System and method for producing a medicinal packaging

The invention relates to a system and a method for manufacturing a medical package, in particular a foil bag made of plastic. A print image with variable information comprising blank spaces is first applied by means of a thermal transfer printer. The blank spaces are filled by means of a hot stamp printing process.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a national phase under 35 U.S.C. 371 of International Application No. PCT/EP2020/064131 filed on May 20, 2020, which claims priority to European Application No. 19175636.0 filed on May 21, 2019 and European Application No. 19218386.1 filed on Dec. 20, 2019, the contents of all of which are hereby incorporated by reference in their entireties.

FIELD OF THE INVENTION

The invention relates to a system and a method for manufacturing a medical package. The invention further relates to a medical package manufactured therewith, in particular formed as a foil bag.

BACKGROUND OF THE INVENTION

Medical packages, such as for example foil bags, must be provided with a label which indicates for example the contents. To this end, the packages are generally printed.

Furthermore, medical packages are also often printed with machine-readable information, such as for example with a barcode which can be read by hospital personnel using a scanner. The contents of the medical package can be identified using the barcode.

It is known in practice to apply machine-readable information to medical foil bags in the form of a negative print image (see for example WO 99/49408 A1). A negative print image impressed in white on a transparent foil is easily readable by a scanner because the transparent regions have only a low light reflection and thus appear virtually dark to the scanner. However, readable information in the form of such a negative print image can only be deciphered with difficulty by the human eye.

A dark, in particular black, print image on a transparent foil is in turn not machine-readable with sufficient ease since it does not form sufficient contrast with the adjoining transparent regions.

For this reason, there are approaches for first providing a white background on the medical package, for example in the form of a label or a printed area, and then impressing the black ink on the white background.

The print must, however, also be formed so as to be smudge-proof and in particular be suitable for also withstanding an autoclaving process. This also applies in particular to foil bags which are often autoclaved in a tear-open secondary package, with the printed surface of the foil bag being in contact with the secondary package and it can therefore be easily smudged.

Furthermore, medical packages are generally first printed with static information, such as for example the product name and/or the contents. This fixed information does not change from batch to batch of the product.

Moreover, there is often also variable information on the medical package, such as for example batch number, serial number and/or expiry date which can change from batch to batch or even from package to package.

To apply such variable information, offline printing processes that work with a fixed stamp are less suitable since the stamp must be changed each time in order to change the print image.

To apply such variable information, online printing processes using a digitally controlled print head are appropriate since the print image can therefore be changed at any time using a control device.

Therefore, there are for example thermal transfer printers which transfer the color from an ink ribbon to the surface to be printed by means of a number of individually actuated heating elements.

Compared to offline printing processes operating using a stamp, thermal transfer printers are, however, rather slow. This is in particular disadvantageous if large regions of the medical package are supposed to be printed.

OBJECT OF THE INVENTION

The object underlying the invention is therefore to provide a system for manufacturing a medical package and a method for manufacturing a medical package and a medical package, in which variable information and static information can be efficiently and in particular permanently impressed on the medical package.

SUMMARY OF THE INVENTION

The object of the invention is already achieved by a system for manufacturing a medical package, by a method for manufacturing a medical package and by a medical package according to one of the independent claims.

Preferred embodiments and further developments of the invention can be inferred from the subject matter of the dependent claims, the description and the drawings.

The invention relates to a system for manufacturing a medical package, preferably made of plastic, which comprises printing in particular a foil and/or a surface of a medical package, having a first printer, which comprises a digitally controlled thermal print head with a number of heating elements, which can be actuated via a control device and by means of which a variable print image can be generated on a surface of the medical package and a second printer arranged downstream which is formed as a hot stamp printer, which comprises a printing plate which comprises a print relief with a flat section, with the flat section being dimensioned and arranged in such manner that it overlaps at least in sections with the print image generated by the first printer.

The knowledge underlying the invention is that a print image, for example a positive print image and/or a negative print image, can be efficiently applied on the surface of a medical package, in particular on a foil, via a digitally controlled thermal print head, which serves or can serve as the template for the following hot stamp printing. At least one blank space, in particular a blank region in the print image of the first printer, is then filled with the ink of the hot stamp printer arranged downstream.

