JP2016129677A - Electron beam sterilization method - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide an electron beam sterilization method which can radiate electron beam on a whole external surface of an irradiated article uniformly by using a small low-energy electronic accelerator with a narrow window of source container, can keep reliability and safety of sterilization effect high by equalizing sterilization levels of each site, and can reduce cost of the electronic accelerator and reduce front-end cost and maintenance cost of the device by lengthening application limits (life).SOLUTION: An electron beam irradiation domain consisting of three electronic accelerators is used. An entire surface of an irradiated article can pass the electron beam irradiation domain uniformly by combining holding change of a holding part, move to one direction and an opposite direction, and 90° horizontal turn of the irradiated article.SELECTED DRAWING: Figure 10

Description

  The present invention relates to an electron beam sterilization method in which an exterior surface of a package containing a sterilized article is sterilized by electron beam irradiation, and the sterilized package is transported to a work room in an aseptic environment.

  Pre-filled syringes and pre-filled vials filled with pharmaceuticals are manufactured in advance for convenience in the medical field. The operation of filling these syringes and vials with medicines is performed in a filling work room (hereinafter referred to as an aseptic work room) in an aseptic environment. Syringes and vials used for this operation are small one by one, and a large quantity to be processed is required. Therefore, these syringes and vials are sterilized by γ-ray irradiation, electron beam irradiation, EOG (ethylene oxide gas), etc. at each manufacturing stage, and are transported into a sterile working room in a state where a predetermined number is stored in a package. The

  As this package, for example, there is a medical instrument package proposed in the following Patent Document 1 or described as the prior art (see FIG. 1). These packages are commonly referred to as peel-open packages, with plastic tabs shaped to the shape of articles such as syringes and vials housed inside and gas permeable top seals. It has. For this top seal, a non-woven fabric made of high-density polyethylene ultrafine fibers, Tyvek (trademark) is generally used. Gas permeation into the plastic tab is possible through the micropores of the Tyvek (trademark). Intrusion is blocked.

  The package thus configured is further distributed and transported by being wrapped in a packaging bag on the outside. However, the outer surface of the plastic tab and the top seal is contaminated during distribution and transportation, or when the plastic bag is taken out of the packaging bag for delivery into the aseptic work chamber. Therefore, the contaminated exterior surface cannot be carried into the aseptic work room unless it is sterilized. Therefore, the plastic tab and the outer surface of the top seal are sterilized by a sterilization device connected to the aseptic work chamber and then transported to the aseptic work chamber, and the top seal is peeled off from the plastic tab in the aseptic work chamber. A filling operation is performed on a sterilized syringe or vial.

  In these sterilizers, various methods such as EOG (ethylene oxide gas), hydrogen peroxide low-temperature gas, ozone gas, plasma, γ-ray irradiation, ultraviolet irradiation, or electron beam irradiation are employed in accordance with the purpose. Among these, one of the most common methods is a method using a hydrogen peroxide cold gas.

  The method using the hydrogen peroxide cold gas can achieve the required level of sterilization effect, but it takes a certain amount of processing time to sterilize the entire package. In the case of entering the inside of the plastic tub through the upper surface seal made of), there is a problem that it takes time to remove the hydrogen peroxide condensed inside.

  Therefore, in a sterilization apparatus that needs to process a large number of articles per unit time, such as in the manufacture of a prefilled syringe, a method that has a high sterilization effect with a short time treatment is desired. Therefore, the following Non-Patent Document 1 discloses a low-energy electron accelerator as a safe device that has a higher sterilization effect than a device using a general hydrogen peroxide low-temperature gas and has high productivity and no residual substances. A sterilizer that incorporates is introduced.

  This sterilizer is actually operated to process the package containing the prefilled syringe. The package containing the pre-sterilized syringe is sterilized with an electron beam on its exterior surface and transported to the aseptic work room by a conveyor. Is done. This device irradiates the entire surface of the package from three directions with three low energy electron accelerators each arranged at an angle of 120 degrees (see FIG. 9).

  In this apparatus, the plastic tab and the upper surface seal can be sterilized efficiently by controlling the dose of the electron beam to be irradiated. According to the following non-patent document 1, this apparatus can process as many as 3,600 syringes per hour, and realizes high productivity.

Patent No. 4,237,489

Japan Radiation Utilization Promotion Association, Radiation Utilization Technology Database, Data No .: 010306 (Creation: 2007/10/03, Masayuki Sekiguchi)

  By the way, in the sterilization apparatus of the said nonpatent literature 1, in order to sterilize the whole exterior surface of a medical instrument package, it is an angle of 120 degree | times to the outer peripheral part side of the medical instrument package conveyed toward a advancing direction, respectively. An electron beam is irradiated simultaneously from the three arranged low energy electron accelerators (see FIG. 9).

  However, this method is sufficient to irradiate the outer peripheral portion of the medical instrument package with an electron beam, but is insufficient to irradiate an electron beam in the front-rear direction of the medical instrument package. There was a problem that it was difficult to maintain high reliability and safety of the effect. Therefore, when irradiating the front and rear direction of the medical instrument package from the outer peripheral part, the distance from the irradiation window of each electron accelerator is increased, so that the irradiation angle is adjusted by enlarging the irradiation window of each electron accelerator and each electron accelerator. It is necessary to increase the irradiation intensity by increasing the acceleration voltage. In such a case, there is a problem that the use limit (life) due to the accumulated use time of the electron accelerator with a high acceleration voltage is shortened, and the maintenance cost of the apparatus is increased.

  Furthermore, when the irradiation intensity of each electron accelerator is increased to sufficiently sterilize the front and rear direction of the medical instrument package, the intensity of the irradiation varies depending on the site of the medical instrument package, and the irradiation intensity from the irradiation window of the electron accelerator is increased. Irradiation with an excessive electron beam is performed at the outer peripheral portion where the distance is short, and the medical instrument package is damaged. Further, in this case, there is a problem that the sterilization level differs depending on each part of the medical instrument package.

  On the other hand, in order to irradiate an electron beam from the outer peripheral part of a medical instrument package, it is necessary to use an irradiation window of three low energy electron accelerators whose irradiation width is wider than the irradiation width of the corresponding medical instrument package. was there. Low energy electron accelerators that have an irradiation window wider than the irradiation width of a medical instrument package that is generally used are expensive in price per unit, and are replaced by the limit of use (life) due to the accumulated usage time. Maintenance costs are also expensive. Therefore, there is a problem that the initial cost and the maintenance cost of the device are increased by operating three expensive devices at the same time.

  On the other hand, in recent years, many types of low-energy electron accelerators having a small apparatus size and a small apparatus size have been manufactured due to the widespread use of electron beam irradiation. Generally, a low-energy electron accelerator has a low device price if the width of the irradiation window is narrowed. Further, since the electron accelerator is reduced in size, the electron beam irradiation apparatus itself is also compact, and both the initial cost and the maintenance cost of the apparatus including the cost of the electron accelerator can be reduced.

  However, using a low energy electron accelerator with an irradiation window that is narrower than the width of the medical instrument package used, the entire exterior surface of the medical instrument package cannot be sterilized. If more than three electron accelerators are used, the initial cost and maintenance cost of the apparatus cannot be reduced compared to the conventional method.

  Therefore, the present invention addresses the above-mentioned problems, and can uniformly irradiate the entire outer surface of the irradiated object using a small low energy electron accelerator with a narrow irradiation window. The same level of sterilization can be maintained to maintain high reliability and safety of the sterilization effect, and the electronic accelerator cost and usage limit (lifetime) can be extended to keep the initial cost and maintenance cost of the equipment low. An object is to provide a method of wire sterilization.

