Multi-sterilization chamber pack

Abstract

A multi-chamber package is disclosed, including first and second chambers, 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 disposed on the top surface of the package and completely covers the first and second chambers, and a second seal is disposed on the bottom surface of the partially open floor of the second chamber and completely seals the second chamber. Methods of packaging medical devices are also described.

Description

[Technical Field]

[0001] The present invention relates to a multi-chamber package, and more specifically, to a multi-chamber package requiring different sterilization processes. [Background technology]

[0002] Clean and sterile products, especially those useful for medical purposes, are packaged to maintain their sterility. The packaging of these items is intended to act as a barrier, preventing microorganisms from entering the packaging and contaminating the contents. In most cases, the packaging, such as that containing syringes, is opened immediately before use to minimize the time the item is exposed to a non-sterile state.

[0003] In the medical industry, packaged items often need to be sterilized during the packaging process, and different sterilization methods can be used for different items. Traditionally, sterilized items are packaged separately from non-sterilized items. Furthermore, traditional packaging involves packaging both together in a single enclosed package. Alternatively, sterilized items are placed in individual packages, which are then placed in non-sterilized kit packaging. These configurations and methods generate more packaging waste and require more steps to unpack the kits.

[0004] Many medical procedures require multiple components, including drugs and medical devices, which must be assembled by the clinician before the procedure begins. Assembling these components before a procedure is known as "kitting," and many hospitals and independent companies offer this service by assembling these components and preparing them for use in medical procedures. Often, these components, including drugs and medical devices, require different sterilization processes.

[0005] For example, drugs or other injectable / injectable solutions packaged in gas-permeable containers such as plastic ampoules, drug vials with rubber stoppers, IV solution bags, IV solution pouches, and pre-filled flush syringes are commonly used in medical procedures and may be included in procedure kits. Often, plastic ampoules, drug vials with rubber stoppers, IV solution bags, IV solution pouches, and pre-filled syringes contain saline and other aqueous solutions. Ethylene oxide (EtO) sterilization is a common method used to prepare kits for use in the sterilization field. Currently, pre-filled saline syringes, plastic ampoules, drug vials with rubber stoppers, IV solution bags, and IV solution pouches are packaged in gas-permeable packaging that is also permeable to EtO gas, which is commonly used for sterilizing medical devices. However, exposure of plastic ampoules, drug vials with rubber stoppers, IV solution bags, IV solution pouches, or pre-filled syringes to ethylene oxide (EtO) gas results in the undesirable effect of increasing the pH of the contents of the plastic ampoules, drug vials with rubber stoppers, IV solution bags, IV solution pouches, or pre-filled syringes (e.g., saline). To overcome this undesirable effect, plastic ampoules, drug vials with rubber stoppers, IV solution bags, IV solution pouches, or plastic pre-filled saline syringes are initially omitted from the medical procedure kit until the other contents of the kit have been treated with ethylene oxide (EtO) gas. In some medical procedures, it is important to have sterile, field-ready plastic ampoules, drug vials with rubber stoppers, IV solution bags, IV solution pouches, and / or pre-filled flush syringes that can also be sterilized after kit assembly. Therefore, packaging is needed that can accommodate products requiring different sterilization methods, such as pre-filled flush syringes, plastic ampoules, drug vials with rubber stoppers, IV solution bags, and IV solution pouches that can withstand EtO sterilization.

[0006] Traditional packaging consumes a considerable amount of material because kits of multiple items may require multiple packages. This extra packaging material increases the cost of each syringe product. Furthermore, the additional packaging must be discarded once opened, increasing the amount of waste generated in hospitals and other healthcare settings. [Overview of the project] [Problems that the invention aims to solve]

[0007] There is a growing need for kit packs containing products requiring different sterilization methods for both sterile and non-sterile items. Therefore, packaging is needed that can accommodate products requiring different sterilization methods for both sterile and non-sterile items. [Means for solving the problem]

[0008] Aspects of the present invention relate to packaging for containing medical products, including devices, pre-filled syringes, or drugs. One aspect of the present disclosure relates to a packaging container having a packaging body including a top and bottom surface, a first chamber protruding from the bottom surface of the body having side walls and a closed chamber floor, a first cavity including the top surface of the body, the side walls of the first chamber, and the closed chamber floor of the first chamber, and a second chamber protruding from the bottom surface of the body having side walls and at least a partially open chamber floor, and the top surface of the body. The second cavity comprises the side walls of the second chamber and at least a partially open chamber floor. A first removable webbing is positioned on the top surface of the body, and a second removable webbing is positioned on at least a partially open chamber floor.

