Reusable pharmaceutical containers and their reuse process

Abstract

The container for reuse can include glass, an interior surface, and an exterior surface. The container can be a pharmaceutical container adapted to hold a pharmaceutical product. The container can have a retained strength within 25% of that of an unused container before first use. The interior surface can have a chemical durability ratio of 5 or less.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of priority under 35 U.S.C. § 119 of U.S. Provisional Application No. 63 / 428,931, filed November 30, 2022, the contents of which are relied upon and incorporated herein by reference in their entirety.

[0002] FIELD OF THE DISCLOSURE The present disclosure relates to pharmaceutical containers, and more particularly to reusable pharmaceutical containers and the reuse of same. [Background technology]

[0003] Historically, glass has been used as a preferred material for packaging pharmaceuticals due to its hermeticity, optical transparency, and superior chemical durability compared to other materials. Specifically, glass used in pharmaceutical packaging must have adequate chemical durability so as not to affect the stability of the pharmaceutical composition contained therein, and adequate mechanical performance to prevent breakage of the packaging during processing or use. However, currently, glass pharmaceutical packaging is often used only once before being recycled or, more commonly, discarded. As a result, a large amount of waste is generated through the use of glass pharmaceutical packaging. Summary of the Invention

[0004] Thus, there is an ongoing need for glass pharmaceutical packaging that can be reused, and processes for refurbishing and reusing glass pharmaceutical packaging. The present disclosure is directed to glass pharmaceutical packaging that can be reclaimed and reused, and processes for refurbishing and reusing glass pharmaceutical packaging.

[0005] According to one or more embodiments, a container for reuse may include glass, an interior surface, and an exterior surface. The container may be a pharmaceutical container adapted to hold a pharmaceutical product. The container may have a retained strength within 25% of that of an unused container before first use. The interior surface may have a chemical durability ratio of 5 or less.

[0006] According to additional embodiments, a process for reusing used pharmaceutical containers may include receiving a used pharmaceutical container and regenerating the used pharmaceutical container to produce a regenerated pharmaceutical container. Regenerating the used pharmaceutical container may include cleaning the used pharmaceutical container with a caustic solution, washing the used pharmaceutical container with water, and depyrogenating the used pharmaceutical container to produce the regenerated pharmaceutical container. After depyrogenating the used pharmaceutical container, the levels of organic and inorganic contaminants in the regenerated pharmaceutical container may be below USP limits.

[0007] Additional features and advantages of the embodiments described herein will be set forth in the detailed description that follows, and in part will become readily apparent to those skilled in the art from that description, or will be learned by practicing the embodiments described herein, including the following detailed description, the claims, and the accompanying drawings.

[0008] It is to be understood that both the foregoing general description and the following detailed description are intended to describe various embodiments and provide an overview or framework for understanding the nature and features 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 various embodiments described herein, and together with the description, serve to explain the principles and operation of the claimed subject matter. [Brief explanation of the drawings]

[0009] [Figure 1] 1A and 1B illustrate schematic cross-sections of glass containers according to one or more embodiments described herein. [Figure 2A] 1 shows a flowchart including steps in a process for reusing used pharmaceutical containers according to one or more embodiments described herein. [Figure 2B] 1 shows a flowchart including steps in a process for reusing used pharmaceutical containers according to one or more embodiments described herein. [Figure 2C] 1 shows a flowchart including steps in a process for reusing used pharmaceutical containers according to one or more embodiments described herein. DETAILED DESCRIPTION OF THE INVENTION

[0010] Specific embodiments of the present application will now be described. However, this disclosure may be embodied in different forms and should not be construed as limited to the embodiments set forth in this disclosure. Rather, 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.

[0011] Embodiments of the present disclosure are also directed to a process for reusing used pharmaceutical containers. The process may include receiving a used pharmaceutical container and reclaiming the used pharmaceutical container to produce a reclaimed pharmaceutical container. Reclaiming the used pharmaceutical container may include washing the used pharmaceutical container with a caustic solution, washing the used pharmaceutical container with water, and depyrogenating the used pharmaceutical container. After depyrogenating the used pharmaceutical container to produce the reclaimed pharmaceutical container, the levels of organic and inorganic contaminants in the reclaimed pharmaceutical container may be below detectable limits.

[0012] The containers and processes for reusing containers of the present disclosure may generate less waste than the use of conventional containers 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 significant amount of waste, much of which may end up in landfills. The containers and processes of the present disclosure may enable the reuse of pharmaceutical containers, reducing the amount of waste generated from using pharmaceutical containers and therefore reducing the amount of waste requiring disposal in landfills.

[0013] As used herein, the term "recycling" refers to the process of melting the glass of pharmaceutical containers and forming the molten glass into one or more glass articles.

[0014] As used herein, the term "reuse" refers to using a pharmaceutical container after it has already been used at least once before and then being regenerated without melting the glass container and forming the molten glass into a new container.

