EP3972910A1

EP3972910A1 - System and method for producing a medicinal packaging

Info

Publication number: EP3972910A1
Application number: EP20731369.3A
Authority: EP
Inventors: Thomas BRÜCKNER; Benjamin Fritz; Gerald Wegner; Stefan Faber; Alexander STOJMANOVSKI; Marko KRENZLIN
Original assignee: Fresenius Kabi Deutschland GmbH
Current assignee: Fresenius Kabi Deutschland GmbH
Priority date: 2019-05-21
Filing date: 2020-05-20
Publication date: 2022-03-30
Also published as: WO2020234386A1; AU2020278163A1; ZA202108320B; CL2021002919A1; CA3141177A1; CN113874215B; BR112021016083A2; KR20220010718A; US20220194073A1; CN113874215A; MX2021014153A

Abstract

The invention relates to a system and to a method for producing a medicinal packaging, in particular a plastic flim bag. Initially, a thermal transfer printer is used to apply a print image with variable information, which includes blank spaces. The blank spaces are filled using a hot stamping printing process.

Description

Plant and method for producing a medical

packaging

description

Field of invention

The invention relates to a system and a method for producing medical packaging. The invention further relates to a produced therewith, in particular as

Medical packaging in foil form.

Background of the invention

Medical packaging, such as foil pouches, must be provided with a label from which, for example, the ingredients can be derived. For this purpose, the packaging is generally printed.

Furthermore, medical packaging is often printed with machine-readable information, such as a barcode, which the hospital staff has with a

Scanner can be read. The ingredients of the medical packaging can be identified via the barcode.

It is known from practice to apply machine-readable information to medical film bags in the form of a negative print image (see, for example, WO 99/49408 A1). A white printed negative print image on a transparent one

Foil is easy to read for a scanner because the transparent

Areas have only a low light reflection and so for the

Scanners appear dark. Are to the human eye however, legible information in the form of such a negative print image is difficult to decipher.

A dark, in particular black, printed image on a transparent film is again not sufficiently good

machine-readable, as this does not form a sufficient contrast to the adjacent transparent areas.

There are therefore approaches to first provide a white background on the medical packaging, for example in the form of a label or a printed surface, and then to print the black color on the white background.

However, the printing must also be made wipe-proof and in particular be suitable for withstanding an autoclaving process. This also applies in particular to foil bags, which are often autoclaved in a tear-open secondary packaging, the printed surface of the foil bag being in contact with the secondary packaging and consequently being easily smeared.

Furthermore, medical packaging is usually on the one hand with static information such as the

Product names and / or ingredients, printed. This fixed information does not change from batch to batch of the product.

In addition, there is often variable information on the medical packaging, such as batch number, serialization number and / or expiry date, which can change from batch to batch or even from packaging to packaging.

To apply such variable information are

Offline printing processes that work with a fixed stamp, not very suitable, since the stamp would have to be changed every time to change the print image.

Online printing processes with a digitally controlled print head are used to apply such variable information

This makes sense because the print image can be changed at any time via a control device.

There are, for example, thermal transfer printers that use a large number of individually controlled heating elements to transfer the color from a ribbon to the surface to be printed.

Compared to offline printing processes that work with a stamp, thermal transfer printers are quite slow. This is particularly disadvantageous when large areas of the

medical packaging to be printed.

Object of the invention

In contrast, the invention is based on the object of providing a system for producing medical packaging and a method for producing medical packaging and medical packaging in which both variable information and static information can be efficiently and in particular permanently accessed medical packaging can be printed on.

Summary of the invention

The object of the invention is already achieved by an installation for producing medical packaging, by a method for producing medical packaging and by medical packaging according to one of the independent claims. Preferred embodiments and developments of the invention can be found in the subject matter of the dependent claims, the description and the drawings.

The invention relates to a system for producing medical packaging, preferably made of plastic, comprising printing, in particular a film and / or a surface of medical packaging, having a first printer which is a digitally controlled

A thermal print head with a plurality of heating elements, which can be controlled via a control device and by means of which a variable print image can be generated on a surface of the medical packaging, and a

downstream second printer, which is designed as a hot stamping printer, which comprises a cliché, which a

Comprises printing relief with a flat section, wherein the flat section is dimensioned and arranged in such a way that it overlaps at least in sections with the print image generated by the first printer.

The invention is based on the knowledge that a digitally controlled thermal print head can efficiently transfer a print image, for example a positive print image and / or a negative print image, onto the surface of a medical

Packaging, in particular on a film, can be applied, which serves as a template for the subsequent

Hot stamping serves or can serve.

At least one blank, in particular an empty area in the print image of the first printer, is then identified with the

Ink of the downstream hot stamping printer filled in.

The flat area of the hot stamping printer overlaps with the print image of the first printer in such a way that only areas not printed with the first printer, i.e. the spaces, can be printed with ink from the second printer. The

The printing ink of the hot stamping printer only adheres to the areas in which the first printer used the digitally controlled one

Thermal printhead 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 so possible by means of the digitally controlled

Thermal print head to apply a, preferably variable, print image to a surface area which only takes up part of the printed area, with other information, in particular static information, such as product name, etc., simultaneously, in particular in a different area of the

Surface of the medical packaging can be applied.

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 an expiration date or a serialization number. The variable machine-readable

Information can in particular be applied inversely and thereby represent a negative print image.

