Systems and methods for making laser marked elastomeric parts

Abstract

The present invention provides a system for manufacturing an elastomeric component. The system may include a molding station having a mold configured to receive an elastomeric material, form a pad including a plurality of untrimmed elastomeric components, and cure the pad. The system may also include an automatic marking station including a laser and a camera. The automatic marking station may be configured to remove the cured pad from the molding station, present the cured pad to the laser to form a mark on each of the untrimmed elastomeric components, and present the cured pad to the camera to capture an image of each mark. A method for manufacturing the elastomeric component is also provided.

Description

Field of the Invention

[0001] Embodiments described herein relate to medical device components, and in particular to elastomeric components, such as plugs or plungers, seals, etc., that are laser marked with data or other identifying information, and methods and systems for marking such components, particularly during multiple manufacturing steps. Background Art

[0002] Previous attempts to serialize or label medical device components have used radio frequency (RF) tags, labels, mold cavity markings, or surface printing. RF tags can be expensive, rigid, and difficult to apply on a large scale. Tags require adhesion, so there can be a risk of leachable materials into the drug, and can also be difficult to apply. Mold cavity markings are not unique, can wear over time, and can only provide limited information. Surface printing can also produce leachable materials, and surface morphology differences can affect sealing or processability. Summary of the invention

[0003] In one aspect, the present invention relates to a method for manufacturing a medical device component. The method may include forming a body of the medical device component, the body having a surface and being at least partially formed of a markable material having a first color, applying a film to at least a portion of the surface of the body, including at least a portion of the markable material; and after forming the film, exposing one or more regions of at least a portion of the markable material to laser radiation having a predetermined wavelength to form a visible mark on the surface of the body by changing the one or more regions to a second color different from the first color.

[0004] In another aspect, the invention relates to a medical device component, the medical device component comprising a body having a first surface, the first surface being at least partially formed of a markable material having a first color, the markable material having a property that an area exposed to laser radiation of ultraviolet light of a predetermined wavelength changes to a second color different from the first color; a film covering at least a portion of the first surface of the body, the film having a transmittance of at least 5% under ultraviolet light of the predetermined wavelength; and a visible mark on the markable material at the first surface of the body covered by the film. The visible mark includes one or more areas of the markable material having a second color at the first surface.

[0005] In yet another aspect, the present invention relates to a method for manufacturing a medical device component. The method may include forming a body of the medical device component during a molding process, the body having a surface and being formed at least in part of a markable material having a first color. The method may also include forming a film on at least a portion of the surface of the body, including at least a portion of the markable material. In another step, the method may include forming a first visual mark on the surface of the body covered by the film by exposing one or more first regions of at least a portion of the markable material to laser radiation having a predetermined wavelength to change the one or more first regions to a second color different from the first color, the first visual mark containing or linked to first data associated with the molding and / or film forming step. In yet another step, the method may include washing the medical device component from the mold, and forming a second visual mark on the surface of the body covered by the film by exposing one or more second regions of at least a portion of the markable material to laser radiation having a predetermined wavelength to change the one or more second regions to a second color, the second visual mark containing or linked to second data associated with the washing step.

[0006] In yet another aspect, the present invention relates to a system for manufacturing an elastomeric component. The system may include a molding station including a mold configured to receive an elastomeric material, form a pad including a plurality of untrimmed elastomeric components, and cure the pad. The system may also include an automatic marking station including a laser and a camera. The automatic marking station may be configured to remove the cured pad from the molding station, present the cured pad to the laser to form a mark on each of the untrimmed elastomeric components, and present the cured pad to the camera to capture an image of each mark.

[0007] In yet another aspect, the present invention relates to a method for manufacturing an elastomeric component. The method may include: providing an elastomeric material to a mold; molding a mat including the elastomeric material, the mat including a plurality of untrimmed elastomeric components; curing the mat; exposing a portion of a surface of each of the untrimmed elastomeric components with a laser to form a mark; and capturing an image of each of the marks.