[0015] As used herein, the term "chemical durability ratio" (CDR) refers to a measurement of the tendency of a glass container to delaminate. As described in U.S. Patent Application Publication No. 2021 / 0080448A1, the entire contents of which are incorporated herein by reference, CDR indicates the level of non-uniformity on the interior surface of the container through the ratio of the "untreated" and "etched" titration values ​​for the container.

[0016] As used herein, the term "delamination" refers to the phenomenon in which glass particles are released from the surface of glass following a series of leaching, corrosion, and / or weathering reactions. Typically, the particles are silica-rich flakes or lamellae of glass that arise from the interior surface of a container as a result of the leaching of modifying ions, such as boron, or weak network formers, into a solution contained within the container. These flakes or lamellae are typically between 1 nm and 2 microns thick and can be greater than about 50 microns wide. Because these flakes or lamellae are primarily composed of silica, they generally do not further decompose after being released from the surface of the glass.

[0017] Referring now to FIG. 1 , one embodiment of a container 100 for reuse is shown schematically in cross section. The container 100 generally comprises a body 102. The body 102 extends between an inner surface 104 and an outer surface 106 and encloses an interior volume 108. In the embodiment shown in FIG. 1 , the body 102 generally comprises a cylindrical wall 110 and a floor 112. The cylindrical wall 110 transitions to the floor 112 via a heel 114. The body 102 has a wall thickness T extending between the inner surface 104 and the outer surface 106. W It has.

[0018] As described herein, in embodiments, container 100 for reuse may include glass, an interior surface 104, and an exterior surface 106. In embodiments, container 100 may be a pharmaceutical container. In embodiments, container 100 may be adapted to hold one or more of a pharmaceutical product, a vaccine, a biologic, a solution, or a combination thereof. While container 100 is shown in FIG. 1 as a vial, it should be understood that container 100 may have other form factors, including, but not limited to, Vacutainers®, cartridges, syringes, bottles, flasks, vials, tubes, beakers, etc.

[0019] In embodiments, the glass may be an aluminosilicate glass composition, such as the glass compositions disclosed in U.S. Patent No. 8,551,898, which is incorporated herein by reference in its entirety, sold by Corning® Incorporated as Valor® glass, and disclosed in U.S. Patent No. 9,145,329, which is incorporated herein by reference in its entirety. <660> In embodiments, the glass may be an aluminosilicate glass composition that meets the criteria for Type 1 as defined in U.S. Pat. No. 10,640,415, entitled "Lithium Containing Aluminosilicate Glasses," filed November 29, 2017, which is incorporated by reference in its entirety, or U.S. Patent Publication No. 2020 / 0290920, entitled "Chemically Durable Aluminosilicate Glass Compositions and Glass Articles Formed Therefrom," filed September 17, 2020, which is incorporated by reference in its entirety. In embodiments, the glass may be an aluminosilicate glass composition that has undergone an etching process, such as an acid etch or a fluoride etch, to remove deposits on the interior surface 104 of the container 100. In embodiments, the glass may be a 33-expanded borosilicate glass, such as that sold by DWK Life Sciences as KIMBAL® 33 or that sold by Schott as BOROFLOAT® 33. Expansion 33 Glass has a coefficient of thermal expansion of 33, USP <660> In embodiments, the glass may be a 51 expansion borosilicate glass, such as that sold by DWK Life Sciences as KIMBAL® 51 or that sold by Corning® as 51-D clear borosilicate glass tubing. Expanded 51 glass has a coefficient of thermal expansion of 51 and is a Type 1A glass according to USP <660> It is a Type 1B glass.In embodiments in which the glass is 33 expansion glass or 51 expansion borosilicate glass, the exterior surface 106 of the container 100 may be coated with an exterior coating; for example, a suitable container may be a coated container sold by Corning® Incorporated as Velocity®.

[0020] 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. Pat. No. 8,551,898, which is incorporated herein by reference in its entirety, and U.S. Pat. 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 contemplated herein.

[0021] Without being bound by theory, it is believed that aluminosilicate glass compositions may have sufficient chemical durability, mechanical strength, and optical performance for reuse. For example, such glass compositions may have a relatively uniform surface chemistry with relatively low non-uniformity, which improves the chemical durability of containers, compared to glass compositions with a less uniform surface chemistry with more non-uniformity. When a glass article containing volatile species, such as a glass with more sodium and / or boron (e.g., a glass with more than 0.1 mol% NaO and / or B2O3, such as more than 0.5 mol%, more than 1 mol%, more than 2 mol%, or more than 4 mol%), is heated (such as during a thermomechanical conversion process for converting a glass tube into multiple glass containers), the sodium and / or boron may be volatilized and released from the surface of the glass. The volatilized sodium and / or boron may later condense on cooler portions of the glass tube or glass container surface, causing compositional non-uniformity on the glass container surface. Such compositional non-uniformity on the glass container surface may result in reduced chemical durability and a greater tendency for delamination of the glass surface.

