KR-102964801-B1 - CONTAINER COMPRISING A BODY WITH A MARKING ELEMENT AND A METHOD FOR PRODUCING A CONTAINER

KR102964801B1KR 102964801 B1KR102964801 B1KR 102964801B1KR-102964801-B1

Abstract

The present invention relates to a container for receiving at least one pharmaceutical composition, comprising a main body having at least one marking element, and a method for manufacturing a container, preferably a container according to the present invention.

Inventors

조어 올리퍼
헌칭거 베른하르트
마우러 플로리안
토마스 피터

Assignees

쇼오트 파르마 아게 운트 코. 카게아아

Dates

Publication Date: 20260513
Application Date: 20201104
Priority Date: 20191104

Claims (16)

As a container for accommodating at least one pharmaceutical composition, The above container includes a main body, and The above main body includes at least one marking element at at least one location so as to enable identification of the container, and At the above position, at least one stress parameter of the body has a value less than or equal to at least one threshold; The above threshold is derived from at least one simulation result of at least one simulation based on the finite element method of stress parameters for at least one surface or volume region of the body where a marking element is present or absent, or for at least one surface region and volume region; At least one average value is obtained by simulation of stress parameters for the surface or volume area of the body, or at least a part of the surface area and volume area; The above threshold is a container in which the sum of the average value and the value less than or equal to 1,000% of the absolute value of the average value.
In paragraph 1, A vessel in which the stress parameter is at least one parameter selected from the group consisting of a first principal stress, mechanically induced tensile stress, mechanically induced compressive stress, thermally generated stress, and chemically generated stress.
In paragraph 2, The mechanically induced tensile stress is the mechanically induced tensile stress during use; If the mechanically induced compressive stress is a mechanically induced compressive stress during use; The thermally generated stress is tensile stress, or compressive stress, or tensile stress and compressive stress; A container in which the chemically generated stress is tensile stress, or compressive stress, or both tensile and compressive stress.
In any one of paragraphs 1 through 3, A container in which, at the above location, the stress parameter of the body has a value less than or equal to the threshold under at least one state condition.
In paragraph 4, the condition of the state Ambient pressure of the main body 1 bar; or At least one force acting radially, or axially, or both radially and axially on at least one part of the main body A container that includes
In any one of paragraphs 1 through 3, A vessel in which each of two or more stress parameters of the body has a value less than or equal to each of two or more thresholds.
In any one of paragraphs 1 to 3, the main body Designed at least partially as a hollow body or as a tubular body; Having at least one closed end, having two open ends, or having at least one opening; A container having at least one inner surface that contacts or may come into contact with the pharmaceutical composition when the pharmaceutical composition is contained in the container, or at least one outer surface that does not contact the composition when the pharmaceutical composition is contained in the container, wherein the position of the marking element extends across at least one area of the inner or outer surface.
In any one of paragraphs 1 through 3, A container in which a marking element is engraved into at least one surface of a main body, wherein the marking element is located on the bottom portion (13) of the main body, or the marking element comprises at least one one-dimensional data code, at least one two-dimensional data code, at least one three-dimensional data code, or a combination thereof.
In paragraph 8, A container in which the data code comprises a plurality of dot-shaped elements or line-shaped elements, or a plurality of dot-shaped elements and line-shaped elements.
In any one of paragraphs 1 through 3, The above marking element is manufactured by one or more of at least one laser ablation technique, at least one etching technique, at least one lithography technique, at least one sandblasting technique, at least one surface modification technique without ablation of the material by at least one laser, and at least one subsequent treatment by plasma; A container in which the above marking element can be read by at least one camera or light, or at least one camera and light.
In any one of paragraphs 1 to 3, the container Glass, or at least one polymer material, or comprising glass and at least one polymer material; A container designed at least partially in the form of a syringe, a cartridge, a vial (1a, 1b, 7), or other pharmaceutical containers.
In any one of paragraphs 1 through 3, A container in which the main body is treated by a tempering procedure at least partially at the location of the marking element at a temperature of 300°C to 400°C or for a duration of 10 to 25 minutes.
A method for manufacturing a container for accommodating at least one pharmaceutical composition according to any one of claims 1 to 3, Step (101) of providing at least one main body; A step of identifying at least one location of the above-mentioned body, wherein at said location the body has at least one stress parameter having a value less than or equal to at least one threshold; The above threshold is derived from at least one simulation result of at least one simulation based on the finite element method of stress parameters for at least one surface or volume region of the body where a marking element is present or absent, or for at least one surface region and volume region; At least one average value is obtained by simulation of stress parameters for the surface or volume area of the body, or at least a part of the surface area and volume area; Step (103) in which the threshold is the sum of the average value and the value that is less than or equal to 1,000% of the absolute value of the average value; and Step (105) of providing at least one marking element that enables the container to be identified at a confirmed location A manufacturing method comprising
In Clause 13, the step of verifying the position of the above-mentioned main body A step of evaluating the simulation results of the main body and identifying at least one region where the value of the stress parameter is below the threshold (103a); and Step (103b) of selecting a location that is at least partially within the area identified above A manufacturing method comprising
In paragraph 13, the step of providing a marking element A manufacturing method comprising the step of ablating or etching a material from at least one surface area of a body at a confirmed location by at least one first laser, at least one etching technique, at least one lithography technique, at least one sandblasting technique, at least one surface modification technique without ablation of the material by at least one laser, and subsequent treatment by at least one plasma, or manipulating at least one volume area of a body at a confirmed location by the first laser, thereby creating a marking element.
In Paragraph 13, Step (107) of processing the above main body at least partially at the location of the marking element at a temperature of 300°C to 400°C or for a duration of 10 to 25 minutes by a tempering procedure A manufacturing method further comprising