[0008] These and other aspects of the invention will be apparent in view of the following description. BRIEF DESCRIPTION OF THE DRAWINGS

[0009] The above summary of the invention and the following detailed description will be better understood when read in conjunction with the accompanying drawings. For the purpose of illustrating the present invention, presently preferred embodiments are shown in the accompanying drawings. However, it should be understood that the present invention is not limited to the precise arrangements and tools shown. In the accompanying drawings:

[0010] Figure 1is a front perspective view of a stopper including laser-generated visual indicia thereon in accordance with an embodiment of the present invention;

[0011] Figure 2 is a schematic cross-sectional elevational view of a stopper including laser-generated visual indicia thereon according to another embodiment of the present invention;

[0012] Figure 3 is a top perspective view of a stopper according to yet another embodiment of the present invention, the stopper including laser-generated visible markings formed thereon using a method according to an embodiment of the present invention;

[0013] Figure 4A yes Figure 3 an enlarged plan view of a portion of a laser-generated visible mark on a stopper with the focus being at the top of the cover film surface;

[0014] Figure 4B yes Figure 3 an enlarged plan view of a portion of a laser-generated visible mark on a stopper with the focus being on the surface of the stopper material located beneath the cover film;

[0015] Figure 5 is a schematic flow chart of an exemplary method of manufacturing a stopper according to another embodiment of the present invention;

[0016] Figure 6 is a schematic flow chart of an exemplary method of manufacturing and continuously marking a stopper according to yet another embodiment of the present invention;

[0017] Figure 7 is an enlarged partial top plan view of a plug including a plurality of laser generated visible markings thereon according to various embodiments of the present invention;

[0018] Fig. 8A and Figure 8B is a top perspective view of a plunger rod having surface markings according to another embodiment of the present invention;

[0019] Fig.9A is an enlarged top plan view of a plastic cover having a seal with surface markings according to another embodiment of the present invention;

[0020] Fig. 9B is an enlarged side view of an aluminum seal having surface markings according to another embodiment of the present invention;

[0021] Fig. 10A is a top perspective view of an elastomeric plug having surface indicia assembled in a closure having a transparent cover according to another embodiment of the present invention;

[0022] Fig. 10B yes Fig. 10A an enlarged view of one of the surface markings in the component;

[0023] Fig.11 is a top perspective view of various elastomeric plungers having surface markings according to yet another embodiment of the present invention;

[0024] Fig. 12A is a top plan view of a molded panel including a plurality of molded plugs; and

[0025] Fig. 12B According to another embodiment of the present invention, Fig. 12A An enlarged view of the top surface of the molded plug.

[0026] Fig.13 is a schematic plan view of a system for manufacturing a plurality of elastomeric parts having surface markings according to another embodiment of the present invention. DETAILED DESCRIPTION

[0027] Certain terms are used in the following description for convenience only and are not intended to be limiting. The words "lower," "bottom," "upper," "top," "front," "rear," and "back" indicate directions in the figures to which reference is made. According to the present disclosure, the words "inwardly" and "outwardly" refer to directions toward and away from the geometric center of the component in question and designated parts thereof, respectively. Unless specifically set forth herein, the terms "a," "an," and "the" are not limited to one element, but are understood to mean "at least one." For clarity or readability, "at least one" may sometimes be used, but such use does not change the interpretation of "a," "an," and "the." The terms include the above words, their derivatives, and words of similar meaning.

[0028] It should also be understood that when referring to dimensions or characteristics of components of the present invention, the terms "about," "approximately," "substantially," and similar terms used herein indicate that the dimensions / characteristics are not strict boundaries or parameters and do not exclude minor variations thereof that are functionally similar. At a minimum, such references including numerical parameters will include variations that will not change the least significant digit using mathematical and industrial principles recognized in the art (e.g., rounding, measurement or other systematic errors, manufacturing tolerances, etc.).

[0029] In certain aspects, through the use of an ultraviolet (UV) laser, drug-contacting elastomeric parts can be marked / serialized to produce a safe, clean and sterilization compatible product. Precise markings can be applied to molded or finished products even after an optional film has been applied. The technology (especially where the marking is produced below the film) poses very little risk to the drug product because any extractables that may be produced are not present on the surface of the part. In addition, the technology may be preferred for parts used in low temperature applications because, unlike labels using adhesives, exposure to large temperature differentials is unlikely to have a substantial effect on the marking. The technology is broadly applicable to elastomeric parts utilizing inorganic fillers and can be extended to other polymer parts, especially those that can be covered in a compatible film or other transparent layer.

