Systems and methods for manufacturing laser engraved elastomeric parts - Patents.com

Abstract

A system and method for manufacturing and imprinting elastomeric parts during multiple manufacturing steps is provided. The system may include a molding station having a mold configured to receive elastomeric material and form and cure a pad including a plurality of untrimmed elastomeric parts. The system may further include an automated marking station having a laser and a camera configured to remove the cured pad from the molding station, expose the cured pad to the laser to form marks on each untrimmed elastomeric part, and capture an image of each mark by positioning the cured pad within the camera's field of view.

Description

[Technical field]

[0001] DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS The embodiments described herein are directed to medical device components, particularly elastomeric components such as stoppers, plungers, seals, etc., that are laser marked with data or other identifying information, as well as methods and systems for marking such components, particularly during multiple manufacturing steps. [Background technology]

[0002] Previous attempts to serialize or mark medical device components have utilized radio frequency (RF) tags, labels, mold cavity identifiers, or surface printing. RF tags are expensive and hard and can be difficult to use in large quantities. Labels can also be difficult to use as they require adhesion and pose a risk of leaching material into the drug. Mold cavity identifiers are not unique, can wear off over time, and provide only limited information. Surface printing can also leach material and differences in surface morphology can affect sealability or machinability. Summary of the Invention

[0003] One aspect of the invention relates to a method of manufacturing a medical device component, the method may include the steps of: forming a body of the medical device component having a surface, at least a portion of which is formed from an imprintable material of a first color; applying a film to at least a portion of the surface of the body, including at least a portion of the imprintable material; exposing one or more areas of the at least a portion of the imprintable material to irradiation with a laser of a predetermined wavelength to change the at least a portion of the imprintable material to a second color different from the first color, thereby forming a visible mark on the surface of the body.

[0004] Another aspect of the invention relates to a medical device component. The component includes a body including a first surface, a film covering at least a portion of the first surface, and a visible mark. The first surface is at least partially formed of an imprintable material of a first color. The imprintable material has a property that an area exposed to irradiation with an ultraviolet laser of a predetermined wavelength changes to a second color different from the first color. The film exhibits at least 5% transmittance to ultraviolet light of the predetermined wavelength. The visible mark is applied to the imprintable material included in the first surface of the body covered by the film. The visible mark includes one or more areas of the imprintable material of the second color included in the first surface.

[0005] Yet another aspect of the invention relates to a method of manufacturing a medical device part, the method may include the steps of: forming a body of the medical device part with a surface using a mold, at least a portion of which is formed of a first color of markable material. The method may also include the steps of: forming a film on at least a portion of the surface of the body, including at least a portion of the markable material. The method may include one further step of forming a first visible mark on the surface of the body covered with the film by exposing one or more first regions of said at least a portion of the markable material to radiation of a laser of a predetermined wavelength, causing the material to change to a second color different from the first color. The first visible mark may include first data, or a link to said data, relating to the molding step and / or the forming step of the film. The method may include further steps, the steps of: removing the medical device part from the mold and cleaning it. Forming a second visible mark on the surface of the body covered with the film by exposing one or more second regions of said at least a portion of the markable material to radiation of a laser of a predetermined wavelength, causing the material to change to a second color. The second visible indicia may include second data relating to the cleaning step, or a link to that data.

[0006] Yet another aspect of the invention relates to a system for manufacturing elastomeric parts. The system may include a molding station having a mold configured to receive elastomeric material and form and cure a pad including a plurality of untrimmed elastomeric parts. The system may also include an automated marking station having a laser and a camera configured to remove the cured pad from the molding station, expose the cured pad to a laser to form marks on each of the plurality of untrimmed elastomeric parts, and capture an image of each mark by viewing the cured pad with the camera.

[0007] Yet another aspect of the invention relates to a method of manufacturing an elastomeric part, which may include the steps of: placing an elastomeric material in a mold; molding a pad including the elastomeric material to have a plurality of untrimmed elastomeric parts; curing the pad; exposing a portion of a surface of each of the plurality of untrimmed elastomeric parts to laser radiation to form a mark; and capturing an image of each mark.

[0008] These and other aspects of the invention will become apparent from a consideration of the following description. [Brief description of the drawings]

[0009] The foregoing summary, as well as the following detailed description, will be better understood when read in conjunction with the accompanying drawings. For the purpose of illustrating the invention, there are shown in the drawings embodiments which are presently preferred. It being understood, however, that the invention is not limited to the precise arrangements and instrumentalities shown. In the drawings,

[0010] [Figure 1] FIG. 2 is a front perspective view of a plug including a laser-created visible mark thereon, according to one embodiment of the present invention.

