Classifications

• • C—CHEMISTRY; METALLURGY
  • C03—GLASS; MINERAL OR SLAG WOOL
  • C03C—CHEMICAL COMPOSITION OF GLASSES, GLAZES OR VITREOUS ENAMELS; SURFACE TREATMENT OF GLASS; SURFACE TREATMENT OF FIBRES OR FILAMENTS MADE FROM GLASS, MINERALS OR SLAGS; JOINING GLASS TO GLASS OR OTHER MATERIALS
  • C03C21/00—Treatment of glass, not in the form of fibres or filaments, by diffusing ions or metals in the surface
  • C03C21/001—Treatment of glass, not in the form of fibres or filaments, by diffusing ions or metals in the surface in liquid phase, e.g. molten salts, solutions
  • C03C21/002—Treatment of glass, not in the form of fibres or filaments, by diffusing ions or metals in the surface in liquid phase, e.g. molten salts, solutions to perform ion-exchange between alkali ions
• • C—CHEMISTRY; METALLURGY
  • C03—GLASS; MINERAL OR SLAG WOOL
  • C03C—CHEMICAL COMPOSITION OF GLASSES, GLAZES OR VITREOUS ENAMELS; SURFACE TREATMENT OF GLASS; SURFACE TREATMENT OF FIBRES OR FILAMENTS MADE FROM GLASS, MINERALS OR SLAGS; JOINING GLASS TO GLASS OR OTHER MATERIALS
  • C03C23/00—Other surface treatment of glass not in the form of fibres or filaments
  • C03C23/007—Other surface treatment of glass not in the form of fibres or filaments by thermal treatment
• • C—CHEMISTRY; METALLURGY
  • C03—GLASS; MINERAL OR SLAG WOOL
  • C03C—CHEMICAL COMPOSITION OF GLASSES, GLAZES OR VITREOUS ENAMELS; SURFACE TREATMENT OF GLASS; SURFACE TREATMENT OF FIBRES OR FILAMENTS MADE FROM GLASS, MINERALS OR SLAGS; JOINING GLASS TO GLASS OR OTHER MATERIALS
  • C03C23/00—Other surface treatment of glass not in the form of fibres or filaments
  • C03C23/0075—Cleaning of glass