  In solving the above problems, the present inventors, as a result of diligent research, combined a small low-energy electron accelerator with a narrow irradiation window, and changed part of the irradiated object within the electron beam irradiation region formed by these electron accelerators. As a result, it was found that the entire surface of the irradiated object can be irradiated uniformly with an electron beam, and the present invention has been completed.

That is, according to the description of claim 1, the electron beam sterilization method according to the present invention,
A method of sterilizing an irradiated object (P) consisting of a hexahedron having an upper surface, a lower surface and four side surfaces by electron beam irradiation,
The irradiation windows (31a, 32a, 33a) of the three electron accelerators (31, 32, 33) face the three irradiation surfaces, with the upper surface, the lower surface, and one side surface of the irradiation object as the irradiation surfaces. Using the electron beam irradiation region (Z) positioned substantially parallel to
A first step of clamping the first clamping part of the irradiated object;
The first object is moved in one direction with the irradiation object sandwiched therebetween, and at least a half of the upper surface and the lower surface of the irradiation object and the entire surface of the first side surface pass through the electron beam irradiation region. Two steps,
A third step of rotating 90 ° horizontally while holding the irradiated object;
The object is moved in the opposite direction while holding the object to be irradiated, and at least one half of the upper surface and the lower surface of the object to be irradiated and the entire surface of the second side surface pass through the electron beam irradiation region. 4 steps,
A fifth step of opening the first holding portion of the irradiated object and holding the second holding portion irradiated with the electron beam in the fourth step;
The first object moves in one direction while holding the irradiation object, and at least a half of the upper surface and the lower surface of the irradiation object and the entire surface of the third side surface pass through the electron beam irradiation region. 6 steps,
A seventh step of rotating 90 ° horizontally while sandwiching the irradiated object;
The object is moved in the opposite direction while holding the object to be irradiated, and at least a half of the upper surface and the lower surface of the object to be irradiated and the entire surface of the fourth side surface pass through the electron beam irradiation region. 8 steps,
A ninth step of opening the second clamping part of the irradiated object,
The entire surface of the irradiated object is sterilized along the first to ninth steps.

  According to the said structure, the electron beam sterilization method which concerns on this invention irradiates an electron beam from the upper side of a to-be-irradiated object, a downward direction, and one side. Further, it is possible to employ an electron accelerator having an irradiation window narrower than the irradiation width of the upper and lower surfaces of the irradiated object, and by combining the holding, moving and rotating of the irradiated object by the holding and moving means, multiple times. The whole surface is irradiated with an electron beam. Thus, since an electron beam is irradiated in multiple times, an electron beam can be irradiated uniformly from a short distance to the surface to be irradiated. In addition, since the electron beam can be irradiated to the irradiated surface from a short distance, the electron accelerator can be operated with a low acceleration voltage.

  For these reasons, the electron beam sterilization method according to the present invention has the same level of sterilization on the entire surface of the irradiated object, and can maintain high reliability and safety of the sterilization effect. In addition, since a compact small-sized low energy electron accelerator having a narrow irradiation window can be adopted, the electron beam irradiation apparatus itself is also compact, and the initial cost of the apparatus including the cost of the electron accelerator can be kept low. Furthermore, since this small low-energy electron accelerator can be operated at a low acceleration voltage, the use limit (life) of the electron accelerator becomes long, and the maintenance cost of the apparatus can be kept low.

  Thus, in the present invention, it is possible to uniformly irradiate the entire outer surface of the irradiated object using a small low energy electron accelerator with a narrow irradiation window, and the sterilization level of each part is comparable. An electron beam sterilization method that can maintain high reliability and safety of the sterilization effect as well as extend the cost and use limit (lifetime) of the electronic accelerator to keep the initial cost and maintenance cost of the apparatus low. be able to.

It is a perspective view which shows the to-be-irradiated object (package) of the electron beam sterilization method which concerns on this embodiment. It is a schematic plan view which shows the electron beam irradiation apparatus used for the electron beam sterilization method which concerns on this embodiment. It is a schematic front view which shows the electron beam irradiation apparatus of FIG. It is the elements on larger scale of A in FIG. It is a schematic perspective view which shows the inside of the main body of the electron beam irradiation apparatus of FIG. It is a schematic perspective view which shows the chuck | zipper slide apparatus in FIG. It is a schematic perspective view which shows the rotation member and chuck member of a chuck slide apparatus. It is a schematic perspective view which shows arrangement | positioning of a positioning cylinder. It is a schematic diagram which shows arrangement | positioning of the electron accelerator of the conventional electron beam irradiation apparatus. It is a schematic diagram which shows arrangement | positioning of the electron accelerator of the electron beam irradiation apparatus used for the electron beam sterilization method which concerns on this embodiment. It is process drawing 1 which shows the action | operation of a chuck slide apparatus. It is process drawing 2 which shows the action | operation of a chuck slide apparatus. FIG. 4 is a process diagram 3 illustrating the operation of the chuck slide device. FIG. 5 is a process diagram 4 illustrating the operation of the chuck slide device. It is process drawing 5 which shows the action | operation of a chuck | zipper slide apparatus. It is process drawing 6 which shows the action | operation of a chuck | zipper slide apparatus. It is process drawing 7 which shows the action | operation of a chuck | zipper slide apparatus. It is process drawing 8 which shows the action | operation of a chuck | zipper slide apparatus. It is process drawing 9 which shows the action | operation of a chuck | zipper slide apparatus. It is process drawing 10 which shows the action | operation of a chuck | zipper slide apparatus.

  In the present invention, “sterilization” is used in a broad sense including the concept of “decontamination” in addition to the concept of “sterilization”. Here, the original “sterilization” means that according to “Guidelines for the production of aseptic medicines by aseptic manipulation” (so-called Japanese guidelines for aseptic manipulation), “All kinds of microorganisms, whether pathogens or non-pathogens, It is defined as "a method for obtaining a state in which no microorganisms are present in a target substance by killing or removing it".

  On the other hand, “decontamination” is defined as “removing or reducing viable microorganisms or fine particles to a predesignated level by a reproducible method” according to the Japanese version of the Aseptic Operation Guidelines.

Here, since the number of bacteria cannot be made zero from a stochastic concept, a sterility assurance level (SAL: Sterility Assurance Level) is adopted in practice. According to this SAL, the original “sterilization” is to kill or remove all kinds of microorganisms from the exterior part of the container, and guarantee a level of SAL ≦ 10 ^−12. . As a method that can guarantee this level, for example, a method of setting the required dose in electron beam irradiation to 25 kGy (see ISO-13409) can be used.

On the other hand, according to SAL, “decontamination” means to reduce viable microorganisms from the exterior part of the container, and guarantee a level of SAL ≦ 10 ⁻⁶ . As a decontamination method that can guarantee this level, a method using hydrogen peroxide gas has been conventionally used. In the present invention, it is possible to cope with the electron beam irradiation by reducing the required dose to about 15 kGy, for example. Therefore, as described above, in the present invention, the term “sterilization” is used as a broad concept including the original “sterilization” and “decontamination”.

  Hereinafter, an embodiment of an electron beam sterilization method according to the present invention will be described with reference to the drawings. First, the irradiation object of the electron beam sterilization method according to the present embodiment will be described. FIG. 1 is a perspective view showing a medical instrument package as an irradiation object in the present embodiment. In FIG. 1, a package P includes a polyethylene tab P1 and a top seal P2 made of Tyvek (trademark). In the present embodiment, a large number of sterilized syringes used for the filling operation of the prefilled syringe are housed therein, and the electron beam is irradiated in a sealed state. In the present embodiment, the size of the package P is 260 mm in length, 230 mm in width, and 100 mm in height.

