JP2021094464A - Main container for at least one of storage and dosage of medical or pharmaceutical compound and method for assembling the main container - Google Patents

Abstract

To improve a main container with respect to its manufacturing, usage, and cost flexibility with a structure as simple as possible.SOLUTION: A main container (1) comprises a container (2), a sealing element (330) configured to fit into a barrel (4) of the container (2), and a needle extraction system (338). The container (2) includes a circumference flange part (10) radially extending at an opened second end. The needle extraction system (338) includes: a plunger bar element (340) having attachment means (342) at its end in an axial direction; and a cylindrical pipe part (350) extending coaxially with the plunger bar element (340). The cylindrical pipe part (350) includes a finger flange (352) extending radially outside. The finger flange (352) includes a protrusion (354) extending radially inside, the protrusion configured to slide along an outer surface of the container (2).SELECTED DRAWING: Figure 8

Description

The present disclosure relates to a main container for at least one of the storage and administration of medical or pharmaceutical compounds, and a method of assembling the main container.

According to prior art, main containers for at least one of the storage and administration of medical or pharmaceutical compounds are well known, and the main container is configured to contain and protect these compounds and directly with the compounds. It may come into contact with or may come into contact with it. According to WHO's "Guidelines for Containers for Pharmaceuticals" in the 2002 World Health Organization (WHO) Technical Report Series No. 902, the main containers are, for example, light, moisture, oxygen, biological contamination. Or, it is necessary to protect pharmaceuticals or medical products from all external adverse effects that affect their quality and efficacy, such as mechanical damage. In particular, such main containers must not physically or chemically interact with the medical or pharmaceutical compounds contained in them in any manner that alters their quality.

The main container for intended use usually includes a container configured to hold or contain and protect a medical or pharmaceutical compound, and a sealing device configured to cover or seal the compound. .. These containers and sealing devices are configured to be disposable or reusable. According to the WHO guidelines above, the main container needs to protect its contents from efflorescence, deliquescent and dissipation under normal conditions of foreign material, material loss, as well as handling, transportation and storage.

In use as a main container, some containers are well known in the art. Containers commonly used for storing medical or pharmaceutical compounds are, for example, vials, ampoules, cartridges, bottles, or (prefilled) syringes. These containers are made of glass or plastic. In these uses, ampoules, which are disposable containers that are sealed by fusion and open only by rupture, vials, which are disposable or reusable containers that are closed by at least one of a stopper and a cover seal, And a syringe, which is a cylindrical device with a cannula-like nozzle and optionally a fixed needle and a movable piston, is of particular importance. In addition, some sealing devices are conventionally well known for use as main containers. For example, this sealing device is made of an elastomer material and polyethylene or polypropylene. It is noted herein that the sealing device usually has different shapes and dimensions, such as a stopper for an injection or syringe bottle, or a plunger for a prefilled syringe, depending on the type of container. Should be.

These containers and sealing devices are specifically specified by standards for containers issued by the International Organization for Standardization (ISO). Particularly relevant ISO standards are ISO 8362-1, ISO 8362-2, ISO 11040-4, and ISO 11040-5.

Each choice or assembly of the main container depends on compatibility with the contents, as well as the degree of protection specifically required, as well as filling methods, manufacturing costs, presentations, forms of administration, such as dimensions, weight, etc. Depends on the convenience of the container to the user, such as the method of opening. Regarding the filling method, it should be noted that the filling equipment is usually laid out for only one type of container. That is, for example, vials can only be filled in equipment that fills vials, and syringes can only be filled in equipment that fills syringes.

Moreover, it is well known that individual elements of such containers, including not only containers and sealing devices but also combinations thereof, need to undergo various tests to be approved or proven as main containers. This test is complicated and expensive. Therefore, the main container for a given medical or pharmaceutical compound is usually set or fixed in the initial stage development of the compound and changed only as needed in the course of further development. Therefore, the disadvantage of conventional main containers according to the prior art is that they are inflexible to changes in their structure, predetermined forms of administration, and / or changes in their individual elements during development.

For example, it is well known that a vaccine filled in a pre-filled syringe or the like is manufactured only seasonally because its usual main use such as vaccination is performed only in a predetermined season. .. However, filling equipment and filling lines for syringes cannot be easily disassembled and rebuilt and must be maintained throughout the year. Therefore, the maintenance cost of the filling equipment used to fill the syringe is high or it is closed for a predetermined period of time in a year. This has a negative impact on medical or pharmaceutical manufacturing costs.

Therefore, it would be desirable to provide a more flexible main container that solves such problems. Several solutions have been proposed in the prior art for this purpose.
For example, Patent Document 1 is well known for prefilled syringes based on the use of vials containing medical compounds so that the vials can be filled using conventional filling facilities and techniques for vials. The vial has an open bottom that is closed by a piston that can be connected to the plunger. An adapter cap with an internal needle and an external connection for the needle that is placed over the sealing device of the vial transforms the system into a prefilled syringe. The disadvantage of this system is that the vial can only be filled by using the filling equipment used to fill the vial. Moreover, due to the open bottom of the vial, this vial can only be used in combination with the proposed system.

Patent Document 2 discloses another prefilled syringe having a tubular barrel that can be filled at either end. Both ends of the syringe barrel are sealed with a standard vial sealer and corrugated aluminum seal. One sealing means for the barrel is a piston and the other sealing means is configured to receive the needle. The disadvantage of the proposed syringe is that it can only be used as a pre-filled syringe.

European Patent Application Publication No. 0298585 U.S. Patent Application Publication No. 4568336

Therefore, an object of the present disclosure is to improve the main container in terms of its manufacturing, use, and cost flexibility with the simplest possible structure.

This problem is solved by a method of assembling a main container having the characteristics of claim 5 in addition to the main container having the characteristics of claim 1.
An effective further embodiment of the present disclosure is set out in the Dependent Section.