The flat region of the hot stamp printer overlaps here with the print image of the first printer in such manner that only regions not printed with the first printer, i.e. the blank spaces, are printed with ink of the second printer. The ink of the hot stamp printer adheres only in the regions where the first printer with the digitally controlled thermal print head has not generated a print image on the surface, in particular in the blank spaces of the print image of the first printer.

It is thus possible to apply, by means of the digitally controlled thermal print head, a preferably variable print image on a surface region, which occupies only a part of the printed area, and other information, in particular static information, such as the product name, etc., can be applied simultaneously, in particular in another region of the surface of the medical package.

This print image can contain preferably variable, machine-readable information. Examples of machine-readable information include a barcode and/or visually readable information, such as for example an expiry date or a serial number. The variable, machine-readable information can in particular be applied inversely and represent a negative print image as a result.

Thus, the blank spaces of the print image of the first printer are filled with the ink of the hot stamp printer.

The result is preferably a dual-color, for example black and white print image in which the inks adjoin one another directly without overlapping and without there being gaps between the individual colors.

Thus, it is possible in a particularly efficient manner to provide a part of the medical package with a, for example, black and white print image, which comprises both machine-readable information and information readable by the user of the medical package. In particular, variable information is present in a black and white print image, with the variable information being arranged inside the region which occupies the flat section during printing.

According to one embodiment of the invention, in the second printer, the flat section of the print relief is dimensioned and arranged in such manner that it covers the print image generated with the first printer. The flat section of the print relief can for example be dimensioned and arranged in such manner that it lies inside the print image generated with the first printer, in particular in the case of a negative print image. The flat region can be formed in particular as a rectangle.

As the flat region preferably completely covers the print region of the print image generated by the first printer, the blank spaces of the print image generated by the first printer are printed with the ink of the second printer. In particular, a rectangle, e.g. of white color, can be formed by the flat region, inside of which the print image of the first printer is arranged.

Since the flat region can preferably lie completely inside the print region of the print image generated by the first printer, only the blank spaces of the print image generated by the first printer are printed with the ink of the second printer, without the flat region protruding over the print image generated by the first printer. The ink of the flat region is thus transferred here only inside the print image of the first printer.

The flat region is preferably a region in which the relief, i.e. the protruding region of the printing plate, occupies the entire area.

According to a further embodiment of the invention, the print relief of the printing plate comprises at least one further section, with the further section containing a structure with static information and being dimensioned and arranged in such manner that it lies outside of the print image generated by the first printer.

Therefore, as described above, only a partial region on the package is provided with the print image of the first printer. This preferably serves to provide variable information.

In contrast, a further region, in particular a larger region than the region of the first print image, which contains only static information, can be printed via the printing plate.

The further section of the print relief can have at least a structure selected from a group consisting of letters, digit, symbol, image, barcode and data matrix code.

The variable and/or static information can comprise information that can be visually read by the user and machine-readable information.

The first printer and the second printer are preferably arranged one behind the other in such manner that a foil tape can be transported along the printers.

According to one embodiment of the invention, the system also comprises a filling station to fill the medical package with a medical liquid and a device to seal the filled medical package.

Furthermore, the system can comprise an autoclaving station in which the medical packages manufactured with the system are sterilized.

The medical package manufactured with the system is formed in particular as a foil bag which comprises printed foils welded together.

The foil is preferably first printed by means of the system and then welded to form a bag.

The system can be used to manufacture a medical package made of plastic, in particular a foil bag, in particular a medical package, as described below.

The invention generally also relates to a method for manufacturing a medical package made of plastic, which preferably comprises printing a foil, in particular for a foil bag, and which is preferably carried out with the previously described system.

The invention is described in detail by a method for manufacturing a medical package, with a print image first being applied on a surface of a foil, in particular of the medical package, with a first printer in the digital printing process and with a printing plate with a print relief then impressing a color foil with a second printer at least in sections flatly on the print image of the first printer and, in this process, at least one blank space of the print image of the first printer is printed with an ink of the color foil. The print image is or comprises a positive print image and/or a negative print image.

In particular for a negative printing process, the invention can also be described by a method for manufacturing a medical package, with a negative print image first being applied on a surface of a foil, in particular of the medical package, with a first printer in the digital printing process, with at least one section of a print image being defined by blank spaces in the negative print image and with a printing plate with a print relief then impressing a color foil at least in sections flatly on the negative print image in a second printer and the blank spaces of the negative print image are printed with an ink of the color foil.