  Next, the electron beam sterilization method according to this embodiment will be described. FIG. 2 is a schematic plan view showing an electron beam irradiation apparatus used in the electron beam sterilization method according to the present embodiment, and FIG. 3 is a schematic front view of the electron beam irradiation apparatus. As shown in FIGS. 2 and 3, the electron beam irradiation apparatus 100 used in the electron beam sterilization method according to the present embodiment is placed on the main body base 10 placed on the floor surface and on the main body base 10. The electron beam irradiating device main body 20 is mounted, and a carry-in pass box 71 and a carry-out pass box 72 are provided in series before and after the electron beam irradiating device main body 20.

  The periphery of the electron beam irradiation apparatus main body 20 is covered with an outer wall portion 21 made of a stainless steel metal plate. The interior of the electron beam irradiation apparatus main body 20 is formed with an electron beam irradiation chamber 22, a decompression chamber 23 positioned below the electron beam irradiation chamber 22, and a lower side thereof. Each wall portion is partitioned into a machine room 24 (see FIG. 4, which will be described later). The outer wall portion 21 shields the electron beam irradiated inside the electron beam irradiation chamber 22 and the X-rays generated by the electron beam irradiation from leaking outside.

  2 and 3, a carry-in pass box 71 is continuously provided on the outer wall portion 21 a on the left side surface of the electron beam irradiation apparatus main body 20. A first carry-in port 73 for carrying the unsterilized package P into the carry-in pass box 71 is opened in the outer wall portion 71 a on the left side surface of the carry-in pass box 71. The first carry-in port 73 is provided with a shutter 73a that can be opened and closed in the vertical direction.

  Further, the wall portion facing the outer wall portion 71 a of the carry-in pass box 71 constitutes a common wall portion with the outer wall portion 21 a of the electron beam irradiation apparatus main body 20. The wall portion is opened with a second carry-in port 25 through which the inside of the electron beam irradiation chamber 22 and the inside of the carry-in pass box 71 are communicated to carry the package P in the carry-in pass box 71 into the electron beam irradiation chamber 22. doing. The second carry-in port 25 is provided with a shutter 25a that can be opened and closed in the vertical direction.

  On the other hand, a carry-out pass box 72 is connected to the outer wall portion 21 b on the right side surface of the electron beam irradiation apparatus main body 20. The left side wall portion of the carry-out pass box 72 constitutes a common wall portion with the outer wall portion 21 b on the right side surface of the electron beam irradiation apparatus main body 20. The wall portion communicates with the inside of the electron beam irradiation chamber 22 and the inside of the unloading pass box 72 so as to unload the sterilized package P from the inside of the electron beam irradiation chamber 22 into the unloading pass box 72. 26 is open. The first carry-out port 26 is provided with a shutter 26a that can be opened and closed in the vertical direction.

  Further, the sterilized package P in the carrying-out pass box 72 is placed on the outer wall 72a on the right side of the carrying-out pass box 72 facing the outer wall 21b on the right-hand side of the electron beam irradiating device main body 20. A second carry-out port 74 for carrying out from 100 is opened. The second carry-out port 74 is provided with a shutter 74a that can be opened and closed in the vertical direction. In the present embodiment, the second carry-out port 74 is opened toward the inside of a sterile work chamber (not shown) connected to the electron beam irradiation apparatus 100, and the entire outer surface is formed by the electron beam irradiation apparatus 100. The package P sterilized is carried into the aseptic work chamber.

  FIG. 4 is a partially enlarged view of A in FIG. In FIG. 4, the electron beam irradiation chamber 22 located in the upper layer part is separated from the decompression chamber 23 located in the lower part thereof by the partition wall part 23a, and inside the electron beam irradiation chamber 22 while carrying the package P, as will be described later. Sterilization by irradiation is performed. On the other hand, the machine room 24 located in the lower layer part is separated from the decompression room 23 located on the upper side by a partition part 23b, and a drive part of a chuck slide device (described later) for transporting the package P is housed in the machine room 24. It has been. The decompression chamber 23 located in the middle layer is separated from the electron beam irradiation chamber 22 and the machine chamber 24 by the partition wall portion 23a and the partition wall portion 23b, and is operated by a vacuum pump (not shown) installed outside. 22 and the machine room 24 are maintained at a negative pressure. In order to maintain the negative pressure, not only a vacuum pump but also an exhaust blower may be used.

  Since the decompression chamber 23 is maintained at a negative pressure from the electron beam irradiation chamber 22 and the machine chamber 24, ozone generated secondary by the electron beam irradiation is externally transmitted from the electron beam irradiation chamber 22 through the decompression chamber 23. By being sucked, corrosion inside the electron beam irradiation chamber 22 and the machine chamber 24 is reduced. Further, the amount of ozone in the electron beam irradiation chamber 22 is reduced by suction, so that the invasion of ozone into the package P is greatly reduced, and the syringe housed therein and the syringe are filled in a subsequent process. The effect on the final product such as filling liquid is reduced. Further, since the decompression chamber 23 is maintained at a negative pressure from the electron beam irradiation chamber 22 and the machine chamber 24, fine dust caused by sliding or the like generated in the machine chamber 24 is passed from the machine chamber 24 through the decompression chamber 23. It is sucked out and the inside of the electron beam irradiation chamber 22, the package P, and the syringe housed therein are not contaminated.

  Here, the inside of the electron beam irradiation apparatus used for the electron beam sterilization method according to the present embodiment will be described. FIG. 5 is a schematic perspective view showing the inside of the electron beam irradiation apparatus main body 20. In FIG. 5, the outer wall portion 21 of the electron beam irradiation apparatus main body 20 and the outer wall portions of the carry-in pass box 71 and the carry-out pass box 72 are indicated by virtual lines, and the partition wall portion 23a of the electron beam irradiation apparatus main body 20 is shown. And the partition wall 23b are omitted. Further, in FIG. 5, on the upper left side, a first carry-in port 73 (shutter 73a is not shown) and a second carry-in port 25 (shutter 25a are not shown) for carrying the package P before sterilization into the electron beam irradiation chamber 22. ) Are provided, and on the lower right side, a first carry-out port 26 (shutter 26a is not shown) for carrying out the sterilized package P from the electron beam irradiation chamber 22 and a second carry-out port 74 (shutter 74a is not shown). ) Is provided. Therefore, in FIG. 5, the package P is transported from the upper left to the lower right. Hereinafter, this direction is referred to as a conveyance direction of the package P.

