Reusable medicament container and method for reuse thereof

Abstract

A reusable container may include glass, an inner surface, and an outer surface. The container may be a pharmaceutical container adapted to contain a pharmaceutical product. The container may have a retention strength of within 25% prior to a first use of an unused container. The inner surface may have a chemical durability ratio of 5 or less.

Description

[0001] Cross - Reference to Related Applications

[0002] This application claims the benefit of priority of U.S. Provisional Application No. 63 / 428,931, filed on November 30, 2022, under 35 U.S.C.§119, the content of which is hereby incorporated by reference in its entirety and made a part hereof. Technical Field

[0003] The present disclosure relates to drug containers, and more particularly to reusable drug containers and methods for their reuse. Background Art

[0004] For a long time, glass has been the preferred material for packaging drugs due to its airtightness, optical transparency, and excellent chemical durability compared to other materials. Specifically, the glass used for drug packaging must have sufficient chemical durability so as not to affect the stability of the drug composition contained therein, and have sufficient mechanical properties to prevent the package from breaking during handling or use. However, currently, glass drug packaging is often sent for recycling after being used only once, or more commonly, thrown away. This results in a large amount of waste generated from the use of glass drug packaging. Summary of the Invention

[0005] Accordingly, there is a continuing need for glass drug packaging that can be reused and methods for refurbishing and reusing glass drug packaging. The present disclosure relates to glass drug packaging that can be refurbished and reused and methods for refurbishing and reusing glass drug packaging.

[0006] According to one or more embodiments, a container for reuse may include glass, an inner surface, and an outer surface. The container may be a drug container adapted to hold a drug product. The container may have a retention strength within 25% before the first use of the unused container. The inner surface may have a chemical durability ratio of 5 or less.

[0007] According to additional embodiments, a method for reusing a used drug container may include receiving a used drug container and refurbishing the used drug container to produce a refurbished drug container. Refurbishing the used drug container may include washing the used drug container with a caustic solution, washing the used drug container with water, and depyrogenating the used drug container to produce a refurbished drug container. After depyrogenating the used drug container, the levels of organic and inorganic contaminants in the refurbished drug container may be less than the USP limits.

[0008] Additional features and advantages of the embodiments described herein will be set forth in the detailed description which follows, and in part will be readily apparent to those skilled in the art from the description or recognized by practicing the embodiments described herein, including the detailed description which follows, the claims, as well as the drawings.

[0009] It is to be understood that both the foregoing general description and the following detailed description describe various embodiments and are intended to provide an overview or framework for understanding the nature and characteristics of the claimed subject matter. The accompanying drawings are included to provide a further understanding of the various embodiments and are incorporated into and constitute a part of this specification. The drawings illustrate the various embodiments described herein and, together with the description, serve to explain the principles and operations of the claimed subject matter. Brief Description of the Drawings

[0010] Figure 1 Schematically depicts a cross-section of a glass container in accordance with one or more embodiments described herein;

[0011] Figure 2A Depicts a flowchart of steps in a method for reusing a used drug container in accordance with one or more embodiments described herein;

[0012] Figure 2B Depicts a flowchart of steps in a method for reusing a used drug container in accordance with one or more embodiments described herein; and

[0013] Figure 2C Depicts a flowchart of steps in a method for reusing a used drug container in accordance with one or more embodiments described herein. Detailed Description

[0014] Specific embodiments of the present application will now be described. However, the present disclosure may be embodied in different forms and should not be construed as limited to the embodiments set forth herein. On the contrary, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the subject matter to those skilled in the art.

[0015] Embodiments of the present disclosure also relate to a method for reusing a used drug container. The method may include receiving a used drug container and refurbishing the used drug container to produce a refurbished drug container. Refurbishing the used drug container may include washing the used drug container with a caustic solution, washing the used drug container with water, and depyrogenating the used drug container. After depyrogenating the used drug container to produce a refurbished drug container, the levels of organic and inorganic contaminants in the refurbished drug container may be less than detectable limits.

[0016] Compared with using conventional containers, the containers of the present disclosure and the method for reusing the containers can generate less waste and / or reduce the energy consumption and processing costs associated with melting glass containers. Typically, pharmaceutical containers are discarded after only one use, generating a large amount of waste, most of which may end up in landfills. The containers and methods of the present disclosure can allow for the reuse of pharmaceutical containers, thereby reducing the amount of waste generated from the use of pharmaceutical containers and thus reducing the amount of waste that needs to be discarded in landfills.

[0017] As used herein, the term "recycle" refers to the process of melting the glass of a pharmaceutical container and forming the molten glass into one or more glass articles.

[0018] As used herein, the term "reuse" refers to using a pharmaceutical container after it has been used at least once and then refurbished without melting the glass container and forming the molten glass into a new container.

[0019] As used herein, the term "chemical durability ratio" (CDR) refers to a measure of the tendency of a glass container to delaminate. As described in U.S. Patent Application Publication No. 2021 / 0080448A1, the content of which is incorporated herein by reference in its entirety, the CDR depicts the level of non-uniformity on the inner surface of a container by the ratio of the "as-received" to the "post-etched" titration values of the container.

[0020] As used herein, the term "delamination" refers to the phenomenon in which glass particles are released from the surface of the glass after a series of leaching, corrosion, and / or weathering reactions. Generally, the particles are silica-rich glass flakes or lamellae that originate from the inner surface of the container due to the immersion of modifier ions or weak network formers (e.g., boron) into the solution contained within the container. These flakes or lamellae are typically 1 nanometer to 2 micrometers thick, with a width greater than about 50 micrometers. Since these flakes or lamellae are mainly composed of silica, they generally do not further degrade after being released from the surface of the glass.