Then the spaces of the print image of the first

Filled in with the printing ink of the hot stamping printer.

The result is preferably a two-color, for example black and white, print image in which the printing inks

directly adjoin each other without overlapping and without gaps between the individual colors.

It is thus possible in a particularly efficient manner to provide part of the medical packaging with, for example, a black and white print image that is both machine-readable Information as well as from the user of the medical

Packaging includes legible information. In particular, there is variable information in a black-and-white print image

present, the variable information being arranged within the area which the flat section occupies during printing.

According to one embodiment of the invention, the flat section of the printing relief in the second printer is of this type

dimensioned and arranged so that he was the first

Printer generated print image covered. For example, the flat section of the print relief can be dimensioned and arranged in such a way that it lies within the print image generated with the first printer, in particular in the case of a

Negative print image. The flat area can in particular be designed as a rectangle.

By the flat area preferably completely

If the print area of the print image generated by the first printer is covered, the spaces in the print image generated by the first printer are printed with the printing ink of the second printer. In particular, a rectangle, e.g. of white color, within which the print image of the first printer is arranged.

Because the flat area can preferably lie completely within the print area of the print image generated by the first printer, only the spaces of the print image generated by the first printer are printed with the printing ink of the second printer, without the flat area being overlaid over the print image generated by the first printer protrudes. The printing ink from the flat area is therefore only transferred within the print image of the first printer. The flat area is preferably an area in which the relief, that is to say the protruding area of the cliché, takes up the entire area.

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

As described above, only a part of the packaging is provided with the print image from the first printer. This is preferably used to provide variable information.

On the other hand, a further area, in particular a larger area than the area of the first print image, can be printed via the cliché, which is only static

Contains information.

The further section of the print relief can have at least one structure which is selected from a group consisting of letters, numbers, symbols, images, bar codes and data matrix codes.

The variable and / or static information can be visually readable by the user as well

include machine readable information.

The first printer and the second printer are preferably arranged one behind the other in such a way that a film strip can be transported along the printer. According to one embodiment of the invention, the system further comprises a filling station for filling the medical packaging with a medical liquid and a device for closing the filled medical packaging

Packaging.

The system can also include an autoclave station in which the medical

Packaging can be sterilized.

The medical packaging produced with the system is designed in particular as a foil pouch which comprises foils which are welded to one another and which are printed.

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

The system can be used to produce medical packaging from plastic, in particular a film bag, in particular medical packaging, as described below.

The invention also relates generally to a method for

Manufacture of a medical packaging made of plastic, which preferably comprises the printing of a film, in particular for a film bag, and which is preferably carried out with the system described above.

The invention is described in detail by a method for producing medical packaging, a print image being first applied to a surface of a film, in particular the medical packaging, using a first printer in digital printing, and

then with a second printer a cliché with a print relief and a color film at least in sections is pressed flat on the print image of the first printer and at least one blank space of the print image of the first printer is printed with a printing ink of the color film. The print image is or includes a positive print image and / or a negative print image.

In particular for a negative print, the invention can also be described by a method for producing a medical packaging, whereby a negative print image is first printed onto a first printer using digital printing

Surface of a film, especially the medical one

Packaging, is applied, wherein at least a portion of a print image is defined by blanks in the negative print image, and

then in a second printer a cliché with a print relief presses a color film at least partially over the surface of the negative print image and the spaces of the negative print image are printed with a printing ink of the color film.

As already discussed in connection with the above-described system, the invention is based on the knowledge that the print image generated with the first printer as

Stencil can be used for a subsequent offline printing, in which a print relief is used which comprises a flat section and in sections, flatly prints a colored film onto the print image, so that the empty spaces and in particular also a type of border are printed with the printing ink of the colored film, especially to be filled out.

The spaces are in particular the areas that lie within the print image of the first printer and are not printed with the first printer, e.g. the between the

Digits, letters and components of a code empty areas. The voids can preferably also include areas that lie outside the print image of the first printer and represent a type of contrasting area in which the print image is embedded.

In one embodiment, the method is thereby

marked that with the first printer one

Negative print image is applied to the surface of the film, with blank spaces in the negative print image

at least a portion of the print image is defined, and then in the second printer the cliché with the

Printing relief presses the color film at least in sections over the surface of the negative print image and the blank spaces of the negative print image are printed with the printing ink of the color film.

As the first printer to apply the print image

preferably a printer with a digitally controlled one

Thermal printhead with a variety of heating elements

used.

This 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 designed as a thermal transfer printer.

According to one embodiment of the invention, a first printing ink can be applied to the film, in particular the medical packaging, to generate the print image with the first printer. . For example, the first printer can print a print color in the form of a negative image of the

Pressure of the second printer can be applied. Furthermore, according to another embodiment of the invention, the first printer can also only be used to heat the surface in areas in order to generate a stencil for the print image of the flat section of the second printer. A print image is generated on the film by means of the first printer without a printing ink being applied. Here, with the first printer, which includes the digitally controlled thermal printhead, the print image with the variable

Information is generated without a color being applied by means of the digitally controlled thermal print head. With the digitally controlled thermal print head, only one image, e.g. a negative image, made in the form of heating the surface of the medical packaging. The first printer with the digitally controlled thermal printhead with a plurality of heating elements is a device for heating in this embodiment. In particular, the first printer in this embodiment is a digitally controllable device for heating, which e.g. a variety of digital

includes controlled heating elements.