A main container for at least one of the storage and administration of a medical or pharmaceutical compound according to the present disclosure comprises a container having a predetermined filling capacity for receiving the medical or pharmaceutical compound. The container is formed integrally with a circumferential flange portion that is permanently closed at the first end and extends radially at the open second end. The container has a cylindrical barrel that extends between the first end and the flange portion. The main container according to the present disclosure is preferably configured to be tightly attached to the flange and / or rigid to the barrel to seal the open second end of the container (after filling the container). It further includes a sealing element configured to fit tightly.

As mentioned above, for the purposes of the present disclosure, "main container" shall mean any container that is in direct physical contact with the medical or pharmaceutical compound to be filled. In addition, the term "container" is used generically for containers made of materials suitable for medical or pharmaceutical compounds, such as glass and plastic. Preferably, as appropriate to the specifications of the ISO11040-4 standard, a "cylindrical barrel" is understood as a hollow cylindrical barrel formed with respect to its shape and dimensions. The "flange portion" according to the present disclosure preferably means a flange formed with respect to its cross-sectional shape, as long as it is appropriate according to the specifications of the ISO 8632-1 standard, on which another element, a sealing element, is required. It can be firmly attached according to the situation. A "standardized syringe" can be said to be a syringe that conforms to the specifications of the ISO11040-4 standard described above. Similarly, "standardized vial" can be said to mean a vial that conforms to the specifications of the ISO8632-1 standard.

Preferably, the cylindrical barrel complies with the relevant specifications of the ISO11040-4 standard for a suitable predetermined standardized nominal capacity with respect to its inner diameter, outer diameter, and wall thickness. The predetermined standardized nominal capacity corresponds to or is close to, i.e. slightly different from, the predetermined filling capacity of the container, which is among the various nominal capacities considered in the ISO11040-4 standard. It is one of the suitable ones. In particular, the cylindrical barrel is formed to satisfy the barrel diameters d1 and d2 and the barrel wall thickness s1 as shown in FIGS. 1 and 1 of the ISO11040-4 standard for a given standardized nominal capacity of a standardized syringe. Will be done. Depending on the predetermined filling capacity, the barrel length is ISO 11040-4 standard Figure 1 and Table B. Corresponds to the standardized syringe length l1 or overall length I as shown in 1, varies within the range defined by these length l1 and overall length I, or further with the specifications of the ISO11040-4 standard. It may be different. Usually the length of the cylindrical barrel is defined so that the predefined filling is done by the inner diameter, outer diameter, and wall thickness adopted from the ISO11040-4 standard for a given nominal capacity as described above. Set. A standardized nominal capacity can be used as a predetermined nominal capacity if the predetermined filling capacity is consistent with the standardized nominal capacity of the standardized syringe, and the cylindrical barrel is this standardized or predetermined. It is formed so as to satisfy the barrel diameters d1 and d2 and the barrel wall thickness s1 as shown in FIGS. 1 and 1 of the ISO11040-4 standard for the nominal capacity of. In this case, the barrel length satisfies the length l1 as shown in FIGS. 1 and 1 of the ISO11040-4 standard for standardized nominal capacity. If the predetermined filling capacity is different from any of the nominal capacities set by the ISO11040-4 standard, any suitable nominal capacity that approximates the predetermined filling capacity can be used as the predetermined nominal capacity. The cylindrical barrel is formed to satisfy the barrel diameters d1 and d2 and the barrel wall thickness s1 as shown in FIGS. 1 and 1 of the ISO11040-4 standard for this suitable or predetermined nominal capacity. However, even if the predetermined filling capacity is consistent with the standardized nominal capacity of the standardized syringe, any other suitable standardized nominal capacity can be used as the predetermined nominal capacity and is cylindrical. The barrel is formed to meet barrel diameters d1 and d2, as shown in FIGS. 1 and 1 of the ISO11040-4 standard for other standardized or predetermined nominal capacities, and barrel wall thickness s1. For example, if the predetermined filling capacity is 1 ml, the cylindrical barrel fills the outer diameter d1, inner diameter d2, and wall thickness s1 of the longitudinal 1 ml syringe, where d1 is 8.15 mm plus or minus 0.1 mm. D2 is 6.35 mm plus or minus 0.1 mm, and s1 is about 0.9 mm (see Table 1 and Table B. for ISO11040-4, 1 ml nominal capacity). In this case, the length of the barrel fills the length l1 of the longitudinal version of the 1 ml syringe, which is 54 mm plus or minus 0.5 mm, with a predetermined nominal volume of 1 ml. However, with the same predetermined filling capacity of 1 ml, the cylindrical barrel instead has a short or standard version with a predetermined nominal capacity of 1 ml (ISO11040-4, Table 1 and 1 ml of nominal capacity). 1 ml syringe outer diameter d1 (equal to 10.85 mm plus or minus 0.1 mm), inner diameter d2 (equal to 8.65 mm plus or minus 0.2 mm), and wall thickness s1 (equal to 1.1 mm) in Table B.1) The outer diameter d1 (ISO11040-4, see Table 1 and Table B.1 for ISO11040-4, 0.5 ml nominal volume) of a 0.5 ml syringe that meets (approximately equal to) or has a predetermined nominal volume of 0.5 ml. It satisfies 6.85 mm plus or minus 0.1 mm), inner diameter d2 (equal to 4.65 mm plus or minus 0.1 mm), and wall thickness s1 (approximately equal to 1.1 mm). In these alternative cases, the barrel length is adequately adjusted to ensure that the container has a predetermined filling capacity.