[0021] Now refer to Figure 1 , which schematically depicts in cross-section an embodiment of a container 100 for reuse. The container 100 generally includes a body 102. The body 102 extends between an inner surface 104 and an outer surface 106 and encloses an internal volume 108. In Figure 1 the illustrated embodiment, the body 102 generally includes a cylindrical wall 110 and a bottom plate 112. The cylindrical wall 110 transitions into the bottom plate 112 through a heel 114. The body 102 has a wall thickness T that extends between the inner surface 104 and the outer surface 106 W .

[0022] As described herein, in an embodiment, the reusable container 100 may include glass, an inner surface 104, and an outer surface 106. In an embodiment, the container 100 may be a pharmaceutical container. In an embodiment, the container 100 may be adapted to hold one or more of a pharmaceutical product, a vaccine, a biologic, a solution, or a combination thereof. Although the container 100 is depicted as a vial in Figure 1 it should be understood that the container 100 may have other form factors, including but not limited to cartridges, syringes, bottles, flasks, ampules, tubes, beakers, and the like.

[0023] In an embodiment, the glass may be an aluminosilicate glass composition. In an embodiment, the glass may be an aluminosilicate glass composition that meets the Type 1 standard as defined in USP <660>, such as those disclosed in U.S. Patent No. 8,551,898, which is incorporated herein by reference in its entirety, and sold by Incorporated as glass, and those disclosed in U.S. Patent No. 9,145,329, which is incorporated herein by reference in its entirety. In an embodiment, the glass may be an alkali aluminosilicate glass, such as those disclosed in U.S. Patent No. 10,640,415, titled Lithium Containing Glasses, filed on November 29, 2017, which is incorporated herein by reference in its entirety, or those disclosed in U.S. Patent Publication No. 2020 / 0290920, titled Chemically Durable Aluminosilicate Glass Compositions and Glass Articles Formed Therefrom, filed on September 17, 2020, which is incorporated herein by reference in its entirety. In an embodiment, the glass may be an aluminosilicate glass composition that has undergone an etching process (e.g., acid etching or fluoride etching) to remove deposits on the inner surface 104 of the container 100. In an embodiment, the glass may be 33 expansion borosilicate glass, such as those sold by DWK Life Sciences as 33 or those sold by Schott as 33. Expansion 33 glass has a thermal expansion coefficient of 33 and is a Type 1A glass that meets USP <660>. In an embodiment, the glass may be 51 expansion borosilicate glass, such as those sold by DWK Life Sciences as 51 or those sold by Those glasses sold as 51-D transparent borosilicate glass tubing. The 51-expansion glass has a coefficient of thermal expansion of 51 and is a Type 1B glass in compliance with USP <660>. In embodiments where the glass is 33-expansion or 51-expansion borosilicate glass, the outer surface 106 of the container 100 may be coated with an external coating. For example, suitable containers may be the coated containers sold by Incorporated.

[0024] In embodiments, the glass may be a strengthened aluminosilicate glass. In embodiments, the strengthened aluminosilicate glass may be formed by ion-exchanging the aluminosilicate glass in a molten salt bath. The ion-exchange process may be carried out in an ion-exchange medium under processing conditions such as those disclosed in U.S. Patent No. 8,551,898, which is incorporated herein by reference in its entirety, and those disclosed in U.S. Patent No. 9,145,329, which is incorporated herein by reference in its entirety. However, it should be understood that the ion-exchange process is not particularly limited and other processes are encompassed herein.

[0025] Without being bound by theory, it is believed that the aluminosilicate glass composition may have sufficient chemical durability, mechanical strength, and optical properties for reuse. For example, when compared to glass compositions having a less homogeneous surface chemistry and high uniformity, such glass compositions may have a relatively homogeneous surface chemistry and relatively low non-uniformity, thereby improving the chemical durability of the container. When a glass article containing volatile substances (e.g., sodium and / or boron) (e.g., glass having >0.1 mol% Na2O and / or B2O3, such as >0.5 mol%, >1 mol%, >2 mol%, >4 mol%) is heated (e.g., during a thermo-mechanical conversion process for converting a glass tubing into multiple glass containers), sodium and / or boron may volatilize and be released from the surface of the glass. The volatilized sodium and / or boron may later condense on cooler portions of the surface of the glass tubing or glass container, thereby causing compositional non-uniformity in the surface of the glass container. Such compositional non-uniformity in the surface of the glass container may cause reduced chemical durability and a greater tendency for delamination of the glass surface.

[0026] The uniformity of the surface concentration of the glass constituent components in the surface region of the glass generally indicates the tendency of the glass composition to delaminate and glass particles to detach from the inner surface 104 of the container 100. When the glass composition has a consistent surface uniformity in the surface region (i.e., when the extreme value of the surface concentration of the glass constituent components in the surface region at a discrete point A on the inner surface 104 is within + / - 30% of the same constituent components in the surface region at any second discrete point B or C on the inner surface 104), the glass composition has improved resistance to delamination.