[0030] refer to Figures 1 to 3 , shows an example of a medical device component (such as a plug 10) according to various preferred embodiments. The plug 10 includes a body 12, which is preferably at least partially formed of an elastomeric material having a first color, such as a synthetic or natural rubber, such as butyl rubber, isoprene rubber, butadiene rubber, halogenated butyl rubber (e.g., brominated butyl rubber), ethylene propylene terpolymer, silicone rubber, ethylene propylene diene monomer (EPDM) rubber, combinations thereof, etc., and the elastomeric material preferably contains an inorganic filler material, such as titanium dioxide, etc. In other embodiments, the body 12 may be at least partially made of a polymer having a large amount of carbon black, resulting in a darker first color of the body 12 material. Such materials are markable, which will be further explained below. The body 12 preferably has a longitudinal axis L and a first surface 12a, which is oriented transversely to the longitudinal axis L, and more preferably, is oriented substantially perpendicular to the longitudinal axis L. In some embodiments, the first surface 12a can be in contact with the drug. The body 12 includes an additional surface that may be connected to or adjacent to the first surface 12a, may extend parallel to the longitudinal axis L or be concentric with the longitudinal axis L, etc. For example, the body 12 may have a cylindrical shape, such as Figure 1 The shape shown in , has one or more ribs formed concentrically about the longitudinal axis L for sealing the stopper 10 within a container or the like, such as a syringe (not shown).

[0031] At least a portion of the surface of the body 12, and in certain embodiments preferably at least a portion of the first surface 12a, may be formed by the film 14 ( Figure 2 , Figure 4A) is covered with a film that acts as a barrier material between the elastomeric material of the body 12 and any drug (not shown) that the body 12 may contact. Common films 14 for such uses may include, but are not limited to, materials including tetrafluoroethylene, ethylene tetrafluoroethylene (ETFE), polytetrafluoroethylene (PTFE), perfluoroalkoxyalkane (PFA), polyvinylidene fluoride (PVDF), fluorinated ethylene propylene (FEP), polyvinylidene fluoride (PVF), polychlorotrifluoroethylene (PCTFE), ethylene chlorotrifluoroethylene (ECTFE), perfluoroelastomer (FFPM), fluoroelastomer polymer (FPM), polyethylene (PE), cyclic olefin polymer (COP), cyclic olefin copolymer (CQC), polypropylene (PP), combinations thereof, and the like.

[0032] like Figures 1 to 4B and Figure 7 As shown, the plug 10 preferably includes a visual mark 16 formed on a surface of the body 12. Preferably, the visual mark 16 is formed on a surface of the body 12 that is highly visible at least during the manufacturing process of the plug, such as the first surface 12a, and is also visible during use of the final medical device (not shown). The visual mark 16 can be at least one of machine-readable or human-readable. Figure 3 , Figure 4A and Figure 4B The visual indicia 16 shown in FIG. 1 is a Data Matrix ECC 200 code, primarily due to the high data density and error correction features of the code. However, other machine readable codes may be used, such as other Data Matrix codes, other two-dimensional bar codes (e.g., QR codes, etc.), one-dimensional or stacked bar codes, etc. For codes such as Figure 7 The human-readable visual indicia 16 is shown, and may use alphanumeric characters, logos, instructional images or messages, etc. The visual indicia 16 may encode or provide data related to, for example, a unique product or part identifier, manufacturing data, tracking information, expiration data, instructions for use, etc. Being human-readable, readable by a smart phone or the like, or with a dedicated visual system, the plug 10 may be tracked by the manufacturer and its customers, caregivers, and / or patients.

[0033] The visual marking 16 is preferably formed on the surface of the body 12 using UV laser radiation, so that one or more areas of the markable material in the body 12 that are exposed to the laser radiation become a second color different from the first color. The laser radiation is absorbed, for example, by inorganic filler materials in the body 12, which subsequently degrade to produce dark areas. In other embodiments (such as those using carbon black), laser absorption can result in brighter areas that exhibit a "bubbled" appearance. Such UV lasers can be purchased from, for example, DPSS Lasers, Inc. in Santa Clara, California. In one embodiment, the visual marking 16 can be formed using a laser (not shown) having a wavelength of 355 nm, which is in the ultraviolet range. Other wavelengths and / or types of lasers, such as CO 2000, may also be used. 2 Laser, etc., depending on the material of the body 12 to be marked. The process is non-contact and generates few, if any, particles.

[0034] As previously described, the laser can be rastered across the surface of the body 12 using a mirror (not shown) to form the visual mark 16. In another approach, an XY carriage can be used to translate the laser over the portion of the surface of the body 12 to which the visual mark 16 is to be applied. In yet another approach, a mask having a plurality of openings can be applied to the surface prior to irradiating the surface of the body 12 with the laser. The openings can be arranged so that when the mask is removed, the desired visual mark 16 remains on the surface of the body 12. Laser parameters, such as power, speed, spot size, etc., can be optimized to achieve the desired effect in the visual mark 16. Additionally, the plug 10 can be stationary during the marking process, or can be in motion during the marking process, such as on a production line.