Further, the flange mounted on the top of the cylindrical barrel preferably forms a circular flange that is continuous in the circumferential direction according to the flange of a conventional vial according to the ISO8632-1 standard. To that extent, the flange further follows Form B of the finger flange of a standardized syringe (ISO11040-4, see FIG. 1, Form B). In addition, the flange portion is formed to conform to the relevant specifications of the ISO 8632-1 standard described above with respect to its cross-sectional shape. In particular, the flanges are as shown in ISO 8632-1 standard FIGS. 1, 2, 3, and 1 with respect to their axial length or height, their upper inner edges, and / or their upper end faces. Meet relevant specifications. Specifically, the axial length or height of the flange is 3.6 mm plus or minus 0.2 mm, the bevel angle of the upper inner edge is about 45 °, and / or the tapered upper end face of the flange. The angle is 3 ° plus or minus 2 ° (ISO8632-1, see FIGS. 1-3). Adopting the length dimensions and angles described above is useful for coordinating the flange portion of the container with conventional sealing elements as specified in the ISO 8362-2 standard. The above 3.6 mm plus or minus 0.2 mm adopted by the ISO8632-1 standard is preferable, but the axial length or height of the flange portion is standardized as long as the flange portion still satisfies the following two functions. It may be slightly different from the dimensions. The function is that, firstly, the flange portion allows the container to be handled and processed using the prior art used for standardized syringe filling and processing in conventional filling equipment. That is, the flange portion fulfills the function of a standardized syringe finger flange (ISO11040-4, see FIG. 1). The function is that, secondly, the flange configuration allows the container to be tightly closed by using a suitable sealing element, eg, a sealing element according to the ISO 8362-2 standard for conventional standardized vials. is there. Further, the flange portion is ISO 8632-1 standard (see ISO 8362-1, FIG. 1, diameter d4 and diameter d2) so that the flange portion smoothly matches the corresponding barrel dimension with respect to its inner diameter, outer diameter, and lower end face. Different from the related specifications of. In particular, the flange portion has a flat lower end face extending in the radial direction, unlike a standard vial having a lower surface that tapers toward the tip (see FIGS. 1 to 3 showing a tapered angle of 10 ° plus or minus 5 °). Has. The flat lower end face allows the container to be easily handled by conventional techniques used in standardized syringe filling and processing in conventional filling equipment. However, the lower end face of the flange portion is usually formed with a tapered angle as is well known by ISO 8362-1 (see FIGS. 1 to 3 showing a tapered angle of 10 ° plus or minus 5 °).

Thus, unlike conventional vials, the container of the main container according to the present disclosure is found and defined in the ISO 8362-1 standard (see ISO 8362-1, FIGS. 1-3, diameter d3 and height h3) on its outer surface. There is no such neck stenosis. On the other hand, the inner surface of the container is the upper end, i.e., according to the finish of any suitable vial model A, B or C of the ISO 8632-1 standard (ISO 8632-1, see FIGS. 1-3). Finished in the area of the upper end opposite the flange.

In addition, the inner surface of the container that comes into contact with the medical or pharmaceutical compound contained in the container is finished by exposing the inner surface to a suitable surface treatment and / or coating step. For example, the inner surface can be finished by various plasma treatments or silicone treated by a silicone oil suspension, a baked-on silicone treatment with silicone oil or a spray silicone treatment. These treatments are well known in conventional prefilled syringes to improve the lubricity of the inner surface of the syringe barrel. However, according to the present disclosure, the surface treatment of the inner surface of the container is not limited to the use of the main container as a syringe, but the use of any type of main container, be it a syringe, vial, or ampoule. It can be said that it will be open to the public. The use of any type will be described later.

The configuration according to the present disclosure provides a modular system for assembling the main container, which is based on one type of container. The container preferably meets the relevant specifications of the standardized syringe with respect to the shape and dimensions of the barrel and the relevant specifications of the standardized vial with respect to the cross-sectional shape of the flange.

The sealing element is the compound to be stored and / or any sealing element selected from a group of multiple sealing elements of different shapes, depending on the purpose of administration of the compound, in combination with a medical or pharmaceutical compound. Formed from materials suitable for use. Preferably, the material of the sealing element is an elastomer material, preferably rubber.

The configuration of the main container according to the present disclosure, that is, having a body formed as a cylindrical barrel according to the relevant specifications of the ISO11040-4 standard of conventional or standardized syringes as appropriate, and as long as appropriate in terms of cross-sectional shape. By a combination of containers with flanges according to the relevant specifications of the ISO 8362-1 standard for vials, the containers according to the present disclosure are used for standardized or conventional filling equipment and standardized syringe filling and processing. By technology, it is effectively configured to be filled. Therefore, the capabilities of these conventional filling facilities and existing machines of the prior art can be effectively used. It should be noted that the container is permanently sealed at one end, unlike the barrel of a conventional standardized syringe, which allows the container to also be used as a vial. Moreover, as mentioned above, unlike conventional standardized vials, the container does not have a neck constriction between the flange and the barrel. According to the present disclosure, preferably, a continuous circular flange portion is directly connected to the barrel.

Another effect of the present disclosure is to meet the standardized accuracy requirements of the standardized vial according to the ISO 8632-1 standard by satisfying the cross-sectional shape of the flange of the standardized vial according to the ISO 8632-1 standard as appropriate. Derived from the fact that the flanges of the are manufactured. Therefore, the disclosed container can be used with any sealing element used in combination with conventional vials. In addition, the configuration of the flange portion of the container according to the present disclosure allows the container to meet all the impermeable requirements of the ISO 8632-1 standard.

That is, the container and sealing element combination according to the present disclosure can be used in place of standardized vials for storing medical or pharmaceutical compounds, and in addition, well-known filling equipment used in standardized syringes. And can be filled and processed by using technology. As such, the main container according to the present disclosure has two or more effective functions.

According to a preferred embodiment, the flange portion is formed to function as a finger flange. This means that the flange portion of the container is formed to function as a finger resting portion. This configuration allows the container to be easily transported through conventional filling equipment for standardized syringes. In addition, the finger flange allows the user to easily grip the container. The composition of the finger flange will be in agreement between the customer and the manufacturer according to the above ISO standard.

Preferably, the sealing element is a plug that includes an inset that is configured to fit tightly into the barrel and a support that is configured to rest on the flange. The stopper substantially has a "T-shaped" longitudinal cross section. The above configuration of the sealing element allows the main container to be used as a conventional vial. Effectively, the container is hermetically sealed with a sealing element, whereby the medical or pharmaceutical compound is stored therein for adequate protection.

