JP7539715B2 - Medical equipment manufacturing plant - Google Patents

Description

The present invention relates to a factory that manufactures syringes, vials, rubber stoppers, caps, pistons, and other medical equipment in general, and in particular to a factory that can store the manufactured medical equipment in packaging materials for shipping and sterilize the packaging materials together, so that the sterilization required for using the medical equipment can be performed within the medical equipment manufacturing factory, between the time of manufacture and the time of shipping.

Conventionally, medical devices such as those described above are manufactured in a manufacturing plant and then shipped to medical device users, such as pharmaceutical companies, research institutes, or disease treatment institutions, where they are sterilized and generally used as intended immediately after sterilization.

As such, medical devices are usually sterilized by the user before use, and if they are not used immediately after sterilization, they are generally stored in storage containers or bags etc. while maintaining the sterile state.

However, sterilization requires special, expensive equipment, and users must be familiar with how to operate such equipment, as well as provide high-level maintenance for such equipment. In addition, it is necessary to secure a place to install such equipment, and provide high-level maintenance for that place, which places a huge burden on users.

Meanwhile, various techniques have been proposed or are in use for sterilizing medical equipment or food and drink containers.
For example, JP 2016-538040 (Patent Document 1) proposes a technology for reducing heat energy costs by circulating the heat energy used when sterilizing a container at low or high temperature, JP 2013-151152 (Patent Document 2) proposes a technology for heat sterilizing the inner and outer surfaces of a plastic preform before molding it into a container, and JP 2017-113257 (Patent Document 3) proposes a system for sterilization by reduced pressure and heat. In addition, the Japanese Standards Association has published a book (Non-Patent Document 1) entitled "Manufacturing Management and Quality Assurance of Sterile Pharmaceuticals Compliant with ISO Standards."

Patent Publication 2016-538040 Patent Publication 2013-151152 Patent Publication 2017-113257

"Manufacturing management and quality assurance of sterile pharmaceuticals in accordance with ISO standards" published by the Japanese Standards Association on May 31, 2000

However, both of the technologies in Patent Documents 1 and 2 relate to sterilization or disinfection technologies for containers, plastic preforms, or individual molded products. There is no problem if the user uses these containers, etc. immediately after sterilization or disinfection. However, when shipping the containers, etc. to the user, packaging for shipping is required, and contamination of the containers, etc. by the packaging materials is inevitable. Not only do measures need to be taken to prevent this, but the user is also required to sterilize or disinfect the containers again immediately before use.
In contrast to these, Patent Document 3 relates to a sterilization technique for disposing of medical equipment such as syringes and surgical tools after use, which is completely different from sterilization immediately before use.
Furthermore, Non-Patent Document 1 specifies aseptic procedures for the manufacture of pharmaceuticals and for filling medical devices such as syringes and vials with pharmaceuticals, but does not specify aseptic procedures at the manufacturer of medical devices.

The present invention aims to propose a technology that differs from the conventional sterilization or disinfection technologies or aseptic methods described above, in that the manufacturer of medical equipment sterilizes the packaging materials that contain the equipment after the equipment is manufactured and before it is shipped to the user.

As a result of extensive investigations to solve the above problems, the present inventors have
First, it was found that it would be sufficient to arrange a sterilization area between the manufacturing area and the shipping area of medical equipment in a medical equipment manufacturing factory. Next, it was found that it would be extremely convenient for users to sterilize the medical equipment together with the shipping packaging material in the sterilization area while the medical equipment is stored in the packaging material.
In order to sterilize the medical devices together with the packaging material while it is still in the packaging material, the packaging material must have the ability to freely pass the sterilization medium (e.g., high-pressure steam or gas, etc.),
Furthermore, they discovered that by spraying (irradiating) a sterilization medium (for example, steam, gas, ultraviolet light, or electron beam) around the packaging materials, it is possible to thoroughly sterilize not only the medical instruments but also the packaging materials in which they are stored.

The present invention has been made based on the above findings, and is a manufacturing plant for medical devices, comprising a sterilization area having a sterilization preparation area, a main sterilization area, and a sterilization regimen area, in that order, disposed between a manufacturing area and a shipping area for the medical devices, the sterilization area being isolated from areas other than the sterilization area,
The medical instruments to be sterilized are housed in a packaging material through which water vapor or gas can pass.
In addition, there may be multiple main sterilization areas, with the passage from the sterilization preparation area to each main sterilization area branching into multiple branches within the preparation area, and multiple passages from each main sterilization area to the sterilization curing area joining in the curing area. Furthermore, each of the multiple main sterilization areas may be provided with a passage connecting each of the main sterilization areas.