Definitions

• glass pharmaceutical packaging that is capable of being reused and for processes for reconditioning and reusing glass pharmaceutical packaging.
• present disclosure is directed to glass pharmaceutical packaging that can be reconditioned and reused and processes for reconditioning and reusing the glass pharmaceutical packaging.
• a container for reuse may comprise a glass, an inner surface, and an outer surface.
• the container may be a pharmaceutical container adapted to hold a pharmaceutical product.
• the container may have a retained strength of within 25% of an unused container prior to the first use.
• the inner surface may have a chemical durability ratio of 5 or less.
• a process for reusing a used pharmaceutical container may comprise receiving a used pharmaceutical container and reconditioning the used pharmaceutical container to produce a reconditioned pharmaceutical container.
• Reconditioning the used pharmaceutical container may comprise 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 reconditioned pharmaceutical container. After depyrogenating the used pharmaceutical container the level of organic and inorganic contaminants in the reconditioned pharmaceutical container may be less than USP limits.
• FIG. 2A depicts a flow chart that includes steps in a process for reusing a used pharmaceutical container, according to one or more embodiments described herein;
• FIG. 2B depicts a flow chart that includes steps in a process for reusing a used pharmaceutical container, according to one or more embodiments described herein;
• FIG. 2C depicts a flow chart that includes steps in a process for reusing a used pharmaceutical container, according to one or more embodiments described herein.
• the containers and processes for reusing containers of the present disclosure may generate less waste than the use of conventional containers and/or may reduce energy consumption and processing costs associated with melting down the glass containers.
• pharmaceutical containers are disposed of after only one use generating a significant amount of waste, much of which may end up in a landfill.
• the containers and processes of the present disclosure may allow for the reuse of pharmaceutical containers reducing the amount of waste generated from using pharmaceutical containers and accordingly reducing the amount of waste that requires disposal in a landfill.
• the term “recycle” refers to a process of melting down the glass of the pharmaceutical container and forming the molten glass into one or more glass articles.
• the term “reuse” refers to using a pharmaceutical container after the pharmaceutical container has already been used at least once before and then reconditioned without melting down the glass container and forming the molten glass into a new container.
• CDR chemical durability ratio
• the term “delamination” refers to a phenomenon in which glass particles are released from the surface of the glass following a series of leaching, corrosion, and/or weathering reactions.
• the particles are silica-rich flakes, or lamellae, of glass that originate from the interior surface of the container as a result of the leaching of modifier ions or weak network formers, such as, for example, boron, into a solution contained within the container.
• These flakes, or lamellae may generally be from 1 nm to 2 microns thick with a width greater than about 50 microns. As these flakes, or lamellae, are primarily composed of silica, the flakes or lamellae, generally do not further degrade after being released from the surface of the glass.
• 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 inner volume 108.
• the body 102 generally comprises a cylindrical wall 110 and a floor 112.
• the cylindrical wall 110 transitions into the floor 112 through a heel 114.
• the body 102 has a wall thickness Tw which extends between the inner surface 104 and the outer surface 106.
• the container 100 for reuse may comprise a glass, an inner surface 104, and an outer surface 106.
• the container 100 may be a pharmaceutical container.
• the container 100 may be adapted to hold one or more of a pharmaceutical product, a vaccine, a biologic, a solution, or combinations of these. While the container 100 is depicted in FIG. 1 as a vial, it should be understood that the container 100 may have other form factors, including, without limitation, Vacutainers®, cartridges, syringes, bottles, flasks, phials, tubes, beakers or the like.
• the glass may be an aluminosilicate glass composition.
• the glass may be an aluminosilicate glass composition that meets Type 1 criteria as defined in USP ⁇ 660>, such as those glass compositions disclosed in U.S. Patent No. 8,551,898 hereby incorporated by reference in its entirety, and sold by Corning® Incorporated as Valor® Glass, and those disclosed in U.S. Patent No. 9,145,329, hereby incorporated by reference in its entirety.
• the glass may be an alkali aluminosilicate glass such as those disclosed in U.S. Patent No. 10,640,415, entitled Lithium Containing Aluminosilicate Glasses filed Nov.
• the glass may be an aluminosilicate glass composition that has been subjected to an etching process, such as acid etching or fluoride etching, to remove deposits on the inner surface 104 of the container 100.
• the glass may be a 33 expansion borosilicate glass such as those sold by DWK Life Sciences as KIMBAL® 33 or those sold by Schott as BOROFLOAT® 33.
• Expansion 33 glass has a coefficient of thermal expansion of 33 and is a Type 1A glass per USP ⁇ 660>.
• the glass may be a 51 expansion borosilicate glass, such as those sold by DWK Life Sciences as KIMBAL® 51 or those sold by Corning® as 51-D clear borosilicate glass tubing.
• Expansion 51 glass has a coefficient of thermal expansion of 51 and is a Type IB glass per USP ⁇ 660.
• the outer surface 106 of the container 100 may be coated with an external coating for example suitable containers may be coated containers sold by Corning® Incorporated as Velocity®.
• aluminosilicate glass compositions may have sufficient chemical durability, mechanical strength, and optical performance to be reused.
• such glass compositions may have relatively uniform surface chemistry with comparatively low heterogeneity improving the chemical durability of the container when compared to glass compositions with less uniform surface chemistry with more heterogeneity.
• glass articles containing volatile species such sodium and/or boron (e.g., glass of >0.1 mol% Na2O and/or B2O3, such as >0.5 mol%, >1 mol%, > 2 mol%, > 4 mol%)
• the sodium and/or boron may be volatilized and released from the surface of the glass.
• the volatized sodium and/or boron later condenses on cooler parts of the glass tube or glass container surface causing compositional heterogeneities in the glass container surface.
• Such compositional heterogeneities in the glass container surface can lead to reduced chemical durability and greater propensity for delamination of the glass surface.
• the homogeneity of the surface concentration of the glass constituent components in the surface region of the glass is generally an indication of the propensity of the glass composition to de-laminate and shed glass particles from the inner surface 104 of the container 100.
• the glass composition has a consistent surface homogeneity in the surface region (i.e., when the extrema of the surface concentration of the glass constituent components in the surface region at a discrete point A on the inner surface 104 are 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.
• Glass containers having consistent surface homogeneity may 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 glass compositions in which the constituent components of the glass composition form species with relatively low vapor pressures (i.e., species with a low volatility) at the temperatures required to form glass tubes into the glass containers having the desired container shape.
