TWI706898B - Method of packaging a multi-monodose container - Google Patents

Abstract

A methods are described for packaging a foldable container including covering a multi-monodons container in an expanded configuration with a hermetically-sealable overwrap, the multi-monodons container including a row of interconnected monodons pharmaceutical vials, each of the monodons pharmaceutical vials enclosing at least one pharmaceutical agent, the interconnected monodons pharmaceutical vials connected to one another by one or more articulating joints sufficiently flexible to form a folded configuration of the multi-monodons container; exerting a force on at least one of the monodons pharmaceutical vials; bending the one or more articulating joints to form the folded configuration of the multi-monodons container in response to the exerted force; and sealing the hermetically-sealable overwrap to form a hermetic seal around the folded configuration of the multi-monodons container.

Description

How to fold the container

The present invention relates to the technical field of packaging containers, in particular to a method for packaging foldable containers.

US2013/079301 discloses an ophthalmic solution that can be used to treat recurrent corneal erosions. US2015/306259 discloses a packaging unit for at least one medicine, medical or cosmetic. US6234333 discloses a reclosable container which can reduce the risk of contamination of the substance contained therein. WO2011/147769 discloses a single-dose container, especially a single-dose container for fluid products. US2009/0100802 discloses a vacuum packaging system for transporting multiple medical containers. US2005/261659 discloses a medical connection container assembly and a manufacturing method thereof.

In one aspect, a method of packaging multiple single-dose containers includes, but is not limited to, covering a molded structure with an air-tight sealable outer wrapper, the molded structure comprising a first part and a second part, the first part comprising rows of Interconnected single-dose vials, each of the interconnected single-dose vials encapsulates a dose of at least one medicament; the second part is attached to the first part and includes a textured surface pattern, The textured surface pattern is positioned to guide the air flow between the first part and the area adjacent to the second part; from the molded structure covered by the airtight seal At least a part of the surrounding air is discharged, and at least a part of the discharged air flows at least partly through the textured surface pattern of the second part of the molded structure; by sealing the airtightly The outer wrapper is bonded to at least a portion of the surface of the molded structure to form an airtight seal around the row of interconnected single-dose vials; and the second portion of the molded structure is connected to The first part of the molded structure is separated. In addition to the foregoing aspects, other method aspects are described in the claims, drawings, and text forming a part of the present invention.

In one aspect, a method of packaging multiple single-dose containers includes, but is not limited to, covering a molded structure with an airtight sealable outer wrapper, the molded structure including rows of interconnected single-dose vials, the interconnecting Each of the single-dose vials encapsulates a certain dose of at least one medicament, and a textured surface pattern, which is positioned to guide in the first part of the molded structure and the second part of the molded structure Air flow between adjacent areas; at least part of the air discharged from around the molded structure covered by the airtight sealable outer wrapper, so that the at least part of the discharged air at least partially flows through The textured surface pattern on the molded structure; and forming an airtight seal around the row of interconnected single-dose vials. In addition to the foregoing aspects, other method aspects are described in the claims, drawings, and text forming a part of the present invention.

In one aspect, a multiple single-dose container includes but is not limited to a molded structure including a first part and a second part, the first part including a row of interconnected single-dose vials, each of the interconnected single-dose vials having An internal volume configured to contain a dose of at least one medicament; and the second part is attached to the first part, the second part comprising a textured surface pattern, the textured surface pattern being positioned to guide The air flow between the first part and the area adjacent to the second part. In addition to the foregoing aspects, other multiple single-dose container aspects are described in the claims, drawings, and text forming a part of the invention.

In one aspect, multiple single-dose containers include, but are not limited to, a molded structure that includes rows of interconnected single-dose vials, each of the interconnected single-dose vials having a structure configured to contain a dose of at least one medicament An internal volume; and a textured surface pattern that is positioned to guide the air flow between the first part of the molded structure and an area adjacent to the second part of the molded structure. In addition to the foregoing aspects, other multiple single-dose container aspects are described in the claims, drawings, and text forming a part of the invention.

In one aspect, a method of packaging a collapsible container includes, but is not limited to, covering a multi-single-dose container in an expanded configuration with an airtight sealable outer wrapper, the multi-single-dose container including rows of interconnected single-dose medications. Bottles, each of the single-dose vials encapsulating a certain dose of at least one medicament; and one or more hinge joints that connect the single-dose drugs in the row of interconnected single-dose vials Each of the bottles is connected to at least one adjacent single-dose vial, and the one or more hinge joints are sufficiently flexible to reversibly match the flat outer surface of each of the single-dose vials with the at least one The flat outer surface of an adjacent single-dose vial to form a folded configuration of the multiple single-dose container; at least one of the single-dose vials in the row of interconnected single-dose vials Applied force, the applied Force toward the at least one adjacent single-dose vial; in response to applying the force on at least one of the single-dose vials in the row of interconnected single-dose vials, bending the one or A plurality of hinge joints to form the folded configuration of the multiple single-dose container; and sealing the airtightly sealable outer wrapper to form around the folded configuration of the multiple single-dose container therein Hermetically sealed. In addition to the foregoing aspects, other method aspects are described in the claims, drawings, and text forming a part of the present invention.

In one aspect, a method of packaging multiple single-dose containers includes, but is not limited to, covering the multiple single-dose containers with an airtight sealable outer wrapper, the multiple single-dose containers including rows of interconnected single-dose vials, the Each of the single-dose vials encapsulates a dose of at least one medicament; and one or more hinge joints that connect each of the single-dose vials in the row of interconnected single-dose vials Connected to at least one adjacent single-dose vial, and the one or more hinge joints are sufficiently flexible to reversibly match the flat outer surface of each of the single-dose vials with the at least one adjacent The flat outer surface of a single-dose medicine bottle to form a folded configuration of the multiple single-dose container; applied on at least a part of the outer surface of the airtight sealable outer wrapper covering the multiple single-dose container Force, the force applied toward the one or more hinge joints of the multiple single-dose container; at least the air is expelled from around the multiple single-dose container covered by the airtight sealable outer wrapper Part; and the air-tight sealable outer wrapper covering the multiple single-dose container to hermetically seal the multiple single-dose container therein. In addition to the foregoing aspects, other method aspects are described in the claims, drawings, and text forming a part of the present invention.

The foregoing summary of the invention is only illustrative and is not intended to be limiting in any way. In addition to the illustrative aspects, embodiments, and features described above, other aspects, embodiments, and features will become apparent by referring to the drawings and the following detailed description.

400: Multiple single-dose containers

400a: multiple single-dose container

400b: multiple single-dose container

400c: multiple single-dose container

410: Molded structure

420: Part One

430: Part Two

440: Single-dose medicine bottle

440a: Single-dose medicine bottle

440b: Single-dose medicine bottle

440c: Single-dose medicine bottle

450: Textured surface pattern

460: area

600: Multiple single-dose container

610: Molded structure

620: Part One

630: Part Two

640: Single-dose medicine bottle

645: articulated joint

650: Textured surface pattern

670: tags

680: Sensor

700: Multiple single-dose container

710: Molded structure

720: Part One

730: Part Two

740: Single-dose medicine bottle

745: articulated joint

750: Textured surface pattern

760: closure

770: Tag

780: Sensor

900: Outer wrap that can be hermetically sealed

910: Stream Pipe

920: vacuum source

930: Pressure seal

940: Sealer

950: airtight sealed bag

960: air

970: seal

1000: inert gas

1500: Multiple single-dose containers

1510: Molded structure

1520: Single-dose medicine bottle

1525: articulated joint

1530: Textured surface pattern

1540: closure

1550: label

1560: Sensor

2200: Multiple single-dose containers

2210: Single-dose medicine bottle

2220: Single-dose medicine bottle

2230: articulated joint

2240: closure

2250: label

2260: Sensor

2270: Cross section of the first rectangular package

2280: Second rectangular packaging cross-sectional area

2600: Multiple single-dose containers

2605: Outer wrap that can be hermetically sealed

2610: Single-dose medicine bottle

2615: articulated joint

2620: mechanical probe

2625: force

2630: Arrow

2640: Stream Pipe

2645: vacuum source

2650: Pockets are formed around the folded configuration

2655: Air

2660: seal

2700: Multiple single-dose containers

2705: Outer wrapping that can be airtightly sealed

2710: Single-dose medicine bottle

2715: articulated joint

2720: Mechanical probe

2725: force

2730: Arrow

2735: inert gas

2740: Stream Pipe

2745: vacuum source

2750: Bags are formed around the folded configuration

2755: inert gas

2760: seal

3300: Multiple single-dose containers

3305: Outer wrapping that can be airtightly sealed

3310: Single-dose medicine bottle

3315: articulated joint

3325: Mechanical Probe

3330: Stream Pipe

3335: vacuum source

3340: Arrow

3345: hermetic seal

3350: Third Cover

3400: Multiple single-dose containers

3405: Outer Wrap

3410: Single-dose medicine bottle

3415: articulated joint

3420: inert gas

3425: Mechanical Probe

3430: Stream Pipe

3435: vacuum source

3440: Arrow

3445: hermetic seal

3450: Third Cover

Figure 1 shows a step diagram of a method of packaging multiple single-dose containers.

Figure 2 shows a further step diagram of the method of packaging multiple single-dose containers as shown in Figure 1.

Fig. 3 shows a further step diagram of the method of packaging multiple single-dose containers as shown in Fig. 1.

Figure 4 is a schematic view of an embodiment of a multiple single-dose container comprising a molded structure with rows of interconnected single-dose vials and a textured surface pattern.

Figure 5A is a schematic diagram of a top view of a molded structure with rows of interconnected single-dose vials and a textured surface pattern.

Figure 5B is a schematic diagram of a top view of a molded structure with rows of interconnected single-dose vials and a textured surface pattern.

Figure 5C is a schematic diagram of a top view of a molded structure with rows of interconnected single-dose vials and a textured surface pattern.

Figure 6 is a schematic view of an embodiment of a multiple single-dose container including a molded structure having rows of interconnected single-dose vials and a textured surface pattern.

Figure 7 is a schematic diagram of an embodiment of a multiple single-dose container including a molded structure having rows of interconnected single-dose vials and a textured surface pattern.

Fig. 8 shows a further step diagram of the method of packaging multiple single-dose containers as shown in Fig. 1.

Figure 9A shows a horizontal side view of an embodiment of a molded structure.

Figure 9B shows a horizontal side view of an embodiment of a molded structure covered by an overwrap that can be hermetically sealed.

Figure 9C shows a horizontal side view of an embodiment of a molded structure covered by an airtight sealable overwrap and pressure seal.

Fig. 9D shows a horizontal side view of an embodiment in which a molded structure covered by an air-tight sealable outer wrapper and air exhaust.

Figure 9E shows a horizontal side view of an embodiment in which a molded structure covered by an air-tight sealable outer wrapper forms an air-tight seal.

Figure 9F shows a horizontal side view of an embodiment of a molded structure covered by an overwrap that can be hermetically sealed.

Figure 10A shows a horizontal side view of an embodiment of a molded structure.

Figure 10B shows a horizontal side view of an embodiment of a molded structure covered by an airtight sealable outer wrapper.

Fig. 10C shows a horizontal side view of an embodiment in which a molded structure covered by an airtight seal and an inert gas is injected.

Figure 10D shows a horizontal side view of an embodiment of a molded structure and pressure seal covered by an airtight sealable outer wrapper.

Fig. 10E shows a horizontal side view of an embodiment of a molded structure covered by an overwrap that can be hermetically sealed and the discharge of injected inert gas.

Figure 10F shows a horizontal side view of an embodiment in which a molded structure covered by an air-tight sealable outer wrapper forms an air-tight seal.

Figure 10G shows a horizontal side view of an embodiment of a molded structure covered by an airtight sealable outer wrapper.

Figure 11 shows a further step diagram of a method of packaging multiple single-dose containers such as that shown in Figure 1.

Figure 12 shows a further step diagram of a method of packaging multiple single-dose containers such as that shown in Figure 1.

Figure 13 shows a step diagram of a method of packaging multiple single-dose containers.

FIG. 14 shows a further step diagram of the method of packaging multiple single-dose containers as shown in FIG. 13.

Figure 15 is a schematic diagram of an embodiment of a multiple single-dose container including a molded structure having rows of interconnected single-dose vials and a textured surface pattern.

FIG. 16 shows a further step diagram of the method of packaging multiple single-dose containers as shown in FIG. 13.

FIG. 17 shows a further step diagram of the method of packaging multiple single-dose containers as shown in FIG. 13.

FIG. 18 shows a further step diagram of the method of packaging multiple single-dose containers as shown in FIG. 13.

Figure 19 is a step diagram showing a method of packaging multiple single-dose containers.

FIG. 20 shows a further step diagram of the method of packaging multiple single-dose containers as shown in FIG. 19.

FIG. 21 shows a further step diagram of the method of packaging multiple single-dose containers as shown in FIG. 19.

Figure 22A is a side view of an embodiment of a multiple single dose container in an elongated configuration.

Figure 22B is a top view of an embodiment of a multiple single dose container in an elongated configuration.

Figure 22C is a side view of an embodiment of a multiple single dose container in a folded configuration.

Figure 22D is a top view of an embodiment of a multiple single dose container in an elongated configuration.

Figure 22E shows the overlap of rectangular packaging cross-sectional areas in elongated and folded configurations of multiple single dose containers.

FIG. 23 shows a further step diagram of the method of packaging multiple single-dose containers as shown in FIG. 19.

FIG. 24 shows a further step diagram of the method of packaging multiple single-dose containers as shown in FIG. 19.

FIG. 25 shows a further step diagram of the method of packaging multiple single-dose containers as shown in FIG. 19.

Figure 26A shows a top view of an embodiment in which a multi-single-dose container can be packaged.

Figure 26B shows a top view of an embodiment in which a multi-single-dose container can be packaged.

Figure 26C shows a top view of an embodiment in which a multi-single-dose container can be packaged.

Figure 26D shows a top view of an embodiment in which the package can be folded for multiple single-dose containers.

Figure 26E shows a top view of an embodiment in which a multi-single-dose container can be packaged.

Figure 27A shows a top view of an embodiment in which a multi-single-dose container can be packaged.

Figure 27B shows a top view of an embodiment in which a foldable multiple single-dose container is packaged.

Figure 27C shows a top view of an embodiment in which a foldable multiple single-dose container is packaged.

Figure 27D shows a top view of an embodiment in which a multi-single-dose container can be packaged.

Figure 27E shows a top view of an embodiment in which a multi-single-dose container can be packaged.

Figure 27F shows a top view of an embodiment in which a multi-single-dose container can be packaged.

Figure 28 shows a step diagram of a method of packaging multiple single-dose containers.

FIG. 29 shows a further step diagram of the method of packaging multiple single-dose containers as shown in FIG. 28.

FIG. 30 shows a further step diagram of the method of packaging multiple single-dose containers as shown in FIG. 28.

FIG. 31 shows a further step diagram of the method of packaging multiple single-dose containers as shown in FIG. 28.

Fig. 32 shows a further step diagram of the method of packaging the multiple single-dose container as shown in Fig. 28.

Figure 33A shows a top view of an embodiment of packaging multiple single-dose containers.

Figure 33B shows a top view of an embodiment of packaging multiple single-dose containers.

Figure 33C shows a top view of an embodiment of packaging multiple single-dose containers.

Figure 33D shows a top view of an embodiment of packaging multiple single-dose containers.

Figure 34A shows a top view of an embodiment of packaging multiple single-dose containers.

Figure 34B shows a top view of an embodiment of packaging multiple single-dose containers.

Figure 34C shows a top view of an embodiment of packaging multiple single-dose containers.

Figure 34D shows a top view of an embodiment of packaging multiple single-dose containers.

In the following detailed description, reference is made to the accompanying drawings, which form a part of the detailed description. In the drawings, similar reference numerals generally identify similar elements, unless context dictates otherwise. The illustrative embodiments described in the detailed description, drawings, and claims are not meant to be limiting. Without departing from the spirit or scope of the subject matter presented by the present invention, other embodiments may be utilized, and other changes may be made.

This document describes devices and methods for packaging multiple single-dose containers. In one aspect, a multiple single-dose container includes a molded structure that includes rows of interconnected single-dose vials and positioned to be guided in a first portion of the molded structure and adjacent to a second portion of the molded structure The textured surface pattern of the airflow between the areas. In one aspect, each of the single-dose vials in the row of interconnected single-dose vials is connected to at least one adjacent single-dose vial by one or more hinge joints. Each of the single-dose vials in the row of interconnected single-dose vials encapsulates a dose of at least one medicament (e.g., a vaccine or a therapeutic agent). The method of packaging multiple single-dose containers includes hermetically sealing the row of interconnected single-dose containers in an airtightly sealable outer wrapper. The textured surface pattern on the molded structure is configured to assist in the process of hermetically sealing the rows of interconnected single-dose vials in the hermetically sealable outer wrapper Air and/or inert gases are extracted or evacuated from the material.

Referring to Figure 1, there is shown an embodiment of a method of packaging multiple single-dose containers that can be used as a context for one or more of the methods and/or devices described herein. Figure 1 shows a step diagram of a method 100 of packaging multiple single-dose containers. The method 100 includes covering a molded structure with an airtight sealable outer wrapper in step 110, the molded structure including a first portion and a second portion, the first portion including rows of interconnected single-dose vials, Each of the interconnected single-dose vials encapsulates a dose of at least one medicament, the second part is attached to the first part and includes a textured surface pattern that is positioned to The air flow between the first part and the area adjacent to the second part is guided. The method 100 includes expelling at least a portion of air from around a molded structure covered by an airtight sealable outer wrapper in step 120, at least a portion of the discharged air flowing at least partially through a second portion of the molded structure Textured surface pattern. The method 100 includes forming an air-tight seal around the row of interconnected single-dose vials by bonding an air-tight sealable overwrap to at least a portion of the surface of the molded structure in step 130. The method 100 includes separating the second part of the molded structure from the first part of the molded structure in step 140.

In one aspect, method 100 is performed by packaging multiple single-dose containers with one or more components of a mechanical device. In one aspect, the method 100 is performed by one or more components of a mechanical device cooperating to pack multiple single-dose containers. For example, the method may include using a mechanical device to cover the molded structure of the single-dose vial, emptying at least a portion, forming a seal, and separating the first portion of the molded structure from the second portion of the molded structure. In one aspect, the method 100 is performed automatically by one or more components of a mechanical device. In one aspect, multiple single-dose containers are cooperatively formed (for example, a molded structure is cooperatively formed), each of the interconnected single-dose vials is filled with a dose of at least one medicament, and the interconnected single-dose medicaments are sealed Bottle to perform method 100.

The method 100 of packaging multiple single-dose containers includes covering the molded structure with an overwrap that can be hermetically sealed. In some embodiments, the method includes covering the entirety of the molded structure. For example, the method may include covering the molded structure with a bag that can be hermetically sealed, the bag sized to accommodate the entirety of the molded structure. In some embodiments, the method includes covering at least a portion of the molded structure. For example, the method can include covering the entire first portion of the molded structure including rows of interconnected single-dose vials and at least a portion of the second portion of the molded structure with an overwrap that can be hermetically sealed. For example, at least a portion of the second portion of the molded structure may extend beyond the opening or edge defined by the outer wrapper that can be hermetically sealed. In one aspect, covering the molded structure with an overwrap that can be hermetically sealed includes transporting at least one of the molded structure and the overwrap that can be hermetically sealed using a conveying mechanism. For example, the method may include moving the molded structure to be covered by an overwrap that can be hermetically sealed, moving the overwrap that can be hermetically sealed to cover the molded structure, or a combination thereof.

Figure 2 shows a diagram illustrating further steps of the method 100 of packaging multiple single-dose containers. In some embodiments, the method 100 includes inserting a molded structure into an opening defined by an overwrap that can be hermetically sealed, as shown in step 200. For example, the method may include inserting a molded structure forming a multiple single-dose container through an opening of an airtightly sealable bag, an airtightly sealable bag, or an airtightly sealable sleeve. In some embodiments, the method 100 includes first inserting the first part of the molded structure into a gas-tight In the opening defined by the sealed outer wrapper, the second part of the molded structure is made close to the opening defined by the hermetically sealed outer wrapper, as shown in step 210. For example, the molded structure may be inserted in a specific orientation through an opening defined by an air-tight sealable outer wrapper such that the second part of the molded structure including the textured surface pattern is closest to the opening through which air or inert gas will pass. The opening is injected and/or drained.

In one embodiment, the method 100 of packaging multiple single-dose containers includes positioning a molded structure between a first layer of an airtightly sealable outer wrapper and a second layer of an airtightly sealable outer wrapper; and One or more edges of the first layer and the second layer of the air-tight sealable outer wrapper are sealed together, as shown in step 220. For example, the method may include using a horizontal flow mechanical device with a conveyor to position the multiple single-dose container between the first and second layers of an airtightly sealable outer wrapper, such as in an airtightly sealable outer wrapper. Between the roller sheets of objects. Mechanical devices for covering containers with outer wraps are commercially available (for example, from Bosch Packaging Technology, Waiblingen, Germany).

Figure 3 is a step diagram showing a further aspect of the method of packaging multiple single-dose containers. The method 100 of packaging multiple single-dose containers includes covering the molded structure with an overwrap that can be hermetically sealed. In one aspect, the method 100 includes covering the molded structure with an airtight sealable bag, as shown in step 300. For example, an overwrap that can be hermetically sealed may include a medical grade heat-sealable foil bag (for example, from Bemis Healthcare Packaging, Oshkosk, WI; Oliver-Tolas, Healthcare Packaging, Grand Rapids, MI). In one aspect, the method 100 includes covering the molded structure with a sleeve that can be hermetically sealed, as shown in step 310. For example, the hermetic sealable outer wrapper may include a medical grade heat-sealable outer wrapper in a tubular form (for example, from Bemis Healthcare Packaging, Oshkosk, WI).

In one aspect, the method 100 of packaging multiple single-dose containers includes covering the molded structure with a foil laminate that can be hermetically sealed, as shown in step 320. For example, the method may include covering the molded structure with a polyester/foil/polyethylene laminate that can be hermetically sealed. Other non-limiting examples of foil laminates include polyester/foil/nylon/polyethylene laminates and coated paper/foil/polyethylene laminates. In one aspect, the method includes covering the molded structure with a metalized laminate that can be hermetically sealed. For example, the method may include covering the mold with a hermetically sealable polymer film (e.g., polyethylene terephthalate (PET)) that is metalized or coated with a thin layer of aluminum, nickel, and/or chromium.制结构。 System structure.

In one aspect, the method 100 includes using polyester, foil, polypropylene, cast polypropylene, polyethylene, high density polyethylene, metallocene polyethylene, linear low density polyethylene or metallized film in step 330 At least one outer wrap made of airtight seal covers the molded structure. On the one hand, the method 100 includes covering molding with a laminate comprising at least one of polyester, foil, polypropylene, cast polypropylene, polyethylene, high density polyethylene, metallocene polyethylene, linear low density polyethylene or metalized film structure. For example, the method may include overlying the molded structure with a metalized polyester/polyethylene laminate.

