Packages with multiple sterilization chambers

Abstract

A multi-chamber package is described, comprising a first chamber and a second chamber, the first chamber having a bottom wall and side walls defining a cavity, and the second chamber having a partially open bottom wall and side walls defining a cavity. A first removable seal is positioned on the top surface of the package to completely cover the first and second chambers, and a second seal is positioned on the bottom surface of the partially open bottom plate of the second chamber to completely seal the second chamber. A method of packaging a medical device is also described.

Description

Technical Field

[0001] This invention relates to multi-compartment packaging, and more particularly to multi-compartment packaging requiring different sterilization processes. Background Technology

[0002] Clean or sterile items, particularly useful for medical applications, are packaged to maintain their sterility. The packaging used for these items is designed to provide a barrier against microorganisms entering the interior and contaminating their contents. In most cases, the packaging (e.g., packaging containing syringes) is opened immediately before use to minimize the time the item is exposed to unsterilized conditions.

[0003] In the medical industry, items placed in packaging often require sterilization during the packaging process, and different items may employ different sterilization methods. Typically, sterilized and non-sterilized items are placed in separate packages. Furthermore, the items' standard packaging is simultaneously encapsulated in a single, closed package. Alternatively, sterilized items are placed in a separate package and then placed inside a non-sterilized kit. These configurations and methods result in more packaging material waste and require more steps to open the kit.

[0004] Many medical procedures require multiple components, including medications and medical devices, which must be collected by the clinician before the procedure begins. The practice of assembling multiple components before a procedure is called "kitting," and many hospitals and independent companies offer services by assembling these components and preparing them for use in medical procedures. In many cases, the multiple components, including medications and medical devices, require different sterilization processes.

[0005] For example, medications or other injectable / infusionable solutions packaged in breathable containers (such as plastic ampoules, rubber-stopped vials, intravenous solution packs, intravenous solution bags, and pre-filled flushing syringes) are commonly used in medical procedures and can be included in procedure kits. In many cases, plastic ampoules, rubber-stopped vials, intravenous solution packs, intravenous solution bags, and pre-filled syringes contain saline and other aqueous solutions. Ethylene oxide (EtO) sterilization is a common method for preparing kits for use in sterile environments. Currently, pre-filled saline syringes, plastic ampoules, rubber-stopped vials, intravenous solution packs, and intravenous solution bags are packaged in breathable materials that can also be permeated with EtO gas, which is commonly used for the sterilization of medical devices. However, exposure of plastic ampoules, rubber-stopped vials, intravenous solution kits, intravenous solution bags, or pre-filled syringes to ethylene oxide (EtO) gas can adversely increase the pH of the contents (e.g., saline). To overcome this adverse effect, plastic ampoules, rubber-stopped vials, intravenous solution kits, intravenous solution bags, or pre-filled saline syringes are initially omitted from medical procedure kits until the other contents of the kit have been treated with ethylene oxide (EtO) gas. For some medical procedures, it is important to have plastic ampoules, rubber-stopped vials, intravenous solution kits, intravenous solution bags, and / or pre-filled flushing syringes prepared for sterile areas, which can also be sterilized after kit assembly. Therefore, there is a need for packaging materials that can accommodate products requiring different sterilization methods, such as pre-filled flushing syringes, plastic ampoules, medicine bottles with rubber stoppers, intravenous solution packs, and intravenous solution bags that can withstand EtO sterilization.

[0006] Traditional packaging consumes a significant amount of material because kits of multiple items may require multiple packages. This additional packaging material increases the cost per syringe product. Furthermore, the need to discard extra packaging material after opening contributes to increased waste generated by hospitals and other healthcare facilities.

[0007] There is a growing need for kits containing products that require different sterilization methods for sterile and non-sterilized products. Therefore, there is a need for packaging capable of containing such products that require different sterilization methods for sterile and non-sterilized products. Summary of the Invention

[0008] Various aspects of the present invention relate to a package for containing medical products, said medical products including devices, pre-filled syringes, or drugs.

[0009] One aspect of this disclosure relates to a packaging container having: a packaging body including a top surface and a bottom surface; a first chamber projecting from the bottom surface of the packaging body and having side walls and a closed bottom plate; a first cavity including the top surface of the packaging body, the side walls of the first chamber, and the closed bottom plate of the first chamber; and a second chamber projecting from the bottom surface of the packaging body and having side walls, a at least partially open bottom plate, and the top surface of the packaging body. The second cavity includes the side walls of the second chamber and a at least partially open bottom plate. A first removable strip is disposed on the top surface of the packaging body, and a second removable strip is disposed on the at least partially open bottom plate.