[0027] Glass containers with consistent surface uniformity can be achieved using various techniques, including but not limited to acid etching at least the inner surface 104 of the body 102 of the glass container 100 or by forming the glass container from a glass composition, where the constituent components of the glass composition form substances with relatively low vapor pressures (i.e., substances with low volatility) at the temperatures required to form the glass tube into a glass container with the desired container shape. Acid etching is assumed to create non-uniformities on the inner surface of the glass container, and acid etching removes the non-uniformities from the inner surface of the glass container to create consistent surface uniformity in the finished glass container. When the constituent components of the glass form substances with relatively low vapor pressures at the reforming temperature, the constituent components are less likely to volatilize and evaporate from the surface of the glass and then condense on the cooler surfaces of the glass. Reducing or preventing the volatilization of the constituent components of the glass can enable the formation of a glass container with a surface of uniform composition above the inner surface of the glass container and throughout the thickness of the glass container.

[0028] In an embodiment, the container 100 can be resistant to delamination after exposure to certain compositions stored in the container 100. The delamination risk of the glass container 100 can be measured using the Chemical Durability Ratio (CDR). The method for evaluating the CDR of a glass container involves: (1) a hydrolysis test of the as-received surface; (2) an etching step to remove any chemical non-uniformities that may be present; and (3) a second hydrolysis test of the 'etched' surface. The 'as-received' container is processed according to the USP <660> surface glass test with one significant deviation: the fill volume is 12.5% of the full capacity. Since the fill volume is reduced, additional containers are required to produce the solution volume needed for titration. The titration volume is recorded as the 'as-received' response.

[0029] After the first USP <600> surface glass test on the 'as-received' container, the 'as-received' container is then subjected to an etching process to remove materials deposited or incorporated during the conversion or molding process. A mixture of HCl / HF acid is used to remove at least one micron (depth) of the surface, with a target concentration of 2.3M HF / 4.6M HCl. The container is exposed to this solution for at least 3 minutes. These conditions are sufficient for most type 1 glass compositions, and the mass loss is measured to confirm the sufficient depth of surface removal. After exposure to the target acid solution, the acidic residues in the container are removed by soaking in two room temperature water baths for 5 minutes each. Subsequently, the container is rinsed several times with high purity water. The container for the 'etched' response is the retained container from the 'as-received' test. After etching, the 'etched' container is subjected to a second USP <660> surface glass test to measure the bulk glass response again at the reduced 12.5% fill volume.

[0030] Process the "etched" containers according to USP <660> surface glass test using a reduced fill volume (12.5% of the full capacity). The resulting titrant volume is recorded as the "etched" titrant response. The recorded titrant volume is calculated as follows (*at the reduced volume):

[0031]

[0032] The CDR value represents the delamination risk, where containers with a homogeneous surface chemistry exhibit a low CDR and the lowest delamination risk.

[0033] As described herein, in an embodiment, the container 100 may have a CDR of 5 or less. In an embodiment, the inner surface 104 of the glass container 100 may have a CDR of 5 or less, such as 4 or less, 3 or less, or even 2 or less. In an embodiment, the inner surface 104 may have a CDR greater than or equal to 0.5 and less than or equal to 5. For example, the inner surface 104 may have a CDR greater than or equal to 0.5 and less than or equal to 4.5, such as greater than or equal to 0.5 and less than or equal to 4, greater than or equal to 0.5 and less than or equal to 3.5, greater than or equal to 0.5 and less than or equal to 3, greater than or equal to 0.5 and less than or equal to 2.5, greater than or equal to 0.5 and less than or equal to 2.0, greater than or equal to 0.5 and less than or equal to 1.5, greater than or equal to 0.5 and less than or equal to 1, greater than or equal to 1 and less than or equal to 5, greater than or equal to 1 and less than or equal to 4.5, greater than or equal to 1 and less than or equal to 4, greater than or equal to 1 and less than or equal to 3.5, greater than or equal to 1 and less than or equal to 3, greater than or equal to 1 and less than or equal to 2.5, greater than or equal to 1 and less than or equal to 2, greater than or equal to 1 and less than or equal to 1.5, greater than or equal to 1.5 and less than or equal to 5, greater than or equal to 1.5 and less than or equal to 4.5, greater than or equal to 1.5 and less than or equal to 4, greater than or equal to 1.5 and less than or equal to 3.5, greater than or equal to 1.5 and less than or equal to 3, greater than or equal to 1.5 and less than or equal to 2.5, greater than or equal to 1.5 and less than or equal to 2, greater than or equal to 2 and less than or equal to 5, greater than or equal to 2 and less than or equal to 4.5, greater than or equal to 2 and less than or equal to 4, greater than or equal to 2 and less than or equal to 3.5, greater than or equal to 2 and less than or equal to 3, greater than or equal to 2 and less than or equal to 2.5, greater than or equal to 2.5 and less than or equal to 5, greater than or equal to 2.5 and less than or equal to 4.5, greater than or equal to 2.5 and less than or equal to 4, greater than or equal to 2.5 and less than or equal to 3.5, greater than or equal to 2.5 and less than or equal to 3, greater than or equal to 3 and less than or equal to 5, greater than or equal to 3 and less than or equal to 4.5, greater than or equal to 3 and less than or equal to 4, greater than or equal to 3 and less than or equal to 3.5, greater than or equal to 3.5 and less than or equal to 5, greater than or equal to 3.5 and less than or equal to 4.5, greater than or equal to 3.5 and less than or equal to 4, greater than or equal to 4 and less than or equal to 5, greater than or equal to 4 and less than or equal to 4.5, greater than or equal to 4.5 and less than or equal to 5, or any combination of these ranges. Without being bound by theory, it is believed that a CDR greater than 5 may result in a greater probability of delamination during repeated use of the container 100. A container 100 that has sufficient delamination performance for single-use applications may not have sufficient delamination performance for repeated use.It is believed that the likelihood of delamination may increase with each use of the container because each use may potentially expose the container to a composition, such as but not limited to a corrosive composition, which can increase the likelihood of delamination. It is believed that a container 100 having an inner surface 104 with a CDR of 5 or less may have sufficient delamination performance even after multiple uses.

