JPWO2021122829A5 - - Google Patents

Description

The present invention relates to a medical product having a transparent area and a label.

The EU, through Directive 2011/62/EU, requires measures to identify counterfeit medicines and prevent their entry into the delivery chain. Similar requirements also apply to medical devices under Directive (EU) 2017/745, which requires a Unique Device Identifier (UDI) as label. In this process, the printing of films such as bags is very demanding both from a technical aspect and with regard to possible leachable components (leachables).

It is therefore an object of the present invention to provide a medical product and method that provides good label adhesion, withstands sterilization treatments, and is resistant to disinfectants. Apart from this, there is also the need to comply with stringent pharmaceutical requirements regarding extractables/leachables over the life of the product, etc.

This object is achieved by a medical product according to claim 1 and a method according to claim 10.

Thus, the hot stamped film is placed over the transparent area and, as a result, the thermal transfer film with the label is placed over the hot stamped film , with the label having a different color than the hot stamped film .

In a preferred embodiment, the transparent area is itself a film, such as a bag film. A hot stamping film is applied over it, and finally a heat transfer film is applied to the hot stamped film .

The thermal transfer film consists of a label or at least constitutes a label.

The transparent area is preferably a film.

In a further preferred embodiment, the medical product is a bag for use as part of a dialysis treatment. The bag may be, for example, a bag containing a dialysis concentrate or dialysis fluid or medicine, or a bag for receiving spent dialysis fluid.

The label can be a code, for example a bar code or a matrix code.

Alternatively or additionally, the label can be clear text information, such as the name of the item.

The labelling with code or clear text can be, inter alia, the name of the article, batch information, production or expiry date, or serial number, i.e. the information is either coded or given in clear text. The printing process must therefore be able to print variable data.

To ensure sufficient contrast, the hot stamped film preferably has a lighter color than the heat transfer film.

It is contemplated that the hot stamped film may be partially or entirely white and the thermal transfer film may be partially or entirely black.

To ensure sufficient label life, the heat transfer film can be configured to withstand the sterilization process of medical products. This preferably means that the label can withstand temperature treatments of 124°C or higher.

Further preferred properties of the label are good adhesion to transparent areas of bags, tubes, etc., and/or resistance to disinfectants, and/or lack of extractables/leachables over its useful life.

The medical supplies are preferably bags containing unused or spent dialysis fluid or concentrate for dialysis or medicines in solid or liquid form.

The present invention further provides a method for manufacturing a medical device according to any one of claims 1 to 9, the method comprising first applying a hot stamping film to the transparent area in a hot stamping process and in a further step applying a thermal transfer film to the hot stamped film .

At this point, it is pointed out that the terms "a" and "one", although this indicates a possible embodiment, do not necessarily refer to exactly one of the elements, but may also indicate a plurality of elements. Also, the use of the plural also includes the presence of a singular of that element, and conversely, the singular also includes a plurality of that element.

Further details and advantages are explained in more detail with reference to the embodiments shown in the drawings.

1 shows a hot stamped film positioned on a bag with a label comprised of a heat transfer film disposed thereon.

The bag or transparent film is indicated by reference number 10 in the figure.

A white hot stamped film 20 is placed over the bag material.

The actual label is formed by a heat transfer film 30 placed over the hot stamped film .

The heat transfer film, in this embodiment, comprises or consists of a label that is reproduced as a code 40 and as a clear text label 50.

Serialized labels (data matrix code + clear text information) must be easily readable, therefore have minimum quality requirements (graded according to ISO 15415) and must be able to print variable data (e.g. random serial numbers as code content).

High contrast is required for legibility, so it is preferable to print black code on a white background.

For this purpose, the bag is first given a white background in a hot stamping process, since the film of the bag is transparent. Then the code and clear text information are printed in black using a thermal transfer process. This process allows for the printing of variable data.

The bag is preferably a bag for containing dialysis fluid or a concentrate for dialysis fluid, a bag for receiving spent dialysis fluid, etc.

10 Bags 20 Hot stamped film
30 Heat transfer film 40 Code 50 Clear text label

Claims (7)

1. A medical product having a transparent area and a label, the medical product being a bag, a hot stamped film being positioned over the transparent area, and a heat transfer film having a label being positioned over the hot stamped film , the label having a different color than the hot stamped film , the transparent area being a film, and the heat transfer film being configured to withstand a sterilization process of the medical product . The medical product of claim 1 , wherein the label is or comprises a code. 3. The medical product of claim 1 or 2 , wherein the label is or comprises clear text information. The medical article of claim 1 , wherein the hot stamped film has a lighter color than the heat transfer film and/or the label. The medical product of claim 1 , wherein the label comprises serial information. 6. The medical article of claim 1, wherein the hot stamped film is partially or entirely white and the heat transfer film or label is partially or entirely black. 7. A method for manufacturing a medical article according to any one of claims 1 to 6 , comprising first applying a hot stamping film to a transparent area of the medical article in a hot stamping process, and in a next step applying the thermal transfer film comprising or consisting of the label to the hot stamped film .