According to the present invention, medical equipment immediately prior to shipment can be sterilized in the equipment manufacturing plant. This allows users of the equipment to use the equipment immediately after it arrives, eliminating the need for sterilization procedures immediately prior to use or storage in a sterile state.
In this case, if the medical instruments are subjected to sterilization while stored in packaging material that allows the passage of high-pressure steam or gas, the medical instruments can be sterilized together with the packaging material for the instruments, eliminating the need to sterilize the packaging material separately.

Furthermore, by having multiple main sterilization areas, branching the passageway from the sterilization preparation area to each main sterilization area into multiple branches within the preparation area, and having the multiple passageways from each main sterilization area to the sterilization curing area merge at the curing area, it is possible to configure the multiple main sterilization areas as sterilization areas for multiple techniques, such as a dry heat sterilization area, a gas sterilization area, a radiation sterilization area, an ultraviolet irradiation sterilization area, an electron beam irradiation sterilization area, etc., in addition to the above-mentioned high-pressure steam sterilization area, and it is possible to carry out multiple sterilization techniques at once according to the use of each medical device and the needs of the user, etc.
Furthermore, if each of the multiple main sterilization areas is provided with a passageway connecting each of the other main sterilization areas, when the same or different types of main sterilization are performed consecutively, it is possible to move directly to the next main sterilization area without having to go through the curing or preparation area each time, resulting in improved sterilization efficiency and energy efficiency.

In addition, in the present invention, if the main sterilization area is, for example, a high-pressure steam sterilization area and the sterilization preparation area is a preheating area, the sterilization preparation area can be preheated with steam whose temperature has been reduced after use in the main sterilization area, resulting in advantageous sterilization in terms of thermal efficiency.

FIG. 1 is an explanatory diagram showing a simplified example of a layout mode of a factory according to the present invention. FIG. 2 is a simplified explanatory diagram showing another arrangement of the sterilization area of FIG. 1. 1A to 1C are explanatory views showing examples of packaging materials used in the present invention. FIG. 2 is an explanatory diagram showing a wire mesh pipe-shaped body used to put packaging materials in the sterilization area of the present invention. FIG. 11 is an explanatory diagram showing a part (container) of another example of a packaging material used in the present invention. 6A to 6E are explanatory diagrams showing a holder that constitutes a set of packaging materials in combination with the container shown in FIG. 5, in which (A) is a plan view, (B) is a partial cross-sectional view, and (C) to (E) are diagrams for explaining examples of usage. 7 is a diagram for explaining a state in which a packaging material consisting of the container of FIG. 5 and the holder of FIG. 6 is placed in the wire mesh pipe-shaped body shown in FIG. 4 . FIG.

FIG. 1 is a simplified diagram showing an example of a layout of a factory according to the present invention. In the diagram, medical devices are molded in a manufacturing area by known molding techniques such as injection molding, casting, cutting, blowing, pressing, etc., and then, in this example, are cleaned in a washing and drying area, packed in packaging materials in a packaging area, and temporarily stored in a storage area.
Thereafter, the medical instruments and packaging materials are introduced into a sterilization area consisting of a sterilization preparation area, a main sterilization area, and a sterilization regimen area, and are sterilized using an appropriate sterilization method, such as high-pressure steam, dry heat, gas, radiation, ultraviolet light, or electron beam.

For example, in the case of high-pressure steam sterilization, the preparation area is the preheating area, sterilization is carried out with high-pressure saturated steam in the main sterilization area, and the curing area is the area where the material is allowed to cool to room temperature.
In the case of dry heat sterilization, the preparation area is the preheating area, the main sterilization area is where the items are sterilized with high-temperature dry air, and the curing area is where the items are allowed to cool to room temperature.
In the case of gas sterilization, sterilization is carried out in the main sterilization area using ethylene oxide or the like. The preparation area is a preliminary heating or drying area, for example in winter or rainy seasons, and the curing area is a cooling area to room temperature or an area for dissipating residual ethylene oxide.
When the sterilization method in the main sterilization area is gamma ray, ultraviolet ray, or electron beam irradiation, the preparation area serves as a preliminary heating or drying area, for example in the winter or rainy season as described above, and the curing area serves as an area for eliminating the residual effects of gamma rays, ultraviolet ray, or electron beam.

