step as part of which an opening between two regions is created.
In particular these aims are attained by the object of the attached claims, and especially by:
Method of creating an environmentally sealed connection for transfer between a first region and a second region, the first region and the second region having each an at least partially flexible barrier separating the first region, respectively the second region from a third external region, the at least partially flexible barriers having each a connection portion comprising a first area at least partially made of thermo-resistant material and a second area comprising a first welding band zone of a closed geometrical shape, the method comprising the following steps:
If required, it is possible to reseal the two joined regions by separation welding along a second welding band zone, which is cut at a separation line situated inside this second welding band zone. The separation between the two regions is preferably performed subsequent to the transfer step. The separated and sealed receiving region can thus be prepared for a further transfer process.
The at least partially flexible barriers are part of a barrier system which hermetically seals the first and/or second regions from the external third region. Advantageously, this barrier is not breached at any stage during the process of connecting the first with the second region. An intact barrier is at all times maintained for one of the regions, preferably the second region. Ideally, the integrity of the barrier is also maintained after separation of the joined first and second regions.
Advantageously, the insert, which is cut from the barriers as part of the welding of the first welding zones, is sealed along its perimeter by means of the welding seam generated as part of said welding. It is detached from the barriers of the first and the second regions in a cut ‘n’ seal welding step generating the welding seam. This is sealing seam particularly important, as it constitutes a barrier between the joined first and second regions and the volume inside this insert, which stems from the third external environment. The integrity of the environmental status of the joined environment is therefore also maintained by the insert's side walls and their connecting welding seams. A volume of the external environment is therefore safely enclosed within the insert.
In the context of transferring sterilised or aseptic goods, objects or material in particular the first region may be a closed container. It may be a packaging bag. Preferable, this container or bag is made from material which is suitable for sterilisation of its contents. Possible sterilisation methods include autoclaving or radiation treatment. Other sterilisation methods, such as chemical sterilisation, are possible if suitable for the transferred objects, goods or (biological) material.
The receiving region, or second region, may be a room or a chamber of desired environmental conditions or contamination status. This region can be a closed region. This region may also be an open region. In case this second region is an open region, the third external region is be a contained region.
For example, the third region may be a contained contaminated or toxic environment and the first region may be a safety suit protecting a person from the hazardous environment of the third region. By joining the uncontaminated environment of the interior of the safety suit, i.e. the first region, with the uncontaminated environment of the open second region, the person can securely exit the safety suit without being exposed to contamination.
A repeated use of the joining mechanism is desirable for a number of applications, by way of example the repeated sterile transfer of objects into a sterile chamber. To this end, the system may provide for an endless liner with multiple serially arranged connection portions. The endless liner forms part of the at least partially flexible barrier of the second region. By separating the two areas after the transfer as suggested above, an unused connection portion may be used for a subsequent transfer.
Optionally, the endless liner may be integrated in an air lock structure. The endless liner can be progressively pulled from this air lock structure, without severing the liner from the air lock structure, in order to provide access to unused connection portions.
The aims of the invention are furthermore achieved by the provision of a device for transferring material or equipment avoiding contamination, characterized in that it comprises a connection portion having a first area at least partially made of thermo-resistant material, and the second area, wherein the second area is weldable to an area with equivalent physical properties, under predetermined welding conditions, whereas the first area (41) is not weldable to said second area under the predetermined welding conditions.
By maintaining intact barriers throughout the joining process, the method and device are therefore well suited for sterile applications, such as sterile or aseptic transfer of material, goods, organs, biological matter, lifeforms, equipment or objects.
In a medical context the system can be used for the transfer of medical equipment, including syringes, containers, catheters, surgical implants or instruments, and other consumables or tools. The transfer can take place, by way of example, between a packaging bag and a clean room or chamber. The transfer can also take place between two clean rooms or chambers.
However, the use of the system described herein is not limited to these applications.
Further application examples include exiting from a safety suit into an uncontaminated region, while the suit is still located in a contaminated environment requires a hermetically sealed connection between the suit and the uncontaminated region through which the person wearing the suit can exit into the uncontaminated area. Since the suit is preferably initially not connected to the uncontaminated region, in order to allow for free movement through the contaminated environment, a save opening has to be generated to join the inside volume of the suit with the uncontaminated region.
The system is furthermore suited for applications for which regions of specific atmospheric conditions, such as anaerobic conditions, need to be joined without risking exposure or influx of the surrounding air.
The invention disclosed herein is furthermore useful for joining a contaminated first region with a second region without risking contamination of the surrounding environment or an uncontaminated third region.
Exemplar embodiments of the invention are disclosed in the description and illustrated by the drawings in which:
With reference to
An additional containment element 58 suited to contain the assembled endless liner 30 is preferably connected to the air-lock structure 55. The liner 30 may be folded, rolled, compressed inside this containment element 58. Other assembly arrangements suited to decrease the volume of the endless liner 30 are possible.
The invention is not limited to the above described embodiments. The bag may be replaced by another confining at least partially flexible barrier 22 for a first region 25, such as a container, a chamber, a room or a protective suit. Other examples are conceivable.
