Packaging bag with removable barrier

Abstract

Packaging bag (10) for a medical application, in particular for an infusion solution or dialysis solution, comprising at least one first chamber (11) for holding a first heat-sterilizable product (12) and at least one second chamber (13) for holding, separately from the first product (12), a second product (14) unsuitable for heat sterilization and / or temperature-sensitive, characterized in that the first chamber (11) is a heat sterilization chamber and the second chamber (13) is an aseptic chamber, wherein a releasable barrier (15) divides the packaging bag (10) into the first chamber (11) and the second chamber (13), and the releasable barrier (15) in its undissolved state prevents the products (12, 14) from mixing and in its dissolved state allows the products (12, 14) to mix within the packaging bag (10).

Description

[0001] The invention relates to a packaging bag, in particular for an infusion solution or dialysis solution, comprising at least one first chamber for receiving a first product and at least one second chamber for receiving a second product separately from the first product. The invention further relates to a device for breaking a barrier in a packaging bag.

[0002] Packaging bags consisting of single-layer or multi-layer films welded together are known. In particular, packaging bags made of welded films and featuring at least one dispensing port are known. Such a packaging bag can be designed as an infusion bag and contain an infusion or dialysis solution, and comparatively high demands are placed on an infusion bag. It is known that infusion bags must withstand a high degree of mechanical stress and that film materials free of harmful substances must be used in their manufacture. It is known to manufacture infusion bags from PVC films or multi-layer PP films. Bags made of multi-layer stretchable films, in particular, exhibit high mechanical stability with regard to unintentional damage to the packaging bag.

[0003] It is also known to mix a product from a packaging pouch with another product to obtain a ready-to-use end product. In particular, a medical solution from a packaging pouch can be mixed with another medical product to obtain, for example, a ready-to-use dialysis or infusion solution. This process is currently mostly carried out manually, which can lead to errors such as human error, and the traceability of the infusions produced in this way cannot be fully guaranteed. In addition to the risk of incorrect mixing of the infusion or dialysis solutions, it is also possible that many solutions or active ingredients, especially partially used ones, have to be disposed of, as opened packaging cannot or may not be reused.Furthermore, manual mixing or dosing outside the infusion bag is prone to errors, comparatively time-consuming, and carries a high risk of contamination.

[0004] It is therefore the object of the present invention to provide a packaging bag with which the dosing and mixing of at least two products can be carried out quickly, reliably, safely and easily. Furthermore, the packaging bag according to the invention should be easy to handle, manufacture and produce.

[0005] To solve the problem, a packaging bag with the features of independent claim 1 is proposed. Furthermore, a device for removing a barrier in such a packaging bag is proposed.

[0006] The packaging bag according to the invention is designed for a medical application and comprises at least one first chamber for holding a first heat-sterilizable product and at least one second chamber for holding, separately from the first product, a second product that is unsuitable for heat sterilization and / or temperature-sensitive. Preferably, the first chamber adjoins the second chamber, with the first and second chambers being separated by a removable barrier. The first and second chambers each have a defined volume, so that the respective product can be held in the chambers in precisely the quantity required to provide the ready-to-use end product. A ready-to-use end product could, for example, be an infusion solution or a dialysis solution. However, it is also conceivable that the ready-to-use end product could be a beverage, for example, an isotonic drink.The ready-to-use end product can also be a technical liquid mixed with a product in powder form. The ready-to-use end product is formed after the first and second products are mixed within the packaging bag. The packaging bag can be made of single-layer or multi-layer plastic films that are welded together at the edges. A packaging bag thus has at least one edge seal, preferably a weld seam, through which two single- or multi-layer films are welded together. Preferably, the edge seal can comprise at least one longitudinal and at least one transverse seal, each of which can be a weld seam. In particular, the edge seal of the packaging bag comprises two longitudinal and two transverse seals. The packaging bag can also have a dispensing port that extends through the edge seal and is preferably welded into it.Preferably, the dispensing port is welded into the transverse seal. The edge seal, preferably the transverse and longitudinal seals, creates a bag with a defined total volume. This total volume can be divided within the bag by the barrier into a plurality of chambers, preferably two chambers. The barrier can be positioned at one end against the edge seal. For example, the barrier can be adjacent to two transverse seals or two longitudinal seals. It is also conceivable that the barrier is adjacent to one longitudinal seal and one transverse seal.

[0007] The packaging bag is characterized in that the first chamber is a hot sterilization chamber and the second chamber is an aseptic chamber, and a barrier dividing the packaging bag into the first and second chambers is removable. In its undissolved state, the removable barrier prevents the products contained in the first and second chambers from mixing, while in its dissolved state, it allows the products within the packaging bag to mix. Thus, the first and second products can be easily mixed under sterile conditions after removing the barrier, without having to open the packaging bag, remove its contents, or add anything to the contents.The barrier is thus designed as a predetermined breaking point between the first and second chambers of the packaging bag, whereby a connection between the chambers can be established by preferably irreversibly releasing the barrier. Preferably, a fluid-permeable connection between the chambers of the bag is established after the barrier is released. In its undissolved state, the bag can be transported, stored, and handled in the conventional manner. The packaging bag according to the invention thus allows the final product to be completed at the point of use, whereby incorrect dosing of the products to be mixed to obtain the final product can be ruled out, since these are already contained in a defined quantity in the chambers of the packaging bag.In addition to minimizing dosing errors, the risk of confusion by the user is also reduced, as the user only needs to select the correct packaging bag and not the majority of the products to be mixed.

[0008] The first chamber is designed as a hot sterilization chamber, allowing it to be hot sterilized with the first product. The second chamber is designed as an aseptic chamber, allowing it to be filled with the second product without contamination, preferably under aseptic conditions. This allows for the simple provision of a packaging bag containing at least two products housed in different chambers, thus enabling the combined packaging of sterilization-sensitive, particularly temperature-sensitive, products with sterilizable products in a single bag.

[0009] The packaging bag may preferably have exclusively two chambers for holding a first product in the first chamber and a second product in the second chamber.