In the present invention, the sterilization area consisting of the above-mentioned sterilization preparation area, main sterilization area, and sterilization regimen area can be configured, for example, as shown in FIG.
In Figure 2, in this example, the main sterilization area is divided into three areas: a first main sterilization area, a second main sterilization area, and a third main sterilization area. The passage from the sterilization preparation area to these three main sterilization areas branches into three passages, a first passage, a second passage, and a third passage, in the preparation area. These three passages are introduced into the first, second, and third main sterilization areas, and sterilization is carried out in these three main sterilization areas using an appropriate sterilization method such as high-pressure steam, dry heat, ultraviolet irradiation, etc., as described above.

In this case, the first, second, and third main sterilization zones may all use one sterilization method, or they may all use different sterilization methods. For example, the first main sterilization zone may be a high-pressure steam sterilization zone, the second main sterilization zone may be a dry heat sterilization zone, and the third main sterilization zone may be an ultraviolet irradiation sterilization zone.

In addition, sterilization can be performed in a variety of ways, for example by performing high-pressure steam sterilization in the first sterilization area, followed by dry heat sterilization in the second sterilization area or ultraviolet sterilization in the third sterilization area, or even by performing three types of sterilization in the order of first → second → third.
To facilitate this sterilization process, as shown in Figure 2, passages PW can be provided between the first and second sterilization areas, and between the second and third sterilization areas, to allow direct movement between these areas.

In addition, different medical devices can be sterilized simultaneously depending on the purpose of the medical devices and the user's request. For example, rubber stoppers can be sterilized in the first sterilization area, vials in the second sterilization area, and syringes in the third sterilization area all at once.

Then, as shown in Figure 2, the materials are transported from each of the multiple sterilization areas through the corresponding passages to the sterilization curing area, where they are cured and then merge together before being transported to the next area (the packaging and unloading area in the example of Figure 1).

The present invention can also perform the above-mentioned sterilization treatment on medical instruments stored in packaging materials. In other words, medical instruments stored in packaging materials that allow the passage of steam or gas can be transported through a sterilization area consisting of the above-mentioned sterilization preparation area, main sterilization area, and sterilization curing area, and sterilized together with the packaging materials. It is clear that if steam or gas can be passed through, ultraviolet rays, electron beams, and gamma rays can also be passed through.
Examples of such packaging materials include bag-shaped materials as shown in Figures 3(A) to (C) into which medical equipment items made of materials having rubber elasticity, such as rubber stoppers and pistons, are placed. Such bag-shaped materials are prepared in whole or in part from commercially available materials that allow the passage of steam (including high-pressure steam) and gas (ethylene oxide and other gases used in sterilization treatment) (for example, "Sterilization Bag" manufactured by Shizuko Sangyo Co., Ltd., "Cleantex Bag" manufactured by Amco Corporation, etc.).

The bag-shaped packaging material 30 shown in Figure 3 (A) is roughly rectangular in shape and has a circular opening 32 on one side (hereinafter referred to as the surface) near one of its longitudinal ends. An outer peripheral member 33 made of a synthetic resin or the like is provided to surround the outer periphery of the opening 32, and a lid 34 (see Figure 4), preferably made of a material that allows water vapor or gas to pass through, is configured to close the opening 32 by utilizing this outer peripheral member 33.
The bag-shaped packaging material 30 has a multi-layer structure including an inner bag 311 and an outer bag 312, and the inner bag 311 can be pulled out to the outside of the bag through an opening 32 as shown in the figure.

The bag-shaped packaging material 30' shown in Fig. 3(B) is roughly rectangular like the material in Fig. 3(A) and has a slit-shaped opening 32' on the surface near one end in the longitudinal direction, and although not shown, the opening 32' may be provided with a closing means such as a snap or a zipper, and although not shown, an inner bag may be pulled out from this opening 32' in the same way as the bag 30. The bag 30' does not have to have a multi-layer structure and may also have a single-layer structure.
Also, as shown in FIG. 3(C), the opening may be provided over the entire length of one of the short sides 32" of the rectangular bag 30" or partially at an appropriate location such as the center or one or both ends. In this bag 30", as in the case of bag 30', a closing means such as a snap or zipper (not shown) may be provided at the opening 32", or the bag may have a double structure of an outer bag and an inner bag so that the inner bag can be pulled out through the opening 32".