In one aspect, the method 100 of packaging multiple single-dose containers includes covering the molded structure with a gas-impermeable outer wrapper, as shown in step 340. For example, the method may include covering the molded structure with an oxygen impermeable outer wrap configured to prevent oxygen from contacting the airtightly sealed multiple unit dose container. For example, the method may include covering the molded structure with an overwrap configured to maintain an inert gas environment (eg, a nitrogen-rich environment) impermeable to an inert gas within the sealed overwrap.

In one aspect, the method 100 of packaging multiple single-dose containers includes covering the molded structure with a vapor-permeable outer wrapper, as shown in step 350. For example, the method may include using laminates configured to generate vapor or moisture barrier (e.g., polyester/foil/polyethylene laminates, polyester/metallized polyethylene laminates or coated paper/foil/ Polyethylene laminate) covering the molded structure of multiple single-dose containers.

In one aspect, the method 100 of packaging multiple single-dose containers includes covering the molded structure with a light impermeable outer wrapper, as shown in step 360. For example, the method may include covering the molded structure of the multiple unit dose container with an airtight sealable overwrap that is opaque and configured to create a light barrier (e.g., foil laminate). In one aspect, the light-impermeable outer wrapper is impermeable to ultraviolet, visible and/or near infrared radiation.

In one aspect, the method 100 of packaging multiple single-dose containers includes covering the molded structure with an electrostatic discharge protective outer wrapper, as shown in step 370. For example, the method may include covering the molded structure of the multiple unit dose container with an air-tight sealable outer wrapper (e.g., polyester/aluminum foil/antistatic low density polyethylene laminate) with antistatic properties.

Airtight sealable with moisture/vapor barrier layer, light barrier layer, gas barrier layer and/or electrostatic discharge barrier layer used in the methods described herein in the form of a bag, bag, sleeve or layer (e.g., sheet) Overwraps are commercially available, for example from Bemis Company, Inc., Oshkosh, WI; Pall Corporation, Port Washington, NY.

In some embodiments, the multiple single-dose container includes a molded structure including a first portion and a second portion, the first portion including rows of interconnected single-dose vials, interconnected single-dose vials Each of the vials encloses a dose of at least one medicament, and the second part is attached to the first part, the second part includes a textured surface pattern, the textured surface pattern is positioned to The air flow between the first part and the area adjacent to the second part is guided.

In some embodiments, the multiple single-dose container includes a molded structure that includes a first portion and a second portion, the first portion includes a row of interconnected single-dose vials, each of the interconnected single-dose vials Each has an internal volume configured to contain a dose of at least one medicament; and the second portion is attached to the first portion, the second portion includes a textured surface pattern, the textured surface pattern is positioned To guide the air flow between the first part and the area adjacent to the second part.

Figure 4 shows a schematic diagram of a non-limiting example of a multiple single-dose container used in the method of packaging multiple single-dose containers as shown in Figure 1. In this non-limiting example, the multiple single-dose container 400 includes a molded structure 410 that includes a first portion 420 and a second portion 430. The first part 420 includes a row of interconnected single-dose vials 440, each vial encapsulating a dose of at least one medicament. The second part 430 is attached to the first part 420 and includes a textured surface pattern 450 (shown in this non-limiting example as a series of) that is positioned to guide the airflow between the first part 420 and the area 460 (dot pattern) Parallel lines), the area 460 is adjacent to the second portion 430. In this non-limiting example, the area 460 adjacent to the second portion 430 is a space adjacent to the edge of the second portion 430. The textured surface pattern 450 on the molded structure 410 is configured to assist in the extraction or exhaust of air and/or inert gas during the process of hermetically sealing the multiple single-dose container 400 within the hermetically sealable outer wrapper.

In one aspect, the molded structure of the multiple single-dose container as described herein is formed using a molding manufacturing process. For example, the first part of the molded structure including rows of interconnected single-dose vials and the second part of the molded structure including the textured surface pattern may be formed by a blow molding manufacturing process. For example, the first part of the molded structure including rows of interconnected single-dose vials and the second part of the molded structure including the textured surface pattern may be formed by an injection molding manufacturing process. In one aspect, the molded structure including the first part and the second part is formed by a blow-fill-seal manufacturing process. For example, the first part of the molded structure including rows of interconnected single-dose vials and the second part of the molded structure including the textured surface pattern may be formed by a blow-fill-seal manufacturing process.

In one aspect, the molded structure including the first part and the second part is formed by a blow molding manufacturing process. See, for example, U.S. Patent No. 3,325,860 entitled "Molding and Sealing Machines" to Hansen and U.S. Patent No. 3,936,264 entitled "Apparatus for Blow Molding a Container with Breachable Sealing Members" to Cornett & Gaspar, which is incorporated by reference. Into this article. In one aspect, the blow molding manufacturing process includes at least the following steps: melting the plastic resin to form a hollow molten plastic resin tube (parison), clamping the two halves of the mold around the hollow tube and placing it Keeping closed, compressed air is used to expand the parison into the cavity by allowing the parison to assume the shape of the cavity, and the air is discharged from the mold section and the plastic resin is cooled. For example, a pharmaceutical grade plastic resin (such as polyethylene and/or polypropylene) can be hot-extruded (vertical hot-extrusion) or injection molded to form a suspended vertical tube or a hollow cylinder (parison). For example, pellets of polyethylene and/or polypropylene can be fed into an extruder and melted at a temperature higher than 160 degrees Celsius. The extruded parison is enclosed by a two-part die to seal the lower end of the parison. The extruded parison is cut on the die. The formed molded structure was cooled and removed from the mold.

In one aspect, the molded structure including the first part and the second part is formed by a blow-fill-seal manufacturing process. For example, a multiple single-dose container including a certain dose of at least one medicament can be formed by an aseptic process in which a molded structure is formed, filled with at least one medicament, and sealed in an uninterrupted sequence of operations in a sterile environment. For example, the molded structure including the first part and the second part may be formed using a highly automated blow molding-fill-seal or form-fill-seal manufacturing process. For example, a multiple single-dose container can be produced by the following steps: 1) forming a molded structure including a first portion having a row of interconnected single-dose vials and a first portion of a textured surface pattern with flow guiding properties Two parts, 2) filling each of the interconnected single-dose vials with a certain dose of at least one medicament, and 3) sealing each of the interconnected single-dose vials, so that the dose of at least one medicament Encapsulated in it. For example, multiple single-dose containers can be formed, filled with at least one medicament, and sealed using a method that includes at least the following steps: a sterile solution containing the at least one medicament is delivered to a blow-fill-seal or Form-fill-seal machine; supply sterile filtered compressed air and plastic material (such as polyethylene, polypropylene or polyethylene/polypropylene copolymer) pellets to the machine; plastic pellets under pressure (such as up to 350 bar) Lower extrusion as a hot hollow moldable plastic parison; the two halves of the mold defining the outer surface of the molding structure of the multiple single-dose container are closed around the parison to seal the base, and at the same time the parison is cut by a hot blade The top; the plastic material is formed into multiple single-dose containers by vacuum and/or sterile air pressure; each of the interconnected single-dose vials is immediately filled with a metered volume of a solution containing at least one medicament; once the required volume is filled For each of the interconnected single-dose vials, the filling unit is raised and each of the interconnected single-dose vials is automatically sealed; the mold is opened, and the release forms, fills and forms in a continuous automatic loop Sealed multiple single-dose container. Mechanical devices for blow-fill-seal and/or form-fill-seal manufacturing processes can be obtained from commercial sources (for example, from Rommelag USA, Inc., Evergreen, CO; Weiler Engineering Inc., Elgin, IL).

In one aspect, the molded structure including the first part and the second part is formed by an injection molding manufacturing process. For example, the first part of a molded structure that includes rows of interconnected single-dose vials and includes The second part of the molded structure of the textured surface pattern may be formed of a resin (for example, a thermoplastic material), which is forced to form a mold of an appropriate shape by an injection head or a screw. Maintain the pressure until the thermoplastic material hardens sufficiently to remove the mold and release the molded structure formed.

In one aspect, multiple single dose containers including molded structures are formed using one or more molds. In one aspect, one or more molds are designed for blow molding manufacturing. For example, the mold may include two concave parts that when closed form a cavity that defines the outer surface of the molded structure of the multiple unit dose container. In one aspect, one or more molds are designed for injection molding manufacturing. For example, the mold may include a cavity into which a plastic polymer or resin is forced under pressure, the mold defining the outer and inner surfaces of a single-dose vial that constitutes a multiple single-dose container. In one aspect, each of the one or more molds is formed of stainless steel or aluminum and precision machined to provide a mold for the external and/or internal features of the molded structure of the multiple single-dose container. Other non-limiting materials used to form molds for blow molding and/or dip molding include beryllium, copper, aluminum, steel, chromium, nickel, stainless steel, and alloys thereof.

In one aspect, the molded structure of the multiple single-dose container including the first part and the second part is made of a biocompatible material. For example, the molded structure may be made of a material that is safe to use and compatible with the contents of a single-dose vial, such as a dry or liquid form of a medicament. For example, a biocompatible material (such as a biocompatible polymer or resin) is sufficiently inert to prevent release or release from the biocompatible material in an amount sufficient to affect the stability and/or safety of the medicament enclosed therein. Filter out the substance into the contents of the single-dose vial. For example, a biocompatible material is a type that does not significantly absorb the components of a dosage form (eg, a drug in a dry or liquid formulation), and/or a type that does not allow components of a drug to migrate through the biocompatible material. Non-limiting examples of biocompatible materials include polyvinyl chloride, fluoropolymers, polyurethane, polycarbonate, silicone, acrylic, polypropylene, low density polypropylene, high density polypropylene, nylon, tungsten resin, thermoplastic Elastomer and thermoplastic polyester.

In one aspect, the molded structure including the first part and the second part is made of at least one thermoplastic material. For example, a molded structure of a multiple single-dose container including a first portion having rows of interconnected single-dose vials and a second portion having a textured surface pattern may use a blow molding or infusion molding manufacturing process Made of thermally bendable or moldable plastic polymer material. Non-limiting examples of thermoplastic materials include ethylene-vinyl acetate, cyclic olefin copolymers, ionomers, fluoropolymers, polyurethanes, polyethylene terephthalate (PET), polyethylene terephthalate Alcohol ester G (PETG), acrylic, cellulose, polymethyl methacrylate, acrylonitrile butadiene styrene, nylon, polylactic acid, polybenzimidazole, Polycarbonate, polyether ether, polyether ether ketone, polyether imide, polyethylene, polyphenylene ether, polyphenylene sulfide, polypropylene, polystyrene, polyvinyl chloride, and polytetrafluoroethylene.

In one aspect, the at least one thermoplastic material includes the form of polyethylene. For example, the thermoplastic material may include low density (LDPE) or branched form polyethylene. For example, the thermoplastic material may include polyethylene in high density (HDPE) or linear form. For example, the thermoplastic material may include linear low density polyethylene (LLDPE), which combines the transparency and density of LDPE and the toughness of HDPE.

In one aspect, the at least one thermoplastic material includes the form of polypropylene. For example, the thermoplastic material may include polypropylene in a highly crystalline form. For example, the thermoplastic material may include polypropylene in an isotactic form with organic groups on the same side of the polymer chain. For example, the thermoplastic material may include higher impact forms of polypropylene, such as syndiotacticity with alternating organic groups above and below the polymer chain, or atacticity with a random sequence of organic side chains. In one aspect, polypropylene is modified with polyethylene or rubber to improve impact resistance, reduce stiffness and improve transparency.

In one aspect, the molded structure including the first part and the second part is made of at least one biocompatible thermoplastic material. Non-limiting examples of biocompatible thermoplastic materials include polyvinyl chloride, fluoropolymers, polyurethane, polycarbonate, acrylic, polypropylene, low density polypropylene, high density polypropylene, nylon, and tungsten resin. Additional non-limiting examples of biocompatible thermoplastic materials include thermoplastic polyolefin elastomers (TEO), styrene ethylene butene styrene (SEBS), thermoplastic vulcanizates (TPV), thermoplastic polyurethanes (TPU), copolymer thermoplastics (COPE) and polyether copolyacetamide (PEBA).

In one aspect, the molded structure of the multiple single-dose container is made of glass using a blow molding or injection molding manufacturing process. For example, a press-blowing process or a blow-blowing process may be used to form molten glass into a molded structure. In both processes, molten glass is pressed or blown into a parison and then blown into a mold that defines the outer surface of the molded structure. In one aspect, the molded structure is made of borosilicate glass. For example, the molded structure can be made of Type I borosilicate glass.

In one aspect, the molded structure of the multiple single-dose container is made of a transparent material. For example, the molded structure of the multiple single-dose container may be made of a transparent material to allow the user to observe the tip of a needle (e.g., syringe needle) in a single-dose vial, which forms part of the multiple single-dose container. For example, the molded structure of the multiple single-dose container may be made of a transparent material using a blow molding or injection molding manufacturing process. In some embodiments, the transparent material includes glass. For example, the transparent material may include Type I borosilicate glass. In some embodiments, the transparent material includes the form of a transparent thermoplastic material. For example, the transparent material may include a copolymer of vinyl acetate and ethylene. For example, transparent materials may include low-density shapes Style polyethylene. For example, the transparent material may include polyvinyl chloride, particularly unplasticized polyvinyl chloride. For example, the transparent material may include a cyclic olefin copolymer. See, for example, US Patent No. 6,951,898 entitled "Cyclofins Copolymer Resins Having Improved Optical Properties" by Hammond and Heukelbach, which is incorporated herein by reference.

In one aspect, the molded structure of the multiple single-dose container is made of an opaque material. For example, the molded structure of the multiple single-dose container including the first part and the second part may be made of opaque plastic (for example, polypropylene PP). In one aspect, the molded structure of the multiple single-dose container is made of colored material. For example, the molded structure of the multiple single-dose container including the first part and the second part may be made of a colored material, such as amber glass or a thermoplastic material, which limits the amount of light or ultraviolet radiation that can pass through the single-dose vial . For example, the molded structure of the multiple single-dose container including the first part and the second part may be made of an extruded thermoplastic material that includes a color (e.g., amber) that is configured to impart a single-dose vial Dyes or pigments.

In one aspect, one or more additives are included in the material forming the molded structure of the multiple single-dose container. For example, one or more additives may include lubricants, stabilizers, antioxidants, plasticizers, antistatic agents, or slip agents. In one aspect, the method of making the molded structure of the multiple single-dose container includes adding one or more of a lubricant, a stabilizer, an antioxidant, a plasticizer, an antistatic agent, a slip agent, or a combination thereof. For example, a lubricant (such as zinc stearate) can be used during the molding or extrusion process to promote the flow of molten thermoplastic on the metal surface of the mold. For example, one or more stabilizers (for example, organometallic compounds, fatty acid salts, and inorganic oxides) can be added to the thermoplastic to delay or prevent the polymer from exposure to heat, light, and/or ultraviolet light during the manufacturing process. Degradation to improve the aging properties of thermoplastics. For example, one or more antioxidants (such as aromatic amines, hindered phenols, thioesters and phosphites) that inhibit the formation of free radicals can be added to the thermoplastic to prevent degradation of the thermoplastic caused by oxidation. For example, one or more plasticizers (e.g., phthalate, dioctyl phthalate) can be added to the thermoplastic during processing to achieve softness, flexibility, and melt flow. For example, one or more antistatic agents can be used to prevent static charges from accumulating on the plastic surface. For example, one or more slip agents (e.g., polyolefin) can be added to the thermoplastic material to reduce the material's coefficient of friction. In one aspect, the outer surface of the multiple single-dose container is surface treated. For example, the surface treatment may include the deposition of a thin layer of corona discharge or other plastics to improve properties such as ink adhesion, adhesion to other films, heat sealability, or gas barrier properties.

Returning to FIG. 4, the molded structure 410 of the multiple single-dose container 400 includes a first part 420 and a second part 430. The first portion 420 of the molded structure 410 of the multiple single-dose container 400 includes a row of interconnected single-dose vials 440. In this non-limiting example, the row of interconnected single-dose vials 440 includes a row of five interconnected single-dose vials. In one aspect, the row of interconnected single-dose vials includes at least two interconnected single-dose vials. In one aspect, the row of interconnected single-dose vials includes three or more interconnected single-dose vials. In one aspect, the rows of interconnected single-dose vials include two, three, four, five, six, seven, eight, nine, or ten interconnected single-dose vials. At least one. In one aspect, the row of interconnected single-dose vials includes about 2 to about 30 interconnected single-dose vials. For example, the first part of the molded structure may include rows of interconnected single-dose vials including 2 bottles, 3 bottles, 4 bottles, 5 bottles, 6 Bottles, 7 bottles, 8 bottles, 9 bottles, 10 bottles, 11 bottles, 12 bottles, 13 bottles, 14 bottles, 15 bottles, 16 bottles, 17 bottles, 18 bottles, 19 bottles, 20 bottles, 21 bottles, 22 bottles, 23 bottles, 24 bottles, 25 bottles, 26 bottles, 27 bottles, 28 bottles, 29 bottles or 30 bottles. In some embodiments, the multiple single-dose container includes more than 30 bottles.

In one aspect, the first part of the molded structure includes rows of 20 to 30 interconnected single-dose vials. For example, the first part of the molded structure may include a row of 25 interconnected single-dose vials. In one aspect, the first part of the molded structure includes a row of 20 to 30 interconnected single-dose vials, the row of 20 to 30 interconnected single-dose vials is configured to be divided into 3 to 10 Group of interconnected single-dose vials. For example, the first part of the molded structure includes rows of 20 to 30 interconnected single-dose vials, and rows of 20 to 30 interconnected single-dose vials are configured to be divided into 3 vials, 4 Groups of 3 bottles, 5 bottles, 6 bottles, 7 bottles, 8 bottles, 9 bottles or 10 bottles. For example, a multiple single-dose container may include a band of 25 interconnected single-dose vials configured to be divided into groups of 5 vials.

In one aspect, each of the interconnected single-dose vials is polygonal in a cross section perpendicular to the axis formed by the first and second parts of the molded structure. In one aspect, each of the interconnected single-dose vials is square, triangular, hexagonal, or polygonal in a cross-section perpendicular to the axis formed by the first and second parts of the molded structure.

Figures 5A-5C show aspects of a multiple single-dose container 400 having rows of interconnected single-dose vials 440 of different cross-sectional shapes. Figure 5A is a top view of a multiple single-dose container 400a including rows of interconnected single-dose vials 440a. In one aspect, each of the interconnected single-dose vials 440a is square in cross-section perpendicular to the axis formed by the first and second parts of the molded structure. Figure 5B is a top view of a multiple single-dose container 400b including rows of interconnected single-dose vials 440b. In one aspect, each of the interconnected single-dose vials 440b is triangular in cross section perpendicular to the axis formed by the first and second portions of the molded structure. Figure 5C is a top view of a multiple single dose container 400c including rows of interconnected single dose vials 440c. In one aspect, each of the interconnected single-dose vials 440c is hexagonal in cross section perpendicular to the axis formed by the first and second portions of the molded structure. The multiple single-dose containers 400a, 400b, and 400c with different cross-sectional shapes include the structure shown in FIG. 4, that is, a first portion including a row of interconnected single-dose vials and a first portion adjacent to the first portion and including a textured The second part of the surface pattern, the textured surface pattern is positioned to guide the air flow between the first part and the area adjacent to the second part.

Each of the interconnected single-dose vials in the multiple single-dose container encapsulates a dose of at least one medicament. In one aspect, a dose of at least one medicament is formulated for parenteral or oral administration. In one aspect, a dose of at least one medicament is in liquid form. For example, a certain dose of at least one agent may be dissolved or suspended in a liquid formulation suitable for oral or parenteral administration. In one aspect, a dose of at least one medicament is in lyophilized form. For example, a dose of at least one medicament may be in lyophilized or dried form, which is intended to be reconstituted with water (e.g., distilled water or water for injection) before being used in a subject. In one aspect, the at least one pharmaceutical agent is scheduled for administration to a human. In one aspect, the at least one pharmaceutical agent is intended for veterinary administration.

In one aspect, a dose of at least one medicament includes a prophylactic agent, such as an medicament capable of preventing medical conditions or infectious diseases. In one aspect, a dose of at least one medicament includes a dose of at least one vaccine. For example, a dose of at least one medicament may include a dose of at least one vaccine capable of eliciting immunity against or preventing infections caused by one or more infectious agents. In one aspect, a dose of at least one medicament includes a dose of at least one vaccine configured to be immune to one or more infectious agents, diseases, or conditions. Non-limiting examples of one or more infectious agents, diseases or conditions include anthrax, tuberculosis (BCG), cholera, dengue fever, diphtheria, tetanus, pertussis, hemorrhagic fever, Haemophilus b (Hib), hepatitis A, hepatitis B, human papilloma virus, influenza, Japanese encephalitis, malaria, measles, meninges Inflammatory coccal meningitis, mumps, poliovirus, rubella, varicella virus, plague, pneumococcal, rabies, rift valley fever, rotavirus, rabies, rubella, smallpox, tick-borne encephalitis, typhoid fever, yellow fever and belt Herpes (Zoster). In one aspect, a dose of at least one medicament includes a dose of two or more vaccines. For example, a certain dose of at least one medicament may include a certain dose of DPT vaccine, which includes vaccines against diphtheria, tetanus, and whooping cough.

In one aspect, a dose of at least one medicament includes a dose of at least one therapeutic agent. For example, a dose of at least one medicament may include one or more drugs capable of treating medical conditions. Non-limiting examples of therapeutic agents include immunoglobulins, antibiotics (e.g. penicillin, cefuroxime, ceftazidime), interferons (e.g. interferon alpha, beta or gamma), peripheral vasodilators (e.g. alprostadil), anticoagulant Agents (e.g. fondapainux), gonadotropins (e.g., follicle stimulating hormone (follitropin)), anabolic hormones (e.g. growth hormone (somatropin)), bone forming agents (e.g. teriparatide), HIV or other anti- Viral drugs (for example, enfuvirtide), contraceptives (for example, medroxyprogesterone acetate), anti-inflammatory agents (for example, etanercept, adalimumab, serotonin receptors) Body antagonists (e.g. sumatriptan), GRH analogues (e.g. leuprolide), chemotherapy, insulin, hormones, anti-infectives, etc.

In one aspect, the medicament includes an active ingredient. In one aspect, the active ingredient includes one or more vaccines. In one aspect, the active ingredient includes one or more therapeutic agents. In some embodiments, the medicament includes additional inactive ingredients (e.g., excipients) that are configured to preserve, stabilize, or otherwise protect the active ingredients in the medicament. Non-limiting examples of inactive ingredients or excipients include solvents or co-solvents (such as water or propylene glycol), buffers, antimicrobial preservatives, antioxidants, or wetting agents (such as polysorbates or poloxamers).