[0010] In one or more embodiments, the first device is positioned within a first cavity, and the second device is positioned within a second cavity.

[0011] In one or more embodiments, the first removable strip has a peel-off tab.

[0012] In one or more embodiments, the first removable strip is peelable.

[0013] In one or more embodiments, the second removable strip is non-peelable.

[0014] In one or more embodiments, the length of the first chamber is slightly greater than or equal to the total length of the first device, the width is slightly greater than or equal to the maximum width of the first device, and the depth is slightly greater than or equal to the maximum depth of the first device.

[0015] In one or more embodiments, the length of the second chamber is slightly greater than or equal to the total length of the second device, the width is slightly greater than or equal to the maximum width of the second device, and the depth is slightly greater than or equal to the maximum depth of the second device.

[0016] Another aspect of this disclosure relates to a method of packaging a medical device, the method comprising: positioning a first medical device in a first cavity of a packaging body; sterilizing the first medical device and the first cavity using a first sterilization process; sealing the first cavity by positioning a first removable strip on a top surface of the packaging body; positioning a second medical device in a second cavity of the packaging body; and sealing the second cavity by positioning a second removable strip on a floor plate at least partially open in the second cavity.

[0017] In one or more embodiments, the method further includes sterilizing the second medical device and the second cavity using a second sterilization process. In one or more embodiments, the first sterilization process and the second sterilization process are the same. In one or more embodiments, the first sterilization process and the second sterilization process are different. Attached Figure Description

[0018] Figure 1 A perspective view of a packaging container according to an embodiment of the present disclosure is shown.

[0019] Figure 2A A perspective view of a conventional syringe according to one or more embodiments of the present disclosure is shown;

[0020] Figure 2B A front view of a conventional vascular access device according to one or more embodiments of the present disclosure is shown;

[0021] Figure 2C A side view of a conventional vascular access device according to one or more embodiments of the present disclosure is shown;

[0022] Figure 3 A top perspective view of a packaging container according to an embodiment of the present disclosure is shown;

[0023] Figure 4 A top perspective view of a packaging container according to an embodiment of the present disclosure is shown;

[0024] Figure 5A A top perspective view of a packaging container according to an embodiment of the present disclosure is shown;

[0025] Figure 5B A bottom perspective view of a packaging container according to an embodiment of the present disclosure is shown;

[0026] Figure 6 A bottom perspective view of a packaging container according to an embodiment of the present disclosure is shown;

[0027] Figure 7 A bottom perspective view of a packaging container according to an embodiment of the present disclosure is shown; and,

[0028] Figure 8 A flowchart illustrating a method for packaging one or more device containers according to an embodiment of the present disclosure is shown. Detailed Implementation

[0029] Before describing several exemplary embodiments of the invention, it should be understood that the invention is not limited to the details of the construction or processing steps set forth in the following description. The invention can have other embodiments and can be practiced or performed in various ways.

[0030] The following definitions are provided for the terms used in this disclosure.

[0031] As used herein, the term "packaging" or "packaging material" includes any material used to enclose or protect a medical device or product, such as plastic ampoules, vials with rubber stoppers, intravenous solution packs, intravenous solution bags, and syringes. Packaging materials can be rigid or flexible. Packaging materials include, but are not limited to, medical packaging materials, pharmaceutical packaging materials, and child-protective packaging materials. Medical and pharmaceutical packaging materials can include plastic trays with straps, blister packs, flow wraps, and bags with three or four sides.

[0032] As used herein, the term "blister pack" or "blister bag" encompasses several types of pre-formed packaging for consumer goods, pharmaceuticals, medical devices, and the like. The main component of a blister bag is a cavity or pouch made of a formable web (typically thermoformable plastic). The formable web can be rigid or flexible. The cavity or pouch is large enough to contain the items housed within the blister pack. Depending on the application, blister bags may have a backing formed of a thermoformable material and a backing made of aluminum foil, paper, etc. A blister pack is a sealed cap made of plastic or other medical-grade materials. Blister packaging provides a barrier against microorganisms and other contaminants and offers a degree of tamper resistance. Blister packs protect pharmaceutical products from external influences that could render them ineffective, while allowing manufacturers to package them using a molding-filling-sealing process. The molding-filling-sealing process involves forming blister packs from rolls of flat sheets or films, and filling blister packs with medical devices or pharmaceuticals.