In an effective embodiment, an additional seal, also called a cover seal, is provided that surrounds the sealing element so as to seal and engages with the flange portion of the container. This seal is effective in sealing and fixing over the sealing element to maintain the integrity of the container seal under normal conditions of transportation, handling and storage during the intended shelf life of the product. Used for For example, this seal is made of aluminum.

According to a preferred embodiment, the seal is configured as a flip-off seal that includes an aluminum cap that is placed on a sealing element that is compatible with the container, surrounding the sealing element and the flange of the container and engaging with the flange of the container. It fits. The aluminum cap has a central opening that is normally closed by a plastic element made of, for example, a flexible or deformable, preferably elastic material, whereby the aluminum cap covers the plastic element after it has been removed. Gain access to the sealing element. The plastic element fits the aluminum cap releasably, for example, by dynamically interacting with the circumferential edge of the central opening of the aluminum cap. This causes the plastic element to be flipped off the aluminum cap, which provides access through the central opening of the aluminum cap to the sealing element covered by the aluminum cap, which still engages the container. In this flip-off state, the user extracts the medical or pharmaceutical compound from the container by a needle extraction system that penetrates the sealing element through the central opening of the aluminum cap.

According to a preferred alternative, the seal has a plastic element having a flat lower surface and resting on the support of the sealing element, and an aluminum cap surrounding the plastic element. The aluminum cap has a central opening that provides access to the plastic elements covered by the aluminum cap.

Preferably, the plastic element of the seal comprises a grip that penetrates the central opening of the aluminum cap so as to extend outward in the axial direction. The grip is either an integral part of the plastic element or is tightly fitted to the plastic element. This configuration allows the user to easily grip the grip to remove the plastic element, aluminum cap, and preferably the sealing element from the container.

According to an effective embodiment, the aluminum cap includes a predetermined break point at a portion that engages with the flange portion of the container. By providing the aluminum cap with a breaking point extending in the circumferential direction, a part of the plastic element and the sealing element can be easily removed by folding the gripping element. For example, the aluminum cap fits tightly to the sealing element by frictional engagement or the like, which allows the entire sealing element to be removed together with the aluminum cap by friction by removing the aluminum cap.

In another example and effective embodiment of the present disclosure, the sealing element is a cylindrical plunger plug with a fitting configured to fit tightly into the barrel of the container.
Another improvement is obtained by optionally providing a needle extraction system for removing medical or pharmaceutical compounds, which is configured to work with a plunger plug. In this case, it is noted that the needle extraction system extends outward from the open second end of the container as it works with the plunger plug. In cooperation of the needle extraction system with a sealing element formed as a plunger plug, the needle extraction system and the plunger plug are provided with suitable engaging or mounting means configured to be compatible with each other. With this configuration, the main container according to the present disclosure can be used either as a vial, as an ampoule, or as a syringe, but can still be manufactured by conventional filling equipment used in standardized syringes. Here, the filling capacity of the barrel is even greater than with a standard syringe, as the needle does not extend from the first end of the container, which is permanently closed. Thus, in this case, the barrel has a longer length compared to a standard syringe, but can still be manufactured by conventional filling equipment.

Preferably, the needle extraction system includes a plunger rod element that can be releasably attached to the plunger plug by a snap connection, or instead a screw engagement connection. Thus, the main container can be easily converted into a syringe. However, unlike traditional prefilled syringes, when the main container is used as a syringe, both filling and extraction are done through the open second end of the container, i.e. on the same end side of the container. ..

Effectively, the plunger rod element has a finger flange to easily remove the medical or pharmaceutical compound stored in the container.
Preferably, the cannula is secured to the plunger bar element.

According to a preferred embodiment, a seal is provided that surrounds the sealing element so as to seal at least partially and further engages with the flange portion of the container. This seal containers the sealing element to maintain the integrity of the seal under normal conditions of transport, handling, and storage during the intended shelf life of the product, especially if the sealing element is made of rubber. It is used as a cover seal for fixing to.

The disclosure additionally relates to a method of assembling a main container for at least one of the storage and administration of medical or pharmaceutical compounds. The method preferably comprises the step of preparing a container. The container has a predetermined filling capacity for receiving a medical or pharmaceutical compound in the container, is permanently closed at the first end, and is integrally formed at the second end to be opened. It has a circumferential flange portion. The container has a cylindrical barrel that extends between the first end and the flange portion. The method comprises selecting a sealing element from a group of plurality of sealing elements of different shapes, depending on the compound to be stored and at least one of the purposes of administration of the compound. The sealing element is configured to be tightly attached to the flange to seal the open second end of the container, or tightly fitted into the barrel, or both. The method optionally prepares a needle extraction system for removing medical or pharmaceutical compounds, with the step of preparing a seal that at least partially surrounds the selected sealing element and engages with the flange of the container. Including the process of The needle extraction system is configured to work with the plunger plug.

The container, sealing element, seal, and optionally provided needle extraction system, including the barrel and flange portion, correspond to the container, sealing element, seal, and needle extraction system specified above, respectively.

With respect to the containers used in the method of assembling the main container for at least one of the storage and administration of medical or pharmaceutical compounds, the containers provided are also with respect to the barrel, depending on the predetermined filling capacity and. With respect to the flange portion, it is selected depending on the desired form of administration of the chemical or pharmaceutical compound stored in the container. As outlined above, the inner diameter, outer diameter, and wall thickness of the cylindrical barrel of the container are the relevant specifications of the ISO11040-4 standard for suitable of the standardized nominal capacities of standardized syringes. Set to meet. Suitable of the standardized nominal capacities correspond to or approximate the predetermined fill capacities of the container. Depending on the predetermined filling capacity, as well as the inner and outer diameters of the barrel, and the wall thickness, the length of the barrel is set to ensure that the container is provided with a predetermined filling capacity. Further, as described above, the flange portion is formed so as to conform to the relevant specifications of the ISO 8632-1 standard with respect to the cross-sectional shape.