[0034] As the container 100 is used, the container 100 may lose a certain level of mechanical strength after each use. In an embodiment, when compared to an unused container 100, a used container 100 may retain a certain percentage of its mechanical strength. In an embodiment, the retained mechanical strength of a used container 100 may be within 25% of the mechanical strength of the original container before its first use. By way of example, the retained mechanical strength of a used container may be within 24% of the mechanical strength of the original container before its first use, such as within 22%, 20%, 18%, 16%, 14%, 12%, 10%, 8%, 6%, 4%, or even 2% of the mechanical strength of the original container before its first use. In an embodiment, the mechanical strength of the container 100 may be measured by a quasi-static modulus of rupture test, where the required level of compressive, vertical compressive, or internal pressure (burst pressure) to break the container 100 is used to determine the mechanical strength of the container 100.

[0035] In an embodiment, the container 100 may include a low-friction coating on the outer surface 106 of the container, which may help maintain the mechanical strength of the container 100. The outer surface coated with the low-friction coating may have a coefficient of friction that is less than or equal to 0.7. In an embodiment, the low-friction coating on the outer surface 106 of the container 100 may be the low-friction coating described in U.S. Patent No. 9,763,852, which is incorporated herein by reference in its entirety. However, it should be understood that other low-friction coatings are contemplated herein. Without being bound by theory, it is believed that coating the outer surface 106 of the container 100 with a low-friction coating may reduce mechanical damage that occurs to the outer surface 106 of the container 100, such as abrasion that occurs when the container 100 contacts processing equipment, handling equipment, or other containers during everyday use. As mechanical damage accumulates, the strength of the container 100 may decrease, which may make the container 100 less suitable for reuse. Therefore, reducing mechanical damage that occurs to the container 100 may improve the service life of the container 100, thereby facilitating the reuse of the container 100.

[0036] When using the container 100, the container 100 and the contents of the container 100 can be visually inspected to ensure that, for example, layering of the container 100 has not occurred. The container 100 can have specific optical properties to ensure that this visual inspection can occur. The optical properties can include but are not limited to light transmittance, color haze, refractive index, light scattering, or combinations thereof. In an embodiment, the light transmittance of the used pharmaceutical container 100 across the entire visible spectrum can be within 10% of the light transmittance of the unused container 100 across the entire visible spectrum. For example, the light transmittance of the used container 100 across the entire visible spectrum can be within 9% of the light transmittance of the unused container 100 across the entire visible spectrum, such as within 8%, 7%, 6%, 5%, 4%, 3%, 2%, or even 1% of the light transmittance of the original container across the entire visible spectrum before its first use.

[0037] In an embodiment, the color haze of the used pharmaceutical container 100 can be within 10% of the color haze of the unused container 100. In an embodiment, the refractive index of the used pharmaceutical container 100 can be within 10% of the refractive index of the unused container 100. In an embodiment, the light scattering of the used pharmaceutical container 100 can be within 10% of the light scattering of the unused container 100. In an embodiment, the container 100 can be free of coloring, scattering, and / or haziness. In an embodiment, the container 100 can have minimal scratching or other accumulated cosmetic damage that can make the appearance of the container 100 inconsistent.

[0038] In an embodiment, the container 100 may further include a unique identification code. In an embodiment, the unique identification code may be used to identify the manufacturing batch of the container, the previous contents of the container 100, the previous usage times of the container 100, or a combination of these. The unique identification code may, by way of example and not limitation, be suitable for providing resolution at the level of billions of unique identifiers and may be encoded into the tag by the shape, structure, or resonance of the tag. The tag including the unique identification code may be permanently attached to or embedded in the surface of the glass. The unique identification code may directly encode partial manufacturing information, such as the manufacturing date, the place of origin, etc. The amount of information to be encoded in any particular unique identification code will vary according to the requirements of the unique identification code to be adopted. As only one example, the tag including the unique identification code may be in the form of a one-dimensional (1-D) or two-dimensional (2-D) barcode. Two-dimensional unique identification codes encoding as few as 10 numerical digits or as small as up to 36 alphanumeric characters or larger may be used to track drugs, where a 16-alphanumeric-character-encoding unique identification code is considered typical. A sixteen-digit pattern may have sufficient information for most manufacturing purposes and can be easily printed in machine-readable size within the glass. In an embodiment, the unique identification code may contain information about the container, may identify the container, may be redirected to a database having information about the used drug container, or a combination of these. In an embodiment, the tag including the unique identification code may be a quick response (QR) code. In an embodiment, the tag including the unique identification code may be visible only when the container 100 is exposed to ultraviolet (UV) light, such as those disclosed in U.S. Patent No. 10,676,240, which is incorporated herein by reference in its entirety. In an embodiment, the tag including the unique identification code may be laser-etched into the glass. In some embodiments, as Figure 1 shown, the tag including the unique identification code may be a laser-etched tag 116 disposed between the inner surface 104 and the outer surface 106 of the container. In an embodiment, the tag including the unique identification code may be printed on the surface of the container 100. Suitable methods for applying the tag including the unique identification code by laser etching, surface printing, or both are disclosed in U.S. Patent No. 10,676,240, which is incorporated herein by reference in its entirety. However, it should be understood that other methods of applying the tag including the unique identification code are covered herein.