[0035] As will be appreciated by those skilled in the art, the size of the marks and cells (squares representing a "bit" of code) incorporated into the various embodiments of the present invention are not limited. For example, as the computing power of the device increases with each new generation of technology, the complexity and number of cells within the mark will also increase, and therefore, will be limited only by the ability of the device to successfully read and process the information provided by the mark and the marking resolution capabilities of the laser and material. In some applications, such as anti-counterfeiting applications, it may be preferable to design small (e.g., microscopic) marks with high cell counts. In other applications, such as high-speed production lines, it may be desirable to have larger area marks that are easily detectable for inspection and have an optimal number of cells with lower complexity to minimize processing time.

[0036] As the area of ​​the visual marker 16 increases, the size of each cell may also increase proportionally so that a device (such as a smart phone) can successfully read and process the information provided by the marker 16. The visual marker 16 may also be optimized by reducing the cell size within the visual marker 16 to allow the maximum amount of information to be encoded while still being able to be successfully recognized and processed by a reading device. The preferred minimum cell sizes within the marker of a specified size are provided in Table 1.

[0037] Table 1

[0038] Total marking size (mm) Cell size (μm) 1.0 71 1.4 100 2.1 150 2.8 200

[0039] According to one embodiment of the invention, a system for manufacturing and marking a plurality of elastomeric components with a pre-applied film can be implemented by using a laser that emits light of a wavelength for which the film is transparent. For example, a plurality of components in the form of plugs can be produced in a first step by compression molding a sheet of elastomeric material to produce a panel such as Fig. 12A Reference Fig.13 , a system for manufacturing a panel may include a mixing station 1302 that is configured to blend or compound an elastomeric material and optional additives for forming elastomeric components. The mixing station 1302 may include one or more types of compounding equipment, such as a Banbury mixer, an extruder, and the like. After the elastomeric material has been compounded, it may be delivered to a molding station 1304. According to a preferred embodiment, the molding station 1304 may be in the form of a carousel that includes a plurality of compression molds 1306a, 1306b. When the carousel is in a first position, after the elastomeric material is delivered into the first mold 1306a, when the carousel rotates to a second position, the elastomeric material is compressed and then cured to form a pad comprising a plurality of components, such as Fig. 12A When the first mold 1306a is rotated to the second position, the second mold 1306b is rotated to the first position to receive the elastomeric material from the mixing station 1302, thereby providing a semi-continuous compression molding process. Examples of elastomeric parts that can be molded in the pad include, but are not limited to, bottle stoppers for containers for containing liquids or freeze-dried products and plungers for cartridges, syringes, or carpur bottles. Each pad may include at least 50 parts, more preferably at least 200 parts, and most preferably at least 800 parts. The pad may have a diameter of at least 10 cm, more preferably at least 20 cm, and most preferably at least 30 cm. During or after the compression molding step, a polymer film (such as ETFE) may be applied to one or more surfaces of the stopper.

[0040] After the pad has been cured and the first mold 1306a or the second mold 1306b is in the second position, the mold is opened and the pad is removed from the mold. The pad is preferably removed by an automated marking system having a device for removing the pad from the mold. For example, in one embodiment, the automated marking system may include a robot 1308a including a robotic arm configured to remove the pad from the mold. The automated marking system may also include a marking system 1312 including a laser for applying a mark to the surface of each component within the pad. For example, if the surface of the cured, untrimmed pad is coated with an ETFE film, a laser emitting light at a wavelength of 355 nm may be used to mark the surface of one or more plugs because ETFE is transparent to light of that particular wavelength. Therefore, reference is made to Figure 2 , a laser can be used to form visible markings 16 on the body 12 even after the ETFE film 14 is formed on the body, because radiation can pass through the film 14 without damaging it. The transmittance of the film 14 at the laser wavelength (usually a predetermined wavelength in the UV range) is at least 5%, at least 10%, at least 20%, at least 30%, at least 40%, at least 50%, at least 60%, at least 70%, and at least 80%, preferably increasing in the order listed.

[0041] As previously mentioned, the laser marking is preferably provided in the form of a Data Matrix ECC 200 code. More preferably, the Data Matrix ECC 200 code is in the form of a square with a side length of about 1.4 mm, and the maximum dimension of each cell within the marking is about 0.10 mm, more preferably about 0.08 mm. This will produce a 14×14 Data Matrix ECC 200 code capable of encoding a 16-bit serial number. The 16-bit serial number can be used to provide a unique identifier for each component within the pad as well as source information. For example, in a preferred embodiment, the 16-bit serial number can be presented as follows:

[0042] YYDDDAABBXXXXXXX,

[0043] Where YY is a two-digit number indicating the year the part was manufactured (e.g., "19" for 2019), DDD is a three-digit number indicating the date the part was manufactured (e.g., "001" for January 1 or "365" for December 31), and AA is a number identifying the system used to manufacture the part (e.g., Fig.13 Wherein, BB is a two-digit number identifying the geographic location of the system, and XXXXXXX is a seven-digit number associated with the specific part. Providing this information will enable an end user or manufacturer to pinpoint the time and location associated with the origin of a specific part, which may be critical information in certain circumstances, such as a product recall, as will be described in more detail below.