To store the medical instruments to be sterilized in such bag-shaped packaging materials 30-30'', for example, an "item input device" proposed by the applicant of the present application in Japanese Patent Application No. 2017-143571 is used, and each of the packaging materials 30-30'' is subjected to the above-mentioned sterilization process in the sterilization area shown in Figures 1 and 2.
Also, for example, a wire mesh pipe-shaped body 4 as shown in FIG. 4 may be used, and packaging material 30 (or 30' or 30") containing the above-mentioned medical instruments may be placed inside this pipe-shaped body 4, and this pipe-shaped body 4 may be rotated or inverted at appropriate angles. Alternatively, if multiple main sterilization zones are provided as shown in FIG. 2, sterilization may be carried out multiple times using different sterilization techniques, such as sterilization with high-pressure steam in the first main sterilization zone, sterilization with ultraviolet light in the second main sterilization zone, and sterilization with gas in the third main sterilization zone.
Of course, by moving the metal mesh pipe body 4 between these areas, sterilization can be performed by rotating or inverting it by an appropriate angle as described above during the movement or during sterilization in each sterilization area.

Furthermore, the container of Japanese Patent Application No. 2016-90235 by the applicant of the present application or an improved version thereof can be used as a packaging material, with vials, syringe cylinders and rods stored inside, and the container as a whole can be subjected to the above-mentioned sterilization treatment in the sterilization area shown in Figures 1 and 2.
For example, a combination of the container 5 shown in FIG. 5 and the holder 6 shown in FIGS. 6(A) and 6(B) is used as a packaging material.
As shown in Figure 5, the container 5 in this example has a roughly rectangular box-like planar shape and is equipped with an annular flange portion 51 extending outward from an upper opening, a first step portion (hereinafter referred to as the first shelf-like portion) 521 provided in an annular shape at a position a predetermined length toward the bottom surface side from the flange portion 51, and a second step portion (hereinafter referred to as the second shelf-like portion) 522 of roughly the same shape as the first shelf-like portion 521, located a certain distance L1 above the first shelf-like portion 521.

The holder 6 used in combination with the above-mentioned container 5 has a plate-shaped base portion 61 and a plurality of cup-shaped portions 62 protruding downward from this base portion 61, as shown in the plan view of Figure 6 (A) and the cross-sectional view of the same figure (B).
The periphery of the base portion 61 fits between the first shelf-like portion 521 and the second shelf-like portion 522 of the above-mentioned container 5 and is supported by the first shelf-like portion 521 (this support is achieved by simply placing the base end portion 61 on the first shelf-like portion 521, without fixing it in place), thereby constituting another example of the packaging material of the present invention.
At this time, it is preferable that the thickness L2 of the base plate portion 61 is smaller than the interval L1 between the first shelf-like portion 521 and the second shelf-like portion 522, in other words, the interval L1 between the first shelf-like portion 521 and the second shelf-like portion 522 is larger than the thickness L2 of the base plate portion 62, so that the holder 6 can move up and down within this interval L1. Of course, it is preferable to design the dimensions of the widths of the first shelf-like portion 521 and the second shelf-like portion 522 (portions protruding from the inner peripheral wall of the container 5 to the inner peripheral side - in other words, the "shelf width") so that the holder 6 does not come off the first shelf-like portion 521 or the second shelf-like portion 522 during this movement. In other words, if the shelf width is too small, the base plate portion 61 of the holder 6 is likely to come off, and if it is too large, the internal volume of the container 5 becomes relatively small, making it difficult to store the holder 6 in the container 5, so it is preferable to design it taking these factors into consideration.

The cup-shaped portion 62 provided in the holder 6 is open at the top and bottom and has a bowl shape with the diameter of the top opening being larger than that of the bottom opening. This bowl-shaped cup-shaped portion 62 is configured by making the cup-shaped portion 62 out of a mesh body (not shown) or by providing a plurality of slits SL in the wall of the cup-shaped portion 62 as shown in Figure 6 (B) so that sterilizing gases such as high-pressure steam and ethylene oxide, or ultraviolet rays, electron beams, gamma rays, etc. can pass through the inside of the cup-shaped portion 62.
In addition, reference numeral 63 in FIG. 6A indicates an upper opening of the bowl-shaped cup portion 62 .

6(C) shows a state in which a vial V is accommodated in the holder 6 configured as described above. The vial V is accommodated in an upright position in the cup-shaped portion 62 of the holder 6, and in this example, the periphery of the bottom of the vial V is partially in contact with the lower inner wall surface of the cup-shaped portion 62.
The vial V may be accommodated in the cup-shaped portion 62 after the holder 6 has been incorporated into the container 5 (the base portion 61 is supported on the first shelf portion 521), or the holder 6 may be incorporated into the container 5 after the vial V has been accommodated in the cup-shaped portion 62.