[0033] The sealing film of medical blister packs can be made of plastic, aluminum, or medical-grade paper that is permeable to gases used for sterilization but impermeable to microorganisms. Most commonly, Used as a sealing material for medical blister packs.

[0034] Blister packs can be sealed in various ways, including but not limited to heat sealing and cold sealing. The capping material can have a heat-sealing coating applied thereto; then, heat is used to activate the coating to seal the cap to the backing. Blister packs can also be sealed using a cold sealing process that uses a combination of pressure-sensitive folding blister packs and clear blister packs; the blister pack is constrained between two packs, which are then joined together under pressure without the use of any heat. Furthermore, blister packs can be sealed by appropriately oriented multilayer films to create a seal.

[0035] It is a synthetic material composed of flash-spun high-density polyethylene fibers (i.e., spunbond olefin fibers). This material is lightweight yet strong and not easily torn, but can be cut with scissors or a knife. Because of its high breathability, water vapor and other gases can pass through. However, at the same time, the material is impermeable to liquid water and microorganisms.

[0036] The term "syringe" as used herein includes syringes intended for use with needles, nozzles, tubes, or in flushing systems. As used herein, the term "syringe" refers to a simple pump-like device consisting of a plunger rod tightly fitted within a barrel or tube. The plunger rod can be pulled or pushed within the barrel, allowing the syringe to draw in and expel liquid or gas through an opening at the open end of the barrel. The open end of the syringe may be fitted with a needle, nozzle, or tube to help guide fluid in and out of the barrel. Syringes can be sterile or unsterilized, depending on the technician's needs.

[0037] As used herein, the term "sterilization" refers to a variety of techniques used to reduce, kill, or eliminate harmful or infectious agents. Examples of sterilization procedures include, for instance, steam sterilization, ethylene oxide sterilization, gas plasma sterilization, ozone sterilization, hydrogen peroxide sterilization, heat sterilization, nitrogen dioxide sterilization, or combinations thereof.

[0038] As used herein, the term "breathable" is intended to refer to a material that allows gases to pass through it but does not allow airborne microorganisms, bacteria, viruses, or mixtures thereof to pass through it.

[0039] As used in this article, "impermeable" means that the material does not easily allow gas to pass through it. In addition, impermeable materials also prevent airborne microorganisms, bacteria, viruses, and mixtures thereof from passing through them.

[0040] As used herein, the term "microorganism" refers to a single-celled organism or a community of cellular organisms. Microorganisms are diverse; they include, but are not limited to, bacteria, fungi, archaea, and protozoa.

[0041] During manufacturing, pre-filled medical devices are placed in an airtight section or chamber of the packaging and sterilized using a non-toxic or harmless sterilization process (e.g., steam sterilization in an autoclave). The sterilized airtight section or chamber of the packaging is then completely sealed. In one or more embodiments, sterilization can also be achieved by heat, nitrogen dioxide, or a combination thereof. Because the pre-filled medical device is completely encapsulated in a bag consisting only of an airtight film, the bag containing the pre-filled medical device can be placed in a kit, which will undergo subsequent EtO sterilization without adversely affecting the pre-filled medical device. This results in an excessive number of steps and materials being used in the kit formation process.

[0042] A first aspect of the invention relates to a packaging container having two or more compartments, each of the two or more compartments having an article disposed within the compartment. A first removable seal is positioned over a top opening of the two or more compartments to completely seal the first compartment, and a second seal is positioned over a bottom opening of the second compartment to seal the second compartment. A second aspect of the invention relates to a method of packaging two or more articles, the method comprising the steps of: positioning a first article in a first compartment; positioning a first removable seal over a top opening of the two or more compartments to seal the first compartment; positioning a second article in a second compartment; and positioning a second removable seal over a bottom opening of the second compartment to seal the second compartment.

[0043] Figure 1 A packaging container 100 according to one or more embodiments of the present disclosure is shown. For illustrative purposes, the packaging container 100 is described as translucent. The packaging container 100 includes a packaging body 102 having a top surface 104 and a bottom surface 106 defining a thickness. Two or more chambers 110 extend from the bottom surface. Each of the two or more chambers 110 has a bottom and walls defining a cavity. Articles are disposed within the cavity of each of the two or more chambers 110 for packaging.