[0010] The first chamber of the packaging bag can contain a first product in liquid form, while the second chamber can contain a product in solid or liquid form. Preferably, the first and second products are different; more preferably, they are in different states of matter. The volume of the second chamber can, for example, be a maximum of 20% of the total volume of the packaging bag. This has proven particularly advantageous when the second product contained in the second chamber includes a medicinal active ingredient, since the medicinal active ingredient is regularly mixed with a relatively large quantity of the first product, such as a solution. For example, with a total packaging bag volume of 180 ml, the second chamber can have a maximum volume of 36 ml.However, it is quite conceivable that the packaging bag is divided into more than two chambers, for example three chambers, four chambers or five chambers, with each chamber being separated from the others by a removable barrier.

[0011] The packaging bag can be made of a sterilizable material, for example, polypropylene. The packaging bag material can thus advantageously withstand a sterilization process, in particular hot sterilization, such as steam sterilization. Within the scope of the invention, the term "hot sterilization" refers to thermal sterilization, which typically takes place at temperatures above 100°C. Preferably, the film from which the packaging bag is formed is made of a sterilizable material. Within the scope of the invention, a sterilizable material is a material that can withstand thermal sterilization, preferably at a temperature between 118°C and 134°C, i.e., that is, is temperature-resistant at the temperature required for thermal sterilization. Preferably, the sterilization takes place in an autoclave under overpressure, more preferably at a pressure of 1.1 bar to 1.9 bar.Furthermore, it is conceivable that the packaging bag, and in particular the film of the packaging bag, is resistant to sterilization by radiation, ETO gas (ethylene oxide), or by another suitable method. Due to the packaging bag being made of a sterilizable material, it can be used in a wide range of applications, especially for packaging medical products such as infusion solutions or dialysis solutions, or even food products.

[0012] The packaging bag according to the invention can preferably be designed as an infusion bag, wherein, after mixing the products within the packaging bag, an infusion solution or dialysis solution is contained. Advantageously, the products required for mixing the ready-to-use infusion or dialysis solution are contained in the chambers of the packaging bag in the required quantities, so that, after breaking open the chambers separating the products, they can be mixed within the packaging bag to provide the user with a ready-to-use infusion or dialysis solution.

[0013] Advantageous embodiments of the invention are the subject of the dependent claims. The invention encompasses all combinations of at least two features disclosed in the description, the claims, and / or the figures. It is understood that the embodiments described for the packaging bag can apply equivalently to the device according to the invention without being specifically mentioned. In particular, it is understood that common linguistic reformulations and the appropriate substitution of the respective terms within the scope of usual linguistic practice, especially through the use of synonyms supported by generally accepted linguistic literature, are included in the present disclosure without being explicitly mentioned in their respective formulations.

[0014] The barrier of the packaging bag can be impermeable to liquids and / or gases. This allows the barrier to ensure effective separation of the chambers, preventing any liquid or gas from passing from one chamber into any of the other chambers of the packaging bag. In particular, this allows reactive or unstable components to be separated and protected. Specifically, the barrier is suitable for separating a liquid from a solid without any liquid, outgassing, or evaporation contaminating the solid contained in another chamber. Furthermore, it is preferred that both the films forming the outer layer of the packaging bag and the barrier itself are impermeable to liquids or gases.

[0015] According to a preferred embodiment, the releasable barrier can be designed as a seal, preferably adjacent to the edge seal of the packaging bag. Preferably, one end of the barrier is connected to the edge seal of the packaging bag. Within the scope of the invention, a seal is a fused or bonded joint between two layers of film or material in a packaging bag, created by sealing. The seal is produced by sealing two films or film sections with heat and / or pressure. In this process, the thermoplastic layers fuse or bond at the contact point, in this case, in the area of ​​the barrier. After cooling, a seal is formed. The seal can also be referred to as a sealing seam or weld seam.In its undissolved state, the seal forms a tight and mechanically stable closure that protects the contents contained in the chambers of the packaging bag and separates the at least two chambers from each other.

[0016] In an advantageous embodiment, the packaging bag includes a dispensing port that extends through the bag's edge seal. The second chamber can be filled with the second product via this dispensing port. The ready-to-use end product can also be removed via this port. It is conceivable that the second chamber can be filled via the dispensing port, and the first chamber can be filled via an open transverse seal, which is then closed after the first product has been introduced into the first chamber. Thus, advantageously, a single port, namely the dispensing port, is sufficient for filling both the first and second chambers.

[0017] The burstable barrier can have a first section and a second section immediately adjacent to the first section. Advantageously, the first and second sections can form an obtuse angle. Preferably, the first and second sections extend from the edge seal towards the dispensing port and converge towards the center of the packaging bag. In other words, the point formed by the first and second sections points towards the dispensing port. Preferably, an acute angle is formed between the edge seal and the first section, and also between the edge seal and the second section.A burstable barrier configured with a first and second section forming an obtuse angle advantageously allows the compartments of the packaging bag, particularly the compartment furthest from the dispensing port, to be completely emptied. It is conceivable to include an additional seal complementary to the first and second sections of the burstable barrier, such that two sections of the additional seal also form an obtuse angle. The bursting stress of the barrier can be lower than that of the additional seal. Preferably, the bursting stress of the additional seal corresponds to the bursting stress of the edge seal of the packaging bag. The additional seal and the burstable barrier can be spaced apart, allowing one of the compartments of the packaging bag to be located between the additional seal and the burstable barrier.Preferably, a second chamber for receiving the second product is formed between the additional seal and the burstable barrier.

[0018] The barrier can be designed as a burstable barrier, wherein the bursting stress of the barrier is lower than the bursting stress of the packaging bag. The burstable barrier can be brought from an unbroken to a broken state by applying pressure or tension to the packaging bag, particularly to the barrier area. In other words, the burstable barrier can be separated or broken open by pressure or tension, so that the separation of two chambers is eliminated and a connection between the chambers is created. Within the scope of the invention, the bursting stress is the maximum mechanical stress that acts on the packaging bag or the barrier when pressure is applied, immediately before the failure (bursting) of the packaging bag or the barrier. Advantageously, the burstable barrier can be cleanly broken open at a defined point without tools.Because the bursting stress of the barrier is lower than that of the packaging bag, it can be ensured that the barrier will break before the packaging bag is damaged due to applied pressure or tension. Preferably, the bursting stress of the barrier is lower than that of the edge seal of the packaging bag and / or the seal of a port in the packaging bag. This, in turn, ensures that the barrier will break before any of the other seals of the packaging bag are damaged and the contents of the packaging bag can leak out.