[0044] refer to Fig. 12B , a mark 17 may be applied to the top surface of the stopper 10, preferably outside of the target area 11. The target area 11, which is bordered by a circle, identifies the area where a syringe needle (not shown) should be inserted in order to extract the contents of a container (not shown) sealed with the stopper 10. The mark 17 is preferably outside of the target area to prevent possible contact between the contents of the container and the portion of the stopper 10 treated with the laser that forms the mark 17.

[0045] After each component on the pad has been laser marked, the robot 1308a can present the untrimmed, laser-marked pad to the inspection station 1314. The inspection station 1314 may include one or more cameras configured to capture images (e.g., photos or videos) of each mark on the pad. For example, in one embodiment, the robot 1308a can move the pad across the field of view of one or more stationary cameras within the inspection station 1314. Alternatively, the robot 1308a can present and hold the pad in a stationary position while the one or more cameras within the inspection station 1314 scan the laser marks. This can be achieved by mounting the one or more cameras on a movable carriage. In another embodiment, the pad and the one or more cameras can move simultaneously to increase the speed of capturing the images of the laser marks. For example, the inspection station 1314 can also be used to scan one or both sides of the pad to identify any defects in the parts.

[0046] The inspection station 1314 may also include a processor configured to identify the location of the mark on the surface of the component and / or read and record each serial number associated with the mark. For example, by identifying the location of the mark on the surface of the component, the inspection station 1314 can confirm that the mark 17 has been applied outside the target area 11 and is readable. If not, the component can be rejected and discarded at a later time in the process. By recording the serial numbers of the components within the untrimmed pad, it is easier to determine whether the source of any defects is associated with the mold. For example, after trimming and separating the components from the pad, the individual elastomeric components can be inspected to identify any physical defects. If a defect is identified, the serial number associated with the component can be recorded. If several defects are identified, the serial numbers can be compared to determine whether the defect occurs in an elastomeric component that can be found in a common position on one or more molded pads in the molded pad before trimming. This can indicate that the root cause of the defect is in one of the compression molds, for example, 1306a or 1306b. Decoding and recording of the serial number associated with each component may be accomplished by the processor after the one or more images are captured and optionally after the mat has been removed from the inspection system 1314 and as the mat continues through the system 1300 .

[0047] After the formation and visual inspection of the mark 17 on each part of the pad, the robot 1308a can place the pad in the cooling system 1310. The cooling system 1310 may include a bracket on which the pad can be placed. The cooling system 1310 may also include other optional features, such as a climate control cabinet, a dehumidifier, or a cooling fan. Once cooled, a second robot 1308b that is the same or similar to the first robot 1308a can remove the pad from the cooling system 1310 and deliver the pad to one or more processes, such as a trimming station 1316 known to those skilled in the art for removing each part from the molded panel by cutting or trimming the excess elastomeric material around each part using a blade or similar tool, a washing station 1318 for cleaning and / or disinfecting these individual parts, and a packaging station 1320 configured to load multiple trimmed and washed parts into packaging (such as bags or boxes). One or more additional inspection stations identical or similar to inspection station 1314 may be added to system 1300 between trim station 1316 and wash station 1318 and / or between wash station 1318 and packing station 1320 to inspect and detect any defects in the parts. As previously described, the serial number of the defective part may be read and recorded before the defective part is discarded.

[0048] As previously mentioned, it is preferred that certain embodiments of the present invention apply the film to a component made of a material that is substantially transparent to the type of laser used to apply the marking to the surface of the component. Figure 4A and Figure 4B ) have demonstrated that the laser produces no visible degradation to the film 14. Various types of lasers can be paired with various polymer films or covers that are substantially transparent to the corresponding wavelengths (e.g., polypropylene or fluorinated ethylene propylene (FEP) covers, etc.) to achieve the same result, namely, forming a visual mark on the surface of the component and beneath a previously applied film or cover. As a result of this effect, the generation of the visual mark 16 can occur at any time after the plug 10 is molded, thereby allowing the inclusion of additional data in the overall manufacturing process while minimally affecting the current manufacturing process. The visual mark 16 has also been shown to withstand steam sterilization temperatures (e.g., up to 121° C.) of various materials.