[0022] The uniformity of the surface concentration of glass components across a surface region of the glass is generally indicative of the tendency of the glass composition to delaminate and shed glass particles from the inner surface 104 of the container 100. When a glass composition has consistent surface uniformity within the surface region (i.e., when the extreme values ​​of the surface concentration of a glass component within the surface region at a discrete point A on the inner surface 104 are within ±30% of the same component within the surface region at any second discrete point B or C on the inner surface 104), the glass composition has improved resistance to delamination.

[0023] A glass container 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 forming the glass container from a glass composition whose components form species with relatively low vapor pressures (i.e., species with low volatility) at the temperatures required to form the glass tube into a glass container having the desired container shape. Acid etching assumes that non-uniformities form on the inner surface of the glass container, and acid etching removes the non-uniformities from the inner surface of the glass container, creating consistent surface uniformity in the finished glass container. When the components of the glass form species with relatively low vapor pressures at the reforming temperature, the components are less likely to volatilize from the surface of the glass, evaporate, and then condense on the cooler surface of the glass. Reducing or preventing volatilization of the components of the glass can enable the formation of a glass container with a compositionally uniform surface on the inner surface of the glass container and throughout the thickness of the glass container.

[0024] In embodiments, the container 100 may be resistant to delamination after exposure to certain compositions stored within the container 100. The delamination risk of a glass container 100 may be measured using a Chemical Durability Ratio (CDR). A method for assessing the CDR of a glass container includes (1) a hydrolysis test of the untreated surface, (2) an etching step to remove any chemical inhomogeneities that may be present, and (3) a second hydrolysis test of the "etched" surface. An "untreated" container may be resistant to delamination following exposure to certain compositions stored within the container 100, as defined by the USP <660> Processed according to the Surface Glass Test with one notable deviation: the fill volume is 12.5% ​​of the full capacity. Due to the reduced fill volume, an additional container is required to generate the amount of solution required for the titration. The titration volume is recorded as the "raw" response.

[0025] First USP for "untreated" containers <600> Following the surface glass test, the "untreated" container is then subjected to an etching process to remove any material deposited or incorporated during the conversion or molding process. At least 1 micron (depth) of the surface is removed using an HCl / HF acid mixture with a target concentration of 2.3M HF / 4.6M HCl. The container is exposed to this solution for a minimum of 3 minutes. These conditions are sufficient for most Type 1 glass compositions, and mass loss is measured to confirm sufficient depth of surface removal. After exposure to the target acid solution, any acid residue in the container is removed by immersion in two room temperature water baths for 5 minutes each. The container is then rinsed several times with high-purity water. The container used for the "etched" response was the retained container from the "untreated" test. After etching, a second USP <660> Surface glass testing is performed on the "etched" container to measure the bulk glass response, again at a reduced loading of 12.5%.

[0026] "Etched" containers are USP <660> The surface is treated according to the glass test and processed using a reduced fill volume (12.5% ​​of the maximum capacity). The resulting titrant volume is recorded as the "etched" titration response. The ratio of the recorded titrant volumes is calculated as follows (*reduced volume):

number

[0027] The CDR value represents the risk of delamination, and containers with uniform surface chemistry exhibit a low CDR and are at the lowest risk of delamination.

[0028] As described herein, in embodiments, the container 100 may have a CDR of 5 or less. In embodiments, the interior 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 embodiments, the interior surface 104 may have a CDR of 0.5 or more to 5 or less. For example, the inner surface 104 has a refractive index of 0.5 or more and 4 or less, 0.5 or more and 3.5 or less, 0.5 or more and 3 or less, 0.5 or more and 2.5 or less, 0.5 or more and 2.0 or less, 0.5 or more and 1.5 or less, 0.5 or more and 1 or less, 1 or more and 5 or less, 1 or more and 4.5 or less, 1 or more and 4 or less, 1 or more and 3.5 or less, 1 or more and 3 or less, 1 or more and 2.5 or less, 1 or more and 2 or less, 1 or more and 1.5 or less, 1.5 or more and 5 or less, 1.5 or more and 4.5 or less, 1.5 or more and 4 or less, 1.5 or more and 3.5 or less, 1.5 or more and 3 or less, 1.5 or more and 2.5 or less, 1.5 or more and 2 or less The container 100 may have a CDR of 0.5 to 4.5, such as 5 or less, 2 to 4.5, 2 to 4, 2 to 3.5, 2 to 3, 2 to 2.5, 2.5 to 5, 2.5 to 4.5, 2.5 to 4, 2.5 to 3.5, 2.5 to 3, 3 to 5, 3 to 4.5, 3 to 4, 3 to 3.5, 3.5 to 5, 3.5 to 4.5, 3.5 to 4, 4 to 5, 4 to 4.5, 4.5 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 reuse of the container 100. A container 100 with adequate delamination performance for disposable use may not have adequate delamination performance for reuse. It is believed that the likelihood of delamination may increase each time the container is used because each use may potentially expose the container to compositions, such as corrosive compositions, that may 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 adequate delamination performance, even after multiple uses.