[0044] In some embodiments, the packaging container 100 is a blister pack. In some embodiments, the packaging container 100 is made of rigid plastic. In some embodiments, the packaging container 100 is made of flexible plastic. In some embodiments, the packaging container 100 is made of glass, ceramic, metal, or a metal alloy. In some embodiments, the packaging container 100 is translucent to allow an operator to see the contents of the two or more chambers 110. In some embodiments, the packaging container 100 is opaque. In some embodiments, the packaging container 100 has symbols or markings indicating the manufacturing date, the contents therein, or warning labels.

[0045] Figure 2A and Figure 2BA conventional medical device is illustrated, which, in one or more embodiments, is an article disposed within a packaging container 100. The described conventional medical device is not intended to be a limiting example, as the article disposed within the packaging container 100 can be any device. The described conventional medical device occupies a volume defined in the XYZ plane. The X, Y, and Z planes are perpendicular to each other. The corresponding volume of each of the two or more chambers 110 is configured to be equal to or slightly larger than the volume of the article. In some embodiments using blister packaging, the volume of the two or more chambers 110 conforms to the shape of the article. The volume of each of the two or more chambers 110 can be of any suitable shape. In some embodiments, the two or more chambers 110 are trapezoidal, triangular-elliptical, or rectangular in shape.

[0046] Figure 2A A conventional syringe 80 is shown. The syringe 80 includes a barrel 81 having a closed distal end 82 and an open proximal end 83. A needleless connector extends from the closed distal end 82. A plunger rod 84 having a distally located plug 85 is at least partially disposed within the barrel 81. In some embodiments, the syringe 80 is a pre-filled flushing syringe. In some embodiments, the syringe 80 is packaged with a vascular access device attached to the needleless connector. In some embodiments, the syringe 80 is packaged with a cap 86. Figure 2A As shown, the syringe 80 (including all components of the syringe 80) has: a total length Ls in the Z-plane; a maximum width Ws in the X-plane; and a maximum width Ws measured at the widest portion of the syringe 80 transverse to the total length Ls. In this embodiment, the total length Ls extends from the barrel 81 to the cap 86 and the maximum width Ws is defined by the flange of the proximal end 83 of the opening. In this embodiment, the flange is substantially cylindrical and has a constant maximum width Ws defined by the diameter of the flange of the proximal end 83 of the opening. In some embodiments, the proximal end 83 of the opening includes two tabs, and thus the syringe 80 has a maximum width Ws and a depth in the Y-plane.

[0047] Figure 2B and Figure 2C A conventional vascular access device 90 is shown. The vascular access device 90 includes a needle hub 91 that receives a needle 92. In some embodiments, the vascular access device 90 further includes a needle cap 93 and a hinged safety cover 94. Figure 2B and Figure 2C As shown, the vascular access device 90 (including all components of the vascular access device 90) has a total length L in the Z-plane. VAD The maximum width W in the X-plane VAD The maximum width W VAD The transverse direction of the vascular access device 90 is perpendicular to the total length L. VAD and maximum depth DVAD The maximum depth D is measured at the widest part. VAD The transverse direction of the vascular access device 90 is perpendicular to the total length L. VAD Measured at the widest part.

[0048] In this embodiment, the total length L VAD It extends from the needle holder 91 to the hinged safety cover 94. Maximum width W VAD The maximum depth is defined by the width of the hinged safety cover 94. VAD It is defined by the distance from the needle seat 91 to the hinged safety cover 94.

[0049] Figure 3 A packaging container is shown, comprising a top surface 104 and a bottom surface 106 having a defined thickness. Two or more compartments extend from the bottom surface. The dimensions and shapes of the two or more compartments are designed to accommodate single items, multiple items, or multiple items as a kit or assembly. Figure 3 In the embodiment shown, the size of the first chamber 112 of the two or more chambers is designed to maintain ( Figure 2B The vascular access device 90 and the second chamber 114 are designed to maintain ( Figure 2A (The) syringe 80. In one or more embodiments, two first chambers 112 are provided for holding two vascular access devices 90.

[0050] The first chamber 112 has a cavity 116 defined by sidewalls 118 and a closed floor plate 120. The cavity 112 has a rectangular shape and is configured to hold a vascular access device 90. To accommodate the vascular access device 90, the length of the cavity 116 is slightly greater than or equal to the total length L of the vascular access device 90. VAD Similarly, the width of cavity 116 is slightly greater than or equal to the maximum width W of vascular access device 90. VAD And the depth is slightly greater than or equal to the maximum depth D of the vascular access device (90°). VAD .