[0039] In an embodiment, the inner surface 104 of the container 100 may include a total concentration of organic and / or inorganic contaminants that is less than a detectable limit. Pharmaceutical manufacturers and government agencies may require specific maximum levels of organic or inorganic contaminants in containers used for pharmaceutical packaging. For example, the acceptable level of organic or inorganic contaminants in the container 100 may be less than the detectable limit such that inorganic or organic contaminants may not be routinely detectable within the interior volume 108 of the container 100 or on the inner surface 104. In an embodiment, the container 100 may have any organic contaminant less than 0.15 μg that is routinely detectable within the interior volume 108 of the container 100 or on the inner surface 104. In an embodiment, the container 100 may have inorganic contaminants detected within the interior volume 108 or on the inner surface 104 that are below the limits established in USP <232> and <233>. In an embodiment, the inner surface 104 of the container 100 may have less than 10 ppm of each element detectable in a USP surface glass test extraction.

[0040] As mentioned above, methods for reusing used pharmaceutical containers are disclosed herein. As Figure 2A shown, in an embodiment, a method 200 for reusing a used pharmaceutical container may include receiving the used pharmaceutical container (step 210) and refurbishing the used pharmaceutical container (step 240) to produce a refurbished pharmaceutical container. In an embodiment, refurbishing the used pharmaceutical container (step 240) may include washing the used pharmaceutical container with a caustic solution (step 242), washing the used pharmaceutical container with water (step 244), and depyrogenating the used pharmaceutical container (step 246). After depyrogenating the used pharmaceutical container (step 246) to produce a refurbished pharmaceutical container, the levels of organic and inorganic contaminants in the refurbished pharmaceutical container may be less than the detectable limit.

[0041] In an embodiment, the used pharmaceutical container may be washed with a caustic solution (step 242). In an embodiment, the caustic solution may have a pH ranging from 11 to 14, such as from 11 to 13, from 11 to 12, from 12 to 14, from 12 to 13, from 13 to 14, or any combination of these ranges. According to the method of claim 16, wherein the caustic solution comprises one or more metal hydroxides, metal carbonates, citrates, acetates, oxidizing substances, chelating substances, complex-forming substances, surfactants, soaps, or combinations thereof. By way of example, the caustic solution may comprise one or more of the following: sodium hydroxide, potassium hydroxide, calcium hydroxide, magnesium hydroxide, magnesium carbonate, calcium carbonate, sodium carbonate, potassium carbonate, sodium citrate, potassium citrate, magnesium citrate, calcium citrate, sodium acetate, potassium acetate, calcium acetate, magnesium acetate, or combinations thereof. Without being bound by theory, it is believed that washing the used pharmaceutical container with the caustic solution may remove any inorganic or organic contaminants remaining on the surface of the glass from the previous use of the used pharmaceutical container.

[0042] In an embodiment, washing the used pharmaceutical container with the caustic solution (step 242) may further comprise heating the caustic solution to a temperature ranging from 50°C to 95°C, such as from 50°C to 90°C, from 50°C to 85°C, from 50°C to 80°C, from 50°C to 75°C, from 50°C to 70°C, from 50°C to 65°C, from 50°C to 60°C, from 50°C to 55°C, from 55°C to 95°C, from 55°C to 90°C, from 55°C to 85°C, from 55°C to 80°C, from 55°C to 75°C, from 55°C to 70°C, from 55°C to 65°C, from 55°C to 60°C, from 60°C to 95°C, from 60°C to 90°C, from 60°C to 85°C, from 60°C to 80°C, from 60°C to 75°C, from 60°C to 70°C, from 60°C to 65°C, from 65°C to 95°C, from 65°C to 90°C, from 65°C to 85°C, from 65°C to 80°C, from 65°C to 75°C, from 65°C to 70°C, from 70°C to 95°C, from 70°C to 90°C, from 70°C to 85°C, from 70°C to 80°C, from 70°C to 75°C, from 75°C to 95°C, from 75°C to 90°C, from 75°C to 85°C, from 75°C to 80°C, from 80°C to 95°C, from 80°C to 90°C, from 80°C to 85°C, from 85°C to 95°C, from 85°C to 90°C, from 90°C to 95°C, or any combination of these ranges. Without being bound by theory, it is believed that the caustic solution at a temperature below 50°C may not be as effective in removing inorganic and organic contaminants from the used pharmaceutical container as the caustic solution at a temperature above 50°C.

[0043] In an embodiment, refurbishing a used pharmaceutical container (step 240) may include washing the used pharmaceutical container with water (step 244). The washing with water in step 244 may be carried out after washing the used pharmaceutical container with a caustic solution in step 242. The water wash may remove any residual caustic solution from the surface of the used pharmaceutical container. In an embodiment, the water used for the water wash in step 244 may be at ambient temperature. In an embodiment, the water used for the water wash or step 244 may be heated to a temperature above ambient temperature, such as a temperature greater than or equal to 30 °C, greater than or equal to 40 °C, greater than or equal to 50 °C, greater than or equal to 60 °C, greater than or equal to 70 °C, greater than or equal to 80 °C or even greater than or equal to 90 °C. The temperature of the water during the water wash step 244 may be less than 100 °C.