[0019] The packaging bag preferably has a volume between 20 ml and 6000 ml. More preferably, the packaging bag has a volume between 50 ml and 1000 ml. Even more preferably, the packaging bag has a volume between 80 ml and 200 ml. Most preferably, the packaging bag has a volume greater than 100 ml. The volumes mentioned refer to the total volume of the packaging bag, which may be divided among multiple compartments. Preferably, the packaging bag contains 50 ml or 100 ml of liquid, preferably a medical solution. Packaging bags with the aforementioned volumes, particularly those between 50 ml and 1000 ml, are especially suitable for containing medical solutions such as infusion solutions or dialysis solutions, as packaging bags with these volumes are used in numerous applications and are relatively frequently required.Furthermore, it has proven advantageous if the compartments of the packaging bag have a larger volume than the products they contain. For example, the first compartment of the packaging bag can hold 100 ml of liquid, with the first compartment having a volume of 150 ml. Or, for example, the first compartment of the packaging bag can hold 50 ml of liquid, with the first compartment having a volume of 85 ml.

[0020] The first chamber of the packaging bag can contain a first product in liquid form, while the second chamber can contain a product in solid form. The barrier, which is preferably impermeable to liquids and gases, reliably separates the second product in solid form from the first product in liquid form until the barrier dissolves, allowing the products to mix within the packaging bag. Thus, the first product in liquid form can be placed in the packaging bag and, for example, sterilized by applying heat, before a temperature-sensitive second product in solid form is subsequently placed in the packaging bag. Preferably, the solid product is a powder. Within the scope of the invention, a powder is defined as a very finely ground solid.

[0021] According to an advantageous embodiment, the first product contained in a first chamber of the packaging bag is a medical solution, and the second product contained in a second chamber of the packaging bag is a medical powder that may contain a medicinal active ingredient. Within the scope of the invention, it was discovered that the packaging bag according to the invention is particularly suitable for containing medicinal active ingredients that cannot be heat-sterilized. The medicinal active ingredients may be thermally sensitive or unstable. After breaking the barrier, the medical solution can be mixed with the medical powder to produce a ready-to-use dialysis solution or a ready-to-use infusion solution.Thus, after mixing the first and second products, the packaging bag contains a ready-to-use dialysis solution or a ready-to-use infusion solution that can be reliably prepared and used directly by the user in a simple manner. Preferably, the first product is a sodium chloride solution, preferably a sodium chloride solution containing 0.9% sodium chloride, a Ringer's solution containing at least sodium chloride, potassium chloride, and calcium chloride, a glucose solution, or water for injection, which can also be referred to as "aqua ad iniectabile." The second product preferably contains at least one antibiotic, at least one protein, and / or at least one antibody. The second product may preferably be contained in powder form in the packaging bag.

[0022] In a second aspect, the invention relates to a device for releasing the barrier of a previously described packaging bag by applying pressure to the packaging bag. The device comprises at least one, preferably movable, first pressure body and a second pressure body, preferably fixed relative to the first pressure body. The first pressure body interacts with the second pressure body to apply pressure to the packaging bag, in particular to the barrier of the packaging bag. Within the scope of the invention, the fixed arrangement of the second pressure body relates to a fixed arrangement relative to the first pressure body, so that the second pressure body can serve as a counter-bearing during the application of pressure to the packaging bag by the first pressure body.In particular, the second pressure body is fixed along the pressure application direction in which the first pressure body applies pressure to the packaging bag and / or is linearly movable. The packaging bag can thus be brought into contact with at least the first pressure body and the second pressure body for compression. The first pressure body can be arranged relative to the second pressure body in such a way that a gap is formed between them. For compression, the packaging bag can be positioned at least partially within this gap and / or guided through it.

[0023] The device can include a frame designed as a housing or as a holder for at least the first and second pressure bodies. The frame can have a receptacle for securing the packaging bag, by means of which the packaging bag can be arranged in the desired position and orientation, in particular relative to the first and / or second pressure body. For example, the receptacle can be designed as a plate. Preferably, the frame is designed to hold the pressure bodies, with the packaging bag being placed on the second pressure body.For example, the packaging bag can be placed on the second pressure body, and the first pressure body can be positioned relative to the second pressure body such that a gap is created between them. The packaging bag is located within this gap or can be moved through it to compress the packaging bag. The first pressure body can be designed as a roller or a punch. The roller can be solid or equipped with a longitudinal slot for receiving the packaging bag, particularly one end of the packaging bag. If the roller has a longitudinal slot for receiving the packaging bag, the packaging bag can advantageously be fixed to the roller and wound onto it for compression.The stamp can, for example, be designed in the form of a press stamp, which can be applied to the packaging bag to compress it.

[0024] Within the scope of the invention, it was recognized as essential that a gap is formed between the first and second pressure bodies. Depending on the width of the gap, a definable compression of the packaging bag can thus be ensured. The width of the gap refers to the distance between the first and second pressure bodies. By changing the distance between the first and second pressure bodies, the gap can be varied and adapted to the barrier and / or the packaging bag, in particular its size and / or volume. In particular, the width of the gap can be selected such that the compression of the packaging bag is sufficient to apply the necessary bursting stress of the releasable barrier, while the bursting stress of the packaging bag is not exceeded.This allows for error-free removal of the packaging bag barrier without damaging the packaging bag, as is possible with purely manual removal of the packaging bag barrier.