[0009] In one or more embodiments, the first device is located in the first cavity, and the second device is located in the second cavity.

[0010] In one or more embodiments, the first removable webbing has a peel tab.

[0011] In one or more embodiments, the first removable webbing is peelable.

[0012] In one or more embodiments, the second removable webbing is not peelable.

[0013] In one or more embodiments, the cavity of the first chamber has a length slightly greater than or equal to the total length of the first device, a width slightly greater than or equal to the maximum width of the first device, and a depth slightly greater than or equal to the maximum depth of the first device.

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

[0015] Another aspect of the present disclosure relates to a method for packaging a medical device, comprising: placing a first medical device in a first cavity of a packaging body; sterilizing the first medical device and the first cavity in a first sterilization process; sealing the first cavity by placing a first removable webbing on the top surface of the packaging body; placing a second medical device in a second cavity of the packaging body; and sealing the second cavity by placing a second removable webbing on at least a partially open chamber floor of the second cavity.

[0016] In one or more embodiments, the method further includes sterilizing the second medical device and the second cavity in 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 is different from the second sterilization process. [Brief explanation of the drawing]

[0017] [Figure 1] A perspective view of a packaging container according to one embodiment of the present disclosure is shown. [Figure 2A]Shows a perspective view of a conventional syringe according to one or more embodiments of the present disclosure. [Figure 2B] Illustrates a front view of a conventional vascular access device according to one or more embodiments of the present disclosure. [Figure 2C] Illustrates a side view of a conventional vascular access device according to one or more embodiments of the present disclosure. [Figure 3] Shows a top perspective view of a packaging container according to an embodiment of the present disclosure. [Figure 4] Shows a top perspective view of a packaging container according to an embodiment of the present disclosure. [Figure 5A] Shows a top perspective view of a packaging container according to an embodiment of the present disclosure. [Figure 5B] Shows a bottom perspective view of a packaging container according to an embodiment of the present disclosure. [Figure 6] Shows a bottom perspective view of a packaging container according to an embodiment of the present disclosure. [Figure 7] Shows a bottom perspective view of a packaging container according to an embodiment of the present disclosure. [Figure 8] Shows a flowchart of a method for packaging one or more device containers according to an embodiment of the present disclosure.

Best Mode for Carrying Out the Invention

[0018] Before describing some exemplary embodiments of the present invention, it is to be understood that the present invention is not limited to the detailed description of the structures or method steps described in the following description. The present invention can have other embodiments and can be implemented or executed in various ways.

[0019] Regarding the terms used in the present disclosure, the following definitions are provided.

[0020] As used herein, the term “packaging” or “to package” includes any material used to package or protect medical devices or products such as plastic ampoules, medicine bottles with rubber stoppers, IV solution bags, IV solution pouches, and syringes. Packaging may be rigid or flexible. Packaging includes, but is not limited to, medical packaging, pharmaceutical packaging, and child-resistant packaging. Packaging for medical products and pharmaceuticals may include plastic trays with webbing, blister packs, flow wraps, and three- or four-sided pouches.

[0021] As used herein, the terms “blister packaging” or “blister pack” include several types of pre-formed packaging used for consumer goods, pharmaceuticals, medical devices, and the like. The main component of a blister pack is a cavity or pocket made of a moldable web, which is usually thermoformable plastic. The moldable web may be rigid or flexible. The cavity or pocket is large enough to hold the goods contained in the blister packaging. Depending on the application, a blister pack may have a thermoformable material backing and a lid seal made of aluminum foil, paper, Tyvek®, plastic, or other medical material. Blister packaging can provide a barrier protection from microorganisms and other contaminants and can be given some degree of tamper resistance. Blister packs protect pharmaceuticals from external influences that would render them unusable while enabling pharmaceutical manufacturers to package pharmaceuticals using bag-filling equipment. The form-fill sealing process involves creating a blister pack from a flat sheet or roll of film and filling it with medical devices or pharmaceuticals.