• Acid etching presumes the formation of heterogeneities on the inner surface of the glass containers, and the acid etching removes the heterogeneities from the inner surface of the glass container to produce consistent surface homogeneity in the finished glass container.
• the constituent components of the glass form species with relatively low vapor pressures at the reforming temperatures, the constituent components are less likely to volatilize and evaporate from the surfaces of the glass and then condense on a cooler surface of the glass. Reducing or preventing volatilization of the constituent components of the glass can enable forming a glass container with a compositionally homogenous surface over the inner surface of the glass container and through the thickness of the glass container.
• the container 100 may be resistant to delamination following exposure to certain compositions stored in the container 100.
• the delamination risk of a glass container 100 may be measured using a chemical durability ratio (CDR).
• CDR chemical durability ratio
• the method for assessing the CDR of a glass container involves (1) a hydrolytic test of the as-received surface, (2) an etching step to remove any chemical heterogeneities that may be present, and (3) a second hydrolytic test of the ‘etched’ surface.
• “As-received” containers are processed according to the USP ⁇ 660> Surface Glass Test with one notable deviation: the filling volume is 12.5 % of the brimful capacity. Due to the reduced filling volume, additional containers are needed to generate the solution volume needed for the titration. The titration volume is recorded as the “as-received” response.
• the “as-received” containers are then subjected to an etching process to remove the material deposited or incorporated during the converting or molding process. At least one micron (depth) of the surface is removed using a mixture of HC1/HF acids, with target concentrations of 2.3 M HF/4.6 M HC1. The containers are exposed to this solution for a minimum of 3 minutes. These conditions are sufficient for most Type 1 glass compositions, and the mass lost is measured to confirm sufficient depth of surface removal. After exposure to the target acid solution, acidic residue in the containers is removed through soaking in two room temperature water baths for 5 minutes each.
• the “etched” containers are processed according to the USP ⁇ 660 Surface Glass Test using the reduced fill volume (12.5 % of the brimful capacity).
• the resulting titrant volume is recorded as the “etched” titrant response.
• a ratio of the recorded titrant volumes is calculated as follows (*at reduced volume):
• the CDR value represents the risk for delamination, where containers with a uniform surface chemistry exhibit a low CDR and have the lowest risk of delamination.
• the container 100 may have a CDR of 5 or less.
• 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.
• the inner surface 104 may have a CDR of greater than or equal to 0.5 to less than or equal to 5.
• the inner surface 104 may have a CDR of greater than or equal to 0.5 to less than or equal to 4.5, such as greater than or equal to 0.5 to less than or equal to 4, greater than or equal to 0.5 to less than or equal to 3.5, greater than or equal to 0.5 to less than or equal to 3, greater than or equal to 0.5 to less than or equal to 2.5, greater than or equal to 0.5 to less than or equal to 2.0, greater than or equal to 0.5 to less than or equal to 1.5, greater than or equal to 0.5 to less than or equal to 1, greater than or equal to 1 to less than or equal to 5, greater than or equal to 1 to less than or equal to 4.5, greater than or equal to 1 to less than or equal to 4, greater than or equal to 1 to less than or equal to 3.5, greater than or equal to 1 to less than or equal to 3, greater than or equal to 1 to less than or equal to 2.5, greater than or equal to 1 to less than or equal to 2, greater than or equal to 1 to less than or equal to 1.5, greater than or equal to 1.5 to less than less than
• a CDR of greater than 5 may result in greater probability of delamination during reuse of the container 100.
• Containers 100 that have adequate delamination performance for single use applications 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 but not limited to corrosive compositions, which may increase the likelihood of delamination. It is believed that containers 100 with an inner surface 104 having a CDR of 5 or less may have adequate delamination performance even after multiple uses.
• low friction coatings are contemplated herein. Without being bound by theory it is believed that applying a low friction coating on the outer surface 106 of the container 100 may reduce the mechanical damage that occurs to the outer surface 106 of the container 100, such as abrasions, that occurs when the container 100 contacts processing equipment, handling equipment, or other containers during routine use. As mechanical damage builds up, the strength of the container 100 may decrease, which may make the container 100 less suitable for reuse. Accordingly, reducing the mechanical damage that occurs to the container 100 may improve the lifespan of the container 100 facilitating the reuse of the container 100.
• the container 100 As the container 100 is used, the container 100 the contents of the container 100 may be visually inspected to ensure, for instance, that delamination of the container 100 has not occurred.
• the container 100 may have specific 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 of these. In embodiments the transparency throughout the visible spectrum of a used pharmaceutical container 100 may be within 10% of the transparency throughout the visible spectrum of an unused container 100.
• the transparency throughout the visible spectrum of the used container 100 may be within 9% of the transparency throughout the visible spectrum of an unused container 100, such as within 8%, with 7%, within 6%, within 5%, within 4%, within 3%, within 2%, or even within 1% of the transparency throughout the visible spectrum of the original container prior to the first use.
• 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 from as few as 10 numerical digits or less to as many as 36 alphanumeric digits or more are useful for the tracking of pharmaceuticals, with unique identification codes encoding 16 alphanumeric digits being considered typical.
• Sixteen-digit patterns can incorporate sufficient information for most manufacturing purposes, are readily printable in machine-readable sizes within the glass.
• the inner surface 104 of the container 100 may comprise a total concentration of organic and/or inorganic contaminates that is less than detectable limits.
• Pharmaceutical manufacturers and government agencies may require specific maximum levels of organic or inorganic contaminates in a container for use as pharmaceutical packaging.
• the acceptable level of organic or inorganic contaminates in the container 100 may be less than detectable limits, such that no inorganic or organic contaminates can be conventionally detected within the interior volume 108 or on the inner surface 104 of the container 100.
• the container 100 may have less than 0.15 pg of any organic contaminates that can be conventionally detected within the interior volume 108 or on the inner surface 104 of the container 100.
• the used pharmaceutical container may be washed with a caustic solution (step 242).
• the caustic solution may have a pH of from 11 to 14, such as from 11 to 13, 11 to 12, 12 to 14, 12 to 13, 13 to 14, or any combination of these ranges.
• the process of claim 16, wherein the caustic solution comprises one or more metal hydroxides, metal carbonates, citrates, acetates, oxidative species, chelating species, complex-forming species, surfactants, soaps, or combinations of these.
• the caustic solution may comprise 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 of these.
• washing the used pharmaceutical container with a caustic solution may remove any inorganic or organic contaminates remaining on the surface of the glass from the prior use of the used pharmaceutical container.