[0049] For some methods according to various embodiments of the present invention, the marking may be applied to the component after it has been incorporated into an assembly. For example, an elastomeric plug may be incorporated into a transparent cover, such as the DAIKYO SURFACE CAP manufactured by Daikyo Seiko Ltd. RUV closure. When an appropriate transparent material for the cover and a corresponding wavelength of light emitted by the laser are selected so that the light will be substantially transmitted through the cover and membrane, rather than being absorbed by the cover and membrane, a marking can be applied to the surface of the elastomeric stopper after assembly into the transparent cover ( Fig. 10A and Fig. 10B ). Similarly, in another example, the surfaces of various types of elastomeric plungers ( Fig.11 ) can be marked with a laser of an appropriate wavelength before or after the plunger is inserted into a transparent syringe or cartridge barrel. Likewise, a certain wavelength of light should be selected so that the light is not substantially absorbed by the transparent material (e.g., glass, polymer material, etc.) of the cartridge or syringe barrel.

[0050] Figure 5 An exemplary method 100 for manufacturing a medical device component, such as the plug 10, is shown. At step 102, a body 12 may be provided, the body having a surface and being at least partially formed of a markable material, such as a rubber having an inorganic filler material as described above. The body 12 may be molded according to conventional techniques. At step 104, a film 14 (such as the ETFE described above) may then be formed to cover at least a portion of the surface of the body 12, and including at least a portion covering the markable material (e.g., where the body 12 may be formed partially of a markable material and partially of some other material designed for structural support and / or aesthetics).

[0051] At step 106, after forming the film 14, a visual mark 16 may be formed on the surface of the body 12 covered by the film 14 by exposing one or more areas of the markable material to laser radiation having a predetermined wavelength (such as in the UV wavelength range) to change the color of the exposed areas. The exposure may include, for example, rastering the laser radiation across multiple areas on the body 12 to form a spatially extended visual mark 16 (e.g., Figures 1 to 4B ) and / or a plurality of visual indicia 16 (e.g., Figure 7 The visible markings 16a to 16d in FIG.

[0052] In one aspect, it is desirable to be able to incrementally add information throughout the manufacturing process to a medical device component, such as plug 10. This can be accomplished by, for example, adding additional data matrix codes, or by extending an already existing visual marking 16 (ie, adding more symbols or characters).

[0053] Figure 6An example of a portion of a manufacturing process 200 of a plug 10 in this manner is shown. At step 202, the plug 10 is molded in a conventional manner, which preferably includes applying the film 14 in place. At step 204, the plug 10 is laser marked in a first area of ​​the body 12 with a molding process indicator before moving the plug 10 to the next process. The molding process indicator and other similar process indicators may be coded marks (similar to a laser marking machine) containing data (e.g., a timestamp, parameter information related to the molding process, etc.). Figures 1 to 4B The molding process indicator may be a visual mark 16 in the mold) or a unique ID or URL that links to an updateable database in which information related to the completed process step (such as molding) can be identified and described. Alternatively, the molding process indicator may be a graphic symbol (e.g., Figure 7 The visual mark 16a) or other similar mark in the figure.

[0054] At step 206, the plug 10 is trimmed from its mold and at step 208, the plug is laser marked (see, e.g., Figure 7 The stopper 10 is then laser marked with a wash process indicator in a third region of the body 12 (see, for example, FIG. 1 ). Figure 7 At step 214, the stopper 10 may be visually inspected for defects manually or by an inspection machine. At step 216, a visual inspection process indicator is laser-marked onto the stopper 10 in a fourth region of the body 12 (see, e.g., Figure 7 In the case where the visual marking 16 is a machine-readable code added thereto after each relevant process, the various marking areas may be adjacent to each other, or each step may call for its own separate and independent code. Figure 6 Various process steps are shown, and each process step is followed by a laser created process indicator mark, but the illustrated process is not limiting and the steps, the number of laser created process indicators, etc. may be changed without departing from the spirit and scope of the invention.

[0055] The above process is beneficial because it eliminates the need for server queries or operations during the manufacturing process. High-speed filling lines cannot tolerate significant delays, and the visual mark 16 can store limited data without delay in retrieval, so it can be implemented on high-speed lines.