Description

Container comprising a body having a marking element and a method for producing a container The present invention relates to a container for receiving at least one pharmaceutical composition, comprising a main body having at least one marking element, and a method for manufacturing a container, preferably a container according to the present invention. In the latest technological fields of the industry, containers for holding pharmaceutical compositions, such as vials, syringes, and cartridges, are widely known. Such containers generally require a means to identify each individual container among others. This can be important not only for the automation of container handling during filling, routing, storage, and dispatching, but also for ensuring quality and safety standards that require significant traceability throughout the life cycle of each container. Such identification means are typically designed in the form of marking elements and used to fulfill the aforementioned requirements. Until now, labels have generally been attached to each container, and a unique identification code, such as a barcode, has been printed on the label. In other applications, the unique identification code has been copied directly onto the container by a printing process using ink. Therefore, both of the above approaches require a printed code. Once an association between the container and the unique identification code is established, the container can be identified by reading each unique identification code. However, applying labels to surfaces or using printers is generally slow and complex, often resulting in bottlenecks on the production line. The size of these printed codes is typically limited by the printing method and cannot be reduced sufficiently to generate the necessary small codes. In particular, for small containers, it is difficult, or even impossible, to provide an area large enough to apply a label. Furthermore, containers generally exhibit complex geometry, which makes it challenging to use labels or printers to provide identification codes on them. Additionally, it has been demonstrated that if the container is exposed to water or other extreme conditions during further processing or use, there is a risk that the container label will peel off or that the code printed directly on the container using ink will vanish. Furthermore, it has been demonstrated that codes provided by the aforementioned known technology have a common problem of fading over time. These drawbacks lead to a situation where containers that can no longer be identified must be disposed of because the label is completely lost or label reading is no longer possible. This is particularly unacceptable in the pharmaceutical sector, where the use of substances of unknown identity is prohibited. However, disposing of containers containing each composition is costly, especially in the aforementioned fields. Furthermore, classifying containers of unclear identity can lead to system downtime or at least require additional resources. In either case, using conventional marking elements as described above can increase service costs. A more serious scenario involves inaccurate identification caused by the vanishing of unique identification codes, followed by the inaccurate assignment of containers. In the worst-case scenario, this could put the patient's health at serious risk. It is also known in the industry to use techniques for engraving information, such as marking elements, directly onto the surface of a container, such as laser ablation. Marking elements provided on a container in such a manner would actually be inexpensive in the production process and would offer additional advantages regarding durability and reliability. However, for glass containers used in the pharmaceutical industry, such as glass vials, axial and lateral compression are common and have been identified as typical loading environments during handling, processing, and transport. This requires that the container be sufficiently robust to withstand such typical loads. Since marking elements engraved on the surface indicate container damage, such marking elements are generally not considered for each application in which the container is subjected to these loads. Accordingly, the object of the present invention is to overcome the disadvantages described above by providing a container having a marking element that is, on the one hand, easy and inexpensive to manufacture, and on the other hand, remains reliable, durable, and completely free from safety issues, and is suitable for a wide variety of containers, particularly in relation to size and geometry. A further object of the present invention is to provide a method for manufacturing a container having the marking element. Various aspects of the present invention will become apparent to those skilled in the art from the following detailed description of preferred embodiments in light of the accompanying drawings. FIG. 1 shows