[0051] The second chamber 114 has a cavity 122 defined by sidewalls 124 and a chamber floor plate 126 that is at least partially open. The cavity 122 has a rectangular shape and is configured to hold a syringe 80. To accommodate the syringe 80, the length of the cavity 122 is slightly greater than or equal to the total length Ls of the syringe 80. Similarly, the width of the cavity 112 is slightly greater than or equal to the maximum width Ws of the syringe 80, and the depth is slightly greater than or equal to the maximum depth Ds of the syringe 80. In some embodiments, the chamber floor plate 126 that is at least partially open forms a lip 128 and a bottom surface 130 (e.g., Figure 5B (As shown).

[0052] like Figure 4 As shown, the vascular access device 90 is positioned within the cavity 116 of the first chamber 112. As shown in this embodiment, there are two first chambers 112, each having a vascular access device 90 positioned therein.

[0053] like Figure 5A As shown, a first removable strip 140 is positioned on the top surface 104 to completely cover and seal the first chamber 112 and the second chamber 114 with an airtight section. In some embodiments, the first removable strip 140 has a peelable pull tab 142. Figure 5B As shown, since the second chamber 114 has at least a partially open chamber bottom plate 126, the cavity 122 of the second chamber 114 remains exposed even after the first removable strip 140 is applied to the top surface 104 of the packaging body 102, so as to sterilize the contents of the second chamber 114 without affecting the contents of the first chamber 112.

[0054] like Figure 6 and Figure 7 As shown, syringe 80 can be placed within cavity 122 of second chamber 114. The bottom surface 130 of second chamber 114 can then be covered by second removable strip 150.

[0055] In some embodiments, one or more of the first removable strip 140 and the second removable strip 150 include a breathable section attached to a separate impermeable section, which allows sterilization using steam, heat, nitrogen dioxide, or a combination thereof through the breathable section. During sterilization, the breathable section in some embodiments may be sealed or removed, thereby creating an impermeable chamber. In some embodiments, the outer periphery of one or more of the first removable strip 140 and the second removable strip 150 is a breathable section, and the inner region surrounded by the outer periphery is an impermeable section. In some embodiments, the entire first removable strip 140 is impermeable. In some embodiments, the entire first removable strip 140 is breathable. In some embodiments, the entire second removable strip 150 is impermeable. In some embodiments, the entire second removable strip 150 is breathable. In some embodiments, as Figure 5A As best shown, only the area directly above the first chamber 112 and the second chamber 114 is either airtight or airtight. Specifically, the surface area 141 of the first removable strip 140 directly above the first chamber 112 and / or the surface area 143 of the first removable strip 140 is either airtight or airtight. The choice of airtight or airtight area or strip depends on the contents of the first chamber 112 or the second chamber 114. Airtight sections can be placed anywhere on the packaging where sterilization can be achieved.

[0056] By completely sealing the first chamber 112 with the first removable strip 140 and then completely sealing the second chamber 114 with the second removable strip 150, the packaging container 100 separates the packaging of the first article from that of the second article without exposing the second article to the sterilization procedure or method of sealing the first chamber 112 with the first removable strip 140. For example, rinsing syringes, medical devices with rubber stoppers, or vials containing medications may be adversely affected by certain chemicals or sterilization methods (such as ETO sterilization). These sensitive medical devices can be sterilized by placing only them in the first chamber 112. The first chamber 112 can then be sealed with the first removable strip 140, and other medical devices that are not sensitive to certain chemicals or sterilization methods (such as ETO sterilization) can be placed in the second chamber 114, sterilized, and then sealed with the second removable strip 150. Therefore, the kit can be created using fewer steps than conventional methods, such as those described above. The benefits described herein can be applied to one or more embodiments of this disclosure, including method 200, which is discussed in detail below.

[0057] Another aspect of this disclosure relates to a method 200 for packaging a medical device, the method comprising: positioning a first medical device in a first cavity of a packaging body; sterilizing the first medical device and the first cavity using a first sterilization process; sealing the first cavity by positioning a first removable strip on a top surface of the packaging body; positioning a second medical device in a second cavity of the packaging body; and sealing the second cavity by positioning a second removable strip on a floor plate at least partially open in the second cavity.