[0029] As the container 100 is used, it may lose a certain level of mechanical strength after each use. In embodiments, a used container 100 may retain a certain percentage of its mechanical strength when compared to an unused container 100. In embodiments, the retained mechanical strength of a used container 100 may be within 25% of the mechanical strength of the original container before first use. For example, the retained mechanical strength of a used container may be within 24% of the mechanical strength of the original container before 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 first use. In embodiments, the mechanical strength of the container 100 may be measured by a quasi-static modulus of burst test, in which the horizontal compression, vertical compression, or internal pressure required to burst the container 100 (burst pressure) is used to determine the mechanical strength of the container 100.

[0030] In embodiments, 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. An outer surface coated with a low-friction coating may have a coefficient of friction of 0.7 or less. In embodiments, the low-friction coating on the outer surface 106 of the container 100 may be a low-friction coating such as that described in U.S. Pat. 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 applying a low-friction coating to the outer surface 106 of the container 100 can reduce mechanical damage 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 routine use. As mechanical damage accumulates, the strength of the container 100 may decrease, which may make the container 100 unsuitable for reuse. Therefore, reducing mechanical damage to the container 100 may improve the lifespan of the container 100 and facilitate reuse of the container 100.

[0031] Once the container 100 is used, the container 100, and its contents, may be visually inspected to ensure, for example, that delamination of the container 100 has not occurred. The container 100 may have certain optical properties to ensure that such visual inspection can occur. Optical properties may include, but are not limited to, transparency, color haze, refractive index, light scattering, or combinations thereof. In embodiments, the transparency across the visible spectrum of a used pharmaceutical container 100 may be within 10% of the transparency across the visible spectrum of an unused container 100. For example, the transparency across the visible spectrum of a used container 100 may be within 9% of the transparency across the visible spectrum of an unused container 100, such as within 8%, within 7%, within 6%, within 5%, within 4%, within 3%, within 2%, or even within 1% of the transparency across the visible spectrum of the original container prior to first use.

[0032] In embodiments, the color haze of a used pharmaceutical container 100 may be within 10% of the color haze of an unused container 100. In embodiments, the refractive index of a used pharmaceutical container 100 may be within 10% of the refractive index of an unused container 100. In embodiments, the light scattering of a used pharmaceutical container 100 may be within 10% of the light scattering of an unused container 100. In embodiments, the container 100 may be free of coloration, scattering, and / or haze. In embodiments, the container 100 may have minimal scratches or other accumulated cosmetic damage that may cause inconsistencies in the appearance of the container 100.

[0033] In embodiments, the container 100 may further comprise a unique identification code. In embodiments, the unique identification code may be used to identify the manufacturing lot of the container, the previous contents of the container 100, the previous number of uses of the container 100, or a combination thereof. The unique identification code may be suitable to provide resolution at the level of billions of unique identities, by way of example and not limitation, and may be encoded into the marking by the shape, structure, or resonance of the marking. A marking comprising the unique identification code may be permanently affixed to or embedded in the surface of the glass. The unique identification code may directly encode component manufacturing information, such as manufacturing date, country of origin, etc. The amount of information that needs to be encoded into any particular unique identification code will vary depending on the requirements of the unique identification code used. However, as one example, the mark comprising 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 numeric digits or less, up to 36 or more alphanumeric digits, are useful for tracking pharmaceutical products, with unique identification codes encoding 16 alphanumeric digits being considered typical. A 16-digit pattern can incorporate sufficient information for most manufacturing purposes and can be easily printed in glass at a machine-readable size. In embodiments, the unique identification code may include information about the container, identify the container, redirect to a database with information about used pharmaceutical containers, or a combination thereof. In embodiments, the mark comprising the unique identification code may be a quick response (QR) code. In embodiments, the mark comprising the unique identification code may be visible only when the container 100 is exposed to ultraviolet (UV) light, such as the mark disclosed in U.S. Pat. No. 10,676,240, the entire contents of which are incorporated herein by reference. In embodiments, the mark comprising the unique identification code may be laser etched into the glass. 1, the mark comprising the unique identification code may be a laser etched marking 116 disposed between the inner surface 104 and the outer surface 106 of the container. In embodiments, the mark comprising the unique identification code may be printed on the surface of the container 100.Suitable methods for applying marks with unique identification codes via laser etching, surface printing, or both are disclosed in U.S. Patent No. 10,676,240, hereinabove, which is incorporated by reference in its entirety. However, it should be understood that other methods of applying marks with unique identification codes are contemplated herein.