Because the ink from the second printer does not adhere to the unheated areas, the print image from the first printer only becomes visible through the subsequent hot stamping process.

It has been found that even by heating the plastic surface, preferably a polypropylene-based film, the surface properties can be changed in such a way that the printing ink of the hot stamping does not adhere to the areas of the print image generated with the thermal print head during the subsequent hot stamping.

The thermal print head is only used to generate a stencil, for example a negative stencil, for the subsequent one Hot stamping process, in which a cliché is pressed onto the surface of the packaging, is used.

This embodiment of the invention is particularly suitable when only a single-color print image is necessary. In this embodiment of the invention, too, a region of the surface of the medical packaging can be provided with variable information in a very effective manner, which is in particular smaller than the printed image of the

Hot stamping. Especially for inversely applied

machine-readable information is suitable for this

Embodiment of the invention.

A material based on polypropylene can be used for medical packaging. Preferably, a polypropylene-based film, in particular a

multilayer polypropylene-based film can be used.

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

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

With such a matrix-phase system,

Provide tear-resistant films that are good at the same time

are weldable. In the case of a matrix-phase-polymer system, at least two different polymers are present, one polymer being present in a demixed state, in particular as dispersed solidified drops, in the matrix of the other polymer.

The styrene-ethylene / butylene-styrene block copolymer is made from styrene, butylene and

Block polymer composed of ethylene sections comprising a hydrated butadiene section followed by styrene groups. This is in particular by a polymerization of a styrene and butadiene monomer and

subsequent hydration of the previously polymerized styrene and butadiene polymer produced. The hydrated butadiene forms a soft mid-block between styrene blocks.

It has been found that with one in particular

Matrix phase polymer system through a surface

Heat treatment, in particular with a thermal transfer printer, is changed in such a way that with a suitable temperature control of a subsequent hot stamping print, the printing ink does not adhere in the thermally pretreated areas.

In one embodiment, the multilayer film has at least three, preferably exactly three, layers. The layers are materially connected to one another. In particular, the layers are connected to one another by co-extrusion and joining in the hot state.

The multilayer film 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 medicinal fluid. The outer layer provides the surface of the medical packaging designed as an infusion bag and thus the printing area. According to one embodiment, the matrix polymer of the outer layer is a polypropylene homopolymer. This creates a solid outer layer of the layer package. In particular, the proportion by weight of the matrix polymer in the outer layer is in a range from 75 to 95% by weight and the proportion by weight of the phase polymer, preferably SEBS, is in a range from 5 to 25% by weight.

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

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

In one embodiment of the invention, the first printing ink comprises white or black color pigments and is transferred to the packaging by an ink ribbon, in particular a polyester ink ribbon. According to one embodiment of the invention, the first printing ink comprises a polyacrylate and a polyolefin.

Such comprising a polyacrylate and a polyolefin

Colors are also known as resin-based colors and, in contrast to colors, enable a high level

Have wax content, a wipe-proof printing, which is also thermally resistant and in particular a Withstand the autoclave cycle. Autoclaving typically takes place at a temperature of 121 ° C.

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

The temperature range described above is suitable

in particular for the application of acrylate-based paints, which are transferred in particular from a paint film and which at the same time are sufficiently temperature-resistant to withstand an autoclaving cycle.

According to one embodiment of the invention, a print image is applied outside of the print image applied by the first printer

Surface of the film or the medical packaging with the printing ink of the printed film with at least one

Information printed.

Outside the print image of the first printer is

in particular static information is applied. As described above, this can include both human-readable and machine-readable information.

The printing ink of the imprinted color film is applied in particular by means of a hot stamping printing process, the cliché used preferably comprising a flat section which is located within the first printer

applied print image and the one to be printed

Surface is pressed on, wherein the cliché comprises at least one further section over which outside of the print image applied with the first printer a,

preferably static, information is printed. In this way, with the second printer, in particular with the hot stamping printer, a large area can be printed quickly and efficiently, whereas the print image of the first printer, which has a smaller area than the

Cliché assumes, the application of variable information serves.

In a first embodiment, the flat section of the cliché is larger than the print image of the first printer. In this way, edge overlaps are avoided. In a second embodiment, the flat section of the cliché is smaller than the negative print image. So become marginal

Overlaps avoided.

The variable information applied by the first printer can in particular be a serialization number, a

Include a lot number and / or an expiration date.

With the second printer, static information, such as a product name and / or a

machine-readable information, for example in the form of a bar code and / or a data matrix code, are applied, in particular an inversely applied bar code and / or data matrix code.

In particular if the static information is located on a transparent area of the packaging, it can include an inversely applied code, since, as stated above, transparent areas appear dark to a scanner. In one embodiment, the color white can therefore be used as the color for printing by the second printer. According to one embodiment of the invention, a pressure is applied by the second printer, which both

contains machine-readable information as well as information available as text and / or numbers.

The printing ink of the printed-on colored film comprises, depending on the embodiment, preferably white or black pigments and a resin.

A polyacrylate-containing ink is preferably used for the printing ink of the printed film, which ink is applied in particular to the surface of the packaging from a ribbon

is transmitted.