[0022] The lid film of medical blister packs can be made of materials such as plastic, aluminum, or medical paper, which are permeable to sterilization gases but not to microorganisms. Tyvek® is the most commonly used lid material for medical blister packs.

[0023] Blister packs can be sealed in a variety of ways, including but not limited to heat sealing and cold sealing. A heat-seal coating can be applied to the lid material, and the lid material can be sealed to the backing material while the coating is activated by heat. Blister packs can also be sealed using a cold-seal method that utilizes a combination of a pressure-sensitive fold-over blister card and a transparent blister. The blister is enclosed between two pressure-sealed plates without the application of heat. Furthermore, blister packs can be sealed by aligning the orientation of multiple layers of film.

[0024] Tyvek® is a synthetic material made of flash-spun high-density polyethylene fibers (i.e., spun-bonded olefin fibers). This material is lightweight, strong, and tear-resistant, yet can be cut with scissors or a knife. Tyvek® is highly breathable, allowing gases such as water vapor to pass through, but is impermeable to liquid water and microorganisms.

[0025] The term "syringe" also includes syringes intended for use with needles, nozzles, and tubing, or for use in cleaning devices, etc. In this specification, the term "syringe" refers to a simple pump-like device consisting of a plunger rod that fits securely into a barrel or tube. The plunger rod can be pulled or pushed along the inside of the barrel to draw in or expel liquids or gases through an opening at the open end of the barrel. Needles, nozzles, tubing, etc., can be attached to the open end of the syringe to control the inflow and outflow of fluid into the barrel. Syringes may be sterile or non-sterile, depending on the needs of the technician.

[0026] As used herein, the term “sterilization” refers to a wide variety of techniques used to reduce, kill, or eliminate harmful or infectious agents. Examples of sterilization procedures include, for example, steam sterilization, ethylene oxide sterilization, gas plasma sterilization, ozone sterilization, hydrogen peroxide sterilization, heat sterilization, nitrogen dioxide sterilization, or combinations thereof.

[0027] As used herein, the term “gas permeable” is intended to mean a material that allows gases to pass through but does not allow airborne microorganisms, bacteria, viruses, and mixtures thereof to pass through.

[0028] As used herein, "gas-impermeable" is intended to mean a material that does not readily allow gases to pass through. In addition, gas-impermeable materials also do not allow airborne microorganisms, bacteria, viruses, and mixtures thereof to pass through the material.

[0029] As used herein, the term “microorganism” refers to a microorganism or organism that is single-celled or lives in a colony of a cellular organism. Microorganisms are very diverse and include, but are not limited to, bacteria, fungi, archaea, and protists.

[0030] During manufacturing, pre-filled medical devices are placed in a gas-impermeable section or chamber of the packaging and sterilized by a non-toxic or hazardous sterilization process, such as steam sterilization in an autoclave. The sterilized gas-impermeable section or chamber of the packaging is then completely sealed. In one or more embodiments, sterilization may also be by heating, nitrogen dioxide, or a combination thereof. Because the pre-filled medical devices are completely sealed in a pouch consisting solely of gas-impermeable film, the pouch containing the pre-filled medical devices may be placed in a kit to undergo subsequent EtO sterilization without adversely affecting the pre-filled medical devices. Therefore, excess steps and materials are used to form the kit.

[0031] A first aspect of the present invention relates to a packaging container having two or more chambers, each of which has articles placed within the two or more chambers. A first removable seal is positioned over the upper opening of the two or more chambers to completely seal the first chamber of the two or more chambers, and a second seal is positioned over the lower opening of the second chamber of the two or more chambers to seal the second chamber. A second aspect of the present invention relates to a method for packaging two or more articles, the method comprising the steps of: placing a first article in a first chamber, placing a first removable seal over the upper opening of the two or more chambers to seal the first chamber; placing a second article in a second chamber, and placing a second removable seal over the bottom opening of the second chamber to seal the second chamber.