[0034] In embodiments, the interior surface 104 of the container 100 may contain a total concentration of organic and / or inorganic contaminants that is below the detectable limit. Pharmaceutical manufacturers and government agencies may require a certain maximum level of organic or inorganic contaminants in a container for use as pharmaceutical packaging. For example, the acceptable level of organic or inorganic contaminants in the container 100 may be below the detectable limit, such that the inorganic or organic contaminants cannot be conventionally detected in the interior volume 108 or on the interior surface 104 of the container 100. In embodiments, the container 100 may have less than 0.15 μg of any organic contaminant that can conventionally be detected in the interior volume 108 or on the interior surface 104 of the container 100. In embodiments, the container 100 may be compliant with USP <232> and <233> In an embodiment, the interior surface 104 of the container 100 may have less than 10 ppm of each element detectable in a USP Surface Glass Test Extraction.

[0035] As described above, a process for reusing used pharmaceutical containers is disclosed herein. As shown in FIG. 2A , in an embodiment, process 200 for reusing used pharmaceutical containers may include receiving a used pharmaceutical container (step 210) and regenerating the used pharmaceutical container to produce a regenerated pharmaceutical container (step 240). In an embodiment, regenerating the used pharmaceutical container (step 240) may include cleaning 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 to produce the regenerated pharmaceutical container (step 246), the levels of organic and inorganic contaminants in the regenerated pharmaceutical container may be below detectable limits.

[0036] In embodiments, the used pharmaceutical containers may be washed with a caustic solution (step 242). In embodiments, the caustic solution may have a pH of 11-14, such as 11-13, 11-12, 12-14, 12-13, 13-14, or any combination of these ranges. The process of claim 16, wherein the caustic solution includes one or more metal hydroxides, metal carbonates, citrates, acetates, oxidizing species, chelating species, complexing species, surfactants, soaps, or combinations thereof. For example, the caustic solution may include one or more of 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 a used pharmaceutical container with a caustic solution may remove inorganic or organic contaminants remaining on the glass surface from the previous use of the used pharmaceutical container.

[0037] In embodiments, washing the used pharmaceutical container with a caustic solution (step 242) includes washing the used pharmaceutical container with a caustic solution at temperatures between 50°C and 90°C, between 50°C and 85°C, between 50°C and 80°C, between 50°C and 75°C, between 50°C and 70°C, between 50°C and 65°C, between 50°C and 60°C, between 50°C and 55°C, between 55°C and 95°C, between 55°C and 90°C, between 55°C and 85°C, between 55°C and 80°C, between 55°C and 75°C, between 55°C and 70°C, between 55°C and 65°C, between 55°C and 60°C, between 60°C and 95°C, between 60°C and 90°C, between 60°C and 85°C, between 60°C and 80°C, between 60°C and 75°C, between 60°C and 70°C, The method may further include heating to a temperature of 50°C to 95°C, such as 60°C to 65°C, 65°C to 95°C, 65°C to 90°C, 65°C to 85°C, 65°C to 80°C, 65°C to 75°C, 65°C to 70°C, 70°C to 95°C, 70°C to 90°C, 70°C to 85°C, 70°C to 80°C, 70°C to 75°C, 75°C to 95°C, 75°C to 90°C, 75°C to 85°C, 75°C to 80°C, 80°C to 95°C, 80°C to 90°C, 80°C to 85°C, 85°C to 95°C, 85°C to 90°C, 90°C to 95°C, or any combination of these ranges. Without being bound by theory, it is believed that caustic solutions at temperatures below 50°C may not be as effective at removing inorganic and organic contaminants from used pharmaceutical containers as caustic solutions at temperatures above 50°C.

[0038] In embodiments, reclaiming the used pharmaceutical containers (step 240) may include rinsing the used pharmaceutical containers with water (step 244). The water rinsing in step 244 may occur after rinsing the used pharmaceutical containers with a caustic solution in step 242. The water rinsing may remove residual caustic solution from the surfaces of the used pharmaceutical containers. In embodiments, the water for the water rinsing in step 244 may be at ambient temperature. In embodiments, the water for the water rinsing, i.e., step 244, may be heated to a temperature above ambient temperature, such as, for example, 30°C or higher, 40°C or higher, 50°C or higher, 60°C or higher, 70°C or higher, 80°C or higher, or even 90°C or higher. The temperature of the water during the water rinsing step 244 may be less than 100°C.

[0039] In embodiments, regenerating the used pharmaceutical container (step 240) may include first cleaning the container with a caustic solution (step 242), then cleaning the container with water after the caustic solution clean (step 244), and then depyrogenating the used pharmaceutical container after the water clean (step 246). In embodiments, regenerating the used pharmaceutical container (step 240) may further include exposing the container to UV light. In embodiments, regenerating the 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 beneficially assist in their removal from the container.