[0025] According to an advantageous embodiment of the invention, the first pressure body of the device can be designed as a roller or a punch. Furthermore, the first pressure body can be designed as a roller and the second pressure body can also be designed as a roller, thus forming a rolling mill. It is conceivable that the device has at least two rollers rotatably mounted about opposing, parallel axes of rotation, with a first roller forming the first pressure body and a second roller forming the second pressure body. It is also conceivable that the device has two rigid plates as pressure bodies, between which the gap opening is formed. The packaging bag can be pulled or pushed between the two rigid plates to compress the packaging bag. According to a further embodiment, the first pressure body can be designed as a punch and the second pressure body as a plate or die.If the second pressure body is designed as a plate with a continuously flat contact surface that comes into contact with the packaging bag during compression, the first pressure body, designed as a punch, can also have a continuously flat contact surface. If the second pressure body is designed as a die, the contact surface can have virtually any shape, whereby the contact surface of the punch can be complementary to the contact surface of the die. The punch, also referred to as the upper tool, can be the movable part that is guided downwards to a specific point with a defined force. The die, also referred to as the lower tool, can be the stationary counterpart to the punch, in particular to its contact surface, with a precisely fitting recess or negative form. The gap opening is formed between the die and the punch, within which the packaging bag can be at least partially positioned.

[0026] It is conceivable that the gap is designed to taper. For this purpose, the roller or the punch and / or the second pressure body, which is preferably designed as a plate, can be arranged at an angle to the horizontal or vertical. If the gap between the first and second pressure bodies is designed to taper, the packaging bag can be easily inserted on the side of the device with the largest gap, while maximum compression of the packaging bag occurs on the side with the smallest gap.

[0027] According to a preferred embodiment, the first pressure body is movable relative to the second pressure body. Preferably, the first pressure body is rotatably and / or linearly movable relative to the abutment. The device can, for example, have two cylindrical rollers that are rotatably movable about parallel axes of rotation. A gap is formed between the two rollers through which the packaging bag can be pushed or pulled. It is conceivable that a first roller, forming the first pressure body, is rotatably driven by means of an operating device designed as a handle, crank, or lever, and that the second rotatably movable roller forms the second pressure body. By turning the handle or lever, the first roller is rotatably driven, and the packaging bag is pushed or pulled through the gap under compression.Between the rollers, the packaging bag can be easily compressed in such a way that the barrier of the packaging bag is broken and the products contained in the compartments of the packaging bag are mixed. Additionally or alternatively, the first pressure body, preferably with the operating device, can be moved linearly towards the second pressure body.

[0028] Furthermore, it is conceivable that the first pressure body is designed as a punch, which is linearly movable towards the packaging bag and the second pressure body, compressing the packaging bag in the manner of a press punch. The second pressure body can form a receptacle for securing the packaging bag within the device. For example, the packaging bag can rest on one side against a fixed plate of the second pressure body, and the linearly movable first pressure body, designed as a punch, can be brought into contact with the packaging bag on the other side. According to a further embodiment, the packaging bag can rest at least partially on one side against the second pressure body, which is designed as a die, and the linearly movable first pressure body, designed as a punch, can be brought into contact with the packaging bag on the other side.The plunger can be moved vertically towards the packaging bag, for example using an operating device such as a handle or lever. Alternatively or additionally, it is conceivable that the plunger, after the required opening has been formed, is moved horizontally to compress the packaging bag and release the barrier.

[0029] Furthermore, it is conceivable that the roller or the piston, which is movable relative to the second pressure body, can be driven via a camshaft.

[0030] The second pressure body can have a recess in which the packaging bag and / or the first pressure body can be at least partially received. The first pressure body, designed as a punch, can then be at least partially complementary to the recess of the second pressure body, with the gap being formed between the recess of the second pressure body and the punch. The second pressure body, which has a recess, can preferably be designed as a die and have a contact surface of almost any shape, the contact surface of the punch being complementary to the contact surface of the die. The recess in the second pressure body, in which the area of ​​the packaging bag preferably forms the contact barrier, offers the advantage of improved protection of the packaging bag during compression and the application of pressure to defined areas of the packaging bag.The recess preferably has the shape of a spherical segment or an ellipsoidal segment.

[0031] According to an advantageous embodiment, a protective frame is included which can be positioned against the packaging bag and has smaller external dimensions than the packaging bag. Thus, the protective frame can be positioned within the edge seals and protect the edge seals from excessive pressure during compression, particularly from the displaced contents of the packaging bag. For this purpose, the protective frame can be positioned as close as possible to the second pressure body. Preferably, the distance between the protective frame and the second pressure body corresponds to the total thickness of the films from which the packaging bag is formed.This prevents the contents of the packaging bag enclosed within the protective frame from escaping into the area of ​​the packaging bag outside the protective frame. Consequently, during compression of the packaging report, no pressure can be exerted on the edge seal by the contents of the packaging bag enclosed within the protective frame. Therefore, damage to the edge seal can be reliably prevented by the protective frame. The packaging bag can preferably be positioned on the second pressure body, so that the protective frame rests on the packaging bag above the second pressure body, and the packaging bag is secured between the protective frame and the second pressure body.A protective frame within the meaning of the present invention refers to a self-contained or partially closed physical structure having at least one wall and being designed in the manner of a border. Preferably, the protective frame is designed to complement the edge seals. That is, if the packaging bag is, for example, rectangular and the edge seals thus form a rectangle, the protective space is also preferably rectangular and preferably has four walls arranged relative to each other in the manner of a rectangle. Furthermore, it is conceivable that the protective frame has a recess for a dispensing port and / or a filling port.The recess in the protective frame for a dispensing port and / or a filling port ensures that the packaging bag is inserted into the device correctly, preventing any mix-ups. Furthermore, it prevents the protective frame from interfering with the packaging bag's contact with the dispensing or filling port. To compress the packaging bag, the first pressure element, preferably designed as a plunger, can be moved within the protective frame towards the second pressure element.

[0032] The protective frame can be pivotally mounted. Preferably, the protective frame is pivotally mounted on the second pressure body. This allows the protective frame to be easily moved into position on the packaging bag by pivoting it. The protective frame can thus be positioned between an insertion position and a compression position. In the compression position, the protective frame moves from the packaging bag to the device, while in the insertion position, the protective frame is pivoted away from the second pressure body, allowing for easy insertion of the packaging bag into the device.