In one embodiment of the invention, the printing ink of the printed color film comprises a lacquer resin. In particular, the printing ink comprises a vinyl chloride-vinyl acetate copolymer and / or a vinyl chloride-vinyl acetate-maleic acid terpolymer.

The polymers mentioned, in particular a combination of the polymers mentioned, also make it possible to provide a paint-resin-based color which is based on a

Can apply hot stamping printing process and which has both a high wipe resistance and a high thermal resistance. Furthermore, the color layer of this printing ink does not adhere either to the color layer transferred with the first printer or to the area of the surface of the medical packaging heated with the first printer

Plastic.

The printing ink of the printed color film can furthermore comprise a plasticizer, in particular p-toluenesulfonamide.

The invention also relates to a medical one

Packaging made with the method described above and / or which is produced, in particular printed, by means of the system described above.

In particular, the medical packaging includes im

In connection with the above-described system or the above-described method, features disclosed, insofar as these relate to the medical packaging as such

Respectively .

The medical packaging is designed in particular as a film pouch which comprises films which are welded to one another and which are printed.

The film is preferably first printed with the above-described system and / or with the above-described method and then into a bag

welded.

The medical packaging is constructed in particular from films welded to one another and has at least one weld seam, preferably at least one longitudinal and at least one transverse weld seam, on which two films are welded to one another. In particular, includes medical

Packaging with two longitudinal and two transverse welds.

The medical packaging can furthermore comprise at least one port for removing a medical liquid.

The port is in particular with its lower part in the

Weld seam or one of the weld seams, in particular in a transverse weld seam, also welded in. The lower part of the port can be designed, for example, in the shape of a boat. The port can be part of a connector in which, in particular, a septum is arranged. A needle, a spike or a Luer lock connector, for example, can be connected to the connector. The medical packaging can furthermore comprise a hanger for attachment to a rack or an infusion stand. The hanger can in particular be designed as a recess or incision in a transverse weld seam opposite the port.

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

The medical liquid is a liquid which is used for medical purposes and preferably

administered intravenously. In a preferred

The medical liquid is one embodiment

Infusion solution. Possible examples of such

Include infusion solutions

sterile water;

Salt solutions, especially 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, amino acids and / or glucose;

Colloid solutions, especially for blood replacement therapy (e.g. Voluven®); and or

so-called premixed systems in which the

an active ingredient has already been added to the medicinal liquid.

The medical packaging is characterized in particular by the fact that it contains, at least in certain areas, a print image through which a print image from the second printer, is defined. In one embodiment, the medical packaging is distinguished in particular by the fact that it contains, at least in some areas, a negative print image through which a print image from the second printer, that is,

Positive print image, is defined.

The printing ink of the second printer extends exactly to the limit of the print image of the first printer without overlapping. In particular, the printing ink of the second printer reaches the border of the printing image of the first printer without a gap or a gap without printing ink being present between the printing image of the first printer and the printing image of the second printer.

In the area of the print image of the first printer, according to one embodiment of the invention, the first printer is used to print a color that prevents the color of the second printer from adhering.

The colors are directly adjacent to one another, even in the case of a film, without a gap or a colorless gap between them.

According to another embodiment, the print image adjoining the print image of the second print image is the first

Printer characterized by a thermal change of the surface, through which a stencil is formed, through which the print image of the second printer at least

is defined in sections. The print image of the first

Printer is only activated by printing the second

Printer, because the printing color is only on that of the first

Printer omitted area adhered. According to a

The embodiment is that which is adjacent to the positive print image

Negative print image due to a thermal change in the

Surface characterized by which a template is formed, within which the positive print image

is located.

The invention particularly relates to a medical one

Packaging according to the aforementioned first embodiment, which has a first printing area with an im

Thermal transfer printing includes printed image, wherein voids in the printed image, through the at least one

Section of a print image is defined, with an im

Hot stamping process applied printing ink are filled. The print image is or includes a positive print image and / or a negative print image.

In particular, this is applied by thermal transfer printing

The print image is provided by a first printing ink, the first printing ink and the printing ink applied as a second printing ink in the hot stamping printing process directly

adjoin each other.

The first printing ink is preferably adjacent to the second printing ink in such a way that there is no gap or a colorless gap and / or an overlap between the first printing ink and the second printing ink.

Through those in the blank spaces of a negative print image

padded ink can preferably be variable

and / or static information can be provided.

The invention enables in particular a printing area in which static and variable information in one

common printing area in which the two printing inks are present, adjoin one another.

According to one embodiment of the invention, the

medical packaging has a second print area that is marked the printing ink applied in the hot stamping process is printed, with the second printing area being arranged separately from the first printing area on the packaging and with static information in the second printing area

is upset.

A separate arrangement of the second printing area is understood to mean that there is an area between the first and the second printing area which was neither printed with the first nor with the second printer.

This area is designed, for example, as an unprinted area of the transparent film.

The provision of such an area in which only static information is present enables the

Make printing in a fast and efficient way, for example with a solid print relief.

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

The first printing ink preferably forms a thinner layer than the second printing ink, in particular a layer that is at least 1 gm thinner.

According to one embodiment of the invention, the medical packaging is arranged in a secondary packaging.

In particular, the medical packaging is arranged in a sterile manner in secondary packaging, for example in a tear-open pouch.

Due to the configuration according to the invention, it is possible to arrange the medical packaging in the

Sterilize secondary packaging, in particular to autoclave without the first and / or second color sticking to the secondary packaging.