[0040] 2A , in embodiments, regenerating the used pharmaceutical container (step 240) may include depyrogenating the used pharmaceutical container (step 246). Depyrogenating the used pharmaceutical container (step 246) may occur after washing the used pharmaceutical container with a caustic solution (step 242) and water (step 244). In embodiments, depyrogenating the used pharmaceutical container may involve depyrogenating the used pharmaceutical container at temperatures ranging from 250°C to 375°C, 250°C to 350°C, 250°C to 325°C, 250°C to 300°C, 250°C to 275°C, 275°C to 400°C, 275°C to 375°C, 275°C to 350°C, 275°C to 325°C, 275°C to 300°C, or 300°C to 400°C. This may include heating to a depyrogenation temperature of 250°C to 400°C, such as 0°C, 300°C to 375°C, 300°C to 350°C, 300°C to 325°C, 325°C to 400°C, 325°C to 375°C, 325°C to 350°C, 350°C to 400°C, 350°C to 375°C, 375°C to 400°C, or any combination of these ranges.

[0041] In embodiments, depyrogenating the used pharmaceutical container (step 246) includes heating the used pharmaceutical container to a depyrogenation temperature, and heating the used pharmaceutical container to the depyrogenation temperature for about 30 seconds to about 60 hours, about 30 seconds to about 48 hours, about 30 seconds to about 36 hours, about 30 seconds to about 24 hours, about 30 seconds to about 12 hours, about 30 seconds to about 6 hours, about 30 seconds to about 1 hour, about 1 hour to about 72 hours, about 1 hour to about 60 hours, about 1 hour to about 48 hours, about 1 hour to about 36 hours, about 1 hour to about 24 hours, about 1 hour to about 12 hours, about 1 hour to about 6 hours, about 6 hours to about 72 hours, about 6 hours to about 60 hours, or about 6 hours to about 48 hours. for a period of about 30 seconds to about 72 hours, such as about 6 hours to about 36 hours, about 6 hours to about 24 hours, about 6 hours to about 12 hours, about 12 hours to about 72 hours, about 12 hours to about 60 hours, about 12 hours to about 48 hours, about 12 hours to about 36 hours, about 12 hours to about 24 hours, about 24 hours to about 72 hours, about 24 hours to about 60 hours, about 24 hours to about 48 hours, about 24 hours to about 36 hours, about 36 hours to about 72 hours, about 36 hours to about 60 hours, about 36 hours to about 48 hours, about 48 hours to about 72 hours, about 48 hours to about 60 hours, about 60 hours to about 72 hours, or any combination of these ranges.

[0042] In embodiments, regenerating (240) a used pharmaceutical container may include first rinsing (242) the container with a caustic solution, then rinsing (244) the container with water after the caustic solution rinse, and then depyrogenating (246) the used pharmaceutical container after the water rinse.

[0043] In embodiments, the process for reusing used pharmaceutical containers may further include sending the refurbished pharmaceutical container for reuse. In embodiments, the refurbished pharmaceutical container may be sent for reuse and may be reused in the same manner as it was used before refurbishment. In embodiments, a refurbished pharmaceutical container that previously contained a particular pharmaceutical product may be sent for reuse with the same pharmaceutical product initially. In embodiments, the refurbished pharmaceutical container may be sent for reuse and may be reused in a manner different from that in which it was used before refurbishment. For example, in embodiments, a refurbished pharmaceutical container previously used to contain a first pharmaceutical product may be sent for reuse with a second pharmaceutical product that is different from the first pharmaceutical product.

[0044] 2B , in an embodiment, a process 200 for reusing a used pharmaceutical container may further include receiving information about the used pharmaceutical container (step 220) after receiving the used pharmaceutical container (step 210). The pharmaceutical container may be received (step 210) after being used (step 205). Process 200 may also further include determining whether to reclaim and reuse the used pharmaceutical container (step 230) based on the information associated with the used pharmaceutical container. When it is determined not to reclaim and reuse the used pharmaceutical container (step 240), the container may be recycled or discarded (step 250). The information about the used pharmaceutical container may include, but is not limited to, the previous contents of the used pharmaceutical container, the number of times the used pharmaceutical container has been reused, the lot number of the used pharmaceutical container, other information about the used pharmaceutical container, or a combination thereof.

[0045] In embodiments, information associated with a used pharmaceutical container may include the previous contents of the used pharmaceutical container, and a decision whether to reclaim and reuse the used pharmaceutical container may be based entirely or partially on the previous contents of the used pharmaceutical container. In embodiments, the previous contents of a used pharmaceutical container may prevent the container from being reused. For example, containers used for human blood and blood components, or containers used for radioactive materials, may not be permitted for reuse by government regulations and must instead be recycled or disposed of. In other embodiments, the previous contents of a used pharmaceutical container may enable reuse of the used pharmaceutical container, and the used pharmaceutical container may be reclaimed.