  In FIG. 5, the electron beam irradiation apparatus main body 20 includes an electron beam generator 30, a chuck slide device 40, a transport device 50, and a positioning cylinder 60 therein. The electron beam generator 30 is disposed in the center of the electron beam irradiation apparatus main body 20 and is composed of three electron accelerators 31, 32, and 33. Each of the three electron accelerators 31, 32, and 33 has a terminal for generating an electron beam, an acceleration tube for accelerating the generated electron beam in a vacuum space, and a power supply device (none of which is shown) for operating them. Irradiation windows 31a, 32a, 33a made of metal foil for irradiating the emitted electron beam are provided. In the present embodiment, each electron accelerator has an irradiation window that is narrower than the width of the upper surface or the lower surface of the package P and wider than the width of the side surface of the package P (width in the height direction). . Specifically, it has an irradiation window with a long side (width direction) of 145 mm and a short side (length direction) of 25 mm with respect to the upper surface size (longitudinal 260 mm) of the package P, and the acceleration voltage is in the range of 40 to 70 kV. A small low energy electron accelerator of the same type that can be adjusted with the

  In FIG. 5, the electron accelerator 31 is provided with an irradiation window 31 a that irradiates an electron beam from an outer wall portion 21 c (see FIG. 3) on the upper surface of the electron beam irradiation apparatus main body 20 facing downward in the electron beam irradiation chamber 22. Yes. The electron accelerator 32 is provided with an irradiation window 32 a that irradiates an electron beam from an outer wall portion 21 d (see FIG. 3) on the lower surface of the electron beam irradiation apparatus main body 20 facing upward inside the electron beam irradiation chamber 22. Further, the electron accelerator 33 is provided with an irradiation window 33a for irradiating an electron beam from an outer wall portion 21e (see FIG. 2) on the back surface of the electron beam irradiation apparatus main body 20 in a slightly upward direction in the front direction inside the electron beam irradiation chamber 22. . The reason why the irradiation direction of the electron accelerator 33 is provided slightly upward rather than in the horizontal direction is to face the inclined side surface of the package P in parallel.

  In this way, each electron accelerator 31, 32, 33 is arranged from three directions so that the long side (width direction) of each irradiation window is perpendicular to the transport direction of the package P, and these three irradiations. The electron beams irradiated from the windows 31a, 32a, and 33a form a U-shaped electron beam irradiation region Z perpendicular to the transport direction of the package P. The relationship between the electron beam irradiation region Z formed by each irradiation window 31a, 32a, 33a and each surface of the package P will be described later.

  Next, the chuck slide device 40 will be described. In FIG. 5, the chuck slide device 40 is arranged across the front side left and right direction (parallel to the transport direction of the package P) in the electron beam irradiation apparatus main body 20, and two linear motor tables 41 and 42, 2 The rotating members 43 and 44 of a base and the two chuck members 45 and 46 are provided. The chuck slide device 40 includes two linear motor tables 41 and 42, two rotating members 43 and 44, and two chuck members 45 and 46. Let Z pass. Here, FIG. 6 is a schematic perspective view showing the chuck slide device 40, and unlike FIG. 5, a partition wall portion 23 a that separates the electron beam irradiation chamber 22, the decompression chamber 23, and the machine chamber 24 in the electron beam irradiation apparatus body 20. And the state which displayed a part of partition part 23b is shown.

  5 and 6, the two linear motor tables 41 and 42 are respectively arranged in the left-right direction (conveyance of the package P) on the front side of the electron accelerator 32 of the machine room 24 located in the lower layer portion of the electron beam irradiation apparatus main body 20. Two beds 41a, 42a arranged in parallel to the direction), two movable tables 41b, 42b mounted on the top of each bed 41a, 42a, each bed 41a, 42a and each movable table And two AC linear servo motors (not shown) incorporated between 41b and 42b.

  5 and 6, the two beds 41 a and 42 a are both long box bodies, which are formed in parallel with each other and are formed by three electron accelerators 31, 32 and 33. It is arranged in a direction perpendicular to the electron beam irradiation area Z of the mold. The bed 41a extends from the center of the electron beam irradiation apparatus main body 20 to the left (the second carry-in entrance 25 side), and the bed 42a extends from the center of the electron beam irradiation apparatus main body 20 to the right (the first carry-out exit 26 side). Exists. The two movable tables 41b and 42b are both square plates, and reciprocate in the transport direction of the package P on the beds 41a and 42a by the operation of the AC linear servo motors. In this embodiment, this reciprocating movement is called movement in the X-axis direction.

  Here, FIG. 7 is a perspective view showing the rotating member 43 and the chuck member 45 which are one of the two rotating members 43 and 44 and the two chuck members 45 and 46. 5, 6, and 7, the two rotating members 43 and 44 extend upward from the two rotating platforms 43a and 44a mounted on the movable tables 41b and 42b, respectively. There are provided two rotating shafts 43b and 44b, and two rotary drive motors (not shown) built in each rotary mount 43a and 44a.

  The two rotary mounts 43a and 44a are both rectangular boxes, and are fixed so as to be integrated with the movable tables 41b and 42b, respectively, and each movable table 41b, 42b is reciprocated in the X-axis direction on the beds 41a and 42a. The two rotary shafts 43b and 44b are both cylindrical bodies, and extend in the vertical direction from the upper surfaces of the rotary mounts 43a and 44a, respectively. Then, it has extended to the electron beam irradiation chamber 22 located in the upper layer part of the electron beam irradiation apparatus main body 20 (refer FIG.4 and FIG.6). The respective rotating shafts 43b and 44b are rotated in either the left or right direction around the extending direction by driving of the respective rotation driving motors. In this embodiment, this rotation is called rotation in the θ-axis direction.

  In FIG. 6, the two rotating shafts 43 b and 44 b are each opened in two partition wall portions 23 a and 23 b that separate the electron beam irradiation chamber 22 and the machine chamber 24 from the decompression chamber 23, each parallel to the transport direction of the package P. It extends from the machine room 24 to the electron beam irradiation chamber 22 through the horizontally long slide openings 23c and 23d. Therefore, when the two rotary members 43 and 44 reciprocate in the X-axis direction on the respective beds 41a and 42a together with the respective movable tables 41b and 42b by the operation of the respective linear motor tables 41 and 42, the two rotation members 43 and 44 are rotated. The shafts 43b and 44b reciprocate in the X-axis direction along the slide openings 23c and 23d.

  5, 6, and 7, the two chuck members 45 and 46 are respectively provided with two support portions 45 a and 46 a fixed to the respective rotation shafts 43 b and 44 b, and horizontally from the support portions 45 a and 46 a. Two pairs of chuck claws 45b and 46b extending, and two opening / closing drive motors (not shown) built in the support portions 45a and 46a are provided.

  The two support portions 45a and 46a are both rectangular box bodies, which are fixed so as to extend in the tangential direction from the outer periphery of the extended end portions 43c and 44c of the rotation shafts 43b and 44b, respectively. The rotation of the rotating shafts 43b and 44b is caused by the operation of the members 43 and 44 to rotate in any of the outer peripheral directions. The two chuck claws 45b and 46b are both made up of a pair of upper and lower L-shaped claws and extend horizontally from the upper and lower ends of the extended end portions 45c and 46c of the support portions 45a and 46a, respectively. The two chuck claws 45b and 46b are opened and closed in the vertical direction by driving of the respective open / close drive motors so as to sandwich the corner portion of the package P from the vertical direction (see FIG. 7). The two chuck claws 45b and 46b are arranged symmetrically with respect to the support portions 45a and 46a (see FIG. 6).

  In FIG. 5, the transport device 50 includes two drive type roller conveyors 51 and 52 each including a drive motor. The two roller conveyors 51 and 52 may be inclined roller conveyors that do not incorporate a drive motor. Alternatively, both may be a combination of a horizontal non-drive type roller conveyor and a pusher.

  The roller conveyor 51 transports the package P from the outside of the electron beam irradiation apparatus 100 to the inside of the carry-in pass box 71 and the electron beam irradiation chamber 22 via the first carry-in port 73 and the second carry-in port 25. The package P before sterilization is carried into the electron beam irradiation chamber 22 (see FIGS. 2 and 3). At this time, a guide for guiding the conveyance of the package P may be provided on the roller conveyor 51. At the front end in the traveling direction of the roller conveyor 51 (in the electron beam irradiation chamber 22), the chuck member 45 receives the package P before sterilization (described later).