[0032] Figure 1 shows a packaging container 100 according to one or more embodiments of the present disclosure. For illustrative purposes, the packaging container 100 is shown as translucent. The packaging container 100 comprises a packaging body 102 having a top surface 104 and a bottom surface 106 defining its 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. A packaged article is placed in the cavity of each of the one or more chambers 110.

[0033] In some embodiments, the packaging container 100 is blister packaging. 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 a practitioner to see the contents of 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, contents inside, or warning labels.

[0034] Figures 2A and 2B show conventional medical devices, which are articles placed in a packaging container 100 in one or more embodiments. The conventional medical devices described are not intended to be illustrative, as the articles placed in the packaging container 100 may be any device. The conventional medical devices described occupy volumes defined in the XYZ planes. 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 utilizing blister packaging, the volumes of the two or more chambers 110 conform to the shape of the article. The volume of each of the two or more chambers 110 may be any suitable shape. In some embodiments, the shape of the two or more chambers 110 is trapezoidal, triangular, elliptical, or rectangular.

[0035] Figure 2A shows a conventional syringe 80. The syringe 80 comprises 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 with a distally positioned stopper 85 is at least partially located within the barrel 81. In some embodiments, the syringe 80 is a pre-filled flush 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. As shown in Figure 2A, the syringe 80 includes all its components and has a total length Ls in the Z plane and a maximum width Ws in the X plane, the maximum width Ws being measured at the widest part of the syringe 80 and traversing 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 open proximal end 83. In this embodiment, the flange is substantially cylindrical and has a constant maximum width Ws defined by the diameter of the flange at the open proximal end 83. In some embodiments, the open proximal end 83 includes two tabs, and therefore the syringe 80 has a maximum width Ws and a depth in the Y plane.

[0036] Figures 2B and 2C show a conventional vascular access device 90. The vascular access device 90 includes a hub 91 that houses a needle 92. In some embodiments, the vascular access device 90 further includes a needle cap 93 and a hinged safety cover 94. As shown in Figures 2B and 2C, the vascular access device 90 includes all components of the vascular access device 90 and has a total length L in the Z plane VAD , a maximum width W in the X plane VAD , the total length L VAD measured at the widest part of the vascular access device 90 that traverses the total length L VAD , and a maximum depth D VAD , the total length L VAD measured at the widest part of the vascular access device 90 that traverses the total length L VAD .

[0037] In this embodiment, the total length L VAD extends from the hub 91 to the hinged safety cover 94. The maximum width W VAD is defined by the width of the hinged safety cover 94. The maximum depth D VAD is defined by the distance from the hub 91 to the hinged safety cover 94.

[0038] Figure 3 shows a packaging container that includes a packaging body 102 having a top surface 104 and a bottom surface (not shown) that define a thickness. Two or more chambers 110 extend from the bottom surface. The two or more chambers are sized and shaped to accommodate a single article, multiple articles, or multiple articles as a kit or assembly. In this embodiment, as shown in Figure 3, the first chamber 112 of the two or more chambers is sized to hold the vascular access device 90 (Figure 2B), and the second chamber 114 is sized to hold the syringe 80 (Figure 2A). In one or more embodiments, there are two first chambers 112 for holding two vascular access devices 90.

[0039] The first chamber 112 has a cavity 116 defined by a side wall 118 and a closed chamber bed 120. The cavity 112 has a rectangular shape and is configured to hold the vascular access device 90. To accommodate the vascular access device 90, the cavity 116 has a length L of the vascular access device 90. VAD It is slightly larger or has the same length. Similarly, the cavity 116 is the maximum width W of the vascular access device 90. VAD A width that is slightly larger or equal to the width, and the maximum depth D of the vascular access device 90 VAD Having a depth that is slightly greater or equal to it.

[0040] The second chamber 114 has a cavity 122 defined by a side wall 124 and at least a partially open chamber floor 126. The cavity 122 has a rectangular shape and is configured to hold the syringe 80. To accommodate the syringe 80, the cavity 122 has a length slightly greater than or equal to the total length Ls of the syringe 80. Similarly, the cavity 112 has a width slightly greater than or equal to the maximum width Ws of the syringe 80 and a depth slightly greater than or equal to the maximum depth Ds of the syringe 80. In some embodiments, the at least partially open chamber floor 126 forms a lip 128 and a bottom surface 130 (as shown in Figure 5B).