In one aspect, each of the interconnected single-dose vials includes an internal volume containing a dose of at least one medicament. In one aspect, each of the interconnected single-dose vials has an internal volume configured to hold a dose of at least one medicament. In one aspect, the internal volume containing a dose of at least one medicament is sufficient to contain a single dose volume of medicament and a minimum overflow volume of medicament. In one aspect, the internal volume containing a certain dose of at least one medicament is sufficient to contain a single dose volume of medicament, the smallest overflow volume of medicament and the head space above the medicament. For example, the internal volume of each of the interconnected single-dose vials containing multiple single-dose containers may be about 0.75 milliliters, which is for a 0.5 milliliter single dose medicament, a 0.1 milliliter overflow and 0.15 milliliter above the liquid medicament The headspace is enough volume. In one aspect, the internal volume is about 0.2 ml to about 6.0 ml. For example, the internal volume of each of the interconnected single-dose vials of the multiple single-dose containers is 0.2 mL, 0.3 mL, 0.4 mL, 0.5 mL, 0.6 mL, 0.7 mL, 0.8 mL, 0.9 mL, 1.0 mL, 1.1 mL, 1.2mL, 1.3mL, 1.4mL, 1.5mL, 1.6mL, 1.7mL, 1.8mL, 1.9mL, 2.0mL, 2.1mL, 2.2mL, 2.3mL, 2.4mL, 2.5mL, 2.6mL, 2.7mL, 2.8mL, 2.9mL, 3.0mL, 3.1mL, 3.2mL, 3.3mL, 3.4mL, 3.5mL, 3.6mL, 3.7mL, 3.8mL, 3.9mL, 4.0mL, 4.1mL, 4.2mL, 4.3mL, 4.5mL , 4.6mL, 4.7 mL, 4.8mL, 4.9mL, 5.0mL, 5.1mL, 5.2mL, 5.3mL, 5.4mL, 5.5mL, 5.6mL, 5.7mL, 5.8mL, 5.9mL or 6.0mL.

In some embodiments, the internal volume containing a dose of at least one medicament is greater than 6.0 milliliters. For example, the internal volume of each of the interconnected single-dose vials may be at least twice the volume of the single-dose volume of medicament to contain two doses of medicament. For example, the internal volume of each of the interconnected single-dose vials may be 10 milliliters and be configured to hold two 3 milliliter single-dose volumes of medicament.

In one aspect, each of the interconnected single-dose vials has an internal volume configured to contain a single dose of at least one medicament. For example, the internal volume of each of the interconnected single-dose vials can be sized to contain a single-dose volume of at least one medicament. In one aspect, the single dose volume of at least one medicament can be expressed in milliliters (mL) or cubic centimeters (cc). In one aspect, a single dose volume includes a liquid or lyophilized formulation of at least one agent configured for intramuscular, intradermal, subcutaneous, intravenous, or intraperitoneal injection. In one aspect, a single dose volume includes a liquid or lyophilized formulation of at least one medicament configured for administration through the mouth, nose, eye, urethra, anus, or vagina. In one aspect, a single dose volume includes a liquid or lyophilized formulation of at least one medicament configured for intraocular injection. In one aspect, a single dose volume includes a liquid or lyophilized formulation of at least one medicament configured to be injected into the central nervous system.

In one aspect, the single dose volume of at least one medicament depends on the type of medicament. In one aspect, the single dose volume of at least one medicament is a clinically determined effective or therapeutic dose of at least one medicament. For example, the recommended dose of common vaccines ranges from 0.05 mL for BCG (tuberculosis) vaccine to 1.0 mL for hepatitis A vaccine. In one aspect, the single dose volume of at least one medicament depends on the injection site, such as intramuscular, subcutaneous or intradermal. For example, the single dose volume for intramuscular injection of liquid drugs can be as high as 5 mL. See, for example, Hopkins & Arias (2013) "Large volume IM injections: A review of best practices", Oncology Nurse Advisor November/February, which is incorporated herein by reference. In one aspect, the single dose volume of the at least one medicament depends on the size of the individual who will receive the at least one medicament. For example, the single dose volume may depend on the size of the intended recipient (e.g., children and adults), such as weight. For example, the single dose volume for subcutaneous injection of the medicament may be 0.5 mL, 1 mL or 2 mL, depending on the size of the child or adult. In one aspect, the single dose volume of the medicament is about 0.01 mL to about 5 mL. For example, in some embodiments, the single dose volume of the drug may be 0.01 mL, 0.02 mL, 0.05 mL, 0.075 mL, 0.1 mL, 0.15 mL, 0.2 mL, 0.25 mL, 0.3 mL, 0.35 mL, 0.4 mL, 0.45 mL , 0.5mL, 0.55mL, 0.6mL, 0.65mL, 0.7mL, 0.75mL, 0.8mL, 0.85mL, 0.9mL, 1.0 mL, 1.25mL, 1.5mL, 1.75mL, 2.0mL, 2.25mL, 2.5mL, 2.75 mL, 3.0mL, 3.25mL, 3.5mL, 3.75mL, 4.0mL, 4.25mL, 4.5mL, 4.75mL or 5.0mL.

In one aspect, the internal volume of each of the interconnected single-dose vials is configured to contain two or more doses of at least one medicament. For example, each of the interconnected single-dose vials of multiple single-dose containers may be configured to hold two or more single-dose volumes of at least one medicament.

In one aspect, each of the interconnected single-dose vials of multiple single-dose containers includes a different medicament. For example, a multiple single-dose container may be configured to be intended for the transportation and storage of a specific number of single doses of multiple drugs for a single patient within a limited period of time (eg, a single medical clinic visit). For example, in some embodiments, a multiple single-dose container including six interconnected single-dose vials is configured to store and transport a single dose of each of HepB, RV, DTaP, HiB, PCV, and IPV vaccines. Each of them has a vaccine to be administered to children according to the regular vaccine schedule recommended for 2 months of age. For example, in some embodiments, a multiple single-dose container including four interconnected single-dose vials is configured to store and transport a single dose of each of DTaP, IPV, MMR, and VAR vaccines, each of the vials There is a vaccine that is used to administer to children according to the regular vaccine schedule recommended for 4-6 years of age. See "Advisory Committee on Immunization Practice (ACIP) Recommended Immunization Schedule for People from 0 to 18 Years Old-United States, 2013" ACIP Child/Adolescent Working Group, MMWR 62:1-8 (2013), which is incorporated by reference Into this article.

For example, in some embodiments, multiple single-dose containers including interconnected single-dose vials can be used to store multiple doses of immunoglobulin therapy that can be administered to a patient consecutively as instructed by a medical professional. Several types of immunoglobulin therapeutics are available, which are usually administered continuously in a dose volume relative to the patient's body weight. An aliquot volume of the immunoglobulin therapy can be stored in separate single-dose vials of multiple single-dose containers in a way that minimizes the waste of immunoglobulin therapy and keeps the immunoglobulin in the vial The treatment is administered to the patient in a manner that minimizes the possibility of contamination of the treatment. For example, in some embodiments, multiple single-dose containers including interconnected single-dose vials can be used to store multiple doses of antiviral therapy administered by injection. For example, in some embodiments, a multiple single-dose container including interconnected single-dose vials can be used to store multiple doses of an antibiotic treatment administered by injection. For example, in some embodiments, multiple single-dose containers including interconnected single-dose vials can be used to store a dose of a biological agent that includes a therapeutic protein. For example, in some embodiments, multiple single-dose containers including interconnected single-dose vials can be used to store a dose of a biological agent that includes antibodies (eg, monoclonal or polyclonal antibodies). For example, in some embodiments, a single-dose vial that includes interconnected Multiple single-dose containers can be used to store multiple doses of therapeutics that are usually administered continuously to a single patient by injection, so that a multiple single-dose container can be included for administration to a single individual patient in a time series under the guidance of a medical professional The standard sequence of injectable doses. For example, in some embodiments, multiple single-dose containers including interconnected single-dose vials can be used to store a dose of an injection-administered therapeutic that has multiple components administered separately, such as Different antibiotics and/or antiviral agents for individual patients in need.

In one aspect, the internal volume containing a dose of at least one medicament includes a headspace volume higher than the dose of at least one medicament. In one aspect, the internal volume containing a dose of at least one medicament includes an inert gas filled headspace. For example, the headspace of a dose of at least one medicament in liquid or lyophilized/solid form can be filled with inert gas. In one aspect, the internal volume containing a dose of at least one medicament includes a nitrogen-filled headspace. For example, each of the interconnected single-dose vials may be configured to contain nitrogen in the headspace above a dose of at least one medicament. For example, each of the interconnected single-dose vials may be configured to contain carbon dioxide in the headspace above a dose of at least one medicament. In one aspect, the internal volume containing a dose of at least one medicament includes a head space filled with a rare gas. For example, each of the interconnected single-dose vials may be configured to contain at least one of argon, neon, krypton, or xenon in the headspace above a dose of at least one medicament. The process of forming, filling and sealing bottles of multiple single-dose containers may further include purging the atmosphere/oxygen in the headspace above a dose of at least one medicament before adding the inert gas.

In one aspect, each of the interconnected single-dose vials includes an access portion. In one aspect, the access portion includes a hole defined by the wall of the single-dose vial. In one aspect, the access portion is adjacent to the internal volume of the single-dose vial. For example, the access portion may include a hole or opening defined by the end of the wall, the wall forming a single-dose vial, the hole or opening allowing access to the internal volume of the single-dose vial. For example, the access part includes an opening in a single-dose medicine bottle for accessing a certain dose of at least one medicament enclosed therein. For example, the access portion is large enough to accommodate the passage of a needle (for example, a syringe needle).

In one aspect, each of the interconnected single-dose vials includes a closure covering the access portion. In some embodiments, the closure includes a removable cover. In some embodiments, the removable cover is broken or twisted to expose the access portion of the single-dose vial. In one aspect, the access portion is an opening or hole defined by the wall of the single-dose vial. For example, the removable cover can be broken or twisted to expose an opening or hole through which the closed at least one medicament can be accessed. In one aspect, the closure includes a closure pierceable by a needle. For example, the closure may include a material that can be pierced by a needle, and a needle connected to the syringe can pass through The material to enter the internal volume of a single-dose vial. For example, the closure may include a removable cap that is broken or twisted to expose material that can be pierced by the needle, through which the needle connected to the syringe may enter the internal volume of the single-dose vial.

In one aspect, each of the interconnected single-dose vials includes an access portion that can be pierced by a needle. In one aspect, the needle-pierceable access portion is configured to allow the needle to pass through the needle-pierceable material forming at least a portion of the multiple single-dose container into the internal volume of the single-dose vial. For example, the needle-pierceable access portion may include a needle-pierceable access portion of the thermoplastic material used to form the multiple single-dose container. For example, the top of a blow-molded-fill-seal bottle may include an entry portion that can be pierced by a needle. For example, the needle pierceable entry portion may include a sealed portion formed by melting or heat sealing a wall at the open end of each of the single-dose vials to cover the entry portion. For example, the sealed portion formed by melting or heat-sealing the wall at the open end of each of the single-dose vials may also be needle pierceable to allow the needle to pass through the sealed portion to enter the inner volume of the bottle. In some embodiments, each of the interconnected single-dose vials forming the multiple single-dose containers may include a removable cap that, once removed, exposes an access portion that the needle can pierce.

In one aspect, the needle-pierceable access portion includes additional components added to each of the interconnected single-dose vials. In one aspect, the needle-pierceable access portion includes an insert. For example, the needle-pierceable access portion may include inserts added to rows of interconnected single-dose vials that are blow-molded or injection-molded. In one aspect, the entry portion that the needle can pierce includes the entry portion that can be pierced by the rubber needle. For example, the closure may include a rubber septum pierceable by a needle, the septum inserted into the entry portion and held in place by an aluminum seal crimped around the tapered neck area of the bottle. For example, the entry part that the rubber needle can pierce is made of bromobutyl or chlorobutyl synthetic rubber. On the one hand, the entry part that the rubber needle can pierce is further protected by a plastic flip cover.

In one aspect, each of the interconnected single-dose vials includes a removable cap covering the access portion. In one aspect, each of the interconnected single-dose vials includes a shearable cap covering the access portion. For example, a shearable cap can be used during the blow-fill-seal manufacturing process so that it can be easily cut from the rest of the single-dose vial to reveal the access part (e.g., the access part accessible by the needle) during use. This way is formed. In one aspect, each of the interconnected single-dose vials includes a twistable cap covering the access portion. For example, a twistable cap can be used during the blow-fill-seal manufacturing process to enable the twistable cap to be easily twisted from the remainder of the single-dose vial to expose the entry portion (e.g., the entry portion into which the needle can enter. ) This way. In one aspect, the removable cover is formed into The base of the row of interconnected single-dose vials is then formed by a second molding process. In one aspect, the removable cover is an insert added during the molding process. See, for example, U.S. Patent No. 3,993,223 entitled "Dispensing Container" issued to Welker &Brady; U.S. Patent No. 6,626,308 issued to Weiler entitled "Hermetically Sealed Container with Self-Draining Closure", and Cambio entitled "Blow Molded Container" "Having an Insert Molded In Situ" US Patent No. 4,319,701, all of which are incorporated herein by reference.

In one aspect, each of the interconnected single-dose vials includes an insert covering the access portion. For example, each of the interconnected single-dose vials may include a removable cap, which is added to each of the interconnected single-dose vials. In one aspect, an insert is added to each of the interconnected single-dose vials during the molding process. See, for example, U.S. Patent No. 4,319,701 entitled "Blow Molded Container Having an Insert Molded In Situ" to Cambio, which is incorporated herein by reference. In one aspect, the insert at least partially includes another sterile element added to each of the interconnected single-dose vials after the molding process. For example, the insert may include a tip type cap, a metal part, or a luer connector. In one aspect, the insert is one of a co-moulded tip and cap insert, a multi-entry rubber plug insert, or a controllable diameter injection moulded insert for producing calibration droplets. In one aspect, the insert is a septum. For example, insertion techniques can be used to insert a sterile tip and cap insert into each of the interconnected single-dose vials.

In one aspect, each of the interconnected single-dose vials includes a luer connector or fitting. For example, each of the interconnected single-dose vials may include a Luer connector that is appropriately sized to mate with a syringe that includes a Luer lock, thereby allowing the contents of the bottle to be removed without the use of a syringe needle Things. See, for example, US Patent No. 4,643,309 entitled "Filled Unit Dose Container" by Evers and Lakemedel, which is incorporated herein by reference.

Returning to FIG. 4, the second portion 430 of the molded structure 410 includes a textured surface pattern 450 that is positioned to guide airflow between the first portion and an area adjacent to the second portion. For example, the second part of the molded structure may include a textured surface pattern that is configured to aid in the process of hermetically sealing the multiple single-dose container in an airtightly sealable outer wrapper. Air and/or inert gas can be drawn or discharged from the outer wrapper that can be airtightly sealed. In one aspect, the textured surface pattern positioned to direct the air flow between the first portion and the area adjacent to the second portion includes a recessed surface pattern positioned to direct the air flow between the first portion and the area adjacent to the second portion. For example, the textured surface pattern may include a series of patterns on the surface of the second part of the molded structure Column recesses or grooves. In one aspect, the textured surface pattern positioned to guide the air flow between the first portion and the area adjacent to the second portion includes a convex surface pattern positioned to guide the air flow between the first portion and the area adjacent to the second portion . For example, the textured surface pattern may include a series of ridges on the surface of the second part of the molded structure. In one aspect, recesses or protrusions are performed after manufacturing the molded structure to form a textured surface pattern. For example, a recessed surface pattern (such as a series of recesses or grooves) can be etched into the surface of the second part of the molded structure. For example, a convex surface pattern, such as a series of ridges, can be created on the surface of the second part of the molded structure. In one aspect, the recesses or protrusions forming the textured surface pattern are performed during the manufacturing process of the molded structure. For example, concave and/or convex textured surface patterns can be incorporated into the mold used to form the molded structure. For example, a textured surface pattern of depressions and/or protrusions may be incorporated into a mold used for blow molding manufacturing of multiple single-dose containers. For example, a textured surface pattern of depressions and/or protrusions can be incorporated into a mold for injection molding multiple single-dose containers. For example, concave and/or convex textured surface patterns can be incorporated into molds for blow-fill-seal manufacturing of multiple single-dose containers.

In one aspect, at least a portion of the textured surface pattern includes channels arranged in parallel with the directed air flow between the first portion and the area adjacent to the second portion. For example, the textured surface pattern may include a series of parallel lines that are raised and/or recessed on the surface of the second part of the molded structure. For example, the textured surface pattern may include a series of broken (e.g., hashed or dotted) lines protruding and/or recessed on the surface of the second portion of the molded structure. In one aspect, at least a portion of the textured surface pattern includes parallel channels recessed on the surface of the second portion of the molded structure, and the parallel channels are connected to the first portion of the molded structure and adjacent to the second portion (eg, adjacent to the second portion). Align the airflow between the end edges). In one aspect, at least a portion of the textured surface pattern includes parallel channels protruding on the surface of the second portion of the molded structure, and the parallel channels are formed between the first portion of the molded structure and the region adjacent to the second portion. The airflow is aligned. In one aspect, at least a portion of the textured surface pattern includes channels positioned at an angle relative to the directed air flow, which converge or nearly converge so as to be parallel to the directed air flow. Other textured surface patterns are contemplated, including, but not limited to, chevron patterns, curved patterns, hash or dot patterns.

The second part of the molded structure including the textured surface pattern is attached to the first part of the molded structure. In one aspect, the second part is attached to the first part near the bottom part of the row of interconnected single-dose vials. A non-limiting example is provided in FIG. 6. FIG. 6 shows a schematic diagram of a multiple single-dose container 600 including a molded structure 610 having a first part 620 and a second part 630. Part 620 packs Includes rows of interconnected single-dose vials 640. The second part 630 includes a textured surface pattern 650. The second part 630 is shown as attached to the first part 620 near the bottom of the row of interconnected single-dose vials 640. Each of the interconnected single-dose vials 640 of the multiple single-dose container 600 also includes a needle-pierceable entry portion 660 through which an injection needle can pass. The multiple single-dose container 600 also includes at least one label 670, and the at least one label 670 includes at least one sensor 680. The label 670 includes information about at least one medicament. The at least one sensor 680 includes at least one of a temperature sensor, a humidity sensor, a light sensor, or an oxygen sensor.

In some embodiments, the first portion 620 of the molded structure 610 includes rows of interconnected single-dose vials 640 connected by one or more hinge joints 645. In one aspect, at least one of the interconnected single-dose vials is connected to at least one adjacent single-dose vial by a hinged joint that is flexible enough to connect at least one of the interconnected single-dose vials The flat outer surface reversibly cooperates with the flat outer surface of at least one adjacent single-dose vial. For example, a multiple single-dose container may include rows of interconnected single-dose vials connected by one or more hinged joints, non-limiting aspects of which are described in more detail in Figures 22A-22E. One or more hinge joints are configured to allow multiple single-dose containers to be folded into a more compact configuration for shipping and storage.

In some embodiments, the articulated joint only functions after the second part of the molded structure is separated from the first part of the molded structure, and can be bent. For example, in some embodiments, the hinge joint can only reversibly mate the flat outer surface of a single-dose vial with the flat outer surface of an adjacent single-dose vial after removing the second part of the molded structure. In some embodiments, the articulated joint is functional in the complete molded structure, that is, bendable. For example, the hinge joint may be positioned to extend the length of the first and second portions of the molded structure. For example, an articulating joint may be positioned between and extend the length of each of the interconnected single-dose vials.

In one aspect, the second portion is attached to the first portion adjacent the top of the row of interconnected single-dose vials. A non-limiting example is provided in FIG. 7. FIG. 7 shows a schematic diagram of a multiple single-dose container 700 including a molded structure 710 having a first part 720 and a second part 730. The first part 720 includes a row of interconnected single dose vials 740. In some embodiments, each of the interconnected single-dose vials 740 is connected to at least one adjacent single-dose vial 740 by one or more hinge joints 745. The second part 730 includes a textured surface pattern 750. The second part 730 is shown attached to the first part 720 near the top of the row of interconnected single-dose vials 740. The multiple single-dose container 700 also includes a closure 760, such as a twistable cap, which is designed to be removed to expose for injection with, for example, an injection needle. Enter the entrance part of the enclosed medicament. The multiple single-dose container 700 also includes a label 770 that includes at least one sensor 780. Tag 770 includes information about at least one medicament. The at least one sensor 780 includes at least one of a temperature sensor, a humidity sensor, a light sensor, or an oxygen sensor.

In one aspect, the multiple single-dose container includes at least one label. In one aspect, the at least one label is associated with at least one surface of the molded structure of the multiple single-dose container. In one aspect, the at least one label is attached to at least one surface of the molded structure of the multiple single-dose container. In one aspect, the at least one label is associated or connected to the first part of the molded structure. In one aspect, the at least one label is associated or connected to the second part of the molded structure. In one aspect, a label is associated or connected to each of the interconnected single-dose vials.

The label includes information about at least one medicament contained in each of the interconnected single-dose vials forming the multiple single-dose containers. For example, the label may include the proper name of the drug, the determined or proper name of the drug, the strength of the drug, the route of administration, warning (if any), warning statement (if any), net quantity, manufacturer Name, expiry date, batch number, recommended storage conditions, recommended single-dose volume (if multiple doses per bottle), barcode, batch number, national drug number, controlled substance program information (if any), radio frequency Identification (RFID) tags or combinations thereof. For liquid form medications, the label may include strength per total volume (e.g., 500 mg/10 mL) and strength per milliliter (e.g., 50 mg/1 mL). For medicaments in powder form, the label may include the amount of medicament per bottle (eg, in milligrams). The label may also include instructions for reconstitution of the medicament in lyophilized or powder form and the strength of the medicament in the reconstituted volume. For additional information on container labels, see, for example, "Guidance for Industry: Safety Considerations for Container Labels and Carton Labelling Design to Minimize Medication Errors, Food and Drug Administration," April 2013, which is incorporated herein by reference.

In one aspect, each of the interconnected single-dose vials includes a label. For example, each of the single-dose vials that constitute a row of interconnected single-dose vials may have a separate label. In one aspect, a label is associated with at least one surface of each of the interconnected single-dose vials. In one aspect, a label is printed on the outer surface of each of the single-dose vials constituting the row of interconnected single-dose vials. For example, thermal transfer overprinting, laser marking systems, continuous inkjet or thermal inkjet can be used to print labels onto each of the single-dose vials. For example, the label may be printed on a portion of the removable cap associated with the single-dose vial.