  The roller conveyor 52 carries the package P from the inside of the electron beam irradiation chamber 22 and the carry-out pass box 72 to the outside of the electron beam irradiation apparatus 100 via the first carry-out port 26 and the second carry-out port 74. The sterilized package P is carried out to the outside of the electron beam irradiation apparatus 100 (inside the aseptic work chamber) (see FIGS. 2 and 3). At this time, a guide for guiding the conveyance of the package P may be provided on the roller conveyor 52. At the rear end in the traveling direction of the roller conveyor 52 (in the electron beam irradiation chamber 22), the sterilized package P is delivered from the chuck member 46 (described later).

  In FIG. 5, the positioning cylinder 60 is composed of two cylinders 61 and 62 provided on the left and right sides of the front end portion (in the electron beam irradiation chamber 22) of the roller conveyor 51, and the sterilization carried by the roller conveyor 51. The position of the previous package P is corrected to a position where the chuck member 45 can pinch the package P accurately. Here, FIG. 8 is a schematic perspective view showing the arrangement of the positioning cylinder 60, and is a perspective view seen from the diagonal side (opposite side) of the package P with respect to FIG. Therefore, in FIG. 8, the package P before sterilization is conveyed from the lower right side to the upper left direction.

  In FIG. 8, a cylinder 61 is disposed on the left side of the front end of the roller conveyor 51 in the traveling direction, and has a rectangular base 61a provided on the bottom wall (partition wall 23a) of the electron beam irradiation chamber 22, and an upper surface of the base 61a. Telescopic support 61b extending upward from the base, an L-shaped fixing claw 61c fixed to the extended end of the telescopic support 61b, and a telescopic drive motor (illustrated) built in the gantry 61a to extend and contract the telescopic support 61b Not).

  The cylinder 62 is disposed slightly diagonally on the right side slightly behind the front end of the roller conveyor 51 in the direction of travel, and extends from the bottom wall (partition wall 23a) of the electron beam irradiation chamber 22 with the cylinder 61 and the package P interposed therebetween. An L-shaped gantry 62a whose tip extends in the direction of the cylinder 61, a telescopic column 62b extending horizontally from the tip of the gantry 62a in the direction of the cylinder 61, and an extension end of the telescopic column 62b A fixed L-shaped fixing claw 62c and a telescopic drive motor (not shown) which is built in the gantry 62a and expands and contracts the telescopic support 62b are provided. The two fixing claws 61c and 62c sandwich two corner portions on the diagonal line of the package P with the L-shaped inner surfaces facing each other. The operation of the positioning cylinder 60 will be described later.

An operation of sterilizing the exterior part of the package P using the electron beam irradiation apparatus 100 used in the electron beam sterilization method according to the present embodiment configured as described above, and carrying the sterilized package P into the aseptic work chamber. Will be described. In FIG. 3, an aseptic work chamber (not shown) is connected to the outer wall 72a on the right side surface of the carry-out pass box 72 of the electron beam irradiation apparatus 100, and the prefilled syringe is filled in the aseptic work chamber. It has been broken. At this time, the shutter 73a of the first carry-in port 73, the shutter 25a of the second carry-in port 25, the shutter 26a of the first carry-out port 26, and the shutter 74a of the second carry-out port 74 of the electron beam irradiation apparatus 100 are all selected. Are closed, and the external environment, the inside of the electron beam irradiation apparatus 100 and the aseptic work room are hermetically shut off. The inside of the electron beam irradiation apparatus 100 is sterilized with hydrogen peroxide gas in advance to a level that guarantees SAL ≦ 10 ⁻⁶ .

  Here, an operator in the external environment opens the shutter 73a of the first carry-in port 73 that opens to the carry-in pass box 71 of the electron beam irradiation apparatus 100, and the package is provided via the roller conveyor 51 of the electron beam irradiation apparatus 100. P is carried into the carrying-in pass box 71. Thereafter, the shutter 73a is closed. The package P carried into the carry-in pass box 71 is carried into the electron beam irradiation chamber 22 through the shutter 25 a of the second carry-in port 25 while being carried by the roller conveyor 51. A series of operation steps from the operation of carrying the package P into the electron beam irradiation device 100 via the roller conveyor 51 to the operation of carrying the package P out of the electron beam irradiation device 100 via the roller conveyor 52 are as follows. Each may be performed manually, or may be controlled by a control mechanism incorporating a microcomputer.

  In FIG. 8, when the roller conveyor 51 is transporting the package P, the cylinder 61 of the positioning cylinder 60 extends the telescopic column 61b, and the fixed pawl 61c is stopped at a fixed position. The position of the fixing claw 61c of the cylinder 61 corresponds to the corner portion P3 on the left front side in the conveyance direction of the package P. In this state, in FIG. 8, the unsterilized package P that has been transported from the lower right side stops at the front end in the traveling direction of the roller conveyor 51. The position of the package P is disturbed by conveyance, and the corner portion P3 on the left front side in the conveyance direction of the package P does not accurately correspond to the L-shaped position of the fixing claw 61c of the cylinder 61.

  Therefore, it is difficult for the chuck member 45 to correctly hold the package P in this state. Therefore, the telescopic support 62b of the cylinder 62 extends and stops at a fixed position while pushing the corner part P4 on the diagonal line of the package P by the fixing claw 62c. In this state, the package P is stopped in a state where the two corner portions P3 and P4 on the diagonal line are sandwiched by the L-shaped fixing claws 61c and 62c of the cylinders 61 and 62 and are corrected to the fixed positions ( (See FIG. 8).

  Next, the chuck member 45 moves backward on the bed 41 a in the X-axis direction (moves backward in the transport direction of the package P) by the operation of the linear motor table 41, and moves to the front end portion in the traveling direction of the roller conveyor 51. At this position, the chuck member 45 pinches and captures another corner portion P5 of the package P from above and below. Next, the telescopic support 61b of the cylinder 61 is retracted downward, and the telescopic support 62b of the cylinder 62 is retracted rearward. From this state, the chuck member 45 advances in the conveyance direction of the package P (upper left direction in FIG. 8, lower right direction in FIG. 5) while holding the package P therebetween. Next, in FIG. 5, the package P is clamped by the chuck member 45 that moves forward in the X-axis direction (moves forward in the transport direction of the package P) on the bed 41a by the operation of the linear motor table 41. It passes through the irradiation area Z.

  Here, regarding the relationship between the arrangement of the three electron accelerators 31, 32, 33 and each surface of the package P in the electron beam irradiation apparatus 100 used in the electron beam sterilization method according to the present embodiment, a conventional electron beam irradiation apparatus This will be described in comparison with the arrangement of the electron accelerator in FIG. FIG. 9 is a schematic diagram showing the arrangement of electron accelerators in a conventional electron beam irradiation apparatus. In FIG. 9, three low energy electron accelerators 34, 35, and 36 arranged at an angle of 120 degrees each irradiate the entire surface of the package P from three directions. Further, the package P moves from the back direction to the front direction in the drawing, and can irradiate the entire surface including the front and back surfaces of the package P with an electron beam.