[0041] As shown in Figure 4, the vascular access device 90 is located 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 located inside.

[0042] As shown in Figure 5A, the first removable webbing 140 is positioned on the top surface 104 and completely covers the first chamber 112 and the second chamber 114, sealing them within the gas-impermeable section. In some embodiments, the first removable webbing 140 has a peel tab 142. Since the second chamber 114 has at least a partially open chamber floor 126, the cavity 122 of the second chamber 114 is exposed even after the first removable webbing 140 has been applied to the top surface 104 of the packaging body 102, in order to sterilize the contents of the second chamber 114 without affecting the contents of the first chamber 112.

[0043] As shown in Figures 6 and 7, the syringe 80 can be placed in the cavity 122 of the second chamber 114. The bottom surface 130 of the second chamber 114 can then be covered by a second removable webbing 150.

[0044] In some embodiments, one or more of the first removable webbing 140 and the second removable webbing 150 include a gas-permeable section attached to a separate gas-impermeable section, which allows sterilization using steam, heating, nitrogen dioxide, or a combination thereof via the gas-permeable section. Once sterilized, the gas-permeable section of some embodiments can be sealed or removed to create a gas-impermeable chamber. In some embodiments, the outer periphery of one or more of the first removable webbing 140 and the second removable webbing 150 is a gas-permeable section, and the inner region surrounded by the periphery is a gas-impermeable section. In some embodiments, the entire first removable webbing 140 is gas-impermeable. In some embodiments, the entire first removable webbing 140 is gas-permeable. In some embodiments, the entire second removable webbing 150 is gas-impermeable. In some embodiments, the entire second removable webbing 150 is gas-permeable. In some embodiments, as best shown in Figure 5A, only the areas directly above the first chamber 112 and the second chamber 114 are gas-impermeable or gas-permeable. Specifically, the surface area 141 of the first removable webbing 140 directly above the first chamber 112, and / or the surface area 143 of the first removable webbing 140 are gas-impermeable or gas-permeable. The choice of gas-impermeable or gas-permeable areas or webbing depends on the contents in the first chamber 112 or the second chamber 114. The gas-permeable section can be placed anywhere on the packaging to allow the sterilization method to be performed.

[0045] By having a first chamber 112 completely sealed by a first removable webbing 140, followed by a second chamber 114 completely sealed by a second removable webbing 150, the packaging container 100 allows the packaging of the first article separated from the packaging of the second article without exposing the second article to a sterilization procedure or method that seals the first chamber 112 with the first removable webbing 140. For example, medical devices having a flush syringe, a rubber stopper containing a medical fluid, or a vial can be adversely affected by certain chemicals or sterilization methods such as ETO sterilization. These sensitive medical devices can be sterilized by placing them only in the first chamber 112. The first chamber 112 can then be sealed by the first removable webbing 140, and other medical devices that are not sensitive to certain chemicals or sterilization methods such as ETO sterilization can then be placed in the second chamber 114, sterilized, and then sealed by the second removable webbing 150. Therefore, the kit is prepared using fewer steps than the conventional methods described above. The aforementioned benefits can be applied to one or more embodiments of this disclosure, including method 200, which will be discussed in detail below.

[0046] Another aspect of the present disclosure relates to a method 200 for packaging a medical device, comprising: placing a first medical device in a first cavity of a packaging body; sterilizing the first medical device and the first cavity in a first sterilization process; sealing the first cavity by placing a first removable webbing on the top surface of the packaging body; placing a second medical device in a second cavity of the packaging body; and sealing the second cavity by placing a second removable webbing on at least a partially open chamber floor of the second cavity.

[0047] In one or more embodiments, the method comprises only one sterilization process. In one or more embodiments, the method comprises sterilizing a first medical device and a first cavity in a first sterilization process. In one or more embodiments, the method further comprises sterilizing a second medical device and a second cavity in 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 is different from the second sterilization process. In one or more embodiments, the first sterilization process utilizes sterilization methods and chemicals that are non-toxic or do not adversely affect sensitive medical devices such as vapor or UV 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 utilizes ETO sterilization.