[0058] In one or more embodiments, the method includes only one sterilization process. In one or more embodiments, the method includes sterilizing a first medical device and a first cavity using a first sterilization process. In one or more embodiments, the method further includes sterilizing a second medical device and a second cavity using a second sterilization process. In one or more embodiments, the first sterilization process and the second sterilization process are identical. In one or more embodiments, the first sterilization process and the second sterilization process are different. In one or more embodiments, the first sterilization process uses non-toxic sterilization methods and chemicals that will not adversely affect sensitive medical devices, such as steam or ultraviolet light. Therefore, in one or more embodiments, the first sterilization process utilizes sterilization methods and chemicals that do not include ETO sterilization. In one or more embodiments, the second sterilization process uses ETO sterilization.

[0059] Figure 8A flowchart illustrating an exemplary method of packaging a medical device is shown, the method including the steps of positioning a first device or article in a first chamber 112 and sterilizing the first device and the first chamber 112. These steps further include sealing the first chamber 112 and the second chamber 114 by positioning a first removable strip 140 on the top surface 104 of the packaging body 102. These steps further include positioning a second medical device in the second chamber 114, sterilizing the second medical device and the second chamber 114, and sealing the second medical device and the second chamber 114 by positioning a second removable strip 150 on the bottom surface 130 of the second chamber 114.

[0060] In the described methods, in some embodiments, the first medical device or article is a conventional vascular access device 90 and the second medical device or article is a syringe 80. In some embodiments, the sterilization practice of the first chamber 112 differs from that of the second chamber 114. In some embodiments, the first chamber 112 is sealed but not sterilized by positioning a first removable strip 140 on the top surface 104 of the packaging body 102. In some embodiments, the second chamber 114 is sealed but not sterilized by positioning a second removable strip 150 on the bottom surface 130 of the second chamber 114.

[0061] In some embodiments, the method further includes sterilizing the first chamber 112 with steam in an autoclave. In one or more embodiments, sterilization may also be performed by heat, nitrogen dioxide, or a combination thereof. After sterilization, a first removable strip 140 is applied to the top surface 104 of the packaging body 102. After the application of the first removable strip 140, and because the syringe is not yet positioned within the second chamber 114, the entire packaging 100 can undergo subsequent EtO sterilization without adversely affecting the syringe. The syringe is positioned within the second chamber 114 and a second removable strip 150 is applied to completely encapsulate the syringe. In some embodiments, both the first removable strip 140 and the second removable strip 150 are airtight, allowing the entire packaging 100 to undergo EtO sterilization without adversely affecting the syringe.

[0062] In some embodiments, the peeling pull tab 142 is used to allow a technician to use it when opening the package to release an item disposed in a first or second chamber.

[0063] In some embodiments, the first removable strip 140 and the second removable strip 150 are plastic films, such as flexible thermoformable plastics, including but not limited to nylon-based films having polyethylene and ethylene-vinyl acetate copolymer (EVA). The first removable strip 140 and the second removable strip 150 may include... Alternatively, other medical-grade materials, such as paper or flexible film, may be used. The flexible web backing material is permeable to radiation and gases but impermeable to microorganisms. Therefore, the packaging according to one or more embodiments can be sterilized.

[0064] In some embodiments, the items contained within the chamber (i.e., the syringe 80 and vascular access device 90 of this embodiment) can be squeezed out of the packaging with one hand, thereby penetrating the first removable band 140 and the second removable band 150. In some embodiments, the holding force of the first removable band 140 and the second removable band 150 will vary depending on the type of item contained in the chamber. Larger or heavier syringes may require a higher / greater holding force compared to smaller or lighter syringes.

[0065] In some embodiments, the first removable strip 140 is peelable. In some embodiments, the second removable strip 150 is ultrasonically welded or thermally welded. In some embodiments, the material of the second removable strip 150 is the same as that of the first removable strip 140. In some embodiments, the second removable strip 150 is a semi-permeable membrane. In some embodiments, the second removable strip 150 is non-peelable.

[0066] It should be understood that the size and location of the breathable membrane or segment are not limited to any particular construction and the location and size can be selected to meet the specific requirements of the end user. Furthermore, it should be understood that the size and location of the first and second chambers are not limited to any particular construction and can vary depending on the items stored therein. Additionally, the location and size of the breathable membrane can be selected to optimize the sterilization process. In the figures, the first removable strip 140 and the second removable strip 150 are depicted as a single breathable membrane having a generally rectangular shape. However, it should be recognized that the invention is not limited to any particular number, shape, or size of the first removable strip 140 and the second removable strip 150; the first removable strip 140 and the second removable strip 150 may comprise multiple breathable membranes of different shapes and sizes.