As already mentioned above, the main container is approved for use in combination with individual elements, i.e. containers, various sealing elements, various seals, etc., and the individual elements are easily replaceable. Assembled by using a modular system. Here, the main container can be used either as a vial, as an ampoule, or as a syringe, but can still be manufactured by conventional filling equipment for standardized syringes. It is noted that the modular system for assembling the main container according to the present disclosure includes one type of container suitable for various sealing elements and optionally a needle extraction system. It is even more noteworthy that for needle extraction systems, the end on the side that removes the medical or pharmaceutical compound from the container is on the same side as the end on the side that fills the container.

According to a preferred embodiment of the present disclosure, the sealing element can be selected from a group of a plurality of sealing elements having different shapes. A group of differently shaped sealing elements is provided on the barrel of the container with a stopper that includes a fitting that is configured to fit tightly into the barrel and a support that is configured to rest on the flange. Includes a cylindrical plunger plug that includes an inset that is configured to fit tightly and is configured to work with an optionally provided needle extraction system.

Hereinafter, effective embodiments of the present disclosure will be described in more detail with reference to the drawings below.

FIG. 5 is a side sectional view schematically showing a container provided with a sealing element and a seal according to an embodiment of the present disclosure. FIG. 5 is a side sectional view schematically showing a container provided with a sealing element and a seal according to another example of the present disclosure. FIG. 2 is an enlarged side sectional view schematically showing the seal according to FIG. FIG. 5 is a side sectional view schematically showing a container provided with a sealing element according to a further embodiment of the present disclosure. A side sectional view schematically showing a needle extraction system according to the present disclosure. FIG. 5 is a side sectional view schematically showing a sealing element and a container provided with the needle extraction system of FIG. 5 attached to the sealing element according to another example of the present disclosure. A side sectional view schematically showing a needle extraction system according to another example of the present disclosure. FIG. 5 is a side sectional view schematically showing a sealing element and a container equipped with the needle extraction system according to FIG. 7 attached to the sealing element.

The same elements are indicated by the same reference numerals throughout the drawing.
FIG. 1 is a side sectional view showing a main container 1 according to an embodiment of the present disclosure. The main container 1 functions to receive any medical or pharmaceutical compound for at least one of storage and administration. The main container 1 is usually in direct contact with these compounds.

The main container 1 includes a container 2 having a defined filling capacity for receiving a medical or pharmaceutical compound 3 and being made of glass or any suitable plastic material. The container 2 has a cylindrical barrel 4 and is permanently closed at a first end 6 forming the bottom of the container 2. In addition, the container 2 has an open second end 8 that forms the top of the container 2. The opened second end 8 is provided with a circumferential flange portion 10 extending radially outward from the barrel 4 and integrally formed. That is, the barrel 4 extends between the closed first end 6 and the cylindrical flange portion 10.

In this embodiment, the container 2 has an exemplary 1.9 ml predetermined filling capacity. For this purpose, according to the ISO11040-4 standard for so-called longitudinal versions of standardized syringes with a nominal volume of only 1 ml (see ISO11040-4, FIGS. 1 and 1 and B.1 for dimensions d1, d2). As specified, the barrel 4 of the container 2 has an outer diameter of 8.15 mm and an inner diameter of 6.35 mm. However, the first end 6 of the container 2 is provided by a conventional standardized syringe (ISO11040-4, see FIGS. A.1 to A.3 showing various head structures) for holding the needle cannula. Permanently closed instead of having a well-known head-shaped end. Therefore, in the present embodiment, the conventional standardized syringe is the head structure of the conventional standardized syringe (ISO11040-4, see FIGS. A.1 to A.3 showing various head structures). Considering the fact that an unspecified amount of additional length corresponding to the length with the rubber needle shield arranged in the head structure is required, the total length of the filling capacity of the barrel 4 is 54 mm. (ISO11040-4, see Tables 1 and 11 for nominal volumes of 1 ml) is about 64 mm, as compared to the full length of the barrel of the longitudinal version of the conventional standardized syringe. Thus, by extending the length of the barrel 4, the container 2 has a filling capacity of 1.9 ml, but still has the inner and outer diameters of a standardized syringe with a nominal capacity of only 1 ml. However, as in this example, other prefilled syringe dimensions as disclosed in the ISO11040-4 standard are also expandable.

The flange portion 10 of the container 2 is manufactured as appropriate according to the cross-sectional shape of the flange of the vial standardized according to the ISO8632-1 standard and the standardized manufacturing accuracy. In particular, the flange portion 10 located on the top in the form of the cylindrical barrel 4 forms a continuous circular flange in the circumferential direction that fits the flange of a conventional vial according to the ISO 8632-1 standard. To that extent, the flange is more compatible with standardized syringe finger flange form B (ISO11040-4, see form B in FIG. 1). Additionally, the flange portion 10 has an ISO 8632-1 standard FIG. 1, FIG. 2, FIG. 3, and a table with respect to its cross-sectional shape, in particular with respect to its axial length or height, its upper inner edge, and its upper end face. It is formed to conform to the relevant specifications as shown in 1. Specifically, the axial length or height of the flange portion 10 is 3.6 plus or minus 0.2 mm, the bevel angle of the upper inner edge is about 45 °, and the tapered angle of the upper end surface of the flange. Is 3 ° plus or minus 2 ° (ISO8632-1, see FIGS. 1 to 3).