As already in connection with the system described above, the knowledge underlying the invention is that the print image generated by the first printer can be used as a template for a subsequent offline printing process, in which a print relief is used, which comprises a flat section, and a color foil is in sections flatly impressed on the print image so that the blank spaces, and in particular a kind of border, are printed, in particular filled, with the ink of the color foil.

The blank spaces are in particular the regions lying inside of the print image of the first printer and are not printed with the first printer, i.e. for example the blank regions present between the digits, letters and parts of a code. The blank spaces can preferably also comprise regions lying outside of the print image of the first printer and represent a kind of contrast area in which the print image is embedded.

In one embodiment, the method is characterized in that a negative print image is applied on the surface of the foil with the first printer, with at least one section of the print image being defined by blank spaces in the negative print image and with the printing plate with the print relief then impressing the color foil at least in sections flatly on the negative print image in the second printer and the blank spaces of the negative print image are printed with the ink of the color foil.

A printer with a digitally controlled thermal print head with a number of heating elements is preferably used as the first printer to apply the print image.

It is preferably connected to a control device, via which the print image can be variably changed, for example from batch to batch or from print to print. The first printer is preferably formed as a thermal transfer printer.

According to one embodiment of the invention, a first ink can be applied on the foil, in particular on the medical package, with the first printer to achieve the print image. Therefore, an ink in the form of a negative image of the print of the second printer can be applied with the first printer, for example.

Furthermore, according to another embodiment of the invention, the first printer can also be used only to heat the surface in regions in order to thus generate a template for the print image of the flat section of the second printer. A print image is generated on the foil by means of the first printer, without an ink being applied. In this case, the print image with the variable information can be generated with the first printer, which comprises the digitally controlled thermal print head, without a color being applied by means of the digitally controlled thermal print head. Thus, only an image, e.g. a negative image, in the form of heating the surface of the medical package is carried out with the digitally controlled thermal print head. The first printer with the digitally controlled thermal print head with a number of heating elements is in this embodiment a device for heating. In particular, the first printer is in this embodiment a digitally controllable device for heating which comprises e.g. a number of digitally controlled heating elements.

Since the ink of the second printer does not adhere in the non-heated regions, the print image of the first printer is visible only by the subsequent hot stamp printing process.

It was found that the surface properties can already be changed by heating the plastic surface, preferably a polypropylene-based foil, in such manner that the ink of the hot stamp printing does not adhere in the regions of the print image generated with the thermal print head during the subsequent hot stamp printing.

The thermal print head is thus used only to generate a template, for example a negative template, for the subsequent hot stamp printing process, in which a printing plate is impressed on the surface of the package.

This embodiment of the invention is suitable in particular if only a single-colored print image is necessary. Even in the case of this embodiment of the invention, a region of the surface of the medical package can be very effectively provided with variable information which is in particular smaller than the print image of the hot stamp printing. This embodiment of the invention is suitable in particular for inversely applied, machine-readable information.

A polypropylene-based material can be used for the medical package. A polypropylene-based foil, in particular a multi-layered polypropylene-based foil, can preferably be used for the medical package.

The plastic of the medical package, in particular the plastic of the surface of the medical package to be printed, comprises a matrix phase-polymer system according to one embodiment of the invention.

In particular, the matrix polymer of the matrix polymer system comprises propylene. In particular, the phase polymer of the matrix phase-polymer system is a styrene-ethylene-butylene-styrene block copolymer (SEBS) and, if necessary, a styrene-isoprene-styrene block polymer (SIS). The matrix preferably consists of polypropylene.

Tear-proof foils, which are also easily weldable, can be provided with such a matrix phase system.

In the case of a matrix phase-polymer system, at least two different polymers are present, with one polymer being present in a segregated manner, in particular as disperse distributed hardened drops, in the matrix of the other polymer.

The styrene-ethylene-butylene-styrene block copolymer is a block polymer composed of styrene and butylene and ethylene parts, which comprises a hydrated butadiene part, to which styrene groups adjoin. This is produced in particular by polymerizing a styrene and butadiene monomer and then hydrating the previously polymerized styrene and butadiene polymer. The hydrated butadiene forms a soft middle block between styrene blocks.

It has been found that, in particular in the case of a matrix phase-polymer system, the surface is changed by a heat treatment, in particular with a thermal transfer printer, in such manner that, in the case of suitable temperature control of a subsequent hot stamp printing process, the ink does not adhere in the thermally pre-treated regions.