In one aspect, a label is attached to at least one surface of each of the interconnected single-dose vials. For example, a label may be attached to one or more outer surfaces of each of the interconnected single-dose vials. For example, a label may be attached to a removable cap associated with each of the interconnected single-dose vials. In one aspect, the label is printed separately and includes an adhesive for adhering at least a portion of the label to at least one surface of the multiple single-dose container. For example, the label may be printed separately and attached with an adhesive to the removable cap of each of the interconnected single-dose vials that make up the multiple single-dose container. For example, the label may be separately printed on a label including a pressure sensitive adhesive. For example, the label may be printed separately on the label, the label being adhered to each of the interconnected single-dose vials that constitute the multiple single-dose container with a separate pressure-sensitive adhesive sheet (such as a transparent adhesive tape sheet) .

In one aspect, a wet glue labeler or pressure sensitive label applicator is used to apply a label including a wet glue or pressure sensitive adhesive to each of the molded structure and/or interconnected single dose vials. In one aspect, the wet glue labeling machine includes a hot melt label applicator. For example, a hot melt label applicator can be used to apply a label with solid glue at room temperature, which becomes liquid when heat is applied. In one aspect, the wet glue labeling machine includes a pre-glued label applicator. For example, a pre-glued label applicator can be used to apply a wet label pre-coated with adhesive.

In one aspect, the label includes in-mold labeling technology that applies the label to the molded structure when the molded structure is formed. For example, at least one label may be applied during blow molding of the molded structure. For example, at least one label may be applied during injection molding of the molded structure. In one aspect, the label is depressed on the surface of the molded structure. In one aspect, the label is embossed on the surface of the molded structure. In one aspect, at least one label is etched into the surface of the molded structure.

In one aspect, the multiple single-dose container includes at least one label having at least one sensor. For example, the multiple single-dose container may include a label with a sensor that is configured to detect or monitor environmental exposure of the multiple single-dose container. For example, a multiple single-dose container may include a label with a sensor configured to detect or monitor environmental exposure to the multiple single-dose container due to a rupture in the secondary packaging. In one aspect, the molded structure includes at least one tag containing at least one sensor. In one aspect, the first part of the molded structure includes at least one tag containing at least one sensor. In one aspect, each of the interconnected single-dose vials includes a label including at least one of a temperature sensor, a humidity sensor, a light sensor, or an oxygen sensor. For example, each of the interconnected single-dose vials including multiple single-dose containers may include a label with a sensor configured to detect or monitor the environmental conditions (e.g., temperature, humidity, Light or oxygen) exposure. For example, the label may include at least one sensor configured to detect or monitor environmental exposure due to a rupture in the secondary packaging (e.g., a vacuum seal cover).

In one aspect, the tag includes at least one temperature sensor. In one aspect, the temperature sensor is configured to monitor temperature excursions, such as the transportation or storage temperature for a given medicament outside the recommended range. For example, the temperature sensor may be configured to monitor whether multiple single-dose containers and/or individual single-dose vials and potentially heat-sensitive medicaments stored therein are exposed to excessive heat during transportation and/or storage. For example, the temperature sensor may include a chemical composition that gradually and/or irreversibly changes color in response to changes in temperature exposure. In one aspect, the temperature sensor includes a substrate, such as a paper laminate, which has an indicator dye configured to change color in response to temperature changes. On the one hand, the color change is irreversible. See, for example, US Patent No. 5,085,802 entitled "Time Temperature Indicator with Distinct End Point" by Jalinski; US Patent No. 5,254,473 entitled "Solid State Device for Monitoring Integral Values of Time and Temperature of Perishables" by Patel; and Prusik U.S. Patent No. 6,544,925 entitled "Activatable Time-Temperature Indicator System" by et al., which are incorporated herein by reference. In one aspect, the temperature sensor is configured to monitor cumulative heat exposure. For example, the temperature sensor may include a HEATmarker® indicator (from Temptime Corporation, Morris Plains, NJ) that gradually changes color in response to accumulated heat exposure. For example, the temperature sensor may include Timestrip PLUS Duo (Timestrip from the United Kingdom), which is used to cumulatively detect temperature excursions above or below a specified threshold. In one aspect, the temperature sensor is configured to detect a threshold or limit the temperature level. For example, the temperature sensor may include LIMITmarker ^TM indicator (from Temptime Corporation, Morris Plains, NJ) or 3M ^TM MonitorMark ^TM time temperature indicator (from 3M, St. Paul, Minnesota) if the label and its contents have been exposed At a potentially destructive threshold temperature, the indicator irreversibly changes color. In one aspect, the temperature sensor is configured to monitor whether the multiple single-dose container and/or its freezing-sensitive contents are exposed to inappropriate freezing temperatures during transportation and/or storage. For example, the temperature sensor may include a FREEZEmarker® indicator (from Temptime Corporation, Morris Plains, NJ) or a 3M ^™ Freeze Watch ^™ indicator (from 3M, St. Paul, Minnesota), which is irreversibly in response to a freezing event Change the color. See, for example, Kartoglu & Milstien (2014) "Tools and approachached to ensure quality of vaccines throughout the cold chain", Expert Rev Vaccines 13:843-854, which is incorporated herein by reference. Other time-temperature indicators include VITSAB®, CheckPoint® (from Vitsab International, Sweden), and Fresh-Check®.

In one aspect, the label includes a vaccine vial monitor (VVM) to indicate the cumulative heat exposure of the vaccine vials to determine whether the cumulative heat history of the product has exceeded a preset limit. On the one hand, according to the product For thermal stability, the vaccine vial monitor includes at least one of VVM30, VVM14, VVM7 or VVM2 indicators. For example, the VVM30 label has an end point of 30 days at 37°C and an end point greater than 4 years at 5°C, while the VVM2 label has an end point of 2 days at 37°C and an end point of 225 days at 5°C. For more information on the international specifications of the vaccine vial monitor, see Vaccine vial monitor, PQS performance specifications, World Health Organization, WHO/PQS/E06/IN05.2, which is incorporated by reference, published on July 26, 2011 This article.

In one aspect, the tag includes at least one humidity sensor. For example, the label may include a sensor configured to detect exposure to moisture due to a rupture in the secondary packaging covering/sealing the multiple single-dose container. For example, the humidity sensor may include a colorimetric water detection label that changes color in response to exposure to moisture (eg, 3M ^™ ultra-thin water contact indicator, from 3M Corporation of St. Paul, Minnesota). See also, for example, U.S. Patent No. 4,098,120 entitled "Humidity Indicating Method and Device" to Manske, which is incorporated herein by reference.

In one aspect, the tag includes at least one light sensor. For example, the at least one sensor may include a light sensor configured to monitor whether the multiple single-dose container and/or the individual single-dose vials constituting the multiple single-dose container have been exposed to light. The light sensor can be used to detect potential ruptures in the hermetically sealed outer wrapper. For example, the light sensor may include a photoresistor, a light-dependent resistor, or a photocell associated with a radio frequency identification (RFID) tag. For example, the light sensor may include a light collecting photovoltaic module (from, for example, ElectricFilm, LLC, Newburyport, MA).

In one aspect, the tag includes at least one oxygen sensor. For example, a multiple single-dose container may include at least one label with an oxygen sensor configured to detect potential ruptures in an airtightly sealed outer wrapper prior to use. In one aspect, the oxygen indicator is a light-based oxygen indicator. For example, the oxygen sensor may include tris(4,7-diphenyl-1,10-phenanthroline) ruthenium(II) packaged in a case-permeable material (such as silicone rubber) Perchlorate, namely [Ru(dpp) ₃ ](ClO ₄ ) ₂ . The luminescence associated with [Ru(dpp) ₃ ](ClO ₄ ) ₂ is quenched in the presence of oxygen. For example, the oxygen sensor may include an O2xyDot ^™ oxygen sensor (from OxySense® Dallas, TX) attached to a tag and/or bottle. In one aspect, the oxygen indicator is a colorimetric indicator configured to change color in response to exposure to oxygen. For example, the oxygen sensor may include a colorimetric redox dye-based indicator, such as Ageless Eye ^™ (from Mitsubishi Gas Company, Japan). In one aspect, the oxygen sensor includes a redox dye-based oxygen indicator activated by colorimetric light. For example, an oxygen sensor may include a light-activated dye that is "triggered" with ultraviolet or visible light and further changes color in response to oxygen exposure. See, for example, Mills (2005) "Oxygen indicators and intelligent inks for packaging food," Chem. Soc. Rev. 34: 1003-1011, which is incorporated herein by reference. US Patent No. 8,707,766 entitled "Leak detection in vacuum bags" by Harris et al., which is incorporated herein by reference. US Patent No. 8,501,100 entitled "Oxygen detection using metalloporphyrins" to Fukui, which is incorporated herein by reference.

Additional information about colorimetric packaging sensors is described in Kamal el Deen (2013) "The Intelligent Colorimetric Timer Indicator Systems to Develop Label Packaging Industry in Egypt" Int. Design J. 4: 295-304.

In one aspect, the tag includes electronics. In one aspect, the tags include XpressPDF temperature monitoring tags (from PakSense, Boise, ID), which include a built-in USB connection point, and generate PDF data files containing complete time and temperature history. In one aspect, the label includes printed electronics. For example, labels include printed radio frequency identification tags. For example, the label may include a printed temperature sensor using ThinFilm technology (from, for example, Thin Film Electronics ASA, Oslo, Norway).

In one aspect, the tags include smart radio frequency identification (RFID) tags. For example, RFID tags can be integrated with sensors (e.g., temperature and/or light sensors) for wireless monitoring of environmental conditions. See, for example, Cho et al. (2005) "A 5.1-W UHF RFID Tag Chip integrated with Sensors for Wireless Environmental Monitoring", Proceedings of ESSCIRC, Grenoble, France, 2005, pages 279-282, which are incorporated by reference Into this article.

Fig. 8 shows a further step diagram of the method of packaging multiple single-dose containers as shown in Fig. 1. FIG. 8 is a step diagram showing aspects of a method 100 of packaging multiple single-dose containers. The method 100 for packaging multiple single-dose containers includes: in step 120, at least a portion of the air is drawn from around a molded structure covered by an airtight sealable outer wrapper, and at least a portion of the drawn air flows at least partially through the molded structure. Textured surface pattern of the second part of the structure. For example, the method includes reducing the total volume of the packaged multiple single-dose container by removing at least a portion of the air from the air-tightly sealable outer wrapper before closing. In some embodiments, the method includes using a vacuum source to evacuate at least a portion of the air surrounding the multiple single-dose container. In one aspect, the method 100 of packaging multiple single-dose containers includes in step 800 inserting a flow tube connected to a vacuum source at a position near the textured surface pattern on the second part of the molded structure into an air-tight seal. In the opening defined by the outer wrapper; pressure seal a portion of the hermetic sealable outer wrapper around the inserted flow pipe to form a bag around the molded structure; and withdraw from the bag around the molded structure At least a portion of the air is such that at least a portion of the extracted air flows at least partially through the textured surface pattern of the second portion of the molded structure.

In one aspect, the method of packaging multiple single-dose containers in an air-tight sealable outer wrapper includes the use of an inert gas. For example, the method may include injecting an inert gas around the hermetically sealable outer wrapper and the multiple single dose container before sealing the multiple single-dose container in the hermetic sealable outer wrapper. In some embodiments, the method 100 includes injecting an inert gas around a molded structure covered by an overwrap that can be hermetically sealed; and expelling the injected inert gas around the molded structure covered by an overwrap that can hermetically seal. At least a portion of the gas, at least a portion of the discharged inert gas that is injected flows at least partially through the textured surface pattern of the second portion of the molded structure, as described in step 810. For example, the method may include creating an oxygen-free and/or inert atmosphere surrounding the molded structure and rows of interconnected single-dose vials by injecting an inert gas into an airtightly sealable outer envelope covering the molded structure . In one aspect, the method 100 includes injecting nitrogen around a molded structure covered by an overwrap that can be hermetically sealed, as shown in step 820. In one aspect, the method 100 includes injecting a rare gas around a molded structure covered by an overwrap that can be hermetically sealed, as shown in step 830. For example, the method may include injecting at least one of argon, neon, krypton, or xenon into an outer envelope that can be hermetically sealed.

In one embodiment, the method 100 of packaging multiple single-dose containers includes expelling at least a portion of the air around the molded structure covered by an air-tight sealable outer wrap before injecting the inert gas, as shown in step 840. For example, the method may include drawing at least a portion of the air around the molded structure covered by the air-tight sealable outer wrap before injecting the inert gas. For example, the method may include exchanging air from around the molded structure covered by an airtight seal with an inert gas. For example, the method may include purging or flushing the air surrounding the molded structure covered by an airtight seal with an inert gas.

In some embodiments, the method includes vacuum sealing the multiple unit dose container in the presence of an inert gas using a vacuum source. For example, a method of packaging multiple single-dose containers may include inserting a flow duct connected to a vacuum source into a position adjacent to the textured surface pattern on the second part of the molded structure defined by an air-tight sealable outer wrapper. Pressure-seal a part of the airtight sealable outer wrapper around the inserted flow pipe to form a bag around the molded structure; and extract at least a part of the injected inert gas from the bag surrounding the molded structure , Allowing at least a portion of the extracted inert gas to flow at least partially through the textured surface pattern on the second portion of the molded structure. In one embodiment, the flow duct is used to exhaust at least a portion of the air, inject inert gas, and remove from the air-tight sealable outer wrapper before forming an air-tight seal around the row of interconnected single-dose vials. Peripheral row of molded structure At least part of the injected inert gas is removed. In one embodiment, the first flow pipe is used to discharge at least a portion of the air and/or injected inert gas, and the second flow pipe is used to inject the inert gas.

Figures 9A-9F show additional aspects of a method of packaging multiple single-dose containers including flow channels. Figure 9A is a schematic diagram of a horizontal side view of a molded structure 410 of a multiple single-dose container. The molded structure 410 includes a first portion 420 including rows of interconnected single-dose vials, and a second portion 430 including a textured surface pattern 450. In this non-limiting example, the textured surface pattern 450 is shown on one surface of the second part 430, but it is also contemplated that the textured surface pattern may exist on more than one surface of the second part. Figures 9B-9F show non-limiting steps in the molded structure 410 for packaging multiple single-dose containers. 9B is a schematic diagram of a horizontal side view of a molded structure 410, which includes a first part 420, a second part 430 and a textured surface pattern 450 covered by an overwrap 900 that can be hermetically sealed. In this non-limiting example, the hermetic sealable outer wrap 900 is shown as a bag covering the molded structure 410, but it is also contemplated that a hermetically sealable sleeve or a hermetically sealable top layer covering the molded structure /Bottom layer. 9C is a schematic diagram of a horizontal side view of a molded structure 410 including a first part 420 and a second part 430 covered by an overwrap 900 that can be hermetically sealed. Also shown is a flow duct connected to a vacuum source 920 and inserted into an opening defined by an airtight sealable outer wrap 900 at a position adjacent to the textured surface pattern 450 of the second part 430 of the molded structure 410 910. The sealer 940 (for example, a pressure seal) is used to form a pressure seal 930, and the pressure seal 930 forms an airtight seal around the molded structure 410 together with a part of the airtight sealable outer wrap 900 and the inserted flow duct 910 Bag 950. FIG. 9D is a horizontal side view of the molded structure 410 including the first part 420 and the second part 430, the first part 420 and the second part 4304 are covered by an airtight sealable outer wrap 900 and are inside the airtight sealed bag 950. Also shown is the exhaust (arrow) of air 960 from the airtightly sealable bag 950 through the flow duct 910 connected to the vacuum source 920. The exhausted air 960 is shown as flowing at least partially through the textured surface pattern 450 of the second portion 430 of the molded structure 410. FIG. 9E is a schematic diagram of a horizontal side view of a molded structure 410 covered by an overwrap 900 that can be hermetically sealed. Also shown is an airtight seal 970 formed around the row of interconnected single-dose vials associated with the first portion 420 of the molded structure 410. In this non-limiting example, a portion of the hermetically sealable outer wrap 900 has been sealed/bonded to the surface of the second part 430 of the molded structure while still connected to the flow duct 910 and the vacuum source 920. 9F is a schematic diagram showing a horizontal side view of the second part 430 of the molded structure separated from the first part 420 of the molded structure. The first portion 420, which includes rows of interconnected single-dose vials, is shown sealed within an air-tight sealable outer wrap 900.

Figures 10A-10G show additional aspects of a method of packaging multiple single-dose containers including flow channels. Figure 10A is a schematic diagram of a horizontal side view of a molded structure 410 of a multiple single-dose container. The molded structure 410 includes a first portion 420 including rows of interconnected single-dose vials, and a second portion 430 including a textured surface pattern 450. In this non-limiting example, the textured surface pattern 450 is shown on one surface of the second part 430, but it is contemplated that the textured surface pattern may be present on more than one surface of the second part. Figures 10B-10G show non-limiting steps in the molded structure 410 for packaging multiple single-dose containers. FIG. 10B is a schematic diagram of a horizontal side view of a molded structure 410 covered by an overwrap 900 that can be hermetically sealed. In this non-limiting example, the hermetic sealable outer wrap 900 is shown as a bag covering the molded structure 410, but it is also contemplated that a hermetically sealable sleeve or a hermetically sealable top layer covering the molded structure /Bottom layer. FIG. 9C is a schematic diagram of a horizontal side view of a molded structure 410 covered by an airtight sealable outer wrap 900 injected with an inert gas 1000. In one aspect, the inert gas 1000 is nitrogen. In one aspect, the noble gas 1000 is a rare gas, such as argon, neon, krypton, or xenon. In some embodiments, before the inert gas 1000 is injected, the air around the molded structure 410 has been exhausted from the outer wrap 900 that can be hermetically sealed. In some embodiments, the air around the molded structure 410 is purged or flushed from the outer wrap 900 that can be hermetically sealed during the injection of the inert gas 1000. 10D is a schematic diagram of a horizontal side view of the molded structure 410, which includes a first part 420 and a second part 430 covered by an outer wrap 900 that can be airtightly sealed. Also shown is connected to the vacuum source 920 and inserted into the opening defined by the hermetically sealable outer wrap 900 at a position adjacent to the textured surface pattern 450 of the second portion 430 of the molded structure 410 Pipe 910. The sealer 940 (for example, a pressure sealer) is used to form a pressure seal 930. The pressure seal 930 forms an airtight seal around the molded structure 410 together with a portion of the airtight sealable outer wrap 900 and the inserted flow duct 910 Bag 950. FIG. 10E is a schematic diagram of a horizontal side view of a molded structure 410 including a first part 420 and a second part 430 covered by an airtight sealable outer wrap 900 and inside an airtight sealed bag 950. Also shown is an inert gas 1000 which is discharged from the airtight sealed bag 950 through a flow pipe 910 connected to a vacuum source 920 (arrow). The discharged inert gas 1000 is shown as flowing at least partially through the textured surface pattern 450 of the second portion 430 of the molded structure 410. FIG. 10F is a schematic diagram of a horizontal side view of a molded structure 410 covered by an overwrap 900 that can be hermetically sealed. Also shown is an airtight seal 970 formed around the row of interconnected single-dose vials associated with the first portion 420 of the molded structure 410. In this non-limiting example, a part of the hermetically sealable outer wrap 900 has been sealed/bonded to the surface of the second part 430 of the molded structure While still connected to the flow pipe 910 and the vacuum source 920. 10G is a schematic diagram showing a horizontal side view of the second part 430 of the molded structure separated from the first part 420 of the molded structure. The first portion 420, which includes rows of interconnected single-dose vials, is shown sealed within an air-tight sealable outer wrap 900.

Fig. 11 shows a further step diagram of the method of packaging multiple single-dose containers as shown in Fig. 1. The method 100 includes forming an airtight seal around the row of interconnected single-dose vials by bonding an airtight sealable overwrap to at least a portion of the surface of the molded structure, as shown in step 130. In one aspect, forming an airtight seal includes heat sealing, pressure sealing, or chemical sealing of an outer wrap that can be airtightly sealed. In one aspect, forming an airtight seal includes at least one of folding, rolling, crimping, welding, fusing, welding, heat sealing, blister sealing, or induction sealing.

In one aspect, forming an airtight seal around a row of interconnected single-dose vials includes using a closure device or a sealing machine. In one aspect, the closing device or sealing machine includes a heat sealing machine, a blister sealing machine, or an induction sealing machine. In one aspect, the closure device or sealing machine includes a belt sealer, a heat sealer, a clamp-type sealer, a glue sealer, or a rotary sealer. For example, the closure device or sealing machine may include heat sealing that uses heat to seal an overwrap (such as a plastic overwrap). For example, the closing device or sealing machine may include a blister sealing machine that seals the filled plastic blister to the coated cardboard sheet by applying heat. For example, the closure device or sealing machine may include an induction sealing machine that uses an electromagnetic field to seal the foil laminate to the container. Other non-limiting examples of closure devices or sealing machines include folding machines, tuck closure machines, crimp closure machines, fusion sealing machines, fusion sealing machines, welding sealing machines, rigid container sealing machines, or bag or bag sealing machines. For example, the closure device or sealing machine may include a bag sealing machine that uses the application of heat to seal the edge of the opening of the bag that can be hermetically sealed.

In one aspect, forming an airtight seal around a row of interconnected single-dose vials includes using a closure device or sealing machine in the presence of a closure material. In one aspect, the closure material may include at least one of an adhesive, pressure sensitive tape, or tape. In one aspect, the closing device or sealing machine includes a glue sealing machine, a tape sealing machine or a belt sealing machine.

In one aspect, forming an airtight seal around the row of interconnected single-dose vials includes forming a gas impermeable seal around the row of interconnected single-dose vials, as shown in step 1100. For example, the method may include heat-sealing the gas-impermeable overwrap to at least a portion of the surface of the molded structure to form a gas-impermeable seal around the row of interconnected single-dose vials. In one aspect, forming an airtight seal around the row of interconnected single-dose vials includes forming a vapor impermeable seal around the row of interconnected single-dose vials, as shown in step 1110. For example, the method can include Heat seal the vapor-impermeable outer wrapper to at least a portion of the surface of the molded structure to form a vapor barrier around the row of interconnected single-dose vials. In one aspect, forming an airtight seal around the row of interconnected single-dose vials includes forming a light impermeable seal around the row of interconnected single-dose vials, as shown in step 1120. For example, the method may include heat sealing the light impermeable outer wrapper to at least a portion of the surface of the molded structure to form a light impermeable seal around the row of interconnected single-dose vials. In one aspect, forming an airtight seal around the row of interconnected single-dose vials includes forming an electrostatic discharge protective seal around the row of interconnected single-dose vials, as shown in step 1130. For example, the method may include heat sealing an electrostatic discharge protective overwrap to at least a portion of the surface of the molded structure to form an electrostatic discharge protective barrier around the row of interconnected single-dose vials.