In this manner, after the vial V is stored in the container 5 using the holder 6, the upper opening of the container 5 is left open, or a sheet 53 (see FIG. 7) that allows water vapor or gas to pass through is attached to the upper surface of the annular flange portion 51.
The container 5, either in its open state or with a sheet 53 attached thereto, is placed in a wire mesh pipe-shaped structure 4 similar to that described above, as shown in Figure 7, and fixed to the wire mesh pipe-shaped structure 4 with a fixing device not shown. In the main sterilization area, the pipe-shaped structure 4 can be rotated an appropriate angle as described above, or sterilization can be performed multiple times using different techniques, such as sterilization with high-pressure steam in the first main sterilization area shown in Figure 2, sterilization with ultraviolet light in the second main sterilization area, and sterilization with gas in the third main sterilization area.

The rotation angle when the wire mesh pipe-shaped body 4 is rotated by an appropriate angle depends on the distance L1 between the first shelf-like portion 521 and the second shelf-like portion 522 and the thickness L2 of the base portion 61. For example, when the wire mesh pipe-shaped body 4 rotates clockwise, the container 5 placed inside also rotates clockwise together with the wire mesh pipe-shaped body 4. With this rotation, the left end of the base portion 61 of the holder 6 in the container 5 supported on the first shelf-like portion 521 of the container 5 gradually tilts upward in the drawing until it hits the second shelf-like portion 522 and stops tilting, while the right end tilts downward, but since it is supported by the first shelf-like portion 521 and the inner wall surface of the container 5, it will not fall off the first shelf-like portion 521.
When the wire mesh pipe 4 is rotated a predetermined angle (for example, 30°) and then turned over and rotated counterclockwise, the right end of the base portion 61 performs the above-mentioned movement.
In this way, the inclination angle of the left and right ends of the holder 6 when it rotates in conjunction with the rotation of the container 5 fixedly inserted within the wire mesh cylinder 4 depends on the above L1.

When the holder 6 moves as described above, the vial V stored in the holder 6 moves from the state shown in Figure 6 (C) to the state shown in Figure 6 (D) (clockwise) and (E) (counterclockwise), creating a non-contact area NC between the vial V and the bowl-shaped cup-shaped body 62.
The size of the non-contact portion NC is sufficient if it is large enough to allow high pressure steam or gas for sterilization, or ultraviolet rays or electron beams to pass through, so it need only be extremely small.

Furthermore, depending on the width of the base portion 61 of the holder 6 (the width of the portion supported on the shelf-like portion) and the dimensions of the shelf width of the shelf-like portion, when rotating clockwise and counterclockwise through the above-mentioned specified angle, the support on the first shelf-like portion 521 is maintained by contact between the periphery of the base portion 61 and the inner wall surface of the container 5, and the base portion 61 will not come off the shelf-like portion 521, so that the second shelf-like portion 522 may not be necessary.
Furthermore, the shelf-like parts supporting the base plate part 61 of the holder 6 can be provided in multiple stages in the height direction of the inner wall surface of the container 5, and the holder 6 can be assembled in multiple stages into the container 5. In such a case, the sterilization process can also be performed by rotating the wire mesh pipe-shaped body 4 in a swiveling manner, so to speak, in a clockwise and counterclockwise direction by a predetermined angle, in a sterilization area.

In addition, in the present invention, the movement of medical instruments stored in packaging materials within the sterilization area consisting of the sterilization preparation area, main sterilization area, and sterilization curing area may be automatic, for example by a conveyor belt or other robotic means, or may be manual, using a hand cart.
Furthermore, the packaging material containing the medical instruments that have been sterilized in the sterilization area is transferred to the packaging/shipping area shown in FIG. 1, where it is packaged for shipment. At least the inner surface of the packaging material for shipment that comes into contact with the packaging material may also be sterilized in advance.

30, 30', 30" bag-shaped packaging material 4 wire mesh pipe-shaped body 5 container 521, 522 shelf-shaped portion 6 holder 61 substrate 62 cup-shaped portion 63 upper opening of cup-shaped portion PW passage V vial NC non-contact portion

Claims (3)

A manufacturing factory for medical equipment,
A sterilization area having a sterilization preparation area, a main sterilization area, and a sterilization regimen area in this order is disposed between a manufacturing area and a shipping area of the medical devices, and is isolated from areas other than the sterilization area ;
A manufacturing factory for medical equipment, wherein the medical equipment to be sterilized is housed inside a packaging material through which water vapor or gas can pass. The medical equipment manufacturing factory according to claim 1, characterized in that there are multiple main sterilization areas, the passages from the sterilization preparation area to each main sterilization area branch into multiple passages within the preparation area, and the passages from each main sterilization area to the sterilization curing area join together in the curing area. A medical equipment manufacturing factory as described in claim 2, characterized in that each of the multiple main sterilization areas is provided with a passageway connecting each of the main sterilization areas.

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