In one embodiment, the multi-layered foil has at least three, preferably exactly three, layers. The layers are materially bonded to one another. In particular, the layers are connected to one another by co-extruding and joining in the hot state.

The multi-layered foil comprises at least one inner layer made of a matrix phase-polymer system, a middle layer made of a matrix phase-polymer system and an outer layer made of a matrix phase-polymer system. The inner layer is in contact with the medical liquid. The outer layer provides the surface of the medical package formed an infusion bag and thus the print region.

According to one embodiment, the matrix polymer of the outer layer is a polypropylene homopolymer. This achieves a fixed outer layer of the layer packet. In particular, in the outer layer, the weight proportion of the matrix polymer is in a range of 75-95% by weight and the weight proportion of the phase polymer, preferably SEBS, is in a range of 5-25% by weight.

According to a further embodiment, the matrix polymer of the middle layer is a PP random copolymer. In particular, in the middle layer, the weight proportion of the matrix polymer is in a range of 40-65% by weight and the weight proportion of the phase polymer, preferably SEBS and SIS, is in a range of 35-60% by weight.

According to a further embodiment, the matrix polymer of the inner layer is a PP random copolymer. In particular, in the inner layer, the weight proportion of the matrix polymer is in a range of 70-90% by weight and the weight proportion of the phase polymer, preferably SEBS, is in a range of 10-30% by weight.

The first ink comprises white or black pigments in the case of one embodiment of the invention and is transferred from an ink ribbon, in particular from a polyester ink ribbon, to the package. According to one embodiment of the invention, the first ink comprises a polyacrylate and a polyolefin.

Such inks comprising a polyacrylate and a polyolefin are also referred to as resin-based inks and, unlike inks with a high wax proportion, enable smudge-proof printing which is also thermally resistant and in particular withstands an autoclaving cycle. Autoclaving typically takes place at a temperature of 121° C.

According to a preferred embodiment of the invention, the surface of the medical package is heated with the first printer to above 130° C., preferably above 140° C. and/or below 200° C., preferably below 190° C. in the print image of the first printer (outside of the blank spaces).

The previously described temperature range is suitable in particular for applying acrylate-based inks which are in particular transferred from a color foil and which are also sufficiently temperature-resistant to withstand an autoclaving cycle.

According to one embodiment of the invention, a surface of the foil or of the medical package is printed with the ink of the impressed foil with at least one item of information outside of the print image applied with the first printer.

Static information is in particular applied outside of the print image of the first printer. This can, as previously described, comprise information readable by humans and machine-readable information.

The ink of the impressed color foil is in particular applied by means of a hot stamp printing process, with the printing plate used preferably comprising a flat section which lies inside the print image applied with the first printer and is impressed on the surface to be printed, with the printing plate comprising at least one further section on which preferably static information is impressed outside of the print image applied with the first printer.

In this way, a large region can be printed quickly and efficiently with the second printer, in particular with the hot stamp printer, whereas the print image of the first printer, which occupies a smaller region than the printing plate, serves to apply variable information.

In a first embodiment, the flat section of the printing plate is larger than the print image of the first printer. Thus, overlaps at the edges are avoided. In a second embodiment, the flat section of the printing plate is smaller than the negative print image. Thus, overlaps at the edges are avoided.

The variable information applied with the first printer can in particular comprise a serial number, a batch number and/or an expiry date.

Static information, such as for example a product name and/or machine-readable information, for example in the form of barcode and/or a data matrix code, in particular an inversely applied barcode and/or data matrix code can also be applied with the second printer.

In particular, if the static information is located on a transparent region of the package, it can include an inversely applied code since, as mentioned above, transparent regions appear dark to a scanner. Therefore, the color white can be used in one embodiment as the color for the printing process of the second printer.

According to one embodiment of the invention, a print containing machine-readable information and information present as text and/or digits is applied by the second printer.

The ink of the impressed color foil, depending on the embodiment, preferably comprises white or black pigments and a resin.

A polyacrylate-containing color is preferably used for the ink of the impressed foil which is in particular transferred from an ink ribbon to the surface of the package.

In the case of one embodiment of the invention, the ink of the impressed color foil comprises a coating resin. In particular, the ink comprises a vinyl chloride-vinyl acetate copolymer and/or a vinyl chloride-vinyl acetate-maleic acid terpolymer.