Further, in the embodiment shown in FIG. 1, the flange portion 10 has a lower portion having a tapered angle of 10 ° plus or minus 5 °, which is tapered toward the tip, similar to a standardized vial (ISO8632-1, see FIGS. 1 to 3). Has an end face. On the other hand, the flange portion 10 is formed so as to smoothly match the corresponding barrel dimensions as shown in FIG. 1, unlike the relevant specifications of the ISO 8362-1 standard with respect to its inner and outer diameters. Instead of the tapered lower end face shown in FIG. 1, the flange portion may have a flat lower end face extending in the radial direction. However, unlike conventional vials, container 2 of the main container according to the present disclosure does not have a neck constriction as defined in the ISO 8362-1 standard (ISO 8362-1, see FIGS. 1: d3 and h3). , As disclosed in the standards described above (see ISO 8632-1, FIG. 1, FIG. 2, and FIG. 3, model A, model B, and model C neck finishing with or without blow back). It may be finished on the inside or it can be finished.

As further shown in FIG. 1, the main container 1 fits tightly onto the flange portion 10 in this embodiment and fits tightly into the barrel 4 through the open second end 8 of the container 2. Further includes a suitable sealing element 12 configured in. In this embodiment, the sealing element 12 is a stopper made of rubber. The sealing element 12 has a fitting portion 14 configured to fit tightly into the barrel 4 and a supporting portion 16 configured to be placed so as to seal the flange portion 10. The sealing element 12 meets the cross-sectional shape of the stopper and related dimensions standardized in the ISO 8362-2 standard, or the dimensions are configured to be more suitable dimensions.

The main container 1 further comprises a flip-off type seal 18 including an aluminum cap 20. The aluminum cap 20 is located on a sealing element 12 that is compatible with the container 2, surrounds the sealing element 12 and the flange portion 10 of the container 2, and engages with the flange portion 10 of the container 2. The aluminum cap 20 has a central opening 22. The central opening 22 provides access to the sealing element 12, which is normally closed by the plastic element 24, for example during storage or transportation, and is covered by the aluminum cap 20 after the plastic element 24 has been removed. The plastic element 24 has a flat lower surface 26 that rests on the aluminum cap 20. The plastic element 24 is made of a flexible, elastic material in this embodiment and can be released by dynamically interacting with the circumferential edge of the central opening 22 of the aluminum cap 20. Fits to. Thereby, when the plastic element 24 is repelled from the aluminum cap 20, access through the central opening 22 to the sealing element 12 located below the aluminum cap 20 still engaged with the container 2. can get. In this flip-off state, the user extracts a medical or pharmaceutical compound from the container 2 by a needle extraction system (not shown) that penetrates the fragile thin film portion 17 of the sealing element 12 through the central opening 22 of the aluminum cap 20. To do. The seal 18 includes an engaging portion 28 that tightly surrounds and seals the sealing element 12 and engages with the flange portion 10 of the container 2. As shown in FIG. 1, the seal 18 functions as a cover seal for fixing the sealing element 12 to the container 2. In this way, the seal 18 keeps the container 2 and the sealing element 12 in a sterile state. With this configuration, the main container 1 functions as a conventional vial.

FIG. 2 is a side sectional view showing another modification of the sealing element, which is indicated by reference numeral 112 in the present embodiment and which fits the container 2 of FIG. 1 instead of the sealing element 12. In this embodiment, the strip-off seal 118 is an aluminum cap 120 comprising a central opening 122 and a plastic element 124 having a flat lower surface 126 configured to rest on a support 116 of the sealing element 112. including. Further, the seal 118 includes a grip portion 128 having a form extending outward. In particular, as shown in FIG. 2, since the grip portion 128 penetrates the central opening 122 of the aluminum cap 120, the user can easily grip the grip portion 128. In the deformation, the grip is an integral part of the plastic element 124. Alternatively, the grip 128 may be formed separately from the plastic element 124 and may be tightly fitted to the plastic element 124. A predetermined breaking point 129 (see FIG. 3) extending in the circumferential direction is arranged at the engaging portion 128 of the aluminum cap 120 that engages with the flange portion 10 of the container 2, whereby the grip portion 128 is lifted and folded. When folded or folded, the sealing element 112, as well as most of the aluminum cap 120, is removed from the container 2. For this purpose, the aluminum cap 120 and the sealing element 112 are in close frictional contact with each other. In this way, the main container 1 functions or is used as an ampoule.

FIG. 3 is an enlarged side sectional view schematically showing the sealing element 112. In particular, the position of the predetermined break point 129 of the engaging portion 128 is clearly indicated.
FIG. 4 is a side sectional view schematically showing a main container according to a further embodiment of the present disclosure. In this embodiment, a container 2 of the same type as described above with respect to FIGS. 1 and 2 is a sealing element in which its open second end 8 is formed as a cylindrical plunger plug 230 in this embodiment. It is plugged by another deformation. The plunger plug 230 has a fitting portion 232 configured to fit tightly into the barrel 4 of the container 2. The plunger plug 230 has mounting means 234 on its top, i.e., on the side of the barrel 4 facing the open second end 8, which mounting means 234 in the present embodiment is FIG. It is formed as a female screw according to ISO11040 No. 4.1b) for screw connection with the needle extraction system 238 shown in the above. The plunger plug 230 has a bottom 236 configured on its bottom, i.e., on the side facing the closed first end 6, which can be penetrated by a known cannula or hollow needle as shown in FIG. .. In the present embodiment, the sealing element 230 is structurally sealed so as to be covered by a seal 218 corresponding to the seal 18 shown in FIG. The seal 218 is particularly suitable when the main container 1 is stored, transported, sold, etc. as an intermediate product, that is, when the needle extraction system 238 cannot be attached to the sealing element 230. However, the main container does not include the seal 218 when the main container is stored, transported, sold, etc. as a final product, i.e. when the needle extraction system 238 is attached to the sealing element 230. Therefore, the seal 218 is provided only when necessary or appropriate. In this latter example, the needle extraction system 238 is half or loosely attached to the sealing element 230 when the main container is assembled as the final product. As a result, the fragile thin film portion 237 of the sealing element 230 is still not penetrated, and the sealing element is penetrated by the user so as to penetrate the fragile thin film portion 237 of the sealing element 230 only when the medical or pharmaceutical compound is removed from the container 2. It is completely or tightly attached to the 230.