[0044] In an embodiment, refurbishing a used pharmaceutical container (step 240) may include first washing the container with a caustic solution (step 242), then washing the container with water after the caustic solution wash (step 244), and then depyrogenating the used pharmaceutical container after the water wash (step 246). In an embodiment, refurbishing a used pharmaceutical container (step 240) may further include exposing the container to UV light. In an embodiment, refurbishing a used pharmaceutical container (step 240) may further include exposing the container to ozone. Without being bound by theory, it is believed that ozone exposure and UV light exposure may oxidize organic contaminants, which may advantageously assist in their removal from the container.

[0045] Referring again to Figure 2A , in an embodiment, refurbishing a used pharmaceutical container (step 240) may include depyrogenating the used pharmaceutical container (step 246). The depyrogenating of the used pharmaceutical container (step 246) may be carried out after washing the used pharmaceutical container with a caustic solution (step 242) and with water (step 244). In an embodiment, depyrogenating the used pharmaceutical container may include heating the used pharmaceutical container to a depyrogenation temperature from 250 °C to 400 °C, such as from 250 °C to 375 °C, from 250 °C to 350 °C, from 250 °C to 325 °C, from 250 °C to 300 °C, from 250 °C to 275 °C, from 275 °C to 400 °C, from 275 °C to 375 °C, from 275 °C to 350 °C, from 275 °C to 325 °C, from 275 °C to 300 °C, from 300 °C to 400 °C, from 300 °C to 375 °C, from 300 °C to 350 °C, from 300 °C to 325 °C, from 325 °C to 400 °C, from 325 °C to 375 °C, from 325 °C to 350 °C, from 350 °C to 400 °C, from 350 °C to 375 °C, from 375 °C to 400 °C or any combination of these ranges.

[0046] In an embodiment, depyrogenating a used pharmaceutical container (step 246) can include heating the used pharmaceutical container to a depyrogenation temperature and maintaining the used pharmaceutical container at the depyrogenation temperature for a period of time ranging from about 30 seconds to about 72 hours, such as from about 30 seconds to about 60 hours, from about 30 seconds to about 48 hours, from about 30 seconds to about 36 hours, from about 30 seconds to about 24 hours, from about 30 seconds to about 12 hours, from about 30 seconds to about 6 hours, from about 30 seconds to about 1 hour, from about 1 hour to about 72 hours, from about 1 hour to about 60 hours, from about 1 hour to about 48 hours, from about 1 hour to about 36 hours, from about 1 hour to about 24 hours, from about 1 hour to about 12 hours, from about 1 hour to about 6 hours, from about 6 hours to about 72 hours, from about 6 hours to about 60 hours, from about 6 hours to about 48 hours, from about 6 hours to about 36 hours, from about 6 hours to about 24 hours, from about 6 hours to about 12 hours, from about 12 hours to about 72 hours, from about 12 hours to about 60 hours, from about 12 hours to about 48 hours, from about 12 hours to about 36 hours, from about 12 hours to about 24 hours, from about 24 hours to about 72 hours, from about 24 hours to about 60 hours, from about 24 hours to about 48 hours, from about 24 hours to about 36 hours, from about 36 hours to about 72 hours, from about 36 hours to about 60 hours, from about 36 hours to about 48 hours, from about 48 hours to about 72 hours, from about 48 hours to about 60 hours, from about 60 hours to about 72 hours, or any combination of these ranges.

[0047] In an embodiment, refurbishing a used pharmaceutical container (240) can include first washing the container (242) with a caustic solution, then washing the container with water after the caustic solution wash (244) and then depyrogenating the used pharmaceutical container (246) after the water wash.

[0048] In an embodiment, a method for reusing a used pharmaceutical container can further include sending the refurbished pharmaceutical container for reuse. In an embodiment, the refurbished pharmaceutical container can be sent for reuse and can be reused in the same manner as it was used before refurbishment. In an embodiment, a refurbished pharmaceutical container that previously contained a specific pharmaceutical product can initially be sent for reuse with the same pharmaceutical product. In an embodiment, the refurbished pharmaceutical container can be sent for reuse and can be reused in a different manner than it was used before refurbishment. For example, in an embodiment, a refurbished pharmaceutical container that previously contained a first pharmaceutical product can be sent for reuse with a second pharmaceutical product different from the first pharmaceutical product.

[0049] Now refer to Figure 2B, in an embodiment, a method 200 for reusing a used drug container may further include receiving information related to the used drug container (step 220) after receiving the used drug container (step 210). The drug container may be received (step 210) after being used (step 205). The method 200 may further include determining whether to refurbish and reuse the used drug container based on the information related to the used drug container (step 230). When it is determined not to refurbish (step 240) and reuse the used drug container, the container may be recycled or discarded (step 250). Information related to the used drug may include, but is not limited to, the previous contents of the used drug container, the number of times the used drug container has been reused, the lot number of the used drug container, other information about the used drug container, or a combination thereof.

[0050] In an embodiment, the information related to the used drug container may include the previous contents of the used drug container, and the decision of whether to refurbish and reuse the used drug container may be based in whole or in part on the previous contents of the used drug container. In an embodiment, the previous contents of the used drug container may prevent the container from being reused. For example, containers for human blood and blood components or for radioactive materials may not be allowed to be reused by government regulations and must be recycled or discarded. In other embodiments, the previous contents of the used drug container may allow the used drug container to be reused and the used drug container may be refurbished.