The mentioned polymers, in particular a combination of the mentioned polymers, also enables a coating resin-based ink to be provided which can be applied via a hot stamp printing process and which has a high smudge resistance and a high thermal resistance. Furthermore, the colored layer of this ink adheres neither on the colored layer transferred with the first printer nor on the region of the surface of the medical package made of plastic that was heated with the first printer.

Furthermore, the ink of the impressed color foil can comprise a plasticizer, in particular p-toluene sulfonamide.

The invention further relates to a medical package which is manufactured with the previously described method and/or which is manufactured, in particular printed, by means of the previously described system.

In particular, the medical package comprises features which are disclosed in connection with the previously described system or the previously described method, insofar as these relate to the medical package as such.

The medical package is in particular formed as a foil bag which comprises printed foils welded together.

Preferably, the foil is first printed with the previously described system and/or with the previously described method and then welded to form a bag.

The medical package is in particular constructed from foils welded together and has at least one weld seam, preferably at least one longitudinal and at least one transverse weld seam along which two foils are welded together. In particular, the medical package comprises two longitudinal and two transverse weld seams.

Furthermore, the medical package can also comprise at least one port for withdrawing a medical liquid. The port is in particular welded with its lower part in the weld seam or in one of the weld seams, in particular in a transverse weld seam. The lower part of the port can for example be configured in the form of a shuttle. The port can be part of a connector in which a septum is in particular arranged. For example, a needle, a spike or a Luer Lock connector can be connected to the connector.

Furthermore, the medical package can also comprise a hanger for attaching it to a rack or an infusion stand. The hanger can in particular be formed as a recess or indent in a transverse weld seam opposite the port.

The package according to the invention can be filled with a medical liquid. The package preferably comprises a capacity of 50 to 1000 ml.

The medical liquid is a liquid which is used for medical purposes and is preferably administered intravenously. In a preferred embodiment, the medical liquid is an infusion solution. Possible examples of such infusion solutions comprisesterile water,saline solutions, in particular solutions with NaCl−, KCl−, CaCl−and/or Mg;solutions with carbohydrates, in particular glucose solutions;solutions, emulsions and/or suspensions with nutrients for parenteral nutrition, in particular with lipids, aminoacids and/or glucose;colloid solutions, in particular for blood replacement therapy (e.g. Voluven®); and/orwhat are known as pre-mixed systems where an active ingredient is already added to the medical liquid.

The medical package is in particular characterized in that it contains at least in regions a print image by way of which a print image of the second printer is also defined. In one embodiment, the medical package is in particular characterized in that it contains at least in regions a negative print image by way of which a print image of the second printer, i.e. a positive print image, is defined.

The ink of the second printer in this case reaches precisely to the border of the print image of the first printer without overlapping. In particular, the ink of the second printer reaches to the border of the print image of the first printer without a gap or break without ink being present between the print image of the first printer and the print image of the second printer.

In the region of the print image of the first printer, an ink preventing adhesion of the ink of the second printer is impressed by means of the first printer according to one embodiment of the invention.

The inks also adjoin one another directly in the case of a foil without a gap or a colorless break being located therebetween.

According to another embodiment, the print image of the first printer adjoining the print image of the second printer is characterized by a thermal change in the surface, by way of which a template is formed by way of which the print image of the second printer is defined at least in sections. The print image of the first printer is in this case only visible through the printing of the second printer, since the ink adheres only to the region skipped by the first printer. According to one embodiment, the negative print image adjoining the positive print image is characterized by a thermal change in the surface, by way of which a template is formed, inside of which the positive print image is located.

The invention relates in particular to a medical package according to the aforementioned first embodiment which comprises a first print region with a print image impressed in the thermal transfer printing process, with blank spaces in the print image, by way of which at least one section of a print image is defined, being filled with an ink applied in the hot stamping process. The print image is or comprises a positive print image and/or a negative print image.

In particular, the print image applied in the thermal transfer printing process is provided by a first ink, with the first ink and the ink applied as the second ink in the hot stamp printing process adjoining one another directly.

In this case, the first ink preferably adjoins the second ink in such manner without there being a gap or colorless break and/or overlap between the first ink and the second ink.

Variable and/or static information can preferably be provided by the ink filled into the blank spaces of a negative print image.