[0056] In certain embodiments, the visual marker 16 can be used for unique serialization. As briefly described above, after each processing step, a database (not shown) can be updated with information related to a unique identifier (e.g., a serial number) associated with the visual marker 16 of each plug 10. For example, once a batch of elastomeric components has been tested for quality parameters such as particles, extractables, and leachables, the laser markings on each component can be scanned and decoded, and the database can be filled with data after each test so that these data are associated with each serial number in the database. When the component is scanned at each step, a timestamp and metadata can be attached to the entry of the specific visual marker 16 in the table. In one embodiment, the visual marker 16 may include a short URL or a unique ID, and each component may point to a manufacturer-controlled website, an API, or a database with a log, where individuals can retrieve data or metadata associated with the component (e.g., batch / lot information, process parameter information, drug safety details, interaction details, management details, recall information, expiration date, etc.). The component can then be tracked by geographic location, time, user, etc. It can also allow drug manufacturers, pharmacies, health care providers, etc. to add information associated with a specific component.

[0057] Through this process, information can be used, for example, to find defective mold cavities, identify where waste is generated in the manufacturing system, provide traceability, assign unique patient IDs for emerging cell therapies, or notify everyone whose patient initiated the treatment. In some cases, database pre-fetching can be done before device manufacturing (e.g., if multiple plugs have been uniquely labeled) to reduce lag.

[0058] This process also serves as an anti-counterfeiting measure. By tracking each component, identification and prevention of reuse of components can be achieved in the case where serialization is copied. It is also desirable to prevent malicious third parties from predicting serial numbers. In order to prevent such activities, the visual mark 16 may contain encrypted information that can only be read by the customer. For example, the visual mark 16 may include a digital signature. As understood by those skilled in the art, the data encoded in the visual mark 16 may be digitally signed. Then, the end user can confirm the authenticity of the message, thereby confirming the authenticity of the component. Various other one-way hashing or password authentication methods (e.g., good privacy (PGP) encryption, etc.) can also be used to verify that the message in the visual mark 16 is actually from the component manufacturer, and these messages are optionally protected. Depending on the application, cryptographic keys can be used differently. In one example, the manufacturer can choose to encrypt the message with its private key so that all authorized users can decrypt and verify the message. In another example, the message of a specific customer can be encrypted with the public key of the customer so that only the specific customer can decrypt the message.

[0059] This process can also be used to serialize components to be tracked together as part of a medical device. For example, each component may have one or more visual markers 16 that can be associated with each other in a database. In this way, the manufacture, sale, shipment and use of the entire device can be tracked, and these can be associated with each component. For example, if the visual marker 16 on the plug 10 is not associated with the visual marker on one of the other device components, early detection of incorrect manufacturing or use of counterfeit components can be detected. Similarly, the recall of a specific component can be easily traced back to the device in which these components are combined. In another embodiment, a single component in these components may include a laser-created visual marker 16, which is then used to link to a database for which all subsequent device information (e.g., manufacturing details, drug information, gene therapy information, patient information, expiration date, serial number) etc. can be stored and tracked. Patient information may include the patient's identity, expected treatment plan, treatment management information (e.g., the frequency and type of medical treatment / device used) and any other patient metadata, so that the visual marker 16 can be used by a system including personalized treatment applications. The personalized therapy application may be available on a system such as an electronic device (eg, a smartphone, tablet, laptop, etc.).

[0060] Similarly, by tying together the visual indicia 16 in a database, an entire shipment of components can be tracked and manufacturing information can be maintained. For example, a bag may contain a plurality of stoppers 10, each having an individual serial number in the form of a laser-generated visual indicia. These serial numbers may be associated with one another in a database. In one exemplary operation, as the bag is sterilized, the data for each stopper 10 in the bag may be updated by scanning a label on the bag that is associated with the serial number of the stopper 10, or by scanning the visual indicia 16 of one of the stoppers 10 and updating the remaining stopper data using a previously established link.

[0061] Although the above embodiments show a single visual marker 16 or describe a series of similar visual markers (e.g., multiple data matrix codes or graphic symbols), multiple visual markers with different characteristics can also be applied to the component. For example, one visual marker 16 can contain relevant manufacturing data, while a second visual marker 16 can be a manufacturer's logo. Other types of visual markers can also be used, such as visual indicators to caregivers, such as the location of needle insertion.

[0062] Although the above embodiments have been discussed with respect to elastomeric medical device components, laser markings according to the present invention may also be used with other medical device components. For example, a laser marking may be applied to one or more surfaces of a plunger rod before or after the plunger rod is inserted into a transparent syringe barrel. Fig. 8A and Figure 8B In another example, the top surface of the plastic cover can be marked or the TiO-containing film formed on the aluminum sidewall can be marked. 2 Aluminum seals with plastic flaps can be marked with pigmented paint or by marking the aluminum itself with clear lacquer ( Fig.9A and Fig. 9B ). Plastic seals and other pigmented plastics, as well as wire seals made from elastomeric sheets, are compatible with the laser marking process. Glass parts can be laser marked, as can glass replacement parts, such as those made with CRYSTAL manufactured by Daikyo Seiko, Ltd of Japan. Materials made using CO 2 Lasers and the like are used to burn and / or ablate materials.