[0051] In an embodiment, the used drug container may include a unique identification code. In these embodiments, the method for reusing a used drug container may further include: reading the unique identification code of the used drug container; using the unique identification code to obtain from a used container database the total number of reuse cycles, an identifier of the previous contents of the used drug container, or both; and determining whether to reuse the drug container based on the total number of reuse cycles of the used drug container, the identifier of the previous contents of the used drug container, or both. The term "used container database" refers to any database or collection of information that associates the unique identification code of a used drug container with information about the used drug container (such as, but not limited to, previous contents, number of reuse cycles, lot number, or other information). In an embodiment, when both the total number of reuse cycles and the identifier of the previous contents indicate that the used drug container is permitted to be reused, the method may include refurbishing the used drug container to produce a refurbished drug container. In an embodiment, when the total number of reuse cycles or the identifier of the previous contents indicates that the used drug container is not permitted to be reused, the method may include recycling or discarding the used drug container.

[0052] In an embodiment, determining whether to reuse a used drug container includes comparing the total number of reuse cycles with a threshold number of reuse cycles, and when the total number of reuse cycles is greater than the threshold number, reusing the drug container is not permitted. As used herein, the term "reuse cycle" refers to using a drug container, refurbishing the drug container, and sending the drug container for reuse again. In an embodiment, the threshold number can be less than or equal to 200 reuse cycles, such as less than or equal to 175 reuse cycles, less than or equal to 150 reuse cycles, less than or equal to 125 reuse cycles, less than or equal to 100 reuse cycles, less than or equal to 75 reuse cycles, less than or equal to 50 reuse cycles, or even less than or equal to 25 reuse cycles. In an embodiment, the threshold number can be greater than 200 reuse cycles. In an embodiment, the threshold number can be greater than or equal to 1.

[0053] Without being bound by theory, it is believed that during each reuse cycle, during normal use of the drug container, the drug container may contain minor physical and / or chemical damage. When the drug container is reused, these minor physical and / or chemical damages may accumulate over time, which can cause the container to no longer be suitable for reuse. Tracking the number of reuse cycles can allow a used drug container to be removed from service at an appropriate time to reduce the risk of failure of the used drug container. It is further believed that a physical inspection of the drug container alone may not be able to correctly identify the need to take the container out of service. Therefore, tracking the total number of reuse cycles can allow for a more accurate determination of whether a used drug container should be refurbished for reuse or sent for recycling or disposal.

[0054] In an embodiment, determining whether to reuse a used drug container can include comparing an identifier of a previous inclusion with a list of materials for which the drug container is not reusable. In an embodiment, the list of materials for which the drug container is not reusable includes materials having radioactive components, materials derived from human blood products, cytotoxic compounds, other incompatible compounds, or combinations thereof. It is contemplated that the list of materials for which the drug container is not reusable may change with changes in regulations or with changes in scientific knowledge, as specific compounds may be added to the list or removed from the list.

[0055] In an embodiment, determining whether to reuse a used drug container further includes inspecting the used drug container to determine whether certain optical properties have been maintained, and when those optical properties have not been maintained, discarding or recycling the used drug container. During use of the container as a drug container, the contents of the container can be visually inspected to ensure, for example, that layering of the container has not occurred. The container can have certain optical properties to ensure that this visual inspection can occur. The optical properties can include, but are not limited to, light transmittance, turbidity, coloring, light scattering, refractive index, and combinations thereof. In an embodiment, the optical properties of a used drug container can be within 10% of the optical properties of the unused container, where the optical properties can be any one or combination of the following: light transmittance, turbidity, color, light scattering, or refractive index. In an embodiment, the light transmittance of a used drug container across the entire visible spectrum can be within 10% of the light transmittance of the unused container across the entire visible spectrum.

[0056] In an embodiment, determining whether to reuse a used drug container further includes checking the used drug container against a database of used drug containers to determine whether the used drug container is part of a manufacturing batch marked for deactivation, and when the used drug container is part of a manufacturing batch marked for deactivation, recycling or discarding the used drug container. As described herein, a unique identification code can contain information about the manufacture of the drug container, such as the manufacturing date, source location, etc. in some embodiments. This can allow for targeted container batch deactivation. If the manufacturing information of the used drug container cannot be determined for each container, then marking a manufacturing batch for removal may require deactivating containers that are not part of the manufacturing batch to ensure that all containers marked for removal are removed, potentially increasing the waste generated by marking the manufacturing batch.

[0057] Now referring to Figure 2C , steps in the life cycle of a drug container are graphically depicted. Starting at step 270, the container can be filled with a drug product, vaccine, biologic, food, or solution. The container is then used as a drug container (step 280). The used drug container is then received in step 210, and information about the container is received in step 220. Using the received information, in step 230, it is determined whether to refurbish the container (step 240) for reuse or discard or recycle the container (step 250). In step 260, the refurbished (step 240) container is then sent for reuse. The container can go through up to 20 cycles from initial use before it is discarded or recycled (step 250).

[0058] It will be apparent to those skilled in the art that various modifications and variations can be made to the embodiments described herein without departing from the spirit and scope of the claimed subject matter. Accordingly, this specification is intended to cover modifications and variations of the various embodiments described herein provided such modifications and variations come within the scope of the appended claims and their equivalents.

Claims

1. A reusable container, the container comprising glass, an inner surface, and an outer surface, wherein the container is a pharmaceutical container adapted to contain a pharmaceutical product, and wherein: the container has a retention strength within 25% of the strength of the unused container prior to its first use; and the inner surface has a chemical durability ratio (CDR) of 5 or less.