  Therefore, in the conventional electron beam irradiation apparatus, as shown in FIG. 9, it is necessary to use an electron accelerator having large irradiation windows 34a, 35a, 36a. Further, the distance from the irradiation window 34a, 35a, 36a of each electron accelerator to each irradiated portion of the package P is different, and uniform electron beam irradiation cannot be performed, and in order to perform stable sterilization, a higher acceleration voltage is required. I need. For example, the irradiation window of a conventional electron accelerator is as large as 400 mm both vertically and horizontally, and the acceleration voltage is as high as 150 to 300 kV. Therefore, the cost of the electron accelerator is high, the initial cost of the apparatus is high, and since the operation is performed with a high acceleration voltage, the use limit (life) of the electron accelerator is short and the maintenance cost is high.

  On the other hand, FIG. 10 is a schematic diagram showing the arrangement of the electron accelerators of the electron beam irradiation apparatus used in the electron beam sterilization method according to the present embodiment. 10, the electron beam irradiation apparatus 100 used for the electron beam sterilization method according to this embodiment includes the three electron accelerators 31, 32, and 33 as described above. The electron accelerator 31 is positioned in parallel so that the long side (width direction) of the irradiation window 31a is opposed to the surface of approximately one half of the upper surface P11 of the package P. The electron accelerator 32 is positioned in parallel so that the long side (width direction) of the irradiation window 32a is opposed to the substantially half surface of the lower surface P12 of the package P. The electron accelerator 33 is positioned in parallel so that the long side (width direction) of the irradiation window 33a faces the entire surface of one side surface P13 of the package P. Although not shown in FIG. 10, the package P moves from the back direction to the front direction or the reverse direction with the left corner portion shown in the figure held between the chuck members 45 or 46.

  Thus, the three electron accelerators 31, 32, 33 of the electron beam irradiation apparatus 100 used for the electron beam sterilization method according to the present embodiment irradiate the electron beam from above, below, and one side of the package P. To do. In FIG. 10, the three electron accelerators 31, 32, and 33 irradiate an electron beam from each irradiation window in a substantially vertical direction, and the U-shaped region surrounded by these becomes the electron beam irradiation region Z. . In the present embodiment, the irradiation windows 31a, 32a, 33a of each electron accelerator have an irradiation width that is less than half that of the conventional electron accelerator of FIG. 9, and the electron accelerators 31, 32, 33 themselves are also compact. Things can be used. Further, as will be described later, since the site at a distance from the irradiation window is sterilized in a separate process, it is not necessary to sterilize the front and rear surfaces. Therefore, the width of the irradiation window may be narrow. In the present embodiment, as described above, an electron accelerator having an irradiation window with a long side (width direction) of 145 mm and a short side (length direction) of 25 mm is employed. As a result, the cost of the electron accelerator is low, and the initial cost of the apparatus can be kept low.

  Further, the irradiation windows 31a, 32a, 33a of each electron accelerator and the upper surface P11, the lower surface P12, and one side surface P13, which are the irradiated portions of the package P, face each other substantially in parallel. Moreover, the distance between these is substantially the same, and uniform electron beam irradiation can be performed from a short distance. As a result, the acceleration voltage of each electron accelerator can be kept low, the use limit (life) of the electron accelerator can be extended, and the maintenance cost of the apparatus can be kept low. In this embodiment, the distance from each irradiation window to the package P was about 20 mm, and the acceleration voltage was 70 kV.

  In the present embodiment, as shown in FIG. 10, the surface of approximately one half of the upper surface P11 of the package P irradiated with the electron beam and the surface of approximately one half of the lower surface P12 are on the same side as the side surface P13. (The right side in FIG. 10) and these surfaces are sterilized by passing through the electron beam irradiation region Z. On the other hand, the remaining surfaces (the left side in FIG. 10) of the upper surface P3 and the lower surface P4 of the package P, and the three side surfaces (the left side surface and the front and rear surfaces in FIG. 10) other than the side surface P5 are hardly subjected to electron beam irradiation and sterilized. Not. However, in this embodiment, the operation of the chuck slide device 40 can sterilize the entire surface of the package P by electron beam irradiation.

  Hereinafter, the method of sterilizing the entire surface of the package P will be described along the first to ninth steps showing the operation of the chuck slide device 40 with reference to FIGS. FIGS. 11 to 20 all show the movement of the two chuck members 45 and 46 relative to the electron beam irradiation region Z and the positional relationship of the package P from above.

(First step)
In the first step, as shown in FIG. 11, the package P conveyed through the two shutters 73a and 25a of the carry-in pass box 71 by the operation of the roller conveyor 51 is placed in the positioning cylinder 60 (not shown). The chuck member 45 is moved to a predetermined position as the movable table 41b is moved backward in the X-axis direction (moving backward in the transport direction of the package P) by the operation of the linear motor table 41. At this position, the package P is held at the corner portion P5 by the chuck 45b of the chuck member 45 (see FIG. 8). The subsequent operation of the cylinder 60 has been described above.

  At this time, in the front of the package P in the transport direction (right side in FIG. 11), the sterilized package P is operated by the roller conveyor 52 and the electron beam irradiation apparatus 100 via the two shutters 26a and 74a of the carry-out pass box 72. Outside (aseptic work room).

(Second step)
In FIG. 12, in the state where the package P is sandwiched by the chuck member 45 in the package P in FIG. 12, the movable table 41b is moved forward in the X-axis direction by the operation of the linear motor table 41 (to the front in the transport direction of the package P). With the movement, at least a half of the upper surface P11 and the lower surface P12 of the package P (the upper half in the drawing) and the entire surface of the side surface P13 pass through the electron beam irradiation region Z. In the second step, at least a half of the upper surface P11 and the lower surface P12 of the package P and the entire surface of the side surface P13 are sterilized.

  At this time, on the rear side in the transport direction of the package P (left side in FIG. 12), another package P to be sterilized next is carried into the carry-in pass box 71 through the shutter 73a by the operation of the roller conveyor 51 and waits. .

(Third step)
In the third step, in FIG. 13, the rotating member 43 rotates the rotating shaft 43 b by 90 ° in the θ-axis direction normal rotation (clockwise) in a state where the corner portion P5 is sandwiched between the chuck members 45 in FIG. The package P sandwiched between the members 45 is rotated by 90 ° in the horizontal direction around the rotation shaft 43b. Thus, the side surface P14 adjacent to the side surface P13 of the package P becomes a position where it can pass through the electron beam irradiation region Z.

(4th process)
In the fourth step, in FIG. 14, with the package P sandwiched by the corner portion P5 between the chuck members 45, the movable table 41b is moved backward in the X axis direction by the operation of the linear motor table 41. (Movement), at least a half of the upper surface P11 and the lower surface P12 of the package P (the upper half in the drawing) and the entire surface of the side surface P14 pass through the electron beam irradiation region Z. In the fourth step, at least a half of the upper surface P11 and the lower surface P12 of the package P and the entire surface of the side surface P14 are sterilized.

  Therefore, by the combined use of the second step and the fourth step, the surface of at least three quarters of the upper surface P11 and the lower surface P12 of the package P and the entire surface of the side surface P13 and the side surface P14 (one half of all the side surfaces) are sterilized. Is done. Here, at least a quarter of the surface diagonally opposite to the chuck member 45 on each of the upper surface P11 and the lower surface P12 of the package P is twice in the electron beam irradiation region Z from a short distance in the second step and the fourth step. Has passed.

(5th process)
In the fifth step, in FIG. 15 and FIG. 16, the package P is transferred from the state of being sandwiched by the chuck member 45 to the state of being sandwiched by the chuck member 46. Specifically, first, in FIG. 15, the rotating member 43 rotates the rotating shaft 43 b by 45 ° in the θ-axis direction forward rotation (clockwise) in a state where the corner portion P <b> 5 is sandwiched between the chuck members 45. . Next, the chuck member 46 moves to a predetermined position as the movable table 42b moves backward (moves backward in the transport direction of the package P) by the operation of the linear motor table 42. At this position, the package P is held at the corner portion P6 by the chuck 46b of the chuck member 46.