[0011] [Diagram 2] 1 is a schematic cross-sectional elevation view of a plug including a laser-created visible mark thereon, in accordance with another embodiment of the present invention.

[0012] [Diagram 3] 13 is a top perspective view of a plug including a laser-created visible mark thereon according to yet another embodiment of the present invention, using a method according to an embodiment of the present invention.

[0013] [Figure 4A] FIG. 4 is an enlarged plan view of a portion of the laser-produced visible mark on the plug of FIG. 3, with the top of the overlying film surface in focus.

[0014] [Figure 4B] FIG. 4 is an enlarged plan view of a portion of the laser-generated visible mark on the plug of FIG. 3, with the surface of the plug material underlying the overlying film in focus.

[0015] [Diagram 5] 4 is a schematic flow chart of an exemplary method for manufacturing a plug in accordance with another embodiment of the present invention.

[0016] [Figure 6] 4 is a schematic flow chart of an exemplary method for manufacturing and sequentially marking a plug, in accordance with yet another embodiment of the present invention.

[0017] [Figure 7] 1 is an enlarged partial top view of a plug including multiple laser-created visible marks thereon, according to various embodiments of the present invention.

[0018] [Figure 8A] FIG. 13 is a top perspective view of a plunger rod having surface marks according to another embodiment of the present invention. [Figure 8B] FIG. 13 is a top perspective view of a plunger rod having surface marks according to another embodiment of the present invention.

[0019] [Figure 9A]FIG. 13 is a top close-up view of a plastic cap of a seal having a surface mark according to another embodiment of the present invention.

[0020] [Figure 9B] FIG. 2 is a side close-up view of an aluminum seal having surface marks according to another embodiment of the present invention.

[0021] [Figure 10A] FIG. 13 is a top perspective view of an elastomeric plug having a surface marking assembled to a closure with a transparent cap according to another embodiment of the present invention.

[0022] [Figure 10B] FIG. 10B is an enlarged view of one of the surface marks in the assembly of FIG. 10A.

[0023] [Figure 11] 11A-11C are top perspective views of various elastomeric plungers having surface marks according to yet another embodiment of the present invention.

[0024] [Figure 12A] FIG. 1 is a top view of a molded panel including a plurality of molded plugs.

[0025] [Figure 12B] FIG. 42B is a close-up view of the top surface of the molded plug of FIG. 42A having surface marks according to yet another embodiment of the present invention.

[0026] [Figure 13] FIG. 2 is a top schematic view of a system for manufacturing a plurality of elastomeric parts having surface marks in accordance with another embodiment of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0027] Certain terminology is used in the following description for convenience and not for limitation. The words "lower", "bottom", "upper", "top", "front", and "rear" refer to directions in the drawings to which reference is made. The words "inward" and "outward" refer to directions toward and away from the geometric center of the part described by this disclosure and its designated portion, respectively. Unless specifically stated in this specification, the terms "a", "an", and "the" are not limited to one element, and instead, "at least one" and "at least one" may occasionally be used for clarity or readability, but such usage is not meant to change the interpretation of "a", "an", and "the". The terms include the above words, derivatives thereof, and words of similar meaning.

[0028] It is also to be understood that the terms "about," "approximately," "generally," "substantially," and the like, when used herein to refer to dimensions or characteristics of the components of the present invention, indicate that the described dimensions / characteristics are not precise boundaries or parameters, but do not exclude slight variations therefrom that are functionally similar. At a minimum, such references involving numerical parameters will include variations that do 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 one embodiment, an ultraviolet (UV) laser can be used to mark / serialize elastomeric parts for drugs, producing a safe, clean, sterilizable product. Detailed marking can be done even if a film is already applied to the molded or finished product. This technique poses little risk to the drug, especially since the mark is formed through the film, since there are no extractable materials on the surface of the part. Additionally, this technique may be suitable for parts that will be used at very low temperatures, since large temperature differences will not affect the mark as much as they would with an adhesive-based label. This technique is broadly applicable to elastomeric parts that utilize inorganic fillers, and can be extended to other polymer parts, especially those that can be covered with a laser-engravable film or other transparent layer.