FIG. 5 is a side sectional view schematically showing a needle extraction system 238 for removing medical or pharmaceutical compound 3 from the container 2. The needle extraction system 238 is provided as an optional element of the main container 1 and includes a cylindrical plunger rod element 240 having an outer diameter smaller than the inner diameter of the barrel 4. Further, the plunger rod element 240 has a length suitable for the length of the barrel 4. Further, the plunger rod element 240 has an attachment means 242 that is located at the first axial end and is formed as a male screw made of plastic so as to be screwed to the sealing element 230. The plunger rod element 240 is releasably attached to the attachment means 234 of the plunger plug 230 by the attachment means 242. Above the second axial end, the plunger rod element 240 has a finger flange 244 that extends radially outward and is formed for easy gripping by the user.

The plunger bar element 240 further includes a cannula 246 extending throughout the plunger bar element 240. That is, the cannula 246 projects from both ends of the plunger rod element 240 in the axial direction. In this embodiment, the cannula 246 is formed as a hollow needle that is firmly secured to the plunger element 240. However, instead, the cannula 246 may be formed integrally with the plunger rod element 240. Further, the cannula 246 is configured to penetrate the bottom 236 of the plunger plug 230. When the needle extraction system 238 is attached to the plunger plug 230 and moved axially towards the second end 8 of the barrel 4, the medical or pharmaceutical compound 3 can be removed from the container 2. The protrusion of the cannula 246 from the underside of the plunger bar element 240 is minimized as short as possible in order to limit the amount of compound 3 remaining in the vessel after fully operating the needle extraction system 238. In this way, the main container functions as a (prefilled) syringe.

FIG. 6 is a side sectional view schematically showing a main container when the needle extraction system 238 is adapted to the plunger plug 230. In order to attach the needle extraction system 238 to the plunger plug 230, the seal 218 must first be removed if available.

FIG. 7 is a side sectional view schematically showing the deformation of the needle extraction system. The deformation needle extraction system, indicated by reference numeral 338, includes an adjacent portion 348 that is integrally formed at the first axial end of the plunger rod element 340 and extends radially. Alternatively, the adjacent portion 348 may be releasably attached to, for example, the first axial end of the plunger rod element 340. The plunger rod element includes mounting means 342 having an outer diameter smaller than the inner diameter of the barrel 4 and conforming to mounting means 242 as described above with respect to FIGS. 5 and 6. The needle extraction system 338 further includes a cannula 346 extending throughout the plunger bar element 340.

The needle extraction system 338 of FIG. 7 includes a cylindrical tube portion 350. The cylindrical tube portion 350 is substantially coaxial with the plunger rod element 340 and is adjacent to the plunger rod element 340 in the direction of the second axial end of the plunger rod element 340, which is separated from the first axial end of the plunger rod element 340. Extend from. Adjacent to the second axial end of the plunger rod element 340, the tube portion 350 has a radial outwardly extending finger flange 352 that is easily gripped by the user. The finger flange 352 is configured to slide along the outer surface of the container 2 and has a protrusion 354 extending radially inward. To assemble the needle extraction system 338 in container 2, the tube portion 350 is elastically deformable within a predetermined range, whereby its end, including the finger flange 352, expands slightly radially. It is possible.

With this configuration, as shown in FIG. 7, the plunger rod element 340 can be arranged so as to cover the barrel 4 of the container 2. The length of the plunger rod element 340 and the length of the pipe portion 350 are adapted to the inner length of the barrel 4, whereby the minimum stroke of the plunger rod element 340 and the minimum passage of the pipe portion 350 are inside the barrel 4, respectively. Corresponds to length or depth.

FIG. 8 is a side sectional view schematically showing a main container 1 having a needle extraction system 338 compatible with the plunger plug 330, and the plunger plug corresponds to the plunger plug 230 as described above. It is clearly shown that the length of the plunger rod element 340 and the length of the tube portion 350 correspond to the length of the barrel 4. The protrusion 354 of the tube 350 allows the needle extraction system 338 to be used as a disposable syringe. As described above, the configuration according to the present disclosure provides a modular system for assembling the main container, which is based on one type of container 2. The container 2 preferably meets the relevant specifications of the standardized syringe barrel with respect to the cross-sectional shape and dimensions of the barrel 4, and at least the relevant specifications of the standardized vial flange with respect to its top cross-sectional shape. In particular, the barrel 4 is preferably shown in FIG. 1 and Table 1 and Table B. of the ISO11040-4 standard. Barrel diameters d1, d2, and d5, as shown in 1, and barrel wall thickness s1, are formed to comply with ISO 11040-4 standard specifications. Further, the flange portion 10 is preferably formed to comply with ISO 8362-1 standard specifications, at least with respect to the cross-sectional shape of the upper end. On the other hand, with respect to the inner and outer diameters, the flange portion 10 may be configured to match the barrel diameter, unlike the ISO 8632-1 standard specifications. Therefore, the container 2 is formed by the barrel 4 and the flange portion 10 that matches the barrel. Therefore, the container 2 does not have a neck constriction like a conventional vial.

In addition, the sealing element is selected from a group of plurality of sealing elements of different shapes depending on the needs of the user and the desired type of administration of the medical or pharmaceutical compound stored in the container. A group of differently shaped sealing elements includes a stopper (see FIG. 1) that includes an inset that is configured to fit tightly into the barrel and a support that is configured to rest on the flange. Includes a cylindrical plunger plug that includes a fitting that is tightly fitted into the barrel of the container and is configured to work with an optionally provided needle extraction system. Other types of sealing elements may be added to a group of sealing elements of different shapes.