At this time, the package P is sandwiched between the two corner portions P5 and P6 on the diagonal line by the two chuck members 45 and 46, respectively. Next, when the chuck 45b of the chuck member 45 opens the corner portion P5, the package P is in a state where the corner portion P6 is clamped by the chuck member 46 alone. Here, the chuck 46b of the chuck member 46 is sterilized in advance with hydrogen peroxide gas to a level that guarantees SAL ≦ 10 ⁻⁶ as described above.

  Next, in FIG. 16, in the state where the package P has the corner portion P6 sandwiched between the chuck members 46, the rotating member 44 rotates the rotating shaft 44b by a predetermined angle in the θ-axis direction reverse rotation (counterclockwise). Does not pass through the electron beam irradiation region Z even if the is moved. In this state, as the movable table 42b moves forward in the X-axis direction (movement of the package P forward in the transport direction) by the operation of the linear motor table 42, the package P is electronic in a state where the corner portion P6 is held between the chuck members 46. It moves to the position on the right side of the line irradiation region Z (front in the transport direction of the package P). During this movement, the package P does not pass through the electron beam irradiation region Z. The reason why such an operation is applied is to irradiate the entire surface of the package P evenly in four steps in which the package P passes through the irradiation region. That is, when the package P passes through the irradiation region other than the above four steps, a part of the surface of the package P is excessively irradiated and the entire surface cannot be irradiated uniformly. In addition, this allows the package P after the sterilization of the entire surface is completed to be positioned on the unloading pass box 72 side in the forward direction (right side in FIG. 16).

  Next, in the state where the package P is sandwiched between the corner portions P6 and the chuck member 46, the rotating member 44 rotates the rotating shaft 44b by a predetermined angle clockwise in the θ-axis direction (clockwise) and is sandwiched by the chuck member 46. The package P is rotated in the horizontal direction around the rotation shaft 44b. Thus, the side surface P15 adjacent to the side surface P14 of the package P becomes a position where it can pass through the electron beam irradiation region Z.

(Sixth step)
In the sixth step, in FIG. 17, the movable table 42b is moved backward in the X-axis direction (backward in the transport direction of the package P) by the operation of the linear motor table 42 with the corner portion P6 held between the chuck members 46 in the package P. With the movement, at least a half of the upper surface P11 and the lower surface P12 of the package P (the upper half in the drawing) and the entire surface of the side surface P15 pass through the electron beam irradiation region Z. In the sixth step, at least a half of the upper surface P11 and the lower surface P12 of the package P and the entire surface of the side surface P15 are sterilized.

  Therefore, the combined use of the second step, the fourth step, and the sixth step allows the entire surface of each of the upper surface P3 and the lower surface P4 of the package P and the entire surface of the side surface P13, the side surface P14, and the side surface P15 (3/4 of all the side surfaces). Is sterilized. Here, at least a half of each of the upper surface P11 and the lower surface P12 of the package P passes through the electron beam irradiation region Z twice from a short distance.

(Seventh step)
In the seventh step, in FIG. 18, the rotating member 44 rotates the rotating shaft 44b by 90 ° in the θ-axis direction normal rotation (clockwise) in a state where the corner portion P6 is sandwiched between the chuck members 46 in FIG. The package P sandwiched between the chuck members 46 is rotated by 90 ° in the horizontal direction around the rotation shaft 44b. Thus, the side surface P16 adjacent to the side surface P15 of the package P becomes a position where it can pass through the electron beam irradiation region Z.

(8th step)
In the eighth step, in FIG. 19, the movable table 42 b is moved forward in the X-axis direction by the operation of the linear motor table 42 in the state where the corner portion P <b> 6 of the package P is held between the chuck members 46. With the movement, at least a half of the upper surface P11 and the lower surface P12 of the package P (the upper half in the drawing) and the entire surface of the side surface P16 pass through the electron beam irradiation region Z. In the eighth step, at least a half of the upper surface P11 and the lower surface P12 of the package P and the entire surface of the side surface P16 are sterilized.

  Accordingly, the combined use of the second step, the fourth step, the sixth step, and the eighth step sterilizes the entire surface and all the side surfaces P13, P14, P15, and P16 of the upper surface P11 and the lower surface P12 of the package P. Here, as for the upper surface P11 and the lower surface P12 of the package P, the entire surface passes through the electron beam irradiation region Z twice from a short distance.

  At this time, in the rear side of the transport direction of the package P (left side in FIG. 19), another package P waiting in the carry-in pass box 71 is moved into the electron beam irradiation chamber 22 via the shutter 25a by the operation of the roller conveyor 51. It is carried in.

(9th step)
In FIG. 20, in the state where the package P is sandwiched by the chuck member 46 in FIG. 20, the movable table 42b is moved forward in the X-axis direction by the operation of the linear motor table 42 (the package P is moved forward in the transport direction). With the movement), the package P moves to the end of the carry-out roller conveyor 52. Here, when the chuck 46 b of the chuck member 46 opens the corner portion P <b> 6, the package P is delivered from the chuck member 46 to the roller conveyor 52.

  At this time, in the rear side of the transport direction of the package P (left side in FIG. 20), another package P carried into the electron beam irradiation chamber 22 in the eighth step is operated by the positioning cylinder 60 at the front end portion of the roller conveyor 51. The corner portion P5 is clamped by the chuck 45b of the chuck member 45 while being fixed at a fixed position.

  In this way, the entire surface of the package P is uniformly sterilized by the electron beam by the operation of the chuck slide device 40 in the first to ninth steps. Next, the package P whose entire surface is sterilized is carried out of the electron beam irradiation apparatus 100 (aseptic work chamber) through the two shutters 26 a and 74 a of the carry-out pass box 72 by the operation of the roller conveyor 52. .

  These steps are repeated, and the package P that is sequentially transported is sterilized and transported to the aseptic work chamber. In the aseptic working chamber in which the package P is thus transported, the top seal is peeled off from the polyethylene tab of the package P, and the filling operation is performed on the sterilized syringe inside.

As described above, in the present embodiment, three small low energy electron accelerators having a long side (width direction) of 145 mm and a short side (length direction) of 25 mm are employed, all of which have an acceleration voltage of 70 kV. Worked with. As a result, there was an absorbed dose of 15 kGy or more at any site on the surface of the package P, and the actual sterilization level of the entire surface of the package P could guarantee a level of SAL ≦ 10 ⁻⁶ . For this reason, by using the electron beam sterilization method according to the present embodiment, the sterilization level of the entire surface of the package P becomes substantially the same, and the reliability and safety of the sterilization effect can be maintained high.

  As described above, the electron beam sterilization method according to the present embodiment employs a small and low energy electron accelerator having an irradiation window narrower than the irradiation width of the upper surface and the lower surface of the package P. Irradiate the electron beam from the side. In addition, a chuck slide device can be employed to uniformly irradiate the entire surface of the package P from a short distance. Further, since the electron beam can be uniformly irradiated from a short distance, the small low energy electron accelerator can be operated with a low acceleration voltage.