2. The container according to claim 1, wherein the inner surface has a CDR of 4 or less.

3. The container according to claim 1, wherein the inner surface has a CDR greater than or equal to 0.5 and less than or equal to 5.

4. The container according to claim 1, wherein the outer surface has a retention strength within 10% of the strength of the unused container prior to its first use.

5. The container according to claim 1, further comprising a unique identification code.

6. The container according to claim 5, wherein the unique identification code is a Quick Response (QR) code.

7. The container according to claim 5, wherein the unique identification code is visible only when the container is exposed to ultraviolet (UV) light.

8. The container according to claim 5, wherein the unique identification code is laser-etched into the glass.

9. The container according to claim 5, wherein the unique identification code is printed on the surface of the container.

10. The container according to claim 1, wherein the inner surface of the container comprises a total concentration of organic and inorganic contaminants less than the USP limit.

11. The container according to claim 1, wherein the glass is aluminosilicate glass.

12. The container according to claim 11, wherein the glass is strengthened aluminosilicate glass.

13. The container according to claim 12, wherein the strengthened aluminosilicate glass is formed by ion-exchanging aluminosilicate glass in a molten salt bath.

14. The container according to claim 1, wherein the container comprises a low-friction coating on the outer surface of the container.

15. The container according to claim 12, wherein the pharmaceutical product comprises a medicament, a vaccine, a biologic, a solution, or a combination thereof.

16. A method for reusing a used pharmaceutical container, the method comprising: receiving a used pharmaceutical container; and refurbishing the used pharmaceutical container to produce a refurbished pharmaceutical container, wherein refurbishing the used pharmaceutical container comprises: washing the used pharmaceutical container with a caustic solution; washing the used pharmaceutical container with water; and depyrogenating the used pharmaceutical container to produce a refurbished pharmaceutical container, wherein after depyrogenating the used pharmaceutical container, the level of organic and inorganic contaminants in the refurbished pharmaceutical container is less than the USP limit.

17. The method according to claim 16, further comprising sending the refurbished pharmaceutical container for reuse.

18. The method according to claim 16, wherein the caustic solution has a pH from 11 to 14.

19. The method according to claim 16, wherein washing the used pharmaceutical container with the caustic solution further comprises heating the caustic solution to a temperature from 50°C to 95°C.

20. The method according to claim 16, wherein the caustic solution comprises one or more metal hydroxides, metal carbonates, citrates, acetates, oxidizing substances, chelating substances, complex-forming substances, surfactants, soaps, or combinations thereof.

21. The method according to claim 16, wherein depyrogenating the used pharmaceutical container comprises heating the used pharmaceutical container to a temperature from 250 °C to 400 °C for a period from about 30 seconds to about 72 hours.

22. The method according to claim 16, further comprising: receiving information related to the previous contents of the used pharmaceutical container; and determining whether to refurbish and reuse the used pharmaceutical container based on the information related to the previous contents of the used pharmaceutical container.

23. The method according to claim 16, wherein the used pharmaceutical container comprises a unique identification code, and the method further comprises: reading the unique identification code of the used pharmaceutical container; obtaining from a used container database the total number of reuse cycles, an identifier of the previous contents of the used pharmaceutical container, or both; and determining whether to reuse the pharmaceutical container based on the total number of reuse cycles of the used pharmaceutical container, the identifier of the previous contents of the used pharmaceutical container, or both.

24. The method according to claim 23, comprising obtaining from the used container database the total number of reuse cycles and the identifier of the previous contents of the used pharmaceutical container, wherein: when the total number of reuse cycles and the identifier of the previous contents permit reuse of the pharmaceutical container, refurbishing the used pharmaceutical container to produce a refurbished pharmaceutical container; and when the total number of reuse cycles or the identifier of the previous contents does not permit reuse of the pharmaceutical container, recycling or discarding the used pharmaceutical container.

25. The method according to claim 23, wherein determining whether to reuse the used pharmaceutical container comprises comparing the total number of reuse cycles with a threshold number of reuse cycles, and when the total number of reuse cycles is greater than the threshold number of reuse cycles, reuse of the pharmaceutical container is not permitted.

26. The method according to claim 25, wherein the threshold number of reuse cycles is less than or equal to 20.

27. The method according to claim 23, wherein determining whether to reuse the used pharmaceutical container comprises comparing the identifier of the previous contents with a list of materials for which the used pharmaceutical container cannot be reused.

28. The method according to claim 27, wherein the list of materials for which the used pharmaceutical container cannot be reused comprises materials having radioactive components, materials derived from human blood products, cytotoxic compounds, or combinations thereof.

29. The method according to claim 23, wherein determining whether to reuse the used drug container further comprises inspecting the used drug container to determine whether the light transmittance of the used drug container across the entire visible spectrum is within 10% of the light transmittance of the unused drug container across the entire visible spectrum before its first use, and whether the used drug container has any unacceptable appearance defects; and when the light transmittance of the used drug container across the entire visible spectrum is not within 10% of the light transmittance of the unused drug container across the entire visible spectrum, or the used drug container exhibits one or more unacceptable appearance defects, discard or recycle the used drug container.

30. The method according to claim 23, wherein determining whether to reuse the used drug container further comprises: checking the used drug container against a database of used drug containers to determine whether the used drug container is part of a manufacturing batch marked as discontinued; and when the drug container is part of a manufacturing batch marked as discontinued, recycle or discard the used drug container.

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