The medical packaging comprises according to one

Embodiment of the invention a material, in particular a film, with a thickness or wall thickness of 50 μm to 1000 μm, preferably 100 to 300 μm.

In the form of a container, the medical packaging can also have a wall thickness of over 1000 μm and in particular be in the form of a bottle.

The invention relates to medical packaging in almost any size. In particular, the

medical packaging have an internal volume of 2 ml to 10 1, in particular from 10 ml to 500 ml or up to 1000 ml, and / or be filled with 2 ml to 10 1, in particular from 10 ml to 500 ml or up to 1000 ml, of a medical liquid .

Brief description of the drawings

The subject matter of the invention is to be explained in more detail below with reference to the drawings, FIGS. 1 to 11c.

Fig. 1 is a schematic view of a plant for

Manufacture of medical packaging.

Fig. 2 is a schematic representation of a printing process using a thermal transfer printer.

Fig. 3 is a schematic representation of a printing process using a hot stamping printer. Figure 4 is a view of a first embodiment of medical packaging.

FIG. 5 is a view of the printing relief used for the medical packaging in FIG.

FIGS. 6a to 6c show the steps via which an area is printed with a variable print image according to FIGS. 4 and 5.

7 is a flow chart of the method steps according to an embodiment of the method according to the invention.

8 shows a further embodiment of a medical packaging.

Figure 9 is a view of another embodiment of a medical package.

FIG. 10 is a view of the printing relief used for the medical packaging in FIG.

11a to 11c show the steps through which a

Area is printed with a variable print image according to Figures 9 and 10.

Detailed description of the drawings

Fig. 1 is a schematic view of a plant 1 for

Manufacture of medical packaging 2.

With the system 1, a film 3, which is provided by a belt 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, so that the film 3 can be guided along the two printers 10, 20 one after the other.

The first printer 10 is a thermal transfer printer

educated. The thermal transfer printer 10 comprises a digitally controllable thermal print head 12 which is controlled by a control device 6. The thermal print head 12 transfers the printing ink 11b of a color film 11 to the film 3. A variable print image can thus be applied by, for example, the thermal print head 12 printing an area of the film 3 line by line. The print image 40 of the first printer 10 is applied to the film 3.

The color film 11 can for example be provided as a tape which is unwound from a roll. The

Printing ink 11b of the color film 11 can also be the first here

Printing ink 11b are designated.

The second printer 20 is designed as a hot stamping printer. It comprises a cliché 22, which is heated and pressed onto the surface of the film 3 to be printed. The printing ink 21b of an ink film 21 is transferred to the film 3 via the cliché 22. The printing ink 21b of the color film 21 can also be referred to here as the second printing ink 21b.

The cliché 22 comprises a print relief 24 (see FIG. 5) with a flat section 24a, through which voids 44 of the print image 40 of the first printer 10 are filled.

The printed film 3 is then a station 5 to

Manufacture of a medical packaging 2 with a

Filling device and a closing device supplied. The station 5 for producing a medical packaging 2 in the form of a film bag 30 comprises a welding tool for producing the bag, a filling device for filling the bag and a closing device for closing the filled bag.

Possible further stations for the production of the medical packaging include in particular a station for packaging in secondary packaging and / or a station for,

preferably thermal, sterilization.

The result is a medical one made of plastic

Packaging 2, which in this exemplary embodiment as

Foil bag 30 is formed, which is provided with a first and a second printing color, in particular with a black and white print.

FIG. 2 schematically shows the thermal transfer printer 10. The thermal transfer printer 10 includes the thermal print head 12 which is controlled by the control device 6 and which includes a plurality of heating elements 13 which can be controlled individually. This creates a print image with variable information

manufacturable.

A color film 11, in particular designed as a color ribbon, with the carrier 11a and the color layer 11b is moved relative to the thermal print head 12 and heated in areas via the individually controllable heating elements. As a result, the printing ink of the ink layer 11b liquefies and becomes the first

Transferring printing ink 11b onto film 3. A print image can thus be applied in a digitally controlled manner

in particular includes pixels which are formed from the color of the color layer 11b. FIG. 3 is a schematic illustration of the second printer 20, which is designed as a hot stamping printer. The

Hot stamping printer 20 comprises a heatable carrier 23 to which a cliché 22 is attached, which comprises a print relief 24. The cliché 22 is pressed onto the ink film 21, which comprises the carrier 21a and the ink layer 21b.

In the area of the protruding print relief 24, the color of the color layer 21b is heated and, under pressure and temperature, is transferred from the color film 21 to the film 3 as the second printing color 21b.

FIG. 4 is an illustration of a first exemplary embodiment of a medical packaging 2, which is designed as a film bag 30. The medical packaging 2 or the

Foil bag 30 consists of one another to the

Transverse welds 32 and the longitudinal welds 31

welded foils 3. The foil bag 30 further comprises connectors 33a, 33b, via which liquid can be removed and / or added. In this exemplary embodiment, the connectors 33a, 33b are in a transverse weld 32

welded in and include a snap-off cap. After removing the snap-off cap, a fluid connection,

for example, by inserting a spike or a needle. The film bag 30 further comprises a hanger 34.

