Patent Publication Number: US-2022227520-A1

Title: System and method for producing medical packaging

Description:
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 printed 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 first relates to a system and a method for manufacturing a medical package, which comprises printing a foil, 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 in particular 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 as the template for the following hot stamp printing. 
     The blank spaces in the negative print image are then filled with the ink of the hot stamp printer arranged downstream. The flat region of the hot stamp printer overlaps here with the negative print image in such manner that the regions not printed by 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 negative print image. 
     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. Other information, in particular static information, such as for example the product name, etc., can be applied simultaneously, in particular in another region of the surface of the medical package. 
     This print image can for example contain machine-readable information applied inversely and as a result represents a negative print image. Thus, the blank spaces of the negative 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 lies inside the print image generated by the first printer. The flat region can be formed in particular as a rectangle. 
     Since the flat region preferably lies completely inside the printed 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 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 negative 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, digits, 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. 
     Furthermore, the invention generally relates to a method for manufacturing a medical package made of plastic, which 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 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 being impressed at least in sections flatly on the negative print image in a second printer and the blank spaces of the negative print image being printed with an ink of the color foil. 
     As already discussed in connection with the system according to the invention, 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 negative print image so that the blank spaces are printed, in particular filled, 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 negative print image. 
     It is preferably connected to a control device, via which the negative 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 negative 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. 
     Furthermore, according to another embodiment of the invention, the first printer or the thermal print head 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 a negative image in the form of heating the surface of the medical package is carried out with the digitally controlled thermal print head. 
     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 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 smaller than the print image of the hot stamp printing. 
     A polypropylene-based foil, in particular a multi-layered polypropylene-based foil, can 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 pigments in the case of one embodiment of the invention. It is preferably 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 negative print image 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. 
     Preferably, 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 negative 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 negative 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 negative 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 negative print image, which occupies a smaller region than the printing plate, serves to apply variable information. 
     The flat section of the printing plate is preferably 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, can be applied with the second printer. 
     According to one embodiment of the invention, a print containing machine-readable information and information with text and/or digits is applied by the second printer. 
     The ink of the impressed color foil preferably comprises 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 by means of the previously described system. 
     In particular, the medical package comprises features which are disclosed in connection with the previously described system and/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, a Luer 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 comprise
         sterile 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/or   what 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 negative print image by way of which a print image of the second printer, i.e. a positive image, is defined. 
     The ink of the second printer in this case reaches precisely to the border of the negative print image without overlapping. In particular, the ink of the second printer reaches to the border of the negative print image without a gap or break without ink being present between the negative print image and the positive print image. 
     In the region of the negative print image, an ink preventing adhesion of the ink of the second printer is impressed either by means of the first printer. 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 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 in particular relates to a medical package which comprises a first print region with a negative print image impressed in the thermal transfer printing process, with blank spaces in the negative 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. 
     In particular, the negative 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 is preferably provided by the ink filled into the blank spaces of the 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. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The subject matter of the invention will be explained in more detail below with reference to the drawings  FIG. 1  to  FIG. 7 . 
         FIG. 1  is a schematic view of a system for manufacturing a medical package. 
         FIG. 2  is a schematic representation of a printing process by means of a thermal transfer printer. 
         FIG. 3  is a schematic representation of a printing process by means of a hot stamp printer. 
         FIG. 4  is a view of an exemplary embodiment of a medical package. 
         FIG. 5  is a view of the print relief used for the medical package. 
         FIG. 6 a    to  FIG. 6 c    show the steps via which a region is printed with a variable print image. 
         FIG. 7  is a flow diagram of the method steps according to an exemplary embodiment of the method according to the invention. 
     
    
    