In one aspect, forming an airtight seal around the row of interconnected single-dose vials includes forming an airtight seal around the row of interconnected single-dose vials at equilibrium or near equilibrium pressure, as in step 1140 Show. In one aspect, the method includes forming an air-tight seal around the row of interconnected single-dose vials at or near the pressure within the sealed single-dose vial. In one aspect, forming an airtight seal around the row of interconnected single-dose vials includes forming an airtight seal around the row of interconnected single-dose vials under positive pressure, as shown in step 1150. For example, the method may include forming an air-tight seal around the row of interconnected single-dose vials at a pressure higher than the pressure in the sealed single-dose vial.

Fig. 12 shows a further step diagram of the method of packaging multiple single-dose containers as shown in Fig. 1. The method 100 includes bonding an overwrap that can be hermetically sealed to at least a portion of the surface of the molded structure, as shown in step 130. For example, the method includes physically bonding/sealing an airtight sealable overwrap (e.g., foil/laminate) to the surface of a molded structure (e.g., thermoplastic molded structure). In one aspect, bonding the hermetically sealable overwrap to at least a portion of the surface of the molded structure includes bonding the hermetic sealable overwrap to the molded structure adjacent to the second portion of the molded structure The surface of the first part is shown in step 1200. For example, the method may include bonding a hermetically sealable laminated overwrap to a portion of the molded structure near the base of the row of interconnected single-dose vials. For example, the method may include bonding an airtight sealable outer wrapper to the molded structure at a location on the molded structure that will be associated with the first part and the row of interconnected single-dose vials when the second part is cut. In one aspect, bonding an airtightly sealable overwrap to at least a portion of the surface of the molded structure includes bonding the airtightly sealable overwrap to each of the interconnected single-dose vials. The surface of the first part of the molded structure is shown in step 1210. For example, the method may include bonding an air-tight sealable outer wrap between and around each of the single-dose vials along the surface of the molded structure to produce individually packaged/sealed single-dose vials.

In one aspect, bonding the hermetically sealable overwrap to at least a portion of the surface of the molded structure includes applying heat to bond the hermetically sealable overwrap to at least a portion of the surface of the molded structure, as in step Shown at 1220. For example, bonding the hermetically sealable overwrap to at least a portion of the surface of the molded structure may include applying heat to melt the hermetic sealable overwrap onto the molded structure, or vice versa. In one aspect, bonding the hermetically sealable overwrap to at least a portion of the surface of the molded structure includes applying pressure to bond the hermetic sealable overwrap to at least a portion of the surface of the molded structure, as in step Shown at 1230. In one aspect, bonding the hermetic sealable overwrap to at least a portion of the surface of the molded structure includes chemically bonding the hermetic sealable overwrap to at least a portion of the surface of the molded structure, as in step 1240 Show. For example, bonding an airtight sealable overwrap to at least a portion of the surface of the molded structure may include the use of an adhesive or glue. For example, bonding an airtight sealable overwrap to at least a portion of the surface of the molded structure may include using chemicals (such as solvents) to "melt" the airtight sealable overwrap to the molded structure, or vice versa Of course.

In one embodiment, the method 100 of packaging multiple single-dose drug containers includes at least partially penetrating an airtight sealable outer wrapper to add a frangible portion between each of the interconnected single-dose vials. The outer wrapper that can be hermetically sealed, as shown in step 1250. For example, the method may include adding a frangible portion between each of the single-dose vials to allow the individual single-dose vials to be combined with the other single-dose vials in the row without compromising the hermetic sealing of the other single-dose vials. The rows of interconnected single-dose vials are separated and opened. In one aspect, the perforations of the hermetic sealable outer wrapper may overlap or align with the frangible perforation pattern associated with the molded structure, for example, between each of the single-dose vials.

In one embodiment, the method 100 of packaging multiple single-dose containers includes applying at least one label having at least one sensor to the outer surface of an airtight sealable outer wrapper, as shown in step 1260. For example, the method may include applying a label with information about the enclosed at least one medicament and at least one sensor to monitor the environment encountered by the packaged multiple single-dose container during transportation and storage. In one aspect, the method includes applying at least one label having a temperature sensor to the outer surface of an airtight sealable outer wrapper. Non-limiting aspects of tags and environmental sensors have been described above.

The method 100 of packaging multiple single-dose containers includes separating the second part of the molded structure from the first part of the molded structure, as shown in step 140. For example, the method may include removing tabs that include the textured surface pattern that constitutes the second part of the molded structure. For example, the method may include removing a contact that includes a textured surface pattern from an area above or below the row of interconnected single-dose vials. sheet. See, for example, Figures 6 and 7. In one aspect, separating the second part from the first part includes using a knife, saw, or other sharp blade to cut the second part from the first part. In one aspect, separating the second part from the first part includes using a hot wire or a blade to cut the second part from the first part. For example, by penetrating the heating wire or the blade into the biocompatible thermoplastic material of the molded structure included between the first part and the second part, the separation of the second part from the first part can be facilitated. In one aspect, separating the second part from the first part includes using a water jet. In one aspect, separating the second part from the first part includes using a laser. In one aspect, the molded structure is formed with a frangible part between the first part and the second part of the molded structure to facilitate separation.

Figure 13 shows a step diagram of a method 1300 of packaging multiple single-dose containers. Method 1300 includes covering a molded structure with an airtight sealable outer wrapper in step 1310, the molded structure comprising rows of interconnected single-dose vials and a textured surface pattern, interconnected single-dose vials Each of the bottles encloses a dose of at least one medicament, and the textured surface pattern is positioned to direct the air flow between the first part of the molded structure and the area adjacent to the second part of the molded structure. The method 1300 includes expelling at least a portion of air from around the molded structure covered by an airtight sealable outer wrapper in step 1320, at least a portion of the expelled air flowing at least partially through the textured surface pattern on the molded structure . The method 1300 includes forming an airtight seal around the row of interconnected single-dose vials in step 1330.

Method 1300 includes covering the molded structure with an overwrap that can be hermetically sealed. In some embodiments, the method includes covering the entirety of the molded structure. For example, the method may include covering the molded structure with a bag that can be hermetically sealed, the bag sized to accommodate the entirety of the molded structure. In some embodiments, the method includes covering at least a portion of the molded structure. For example, at least a portion of the molded structure may extend beyond the opening or edge of the outer wrapper that can be hermetically sealed.

Figure 14 shows a further step diagram illustrating a method 1300 of packaging multiple single-dose containers. In some embodiments, the method 1300 includes inserting the molded structure into an opening defined by an overwrap that can be hermetically sealed in step 1400. For example, a method of packaging a multiple single-dose container may include inserting a molded structure forming the multiple single-dose container through an opening of a bag or bag that can be hermetically sealed. For example, a method of packaging a multiple single-dose container may include inserting a molded structure forming the multiple single-dose container through an opening at either end of a sleeve that can be hermetically sealed. In one embodiment, the method 1300 includes positioning the molded structure in step 1410 between a first layer of an airtightly sealable overwrap and a second layer of an airtight sealable overwrap; and The first layer and the second layer of the outer wrapper that can be hermetically sealed One or more edges are sealed together. For example, the method may include transferring multiple single-dose containers between two layers of an overwrap that can be hermetically sealed. In one aspect, the method 1300 includes covering the molded structure in step 1420 with an energy-tightly sealed bag. In one aspect, the method 1300 includes covering the molded structure in step 1430 with a sleeve that can be hermetically sealed. Non-limiting aspects of covering the molded structure with an overwrap that can hermetically seal have been described above.

In one aspect, the method 1300 of packaging multiple single-dose containers includes covering the molded structure in step 1440 with a foil laminate that can be hermetically sealed. For example, the method may include overmolding the structure in a polyester/foil/polyethylene laminate. Other non-limiting aspects of the foil laminate have been described above. In one aspect, the method comprises using at least one of polyester, foil, polypropylene, cast polypropylene, polyethylene, high-density polyethylene, metallocene polyethylene, linear low-density polyethylene, or metallized film to form An air-tight sealable outer wrapper covers the molded structure. In one aspect, the method 1300 includes covering the molded structure in step 1450 with an overwrap that is impermeable to gas. In one aspect, the method 1300 includes covering the molded structure in step 1460 with an overwrap that is impermeable to vapor. In one aspect, the method 1300 includes covering the molded structure with an overwrap that is impermeable to light in step 1470. In one aspect, the method 1300 includes covering the molded structure with an electrostatic discharge protective overwrap in step 1480. The non-limiting aspects of gas-impermeable, vapor-impermeable, light-impermeable, and/or hermetically sealed outer wraps with electrostatic discharge protection properties have been described above.

The method 1300 of packaging multiple single-dose containers includes covering the molded structure with an overwrap that can be hermetically sealed. The molded structure of the multiple single-dose container includes rows of interconnected single-dose vials encapsulating a certain dose of at least one medicament; and a textured surface pattern that is positioned to be guided in the first part of the molded structure and Air flow between areas adjacent to the second part of the molded structure. Figure 15 shows aspects of the molded structure. 15 is a schematic diagram of a multiple single-dose container 1500 including a molded structure 1510, the molded structure 1510 includes rows of interconnected single-dose vials 1520 and a textured surface pattern 1530, in the interconnected single-dose vials 1520 Each packs a dose of at least one medicament, and the textured surface pattern 1530 is positioned to guide airflow between the first portion of the molded structure 1510 and the area adjacent to the second portion of the molded structure 1510.

In one aspect, a molded structure 1510 including rows of interconnected single-dose vials 1520 and a textured surface pattern 1530 is formed by a blow-fill-seal manufacturing process. In one aspect, a molded structure 1510 including rows of interconnected single-dose vials 1520 and a textured surface pattern 1530 is formed by a blow molding manufacturing process. In one aspect, it includes rows of interconnected single-dose vials 1520 and texturing The molded structure 1510 of the surface pattern 1530 is formed by an injection molding manufacturing process. In one aspect, a molded structure 1510 including rows of interconnected single-dose vials 1520 and a textured surface pattern 1530 is formed of at least one biocompatible material. In one aspect, a molded structure 1510 including rows of interconnected single-dose vials 1520 and a textured surface pattern 1530 is formed of at least one thermoplastic material. In one aspect, a molded structure 1510 including rows of interconnected single-dose vials 1520 and a textured surface pattern 1530 is formed of at least one biocompatible thermoplastic material. Non-limiting aspects of forming molded structures from biocompatible, thermoplastic, and biocompatible thermoplastic materials have been described herein above.

In one aspect, the row of interconnected single-dose vials 1520 includes two or more interconnected single-dose vials. In one aspect, the row of interconnected single-dose vials 1520 includes 2 to 30 interconnected single-dose vials. For example, a row of interconnected single-dose medicine bottles may include 2 bottles, 3 bottles, 4 bottles, 5 bottles, 6 bottles, 7 bottles, 8 bottles, 9 bottles, 10 bottles, 11 bottles, 12 bottles, 13 bottles, 14 bottles, 15 bottles, 16 bottles, 17 bottles, 18 bottles, 19 bottles, 20 bottles, 21 bottles, 22 bottles, 23 Bottles, 24 bottles, 25 bottles, 26 bottles, 27 bottles, 28 bottles, 29 bottles or 30 bottles. In one aspect, each of the interconnected single-dose vials 1520 is square, triangular, hexagonal, or polygonal in horizontal cross-section, non-limiting examples of which are shown in Figures 5A-5C.

In one aspect, each of the interconnected single-dose vials 1520 pack a dose of at least one medicament. In one aspect, the dose of at least one medicament is formulated for at least one of oral or parenteral administration. In one aspect, the dose of at least one medicament includes a dose of at least one vaccine. In one aspect, the dose of at least one medicament includes a dose of at least one therapeutic agent. In one aspect, the dose of at least one medicament is in liquid form. In one aspect, the dose of at least one medicament is in lyophilized form. Non-limiting examples of vaccines and therapeutic agents have been described herein above.

In one aspect, each of the interconnected single-dose vials 1520 includes an internal volume that holds the dose of at least one medicament. In one aspect, the internal volume of each of the single-dose vials 1520 is about 0.2 milliliters to about 6.0 milliliters. For example, the internal volume of each of the single-dose vials is 0.2mL, 0.3mL, 0.4mL, 0.5mL, 0.6mL, 0.7mL, 0.8mL, 0.9mL, 1.0mL, 1.1mL, 1.2mL, 1.4mL, 1.5mL, 1.6mL, 1.7mL, 1.8mL, 1.9mL, 2.0mL, 2.1mL, 2.2mL, 2.3mL, 2.4mL, 2.5mL, 2.6mL, 2.7mL, 2.8mL, 2.9mL, 3.0mL, 3.1mL , 3.2mL, 3.3mL, 3.4mL, 3.5mL, 3.6mL, 3.7mL, 3.8mL, 3.9mL, 4.0mL, 4.1mL, 4.2mL, 4.3mL, 4.4mL, 4.5mL, mL, 4.8mL, 4.9mL, 5.0mL, 5.1mL, 5.2mL, 5.3mL, 5.4mL, 5.5mL, 5.6mL, 5.7mL, 5.8mL, 5.9mL or 6.0mL.

In one aspect, the internal volume of the at least one medicament that holds the dose includes an inert gas filled headspace. For example, the headspace above a dose of at least one medicament in liquid or lyophilized form may include an inert gas, such as nitrogen or a rare gas.

In one aspect, each of the interconnected single-dose vials 1520 includes a closure 1540 covering the access portion. In one aspect, the access portion is an opening or hole defined by the wall of the single-dose vial. In some embodiments, the closure includes a removable cover. In some embodiments, the removable cover is broken or twisted to expose the access portion of the single-dose vial. For example, the removable cover can be broken or twisted to expose an opening or hole through which the closed at least one medicament can be accessed. In one aspect, the closure includes a closure pierceable by a needle. For example, the closure may include a needle pierceable material through which a needle connected to the syringe can pass to enter the internal volume of a single-dose vial. For example, the closure may include a removable cap that is broken or twisted to expose a needle pierceable material through which the needle connected to the syringe can enter the internal volume of the single-dose vial.

In one aspect, each of the interconnected single-dose vials 1520 includes an access portion that can be pierced by a needle. In one aspect, the needle-pierceable access portion is configured to allow the needle to pass through the needle-pierceable material forming at least a portion of the multiple single-dose container into the internal volume of the single-dose vial. For example, the needle-pierceable access portion may include a needle-pierceable access portion of the thermoplastic material used to form the multiple single-dose container. For example, the top of a blow-molded-fill-seal bottle may include an entry portion that can be pierced by a needle. For example, the entry portion that can be pierced by the needle may include a sealing portion formed by welding or heat-sealing the wall at the open end of each of the single-dose vials to cover the entry portion. For example, the sealing portion formed by welding or heat sealing the wall at the open end of each of the single-dose vials may also be needle pierceable to allow the needle to pass through the sealing portion to enter the inner volume of the bottle. In some embodiments, each of the interconnected single-dose vials forming the multiple single-dose containers may include a removable cap that, once removed, exposes an access portion that the needle can pierce. In one aspect, the needle-pierceable access portion includes an insert. For example, the needle pierceable access portion may include an insert added to a row of interconnected single-dose vials that are blow-molded or injection-molded. In one aspect, the needle-pierceable entry portion includes a needle-pierceable rubber entry portion. For example, the entry portion that the needle can pierce may include a rubber septum, which is inserted into the entry portion and held in place by an aluminum seal crimped around the tapered neck area of the bottle. On the one hand, the rubber entry part that the needle can pierce is further protected by a plastic flip cover.

In one aspect, at least one of the single-dose vials 1520 is attached to at least one adjacent single-dose vial 1520 via a hinged joint 1525 that is flexible enough to reversibly fit at least one of the single-dose vials 1520 One flat outer surface and at least one adjacent single-dose vial 1520 flat outer surface. For non-limiting examples, see, for example, Figures 22A-22E.

The molded structure 1510 of the multiple single-dose container 1500 includes a textured surface pattern 1530. In one aspect, at least a portion of the textured surface pattern 1530 includes channels aligned in parallel with the guided airflow between the first portion of the molded structure and the area adjacent to the second portion of the molded structure. In one aspect, the textured surface pattern 1530 is on the outer surface of at least one of the interconnected single-dose vials 1520 as shown in FIG. 15. In one aspect, the textured surface pattern is on the surface of the molded structure adjacent to the rows of interconnected single-dose vials. In one aspect, the textured surface pattern is on the tab portion adjacent to the top of the row of interconnected single-dose vials, as shown in FIG. 7. In one aspect, the textured surface pattern is on the tab portion adjacent to the bottom of the row of interconnected single-dose vials, as illustrated in FIG. 6. In some embodiments, during the packaging process, the portion of the tab that includes the textured surface pattern and is adjacent to the top or bottom of the row of interconnected single-dose vials is separated from the remainder of the molded structure.

In one aspect, the textured surface pattern 1530 that is positioned to direct the air flow between the first portion of the molded structure 1510 and the area adjacent to the second portion of the molded structure 1510 includes a recessed surface pattern, the recessed surface pattern being It is positioned to guide the air flow between the first part of the molded structure and the area adjacent to the second part of the molded structure 1510. In one aspect, the textured surface pattern 1530 positioned to guide the air flow between the first portion of the molded structure 1510 and the area adjacent to the second portion of the molded structure 1510 includes a textured surface pattern 1530 positioned to guide the molded structure The convex surface pattern of the air flow between the first part and the area adjacent to the second part of the molded structure 1510. The non-limiting aspects of recesses and protrusions have been described above.

In one aspect, the molded structure 1510 includes at least one label 1550, and the at least one label 1550 includes at least one sensor 1560. In one aspect, each of the interconnected single-dose vials 1520 includes a label 1550 that includes at least one of a temperature sensor, a humidity sensor, a light sensor, or an oxygen sensor. Non-limiting aspects of tags and sensors related to tags have been described above.

FIG. 16 is a step diagram showing a method of packaging multiple single-dose containers, as shown in FIG. 13. The method 1300 of packaging multiple single-dose containers includes expelling at least a portion of air from around a molded structure covered by an airtight sealable outer wrapper in step 1320, at least a portion of the expelled air flowing at least partially through the molded Structurally textured surface pattern. For example, the method includes Previously, at least a portion of the air was removed from the airtightly sealed outer wrapper to reduce the total volume of the packaged multiple single-dose container. In some embodiments, the method includes using a vacuum source to exhaust at least a portion of the air surrounding the multiple single-dose container. In one aspect, the method 1300 of packaging multiple single-dose containers includes inserting a flow tube connected to a vacuum source into an opening defined by an air-tight sealable outer wrapper in step 1600; A part of the object is pressure-sealed around the inserted flow duct to form a bag around the molded structure; and at least a part of the air is discharged from the bag around the molded structure, and at least a part of the discharged air Flow at least partially through the textured surface pattern on the molded structure.

In one aspect, the method of packaging multiple single-dose containers in an air-tight sealable outer wrapper includes the use of an inert gas. For example, the method may include injecting an inert gas into and around the multiple single-dose container before sealing the multiple single-dose container in the air-tightly sealed outer wrapper. In some embodiments, the method 1300 includes injecting an inert gas around a molded structure covered by an overwrap that can be hermetically sealed; and expelling the injected inert gas around the molded structure covered by an overwrap that can hermetically seal. At least part of the gas, at least a part of the discharged inert gas injected at least partially flows through the textured surface pattern on the molded structure, as shown in step 1610. For example, the method may include generating an inert gas around the molded structure and the row of interconnected single-dose vials by injecting an inert gas into an air-tight sealable outer wrapper covering the molded structure. Oxygen-free and/or inert atmosphere. In one aspect, the method 1300 includes injecting nitrogen around the molded structure covered by an overwrap that can be hermetically sealed, as shown in step 1620. In one aspect, the method 1300 includes injecting a rare gas around the molded structure covered by an overwrap that can be hermetically sealed, as shown in step 1630. For example, the method may include injecting at least one of argon, neon, krypton, or xenon into an outer envelope that can be hermetically sealed.

In one embodiment, the method 1300 of packaging multiple single-dose containers includes expelling at least a portion of the air around the molded structure covered by an air-tight sealable outer wrapper before injecting inert gas, as shown in step 1640. For example, the method may include drawing at least a portion of the air around the molded structure covered by the air-tight sealable outer wrap before injecting the inert gas. For example, the method may include exchanging the air around the molded structure covered by an airtight seal with an inert gas. For example, the method may include purging or flushing the air surrounding the molded structure covered by an airtight seal with an inert gas.

In some embodiments, the method includes vacuum sealing the multiple unit dose container in the presence of an inert gas using a vacuum source. For example, the method of packaging multiple single-dose containers may include The adjacent position of the textured surface pattern on the second part inserts the flow duct connected to the vacuum source into the opening defined by the airtight sealable outer wrapper; pressure seals a part of the airtight sealable outer wrapper Around the inserted flow pipe to form a bag around the molded structure; and extract at least a part of the injected inert gas from the bag around the molded structure so that the injected inert gas At least a portion at least partially flows through the textured surface pattern on the molded structure. In one embodiment, the flow duct is used to exhaust at least a portion of the air before forming an air-tight seal around the row of interconnected single-dose vials, inject inert gas, and remove from the air-tightly sealed outer wrapper. At least a part of the injected inert gas is discharged around the molding structure. In one embodiment, the first flow pipe is used to exhaust air and/or at least a part of the injected inert gas, and the second flow pipe is used to inject the inert gas.

FIG. 17 is a step diagram showing aspects of the method of packaging multiple single-dose containers as shown in FIG. 13. The method 1300 includes forming an airtight seal around the row of interconnected single-dose vials in step 1330. In one aspect, forming an airtight seal around the row of interconnected single-dose vials includes forming a gas impermeable seal around the row of interconnected single-dose vials in step 1700. In one aspect, forming an airtight seal around the row of interconnected single-dose vials includes forming a vapor impermeable seal around the row of interconnected single-dose vials in step 1710. In one aspect, forming an airtight seal around the row of interconnected single-dose vials includes forming a light impermeable seal around the row of interconnected single-dose vials in step 1720. In one aspect, forming an airtight seal around the row of interconnected single-dose vials includes forming an electrostatic discharge protective seal around the row of interconnected single-dose vials in step 1730. In one aspect, forming an airtight seal around the row of interconnected single-dose vials includes forming an airtight seal around the row of interconnected single-dose vials at equilibrium or near equilibrium pressure in step 1740 seal. In one aspect, forming an airtight seal around the row of interconnected single-dose vials includes forming an airtight seal around the row of interconnected single-dose vials under positive pressure in step 1750.