[0033] According to an advantageous embodiment, the device can include a pressure control device for limiting the maximum pressure that can be applied to the packaging bag. Preferably, the pressure applied can be regulated by means of the pressure control device depending on the design of the packaging bag. It was discovered within the scope of the invention that the pressure that can be applied by the device is directly proportional to the compression of the packaging bag. Regulating the maximum applicable pressure can thus ensure that the bursting stress of the packaging bag, in particular of the edge seal of the packaging bag, is not exceeded during compression of the packaging bag, but rather that the barrier is only released by exceeding the bursting stress of the barrier. Preferably, the maximum pressure applied to the packaging bag can be set using the pressure control device.In particular, the regulation of the pressure application can be made depending on the size of the packaging bag, the strength of the barrier and / or the thickness of the films from which the packaging bag is formed, and / or the length of the barrier and / or the shape of the barrier.

[0034] The maximum pressure that can be applied to the packaging bag can be limited in a particularly simple way if the pressure control device has a travel limiter that defines the minimum width of the gap. The travel limiter can be designed as a particularly compact stop. The stop can limit the displacement of the first pressure element, in particular the roller or the plunger, towards the abutment, so that even when maximum pressure is applied to the first pressure element, for example by a user of the device, the desired minimum width of the gap is maintained. Furthermore, it is conceivable that the travel limiter has at least one spring against which the first pressure element can be moved towards the second pressure element, with the spring tension preventing any reduction of the gap beyond the desired minimum width.

[0035] The device can be operated manually using a control mechanism. For example, the control mechanism might include a lever, handle, or crank that allows manual operation of the device. It is conceivable that the control mechanism could, on the one hand, move the first pressure body toward the second pressure body, and on the other hand, or additionally or alternatively, drive the first pressure body rotaryally or linearly. It is also conceivable that the device could be operated automatically or by a motor. However, manual operation offers the advantages of simple handling without the need for a power supply or motor. Furthermore, the manually operated device is robust and reliable and also requires less space.

[0036] The packaging bag can be filled according to the following steps, for example: a) Creating a releasable barrier to form at least one first chamber within a packaging bag; b) Introducing a first product, preferably a product in liquid form, into the first chamber of the packaging bag; c) Sealing a second chamber of the packaging bag; d) Sterilizing the packaging bag containing the first product; and e) Introducing the second product, preferably a product in solid form, into the second chamber of the packaging bag, particularly under aseptic conditions.

[0037] The packaging bag allows for the introduction of a second product—one that is unsuitable for sterilization or would be damaged during sterilization—only after the packaging bag, which already contains a first product, has been sterilized. For example, a removable barrier can be created within the packaging bag to form a first chamber for the first product. A liquid product is then introduced into the packaging bag before the second chamber is sealed. The packaging bag, along with the first product, can then be sterilized, for example, by steam sterilization. Subsequently, a second product, preferably a powder, can be introduced into a second chamber of the bag.The introduction of the second product preferably takes place under aseptic conditions, since subsequent re-sterilization is often not possible. Aseptic introduction of a product into the packaging bag, as defined in the invention, is a process in which a product is introduced into the sterilized packaging bag under sterile conditions to prevent contamination of the product to be introduced, a product already introduced, and / or the packaging bag itself. After the second product has been introduced into the second chamber, the second chamber can be closed or resealed, thereby also completely sealing the packaging bag itself after the introduction of the second product. A packaging bag with exclusively two chambers is preferred; however, the invention is by no means limited to a packaging bag with two chambers.Rather, the packaging bag can have multiple compartments, each of which can be filled with different or similar products. It is essential, however, that the compartments are separated by a removable barrier. Sterilization of the packaging bag containing the first product can preferably be carried out by steam sterilization.

[0038] As a result, a packaging bag can be easily provided that contains at least two products in separate compartments, enabling the combined packaging of sterilization-sensitive, particularly temperature-sensitive, products with sterilizable products. Thus, the first and second products can be contained within a single packaging bag in defined quantities and mixed into a ready-to-use end product by breaking the removable barrier, without the need for manual dosing, for example, of the second product to the first product outside the packaging bag. The removable barrier of the packaging bag, as described elsewhere, can be broken in a particularly suitable manner using the barrier-breaking device described above.Preferably, the first product is a medical solution, for example a sodium chloride solution, and the second product is a medical powder, for example an antibiotic-containing powder, so that after dissolving the soluble barrier and mixing the first and second products, a ready-to-use dialysis solution or a ready-to-use infusion solution can be obtained.

[0039] Within the scope of the invention, it was further recognized that steps a) to e) for the production of the packaging bag do not necessarily have to be carried out in the order a) to e). Rather, it is also conceivable, for example, that the packaging bag is first filled with the first product and then the removable barrier is created according to step a), thereby forming two chambers within the bag. The first product can be introduced into the first chamber and sterilized according to steps b) and d), for example via a filling port. Subsequently, a second product can be introduced into the second chamber via another filling port according to step e), and the other filling port can be closed to close the second chamber according to step c). However, it was recognized as essential within the scope of the invention that step e) is carried out at least after step d).This means that the first product is sterilized before the second product is placed in the packaging bag to prevent damage to the second product during sterilization. Furthermore, it has proven advantageous if step c), i.e., closing the second chamber, is performed before step d), i.e., sterilizing the packaging bag containing the first product, whereby the second chamber remains accessible for adding the second product after sterilization, for example, via a fill port that can be opened and closed.

[0040] After sterilization in step d) and before adding the second product in step e), the packaging bag can be dried and / or cooled. This means that after sterilization, which can preferably be done by steam sterilization, the packaging bag is dried and / or cooled before the second product is added. This reliably protects the second product, especially if it is in powder form, from contamination or damage, for example, due to residual steam or liquid in the packaging bag or due to temperature fluctuations.

[0041] It is understood that the aforementioned and subsequently explained embodiments and exemplary embodiments can be implemented not only individually, but also in any combination with one another, without departing from the scope of the present invention. It is also understood that the aforementioned and subsequently explained embodiments and exemplary embodiments relate to the device according to the invention in an equivalent or at least similar manner, without being specifically named for it.

[0042] Embodiments of the invention are shown schematically in the drawings and are explained below by way of example.