[0048] Figure 8 shows a flowchart of an exemplary method for packaging a medical device, the method comprising the steps of placing a first device or article in a first chamber 112 and sterilizing the first device and the first chamber 112. The step further includes sealing the first chamber 112 and the second chamber 114 by placing a first removable webbing 140 on the top surface 104 of the packaging body 102. The step further includes placing 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 placing a second removable webbing 150 on the bottom surface 130 of the second chamber 114.

[0049] In the described method, 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 procedure for the first chamber 112 is different from the sterilization procedure for the second chamber 114. In some embodiments, the first chamber 112 is sealed by placing a first removable webbing 140 on the top surface 104 of the packaging body 102, but is not sterilized. In some embodiments, the second chamber 114 is sealed by placing a second removable webbing 150 on the bottom surface 130 of the second chamber 114, but is not sterilized.

[0050] In some embodiments, the method further includes sterilizing the first chamber 112 using steam sterilization in an autoclave. In one or more embodiments, sterilization may also be by heating, nitrogen dioxide, or a combination thereof. After sterilization, the first removable webbing 140 is applied to the top surface 104 of the packaging body 102. After the application of the first removable webbing 140, and since the syringe is not yet placed in the second chamber 114, the entire packaging 100 can undergo subsequent EtO sterilization without adversely affecting the syringe. The syringe is then placed in the second chamber 114, and the second removable webbing 150 is applied to completely enclose the syringe. In some embodiments, both the first and second removable webbings 140 and 150 are gas impermeable, and the entire package 100 can undergo EtO sterilization without adversely affecting the syringe.

[0051] In some embodiments, the release tab 142 is intended to allow a technician to use it when opening the packaging to release an article located in the first or second chamber.

[0052] In some embodiments, the first removable webbing 140 and the second removable webbing 150 are plastic films, such as flexible thermoformable plastics, including but not limited to nylon-based films having polyethylene and ethyl vinyl acetate (EVA). The first removable webbing 140 and the second removable webbing 150 may also include Tyvek® or other medical-grade materials such as paper or flexible films. Flexible web backing materials are permeable to radiation and gases but not to microorganisms. Therefore, packaging according to one or more embodiments can be sterilized.

[0053] In some embodiments, the article placed in the chamber (i.e., the syringe 80 and the vascular access device 90 in this embodiment) can be squeezed out of its packaging with one hand, thereby penetrating the first removable webbing 140 and the second removable webbing 150. In some embodiments, the retaining force of the first removable webbing 140 and the second removable webbing 150 varies depending on the type of article contained in the chamber. A larger or heavier syringe may require a higher / greater retaining force than a smaller or lighter syringe.

[0054] In some embodiments, the first removable webbing 140 is peelable. In some embodiments, the second removable webbing 150 is ultrasonically welded or heat-welded. In some embodiments, the second removable webbing 150 is made of the same material as the first removable webbing 140. In some embodiments, the second removable webbing 150 is a semi-permeable film. In some embodiments, the second removable webbing 150 is not peelable.

[0055] It should be understood that the size and position of the gas permeable membrane or section are not limited to any particular configuration, and the position and size can be selected to meet the specific requirements of the end user. In addition, it should be understood that the size and position of the first and second chambers are not limited to any particular configuration and may vary depending on the articles stored inside. Furthermore, the position and size of the gas permeable membrane can be selected to optimize the sterilization process. In the figure, the first removable webbing 140 and the second removable webbing 150 are shown as having a single gas permeable membrane having a generally rectangular shape. However, it should be recognized that the present invention is not limited to any particular number, shape, or size of the first removable webbing 140 and the second removable webbing 150, and the first removable webbing 140 and the second removable webbing 150 may include multiple gas permeable membranes of various shapes and sizes.

[0056] In one or more embodiments, the type of packaging 100 may be a blister, a flow wrap, or a three- or four-sided sealed pouch.

[0057] In one or more embodiments, the present invention can be applied to either a blister packaging or flow wrap packaging apparatus for automated manufacturing.

[0058] In one or more embodiments, the material for the first removable webbing 140 and the second removable webbing 150, or for a portion of the first removable webbing 140 and the second removable webbing 150, may be paper or Tyvek that can withstand the autoclave process.