FIG. 18 is a step diagram showing aspects of a method of packaging a multiple single-dose container as shown in FIG. 13. The method 1300 also includes forming an airtight seal around the row of interconnected single-dose vials in step 1330. In one aspect, forming an airtight seal around the row of interconnected single-dose vials includes forming an airtight seal around the entirety of the molded structure including the row of interconnected single-dose vials in step 1800. In one aspect, forming an airtight seal around the row of interconnected single-dose vials includes bonding at least a portion of the airtight sealable outer wrapper to at least a portion of the surface of the molded structure in step 1810. In one aspect, forming an airtight seal around the row of interconnected single-dose vials is included in step 1820 At least a portion of an airtight sealable outer wrapper is bonded to at least a portion of the surface of the molded structure around and between each of the interconnected single-dose vials. In one aspect, forming an air-tight seal around the row of interconnected single-dose vials includes applying heat to an air-tight sealable outer wrapper in step 1830, so that the rows of interconnected single-dose vials An airtight seal is formed around the bottle. In one aspect, forming an airtight seal around the row of interconnected single-dose vials includes applying pressure to an airtight sealable outer wrapper in step 1840 to surround the row of interconnected single-dose vials Form an airtight seal. In one aspect, forming an airtight seal around the row of interconnected single-dose vials includes chemically binding an overwrap that can be hermetically sealed in step 1850 to form an airtight seal around the row of interconnected single-dose vials Hermetically sealed.

In one aspect, the method 1300 includes separating the first portion of the molded structure from the second portion of the molded structure in step 1860. In one aspect, the method includes separating rows of interconnected single-dose vials that can be hermetically sealed from tabs that include a textured surface pattern. For example, the method can include separating rows of interconnected single-dose vials that can be hermetically sealed from tabs located at the top or bottom of the molded structure, the tabs including a textured surface pattern.

In one aspect, the method 1300 includes at least partially penetrating an air-tight sealable outer wrapper in step 1870 to add a frangible portion to a single-dose vial in a row of interconnected single-dose vials The outer wrapper between each can be airtightly sealed.

In one aspect, the method 1300 includes in step 1880 applying at least one label having at least one sensor to the outer surface of an overwrap that can be hermetically sealed. For example, the method may include applying at least one label including information about the identity and use of the medicament and a temperature sensor to monitor temperature conditions during transportation and storage of the packaged multiple single-dose container. The non-limiting aspects of marking with sensors have been described above.

Figure 19 shows a method of packaging a collapsible container. FIG. 19 is a step diagram showing a method 1900 of packaging a collapsible container. The method 1900 includes covering, in step 1910, a multiple single-dose container in an expanded configuration with an air-tight sealable outer wrap, the multiple single-dose container including a row of interconnected single-dose vials, each of the single-dose vials Encloses a dose of at least one medicament; and one or more hinge joints that connect each of the single-dose vials in the row of interconnected single-dose vials to at least one adjacent single-dose vial The one or more hinge joints are sufficiently flexible to reversibly fit the flat outer surface of each single-dose vial with the flat outer surface of at least one adjacent single-dose vial to form a multiple single-dose container The folded configuration. The method 1900 includes applying a force to at least one of the single-dose vials in the row of interconnected single-dose vials in step 1920, the applied force is toward at least one adjacent single-dose Pill measuring bottle. Method 1900 includes bending one or more hinge joints to form a folded configuration of multiple single-dose containers in response to applying a force on at least one of the single-dose vials in the row of interconnected single-dose vials in step 1930. type. Method 1900 includes sealing an air-tightly sealable outer wrapper in step 1940 to form an air-tight seal around the folded configuration of the multiple single-dose container therein.

20 is a step diagram showing another aspect of a method 1900 of packaging a collapsible container. The method 1900 includes covering the multiple single-dose container with an overwrap 1910 that can be hermetically sealed. In one aspect, covering the multiple single-dose container in the expanded configuration with an air-tightly sealable outer wrapper includes inserting the multiple single-dose container in the expanded configuration through an opening defined by the air-tight sealable outer wrap in step 2000. For example, it is possible to move the multi-unit-dose container in the expanded configuration into an air-tight sealable outer wrapper (for example, an air-tight sealable bag), and move the air-tightly sealed outer package on the multi-unit-dose container in the expanded configuration. The wrapper, or at least one of the combination thereof, is inserted into the multiple single-dose container in an expanded configuration into an airtightly sealed outer wrapper. In one aspect, covering the multi-single-dose container in the expanded configuration with an air-tight sealable outer wrapper includes positioning the multi-single-dose container in the expanded configuration on the first layer of the air-tight sealable outer wrapper in step 2010 And sealing one or more edges of the first layer and the second layer of the airtightly sealed outer wrapper together. For example, a multiple single-dose container in an expanded configuration can be moved between two wound sheets (e.g. foil laminates) of an airtight sealable outer wrapper and sealed on at least one edge to at least partially Enclose multiple single-dose containers. In one aspect, covering the expanded configuration multiple single-dose container with an airtight sealable outer wrapper includes covering the expanded configuration multiple single-dose container with an airtight sealable bag in step 2020. In one aspect, covering the multiple single-dose container in the expanded configuration with an air-tight sealable outer wrapper includes covering the multiple single-dose container in the expanded configuration with a sleeve that can be air-tightly sealed in step 2030.

FIG. 21 is a step diagram showing a further aspect of the method of packaging a collapsible container 1900. In one aspect, covering the multiple single-dose container in the expanded configuration includes covering the multiple single-dose container in the expanded configuration with an airtight sealable foil laminate in step 2100. In one aspect, covering the multiple single-dose container in the expanded configuration includes covering the multiple single-dose container in the expanded configuration with an air-tight sealable outer wrapper in step 2110, the air-tight sealable outer wrapper being made of polyester , Foil, polypropylene, cast polypropylene, polyethylene, high-density polyethylene, metallocene polyethylene, linear low-density polyethylene, or metallized film. In one aspect, covering the multiple single-dose container in the expanded configuration includes covering the multiple single-dose container in the expanded configuration with a gas-impermeable outer wrapper in step 2120. In one aspect, covering the multiple single-dose container in the expanded configuration includes covering the multiple single-dose container in the expanded configuration with a vapor impermeable outer wrapper in step 2130. in In one aspect, covering the multiple single-dose container in the expanded configuration includes covering the multiple single-dose container in the expanded configuration with an outer wrapper that is impermeable to light in step 2140. In one aspect, covering the multi-unit-dose container in the expanded configuration includes covering the multi-unit-dose container in the expanded configuration with an electrostatic discharge protective overwrap in step 2150. The non-limiting aspect of covering the multiple single-dose container with an air-tight sealable outer wrapper has been described herein above and can be applied to cover an expanded configuration multiple single-dose container with an air-tight sealable outer wrapper.

Figures 22A-22E show aspects of a multiple single-dose container including rows of interconnected single-dose vials connected to each other by one or more hinge joints. Figure 22A is a schematic diagram of a multiple single dose container 2200 in an expanded configuration. The multiple single-dose container 2200 includes a row 2210 of interconnected single-dose vials 2220. The multiple single-dose container 2200 also includes one or more hinged joints 2230 that connect each of the single-dose vials 2220 in the row 2210 of interconnected single-dose vials 2220 to at least one adjacent single-dose drug. Bottle 2220. Each of the single-dose vials 2220 also includes a closure 2240 and a label 2250 including a sensor 2260.

Figure 22B is a schematic diagram of a top view of a multiple single dose container 2200 in an expanded configuration. In this view, each of the single-dose vials 2220 in the row 2210 of interconnected single-dose vials 2210 is connected to an adjacent single-dose vial 2220 by an articulated joint 2230 at the edge. The multiple single-dose container 2200 in the expanded configuration has a first rectangular package cross section 2270 (dashed line).

In some embodiments, the multiple single-dose container includes one or more hinge joints. In one aspect, the one or more hinge joints are splittable. For example, the hinge joint connecting a single-dose vial to an adjacent single-dose vial is splittable, thereby allowing separation of two single-dose vials. In one aspect, the hinged joint is at least one of tearable, splittable, tearable, breakable, breakable, or detachable. For example, the hinge joint that connects a single-dose vial to an adjacent single-dose vial can be tearable, splittable, tearable, breakable, breakable or separable. At least one of. In one aspect, the subset of hinge joints that connect single-dose vials in multiple single-dose containers are splittable. For example, a subset of splittable hinge joints can be used to divide a large multiple single-dose container (e.g., with 25 single-dose vials) into smaller multiple single-dose containers (e.g., with 5 single-dose vials). In one aspect, all hinge joints connecting the single-dose vials in the multiple single-dose container are splittable. For example, a cleavable hinge joint can be used to detach or separate each of the single-dose vials from the other single-dose vials in the multiple single-dose container.

In one aspect, the multiple single-dose container 2200 is formed by a blow molding manufacturing process. In one aspect, the multiple single-dose container 2200 is formed by a blow-fill-seal manufacturing process. On the one hand, more than a single dose The measuring container 2200 is formed by an injection molding process. Non-limiting aspects of manufacturing multiple single-dose containers by a molding process have been described above.

In one aspect, the hinge joint 2230 and the single-dose vial are formed as a single entity, such as from a single mold. In one aspect, the hinge joint 2230 is formed separately and then attached to the single-dose vial. For example, one or more hinge joints used to connect rows of glass bottles may be formed of flexible plastic resin that is subsequently attached to the glass bottles. In one aspect, the one or more hinge joints 2230 are formed of a first material and the single-dose vial 2220 is formed of a second material. For example, the hinge joint may be formed of a flexible plastic material, while the single-dose vial is formed of a relatively rigid plastic material. For example, the hinge joint may be formed of a flexible plastic material, while the single-dose vial is formed of glass.

In one aspect, the multiple single-dose container 2200 is formed of at least one biocompatible material. In one aspect, the multiple single-dose container 2200 is formed of at least one thermoplastic material. In one aspect, the multiple single-dose container 2200 is formed of at least one biocompatible thermoplastic material. Non-limiting examples of biocompatible, thermoplastic, and biocompatible thermoplastic materials used to form multiple single-dose containers have been described herein above.

In one aspect, the row 2210 of interconnected single-dose vials 2220 includes a row of two or more interconnected single-dose vials. In the non-limiting example of FIG. 22A, the multiple single-dose container 2200 includes five interconnected single-dose vials 2220. In one aspect, the row of interconnected single-dose vials includes three or more interconnected single-dose vials. In one aspect, the rows of interconnected single-dose vials include two, three, four, five, six, seven, eight, nine, or ten interconnected single-dose vials. At least one. In one aspect, the row of interconnected single-dose vials includes about 2 to about 30 interconnected single-dose vials. For example, a row of interconnected single-dose medicine bottles may include 2 bottles, 3 bottles, 4 bottles, 5 bottles, 6 bottles, 7 bottles, 8 bottles, 9 bottles, 10 bottles, 11 bottles, 12 bottles, 13 bottles, 14 bottles, 15 bottles, 16 bottles, 17 bottles, 18 bottles, 19 bottles, 20 bottles, 21 bottles, 22 bottles, 23 Bottles, 24 bottles, 25 bottles, 26 bottles, 27 bottles, 28 bottles, 29 bottles or 30 bottles. In some embodiments, the multiple single-dose container includes more than 30 single-dose vials.

In one aspect, the multiple single-dose container includes a row of 20 to 30 interconnected single-dose vials. For example, a multiple single-dose container may include a row of 25 interconnected single-dose vials. For example, a mold for blow molding or injection molding may include a mold for 25 individual single-dose vials interconnected by hinged joints. For example, a multiple single-dose container comprising 25 interconnected single-dose vials can be manufactured, filled with an appropriate medicament, sealed and packaged in a folded configuration for ease of dispensing. On the one hand, multiple single-dose volumes The dispenser includes a row of 20 to 30 interconnected single-dose vials, which are configured to be divided into groups of 3 to 10 interconnected single-dose vials. For example, a multi-single-dose container includes a row of 20 to 30 interconnected single-dose vials, which are configured to have 3 bottles, 4 bottles, 5 bottles, 6 bottles, 7 bottles, 8 Bottles, 9 bottles or groups of 10 bottles. For example, a multiple single-dose container may include a bar with 25 bottles configured to be divided into groups of 5 bottles. In this way, large strips of interconnected single-dose vials can be manufactured, filled with medicament, sealed, and then separated into smaller units for packaging and dispensing.

In one aspect, each of the interconnected single-dose vials is polygonal in horizontal cross-section. In the non-limiting example of Figure 22B, the horizontal cross-section of the interconnected single-dose vials 2220 is rectangular. In one aspect, the horizontal cross-section of each of the interconnected single-dose vials is square, triangular, hexagonal, or polygonal. Non-limiting examples of different cross-sectional shapes of single-dose vials in rows of interconnected single-dose vials are shown in Figures 5A-5C.

Each of the single-dose vials 2220 encapsulates a certain dose of at least one medicament. In one aspect, the dose of at least one medicament includes a dose of at least one vaccine. In one aspect, the dose of at least one medicament includes a dose of at least a therapeutic agent. Non-limiting examples of vaccines and therapeutic agents have been described above. In one aspect, the dose of at least one medicament is in liquid form. For example, a certain dose of at least one medicament (such as a vaccine) is dissolved and/or suspended in a liquid medium (such as water for injection). In one aspect, the dose of at least one medicament is in lyophilized form. For example, a certain dose of at least one medicament (e.g., vaccine) is prepared in lyophilized form for reconstitution with a liquid medium (e.g., water) for injection before administration to a subject.

In one aspect, each of the single-dose vials 2220 in the row 2210 of single-dose vials 2220 includes an internal volume that holds a dose of at least one medicament. In one aspect, the internal volume is about 0.2 ml to about 6.0 ml. For example, the internal volume of each of the single-dose vials is about 0.2mL, 0.3mL, 0.4mL, 0.5mL, 0.6mL, 0.7mL, 0.8mL, 0.9mL, 1.0mL, 1.1mL, 1.2mL, 1.3mL , 1.4mL, 1.5mL, 1.6mL, 1.7mL, 1.8mL, 1.9mL, 2.0mL, 2.1mL, 2.2mL, 2.3mL, 2.4mL, 2.5mL, 2.6mL, 2.7mL, 2.8mL, 2.9mL, 3.0 mL, 3.1mL, 3.2mL, 3.3mL, 3.4mL, 3.5mL, 3.6mL, 3.7mL, 3.8mL, 3.9mL, 4.0mL, 4.1mL, 4.2mL, 4.3mL, 4.4mL, 4.5mL, 4.7mL, 4.8mL, 4.9mL, 5.0mL, 5.1mL, 5.2mL, 5.3mL, 5.4mL, 5.5mL, 5.6mL, 5.7mL, 5.8mL, 5.9mL or 6.0mL. In some embodiments, the internal volume of each single-dose vial is greater than 6.0 ml.

In one aspect, the internal volume of the at least one medicament holding a dose includes an inert gas filled headspace. For example, the headspace above a dose of at least one medicament may include nitrogen or a rare gas, such as argon, xenon, neon, or krypton.

In one aspect, each of the single-dose vials 2220 in the row 2210 of interconnected single-dose vials 2220 includes a closure 2240. In one aspect, the closure 2240 includes a twisted or snapped closure. In one aspect, each of the single-dose vials 2220 in the row 2210 of interconnected single-dose vials 2220 includes an entry portion through which a needle can penetrate. Non-limiting aspects of the closure and/or the needle-pierceable access portion of the single-dose vial for multiple single-dose containers have been described herein above.

In one aspect, the hinge joint 2230 is frangible. For example, one or more hinge joints may be accompanied by frangible portions, such as perforations in the molded material, which allows single-dose vials to be separated from each other.

In one aspect, the multiple single-dose container 2200 is configured to form an expanded configuration (as shown in Figures 22A and 22B) and a folded configuration. Figures 22C and 22D show the multiple single dose container 2200 in a folded configuration. Figure 22C is a side view showing the multiple single dose container 2200 in a folded configuration. In this configuration, the hinge joint 2230 has been bent to connect the flat outer surface of each of the single-dose vials 2220 in the row 2210 of interconnected single-dose vials 2220 with at least one adjacent single-dose The flat outer surface of the medicine bottle 2220 is reversibly matched. Figure 22D is a top view of the multiple single dose container 2200 in a folded configuration. The row 2210 of interconnected single-dose vials 2220 has been folded along the hinge joint 2230 to form a folded configuration. The multiple single-dose container 2200 in the folded configuration has a second rectangular package cross-sectional area 2280 (dashed line).

In one aspect, the expanded configuration of the multiple single-dose container 2200 has a first rectangular package cross-sectional area 2270, and the folded configuration of the multiple single-dose container 2200 has a second rectangular package cross-sectional area 2280. Figure 22E shows the juxtaposition of a first rectangular package cross-sectional area 2270 of the multiple single-dose container 2200 in an expanded configuration and a second rectangular package cross-sectional area 2280 of the multiple single-dose container 2200 in a folded configuration. The second rectangular package cross-sectional area 2280 is smaller than the first rectangular package cross-sectional area 2270.

Further non-limiting aspects of multiple single-dose containers with hinged joints are described in US Patent Application No. 14/736,542 entitled "Multi-Monodose Containers", which is incorporated herein by reference.

In one aspect, the multiple single-dose container includes at least one label, and the at least one label includes at least one sensor. Returning to FIG. 22A, each of the single-dose vials 2220 includes at least one label 2250, and the at least one label 2250 includes at least one sensor 2260. In one aspect, the single-dose medicine bottle 2220 in Each includes at least one tag 2250, and the at least one tag 2250 includes at least one of a temperature sensor, a humidity sensor, a light sensor, or an oxygen sensor. Non-limiting aspects of tags and environmental sensors for use with tags have been described above.

Figure 23 is a step diagram illustrating aspects of a method 1900 of packaging a collapsible container. The method 1900 includes covering the multiple single-dose container in an expanded configuration with an overwrap that can be hermetically sealed, as shown in step 1910. The method 1900 also includes applying a force on at least one of the single-dose vials in the row of interconnected single-dose vials, the applied force directed to at least one adjacent single-dose vial, as shown in step 1920. In one aspect, the method 1900 includes applying a force on at least one of the single-dose vials in the row of interconnected single-dose vials with at least one mechanical probe, as shown in step 2300. For example, the method may include applying a force with one or more pistons configured to contact and push at least one end of a row of interconnected single-dose vials. In one aspect, the method 1900 includes using pressurized gas to exert a force on at least one of the single-dose vials in the row of interconnected single-dose vials, as shown in step 2310. For example, the method may include applying a force directed at at least one end of a row of interconnected single-dose vials with pressurized gas from one or more nozzles.

In one aspect, the method 1900 includes, in step 2320, applying a force toward a first adjacent single-dose vial on a first single-dose vial at a first end of the row of interconnected single-dose vials, and A force is applied to the second adjacent single-dose vial on the second single-dose vial at the second end of the row of interconnected single-dose vials. For example, the method may include using one or more pistons to apply force on both ends of a row of interconnected single-dose vials. For example, the method may include applying a force with pressurized gas at both ends of a row of interconnected single-dose vials. In one aspect, the method 1900 includes applying a force toward a first adjacent single-dose vial on a first single-dose vial at the first end of the row of interconnected single-dose vials in step 2330, while A force is applied towards the second adjacent single-dose vial on the second single-dose vial at the second end of the row of interconnected single-dose vials. For example, the method may include simultaneous application of force at both ends of a row of interconnected single-dose vials. In one aspect, the method 1900 includes, in step 2340, sequentially applying a single-dose vial toward a first adjacent single-dose vial on a first single-dose vial at the first end of the row of interconnected single-dose vials And exert a force towards the second adjacent single-dose vial on the second single-dose vial at the second end of the row of interconnected single-dose vials. For example, the method may include sequentially applying the force to one end of a row of interconnected single-dose vials and then to the other end.

FIG. 24 is a step diagram showing another aspect of a method 1900 of packaging a collapsible container. In some embodiments, the method 1900 includes removing from a folded bag covered by an airtight sealable outer wrapper. At least a part of the air is discharged from the periphery of the configured multiple single-dose container, as shown in step 2400. For example, the method may include drawing at least a portion of the air from around the multiple unit dose container before sealing the airtightly sealable outer wrapper. In one aspect, the method 1900 includes inserting a flow tube connected to a vacuum source into an opening defined by an air-tight sealable outer wrapper in step 2410, and pressure-seals the air-tight seal around the inserted flow tube. A portion of the outer wrapper is to form a bag around the folded configuration of the multiple single-dose container, and at least a portion of air is drawn from the bag around the folded configuration of the multiple single-dose container.

In some embodiments, the method 1900 includes injecting an inert gas around the folded configuration of a multiple single-dose container covered by an airtightly sealable outer wrap; At least a part of the injected inert gas is drawn around the folded configuration of the container, as shown in step 2420. For example, the method can include creating a non-inert and non-inert gas around a row of interconnected single-dose vials by injecting an inert gas around the folded configuration of the multiple single-dose container covered by an airtight sealable outer wrapper. / Or oxygen atmosphere. In one aspect, injecting an inert gas around the folded configuration of the multiple single-dose container covered by the air-tight sealable outer wrapper includes in step 2430 the multiple single-dose container covered by the hermetic sealable outer wrapper Nitrogen is injected around the folded configuration. In one aspect, injecting an inert gas around the folded configuration of the multiple single-dose container covered by the air-tight sealable outer wrapper includes in step 2440 the multiple single-dose container covered by the airtight sealable outer wrapper. Noble gas is injected around the folded configuration. For example, the method may include injecting at least one of argon, neon, krypton, or xenon into an air-tight sealable outer wrapper around the folded configuration of the multiple single-dose container. In one aspect, discharging the injected inert gas from around the folded configuration of the multiple single-dose container covered by the air-tight sealable outer wrapper includes inserting the flow tube connected to the vacuum source into the air-tightly sealed flow tube in step 2450 An opening defined by the outer wrapper; pressure-seal a portion of the outer wrapper that can be hermetically sealed around the inserted flow pipe to form a bag around the folded configuration of the multiple single-dose container, and from the multiple single-dose container At least part of the injected inert gas is discharged from the bag surrounding the folded configuration of the dose container.

In one embodiment, the method 1900 of packaging a collapsible container includes expelling at least a portion of the air from around the folded configuration of the multiple single-dose container covered by an airtight sealable outer wrapper, and thereafter in the folded configuration of the multiple single-dose container Inert gas is injected around the mold, as shown in step 2460. In one aspect, expelling at least a portion of the air from around the folded configuration of the multi-unit-dose container includes drawing air from around the folded configuration of the multi-unit-dose container covered by an overwrap that can be hermetically sealed before the inert gas is injected. At least part of it. In one aspect, expelling at least a portion of the air from around the folded configuration of the multiple single-dose container covered by an air-tight sealable outer wrapper includes exchanging the air for an inert gas. On the one hand, from At least a portion of the air discharged around the folded configuration of the multiple single-dose container covered by the airtight sealable outer wrapper includes blowing or sweeping air from around the folded configuration of the multiple single-dose container. In one embodiment, the flow duct is used to discharge air from around the folded configuration of the multiple single-dose container covered by an airtight sealable outer wrapper, inject inert gas around the folded configuration of the multiple single-dose container, and At least a part of the injected inert gas is discharged around the folded configuration of the multiple single-dose container covered by the hermetic sealable outer wrapper, and then an airtight seal is formed around the folded configuration of the multiple single-dose container. In one embodiment, the first flow pipe is used to inject inert gas, and the second flow pipe is used to discharge at least a part of the injected inert gas.