[0043] They show: Fig. 1 a first embodiment of a packaging bag according to the invention, which is designed in the manner of an infusion bag; Fig. 2 a second embodiment of a packaging bag according to the invention, which is designed in the manner of an infusion bag; Fig. 3 a third embodiment of a packaging bag according to the invention, which is designed in the manner of an infusion bag; Fig. 4 a fourth embodiment of a packaging bag according to the invention, which is designed in the manner of an infusion bag; Fig. 5 a fifth embodiment of a packaging bag according to the invention, which is designed in the manner of an infusion bag; Fig. 6 a sixth embodiment of a packaging bag according to the invention, which is designed in the manner of an infusion bag; Fig. 7 a seventh embodiment of a packaging bag according to the invention, which is designed in the manner of an infusion bag; Fig. 8 an eighth embodiment of a packaging bag according to the invention, which is designed in the manner of an infusion bag; Fig. 9 a first embodiment of a device according to the invention for releasing the barrier of a packaging bag in perspective view; Fig. 10 a second embodiment of a device according to the invention for releasing the barrier of a packaging bag in perspective view; Fig. 11 a third embodiment of a device according to the invention for releasing the barrier of a packaging bag in a side sectional view with the protective frame in insertion position; Fig. 12 the third embodiment of the device according to the invention in a side sectional view with the protective frame in compression position; Fig. 13 the third embodiment of the device according to the invention in a top view with the protective frame in compression position; Fig. 14 a fourth embodiment of a device according to the invention for breaking the barrier of a packaging bag in a side sectional view; and Fig. 15 a fifth embodiment of a device according to the invention for releasing the barrier of a packaging bag in a side sectional view;

[0044] The in Fig. The packaging bag 10 shown consists of two single- or multi-layer films welded together. The films are joined by the edge seal 16, which is designed as a weld seam, forming a bag suitable for containing medical products, such as medical liquids. The packaging bag 10 is divided into two adjacent chambers 11 and 13 by means of the barrier 15. The first chamber 11 contains a first product 12, while the second chamber 13 contains a second product 14, separate from the first product 12 within the packaging bag 10. The first product 12 differs from the second product 14. For example, the first product 12 could be a liquid medical solution and the second product 14 a medical powder.The removable barrier 15 can be removed manually by a user or by means of a device 30, so that after removing the barrier 15, the first product 12 and the second product 14 can be mixed. After removing the barrier 15, the user can mix the first product 12 and the second product 14 within the packaging bag 10 without having to open the packaging bag or manually add either product. Thus, a ready-to-use end product, for example, a ready-to-use infusion solution, can be easily produced within the packaging bag 10 by opening the removable barrier 15 and subsequently mixing the first product 12 and the second product 14, thereby preventing incorrect dosages or contamination of the individual products to be mixed or of the end product.After mixing the products 12, 14 within the packaging bag 10, the ready-to-use end product can be removed via the dispensing port 17 and, for example, administered to a patient. For this purpose, the packaging bag can advantageously be suspended from a hanging device (not shown) using the recesses 19.

[0045] Fig. Figure 2 shows a second embodiment of a packaging bag 10 according to the invention. The one in Fig. The packaging bag 10 shown in Figure 2 is designed in the manner of an infusion bag and is particularly suitable for holding an infusion solution or dialysis solution. The Fig. The packaging bag 10 shown in Figure 2 also essentially consists of two single-layer or multi-layer films welded together, with the edge seal 16 designed to form a fillable bag. The edge seal 16 has two transverse weld seams 161 and two longitudinal weld seams 162 that join the films together. The edge seal 16 defines the volume of the packaging bag 10. The volume of the packaging bag 10 is further divided into two chambers 11 and 13. The first chamber 11 contains a first product 12, and the second chamber 13 contains a second product 14, distinct from the first product 12, kept separate from the first product 12. The first chamber 11 is separated from the second chamber 13 by means of the removable barrier 15, so that when the barrier 15 is intact, mixing of the products 12 and 14 is prevented.After the barrier 15, which can be designed, for example, as a weld seam, is released, the products 12, 14 can mix within the packaging bag 10. According to the illustrated embodiment, the removable barrier 15 extends from one longitudinal seal 162 to the opposite longitudinal seal 162 of the packaging bag 10. In other words, the removable barrier 15 connects the two longitudinal weld seams 162. A section of each longitudinal seal 162, together with the removable barrier 15 and a transverse seal 161, thus forms the first chamber and the second chamber. However, it is also conceivable that the removable barrier 15 extends between a longitudinal seal 162 and a transverse seal 161. It was found to be advantageous that a first end of the removable barrier 15 borders the edge seal 16 and a second end of the removable barrier 15 borders the edge seal 16 at a different location.For easy filling of the first chamber 13 and the second chamber 11, each chamber 11, 13 is equipped with a filling port 18 through which the first product 12 or the second product 14 can be introduced into the respective chamber 11, 13. After breaking the removable barrier 15, for example by applying pressure, and mixing the first product 12 with the second product 14, the ready-to-use end product, for example a ready-to-use infusion solution or a ready-to-use dialysis solution, can be withdrawn from the packaging bag 10 via the dispensing port 17. To facilitate withdrawal, the packaging bag 10 has a cutout 19 for hanging it.

[0046] The in Fig. The 3 packaging bags shown (10) largely correspond to the one shown in [reference]. Fig. 2, however, differs from this in that the burstable barrier 15 has a first section 151 and a second section 152, which enclose an obtuse angle α. It can be seen that the two sections 151, 152 connect directly to the longitudinal seals 162 and extend from there towards the extraction port 17, converging in the middle.

[0047] The in Fig. The 4 packaging bags shown (10) largely correspond to the one shown in [reference]. Fig. Figure 3 differs from the latter in that an additional seal 20 is provided to form the second chamber 13. The second chamber 13 is formed between the additional seal 20 and the burstable barrier 15. It can be seen that the additional seal 20 is essentially complementary to the burstable barrier 15, i.e., that the sections of the additional seal 20 also extend to each other at an obtuse angle corresponding to the obtuse angle α. The first chamber 11 can be filled via the open upper transverse seal 161, which is closed after the first product 12 has been introduced into the first chamber 11.Furthermore, it can be seen that the sections of the additional seal 20 connect directly to the longitudinal seals 162 and extend from there towards the dispensing port 17, adjoining the dispensing port 17, thus enabling the second chamber 13 to be filled with the second product 14 via the dispensing port 17. Likewise, after breaking the rupturable barrier 15 by mixing the first product 12 with the second product 14, the ready-to-use end product can be removed from the packaging bag 10 via the dispensing port 17.