In the example shown, the film bag 30 is placed in a secondary packaging 7. The secondary packaging 7 is designed here as a tear-open bag and serves in particular as a barrier against oxygen. During production, the film bag 30 filled with the medical liquid is autoclaved in the secondary packaging 7, so that the contents of the secondary packaging 7, in particular the entire film bag 30, is sterile. The foil bag 30 is printed. The print image comprises an area 35 with variable information. The variable

Information can in particular include a serialization number, a batch number and / or an expiration date.

The print image further comprises an area with a

static information 36. The area with static

In this exemplary embodiment, information 36 comprises a printed image 36 that can be read visually by humans, that is to say, for example, inscription with ingredients and / or product name. The area can furthermore include machine-readable information, for example in the form of a barcode (not shown). This can be used, for example, to provide machine-readable information about the content of the medical packaging 2. In particular, it can be an inversely applied barcode.

The print areas shown in black in FIG. 4, both of the print image with variable information 35 and of the

Printing areas with static information 36 are, after the area 35 with variable information has been previously printed by the first printer 10, with the second printer 20

applied, the plate 22 shown in Fig. 5 being used. The first printer 10 prints the first

Printer ink 11b. The second printer 20 prints the second ink 21b.

The cliché 22 comprises a print relief 24, which comprises the flat section 24a, within which the second printing ink 21b to fill in the blanks 44 of the print image 40 (see FIGS. 6.a and 11.a) of the first printer 10, which is through the first Printing ink 11b is provided, is used. In the further non-planar section 24b, the printed relief 24 comprises information that can be read by a person and / or by a machine. In this exemplary embodiment, the information includes a label. Via the non-planar section 24b of the pressure relief 24, the one shown in FIG. 4

The visually readable information 36 shown is transferred onto the film 3.

The steps relating to the printing of the area 35 with variable information are shown in FIGS. 6a to 6c.

First, as shown in FIG. 6a, a print image 40 is applied by means of the first printer 10, which is designed as a thermal transfer printer. In this exemplary embodiment, the print image 40 is a print image, preferably applied with black printing ink, which contains a barcode 41, a data matrix code 42 and an inscription 43 which, for example, contains an expiration date or a

Contains serialization number. The print image 40 is a positive print image here. In between there are spaces 44 which are defined as non-printed areas. The print image 40 is here a positive print image is therefore formed by the first printing ink 11b of the color film 11 of the first printer 10.

Subsequently, as shown in FIG. 6b, the film 3 is made by means of the second, designed as a hot stamping printer

Printer 20, in particular with a white printing ink 21b, printed. The flat section 24a of the

Printing relief 24 with the second printing ink 21b, the print image 40 of the first printer 10, which has transferred the first printing ink 11b.

The spaces 44 of the print image 40 are with the second

Filled in ink 21b. As then shown in Fig. 6c is, the print image 50 generated by the two printers 10, 20 now contains the print image 40 and the printed blanks 44 which are filled with the second printing ink 21b in hot stamping.

The print image generated by both printers can therefore

in particular comprise a white area within which the print image 40 of the first printer 10 from the first printing ink 11b is arranged. The print image 40, which is black here, is embedded in the color section 21b, which is white here.

At the same time, a further area 36 (see FIG. 4) is printed with static information in one step.

In the first print area 35, which is a combination of thermal transfer and hot stamping printing, a black and white print has been created, which consists of a positive print image of the first printer 10 with black color of the first print color 11b, the spaces 44 of which are different from the second, white one Ink 21b are filled.

The first print area 35 is designed to be smaller than the entire area of the print area of the second printer 20 and comprises both variable machine-readable information and variable, visually readable information. The first pressure area 35 can also contain static information, in particular additionally.

In Fig. 7 the method steps according to a

Shown embodiment of the invention.

First, a print image 40, which contains at least variable information, is applied to a film 3 by means of a

Thermal transfer printer 10 printed. The print image 40 of the first printer 10 is made with the first printer color 11b generated. The print image 40 can be a positive print image or a negative print image.

A cliché 22 is then pressed onto the film 3 by means of a hot stamping printer 20. A flat section 24a of the print relief 24 of the cliché 22 overlaps with the print image 40 of the first printer. The spaces 44 or the empty area of the print image 40 of the first printer are filled with the second printing ink 21b of the hot stamping printer 20.

The film 3 is then welded to form a film bag 30, and the film bag 30 is filled and sealed. The closed film bag 30 is then preferably additionally wrapped in secondary packaging 7 and the medical packaging 2 produced in this way is then autoclaved.

Fig. 8 shows a further embodiment of the invention. In contrast to the embodiment according to FIG. 4, in this exemplary embodiment the foil bag 30 comprises

formed medical packaging 2 in the second printing area 36 not only a visually readable label, but also a machine-readable barcode 37.

The barcode 37, like the inscription, is applied by means of the second printer 20, that is to say via a cliché 22. Accordingly, the bar code consists of the second color 21b, which is preferably a white color. The barcode 37 is designed here as an inverse barcode 37, in which the actual barcode consists of unprinted spaces, e.g. appear dark to a scanner. In this embodiment, the positive image is formed by the unprinted spaces. Since the barcode 37 cannot be changed, it can in particular be a

include machine-readable information about the contents of the foil pouch 30. The first print area 35, on the other hand, as explained in connection with FIG. 4, comprises a black-and-white print in which machine-readable codes, in particular variable codes, are not executed inversely, but in which the black print forms the contrast to the surrounding white.