[0046] In embodiments, the used pharmaceutical container may include a unique identification code. In these embodiments, the process for reusing a used pharmaceutical container may further include reading the unique identification code of the used pharmaceutical container, using the unique identification code to obtain the total number of reuse cycles for the used pharmaceutical container, the identity of the previous contents, or both, from a used container database, and determining whether to reuse the pharmaceutical container based on the total number of reuse cycles for the used pharmaceutical container, the identity of the previous contents of the used pharmaceutical container, or both. The term "used container database" refers to, but is not limited to, any database or collection of information that links the unique identification code of the used pharmaceutical container with information about the used pharmaceutical container, such as the previous contents, the number of reuse cycles, lot number, or other information. In embodiments, when both the total number of reuse cycles and the identity of the previous contents indicate that the used pharmaceutical container is acceptable for reuse, the process may include reclaiming the used pharmaceutical container to produce a reclaimed pharmaceutical container. In embodiments, when either the total number of reuse cycles or the identity of the previous contents indicates that the reuse of the used pharmaceutical container is not permitted, the process may include recycling or disposal of the used pharmaceutical container.

[0047] In embodiments, determining whether to reuse a used pharmaceutical container includes comparing the total number of reuse cycles to a threshold number of reuse cycles and not allowing reuse of the pharmaceutical container when the total number of reuse cycles is greater than the threshold number. As used herein, the term "reuse cycle" refers to using the pharmaceutical container, refurbishing the pharmaceutical container, and sending the pharmaceutical container for reuse. In embodiments, the threshold number may be 200 or fewer reuse cycles, such as 175 or fewer reuse cycles, 150 or fewer reuse cycles, 125 or fewer reuse cycles, 100 or fewer reuse cycles, 75 or fewer reuse cycles, 50 or fewer reuse cycles, or even 25 or fewer reuse cycles. In embodiments, the threshold number may be 200 or more reuse cycles. In embodiments, the threshold number may be 1 or greater.

[0048] Without being bound by theory, it is believed that pharmaceutical containers may experience small amounts of physical and / or chemical damage during normal use of the pharmaceutical container during each reuse cycle. When a pharmaceutical container is reused, these small amounts of physical and / or chemical damage may accumulate over time, potentially rendering the container no longer suitable for reuse. Tracking the number of reuse cycles may enable used pharmaceutical containers to be removed from service in a timely manner to reduce the risk of failure of the used pharmaceutical container. Furthermore, it is believed that physical inspection of a pharmaceutical container may not, by itself, correctly identify the need to remove the container from service. Therefore, tracking the total number of reuse cycles may enable a more accurate determination of whether a used pharmaceutical container should be reclaimed for reuse or sent for recycling or disposal.

[0049] In embodiments, determining whether to reuse a used pharmaceutical container may include comparing the identity of the previous contents to a list of materials for which the pharmaceutical container cannot be reused. In embodiments, the list of materials for which the pharmaceutical container cannot be reused includes materials with 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 pharmaceutical container cannot be reused may change with changing regulations or scientific knowledge, as certain compounds may be added or removed from the list.

[0050] In embodiments, determining whether to reuse a used pharmaceutical container further includes inspecting the used pharmaceutical container to determine whether certain optical properties are maintained and discarding or recycling the used pharmaceutical container when those optical properties are not maintained. During use of the container as a pharmaceutical container, the contents of the container may be visually inspected, for example, to ensure that delamination of the container has not occurred. The container may have certain optical properties to ensure that such visual inspection can occur. Optical properties may include, but are not limited to, transparency, haze, color, light scattering, refractive index, and combinations thereof. In embodiments, the optical properties of the used pharmaceutical container may be within 10% of the optical properties of an unused container, and the optical properties may be any one or combination of transparency, haze, color, light scattering, or refractive index. In embodiments, the transparency across the visible spectrum of the used pharmaceutical container may be within 10% of the transparency across the visible spectrum of the unused container.

[0051] In embodiments, determining whether to reuse the used pharmaceutical container further includes checking the used pharmaceutical container against a used pharmaceutical container database to determine whether the used pharmaceutical container is part of a manufacturing lot flagged for removal from service, and recycling or disposing of the used pharmaceutical container when the used pharmaceutical container is part of a manufacturing lot flagged for removal from service. As described herein, the unique identification code, in some embodiments, may include information regarding the manufacturing of the pharmaceutical container, such as manufacturing date, country of origin, etc. This may allow the target container lot to be removed from service. If manufacturing information for the used pharmaceutical container could not be determined for each container, flagging a manufacturing lot for removal may require containers that are not part of that manufacturing lot to be removed from service to ensure all containers flagged for removal have been removed, potentially increasing the waste generated from flagging the manufacturing lot.