[0048] The Fig. Figures 5 to 8 show a further embodiment of the packaging bag 10 according to the invention. The one in the Fig. Packaging bags 5 to 8 shown largely correspond to the one shown below. Fig. 4 and differs from this one, however, in that at least one filling port 18 is provided. Thus, the one with Fig. Figure 5 shows the fifth embodiment of the packaging bag 10 according to the invention, which has a filling port 18 for introducing a first product 12 into the first chamber 11. The filling port 18 allows the first chamber 11 to be filled through the transverse seal 161. The filling direction for filling through the filling port 18 is shown in the Fig. Numbers 5 to 8 are each indicated by an arrow.

[0049] The packaging bag 10 according to the sixth embodiment, which is in Fig. Figure 6 shows two filling ports 18, wherein the first chamber 11 can be filled with a first product 12 via a first filling port 18 and the second chamber 13 can be filled with a second product 14 via a second filling port 18. The filling port 18 for filling the second chamber 13 passes through the transverse seal 161 and the additional seal 20.

[0050] The one with Fig. The packaging bag 10 shown in the seventh embodiment also has two filling ports 18, which, however, differ from those shown in the seventh embodiment. Fig. 6 are located at the transverse seal 161, as is the dispensing port 17. It can be seen that a first filling port 18, which is located to the left of the dispensing port 17 in the present illustration, passes through the transverse seal 161 and the additional seal 20 to fill the second chamber 13 with a second product 14. To fill the first chamber 11 with a first product 12, the further filling port 18, which is located to the right of the dispensing port 17 in the present illustration, passes through the transverse seal 161, the additional seal 20 and the burstable barrier 15.

[0051] An eighth embodiment of a packaging bag according to the invention is equipped with Fig. Figure 8 shows the packaging bag in the eighth embodiment having a filling port 18 for filling the first chamber 11 with the first product 12, and the second chamber 13 can be filled with the second product 14 via the dispensing port 17. The filling port 18 extends through the first chamber 11 for filling, as already described in Figure 8. Fig. 7 described, the transverse seal 161, the additional seal 20 and the burstable barrier 15. Otherwise, the packaging bags of the embodiments according to the Fig. 5 to 8 of those after Fig. 4, therefore, to avoid repetition, reference is made to the relevant description.

[0052] Fig. 9 and Fig. Figures 10 each show an embodiment of a device 30 according to the invention for releasing the barrier 15 of a packaging bag 10, for example a packaging bag 10 described above. Fig. Figure 9 shows an embodiment of a device 30 for releasing the barrier 15 of a packaging bag 10, comprising a frame 31 and two pressure bodies 33, 34. The second pressure body 34 is designed as a plate. The first pressure body, designed as a roller 33, and the second pressure body 34, designed as a plate, are spaced apart from each other, so that a gap 35 with a defined gap width S is formed between the roller 33 and the plate 34. The roller 33 is designed as a rotatably driven roller, which can be manually rotated by the user via the operating device 38. The infusion bag 10 can be inserted into the gap 35 and pulled or pushed through it by the rotational movement of the roller 33.The gap width S of the opening 35 is designed such that the packaging bag 10 is compressed at least partially within the opening 35, i.e., between roller 33 and plate 34, and that the pressure applied during compression causes the releasable barrier 15 of the packaging bag 10 to be transformed from an unleashed state to a detached state. Furthermore, the gap width S is designed such that the compression or pressure applied to the packaging bag 10 is sufficient to release the releasable barrier 15, which is designed as a burstable barrier, but at the same time does not exceed a bursting stress of the packaging bag 10, which would damage the packaging bag 10.

[0053] Fig. Figure 10 shows a second embodiment of a device 30 according to the invention for releasing the barrier 15 of the packaging bag 10. Again, the device 30 has a frame 31 and two pressure bodies 33, 34. According to the Fig. In the embodiment shown in Figure 10, the device 30 has a first pressure body 33 designed as a rotatably driven roller and a second pressure body 34 designed as a roller. The roller 33 can again be rotatably driven by a user via the operating device 38, which is designed in the form of a crank. The packaging bag 10 can be moved between the rollers 33 and 34 due to the rotation of the roller 33. To prevent damage to the packaging bag 10, in particular to the edge seal 16 of the packaging bag 10, and at the same time to release the barrier 15 by exceeding its bursting stress, the roller 33 and the second roller 34 are arranged at a distance from each other, with a gap 35 having a defined gap width S formed between the roller 33 and the roller 34. In contrast to the one shown in Figure 10, the first pressure body 33 and the second roller 34 are arranged at a distance from each other. Fig. Device 30 shown in 9 has the following features: Fig. The device 30 shown in Figure 10 comprises a pressure control device 36 for regulating the pressure applied to the packaging bag 10 depending on the design of the packaging bag 10. For this purpose, the roller 33 forming the first pressure body can be moved horizontally along the direction of movement B relative to the stationary second pressure body 34, thereby changing the width S of the gap opening 35. In order to easily determine the minimum width S of the gap opening 35, the pressure control device 36 has two travel limiters 37 which, acting like stops, limit the displacement of the roller 33 in the direction of the second pressure body 34 and thus determine the minimum width S of the gap opening 35.Since the width S of the slot opening 35 correlates directly with the pressure applied to the packaging bag 10 between the first pressure body 33 and the second pressure body 34, the maximum pressure that can be applied to the packaging bag 10 can thus be defined via the width S of the slot opening 35. Depending on the design of the packaging bag 10, for example, depending on the size of the bag, the thickness and / or the length of the barrier 15 of the packaging bag 10, the width S of the slot opening 35 can be reduced or increased. This can be done, for example, by replacing the travel limiters 37. Furthermore, the Fig. The device 30 shown in Figure 10 allows for the simple insertion of the packaging bag 10 into the device, since the roller 33 can be moved horizontally upwards in the direction of movement B to insert the packaging bag 10. After the packaging bag 10 has been inserted, the roller 33 can be moved downwards again in the direction of movement B until it reaches the travel limiters 37, and then the packaging bag 10 can be guided through the slot opening 35 by rotating the roller 33 using the operating device 38, which results in the compression of the packaging bag 10.Due to the required compression of the packaging bag 10 within the device 30, pressure can be applied to the packaging bag 10, which ensures that the releasable barrier 15 of the packaging bag 10 is released and at the same time reliably excludes damage to the packaging bag 10, for example, bursting of the packaging bag 10 or damage to an edge seal 16 of the packaging bag 10.