[0030] 1-3, a stopper 10 is shown as an example of a medical device component according to various preferred embodiments. Stopper 10 includes a body 12. Body 12 is at least partially formed of an elastomeric material, preferably of a first color. The material may be a synthetic or natural rubber, such as butyl rubber, isoprene rubber, butadiene rubber, halogenated butyl rubber (e.g., bromobutyl rubber), ethylene propylene terpolymer, silicone rubber, ethylene propylene diene monomer (EPDM) rubber, or combinations thereof. The material preferably includes an inorganic filler, such as titanium dioxide. In other embodiments, body 12 may be at least partially formed of a polymer that includes a significant amount of carbon black. As a result, the first color of the material of body 12 is darker. Such materials are imprintable, as will be further described below. Preferably, body 12 has a longitudinal axis L and a first surface 12a. First surface 12a is transverse to longitudinal axis L, and more preferably substantially perpendicular. In some embodiments, first surface 12a may contact a medicament. Body 12 also includes other surfaces, which may be connected to or adjacent to first surface 12a and may extend parallel to or be coaxial with longitudinal axis L. For example, body 12 may have a cylindrical shape, such as that shown in FIG. 1, which includes one or more ribs formed coaxially about longitudinal axis L for the purpose of sealing stopper 10 within a container, such as a syringe barrel (not shown).

[0031] At least a portion of the surface of the body 12, and in some embodiments preferably at least a portion of the first surface 12a, may be covered with a film 14 (see Figs. 2, 4A). The film 14 acts as a barrier between the elastomeric material of the body 12 and any agents (not shown) that the body 12 may come into contact with. Typical materials that may be included in the film 14 for such applications include, but are not limited to, tetrafluoroethylene, ethylene tetrafluoroethylene (ETFE), polytetrafluoroethylene (PTFE), perfluoroalkoxyalkanes (PFA), polyvinylidene fluoride (PVDF), fluorinated ethylene propylene (FEP), polyvinylidene fluoride (PVF), polychlorotrifluoroethylene (PCTFE), ethylene chlorotrifluoroethylene (ECTFE), perfluoroelastomers (FFPM), fluoroelastomer polymers (FPM), polyethylene (PE), cyclic olefin polymers (COP), cyclic olefin copolymers (COC), polypropylene (PP), and combinations thereof.

[0032] As shown in Figures 1-4B and 7, the plug 10 preferably includes a visible mark 16. The visible mark 16 is formed on a surface of the body 12. Preferably, that surface, e.g., the first surface 12a, is highly visible at least during the manufacture of the plug and may also be visible during use of the finished medical device (not shown). The visible mark 16 may be machine and / or human readable. The visible mark 16 shown in Figures 3, 4A and 4B is a Data Matrix ECC200 code. This is primarily due to the high data density and error correction capabilities 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), or one-dimensional or stacked bar codes. The human readable visible mark 16, e.g., as shown in Figure 7, may be alphanumeric characters, logos, or instructional images or messages. The visible marking 16 may be encoded with or provided with data relating to, for example, a unique product or part identifier, manufacturing data, tracking information, expiration date data, or instructions for use, etc. Because the visible marking 16 is readable by humans, smartphones, etc., or by dedicated vision systems, the stopper 10 may be traceable by manufacturers and their customers, caregivers, and / or patients.

[0033] The visible mark 16 is preferably created on the surface of the body 12 by irradiating the surface with a UV laser to cause one or more areas of the markable material of the body 12 exposed to the laser radiation to change to a second color different from the first color. The laser light is absorbed, for example, by an inorganic filler in the body 12. The inorganic filler then decomposes, producing darker colored areas. Other embodiments, such as those utilizing carbon black, can produce lighter colored areas that appear to "bubble" due to the absorption of the laser. Such UV lasers are available, for example, from DPSS Lasers, Inc. (Santa Clara, Calif.). In one embodiment, a 355 nm wavelength laser (not shown) (in the ultraviolet range) can be used to create the visible mark 16. Other wavelengths and / or types of lasers, such as CO2 lasers, can also be used depending on the material of the body 12 that is desired to be inscribed. This method is non-contact and generates few, if any, particulates.

[0034] As previously mentioned, the laser may be raster scanned across the surface of the body 12 using mirrors (not shown) to form the visible mark 16. Alternatively, an XY carriage may be used to translate the laser over the portion of the surface of the body 12 where the visible mark 16 is to be applied. Alternatively, the surface of the body 12 may be covered with a mask having a number of holes before the laser is applied. The holes may be positioned such that when the mask is removed, the desired visible mark 16 remains on that surface of the body 12. Parameters such as laser power, speed, spot size, etc. may be optimized to achieve the desired effect on the visible mark 16. Additionally, the plug 10 may be stationary or moving along a production line during imprinting.