The invention in particular enables a print region in which static and variable information adjoin one another in a common print region in which the two inks are present.

According to one embodiment of the invention, the medical package comprises a second print region which is printed with the ink applied in the hot stamping process, with the second print region being arranged separate from the first print region on the package and with static information being applied in the second print region.

A separate arrangement of the second print region is understood as a region being located between the first and the second print region which has been printed neither with the first nor with the second printer.

This region is for example formed as an unprinted region of the transparent foil.

The provision of such a region in which only static information is present enables quick and efficient printing to be carried out, for example with a fixed print relief.

In the case of one embodiment of the invention, the first and/or the second ink forms a 3 to 8 μm thick layer.

The first ink preferably forms a thinner layer than the second ink, in particular a layer at least 1 μm thinner.

According to one embodiment of the invention, the medical package is arranged in a secondary package. In particular, the medical package is arranged in a sterile manner in a secondary package, for example in a tear-open bag.

Owing to the configuration according to the invention, it is possible to sterilize, in particular to autoclave, the medical package arranged in the secondary package without the first and/or second ink adhering to the secondary package.

According to one embodiment of the invention, the medical package comprises a material, in particular a foil, with a thickness or wall thickness of 50 μm to 1000 μm, preferably of 100 to 300 μm.

When formed as a container, the medical package can also have a wall thickness of over 1000 μm and in particular when formed as a bottle.

The invention relates to a medical package in virtually any desired size. In particular, the medical package can have an inner volume of 2 ml to 10 l, in particular 10 ml to 500 ml or 1000 ml and/or can be filled with 2 ml to 10 l, in particular 10 ml to 500 ml or up to 1000 ml, of a medical liquid.

DETAILED DESCRIPTION OF THE DRAWINGS

FIG.1is a schematic view of a system1for manufacturing a medical package2.

Using the system1, a foil3, which is provided by a tape4, is printed with a first printer10and a second printer20.

The first printer10and the second printer20are arranged one behind the other such that the foil3can be guided successively along the two printers10,20.

The first printer10is formed as a thermal transfer printer. The thermal transfer printer10comprises a digitally controllable thermal print head12which is actuated by a control device6. The thermal print head12transfers the ink11bof a color foil11to the foil3. Thus, a variable print image can be applied by, for example, the thermal print head12printing a region of the foil3line by line. In this process, the print image40of the first printer10is applied to the foil3.

The color foil11can for example be provided as an ink ribbon which is unwound from a roll. The ink11bof the color foil11can also be referred to here as the first ink11b.

The second printer20is formed as a hot stamp printer. It comprises a printing plate22which is heated and impressed on the surface of the foil3to be printed. The ink21bof a color foil21is transferred via the printing plate22on the foil3. The ink21bof the color foil21can also be referred to here as the second ink21b.

The printing plate22comprises a print relief24(seeFIG.5) with a flat section24aby way of which blank spaces44of the print image40of the first printer10are filled.

The printed foil3is then supplied to a station5for manufacturing a medical package2with a filling device and a sealing device.

The station5for manufacturing a medical package2in the form of a foil bag30comprises a welding tool for manufacturing the bag, a filling device for filling the bag and a sealing device for sealing the filled bag.

Possible other stations for manufacturing the medical package include in particular a station for packaging into a secondary package and/or a station for preferably thermal sterilization.

As a result, a medical package2made from plastic and which is formed as a foil bag30in this embodiment, is provided with a first and a second ink, in particular with a black and white print.

FIG.2schematically shows the thermal transfer printer10. The thermal transfer printer10comprises the thermal print head12, which is actuated by the control device6and comprises a number of heating elements13which can be individually actuated. As a result, a print image with variable information can be produced.

A color foil11, in particular formed as an ink ribbon, with the support11aand the colored layer11bis moved relative to the thermal print head12and is heated in regions via the individually actuatable heating elements. The ink of the colored layer11bis liquefied in this way and is transferred to the foil3as the first ink11b. Thus, a print image, which in particular comprises pixels formed from the ink of the colored layer11b, can be applied in a digitally controlled manner.

FIG.3is a schematic representation of the second printer20, which is formed as a hot stamp printer. The hot stamp printer20comprises a heatable support23to which a printing plate22is attached which comprises a print relief24. The printing plate22is impressed on the color foil21which comprises the support21aand the colored layer21b.