     DETAILED DESCRIPTION OF THE DRAWINGS 
       FIG. 1  is a schematic view of a system  1  for manufacturing a medical package  2 . 
     Using the system  1 , a foil  3 , which is provided by a tape  4 , is printed with a first printer  10  and a second printer  20 . 
     The first printer  10  and the second printer  20  are arranged one behind the other such that the foil  3  can be guided successively along the two printers  10 ,  20 . 
     The first printer  10  is formed as a thermal transfer printer. The thermal transfer printer  10  comprises a digitally controllable thermal print head  12  which is actuated by a control device  6 . The thermal print head  12  transfers the ink  11   b  of a color foil  11  to the foil  3 . Thus, a variable print image can be applied by, for example, the thermal print head  12  printing a region of the foil  3  line by line. In this case, a negative print image is applied on the foil  3 . 
     The color foil  11  can for example be provided as an ink ribbon which is unwound from a roll. The ink  11   b  of the color foil  11  can also be referred to here as the first ink  11   b.    
     The second printer  20  is formed as a hot stamp printer. It comprises a printing plate  22  which is heated and impressed on the surface of the foil  3  to be printed. The ink  21   b  of a color foil  21  is transferred via the printing plate  22  on the foil  3 . The ink  21   b  of the color foil  21  can also be referred to here as the second ink  21   b.    
     The printing plate  22  comprises a print relief  24  (see  FIG. 5 ) with a flat section  24   a  by way of which blank spaces  44  of the negative print image  40  are filled. 
     The printed foil  3  is then supplied to a station  5  for manufacturing a medical package  2  with a filling device and a sealing device. 
     The station  5  for manufacturing a medical package  2  in the form of a foil bag  30  comprises a welding tool for manufacturing the bag  30 , a filling device for filling the bag and a sealing device for sealing the filled bag. 
     Possible other stations for manufacturing the medical package  2  include in particular a station for packaging into a secondary package and/or a station for preferably thermal sterilization. 
     As a result, a medical package  2  made from plastic and which is formed as a foil bag  30  in this embodiment, is provided with a first and a second ink, in particular with a black and white print. 
       FIG. 2  schematically shows the thermal transfer printer  10 . 
     The thermal transfer printer  10  comprises the thermal print head  12 , which is actuated by the control device  6  and comprises a number of heating elements  13  which can be individually actuated. As a result, a print image with variable information can be produced. 
     A color foil  11 , in particular formed as an ink ribbon, with the support  11   a  and the colored layer  11   b  is moved relative to the thermal print head  12  and is heated in regions via the individually actuatable heating elements. 
     The ink of the colored layer  11   b  is liquefied in this way and is transferred to the foil  3  as the first ink  11   b.    
     Thus, a print image, which in particular comprises pixels formed from the ink of the colored layer  11   b , can be applied in a digitally controlled manner. 
       FIG. 3  is a schematic representation of the second printer  20 , which is formed as a hot stamp printer. 
     The hot stamp printer  20  comprises a heatable support  23  to which a printing plate  22  is attached which comprises a print relief  24 . 
     The printing plate  22  is impressed on the color foil  21  which comprises the support  21   a  and the colored layer  21   b.    
     In the region of the protruding print relief  24 , the ink of the colored layer  21   b  is heated and transferred under pressure and temperature as the second ink  21   b  from the color foil  21  to the foil  3 . 
       FIG. 4  is a representation of an exemplary embodiment of a medical package  2  which is formed as a foil bag  30 . 
     The medical package  2  or the foil bag  30  consists of foils  3  welded together at the transverse weld seams  32  and the longitudinal weld seams  31 . 
     Furthermore, the foil bag  30  comprises connectors  33   a ,  33   b  via which liquid can be withdrawn and/or added. 
     The connectors  33   a ,  33   b  are welded into a transverse weld seam  32  in 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 bag  30  comprises a hanger  34 . 
     The foil bag  30  is laid into a secondary package  7  in the example represented. The secondary package  7  is formed here as a tear-open bag and serves in particular as a barrier against oxygen. 
     In the case of manufacture, the foil bag  30  filled with the medical liquid is autoclaved in the secondary package  7  such that the content of the secondary package  7 , in particular the entire foil bag  30 , is sterile. 
     The foil bag  30  is printed. 
     The print image comprises a region  35  with 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 information  36 . The region with static information  36  comprises in this exemplary embodiment firstly a print image  36   a  visually 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 barcode  36   b . This can for example serve as machine-readable information regarding the content of the medical package  2 . 