[0035] As will be appreciated by those skilled in the art, the dimensions of the marks and cells (squares representing the "bits" of the code) incorporated in the various embodiments of the present invention are not limited. For example, the complexity and number of cells in a mark may increase as the computing power of devices improves with each new generation of technology. The complexity and number of cells are therefore limited only by the ability of the device to successfully read and process the information provided by the mark, and the capabilities of the laser and material that determine the resolution of the inscription. In some applications, such as anti-counterfeiting, a design with a small, e.g., microscopic, mark with a large number of cells may be preferred. In other applications, such as high-speed production lines, it may be desirable to limit the complexity of the mark with a larger area that is easily detectable during inspection, with the number of cells optimized to minimize processing time.

[0036] As the area of ​​the visible mark 16 increases, the size of each cell can be increased proportionately so that a device such as a smart phone can successfully read and process the information provided by the visible mark 16. The visible mark 16 may also be optimized to allow the maximum amount of information to be encoded therein while still being able to be successfully recognized and processed by a reading device through the miniaturization of the cells therein. For particular size marks, preferred minimum sizes for the cells therein are shown in Table 1.

[0037] [Table 1]

[0038] According to one embodiment of the present invention, a system for producing elastomeric parts and imprinting them with a film already applied thereto may be realized by using a laser that emits light of a wavelength that is transparent to the film. For example, in the production of parts in the form of plugs, a first step may be compression molding a sheet of elastomeric material to produce a panel, such as the molded panel of FIG. 12A. Referring to FIG. 13, a system for producing the panel may include a mixing station 1302. The mixing station 1302 is configured to mix with the elastomeric material, i.e., compound the elastomeric material, additives selected according to the needs of the formation of the elastomeric part. The mixing station 1302 may include one or more types of mixing devices, such as a Banbury mixer or an extruder. After the elastomeric material has been compounded, it may be sent to a molding station 1304. According to a preferred embodiment, the molding station 1304 may be in the form of a carousel equipped with a plurality of compression molds 1306a, 1306b. When the carousel is in the first position, the elastomeric material is compressed after being delivered to the first mold 1306a. The elastomeric material then hardens while the carousel rotates to the second position, forming a pad with multiple parts, such as the pad in 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. Thus, a semi-continuous compression molding process is performed. Examples of elastomeric parts that can be molded into pads include, but are not limited to, bottle stoppers for containers containing liquids or lyophilized products, and plungers for cartridges, syringes, or Carpoules. Each pad contains at least 50 parts, more preferably at least 200 parts, and most preferably at least 800 parts. The pads 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 process, a film of a polymer such as ETFE may be applied to one or more surfaces of the plug.

[0039] After the curing of the pad is completed, the mold is opened when the first mold 1306a or the second mold 1306b is in the second position, and the pad is removed from the mold. The removal of the pad from the mold is preferably performed by an automated marking system having a means for the removal. For example, in one embodiment, the automated marking system may include a robot 1308a including a mechanical arm configured to remove the pad from the mold. The automated marking system may further include an marking system 1312 including a laser for marking the surface of each part in the pad. For example, if the surface of the cured untrimmed pad is covered with a film made of ETFE, since ETFE is transparent to light of wavelength 355 nm, a laser emitting light of that particular wavelength can be used to mark the surface of one or more plugs. Thus, the laser can be used to form a visible mark 16 on the body 12 even after the ETFE film 14 is formed on the body 12, as shown in FIG. 2, because the laser light can penetrate the film 14 without damaging the film 14. The transmittance of film 14 to the wavelength of the laser (often a given wavelength in the UV region) 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%, with each subsequent range being more preferred.

[0040] As previously mentioned, the laser marks are preferably formed as a Data Matrix ECC200 code. More preferably, the Data Matrix ECC200 code is approximately 1.4 mm square with each cell in the mark having a maximum dimension of approximately 0.10 mm, more preferably approximately 0.08 mm. The result is a 14x14 Data Matrix ECC200 code capable of encoding a 16-digit serial number. The 16-digit serial number may be used to provide a unique identifier for each component in the pad along with manufacturer information. For example, in a preferred embodiment, the 16-digit serial number may be expressed as: YYDDDAABBXXXXXXX, where YY is a two digit number representing the year of manufacture of the part (e.g., "19" for 2019), DDD is a three digit number representing the date of manufacture of the part (e.g., "001" for January 1st or "365" for December 31st), AA is a two digit number identifying the system used to manufacture the part, such as the system shown in FIG. 13, BB is a two digit number identifying the geographic location of the system, and XXXXXXX is a seven digit number associated with a particular part. Providing this information allows an end user or manufacturer to identify the time and location associated with the origin of a particular part. This information can be important in certain situations, such as product recalls, as will be explained in more detail below.

[0041] 12B, mark 17 is located on the top surface of stopper 10, preferably outside of target 11. Target 11 has a circular boundary and indicates the area into which a needle (not shown) should be inserted to withdraw the contents of a container (not shown) sealed by stopper 10. Because mark 17 is preferably located outside of the target, the possibility of contact between the portion of stopper 10 treated with the laser that created mark 17 and the contents of the container is reduced.