9 is an illustration of a third exemplary embodiment of a medical packaging 2, which is designed as a film bag 30. The print image comprises an area 35 with variable information. The variable information can in particular include a serialization number, a batch number and / or an expiration date. This also includes

Print image an area with static information 36. In this exemplary embodiment, the area with static information 36 includes, on the one hand, a human visual

readable print image 36a, that is, for example, inscription with ingredients and / or the product name. On the other hand, the area includes machine-readable information, for example in the form of a barcode 36b. This can

for example, the machine-readable information about the contents of the medical packaging 2 are used.

The print areas shown in black in FIG. 9, both the

Print image with variable information 35 as well as des

Print area with static information 36, after the area 35 with variable information before from the first

Printer 10 was printed with the second printer 20

applied using the plate 22 shown in FIG. 10. The first printer 10 prints the first

Printer ink 11b. The second printer 20 prints the second

Printer ink 21b. The cliché 22 comprises a printed relief

24, which comprises the flat section 24a, within which the second printing ink 21b is used to fill in the voids

44 of the print image 40 (see FIGS. 11a-11c) of the first printer 10, which is provided by the first printing ink 11b, is used.

In the further non-planar section 24b, the printed relief 24 comprises information that can be read by a person and / or by a machine. In this exemplary embodiment, the information includes a label and a barcode. The visually readable information 36a shown in FIG. 9 and the barcode 36b are transferred to the film 3 via the non-planar section 24b of the printed relief 24.

FIGS. 11a to 11c show the steps relating to the printing of the area 35 with variable information.

First, as shown in FIG. 11a, a print image 40 is applied by means of the first printer 10, which is designed here as a thermal transfer printer. The print image 40 is a negative print image which contains spaces 44. The

Spaces 44 of the print image 40 represent the actual information.

In this exemplary embodiment, the spaces 44 include a barcode 41, a data matrix code 42 and a

Labeling 43 which contains, for example, an expiration date and / or a serialization number.

This negative print image is formed by the first printing ink 11b of the color film 11 of the first printer 10. The first printing ink 11b is, in particular, white

Colour .

The machine-readable information, for example the barcode 41 and / or the data matrix code 42, can be read in via a scanner, since the spaces 44 reflect little or no light and appear dark to a scanner. For the However, the inscription 43 is difficult to read for the human eye.

Subsequently, as shown in FIG. 11b, the film 3 is made by means of the second, designed as a hot stamping printer

Printer 20 printed. The flat section 24a of the print relief 24 with the second printing ink 21b lies within the print image 40 of the first printer 10, which is the first

Has transferred ink 11b.

The spaces 44 of the print image 40 are filled with the second printing ink 21b. As is then shown in FIG. 11c, the print image 50 generated by the two printers 10, 20 now contains the print image 40 and the printed spaces 44 which are filled with the second printing ink 21b by hot stamping. At the same time, a further area 36 (see FIG. 9) with static

Information printed.

In the first print area 35, which is a combination of thermal transfer and hot stamping printing, a black and white print has been created, which consists of a negative print image with a white color of the first printing color 11b

Spaces 44 are filled by the second, black printing ink 21b.

The invention provides a method for producing medical packaging, in particular film bags provided with which both variable and static in a very effective and accurate way

Apply information, especially at the same time.

Reference character list

1 system for manufacturing medical packaging

2 medical packaging

3 slide

4 role

5 station for making the bag along with

Filling station and station for closing

6 control device

7 secondary packaging

10 first printer / thermal transfer printer

11 colored foil

11a carrier

11b color layer / (first) printing color

12 thermal print head

13 heating element

20 second printer / hot stamping printer

21 colored foil

21a carrier

21b color layer / (second) printing color

22 cliché

23 carriers

24 pressure relief

24a flat section

24b non-planar section

30 foil bags

31 longitudinal weld seam

32 cross weld

33a connector

33b connector

34 trailer

35 first print area / area with variable print image

36 second print area / area with static print image

36a visually readable print image

36b machine-readable information / barcode 37 barcode

40 print image (thermal transfer printer) Positive print image / negative print image

41 barcode

42 data matrix code

43 Labeling

44 Space / empty area

Claims

Expectations :

1. Plant (1) for producing medical packaging

(2), comprehensive

a first printer (10) which comprises a digitally controlled thermal printhead (12) with a plurality of heating elements (13), which via a

Control device (6) can be controlled and by means of which a variable print image (35, 40) can be generated on a surface of the medical packaging (2),

and a downstream second printer (20) which is designed as a hot stamping printer (20) which comprises a cliché (22) which comprises a printing relief (24) with a flat section (24a), the flat section (24a) having such dimensions and

is arranged so that it overlaps at least in sections with the print image (35, 40) generated by the first printer (10).

2. Plant (1) according to the preceding claim, characterized

characterized in that the first printer (10) and the second printer (20) are arranged one behind the other, so that a ribbon of film along the printer (10, 20)

can be transported.

3. Plant (1) according to one of the preceding claims, characterized in that in the second printer (20) the flat section (24a) of the printing relief (24) is dimensioned and arranged in such a way that it corresponds to the first printer (10) generated print image (35, 40) or it lies within the print image (40) generated with the first printer (10).