• washing the used pharmaceutical container with a caustic solution may further comprise heating the caustic solution to a temperature of 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
• caustic solutions at a temperature less than 50 °C may not as effectively remove inorganic and organic contaminates from the used pharmaceutical container as caustic solutions at temperatures greater than 50 °C.
• reconditioning the used pharmaceutical container may comprise washing the used pharmaceutical container with water (step 244). Washing with water in step 244 may be conducted after washing the used pharmaceutical container with the caustic solution in step 242. The water wash may remove any residual caustic solution from the surfaces of the used pharmaceutical container. In embodiments, the water for the water wash of step 244 may be at ambient temperature.
• reconditioning the used pharmaceutical container may comprise first washing the container with a caustic solution (step 242), then washing the container with water (step 244) after the caustic solution wash, and then depyrogenating the used pharmaceutical container (step 246) after the water wash.
• reconditioning the used pharmaceutical container may further comprise exposing the container to UV light.
• reconditioning the used pharmaceutical container may further comprise exposing the container to ozone. Without being bound by theory, it is believed that ozone exposure and UV light exposure may oxidize organic contaminates, which may beneficially assist their removal from the container.
• reconditioning the used pharmaceutical container may comprise depyrogenating the used pharmaceutical container (step 246).
• the depyrogenating the used pharmaceutical container may be conducted after washing the used pharmaceutical container with the caustic solution (step 242) and the water (step 244).
• depyrogenating the used pharmaceutical container may comprise heating the used pharmaceutical container to a depyrogenation temperature of 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
• depyrogenating the used pharmaceutical container may comprise heating the used pharmaceutical container to the depyrogenation temperature and maintaining the used pharmaceutical container at the depyrogenation temperature for a time period of 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, 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, from about 1 hour to about 12 hours, from about 1 hour to about 6 hours, from about 6 hours to about 72 hours
• the process for reusing a used pharmaceutical container may further comprise sending the reconditioned pharmaceutical container for reuse.
• the reconditioned pharmaceutical container may be sent for reuse and may be reused in the same manner as it was being used prior to reconditioning.
• the reconditioned pharmaceutical container that previously contained a particular pharmaceutical product initially may be sent for reuse with the same pharmaceutical product.
• the reconditioned pharmaceutical container may be sent for reuse and may be reused in a different manner than it was used prior to reconditioning. For instance, in embodiments, the reconditioned pharmaceutical container that was 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.
• the process 200 for reusing the used pharmaceutical container may further comprise receiving information relating to 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).
• the process 200 may also further comprise determining whether to recondition and reuse the used pharmaceutical container (step 230) based on the information relating to the used pharmaceutical container. When it is determined not to recondition (step 240) and reuse the used pharmaceutical container the container may be recycled or disposed of (step 250).
• the information relating to the used pharmaceutical containing may include, but is not limited to, the prior contents of the used pharmaceutical container, the number of times that the used pharmaceutical container has been reused, the lot number of the used pharmaceutical container, other information on the used pharmaceutical container, or combinations thereof.
• determining whether to reuse the used pharmaceutical container comprises comparing the total number of reuse cycles against a threshold number of reuse cycle, and when the total number of reuse cycles is greater than the threshold number not permitting the reuse of the pharmaceutical container.
• the term “reuse cycle” refers to using the pharmaceutical container, reconditioning the pharmaceutical container, and sending the pharmaceutical container for use again.
• the threshold number may 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.
• the threshold number may be greater than 200 reuse cycles.
• the threshold number may be greater than or equal to 1.
• the pharmaceutical container may include small amounts of physical and/or chemical damage during normal use of the pharmaceutical container during each reuse cycle. When reusing the pharmaceutical container, these small amounts of physical and/or chemical damage may build up over time, which may cause the container to no longer be suitable for reuse. Tracking the number of reuse cycles may allow used pharmaceutical containers to be removed from service at an appropriate time to reduce the risk of failure of the used pharmaceutical containers. It is further believed that a physical inspection of a pharmaceutical container may not, on its own, correctly identify a need to remove the container from service. Accordingly tracking the total number of reuse cycles may allow for a more accurate determination of whether a used pharmaceutical container should be reconditioned for reuse or sent for recycling or disposal.
• determining whether to reuse the used pharmaceutical container may comprise comparing the identification of the prior contents against a list of materials for which the pharmaceutical containers cannot be reused.
• the list of materials for which pharmaceutical containers cannot be reused comprises 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 pharmaceutical containers cannot be reused may change with regulatory changes or with changing scientific knowledge as specific compounds may be added or removed from the list.
• determining whether to reuse the used pharmaceutical container further comprises inspecting the used pharmaceutical container to determine whether specific optical properties have been maintained, and when those optical properties have not been maintained disposing of or recycling the used pharmaceutical container.
• the container uses as a pharmaceutical container the contents of the container may be visually inspected to ensure, for example, that delamination of the container has not occurred.
• the container may have specific optical properties to ensure that such visual inspection can occur.
• Optical properties may include, but are not limited to, transparency, haze, coloration, light scattering, refractive index, and combinations of these.
• the optical property of the used pharmaceutical container may be within 10% of the optical property of an unused container, where the optical property can be any one or a combination of transparency, haze, color, light scattering, or refractive index. In embodiments the transparency throughout the visible spectrum of a used pharmaceutical container may be within 10% of the transparency throughout the visible spectrum of an unused container.
• the steps in the life cycle of a pharmaceutical container are graphically depicted.
• the container may be filled with pharmaceutical product, a vaccine, a biologic, a foodstuff, or a solution.
• the container may then be used as pharmaceutical container (step 280).
• the used pharmaceutical container is then received in step 210 and information about the container is received in step 220.
• a container that is reconditioned (step 240) is then sent for reuse in step 260.
• a container may go through as many as 20 cycles starting from the initial use, before it is disposed of or recycled (step 250)>.