Figure 25 is a step diagram showing further aspects of a method 1900 of packaging a folded container. Method 1900 includes sealing an air-tightly sealable outer wrapper in step 1940 to form an air-tight seal around the folded configuration of the multiple single-dose container therein. In one aspect, the method 1900 includes heat sealing the hermetically sealable outer wrapper in step 2500 to form an hermetic seal around the folded configuration of the multiple single-dose container therein. In one aspect, the method 1900 includes, in step 2510, pressure sealing the hermetically sealable outer wrapper to form an hermetic seal around the folded configuration of the multiple single-dose container therein. In one aspect, the method 1900 includes chemically sealing the hermetic sealable outer wrapper in step 2520 to form an hermetic seal around the folded configuration of the multiple single-dose container therein. In one aspect, the outer wrap that can be hermetically sealed includes heat seal, pressure seal, or chemical seal that can be hermetically sealed. In one aspect, the sealing includes at least one of folding, rolling, crimping, welding, fusing, welding, heat sealing, blister sealing, or induction sealing.

In one aspect, the method 1900 includes sealing an overwrap that can be hermetically sealed to form a gas impermeable seal around the folded configuration of the multiple unit dose container therein. In one aspect, the method 1900 includes sealing an overwrap that can be hermetically sealed to form a vapor impermeable seal around the folded configuration of the multiple unit dose container therein. In one aspect, the method 1900 includes sealing an airtightly sealable outer wrapper to form a light impermeable seal around the folded configuration of the multiple unit dose container therein. In one aspect, method 1900 includes sealing an overwrap that can be hermetically sealed to form an electrostatic discharge protective seal around the folded configuration of the multiple unit dose container therein.

In one aspect, the method 1900 includes sealing at least a portion of an airtightly sealable outer wrapper in step 2530 to form a bag around the folded configuration of the multiple single-dose container; injecting an inert gas into the multiple single-dose container In the bag formed around the folded configuration; from the folded in the multiple single-dose container The formed bag around the stacked configuration discharges at least a portion of the injected inert gas; and the formed bag is sealed to form an airtight seal around the folded configuration of the multiple single-dose container therein.

In one aspect, the method 1900 includes attaching, in step 2540, at least one label to an outer surface of an airtightly sealable outer wrapper, the at least one label including at least one sensor. In one aspect, the method 1900 includes attaching at least one label to an outer surface of an airtightly sealable outer wrapper in step 2550, the at least one label including at least one temperature sensor. Non-limiting aspects of the tags and associated environmental sensors have been described above.

26A-26E show another aspect of the method of packaging a collapsible container as shown in FIG. 19. Figure 26A is a top view of a multiple single-dose container 2600 in an expanded configuration covered by an overwrap 2605 that can be hermetically sealed. The multiple single-dose container 2600 includes a row 2610 of interconnected single-dose vials. Each of the single-dose vials 2610 is connected to at least one adjacent single-dose vial 2610 by an articulated joint 2615. The hinge joint 2615 is flexible enough to reversibly match the flat outer surface of each of the single-dose vials 2610 and the flat outer surface of at least one adjacent single-dose vial 2610 to form the folded structure of the multiple single-dose container 2600 type. Figure 26B shows a top view of a multiple single-dose container 2600 in an expanded configuration covered by an overwrap 2605 that can be hermetically sealed. The force 2625 shown is applied to the first single-dose vial 2610 in the row of interconnected single-dose vials 2610 of the multiple single-dose container 2600. In this non-limiting example, force 2625 is applied by mechanical probe 2620. In one aspect, the mechanical probe 2620 is a piston-like device that pushes the first single-dose vial to the adjacent single-dose vial to initiate a folded chain reaction. Figure 26C shows a top view of a multiple single-dose container 2600 in an expanded configuration covered by an overwrap 2605 that can be hermetically sealed. The articulating joint 2615 is shown as bending corresponding to the force 2625 applied by the mechanical probe 2620 (arrow 2630). The hinge joint 2615 that bends the flat outer surface of the adjacent single-dose vial 2610 will reversibly fit to form a folded configuration of the multiple single-dose container. Figure 26D shows a top view of the multiple single-dose container 2600 in a folded configuration covered by an overwrap 2605 that can be hermetically sealed. In this non-limiting example, a flow tube 2640 connected to a vacuum source 2645 is shown inserted into an opening defined by an overwrap 2605 that can be hermetically sealed. In one aspect, a portion of the hermetic sealable outer wrap 2605 is pressure-sealed around the inserted flow conduit 2640 to form a bag 2650 around the folded configuration of the multiple single-dose container 2600. Also shown is the air 2655 exhausted by the vacuum source 2645 from the bag 2650 around the folded configuration of the multiple single-dose container 2600. Figure 26E shows a top view of the multiple single-dose container 2600 in a folded configuration covered by an overwrap 2605 that can be hermetically sealed. The seal 2660 has been formed with an air-tight sealable outer wrap 2605 to hermetically seal the folded configuration of the multiple unit dose container 2600 therein.

27A-27E show another aspect of the method of packaging a folded container as shown in FIG. 19. Figure 27A is a top view of a multiple single-dose container 2700 in an expanded configuration covered by an overwrap 2705 that can be hermetically sealed. The multiple single-dose container 2700 includes a row 2710 of interconnected single-dose vials. Each of the single-dose vials 2110 is connected to at least one adjacent single-dose vial 2710 through a hinged joint 2715. The hinge joint 2715 is flexible enough to reversibly match the flat outer surface of each of the single-dose vials 2710 and the flat outer surface of at least one adjacent single-dose vial 2710 to form the folded structure of the multiple single-dose container 2700 type. Figure 27B shows a top view of a multiple single-dose container 2700 in an expanded configuration covered by an overwrap 2705 that can be hermetically sealed. The force 2725 shown is applied to the first single-dose vial 2710 in the row of interconnected single-dose vials 2710 of the multiple single-dose container 2700. In this non-limiting example, force 2725 is applied by mechanical probe 2720. In one aspect, the mechanical probe 2720 is a piston-like device that pushes the first single-dose vial to the adjacent single-dose vial to initiate a folded chain reaction. Figure 27C shows a top view of a multiple single-dose container 2700 in an expanded configuration covered by an overwrap 2705 that can be hermetically sealed. The articulating joint 2715 is shown as bending corresponding to the force 2725 applied by the mechanical probe 2720 (arrow 2730). The hinge joint 2715 that curves the planar outer surface of the adjacent single-dose vial 2710 will reversibly fit to form a folded configuration of the multiple single-dose container. Figure 27D shows a top view of a multiple single-dose container 2700 in a folded configuration covered by an overwrap 2705 that can be hermetically sealed. It is shown that inert gas is injected 2735 (arrow) into the air-tight sealable outer wrap 2705 and around the multiple unit dose container 2700 in the folded configuration. Figure 27E shows a top view of the multiple single-dose container 2700 in a folded configuration covered by an overwrap 2705 that can be hermetically sealed. In this non-limiting example, a flow tube 2740 connected to a vacuum source 2745 is shown inserted into an opening defined by an outer wrap 2705 that can be hermetically sealed. In one aspect, a portion of the hermetically sealable outer wrap 2705 is pressure-sealed around the inserted flow conduit 2740 to form a bag 2750 around the folded configuration of the multiple single-dose container 2700. It is also shown that the injected inert gas 2755 (arrow) is discharged from the bag 2750 around the folded configuration of the multiple single-dose container 2700 by a vacuum source 2745. Figure 27F shows a top view of the multiple single-dose container 2700 in a folded configuration covered by an overwrap 2705 that can be hermetically sealed. The seal 2760 has been formed with an overwrap 2705 that can be hermetically sealed in a folded configuration of the multiple single-dose container 2700 hermetically sealed therein.

Figure 28 is a step diagram illustrating a method 2800 of packaging multiple single-dose containers. The method 2800 includes covering a multiple single-dose container with an airtight sealable outer wrapper in step 2810, the multiple single-dose container comprising a row of interconnected single-dose vials, each of the single-dose vials being enclosed A dose of at least one medicament; and one or more hinge joints that connect a single dose in a row of interconnected single-dose vials Each of the vials is connected to at least one adjacent single-dose vial, and the one or more hinge joints are sufficiently flexible to allow the flat outer surface of each of the single-dose vials to interact with at least one adjacent single-dose vial. The flat outer surface of the dose vial reversibly fits to form a folded configuration of multiple single dose containers. The method 2800 includes applying a force on at least a portion of the outer surface of the hermetic sealable outer wrapper covering the multi-unit-dose container in step 2820, the applied force directed toward one or more hinge joints of the multi-unit-dose container. The method 2800 includes expelling at least a portion of the air in step 2830 from around the multiple unit dose container covered by an air-tight sealable outer wrapper. The method 2800 includes sealing an air-tight sealable outer wrapper covering the multiple single-dose container in step 2840 to hermetically seal the multiple single-dose container therein.

Figure 29 is a step diagram showing further aspects of a method 2800 of packaging multiple single-dose containers. Method 2800 includes covering the multiple single-dose container with an overwrap that can be hermetically sealed, as shown in step 2810. In one aspect, covering the multiple single-dose container with an airtightly sealable outer wrapper includes inserting the multiple single-dose container into an opening defined by the airtightly sealable outer wrapper in step 2900. In one aspect, covering the multiple single-dose container with an airtight sealable outer wrapper includes positioning the multiple single-dose container on the first layer of the airtight sealable outer wrapper and the airtight sealable outer wrapper in step 2910 And sealing one or more edges of the first layer and the second layer of the outer wrapper that can be hermetically sealed. In one aspect, covering the multiple single-dose container with an air-tightly sealable outer wrapper includes covering the multiple single-dose container with an air-tight sealable bag in step 2920. In one aspect, covering the multiple single-dose container with an airtight sealable outer wrapper includes covering the multiple single-dose container with an airtightly sealable sleeve in step 2930. In one aspect, covering the multiple single-dose container with an airtight sealable outer wrapper includes covering the multiple single-dose container with an airtightly sealable foil laminate in step 2940. In one aspect, covering multiple single-dose containers with an airtight sealable outer wrapper includes using polyester, foil, polypropylene, cast polypropylene, polyethylene, high-density polyethylene, metallocene polyethylene, linear low-density An air-tight sealable outer wrapper formed of at least one of polyethylene or metalized film covers the multiple single-dose container. In one aspect, covering the multiple single-dose container with an outer wrap that can be hermetically sealed includes covering the multiple single-dose container with a gas-impermeable outer wrap in step 2950. In one aspect, covering the multiple single-dose container with an outer wrap that can be hermetically sealed includes covering the multiple single-dose container with an outer wrap that is impermeable to vapor in step 2960. In one aspect, covering the multiple single-dose container with an outer wrap that can be hermetically sealed includes covering the multiple single-dose container with an outer wrap that is impermeable to light in step 2970. In one aspect, covering the multiple single-dose container with an outer wrap that can be hermetically sealed includes covering the multiple single-dose container with an electrostatic discharge protective outer wrap in step 2980. Non-limiting aspects of covering multiple single-dose containers with overwraps that can be hermetically sealed have been described above.

Figure 30 is a step diagram showing further aspects of a method 2800 of packaging multiple single-dose containers. The method 2800 includes applying a force on at least a portion of the outer surface of the hermetic sealable outer wrapper covering the multiple unit dose container, as shown in step 2820. The applied force is towards one or more articulated joints of the multiple single-dose container. In one aspect, applying a force on at least a portion of the outer surface of the air-tight sealable outer wrap covering the multiple single-dose container includes using one or more mechanical probes in step 3000 to cover the multiple single-dose container. A force is applied to at least a portion of the outer surface of the tightly sealed outer wrapper. For example, the method may include using one or more mechanical probes to push an air-tight sealable overwrap into close proximity to one or more underlying hinge joints of the multiple single-dose container. In one aspect, applying a force on at least a portion of the outer surface of the air-tight sealable outer wrapper covering the multiple single-dose container includes using pressurized gas in step 3010 to cover the air-tight sealable outer surface of the multiple single-dose container A force is applied to at least a part of the outer surface of the wrapper. For example, the method may include using pressurized gas from one or more high-pressure nozzles to push an air-tight sealable overwrap to one or more underlying hinged joints in close proximity to the multiple single-dose container.

The method 2800 includes extracting at least a portion of air from around the multiple unit dose container covered by an airtight sealable outer wrapper in step 2830. For example, the method may include evacuating at least a portion of the air around the multiple single-dose container before sealing the multiple single-dose container in an airtightly sealable outer wrapper. In some embodiments, expelling at least a portion of the air from around the multiple single-dose container covered by an air-tight sealable outer wrapper includes inserting a flow tube connected to a vacuum source into the portion covered by the multiple single-dose container in step 3020. An air-tight sealable outer wrapper; pressure-seal a part of the airtight sealable outer wrapper around the inserted flow pipe to form a bag around the multiple single-dose container; and from the bag around the multiple single-dose container Exhaust at least a part of the air. In one aspect, the method includes expelling at least a portion of the air while applying a force on at least a portion of the outer surface of the air-tight sealable outer wrapper covering the multiple unit dose container.

In some embodiments, the method 2800 includes injecting an inert gas around a multiple single-dose container covered by an air-tight sealable outer wrap; At least a part of the inert gas, as shown in step 3030. In one aspect, injecting inert gas around the multiple single-dose container covered by the air-tightly sealed outer wrap includes injecting nitrogen around the multiple single-dose container covered by the hermetic sealable outer wrap in step 3040. In one aspect, injecting an inert gas around the multiple single-dose container covered by the air-tight sealable outer wrapper includes injecting dilute gas around the multiple single-dose container covered by the hermetic sealable outer wrapper in step 3050. There is gas. For example, the method may include injecting at least one of argon, neon, xenon, or krypton around a multiple single-dose container covered by an overwrap that can be hermetically sealed.

In some embodiments, the method 2800 of packaging a multiple single-dose container includes expelling at least a portion of the air around the multiple single-dose container covered by an air-tight sealable outer wrapper before injecting an inert gas around the multiple single-dose container, as in the step Shown in 3060. For example, the method may include evacuating air, exchanging air with inert gas, and/or purging or flushing air with inert gas.

The method 2800 includes discharging at least a portion of the injected inert gas from around the multiple unit dose container covered by an overwrap that can be hermetically sealed, as shown in step 3030. For example, the method may include venting at least a part of the injected inert gas from the outer envelope that can be hermetically sealed under vacuum. In one aspect, discharging at least a portion of the injected inert gas from around the multiple single-dose container covered by an airtightly sealable outer wrap includes inserting a flow tube connected to a vacuum source into a gas-tight sealable outer wrapper. Opening; pressure-seal a part of the air-tight sealable outer wrapper around the inserted flow pipe to form a bag around the multiple single-dose container; and discharge the injected inert gas from the bag around the multiple single-dose container At least part of. In one aspect, the method includes expelling at least a portion of the injected inert gas while applying a force on at least a portion of the outer surface of the hermetic sealable outer wrapper covering the multiple unit dose container.

Figure 31 is a step diagram showing further aspects of a method 2800 of packaging multiple single-dose containers. The method 2800 includes sealing an air-tight sealable outer wrapper covering the multiple single-dose container to hermetically seal the multiple single-dose container therein, as shown in step 2840. In one aspect, the method 2800 includes sealing the first layer of the hermetic sealable outer wrapper to the second layer of the hermetic sealable outer wrapper in step 3100 to hermetically seal the multiple single-dose container therein . In one aspect, the method 2800 includes bonding at least a portion of an airtight sealable outer wrap covering the multiple single-dose container to at least a portion of the surface of the multiple single-dose container in step 3110 to hermetically seal the multiple single-dose container In it. In one aspect, combining at least a portion of the air-tight sealable outer wrapper includes combining at least a portion of the air-tight sealable outer wrapper covering the multiple single-dose container to the one or more hinge joints in step 3120 At least a portion of the surface of the associated multiple single-dose container to hermetically seal the multiple single-dose container therein. In one aspect, incorporating at least a portion of the outer wrapper that can be hermetically sealed includes in step 3130 covering multiple single-dose vials around and between each of the single-dose vials in the row of interconnected single-dose vials. At least a part of the air-tight sealable outer wrapper of the dose container is bonded to at least a part of the surface of the multiple single-dose container. For example, an overwrap that can be hermetically sealed can be bonded to the surface of a multiple single-dose container to form a single package Wrapped/airtightly sealed single-dose vial. In one aspect, the hermetic sealable outer wrapper includes perforations aligned with a frangible hinge joint that allows individually packaged/hermetically sealed single-dose vials to be separated from each other. In one aspect, sealing the hermetic sealable outer wrapper includes heat-sealing the hermetic sealable outer wrapper covering the multiple single-dose container in step 3140 to hermetically seal the multiple single-dose container therein. In one aspect, sealing the hermetically sealable outer wrapper includes pressure-sealing the hermetic sealable outer wrapper covering the multiple single-dose container in step 3150 to hermetically seal the multiple single-dose container therein. In one aspect, sealing the hermetic sealable outer wrapper includes chemically sealing the hermetic sealable outer wrapper covering the multiple single-dose container in step 3160 to hermetically seal the multiple single-dose container therein.

In one aspect, the method 2800 includes forming a gas impermeable seal around the multiple unit dose container. In one aspect, the method 2800 includes forming a vapor impermeable seal around the multiple unit dose container. In one aspect, the method 2800 includes forming a light impermeable seal around the multiple unit dose container. In one aspect, the method 2800 includes forming an electrostatic discharge protective seal around the multiple unit dose container.

Figure 32 is a step diagram showing further aspects of a method 2800 of packaging multiple single-dose containers. In one aspect, the method 2800 includes attaching at least one label to the outer surface of the hermetic sealable outer wrapper in step 3200, the at least one label including at least one sensor. In one aspect, the method 2800 includes in step 3210 attaching at least one label to the outer surface of the hermetic sealable outer wrapper, the at least one label including at least one temperature sensor. The non-limiting aspects of the tags and associated environmental sensors have been described above.

In one aspect, the method 2800 of packaging a multiple single-dose container further includes bending the air-tightly sealed multiple single-dose container at one or more hinge joints of the multiple single-dose container to form a folded configuration in step 3220; and adding a third The cover keeps the hermetically sealed multiple single-dose container in a folded configuration. For example, once the multiple single-dose container has been sealed in an air-tight sealable outer wrapper, the air-tightly sealed multiple single-dose container can be folded along the length of the hinge joint connecting the single-dose vial to produce a more compact structure. type. This compact configuration can be further covered with a third wrap (e.g. shrink wrap) to keep the hermetically sealed multiple single-dose container in a compact or folded configuration.

In one aspect, the method 2800 of packaging multiple single-dose containers further includes at least partially penetrating an air-tight sealable outer wrapper in step 3230 to add a frangible portion to the row of interconnected single-dose vials An air-tight sealable outer wrapper between each of the single-dose vials. For example, an airtight sealable outer wrapper may include perforations to allow single-dose vials to be separated from each other.

Figures 33A-33D show additional aspects of a method of packaging multiple single-dose containers. FIG. 33A shows a top view of a multiple single-dose container 3300 covered by an outer wrap 3305 that can be hermetically sealed. The multiple single-dose container 3300 includes a row of interconnected single-dose vials 3310 connected by one or more hinged joints 3315. FIG. 33B shows a top view of the multiple single-dose container 3300 covered by an outer wrap 3305. FIG. In this non-limiting example, force is applied while at least a part of the injected inert gas is discharged from the outer envelope that can be hermetically sealed. In this non-limiting example, a plurality of mechanical probes 3325 are used to apply force on the outer surface of an air-tight sealable outer wrap 3305 covering the multiple single-dose container 3300. Each of the mechanical probes 3325 exerts a force on the outer surface of the airtight sealable outer wrap 3305 at a position aligned with or adjacent to the hinge joint 3315. In this non-limiting example, the flow duct 3330 connected to the vacuum source 3335 is shown inserted into an opening defined by an overwrap 3305 that can be hermetically sealed. In some embodiments, a portion of the hermetic sealable outer wrap 3305 is pressure-sealed to the flow duct 3330 to form a bag around the multiple single-dose container 3300. It is also shown that at least a part of the air is discharged from the arrow 3340 in the air-tight sealable outer wrap 3305 through the vacuum source 3335. FIG. 33C shows a top view of a multiple single-dose container 3300 and a row of single-dose vials 3310 airtightly sealed 3345 in an outer wrap 3305 that can be airtightly sealed. In some embodiments, the hermetically sealed multiple single-dose container is bent at one or more hinged joints to form a folded and more compact configuration. FIG. 33D shows a top view of a multiple single-dose container 3300 hermetically sealed in an overwrap 3305 that can be hermetically sealed. The multiple single-dose container 3300 and the hermetic sealable outer wrap 3305 are bent at the hinge joint 3315 to bring the single-dose vials 3310 closer to each other in the folded configuration. In some embodiments, the multiple single-dose container 3300 in the folded configuration is further covered by a third cover 3350.

Figures 34A-34D show top views of an embodiment of a method of packaging multiple single-dose containers. Figure 34A shows a top view of a multiple single-dose container 3400 covered by an overwrap 3405 that can be hermetically sealed. The multiple single-dose container 3400 includes a row of interconnected single-dose vials 3410 connected by one or more hinged joints 3415. It is also shown that an inert gas 3420 is injected (arrow) into an air-tight sealable outer wrap 3405 covering the multiple single-dose container 3400. FIG. 34B shows a top view of the multiple single-dose container 3400 covered by the outer wrap 3405. In this non-limiting example, force is applied while at least a part of the injected inert gas is discharged from the outer envelope that can be hermetically sealed. In this non-limiting example, a plurality of mechanical probes 3425 are used to apply force on the outer surface of an air-tight sealable outer wrap 3405 covering the multiple single-dose container 3400. Each of the mechanical probes 3425 exerts a force on the outer surface of the outer wrap 3405 that can be hermetically sealed at a position aligned with the hinge joint 3415 or a position adjacent to the hinge joint 3415. In the unrestricted In the illustrative example, the flow pipe 3430 is shown connected to the vacuum source 3435, and the flow pipe 3430 is inserted into an opening defined by an outer wrap 3405 that can be airtightly sealed. In some embodiments, a portion of the hermetic sealable outer wrap 3405 is pressure sealed to the flow conduit 3430 to form a bag around the multiple single-dose container 3400. It also shows that at least a part of the injected inert gas is discharged 3440 (arrow) from the outer wrap 3405 which can be hermetically sealed by the vacuum source 3435. FIG. 34C shows a top view of the multiple single-dose container 3400 hermetically sealed 3445 and the row of single-dose vials 3410 within the hermetically sealable outer wrap 3405. In some embodiments, the hermetically sealed multiple single-dose container is bent at one or more hinged joints to form a folded and more compact configuration. Figure 34D shows a top view of a multiple single-dose container 3400 hermetically sealed in an overwrap 3405 that can be hermetically sealed. The multiple single-dose container 3400 and the hermetically sealed outer wrap 3405 are bent at the hinge joint 3415 to bring the single-dose vials 3410 closer to each other in the folded configuration. In some embodiments, the multiple single-dose container 3400 in the folded configuration is further covered by a third cover 3450.