4. Plant (1) according to one of the preceding claims, characterized in that the printing relief (24) of the cliché (22) comprises at least one further section (24b), the further section (24b) containing a structure with static information and such

is dimensioned and arranged that it lies outside the print image (40) generated with the first printer (10), in particular wherein the further section (24b) of the print relief (24) has at least one structure selected from a group consisting of letters , Number, symbol, picture, barcode (41) and data matrix code (42).

5. Plant (1) according to one of the preceding claims, further comprising a filling station for filling the

medical packaging with a medical

Liquid and a device for closing the filled medical packaging (2) and in particular an autoclave station.

6. Use of a system (1) according to one of the preceding claims for producing medical packaging

(2) made of plastic, in particular a foil bag (30).

7. Method of manufacturing medical packaging

(2) made of plastic, comprising printing a film

(3), especially for a foil bag (30),

preferably designed with a system (1) according to one of the preceding claims,

wherein a first printer (10) is used to apply a print image (40) to a surface of the film (3), in particular the medical packaging (2), in digital printing, and

then using a second printer (20) Cliché (22) with a print relief (24) prints a color film (21) at least in sections over the area of the print image (40) and thereby at least one space (44) of the print image (40) of the first printer (10) with a printing ink (21b) the color film (21) is printed.

8. The method according to the preceding claim, characterized

characterized in that the print image (40) is a

Includes positive print image and / or a negative print image.

9. The method according to any one of the preceding claims, characterized in that the negative print image (40) is applied to the surface of the film (3) with the first printer (10), at least one through voids (44) in the negative print image (40) Section of the

Print image (35) is defined, and then in the second printer (20) the cliché (22) with the

At least the color film (21) is printed in relief (24)

is pressed flat in sections onto the negative print image (40) and the spaces (44) of the negative print image (40) are printed with the printing ink (21b) of the color film (21).

10. The method according to any one of the preceding claims, characterized in that the first printer (10) for

Applying the print image (40) with a digital

controlled thermal printhead (12) is provided with a plurality of heating elements (13).

11. The method according to the preceding claim, characterized

characterized in that the print image (40) of the first

Printer (10) is generated by printing a first printing color (11b).

12. The method according to the preceding claim, characterized in that the first printing ink (11b) comprises white or black color pigments and is transferred by an ink ribbon (11).

13. The method according to any one of the preceding claims, characterized in that in the print image (40) of the first printer a surface of the medical packaging (2) with the first printer (10) to above 130 ° C, preferably above 140 ° C, and / or is heated below 200 ° C, preferably below 190 ° C.

14. The method according to any one of the preceding claims, characterized in that outside of the print image (40) applied with the first printer (10), a surface of the medical packaging (2), in particular the film (3), with the printing ink (21b) of the imprinted color film (21) is printed with at least one piece of information.

15. The method according to any one of the preceding claims, characterized in that the printing ink (21b) of

imprinted color film (21) by means of a

Hot stamping process is applied.

16. The method according to the preceding claim, characterized

characterized in that the cliché (22) used in the hot stamping printing process comprises a flat section (24a) which is printed onto the

applied print image (40) is pressed, and wherein the cliché (22) comprises at least one further section (24b) over which outside of the print image (40) applied with the first printer (10) a

static information is printed.

17. The method according to any one of the preceding claims, characterized in that variable information is applied at least with the first printer (10),

especially a serialization number, a

Batch number and / or an expiration date.

18. The method according to any one of the preceding claims, characterized in that the second printer (20) provides static information, in particular a product name, a bar code and / or a data matrix code, in particular an inverse bar code and / or a data matrix Code is applied.

19. The method according to any one of the preceding claims, characterized in that a print is applied by the second printer (20) which contains both machine-readable information (36b) and information (36a) available as text and / or numbers.

20. The method according to any one of the preceding claims, characterized in that in the printing ink (21b)

The imprinted color film contains white and black color pigments and a resin.

21. The method according to any one of the preceding claims, characterized in that a film (3) is printed from which the medical packaging is made.

22. Medical packaging (2) made with a

Method and / or by means of a system according to one of the preceding claims.

23. Medical packaging (2) made of plastic according to

preceding claim comprising a first

Print area (35) with a thermal transfer print applied print image (40), at least one

Blank (44) in the print image (40) through which

at least one section of a print image is defined, is filled with a printing ink (21b) applied in the hot stamping process.

24. Medical packaging (2) made of plastic according to one of the two preceding claims, characterized

characterized in that the print image (40) is a

Includes positive print image and / or a negative print image.

25. Medical packaging (2) made of plastic according to one of the three preceding claims, characterized in that the printed image (40) applied in thermal transfer printing is provided by a first printing ink (11b), the first printing ink (11b) and the im

Hot stamping process as a second printing color (21b)

directly adjoin the applied printing ink.

26. Medical packaging (1) according to one of the preceding claims, characterized in that by the

Printing ink (21b) which fills the at least one blank space (44) of the print image (40), variable and / or static information is provided.

27. Medical packaging (2) according to one of the preceding claims, comprising a second printing area (36), the second with the hot stamping process applied

Printing ink (21b) is printed, the second

The printing area (36) is arranged separately from the first printing area (50) on the packaging (2) and static information is applied in the second printing area (36).

28. Medical packaging according to one of the preceding

Claims, characterized in that the medical packaging is designed as a bag (30) and / or that the medical packaging (2) in a

Secondary packaging (7), in particular designed as a tear-open bag, is arranged.