[0042] After each component on the pad is laser marked, the robot 1308a may bring the laser marked, untrimmed pad into the field of view of the inspection station 1314. The inspection station 1314 may include one or more cameras configured to capture an image (e.g., photo or video) of each mark on the pad. For example, in one embodiment, the robot 1308a may move the pad through the inspection station 1314 to traverse the field of view of one or more fixed cameras. Alternatively, the robot 1308a may hold the pad stationary while one or more cameras within the inspection station 1314 scan the laser marks. This may be accomplished by mounting one or more cameras on a movable platform or carriage. In another embodiment, both the pad and one or more cameras may move simultaneously to speed up the capture of images of the laser marks. The inspection station 1314 may also be used to scan one or both sides of the pad, for example to identify defects in the part.

[0043] The inspection station 1314 may further include a processor configured to locate the marks on the surface of the part and / or read and record each of the serial numbers associated with the marks. By locating the marks on the surface of the part, the inspection station 1314 may, for example, verify that the marks 17 are on the outside of the target 11 and are readable. If not, the part may be rejected and discarded for further processing. Recording the serial numbers of the parts contained within the untrimmed pad may facilitate determining whether the cause of the defect is mold-related. For example, the elastomeric parts may be trimmed and separated from their pads and then individually inspected to identify physical defects. If a defect is identified, the serial number associated with the part may be recorded. If multiple defects are identified, the serial numbers may be compared to determine whether the defects occur in elastomeric parts that were located in a common location between one or more molded pieces of the untrimmed pad. The occurrence of defects in those parts may suggest that the root cause of those defects is one of the compression types, e.g., 1306a or 1306b. Decoding and recording of the serial number associated with each part may be accomplished by a processor after one or more images have been captured and, if necessary, after the pad has been removed from the inspection system 1314 while the pad continues its passage through the system 1300.

[0044] After the mark 17 is formed on each part of the pad and its appearance is inspected, the robot 1308a may place the pad in a cooling system 1310. The cooling system 1310 may include a rack on which the pads can be placed. The cooling system 1310 may further include other features such as temperature controlled shelves, dehumidifiers, or cooling fans, if necessary. After the pads have cooled, a second robot 1308b, the same as or similar to the first robot 1308a, may remove the pads from the cooling system 1310 and send them to one or more processing stations, such as a trimming station 1316, a cleaning station 1318, a packaging station 1320, etc. The trimming station 1316 removes each part from the panel molding. This is done by cutting or trimming the excess elastomeric material around each part with a blade or similar device, as known to those skilled in the art. The cleaning station 1318 cleans and / or sterilizes the parts individually. The packing station 1320 is configured to pack multiple trimmed and cleaned parts into a package, such as a bag or box. The system 1300 may include one or more additional inspection stations, the same as or similar to the inspection station 1314, to inspect and detect defects in the parts between the trimming station 1316 and the cleaning station 1318 and / or between the cleaning station 1318 and the packing station 1320. As previously described, the serial numbers of defective parts may be read and recorded before the defective parts are discarded.

[0045] As mentioned above, preferably, the film that an embodiment of the present invention applies to the part is made of a material that is substantially transparent to the laser light used to mark the surface of the part. Optical microscopy, such as that shown in Figures 4A and 4B, demonstrates that the laser does not cause any visible degradation of the film 14. The same result can be achieved by combining different types of lasers with different polymeric films or covers that are essentially transparent to their respective wavelengths (e.g., polypropylene or fluorinated ethylene propylene (FEP) caps), i.e., a visible mark can be formed on the surface of a part that already has a film or cover applied to it. As a result of this effect, the visible mark 16 can be created at any time after the formation of the stopper 10. This allows data to be added throughout the manufacturing process with minimal impact on the manufacturing process that is currently taking place. It has also been demonstrated that the visible mark 16 can withstand steam sterilization temperatures (e.g., up to 121°C) for various materials.

[0046] In some methods according to various embodiments of the present invention, a part may be marked after it is assembled into a device. For example, an elastomeric stopper may be assembled into a transparent cap (such as DAIKYO PLASCAP® RUV closure manufactured by Daikyo Seiko Ltd.). After a suitable transparent material and a corresponding wavelength of laser light are selected for the cap so that the laser light is substantially transmitted through the cap and film without being absorbed, a mark may be applied to the surface of the elastomeric stopper after it is assembled into the transparent cap (see FIGS. 10A and 10B). Similarly, in another example, various types of elastomeric plungers (see FIG. 11) may be laser-engraved with an appropriate wavelength before or after they are inserted into the transparent cylinder of a transparent syringe or cartridge. Again, the wavelength of light should be selected so that the light is not substantially absorbed by the transparent material (e.g., glass or polymeric material) of the syringe or cartridge cylinder.