Landscapes

• Chemical & Material Sciences (AREA)
• Materials Engineering (AREA)
• Engineering & Computer Science (AREA)
• Chemical Kinetics & Catalysis (AREA)
• General Chemical & Material Sciences (AREA)
• Geochemistry & Mineralogy (AREA)
• Life Sciences & Earth Sciences (AREA)
• Organic Chemistry (AREA)
• Physics & Mathematics (AREA)
• Thermal Sciences (AREA)
• Medical Preparation Storing Or Oral Administration Devices (AREA)
• Surface Treatment Of Glass (AREA)
• Apparatus For Disinfection Or Sterilisation (AREA)
• Containers Having Bodies Formed In One Piece (AREA)

Applications Claiming Priority (2)

Publications (1)

Family

ID=89222902

Family Applications (1)

Country Status (4)

Family Cites Families (11)

• 2023
  • 2023-11-22 EP EP23825170.6A patent/EP4626840A1/de active Pending
  • 2023-11-22 JP JP2025530004A patent/JP2025540020A/ja active Pending
  • 2023-11-22 WO PCT/US2023/080827 patent/WO2024118413A1/en not_active Ceased
  • 2023-11-22 CN CN202380080169.XA patent/CN120225474A/zh active Pending

Also Published As

Similar Documents

Legal Events