[0054] Fig. Figures 11 to 13 show a third embodiment of a device 30 according to the invention for releasing the barrier 15 of a packaging bag 10. From the overall view of the Fig. Figures 11 to 13 show that the device 30 has a first pressure body, designed as a punch 32, and a second pressure body 34, designed as a plate with a recess 40. The punch 32, in particular its contact surface, is designed to be complementary to the recess 40. The punch 32 is linearly movable in the direction of movement B towards the second pressure body 34 and can be brought into contact with the packaging bag 10 within the recess 40 in order to compress the packaging bag 10 in the area of ​​the recess 40. The packaging bag 10 can, for example, be arranged on the second pressure body 34 such that the barrier 15 is located within the recess 40. Furthermore, it is evident from the Fig. As can be seen from Figures 11 to 13, the device 30 has a protective frame 39 which is pivotably mounted about the joint 41. Fig. Figure 11 shows the protective frame 39 in the insertion position, i.e., that the protective frame 39 is pivoted away from the second pressure body 34, so that the second pressure body 34 is easily accessible and the packaging bag 10 can be inserted in a simple manner. Fig. In contrast, Figure 12 shows the protective frame 39 in the compression position. In the compression position, the protective frame 39 is brought into contact with the packaging bag 10 by pivoting about the joint 41 above the second pressure body 34. The first pressure body, designed as a plunger 32, can be inserted within the protective frame 39 into the recess 40 of the second pressure body 34 until the desired gap width S of the gap 35 between the first pressure body 32 and the second pressure body 34 is reached for the required compression of the packaging bag 10. As can be seen in particular from Fig. As can be seen in Figure 13, the outer dimensions of the protective frame 39 are smaller than the outer dimensions of the packaging bag 10. This allows the edge seal 16 of the packaging bag 10 to be reliably protected by the protective frame 39 during compression of the packaging bag 10, as the protective frame 39 reliably prevents or reduces pressure on the edge seal 16. For this purpose, the protective frame 39 is positioned as close as possible to the second pressure body 34. Preferably, the distance between the protective frame 39 and the second pressure body 34 in the compression position corresponds to the total thickness of the films from which the packaging bag 10 is formed.This prevents the contents of the packaging bag 10 enclosed within the protective frame 39 from escaping into the area of ​​the packaging bag 10 located outside the protective frame 39. Consequently, during compression of the packaging report 10, no pressure can be exerted on the edge seal 16 by the contents of the packaging bag 10 enclosed within the protective frame 39. Therefore, damage to the edge seal 16 by means of the protective frame 39 can be reliably prevented.

[0055] The Fig. 14 and Fig. Figure 15 shows a further embodiment of a device 30 according to the invention for releasing the barrier 15 of the packaging bag 10. It can be seen that the devices 10 according to Fig. 14 and Fig. Each of the devices 10 comprises an upper part 45 and a lower part 46, which are pivotably mounted about the joint 42. The plunger 32 is arranged on the upper part 45 of the device 10 and is moved by a pivoting motion in the direction of movement B towards the second pressure body 34 and can be inserted into the recess 40 in the second pressure body 34. If the plunger 32, which according to Fig. In the embodiment shown in Figure 14, which is formed integrally with the upper part 45 of the device 30 and is completely lowered onto the second pressure body 34, a gap opening is formed between the plunger 32 and the second pressure body 34. The packaging bag 10 (not shown here) can be compressed in this gap to release the barrier 15. In other words, the packaging bag 10, particularly the area of ​​the packaging bag containing the releasable barrier 15, can be inserted into the recess 40 of the second pressure body 34. By pivoting the first pressure body 32 relative to the second, stationary pressure body 34, the required pressure can be applied to the packaging bag 10, thus releasing the barrier 15 of the packaging bag 10 without damaging the packaging bag 10, especially its edge seal 16.

[0056] The with Fig. The fifth embodiment of a device 10 according to the invention for releasing the barrier 15 of a packaging bag 10, shown in Figure 15, essentially corresponds to the one described in Figure 15. Fig. The device 30 shown in Figure 14 differs in that the first pressure body 33, which is arranged on the upper part 45 of the device 30, is designed differently from that of the fourth embodiment. The second pressure body 34 is again stationary, but the first pressure body 33 is pivotable about the joint 42 by means of the upper part 45 of the device and can be moved towards the second pressure body 34 in the direction of movement B. The first pressure body is designed as a roller 33, which is linearly movable in the guide 44 by means of the operating device 38, which is designed as a handle. When the first pressure body 33 is completely lowered towards the second pressure body 34, a gap is created between the first pressure body 33 and the second pressure body 34, in which the packaging bag 10 (not shown here) can be compressed. To release the barrier 15, the roller 33 can be moved along the guide 44 over the packaging bag 10 and compress it, at least partially. The in the Fig. 14 and Fig. The lower part 46 and the upper part 45 shown in Figure 15 can be part of the frame 31 of the device or form the frame 31 of the device, wherein the lower part 46 can form the second pressure body 34 or can be manufactured integrally with the second pressure body. Reference sign 10 packaging bags 11 first chamber 12 first product 13 second chamber 14 second product 15 barrier 151 first section of the barrier 152 second section of the barrier 16 Edge sealing 161 Cross-sealing 162 Longitudinal sealing 17 extraction ports 18 filling ports 19 Cutout Bag 20 Additional Sealing 30 Device 31 frame 32 stamps 33 roller 34 second pressure vessel 35 Gap opening 36 Pressure regulating device 37 path limiters 38 Control unit 39 protective frames 40 Recess of second pressure body 41 Joint Protective Frame 42 joint 43 handle 44 Leadership 45 Top 46 Lower part B Direction of movement of first pressure body S Wide slit opening

Images