[0052] Referring now to FIG. 2C, steps in the life cycle of a pharmaceutical container are graphically illustrated. Starting at step 270, the container may be filled with a pharmaceutical product, vaccine, biologic, food, or solution. The container may then be used as a pharmaceutical container (step 280). A used pharmaceutical container is then received at step 210, and information about the container is received at step 220. Using the received information, it is determined at step 230 whether to refurbish the container for reuse (step 240) or to discard or recycle the container (step 250). The refurbished (step 240) container is then sent for reuse at step 260. The container may survive as many as 20 cycles (step 250), starting from its first use, before being discarded or recycled.

[0053] 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. Thus, it is intended that the present specification 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 interior surface, and an exterior surface, the container being a pharmaceutical container adapted to hold a pharmaceutical product; the container has a retained strength within 25% of the strength of an unused container before first use; The interior surface has a chemical durability ratio (CDR) of 5 or less.

2. 10. The container of claim 1, wherein the interior surface has a CDR of 4 or less.

3. 10. The container of claim 1, wherein the inner surface has a CDR of 0.5 or more and 5 or less.

4. 10. The container of claim 1, wherein the exterior surface has a retained strength within 10% of that of an unused container prior to the first use.

5. The container of claim 1 further comprising a unique identification code.

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

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

8. 6. The container of claim 5, wherein the unique identification code is laser etched into the glass.

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

10. 10. The container of claim 1, wherein the interior surface of the container comprises a total concentration of organic and inorganic contaminants that is below USP limits.

11. 10. The container of claim 1, wherein the glass is an aluminosilicate glass.

12. 12. The container of claim 11, wherein the glass is a toughened aluminosilicate glass.

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

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

15. 13. The container of claim 12, wherein the pharmaceutical product comprises a drug, a vaccine, a biologic, a solution, or a combination thereof.

16. 1. A process for reusing used pharmaceutical containers, the process comprising: Receiving used medication containers; and reclaiming the used pharmaceutical container to produce a reclaimed pharmaceutical container, wherein reclaiming 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 levels of organic and inorganic contaminants in the refurbished pharmaceutical container are below USP limits.

17. 17. The process of claim 16, further comprising sending the refurbished pharmaceutical container for reuse.

18. 17. The process of claim 16, wherein the caustic solution has a pH of 11 to 14.

19. 17. The process of claim 16, wherein said washing said used pharmaceutical container with a caustic solution further comprises heating said caustic solution to a temperature of from 50°C to 95°C.

20. 17. The process of claim 16, wherein the caustic solution comprises one or more metal hydroxides, metal carbonates, citrates, acetates, oxidizing species, chelating species, complexing species, surfactants, soaps, or combinations thereof.

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

22. receiving information regarding the previous contents of the used pharmaceutical container; 17. The process of claim 16, further comprising: determining whether to reclaim and reuse the used pharmaceutical container based on the information regarding the previous contents of the used pharmaceutical container.

23. The used pharmaceutical container is provided with a unique identification code, and the process comprises: reading the unique identification code of the used pharmaceutical container; obtaining a total number of reuse cycles for the used pharmaceutical container, an identity of the previous contents, or both from a used container database; 17. The process of claim 16, further comprising: determining whether to reuse the pharmaceutical container based on the total number of reuse cycles of the used pharmaceutical container, the identity of the previous contents of the used pharmaceutical container, or both.

24. obtaining the total number of reuse cycles of the used pharmaceutical container and the identification of the previous contents from the used container database; reclaiming the used pharmaceutical container to produce a reclaimed pharmaceutical container when the total number of reuse cycles and the identification of the previous contents permit reuse of the pharmaceutical container; 24. The process of claim 23, wherein the used pharmaceutical container is recycled or discarded when either the total number of reuse cycles or the identification information of the previous contents does not permit reuse of the pharmaceutical container.

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

26. 26. The process of claim 25, wherein the threshold number of reuse cycles is 20 or less.

27. 24. The process of claim 23, wherein determining whether to reuse the used pharmaceutical container includes comparing the identification information of the previous contents to a list of materials for which the used pharmaceutical container cannot be reused.

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

29. Determining whether to reuse the used pharmaceutical container includes inspecting the used pharmaceutical container to determine whether the transparency across the visible spectrum of the used pharmaceutical container is within 10% of the transparency across the visible spectrum of an unused pharmaceutical container before first use, and whether the used pharmaceutical container has any disqualifying cosmetic defects; 24. The process of claim 23, further comprising: discarding or recycling the used pharmaceutical container when the transparency across the visible spectrum of the used pharmaceutical container is not within 10% of the transparency across the visible spectrum of an unused pharmaceutical container or when the used pharmaceutical container exhibits one or more disqualifying cosmetic defects.

30. Determining whether to reuse the used pharmaceutical container includes: checking the used pharmaceutical container against a used pharmaceutical container database to determine if the used pharmaceutical container is part of a manufacturing lot that has been flagged for removal from service; 24. The process of claim 23, further comprising: recycling or disposing of the used pharmaceutical container when the pharmaceutical container is part of a manufacturing lot that has been flagged for removal from service.

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