[0063] Although specific and different embodiments have been shown in the drawings, various single elements or combinations of elements from different embodiments may be combined with each other while being consistent with the spirit and scope of the present invention. Therefore, a single feature described herein for only one embodiment should not be interpreted as being incompatible with other embodiments described herein or otherwise included in the present invention.

[0064] It will be appreciated by those skilled in the art that changes may be made to the above embodiments without departing from the broad inventive concept of the present invention. Therefore, it should be understood that the present invention is not limited to the specific embodiments disclosed, but is intended to cover modifications within the spirit and scope of the present invention as defined by the disclosure herein.

Claims

1. A system for manufacturing an elastomeric component, comprising: a molding station including a mold configured to receive an elastomeric material, form a mat including a plurality of untrimmed elastomeric components, and cure the mat; an automated marking station including a laser configured to remove the cured mat from the molding station and present the cured mat to the laser to form a mark on each of the untrimmed elastomeric components; and An inspection station includes a camera to capture an image of each mark, identify any defects in the elastomeric component, and compare the marks on the defective elastomeric component to identify a common location on the cured mat that includes the defective elastomeric component.

2. The system of claim 1, further comprising a mixing station configured to compound the elastomeric material and deliver the elastomeric material to the molding station.

3. The system of claim 1, wherein the molding station comprises a plurality of compression molds.

4. The system of claim 1, wherein the marking is a data matrix code.

5. The system of claim 1, wherein the camera is connected to a processor configured to decode each marker and record a unique identifier associated with each marker.

6. The system of claim 1, further comprising a cooling station configured to receive the cured mat after applying the indicia to each untrimmed elastomeric component.

7. The system of claim 6, further comprising a robot configured to remove the cured mat from the cooling station and deliver the cured mat to at least one of a finishing station, a washing station, or a packaging station.

8. The system of claim 7, further comprising a second camera configured to capture a second image of the marking of at least one of the elastomeric components after being processed by at least one of the finishing station or the washing station.

9. The system of claim 1, wherein the inspection station further comprises a processor configured to determine a location of each marking on the surface of the elastomeric component.

10. The system of claim 9, wherein the processor is configured to determine that the location of the mark on the surface of the elastomeric component is not outside a target area, and the system is configured to reject the elastomeric component based on the location of the mark on the surface of the elastomeric component being not outside the target area.

11. The system of claim 1 , wherein the inspection station further comprises a processor configured to determine whether each marking on the surface of the elastomeric component is readable.

12. The system of claim 11, wherein the processor is configured to determine that the marking on the surface of the elastomeric component cannot be read, and the system is configured to reject the elastomeric component based on the determination that the marking on the surface of the elastomeric component cannot be read.

13. A method for manufacturing an elastomeric component, the method comprising: providing an elastomeric material to the mold; molding a pad comprising said elastomeric material, said pad comprising a plurality of untrimmed elastomeric components; curing the mat; exposing a portion of a surface of each of the untrimmed elastomeric components with a laser to form a mark; capturing an image of each of the markings and identifying any defects in the elastomeric component; as well as The markings on the defective elastomeric components are compared to identify a common location on the cured mat that includes the defective elastomeric component.

14. The method of claim 13, further comprising compounding the elastomeric material prior to providing the elastomeric material to the mold.

15. The method of claim 13, wherein providing the elastomeric material to the mold comprises providing the elastomeric material to a plurality of compression molds.

16. The method of claim 13, wherein the marking is a data matrix code.

17. The method of claim 13, further comprising decoding each tag and recording a unique identifier associated with each tag.

18. The method of claim 13, further comprising cooling the solidified mat.

19. The method of claim 13, further comprising at least one of conditioning, washing, or packaging each of the elastomeric components.

20. The method of claim 19, further comprising capturing a second image of the marking after at least one of the trimming step or the washing step.

21. The method according to claim 13, further comprising determining that the location of the marking on the surface of the elastomeric member is not outside a target area; and The elastomeric member is rejected based on the location of the marking on the surface of the elastomeric member being outside of the target area.

22. The method according to claim 13, further comprising determining that the marking on the surface of the elastomeric member cannot be read; and The elastomeric component is rejected based on the determination that the indicia on the surface of the elastomeric component cannot be read.

23. An elastomeric component manufactured according to the method of claim 13.

Images