In the region of the protruding print relief24, the ink of the colored layer21bis heated and transferred under pressure and temperature as the second ink21bfrom the color foil21to the foil3.

FIG.4is a representation of a first exemplary embodiment of a medical package2which is formed as a foil bag30. The medical package2or the foil bag30consists of foils3welded together at the transverse weld seams32and the longitudinal weld seams31. Furthermore, the foil bag30comprises connectors33a,33bvia which liquid can be withdrawn and/or added. The connectors33a,33bare welded into a transverse weld seam32in the case of this exemplary embodiment and comprise a break-off cap. After removing the break-off cap, a fluid connection can be established, for example by inserting a spike or a needle. Furthermore, the foil bag30comprises a hanger34.

The foil bag30is laid into a secondary package7in the example represented. The secondary package7is formed here as a tear-open bag and serves in particular as a barrier against oxygen. In the case of manufacture, the foil bag30filled with the medical liquid is autoclaved in the secondary package7such that the content of the secondary package7, in particular the entire foil bag30, is sterile.

The foil bag30is printed. The print image comprises a region35with variable information. The variable information can in particular comprise a serial number, a batch number and/or an expiry date.

Furthermore, the print image comprises a region with static information36. The region with static information36comprises in this exemplary embodiment a print image36visually readable by humans, i.e. for example a label with contents and/or product name. Furthermore, the region comprises machine-readable information, for example in the form of a barcode (not represented). This can for example serve as machine-readable information regarding the content of the medical package2. This can in particular be an inversely applied barcode.

The print regions of the print image with variable information35and of the print region with static information36, represented in black inFIG.4, are applied with the second printer20after the region35with variable information has been printed beforehand by the first printer10, with the printing plate22represented inFIG.5being used. The first printer10impresses the first ink11b. The second printer20impresses the second ink21b.

The printing plate22comprises a print relief24, which comprises the flat section24a, inside of which the second ink21bserves to fill the blank spaces44of the print image40(seeFIGS.6aand11a) of the first printer10which is provided by the first ink11b.

In the further, non-flat section24b, the print relief24comprises information readable by a human and/or by a machine. In this exemplary embodiment, the information comprises a label. The visually readable information36represented inFIG.4is transferred on the foil3via the non-flat section24bof the print relief24.

The steps in relation to printing the region35with variable information are represented inFIGS.6ato6c.

First, as represented inFIG.6a, a print image40is applied by means of the first printer10which is formed as a thermal transfer printer. The print image40is, in this exemplary embodiment, a print image preferably applied with black ink, which comprises a barcode41, a data matrix code42and a label43which contains an expiry date or a serial number for example. The print image40is a positive print image here. Blank spaces44defined as non-printed regions are present therebetween. The print image40is positive print image here, i.e. formed by the first ink11bof the color foil11of the first printer10.

Then, as represented inFIG.6b, the foil3is printed, in particular with a white ink21b, by means of the second printer20formed as a hot stamp printer. In this process, the flat section24aof the print relief24with the second ink21bcovers the print image40of the first printer10which has transferred the first ink11b.

The blank spaces44of the print image40are filled with the second ink21b. As represented inFIG.6c, the print image50generated by the two printers10,20now contains the print image40and the printed blank spaces44which are filled with the second ink21bin the hot stamp printing.

The print image generated by both printers can thus in particular comprise a white area, inside of which the print image40of the first printer10made up of the first ink11bis arranged. The print image40, which is black here, is embedded in the colored section21b, which is white here.

At the same time, a further region36(seeFIG.4) is printed with static information in one step.

In the first print region35which is a combination of thermal transfer and hot stamp printing, a black and white print results which consists of a positive print image of the first printer10with black color of the first ink11bwhose blank spaces44are filled by the second white ink21b.

The first print region35is smaller than the entire region of the print region of the second printer20and comprises variable, machine-readable information and variable, visually readable information. The first print region35, in particular additionally, can also contain static information.

InFIG.7, the method steps according to one exemplary embodiment of the invention are represented.

First, a print image40, which contains at least variable information, is impressed on a foil3by means of a thermal transfer printer10. The print image40of the first printer10is generated with the first ink11b. The print image40can be a positive print image or a negative print image.

Then, a printing plate22is impressed on the foil3by means of a hot stamp printer20. A flat section24aof the print relief24of the printing plate22overlaps with the print image40of the first printer. The blank spaces44or the blank region of the print image40of the first printer are filled with the second ink21bof the hot stamp printer20.