Those skilled in the art will recognize that, for the sake of conceptual clarity, the components, devices, objects described herein, and discussions accompanying them are used as examples, and various configuration modifications are contemplated. Therefore, as used herein, the specific examples set forth and the accompanying discussion are intended to represent their more general categories. In general, the use of any specific example is intended to represent its category, and specific components, devices, and items not included should not be considered as limiting.

Regarding the use of basically any plural and/or singular term in the present invention, the plural can be translated into the singular and/or from the singular to the plural depending on the context and/or application. For the sake of clarity, the various singular/plural permutations are not explicitly stated in this article.

In some cases, one or more components may be referred to herein as "configured to", "configured by", "configurable to", "operable/operable as", "suitable/adaptable to" ", "Able", "Compliant/Compliant", etc. Those skilled in the art will recognize that such terms (eg, "configured to") may generally include active components and/or inactive components and/or standby components, unless the context requires otherwise. .

Although the specific aspects of the subject described herein have been shown and described, changes and modifications can be made without departing from the subject described herein and its broader aspects, and therefore, the appended claims will fall within its scope All these changes and modifications within the true spirit and scope of the subject described in this article are included. The terms used herein, and particularly the terms used in the appended claims (e.g., the subject of the appended claims), are generally intended as "open-ended" terms (e.g., term The term "including" shall be interpreted as "including but not limited to", the term "having" shall be interpreted as "at least having", the term "including" shall be interpreted as "including but not limited to", etc.). If it is intended to introduce a specific number of claim statements, such an intent will be explicitly stated in the claims, and in the absence of such a statement, there is no such intent. For example, to aid understanding, the following appended claims may contain usage of the introductory phrases "at least one" and "one or more" to introduce claim recitations. However, the use of such phrases should not be understood as meaning that a claim statement introduced by the indefinite article "a" or "an" defines any particular claim containing such an introduced claim statement as merely A claim that includes a statement of this kind, even when the same claim includes the introductory phrase "one or more" or "at least one" and indefinite articles such as "a" or "an" (e.g., "One (a)" and/or "one (an)" should generally be interpreted as meaning "at least one" or "one or more"); the same applies to the use of Definite article. In addition, even if a specific quantity of an introduced claim statement is clearly stated, such a statement should generally be interpreted as meaning at least the listed quantity (for example, an unmodified statement "two statements" without other modifiers usually means Means at least two statements or two or more statements). In addition, in those cases where idioms similar to "at least one of A, B, and C, etc." are used, generally such a construction means that those skilled in the art will understand the meaning of the idiom (for example, "having A, B "System with at least one of C" shall include but is not limited to having A alone, B alone, C alone, A and B together, A and C together, B and C together, and/or A, B, and C together System etc.). In those cases where idioms similar to "at least one of A, B or C" are used, generally such a construction means that those skilled in the art will understand the meaning of the idiom (for example, "having A, B or C in "At least one system of "will include but not limited to systems with A alone, B alone, C alone, A and B together, A and C together, B and C together and/or A, B, C together, etc. ). Generally, transition words and/or phrases that generally indicate two or more optional terms, whether in the specification, claims or drawings, should be understood as envisaged to include one of the terms, the alternative of the two or Possibility to term both, unless the context dictates otherwise. For example, the phrase "A or B" will generally be understood to include the possibilities of "A" or "B" or "A and B."

All the above-mentioned US patents, US patent application publications, US patent applications, foreign patents, foreign patent applications and non-patent publications cited in this specification and/or listed in any application data sheet are incorporated herein by reference, as long as they are not related to This application can be inconsistent.

Although various aspects and embodiments are disclosed herein, other aspects and embodiments will be apparent to those skilled in the art. The various aspects and embodiments disclosed herein are for illustrative purposes and are not intended to limit, and the true scope and spirit are indicated by the appended claims.

100: method

110~140: Step

Claims (84)

A method of packaging a collapsible container, comprising: covering a multi-single-dose container in an expanded configuration with an airtight sealable outer wrapper, the multi-single-dose container comprising: a row of interconnected single-dose vials, Each of the single-dose vials encapsulates a dose of at least one medicament; and one or more hinge joints that connect the single-dose vials in the row of interconnected single-dose vials Each of the single-dose vials is connected to at least one adjacent single-dose vial, and the one or more hinge joints are sufficiently flexible to make the flat outer surface of each of the single-dose vials and the at least one adjacent The flat outer surface of the single-dose vial is reversibly matched to form the folded configuration of the multiple single-dose container; on at least one of the single-dose vials in the row of interconnected single-dose vials Applying a force, the applied force being directed towards the at least one adjacent single-dose vial; in response to at least one of the single-dose vials in the row of interconnected single-dose vials Applying the force, bending the one or more hinged joints to form the folded configuration of the multiple single-dose container; and sealing the airtightly sealable outer wrapper so that the multiple single-dose container therein An airtight seal is formed around the folded configuration of the dose container. The method according to claim 1, wherein covering the multiple single-dose container in an expanded configuration with the air-tightly sealable outer wrapper comprises: by being defined by the air-tightly sealable outer wrapper The opening is inserted into the multiple single-dose container in an expanded configuration. The method according to claim 1, wherein covering the multiple single-dose container in the expanded configuration with the airtight sealable outer wrapper comprises: positioning the multiple single-dose container in the expanded configuration at Between the first layer of the airtightly sealable outer wrapper and the second layer of the hermetic sealable outer wrapper; and between the first layer and the first layer of the hermetic sealable outer wrapper One or more edges of the second layer are sealed together. The method according to claim 1, wherein covering the multiple single-dose container in the expanded configuration with the air-tight sealable outer wrapper includes: covering the air-tightly sealed bag or sleeve in the expanded configuration Type of the multiple single-dose container. According to the method described in claim 1, the airtight sealable outer wrap is used to cover The multiple single-dose container in the expanded configuration includes: covering the multiple single-dose container in the expanded configuration with a foil laminate that can be hermetically sealed. The method according to claim 1, wherein covering the multiple single-dose container in the expanded configuration with the airtight sealable outer wrapper comprises: using polyester, foil, polypropylene, cast polypropylene An airtight sealable outer wrapper formed by at least one of polyethylene, high-density polyethylene, metallocene polyethylene, linear low-density polyethylene, or metallized film covers the multiple single-dose container in an expanded configuration. The method according to claim 1, wherein covering the multiple single-dose container in the expanded configuration with the air-tight sealable outer wrapper includes: covering the gas-impermeable outer wrapper in the expanded configuration The multiple single-dose container. The method according to claim 1, wherein covering the multiple single-dose container in the expanded configuration with the airtight sealable outer wrapper comprises: covering the multiple single-dose container in the expanded configuration with a vapor impermeable outer wrapper The multiple single-dose container. The method according to claim 1, wherein covering the multiple single-dose container in the expanded configuration with the air-tight sealable outer wrapper comprises: covering the multiple single-dose container in the expanded configuration with a light impermeable outer wrapper The multiple single-dose container. The method according to claim 1, wherein covering the multiple single-dose container in the expanded configuration with the airtight sealable outer wrapper comprises: covering the multiple single-dose container in the expanded configuration with an electrostatic discharge protective outer wrapper The multiple single-dose container. The method according to claim 1, wherein the multiple unit dose container is formed by blow molding-fill-seal manufacturing. The method of claim 1, wherein the multiple single-dose container is formed of at least one biocompatible thermoplastic material. The method of claim 1, wherein the row of interconnected single-dose vials includes two or more interconnected single-dose vials in a row. The method according to claim 1, wherein the horizontal cross section of each of the single-dose vials is square, triangle, hexagon, or polygon. The method according to claim 1, wherein the certain dose of at least one medicament comprises: a certain dose of at least one vaccine. The method according to claim 1, wherein the certain dose of at least one medicament comprises: a certain dose of at least one therapeutic agent. The method according to claim 1, wherein the dose of at least one medicament is in liquid form. The method according to claim 1, wherein the dose of at least one medicament is in a lyophilized form. The method of claim 1, wherein each of the single-dose vials in the row of single-dose vials includes an internal volume containing the dose of at least one medicament. The method of claim 19, wherein the internal volume containing the dose of at least one medicament includes an inert gas-filled headspace. The method of claim 1, wherein each of the single-dose vials in the row of interconnected single-dose vials includes an access portion pierceable by a needle. The method according to claim 1, wherein the articulated joint is frangible. The method of claim 1, wherein the expanded configuration of the multiple single-dose container has a first rectangular packaging cross-sectional area, and the folded configuration of the multiple single-dose container has a second rectangular packaging The cross-sectional area, the second rectangular package cross-sectional area is smaller than the first rectangular package cross-sectional area. The method of claim 1, wherein the multiple single-dose container includes at least one label, and the at least one label includes at least one sensor. The method of claim 1, wherein each of the single-dose vials in the row of interconnected single-dose vials includes a label including a temperature sensor, a humidity sensor, At least one of a light sensor or an oxygen sensor. The method of claim 1, wherein applying a force on the at least one of the single-dose vials in the row of interconnected single-dose vials comprises: using at least one mechanical probe to A force is applied to the at least one of the single-dose vials in the row of interconnected single-dose vials. The method of claim 1, wherein applying a force on the at least one of the single-dose vials in the row of interconnected single-dose vials comprises: using pressurized gas on the A force is applied to the at least one of the single-dose vials in the row of interconnected single-dose vials. The method of claim 1, wherein applying a force on the at least one of the single-dose vials in the row of interconnected single-dose vials comprises: The dose vials exert a force on the first single-dose vials at the first end of the row of interconnected single-dose vials, And applying a force on the second single-dose vial at the second end of the row of interconnected single-dose vials towards the second adjacent single-dose vial. The method of claim 28, further comprising simultaneously applying the force at the first end of the row of interconnected single-dose vials toward the first adjacent single-dose vials On the first single-dose vial and toward the second adjacent single-dose vial at the second end of the row of interconnected single-dose vials applying the force at all Said on the second single-dose medicine bottle. The method of claim 28, further comprising sequentially applying the first end of the row of interconnected single-dose vials toward the first adjacent single-dose vials. A force is on the first single-dose vial, and applying the force at the second end of the row of interconnected single-dose vials toward the second adjacent single-dose vial The second single-dose medicine bottle. The method according to claim 1, comprising: expelling at least a portion of air from around the folded configuration of the multiple single-dose container covered by the airtight sealable outer wrapper; and sealing the energy An airtightly sealed outer wrapper to form an airtight seal around the folded configuration of the multiple single-dose container therein. The method of claim 31, wherein expelling the at least a portion of the air from around the folded configuration of the multiple single-dose container covered by the airtight sealable outer wrapper comprises: The flow pipe connected to the vacuum source is inserted into the opening defined by the airtight sealable outer wrapper; a part of the airtight sealable outer wrapper is pressure-sealed around the inserted flow pipe so as to A bag is formed around the folded configuration of the multiple single-dose container; and the at least a portion of the air is discharged from the bag around the folded configuration of the multiple single-dose container. The method according to claim 1, comprising: injecting an inert gas around the folded configuration of the multiple single-dose container covered by the air-tight sealable outer wrapper; At least a part of the injected inert gas is discharged around the folded configuration of the multiple single-dose container covered by the outer wrapper. The method according to claim 33, wherein the at least one of the injected inert gas is discharged from around the folded configuration of the multiple single-dose container covered by the airtight sealable outer wrapper One part includes: inserting the flow pipe connected to the vacuum source into the opening defined by the airtight sealable outer wrapper; pressure sealing the airtight sealable outer wrapper around the inserted flow pipe A part to form a bag around the folded configuration of the multiple single-dose container; and vent the injected inert gas from the bag around the folded configuration of the multiple single-dose container Said at least part of the body. The method according to claim 33, wherein injecting an inert gas around the folded configuration of the multiple single-dose container covered by the air-tight sealable outer wrapper includes: Nitrogen is injected around the folded configuration of the multiple single-dose container covered by a sealed outer wrapper. The method according to claim 33, wherein injecting the inert gas around the folded configuration of the multiple single-dose container covered by the airtight sealable outer wrapper includes: A rare gas is injected around the folded configuration of the multiple single-dose container covered by an airtightly sealed outer wrapper. The method according to claim 33, further comprising: before injecting the inert gas around the folded configuration of the multiple single-dose container, removing from the airtight sealable outer wrapper At least a portion of the air is expelled around the folded configuration of the multiple single-dose container. The method of claim 1, wherein sealing the air-tight sealable outer wrapper to form the air-tight seal around the folded configuration of the multiple single-dose container therein includes: heat sealing The airtight sealable outer wrapper forms the airtight seal around the folded configuration of the multiple unit dose container therein. The method of claim 1, wherein sealing the airtightly sealable outer wrapper to form the airtight seal around the folded configuration of the multiple single-dose container therein includes: pressure sealing The airtight sealable outer wrapper forms the airtight seal around the folded configuration of the multiple unit dose container therein. The method of claim 1, wherein sealing the airtightly sealable outer wrapper to form the airtight seal around the folded configuration of the multiple single-dose container therein includes: chemical sealing The airtight sealable outer wrapper forms the airtight seal around the folded configuration of the multiple unit dose container therein. The method according to claim 1, further comprising: attaching at least one label to the outer surface of the airtight sealable outer wrapper, the at least one label including at least one sensor. The method according to claim 1, further comprising: attaching at least one label to the outer surface of the airtight sealable outer wrapper, the at least one label including at least one temperature sensor. A method for packaging a multiple single-dose container, comprising: covering the multiple single-dose container with an airtight sealable outer wrapper, the multiple single-dose container comprising: a row of interconnected single-dose vials, the Each of the single-dose vials encapsulates a certain dose to One less medicament; and one or more hinge joints that connect each of the single-dose vials in the row of interconnected single-dose vials to at least one adjacent single-dose vial, The one or more hinge joints are sufficiently flexible to reversibly match the flat outer surface of each of the single-dose vials with the flat outer surface of the at least one adjacent single-dose vial to form The folded configuration of the multiple single-dose container; a force is applied to at least a portion of the outer surface of the air-tight sealable outer wrapper covering the multiple single-dose container, and the applied force is directed toward the The one or more hinge joints of the multiple single-dose container; exhaust at least a portion of the air around the multiple single-dose container covered by the air-tight sealable outer wrapper; and sealingly cover the multiple single-dose The airtight sealable outer wrapper of the container is used to airtightly seal the multiple single-dose container therein. The method according to claim 43, wherein covering the multiple single-dose container with the airtightly sealable outer wrapper includes inserting the multiple dose container through an opening defined by the airtightly sealable outer wrapper. Single-dose container. The method according to claim 43, wherein covering the multiple single-dose container with the air-tightly sealed outer wrapper comprises: positioning the multiple single-dose container on the second airtight sealable outer wrapper Between one layer and the second layer of the airtight sealable outer wrapper; and seal one or more edges of the first layer and the second layer of the airtight sealable outer wrapper in together. The method according to claim 43, wherein covering the multiple single-dose container with the airtightly sealable outer wrapper includes: covering the multiple single-dose container with an airtightly sealable bag. The method according to claim 43, wherein covering the multiple single-dose container with the air-tightly sealed outer wrapper includes: covering the multiple single-dose container with a sleeve that can be airtightly sealed. The method according to claim 43, wherein covering the multiple single-dose container with the airtightly sealable outer wrapper includes: covering the multiple single-dose container with a foil laminate that can be airtightly sealed. The method according to claim 43, wherein covering the multiple single-dose container with the air-tight sealable outer wrapper includes: using polyester, foil, polypropylene, cast polypropylene, polyethylene, high An airtight sealable outer wrapper formed by at least one of density polyethylene, metallocene polyethylene, linear low density polyethylene or metalized film covers the multiple single-dose container. The method according to claim 43, wherein the airtight sealable outer wrapper is used Covering the multiple single-dose container includes: covering the multiple single-dose container with a gas impermeable outer wrapper. The method according to claim 43, wherein covering the multiple single-dose container with the air-tight sealable outer wrapper includes: covering the multiple single-dose container with a vapor impermeable outer wrapper. The method according to claim 43, wherein covering the multiple single-dose container with the airtight sealable outer wrapper includes: covering the multiple single-dose container with a light impermeable outer wrapper. The method according to claim 43, wherein covering the multiple single-dose container with the airtight sealable outer wrapper includes: covering the multiple single-dose container with an electrostatic discharge protective outer wrapper. The method according to claim 43, wherein the multiple unit dose container is formed by a blow molding-fill-seal manufacturing process. The method of claim 43, wherein the multiple single-dose container is formed of at least one biocompatible thermoplastic material. The method of claim 43, wherein the row of interconnected single-dose vials includes two or more single-dose vials in a row. The method of claim 43, wherein the horizontal cross-section of each of the single-dose vials in the row of interconnected single-dose vials is a square, a triangle, a hexagon, or a polygon. The method according to claim 43, wherein the dose of at least one medicament includes a dose of at least one vaccine. The method according to claim 43, wherein the dose of at least one medicament includes a dose of at least one therapeutic agent. The method of claim 43, wherein the dose of at least one medicament is in liquid form. The method of claim 43, wherein the dose of at least one medicament is in a lyophilized form. The method of claim 43, wherein each of the single-dose vials in the row of interconnected single-dose vials contains an internal volume containing the dose of at least one medicament. The method of claim 62, wherein the internal volume containing the dose of at least one medicament includes an inert gas-filled headspace. The method of claim 43, wherein each of the single-dose vials in the row of interconnected single-dose vials includes an entry portion pierceable by a needle. The method of claim 43, wherein the multiple single-dose container includes at least one label, and the at least one label includes at least one sensor. The method of claim 43, wherein each of the single-dose vials in the row of interconnected single-dose vials includes a label including a temperature sensor, a humidity sensor, At least one of a light sensor or an oxygen sensor. The method according to claim 43, wherein applying a force on the at least a portion of the outer surface of the airtight sealable outer wrapper covering the multiple single-dose container comprises: applying a pressurized gas to A force is applied to the at least a portion of the outer surface of the air-tight sealable outer wrapper covering the multiple unit dose container. The method of claim 43, wherein exhausting the at least a portion of the air from around the multiple single-dose container covered by the air-tight sealable outer wrapper comprises: connecting a flow connected to a vacuum source The pipe is inserted into the opening defined by the air-tight sealable outer wrapper; a part of the air-tight sealable outer wrapper is pressure-sealed around the inserted flow pipe, so that the multiple single dose A bag is formed around the container; and the at least a portion of the air is discharged from the bag around the multiple single-dose container. The method according to claim 43, further comprising: injecting an inert gas around the multiple single-dose container covered by the airtightly sealed outer wrapper; and from the airtightly sealed outer wrapper At least part of the injected inert gas is discharged around the multiple single-dose container covered by the substance. The method according to claim 69, wherein injecting the inert gas around the multiple single-dose container covered by the air-tightly sealed outer wrapper includes: Nitrogen is injected around the multiple single-dose container covered by the substance. The method according to claim 69, wherein injecting the inert gas around the multiple single-dose container covered by the air-tightly sealed outer wrapper includes: Rare gas is injected around the multiple single-dose container covered by the substance. The method according to claim 69, further comprising: before injecting the inert gas into the airtightly sealable outer wrapper, from the multiple unit covered by the hermetically sealable outer wrapper The at least a portion of the air is discharged around the dose container. The method according to claim 43, wherein applying a force on the at least a portion of the outer surface of the airtight sealable outer wrapper covering the multiple single-dose container comprises: using one or more A mechanical probe exerts the force on the at least a portion of the outer surface of the airtightly sealable outer wrapper covering the multiple single-dose container. The method according to claim 43, wherein sealing the air-tight sealable outer wrapper covering the multiple single-dose container to air-tightly seal the multiple single-dose container includes: The first layer of the hermetically sealed outer wrapper is sealed to the second layer of the hermetically sealable outer wrapper to hermetically seal the multiple single-dose container therein. The method according to claim 43, wherein sealing the air-tight sealable outer wrapper covering the multiple single-dose container to air-tightly seal the multiple single-dose container therein includes: At least a portion of the air-tight sealable outer wrapper of the multiple single-dose container is bonded to at least a portion of the surface of the multiple single-dose container to hermetically seal the multiple single-dose container therein. The method according to claim 75, wherein at least a part of the air-tight sealable outer wrap covering the multiple single-dose container is bonded to at least a part of the surface of the multiple single-dose container to The air-tight sealing of the multiple single-dose container includes: joining at least a part of the air-tight sealable outer wrapper covering the multiple single-dose container to the one or more hinge joints. On at least a part of the surface of the multiple single-dose container to hermetically seal the multiple single-dose container therein. The method of claim 75, wherein bonding the at least a portion of the airtight sealable outer wrapper to the at least a portion of the surface of the multiple single-dose container therein comprises: At least a portion of the airtight sealable outer wrapper covering the multiple single-dose container is combined around and between each of the single-dose vials in the row of interconnected single-dose vials Onto at least a portion of the surface of the multiple single-dose container. The method according to claim 43, wherein sealing the airtightly sealable outer wrapper covering the multiple single-dose container to airtightly seal the multiple single-dose container therein includes: heat-sealing covering the The air-tight sealable outer wrapper of the multiple single-dose container is used to air-tightly seal the multiple single-dose container therein. The method according to claim 43, wherein sealing the air-tightly sealable outer wrapper covering the multiple single-dose container to air-tightly seal the multiple single-dose container therein comprises: pressure sealing covering the The air-tight sealable outer wrapper of the multiple single-dose container is used to hold the multiple single-dose container The device is hermetically sealed in it. The method according to claim 43, wherein sealing the air-tight sealable outer wrapper covering the multiple single-dose container to air-tightly seal the multiple single-dose container therein comprises: chemically sealing covering the The air-tight sealable outer wrapper of the multiple single-dose container is used to air-tightly seal the multiple single-dose container therein. The method according to claim 43, further comprising: attaching at least one label to the outer surface of the air-tight sealable outer wrapper, the at least one label including at least one sensor. The method according to claim 43, further comprising: attaching at least one label to the outer surface of the air-tight sealable outer wrapper, the at least one label including at least one temperature sensor. The method of claim 43, further comprising: bending the airtightly sealed multiple single-dose container at the one or more hinge joints of the multiple single-dose container to form a folded configuration; and adding The third cover maintains the hermetically sealed multiple single-dose container in the folded configuration. The method of claim 43, comprising: at least partially penetrating the air-tight sealable outer wrapper to be in a single-dose vial in the row of interconnected single-dose vials A fragile part is added to the outer wrapper that can be airtightly sealed between each.

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