[0067] In one or more embodiments, the type of packaging 100 may be a blister pack, a flow wrap, or a sealed bag with three or four sides.

[0068] In one or more embodiments, the present invention can be applied to packaging equipment for blister packaging or flow wrapping for automated manufacturing.

[0069] In one or more embodiments, the material used for the first removable strip 140 and the second removable strip 150, or the sections of the first removable strip 140 and the second removable strip 150, may be paper or Tyvek, which can withstand autoclaving.

[0070] According to one aspect of the invention, before the package 100 is sealed, a desiccant, an antioxidant, an oxygen scavenger, an oxygen barrier, or a combination thereof may be added to one or more of the first or second chamber.

[0071] In one or more embodiments, the first chamber 112 and the second chamber 114 can be closed and sealed by applying heat seals, mechanical joints, adhesive joints, etc. Furthermore, those skilled in the art will understand that the invention is not limited to the position of the strip and the specific configurations shown and described herein. The seal can be configured and positioned in many different ways, as long as the strip provides the function of closing the chambers.

[0072] According to another embodiment, the present invention can be practiced using an automated high-speed blister packing system. Blister packs can be made by thermoforming or cold forming. In the case of thermoforming, a plastic film or sheet is unrolled from a spool and guided through a preheating station on the blister production line. The temperature of the preheating plate softens the plastic and makes it flexible. The warm plastic then reaches a forming station, where high pressure forces the blister cavity to form in a mold. Cooling the mold causes the plastic to harden again and retain its shape when removed from the mold.

[0073] In cold forming, the aluminum-based pressure film is simply pressed into a mold by a stamping device. The aluminum elongates and retains the formed shape. The use of aluminum provides a complete barrier against water and oxygen.

[0074] The thermoformable backing of medical blister packs is typically composed of a flexible, thermoformable plastic film. The film is usually multi-layered. The main component is typically a single layer of approximately 15-30% nylon, while the remaining layers may contain materials including, but not limited to, polyethylene. The sealant layer may contain materials such as ethylene-vinyl acetate copolymer (EVA).

[0075] In one or more embodiments, the sealing film of the medical blister pack may be made of an airtight material. In another embodiment, the sealing film of the medical blister pack may be made of plastic, aluminum, or medical paper, materials that are permeable to gases used for sterilization but impermeable to microorganisms. Most commonly, Used as a sealing material for medical blister packs.

[0076] Blister packs can be sealed in various ways, including but not limited to heat sealing and cold sealing. A heat-sealing coating can be applied to the cap material; then, heat is used to activate the coating to seal the cap to the backing. Blister packs can also be sealed using a cold sealing process that uses a combination of pressure-sensitive folding blister packs and clear blister packs; the blister pack is constrained between two packs that are bonded together under pressure without the use of any heat. Furthermore, blister packs can be sealed by appropriately oriented multilayer films to form a seal.

[0077] In one or more embodiments, the blister pack, comprising a breathable manifold section and an impermeable section, is steam-sterilized in an autoclave. In one or more embodiments, sterilization may also be performed by heat, nitrogen dioxide, or a combination thereof. After sterilization, the breathable section of the backing is cut and removed from the impermeable section by cutting along a separation line to create an impermeable bag. An impermeable capping material is sealed to the backing, thereby forming an impermeable blister pack. Because medical devices (e.g., pre-filled syringes, plastic ampoules, vials with rubber stoppers, intravenous solution packs, intravenous solution bags, etc.) are fully encapsulated in a bag consisting only of an impermeable membrane, the bag containing the pre-filled syringe can be placed in a kit that will undergo subsequent EtO sterilization without adversely affecting the pre-filled syringe.

[0078] Blister packs are commonly used as unit-dose packaging for tablets, capsules, or lozenges. The pharmaceutical product and its blister pack together form a single unit. The blister pack protects the pharmaceutical product from external influences that could render it ineffective, while allowing pharmaceutical manufacturers to package it using a form-fill-seal apparatus. The form-fill-seal process involves manufacturing the blister pack from a roll of flat sheet or film, filling it with the pharmaceutical product (e.g., a tablet), and closing (sealing). This type of blister pack is sometimes called a pressure-puncture pack because consumers can push the product (e.g., a tablet) through the backing. For pharmaceutical blister packs, manufacturers must pay attention to the moisture permeability of the blister pack, as many pharmaceutical products degrade and lose their efficacy through hydrolysis. Furthermore, the blister pack must provide an oxygen barrier to prevent the pharmaceutical product from degrading due to oxidation. In one or more embodiments, the blister pack is a pressure-puncture pack.