The second region may be limited by an at least partially flexible barrier 32 enclosing a container, a chamber, a room or an open region. If the second region is an open region, it is separated from the external environment by a separation barrier, which may be a wall. If the second region is an open region, the external environment is an enclosed region confined by barriers.
The barrier of the first region 22 and the barrier of the second region 32 each comprise connection portions 40. In
Each connection portion 402, 403 includes a at least partially thermo-resistant first area 412, 413 which is at least partially made from material which is not weldable under predetermined welding conditions, at which the second area 422, 423 comprised by the connection portion is weldable. By way of example, predetermined welding conditions may be welding temperatures between 250° C. and 120° C., or between 200° C. and 100° C. In this case, the material must be able to withstand the heat above 200° C., or above 250° C. In particular, the material must not lose its physical integrity at the predetermined welding conditions. In the exemplified case, the material must furthermore be suited to transfer sufficient heat from the welding stamp 605 of the welding device 600 to the first welding band zones 44 (
In a preferred embodiment the at least partially thermo-resistant first area 412, 413 is a two layer film comprising a thermo-resistant PET layer at the inner surface, i.e. the second area 422, 423 facing surface, of the connection portion 40, and a weldable layer, for example a polyethylene (PE) layer at the outer surface, i.e. the external environment 200 facing surface, of the connection portion 40. This arrangement permits welding of an insertable first area 412, 413 to the surrounding material of the at least partially flexible barrier, as mentioned below.
Alternatively, a thermo-resistant layer, for example a PET layer, can be affixed to the inner surface of the first area 41, i.e. the surface facing the second area 42, for example by means of a bonding agent.
The first at least partially thermo-resistant area 412, 413 may be an area, which is inserted into the at least partially flexible barrier. An area of the at least partially flexible barrier may be removed and replaced by the inserted at least partially thermo-resistant area 412, 413. The inserted first area 41 is attached to the barrier along an attachment zone 43 which follows the perimeter of the at least partially thermo-resistant area 412, 413. The connection between the barrier and the first area 412, 413 is a hermetic connection. Said hermetic connection may be a welded or a glued connection. Other forms of hermetic connections are conceivable.
Each portion 402, 403 furthermore includes a second area 422, 423, which is located in an area of the respective barrier, which is opposite the first area 412, 413. The second areas 422, 423 are facing the first areas 413, 412.
A schematic top view of a second area is shown in
Preferably the first welding band zone 44 and the second area are made of the same material. Preferably the second area 42 is made of the same material as the surrounding area of the barrier 22, 32.
Welding band zones 44 are welded employing a separation welding method. During the cut ‘n’ seal welding step the welded areas are cut along the separation line 45. Preferably, said separation welding method ensures that the cut edges of the welded zones are sealed off with a welded seam 47.
Preferably the welding method is impulse welding. Welding temperatures range from 250° C. to 120° C., or from 200° C. to 100° C.
In an alternative embodiment the welding method is ultrasonic welding.
The shape and size of the connecting opening 80, which is generated as part of the separation welding step, is defined by the size and shape of the welding zone band 44. As a consequence, is a wider opening is desired for a particular application, the size of the welding zone band 44 needs to be adjusted accordingly.
In
Positioning the two connection portions 402, 403 of the respective barriers in the demonstrated sandwich position in the welding device, is a first step in the separation welding process. Importantly, the first areas 412, 413 and the second areas 422, 423 must be super-positioned, wherein the second areas 422, 423 form the inner layers of the sandwich arrangement and the first areas 412, 413 form the outer layers of the sandwich arrangement 100. At a minimum the first areas 412, 413 cover the entire area of the first welding band zones 44.
The individual steps of the cut ‘n’ seal welding process are exemplified in
As a result of this step a welding seam 47 a separating cut along the separation line are generated. A cross sectional view of the closed welding seam 47 is shown in
An insert 50 is detached from the joined barriers. As a result of the location of the cut inside the welding seam 47, both, the entire perimeter of the insert 50, as well as the entire perimeter of the opening 80 are sealed by portions of the generated welding seam. The barriers of the first and the second regions 22, 32 are fused together by the welding seam 47. The welding seam 47 at the joined barriers 22, 32 describes an opening 80 which between the first 20 and the second 30 region.
The edges of the two walls of the insert 50 are fused together by the welding seam 47. The inside of the insert contains a part of the external environment 200. Once removed from the opening 80, the insert 50 is situated within the joined first and second regions 25, 35. In order to avoid exposure to the external environment, it is therefore essential, that the welding seam 47 seals the part of the external environment securely within the volume contained inside the insert 50.
No additional step is required to detach the cut insert 50 from the joined barriers 22, 32. However, pulling apart of the outer surfaces of the sandwich arrangement may help to remove the cut insert 50 from the opening 80.
As an optional subsequent step shown in
Referred devices for the procedure described above are shown in
In a preferred embodiment the first region 25 is confined in a sealed bag 20, such as schematically illustrated in
The position of the welding device 600 in relation to an air lock system 55 of a second region 35 without the endless liner or the first barrier is shown in
| Number | Date | Country | Kind |
|---|---|---|---|
| 20174350.7 | May 2020 | EP | regional |