[0059] According to one aspect of the present invention, a desiccant, antioxidant, oxygen scavenger, oxygen barrier, or a combination thereof may be added to one or more of the first or second chambers before the packaging 100 is sealed.

[0060] In one or more embodiments, the closure and sealing of the first chamber 112 and the second chamber 114 can be achieved by the application of heat sealing, mechanical engagement, adhesive engagement, etc. In addition, those skilled in the art will understand that the present invention is not limited with respect to the position of the webbing and the specific configurations exemplified and described herein. The sealing can be configured and arranged in several different implementation forms, insofar as the webbing provides the function of sealing the chambers.

[0061] According to another embodiment, the present invention may be implemented in an automated high-speed blister packing system. The blister packs can be produced by thermoforming or cold forming. In the case of thermoforming, a plastic film or sheet is unwound from a reel and led to a preheating station on the blister line. The temperature of the preheating plate is such that the plastic softens and becomes pliable. The heated plastic is then transported to a molding station where it is molded under high pressure into a negative mold for the blister cavity. The mold is cooled so that the plastic hardens again and maintains its shape when removed from the mold.

[0062] In cold forming, a laminated film primarily composed of aluminum is simply pressed into a mold using a stamp. The aluminum stretches to maintain the formed shape. Using aluminum allows for complete isolation from water and oxygen.

[0063] The thermoformable backing material for medical blister packs is generally composed of a flexible thermoformable plastic film. The film is often multilayered. The main component is usually a layer of nylon, typically about 15-30%, with the remaining layers consisting of materials including polyethylene, but not limited to this. The sealant layer can, in particular, be made of ethyl vinyl acetate (EVA).

[0064] In one or more embodiments, the lid film of a medical blister pack can be made from a gas-impermeable material. The lid film of a medical blister pack can be made from a material that allows sterilization gases to pass through but not microorganisms, such as plastic, aluminum, or medical paper. Tyvek® is the most commonly used lid material for medical blister packs.

[0065] Blister packs can be sealed in a variety of ways, including but not limited to heat sealing and cold sealing. A heat-seal coating can be applied to the lid material, and the lid material can be sealed to the backing material while the coating is activated by heat. Blister packs can also be sealed using a cold-seal method that utilizes a combination of a pressure-sensitive fold-over blister card and a transparent blister. The blister is enclosed between two pressure-sealed plates without the application of heat. Furthermore, blister packs can be sealed by aligning the orientation of multiple layers of film.

[0066] In one or more embodiments, the blister pack, including a gas-permeable header section and a gas-impermeable section, is steam-sterilized in an autoclave. In one or more embodiments, sterilization may also be by heating, nitrogen dioxide, or a combination thereof. After sterilization, the gas-permeable section of the lining is cut and removed from the gas-impermeable section by cutting along the separation line to create a gas-impermeable pouch. A gas-impermeable lid is sealed to the lining to produce a gas-impermeable blister pack. Medical devices, such as pre-filled syringes, plastic ampoules, drug vials with rubber stoppers, IV solution bags, IV solution pouches, etc., are completely sealed in pouches made solely of gas-impermeable film, so that pouches containing pre-filled syringes can be placed in kits to undergo subsequent EtO sterilization without adversely affecting the pre-filled syringes.

[0067] Blister packs are commonly used as unit-dose packaging for pharmaceuticals such as tablets, capsules, and lozenges. The pharmaceutical product and its blister pack function as a single unit. The blister pack protects the pharmaceutical product from external influences that could render it unusable while allowing pharmaceutical manufacturers to package it using blister packing equipment. The blister packing process includes the steps of creating a blister pack from a flat sheet or roll of film, filling it with the pharmaceutical product (such as tablets), and closing (sealing) it. This type of blister pack is sometimes called a push-through pack because consumers can push the product (e.g., pharmaceutical tablets) out of the backing material. In pharmaceutical blister packs, attention must be paid to the water vapor permeability of the blister pack, as many pharmaceuticals degrade and lose their efficacy due to hydrolysis. Furthermore, oxygen barrier properties are required in the blister pack to prevent degradation of the pharmaceutical product due to oxidation. In one or more embodiments, the blister pack is a push-through pack.