Therefore, the assembly of the main container 1 according to the present disclosure may be performed as described later. It is noted that the method according to the present disclosure provides a main container assembled by using a modular system. First, a container 2 for receiving the medical or pharmaceutical compound 3 is provided. The container 2 functions as an integral multifunctional container for any given use of the main container 1, that is, whether the main container 1 is used as a vial, a syringe, or an ampoule. To do. In addition, a suitable sealing element is selected from a group of differently shaped sealing elements, depending on the compound to be stored and / or the purpose of administration of the compound. A group of differently shaped sealing elements is formed as a sealing element 12 according to FIG. 1, a sealing element 112 according to FIG. 2, and a plunger stopper 230 or a plunger stopper 330 according to FIG. 4, FIG. 6, or FIG. Includes a sealing element to be made. A seal 18 or 118 is attached to the container 2 to seal over the selected sealing element after filling the container 2. When the main container 1 is used as a syringe, the needle extraction system 238 or the needle extraction system 338 is optionally provided in the main container 1. Therefore, the main container 1 can be assembled according to the compound to be stored and / or the purpose of administration of the compound. As described above, the needle extraction system 238 or the needle extraction system 338 is provided in the main container 1 as a separate accessory element or penetrates the fragile thin film portion 237 or thin film portion 337 of the sealing element 230 or sealing element 330. Half or loosely attached to the sealing element 230 or sealing element 330 without.

Based on an exemplary embodiment, the main container 1 according to the present disclosure may be modified in many ways. For example, the screw fixing mounting means 232 and 242 of FIG. 6 or the mounting means 332 and 342 of FIG. 8 may be replaced with the conventional snap type connection according to ISO 11040-5 No. 4.1a).

Further, in any of the embodiments described above, in the assembly method, the inner surface of the container 2 in contact with the medical or pharmaceutical compound stored in the container 2 is exposed to a suitable surface treatment process and / or coating process. It will be finished. For example, the inner surface is treated by various plasma treatments, or is silicone treated by a silicone oil suspension, a baked-on silicone treatment with silicone oil, or a spray silicone treatment. These treatments are well known in conventional prefilled syringes to improve the lubricity of the inner surface of syringe barrels and vials to reduce the loss of extractable capacity. However, according to the present disclosure, the surface treatment of the inner surface of the container is not limited to the use of the main container as a syringe, but the use of any type of main container, be it a syringe, vial, or ampoule. It can be said that it will be open to the public. The use of any type will be described later.

Taken together, the present disclosure relates to a main container for at least one of the storage and administration of medical or pharmaceutical compounds. The main container includes a container having a predetermined filling capacity for receiving a medical or pharmaceutical compound. The container is permanently closed at the first end and also has a circumferential flange that is integrally formed at the open second end. According to the present disclosure, the container has a cylindrical barrel extending between the first end and the flange portion. The barrel preferably has an inner diameter and an outer diameter corresponding to a standardized syringe inner and outer diameter relative to a standardized syringe nominal capacity that corresponds to or approximates a predetermined filling capacity. Further, the cross-sectional shape of the flange portion preferably corresponds to the cross-sectional shape of the flange of the standardized vial. The main vessel is further configured with a sealing element configured to be tightly attached to the flange and / or fitted into the barrel to seal the open second end of the vessel. Including.

Claims (5)

A main container (1) for at least one of the storage and administration of medical or pharmaceutical compounds.
A container (2) having a predetermined filling capacity for receiving a medical or pharmaceutical compound (3), which is permanently closed at the first end (6) and also. The container has a circumferential flange portion (10) that extends radially and is integrally formed at the open second end (8), and the container has the first end (6) and the circumferential flange. It has a cylindrical barrel (4) extending between the portion (10), and the circumferential flange portion (10) has an outer diameter larger than the outer diameter of the cylindrical barrel (4), and has an outer diameter larger than that of the cylindrical barrel (4). A container (2) having a flat lower end face in its cross-sectional shape,
A sealing element (330) configured to fit tightly into the cylindrical barrel (4) to seal the open second end (8) of the container (2).
The sealing element is a cylindrical plunger plug (330) made of an elastic material, including a fitting portion (332) configured to fit tightly into the cylindrical barrel (4) of the container (2). The plunger plug (330) has a bottom portion (236) that forms a closed thin film portion (337), the thin film portion (337) only when removing the medical or pharmaceutical compound from the container (2). It is configured to be pierced by making a hole,
A needle extraction system (338) for removing the medical or pharmaceutical compound from the container (2) is further provided, and the needle extraction system (338) is configured to cooperate with the plunger stopper (330). Along with, including the plunger bar element (340),
The plunger rod element (340) is arranged at the axial end of the plunger rod element (340) and can be releasably attached to the plunger plug (330) by a snap connection or a screw connection (334). A mounting means (342) and a cannula (346) configured to be firmly fixed to the plunger rod element (340) and to make a hole in the thin film portion (337) of the plunger plug (330). Including, the cannula (346) protrudes from the mounting means (342).
The needle extraction system (338) further has a cylindrical tube portion (350) extending coaxially with the plunger rod element (340), the cylindrical tube portion (350) extending radially outwardly with a finger flange (352). ), The finger flange (352) has a radially inwardly extending protrusion (354) configured to slide along the outer surface of the container (2). container. The main item according to claim 1, wherein the container (2) meets the selected specifications of the ISO11040-4 standard for a barrel of a prefilled syringe with respect to the shape and dimensions of the cylindrical barrel (4). container. Claim 1 or 2, wherein the container (2) meets the selected specifications of the ISO 8632-1 standard for flanges of injection vials with respect to the cross-sectional shape of the circumferential flange portion (10). The main container described. The sealing element (330) according to any one of claims 1 to 3, characterized in that the sealing element (330) meets the selected specifications of the ISO 8362-2 standard for sealing devices for injection vials in terms of cross-sectional shape. Main container. The method of assembling a main container for at least one of the storage and administration of a medical or pharmaceutical compound according to any one of claims 1 to 4.
When the main container (1) is assembled as a final product, the means for attaching the plunger rod element (340) so that the thin film portion (337) of the plunger plug (330) is not penetrated by the cannula (346). A method of assembling a main container, wherein (342) is attached to the plunger plug (330) by a snap connection or a screw connection (334).

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