Medical supplies having identifiers and methods for applying identifiers on medical supplies
A medical article with a hot stamped film and thermal transfer film combination addresses adherence and sterilization resistance issues, ensuring label integrity and compliance with pharmaceutical standards by providing durable and readable labels.
Patent Information
- Application Number
- JP2022536868
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2019-12-16
- Filing Date
- 2020-12-16
- Publication Date
- 2025-01-14
- Estimated Expiration
- Not applicable · inactive patent
AI Technical Summary
Existing medical products face challenges in ensuring that labels adhere well, withstand sterilization treatments, and are resistant to disinfectants while meeting pharmaceutical requirements regarding extractables/leachables over their lifetime.
A medical article with a transparent area featuring a hot stamped film and a thermal transfer film, where the hot stamped film is applied first and has a lighter color, followed by the thermal transfer film, which forms a label, ensuring good adhesion and resistance to disinfectants, and is capable of withstanding sterilization processes.
The solution provides labels that maintain adhesion and resistance to disinfectants, withstand sterilization, and comply with pharmaceutical requirements by ensuring the label's integrity over its lifetime, with the ability to print variable data and maintain high contrast for readability.
Smart Images
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Abstract
Description
[Technical field]
[0001] The present invention relates to medical articles having transparent areas and labels. [Background technology]
[0002] 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). Summary of the Invention [Problem to be solved by the invention]
[0003] It is therefore an object of the present invention to provide a medical article and method that provides good label adhesion, withstands sterilization procedures, and is resistant to disinfectants, apart from the need to comply with stringent pharmaceutical requirements regarding extractables / leachables over the life of the product, etc. [Means for solving the problem]
[0004] This object is achieved by a medical product according to claim 1 and a method according to claim 10.
[0005] Therefore, Hot stamped film is placed on the transparent area, resulting in a thermal transfer film with a label. Hot stamped film Located on top and labeled Hot stamped film has a different color.
[0006] In a preferred embodiment, the transparent area is itself a film, such as a bag film, onto which the hot stamping film is applied, and finally the heat transfer film. Hot stamped film It can be attached to.
[0007] The heat transfer film comprises or at least constitutes the label.
[0008] The transparent area is preferably a film.
[0009] In a further preferred embodiment, the medical product is a bag as used as part of a dialysis treatment. The bag may for example be a bag containing a dialysis concentrate or dialysate or medicine, or a bag for receiving spent dialysate.
[0010] The label may be, for example, a code, such as a bar code or a matrix code.
[0011] Alternatively or additionally, the label may be clear text information such as the name of the item.
[0012] 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.
[0013] To ensure sufficient contrast, Hot stamped film Preferably, the adhesive has a lighter color than the heat transfer film.
[0014] Hot stamped film It is contemplated that the thermal transfer film may be partially or entirely white and the thermal transfer film may be partially or entirely black.
[0015] To ensure sufficient label life, the heat transfer film can be configured to withstand the sterilization process of medical products, which preferably means that the label will withstand temperature treatments of 124° C. or greater.
[0016] Further preferred properties of the label are good adhesion to clear areas of bags, tubes, etc., and / or resistance to disinfectants, and / or lack of extractables / leachables over its useful life.
[0017] The medical supplies are preferably bags containing unused or spent dialysis fluid or concentrate for dialysis or medicines in solid or liquid form.
[0018] The present invention further provides a method for producing 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: Hot stamped film Attach the heat transfer film to the
[0019] 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 an element, 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.
[0020] Further details and advantages are explained in more detail with reference to the embodiments shown in the drawings. [Brief description of the drawings]
[0021] [Figure 1] 1 shows a hot stamped film positioned on a bag with a label comprised of a heat transfer film disposed thereon. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0022] The bag or transparent film is designated by reference numeral 10 in the figures.
[0023] White Hot stamped film 20 is located on this bag material.
[0024] The actual label is Hot stamped filmThe insulating layer 30 is formed by a thermal transfer film 30 positioned thereon.
[0025] The heat transfer film comprises or consists of the label which in this embodiment is reproduced as the code 40 and as the clear text label 50 .
[0026] Serialized labels (data matrix code + clear text information) must be easily readable, therefore have minimum quality requirements (graded according to ISO15415) and must be able to print variable data (e.g. a random serial number as code content).
[0027] For legibility, high contrast is required, which is why it is desirable to print a black code on a white background.
[0028] 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, which allows for the printing of variable data.
[0029] The bag is preferably a bag containing dialysate or a concentrate for dialysate, a bag for receiving spent dialysate, or the like. [Explanation of symbols]
[0030] 10 Bags 20 Hot stamped film 30 Heat transfer film 40 Code 50 Clear Text Labels
Claims
1. 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.
2. The medical product of claim 1 , wherein the label is or comprises a code.
3. 3. The medical product of claim 1 or 2, wherein the label is or comprises clear text information.
4. The medical article of claim 1 , wherein the hot stamped film has a lighter color than the heat transfer film and / or the label.
5. The medical product of claim 1 , wherein the label comprises serial information.
6. 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 product as described in any one of claims 1 to 6, comprising first applying a hot stamping film to a transparent area of the medical product 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.