[0068] Blister packs can be manufactured via thermoforming or cold forming. In thermoforming, a plastic film or sheet is unwound from a reel and led to a preheating station on the blister line. The temperature of the preheating plate is the temperature at which the plastic softens and becomes pliable. The heated plastic is then transported to a molding station, where it is molded under high pressure into a negative mold to form the blister cavity. The mold is then cooled so that the plastic hardens again and maintains its shape when removed from the mold.

[0069] In cold forming, a laminated film primarily composed of aluminum is simply pressed into a mold using a stamp. The aluminum stretches to maintain the formed shape. Using aluminum allows for complete sealing against water and oxygen. However, cold-formed blister packs take longer to produce than thermoformed ones. Also, because cold-formed blister packs are not transparent, consumers may not adhere to their medication instructions.

[0070] The thermoformable backing material for medical blister packs is generally composed of a flexible thermoformable plastic film. The film is often multilayered. The main component is usually a layer of nylon, typically about 15-30%, with the remaining layers consisting of materials including polyethylene, but not limited to this. The sealant layer can, in particular, be made of ethyl vinyl acetate (EVA).

[0071] Blister packaging also includes skin packs, in which a backing material such as cardboard and the product are covered with a thin sheet of clear plastic. The backing material is typically coated with a heat-seal coating. A plastic film is softened with heat and poured over the product attached to the backing material. Vacuum may be used to help ensure a tight fit. Immediately after forming the blister, the blister is transported to a vacuum sealing station, where it is vacuumed and sealed to provide a tight fit. The plastic film adheres to the heat-seal coating applied to the cardboard or backing material. In one or more embodiments, the blister pack is a vacuum-sealed thermoformed blister pack.

[0072] While the inventions described herein have been described 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 many modifications can be made to the exemplary embodiments, and other configurations can be devised without departing from the spirit and scope of the disclosed disclosure.

Claims

1. A packaging container, Packaging body including top and bottom, A first chamber protruding from the bottom surface of the packaging body having side walls and a closed chamber floor, The first cavity including the upper surface of the packaging body, the side wall of the first chamber, and the closed chamber floor of the first chamber; A second chamber protruding from the bottom surface of the packaging body, having side walls and at least partially open chamber floor, the top surface of the packaging body, A second cavity comprising the side wall of the second chamber and the at least partially open chamber floor; A first removable webbing positioned to cover the upper surface of the packaging body; and A second removable webbing positioned to cover the at least partially open chamber floor, Includes, A packaging container in which the first removable webbing is gas-impermeable and the second removable webbing is gas-permeable.

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

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

4. The packaging container according to claim 1, wherein the first removable webbing has a peel tab.

5. The packaging container according to claim 1, wherein the first removable webbing is peelable.

6. The packaging container according to claim 1, wherein the second removable webbing is removable by cutting along a cutting line.

7. The packaging container according to claim 2, wherein the first cavity has a length slightly greater than or equal to the total length of the first device, a width slightly greater than or equal to the maximum width of the first device, and a depth slightly greater than or equal to the maximum depth of the first device.

8. The packaging container according to claim 3, wherein the second cavity has a length slightly greater than or equal to the total length of the second device, a width slightly greater than or equal to the maximum width of the second device, and a depth slightly greater than or equal to the maximum depth of the second device.

9. A method for packaging a medical device, wherein the method is A step of placing a first medical device in a first cavity within a first chamber of a packaging body including its top and bottom surfaces, wherein the first chamber includes a closed chamber bed, A step of sterilizing the first medical device in the first cavity using a first sterilization process, The steps include sealing the first cavity by placing a first removable webbing over the upper surface of the packaging body, The steps include: placing the second medical device in the second cavity of the packaging body; A step of sterilizing the second medical device and the second cavity in a second sterilization process, The steps include sealing the second cavity by arranging a second removable webbing to cover at least a partially open chamber floor of the second chamber, Includes, The first removable webbing is positioned to cover the upper surface of the packaging body, The second removable webbing is positioned to cover the at least partially open chamber floor, and the first sterilization process is a method of packaging a medical device different from the second sterilization process.

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