[0047] FIG. 5 illustrates an example method 100 for manufacturing a medical device component, such as a stopper 10. In step 102, a body 12 is formed. The body 12 includes a surface. At least a portion of the body 12 is formed from an imprintable material, such as a rubber containing inorganic fillers as described above. The body 12 may be formed using a mold by conventional techniques. Then, in step 104, a film 14, such as one made from ETFE as described above, is formed to cover at least a portion of the surface of the body 12. The portion covered by the film 14 includes at least a portion of the imprintable material (e.g., if the body 12 includes portions formed from the imprintable material and portions formed from other materials selected for structural support and / or aesthetics).

[0048] In step 106, after the film 14 is formed, a visible mark 16 is formed on the surface of the body 12 covered by the film 14 by exposing an area of ​​the markable material to irradiation with a laser of one or more predetermined wavelengths (e.g., wavelengths in the UV range) to change its color. This irradiation may include, for example, the following operations: The laser irradiation is raster scanned over multiple areas of the surface of the body 12 to form a spatially extending visible mark 16 (e.g., the machine-readable code shown in Figures 1-4B) and / or multiple visible marks 16 (e.g., visible marks 16a-16d shown in Figure 7).

[0049] In one aspect, it is desirable to be able to gradually add information throughout the manufacturing process to a medical device component, such as the plug 10. This can be done, for example, by adding a Data Matrix code or by expanding an existing visible marking 16 (i.e., increasing the number of symbols or characters).

[0050] FIG. 6 shows an example of a portion of a process 200 for manufacturing a stopper 10 in such a manner. In step 202, the stopper 10 is molded in a conventional manner using a mold. This step preferably includes applying the film 14 in place. In step 204, a molding indicator is laser-formed in a first area of ​​the body 12 before the stopper 10 is moved to the next step. The molding indicator and similar indicators for other steps may be coded marks (similar to the visible marking 16 shown in FIGS. 1-4B) that contain data, a unique identifier, or a URL. The data may be a timestamp or parameter information for the molding step. The unique identifier or URL is linked to an updateable database where information about completed steps such as molding can be identified and explained. Alternatively, the molding indicator may be a graphic symbol (e.g., the visible marking 16a shown in FIG. 7) or other similar markings that indicate the completion of the molding step.

[0051] In step 206, the plug 10 is trimmed from the mold. In step 208, a marking relating to the trimming process (see, for example, visible marking 16b shown in FIG. 7) is laser-formed in a second region of the body 12 of the plug 10. In step 210, the plug 10 is cleaned in a conventional manner. In step 212, a marking relating to the cleaning process (see, for example, visible marking 16c shown in FIG. 7) is laser-formed in a third region of the body 12 of the plug 10. In step 214, the plug 10 is inspected for visual defects, either by a person or by an inspection device. In step 216, a marking relating to the visual inspection process (see, for example, visible marking 16d shown in FIG. 7) is laser-formed in a fourth region of the body 12 of the plug 10. If the visible marking 16 is a machine-readable code that is added after each associated process, the various imprinted regions may be attached to each other or each process may have its own code that is read separately and independently. 6 shows various steps, each followed by a step of laser forming indicia associated with that step, however, the illustrated process is not limiting and variations may be made in the number of steps, laser formed indicia, etc. without departing from the spirit and scope of the present invention.

[0052] The above method is beneficial in that it avoids the need to query or operate a server during the manufacturing process: high speed packaging lines do not tolerate significant latency, because the data stored in the visible mark 16 can be limited so that there is no latency in retrieval and therefore can be implemented on high speed lines.

[0053] In some embodiments, the visible markings 16 can be used to assign a unique serial number. As briefly described above, after each processing step, a database (not shown) may be updated with information regarding the unique identifier (e.g., serial number) associated with the visible markings 16 of each stopper 10. For example, after a batch of elastomeric parts is tested for quality parameters, such as particulates, extractables, and leachables, the laser markings of each part may be scanned and decoded. Data may be added to the database after each test and associated with each serial number in the database. As parts are scanned at each step, timestamps and metadata may be added to entries in a table for the particular visible markings 16. In one embodiment, the visible markings 16 may include a short URL or unique identifier to link each part to a website, API, or database managed by the manufacturer. These websites or the like may have logs from which individuals can retrieve data or metadata associated with the parts (e.g., lot / batch information, process parameter information, drug safety details, interaction details, dosing details, recall information, expiration dates, etc.). Additionally, parts can be tracked by geography, time, user, etc. Also, drug manufacturers, pharmacies, healthcare providers, etc. can be allowed to add information associated with a particular part.