Then, the foil3is welded to form a foil bag30, the foil bag30is filled and sealed. The sealed foil bag30is preferably then also enclosed in a secondary package7and the medical package2manufactured in this way is lastly autoclaved.

FIG.8shows a further embodiment of the invention. Unlike the embodiment according toFIG.4, the medical package2, formed as a foil bag30, in this exemplary embodiment comprises, in the second print region36, not only a visually readable label, but also a machine-readable barcode37.

The barcode37is also applied, like the label, by means of the second printer20, i.e. via a printing plate22. Therefore, the barcode consists of the second ink21bwhich is preferably a white color. The barcode37is formed here as an inverse barcode37, in which the actual barcode consists of non-printed intermediate blank spaces, which appear dark e.g. to a scanner. The positive image is formed in this configuration by the non-printed intermediate blank spaces. Since the barcode37is not modifiable, it can comprise in particular machine-readable information regarding the content of the foil bag30.

The first print region35, in contrast, comprises, as mentioned in connection withFIG.4, a black and white print, in which machine-readable codes, in particular variable codes are not inversely configured, but rather in which the black print forms the contrast with the surrounding white.

FIG.9is a representation of a third exemplary embodiment of a medical package2which is formed as a foil bag30. The print image comprises a region35with variable information. The variable information can in particular comprise a serial number, a batch number and/or an expiry date. Furthermore, the print image comprises a region with static information36. The region with static information36comprises, in this exemplary embodiment, firstly a print image36avisually readable by humans, i.e. for example a label with contents and/or the product name. Secondly, the region comprises machine-readable information, for example in the form of a barcode36b. This can for example serve as machine-readable information regarding the content of the medical package2.

The print regions of the print image with variable information35and of the print region with static information36, represented in black inFIG.9, are applied with the second printer20after the region35with variable information has been printed beforehand by the first printer10, with the printing plate22represented inFIG.10being used. The first printer10impresses the first ink11b. The second printer20impresses the second ink21b. The printing plate22comprises a print relief24, which comprises the flat section24a, inside of which the second ink21bserves to fill the blank spaces44of the print image40(seeFIG.11a-11c) of the first printer10which is provided by the first ink11b.

In the further, non-flat section24b, the print relief24comprises information readable by a human and/or by a machine. In this exemplary embodiment, the information comprises a label and a barcode. The visually readable information36aand the barcode36brepresented inFIG.9are transferred on the foil3via the non-flat section24bof the print relief24.

The steps in relation to printing the region35with variable information are represented inFIG.11ato11c.

First, as represented inFIG.11a, a print image40is applied by means of the first printer10which is formed here as a thermal transfer printer. The print image40is a negative print image here which contains blank spaces44. The blank spaces44of the print image40represent the actual information.

In this exemplary embodiment, the blank spaces44comprise a barcode41, a data matrix code42and a label43containing for example an expiry date and/or a serial number.

This negative print image is formed by the first ink11bof the color foil11of the first printer10. The first ink11bis in particular a white color.

The machine-readable information, i.e. e.g. the barcode41and/or the data matrix code42, is readable via a scanner since the blank spaces44do not reflect light or only reflect a little light and appear dark to a scanner. The label43is, however, difficult for the human eye to read.

Then, as represented inFIG.11b, the foil3is printed by means of the second printer20formed as a hot stamp printer. In this process, the flat section24aof the print relief24with the second ink21blies inside the print image40of the first printer10which has transferred the first ink11b.

The blank spaces44of the print image40are filled with the second ink21b. As represented inFIG.11c, the print image50generated by the two printers10,20now contains the print image40and the printed blank spaces44which are filled with the second ink21bin the hot stamp printing. At the same time, a further region36(seeFIG.9) is printed with static information in one step.

In the first print region35which is a combination of thermal transfer and hot stamp printing, a black and white print results which consists of a negative print image with white color of the first ink11bwhose blank spaces44are filled by the second black ink21b.

The first print region35is smaller than the entire region of the print region of the second printer20and comprises variable, machine-readable information and variable, visually readable information. The first print region35, in particular additionally, can also contain static information.

A method for manufacturing medical packages, in particular foil bags, is provided by the invention by means of which variable and static information can be, in particular simultaneously, applied in a very effective and accurate manner.

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