[0079] Blister packs can be made by thermoforming or cold forming. In the case of thermoforming, a plastic film or sheet is unrolled from a spool and guided through a preheating station on the blister production line. The temperature of the preheating plate softens the plastic and makes it flexible. The warm plastic then reaches the forming station, where high pressure shapes the blister cavity into a mold. Cooling the mold hardens the plastic again and allows it to retain its shape when removed from the mold.

[0080] In cold forming, the aluminum-based blister pack is simply pressed into a mold using a stamping device. The aluminum elongates and retains its formed shape. The use of aluminum provides a complete barrier against water and oxygen. However, cold-formed blister packs require a longer production time compared to thermoforming. Cold-formed blister packs are also opaque, which can lead to consumers not adhering to medication regimens.

[0081] The thermoformable backing of medical blister packs is typically composed of a flexible, thermoformable plastic film. The film is usually multi-layered. The main component is typically a single layer of approximately 15-30% nylon, while the remaining layers may contain materials including, but not limited to, polyethylene. The sealant layer may contain materials such as ethylene-vinyl acetate copolymer (EVA).

[0082] Blister packaging may also include skin packs, in which cardboard or other backing material and the product are covered with a sheet of clear plastic. The backing typically has a heat-sealable coating. The plastic film is heated and softened, then applied to the product on the backing. Sometimes vacuum is used to aid in a tight fit. After blister formation, the blister is immediately transported to a vacuum sealing station, where a vacuum is drawn, and the blister is sealed shut, thus providing a tight fit. The plastic film is bonded to the heat-sealable coating on the cardboard or other backing. In one or more embodiments, the blister pack is a vacuum-sealed thermoformed blister pack.

[0083] Although the invention has been described herein with reference to specific embodiments, it should be understood that these embodiments are merely illustrative of the principles and applications of the invention. Therefore, it should be understood that various modifications can be made to the illustrative embodiments and other arrangements can be designed without departing from the spirit and scope of the disclosed invention.

Claims

1. A packaging container, the packaging container comprising: The packaging body has an open top surface and a bottom surface. A first chamber, which protrudes from the bottom surface of the packaging body and has side walls and a closed chamber floor, A first cavity, the first cavity including the open top surface of the packaging body, the side wall of the first chamber and the closed bottom plate of the first chamber; The second chamber protrudes from the bottom surface of the packaging body and has side walls, a chamber floor that is at least partially open, and the top surface of the packaging body that is open. The second cavity includes the sidewall of the second chamber and the at least partially open chamber floor. A first removable strip is disposed on the open top surface of the packaging body; and, A second removable strip is disposed on the at least partially open chamber floor. The first removable strip is non-breathable, while the second removable strip is breathable.

2. The packaging container according to claim 1, wherein, The first device is positioned within the first cavity.

3. The packaging container according to claim 1, wherein, The second device is positioned within the second cavity.

4. The packaging container according to claim 1, wherein, The first removable strip has a peel-off tab.

5. The packaging container according to claim 1, wherein, The first removable strip can be peeled off.

6. The packaging container according to claim 1, wherein, The second removable strip can be removed by cutting along the separation line.

7. The packaging container according to claim 1, wherein, The length of the first cavity is slightly greater than or equal to the total length of the first device, the width is slightly greater than or equal to the maximum width of the first device, and the depth is slightly greater than or equal to the maximum depth of the first device.

8. The packaging container according to claim 1, wherein, The length of the second cavity is slightly greater than or equal to the total length of the second device, the width is slightly greater than or equal to the maximum width of the second device, and the depth is slightly greater than or equal to the maximum depth of the second device.

9. A method for packaging a medical device, the method comprising the following steps: Provide a packaging container according to any one of claims 1 to 8; Position the first medical device within the first cavity of the packaging body of the packaging container; The first medical device is sterilized using the first sterilization process; The first cavity is sealed by positioning a first removable strip on the open top surface of the packaging body; Position the second medical device within the second cavity of the packaging body; and The second cavity is sealed by positioning a second removable strip on at least a partially open chamber floor of the second chamber.

10. The method of claim 9, further comprising sterilizing the second medical device and the second cavity using a second sterilization process.

11. The method according to claim 10, wherein, The first sterilization process is different from the second sterilization process.

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