     The print regions of the print image with variable information  35  and of the printed region with static information  36 , represented in black in  FIG. 4 , are applied with the second printer  20  after the region  35  with variable information has been printed beforehand by the first printer  10 , with the printing plate  22  represented in  FIG. 5  being used. The first printer  10  impresses the first ink  11   b . The second printer  20  impresses the second ink  21   b.    
     The printing plate  22  comprises a print relief  24 , which comprises the flat section  24   a , inside of which the second ink  21   b  serves to fill the blank spaces  44  of the print image  40  (see  FIG. 6 a -6 c   ) of the first printer  10  which is provided by the first ink  11   b.    
     In the further, non-flat section  24   b , the print relief  24  comprises 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 information  36   a  and the barcode  36   b  represented in  FIG. 4  are transferred on the foil  3  via the non-flat section  24   b  of the print relief  24 . 
     The steps in relation to printing the region  35  with variable information are represented in  FIGS. 6 a    to  6   c.    
     First, as represented in  FIG. 6 a   , a print image  40  is applied by means of the first printer  10  which is formed as a thermal transfer printer. The print image  40  is a negative print image here which contains blank spaces  44 . The blank spaces  44  of the print image  40  represent the actual information. 
     In this exemplary embodiment, the blank spaces  44  comprise a barcode  41 , a data matrix code  42  and a label  43  containing for example an expiry date and/or a serial number. 
     This negative print image is formed by the first ink  11   b  of the color foil  11  of the first printer  10 . The first ink  11   b  is in particular a white color. 
     The machine-readable information, i.e. e.g. the barcode  41  and/or the data matrix code  42 , is readable via a scanner since the blank spaces  44  do not reflect light or only reflect a little light and appear dark to a scanner. 
     The label  43  is, however, difficult for the human eye to read. 
     Then, as represented in  FIG. 6 b   , the foil  3  is printed by means of the second printer  20  formed as a hot stamp printer. In this process, the flat section  24   a  of the print relief  24  with the second ink  21   b  lies inside the print image  40  of the first printer  10  which has transferred the first ink  11   b.    
     The blank spaces  44  of the print image  40  are filled with the second ink  21   b . As represented in  FIG. 6 c   , the print image  50  generated by the two printers  10 ,  20  now contains the print image  40  and the printed blank spaces  44  which are filled with the second ink  21   b  in the hot stamp printing. 
     At the same time, a further region  36  (see  FIG. 4 ) is printed with static information in one step. 
     In the first print region  35  which 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 ink  11   b  whose blank spaces  44  are filled by the second black ink  21   b.    
     The first print region  35  is smaller than the entire region of the print region of the second printer  20  and comprises variable, machine-readable information and variable, visually readable information. The first print region  35 , in particular additionally, also contains static information. 
     In  FIG. 7 , the method steps according to one exemplary embodiment of the invention are represented. 
     First, a negative print image  40 , which contains at least variable information, is impressed on a foil  3  by means of a thermal transfer printer  10 . The negative print image  40  is generated here by the first ink  11   b.    
     Then, a printing plate  22  is impressed on the foil  3  by means of a hot stamp printer  20 . A flat section  24   a  of the print relief  24  of the printing plate  22  overlaps with the negative print image  40 . The blank spaces  44  of the negative print image  40  are filled with the second ink  21   b  of the hot stamp printer  20 . 
     Then, the foil  3  is welded to form a foil bag  30 , the foil bag  30  is filled and sealed. The sealed foil bag  30  is preferably then also enclosed in a secondary package  7  and the medical package  2  manufactured in this way is lastly autoclaved. 
     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. 
     LIST OF REFERENCE NUMERALS 
     
         
           1  System for manufacturing a medical package 
           2  Medical package 
           3  Foil 
           4  Roll 
           5  Station for manufacturing the bag, together with filling station and station for sealing 
           6  Control device 
           7  Secondary package 
           10  First printer/thermal transfer printer 
           11  Color foil 
           11   a  Support 
           11   b  Colored layer/(first) ink 
           12  Thermal print head 
           13  Heating element 
           20  Second printer/hot stamp printer 
           21  Color foil 
           21   a  Support 
           21   b  Colored layer/(second) ink 
           22  Printing plate 
           23  Support 
           24  Print relief 
           24   a  Flat section 
           24   b  Non-flat section 
           30  Foil bag 
           31  Longitudinal weld seam 
           32  Transverse weld seam 
           33   a  Connector 
           33   b  Connector 
           34  Hanger 
           35  First print region/region with variable print image 
           36  Second print region/region with static print image 
           36   a  Visually readable print image 
           36   b  Machine-readable information/barcode 
           40  Negative print image/print image thermal transfer printer 
           41  Barcode 
           42  Data matrix code 
           43  Label 
           44  Blank space