[0054] In this way, the information can be used to, for example, find defects in a mold cavity, identify where waste is continuing in the manufacturing system, make parts traceable, assign a unique identifier to a new cell therapy patient, or inform a patient of all the people who can treat them. In some cases (e.g., if multiple plugs are all already uniquely marked), the information can be retrieved from the database before the device is manufactured to limit delays.

[0055] This method also serves as an anti-counterfeiting measure. By tracking each part, it is feasible to identify and prevent reuse of parts with duplicate serial numbers. It may also be desirable to prevent malicious third parties from guessing the serial numbers. To prevent such actions, the visible mark 16 may contain encrypted information that is only readable by the customer. For example, the visible mark 16 may contain a digital signature. As will be appreciated by those skilled in the art, the data encoded in the visible mark 16 may be digitally signed. In this case, the end user can verify the authenticity of the message and therefore the part. Various other one-way hash or cryptographic authentication methods (e.g., Pretty Good Privacy (PGP) encryption) can also be used to verify that messages contained in the visible mark 16 actually originate from the manufacturer of the part and, if necessary, to protect those messages. Cryptographic keys may be used in different ways depending on the application. In one example, a manufacturer may choose to encrypt messages with their own private key, so that the messages can be decrypted and verified by all authorized users. In another example, messages intended for a particular customer may be encrypted with that customer's public key, so that only that particular customer can decrypt the messages.

[0056] This method can also be useful for assigning serial numbers to multiple components that are to be tracked together as part of the same medical device. For example, each component may be provided with one or more visible marks 16 that can be associated with each other in a database. This allows the manufacturing, sale, transport, and use of the finished device to be tracked and associated with the individual components. For example, if the visible mark 16 on the stopper 10 is not associated with a visible mark on one of the other components of the same device, fraudulent manufacturing or use of counterfeit components may be detected early. Similarly, recall of certain components allows easy tracing of the device in which they are incorporated. In another embodiment, only one of the components may have the visible mark 16 laser-formed. The visible mark then serves as a link to a database that stores and allows tracking of all subsequent information about the device (e.g., manufacturing details, drug information, gene therapy information, patient information, expiry date, serial number, etc.). Information about the patient may include the patient's identity, the schedule of planned treatments, administrative information about the treatments (e.g., frequency and type of treatment / medical device use), and any other metadata. As a result, the visible markings 16 can be used by a system that includes a patient-specific therapeutic application, which may be available on a system such as an electronic device (e.g., a smartphone, tablet, laptop).

[0057] Similarly, by bundling multiple visible marks 16 in the database, the entire shipment of multiple parts can be tracked and their entire manufacturing information can be maintained. For example, a bag may contain multiple stoppers 10, each including its own serial number in the form of a laser-engraved visible mark. These serial numbers may be linked to each other in the database. In one example of operation, when the bag is sterilized, the data for each stopper 10 in the bag can be updated by scanning the tag associated with the stopper's 10 serial number, or by scanning the visible mark 16 of one of the stoppers 10 and using the established link to update the remaining data for that stopper.

[0058] The above embodiments show a single visible mark 16 or an array of similar visible marks (e.g. multiple Data Matrix codes or graphic symbols). However, multiple visible marks of different natures may be applied to a part. For example, one visible mark 16 may contain relevant manufacturing data while a second visible mark 16 may be a manufacturer's logo. Other types of visible marks may also be used, such as visual indications to a caregiver (e.g. needle insertion position).

[0059] The above embodiment has been described in relation to elastomeric parts of a medical device. However, laser marking according to the present invention can be used on other parts of a medical device. For example, a mark can be laser applied to one or more surfaces of a plunger rod before or after it is inserted into a transparent syringe barrel (see FIGS. 8A and 8B). In another example, an aluminum seal containing a flip-up plastic cap can be laser marked (see FIGS. 9A and 9B). This can be done by marking the top surface of the plastic cap, by marking a colored lacquer containing TiO2 formed on the surface of the aluminum sidewall, or by marking through the clear lacquer into the aluminum itself. Plastic seals and other colored plastics are a good match for laser marking, as are linear seals made from elastomeric sheets. Glass parts can be laser marked using a CO2 laser or the like to burn and / or remove the material. Glass replacement parts, such as those made with CRYSTAL ZENITH® material from Daikyo Seiko, Ltd. (Japan), can be similarly possible.

[0060] Although specific and distinct embodiments have been shown in the drawings, various individual elements or combinations of elements from the various embodiments can be combined with each other while maintaining the spirit and scope of the invention. Thus, individual features described in this specification with respect to only one embodiment should not be construed as being incompatible with other embodiments described in this specification or encompassed by the invention.

[0061] It will be appreciated by those skilled in the art that changes could be made to the embodiments described above without departing from the broad inventive concept thereof. It is understood, therefore, that the invention is not limited to the particular embodiments disclosed, but is intended to cover modifications within the spirit and scope of the disclosure as defined by the present disclosure.

Claims

1. 1. A system for manufacturing an elastomeric part, comprising: a molding station having a mold and configured to receive elastomeric material and form and cure a pad including a plurality of untrimmed elastomeric parts; an automated marking station having a laser configured to remove the cured pad from the molding station and expose the cured pad to the laser to form marks on each of the plurality of untrimmed elastomeric parts; an inspection station having a camera configured to capture images of the marks formed on each of the plurality of untrimmed elastomeric parts, identify defects among the plurality of trimmed elastomeric parts, and identify common locations of the defects among the plurality of pad moldings by comparing the marks formed on the plurality of elastomeric parts including the defects; A system comprising:

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

3. The system of claim 1 or claim 2, wherein the molding station comprises a plurality of compression molds.

4. The system of claim 1 , wherein the mark is a Data Matrix code.

5. The camera, a processor configured to decode each mark and record a unique identifier associated with each mark.

5. The system according to claim 1, further comprising:

6. a cooling station configured to receive the cured pad after applying the mark to each of the plurality of untrimmed elastomeric parts; The system of claim 1 , further comprising:

7. a robot configured to remove the cured pad from the cooling station and deliver it to at least one of a trimming station, a cleaning station, and a packaging station; The system of claim 6 further comprising:

8. A second camera configured to capture a second image of the mark on at least one of the plurality of elastomeric parts separated by the trimming. The system of claim 7 further comprising:

9. The inspection station comprises: a processor configured to determine a position of each mark on a surface of the plurality of elastomeric parts; The system of claim 1 , further comprising:

10. the processor is configured to determine that a location of the mark on a surface of the one elastomeric part is not outside of a target; The system of claim 9 , configured to reject the elastomeric part based on a location of a mark on a surface of the elastomeric part not outside the target.

11. The inspection station further comprises: a processor configured to determine whether each mark on a surface of the plurality of elastomeric parts is readable; The system according to any one of claims 1 to 10, comprising:

12. the processor is configured to determine that a mark on a surface of an elastomeric part is unreadable; The system of claim 11 , configured to reject the elastomeric part based on a determination that a mark on a surface of the elastomeric part is unreadable.

13. 1. A method for producing an elastomeric part, comprising the steps of: placing an elastomeric material in a mold; molding a pad including said elastomeric material such that said pad has a plurality of untrimmed elastomeric parts; curing the pad; exposing a portion of a surface of each of the plurality of untrimmed elastomeric parts to a laser to form a mark; capturing an image of a mark formed on each of the plurality of untrimmed elastomeric parts; identifying defects among the plurality of separated elastomeric components by trimming; comparing marks formed on the plurality of elastomeric parts containing defects to identify locations of the defects common among the plurality of pad moldings; The method includes:

14. Compounding the elastomeric material prior to placing it in the mold. The method of claim 13 further comprising:

15. 15. The method of claim 13 or claim 14, wherein the step of placing the elastomeric material in the mold comprises placing the elastomeric material in a plurality of compression molds.

16. 16. The method according to any one of claims 13 to 15, wherein the mark is a Data Matrix code.

17. Decoding each mark; recording a unique identifier associated with each mark; 17. The method of any one of claims 13 to 16, further comprising:

18. Cooling the hardened pad.

18. The method of any one of claims 13 to 17, further comprising:

19. subjecting each of the plurality of elastomeric parts to at least one of trimming, cleaning, and packaging.

19. The method of any one of claims 13 to 18, further comprising:

20. Capturing a second image of the mark formed on at least one of the plurality of elastomeric parts separated by the trimming.

20. The method of claim 19, further comprising:

21. determining that a location of the mark on a surface of one of the elastomeric parts is not outside of a target; rejecting the elastomeric part based on a location of the mark on a surface of the elastomeric part not outside the target; 21. The method of any one of claims 13 to 20, further comprising:

22. determining that a mark on a surface of one of the elastomeric parts is unreadable; rejecting the elastomeric part based on a determination that the mark on the surface of the elastomeric part is unreadable; 22. The method of any one of claims 13 to 21, further comprising:

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