  Further, since the acceleration voltage of the electron accelerator is operated to be low, the amount of secondary X-rays and ozone generated is reduced as compared with the conventional electron beam irradiation apparatus. Since the amount of generated X-rays is reduced, a stainless steel metal plate can be used without using a lead plate for the outer wall of the electron beam irradiation apparatus. Further, since the amount of ozone generated is reduced, corrosion of the electron beam irradiation chamber and the machine chamber can be reduced. In addition, by reducing the amount of ozone generated, the invasion of ozone into the package P is greatly reduced, and the final product such as a syringe housed inside and a filling liquid filled in the syringe in a subsequent process The effect on is reduced.

  In addition, since the electron beam sterilization method according to the present embodiment employs a compact, low-energy electron accelerator having a narrow irradiation window, the electron beam irradiation apparatus itself is also compact, and the initial cost of the apparatus including the cost of the electron accelerator is reduced. Can be kept low. Furthermore, in this embodiment, since the small low energy electron accelerator can be operated with a low acceleration voltage, the use limit (life) of the electron accelerator becomes long, and the maintenance cost of the apparatus can be kept low.

  Further, in the present embodiment, the use of the chuck slide device makes it possible to perform uniform electron beam irradiation on the entire surface of the package P from a short distance. Normally, when considering electron beam irradiation on the entire surface of an object to be irradiated, a complicated mechanism that combines three-axis movement in the X-axis, Y-axis, and Z-axis directions and rotational movement in the θ-axis direction is required. To do. In contrast, in the present embodiment, the package P is sandwiched and delivered by the chuck member, the package P is uniaxially moved in the X-axis direction by the linear motor table, and the package P is rotated by the rotating member in the θ-axis direction. Combine.

  Thus, in the chuck slide device of the present embodiment, uniform electron beam irradiation can be performed from a short distance on the entire surface of the package P with only a simple structure and a small number of driving units. As a result, the electron beam irradiation apparatus itself is further compact, and the initial cost and maintenance cost of the apparatus can be further reduced.

  Further, in the present embodiment, the electron beam irradiation apparatus includes a carry-in pass box and a carry-out pass box before and after the electron beam irradiation apparatus. As a result, the sterilized state in the electron beam irradiation apparatus is maintained, and leakage of X-rays generated in the electron beam irradiation apparatus to the outside can be prevented. Furthermore, both of these pass boxes are equipped with two shutters, and by controlling so that these shutters are not released simultaneously, the sterilized state in the electron beam irradiation apparatus is maintained more stably, Leakage of X-rays generated in the electron beam irradiation apparatus to the outside can be completely prevented.

  Therefore, in the present invention, it is possible to uniformly irradiate the entire outer surface of the irradiated object by using a small low energy electron accelerator with a narrow irradiation window, and the sterilization level of each part is set to the same level. To provide an electron beam irradiation apparatus that can maintain high reliability and safety of the sterilization effect, and can extend the cost and use limit (lifetime) of the electron accelerator to keep the initial cost and maintenance cost of the apparatus low. it can.

In carrying out the present invention, not only the above-described embodiment but also the following various modifications can be mentioned.
(1) In the above embodiment, a small low-energy electron accelerator that can be adjusted within the range of 40 to 70 kV in acceleration voltage is employed to guarantee a sterilization level of SAL ≦ 10 ^−6. Instead, various sterilization levels can be guaranteed by adopting an electronic accelerator having a higher acceleration voltage and adjusting the moving speed of the package by the chuck slide device. For example, it is possible to ensure a sterilization level of SAL ≦ 10 ⁻¹² by operating at a higher acceleration voltage.
(2) In the above embodiment, the entire upper surface and lower surface of the package pass through the electron beam irradiation region twice. On the other hand, all side surfaces of the package have passed through the electron beam irradiation region once. Therefore, in order to make the absorbed dose of the electron beam irradiated to the entire surface of the package the same level, the output of the electron accelerator that irradiates the upper surface and the lower surface of the package with the electron accelerator is used as the output of the electron accelerator that irradiates the package with the electron beam. You may make it operate | move below output. Thereby, the use limit (life) of the electron accelerator which irradiates an electron beam to the upper surface and lower surface of a package can be lengthened.
(3) In the above embodiment, a stainless steel metal plate is adopted for the outer wall portion of the electron beam irradiation apparatus main body. However, the present invention is not limited to this, and the case where the acceleration voltage of the electron accelerator is operated high is also considered. In place of the stainless steel metal plate, a lead plate may be adopted for the outer wall portion of the electron beam irradiation apparatus main body.
(4) In the above embodiment, the linear motor table is employed for the movement of the chuck slide device in the X-axis direction. However, the present invention is not limited to this, and movement by a rotary motor and a gear mechanism may be employed. .
(5) Although not described in the above embodiment, the aseptic condition of the aseptic work chamber is further reduced by making the interior of the electron beam irradiation chamber of the electron beam irradiation apparatus have a negative pressure from the inside of the aseptic work chamber connected in series. It can be kept stable.
(6) In the above embodiment, the W shutter system is adopted. That is, the first carry-in port and the second carry-in port of the carry-in pass box, and the first carry-out port and the second carry-out port of the carry-out pass box are all aligned in a straight line in the package carrying direction. The shutters are provided at the respective carry-in ports and carry-out ports. Control is performed so that the shutters of the carry-in port and the carry-out port arranged in this way do not open at the same time, so that X-rays generated in the electron beam irradiation apparatus do not leak outside. However, the arrangement of the entrance and exit of each pass box is not limited to this, and a general W crank system may be adopted. That is, the first carry-in port and the second carry-in port of the carry-in pass box and the first carry-out port and the second carry-out port of the carry-out pass box are arranged so as to be orthogonal to each other. X-rays generated in the electron beam irradiation device are externally emitted by bending the package transport direction between the carry-in ports arranged in this way and between the carry-out ports by 90 degrees twice. Do not leak.
(7) In the above embodiment, the chuck claw of the chuck slide device that holds the package is operated so as not to pass through the electron beam irradiation region. However, the present invention is not limited to this, and the chuck claw may pass through the electron beam irradiation region so that sterilization of this part is always performed. In this case, it is preferable that the portion of the chuck claw that contacts the package is sterilized so that the chuck claw passes through the electron beam irradiation region without holding the package.
(8) In the above embodiment, about half of the upper and lower surfaces of the package are operated so as to pass through the electron beam irradiation region, and the chuck pawl of the chuck slide device passes through the electron beam irradiation region. There is nothing. However, the present invention is not limited to this, and the width of the irradiation window of the electron accelerator may be increased to irradiate the entire upper and lower surfaces of the package with the electron beam. In this case, the chuck claw of the chuck slide device is always sterilized by passing through the electron beam irradiation region.

DESCRIPTION OF SYMBOLS 100 ... Electron beam irradiation apparatus, 10 ... Main body stand, 20 ... Electron beam irradiation apparatus main body,
22 ... Electron beam irradiation chamber, 23 ... Decompression chamber, 24 ... Machine room, 25 ... Carry-in port, 26 ... Carry-out port,
21, 21a to 21e ... outer wall part, 23a, 23b ... partition part,
23c, 23d ... slide opening, 25a, 26a ... shutter,
30 ... Electron beam generator, 31, 32, 33 ... Electron accelerator,
31a, 32a, 33a ... irradiation window, 40 ... chuck slide device,
41, 42 ... linear motor table, 41a, 42a ... bed,
41b, 42b ... movable table, 43, 44 ... rotating member, 43a, 44a ... rotating rack,
43b, 44b ... rotating shaft, 45, 46 ... chuck member, 45a, 46a ... support part,
45b, 46b ... chuck claw, 50 ... transport device, 51, 52 ... roller conveyor,
60 ... positioning cylinder, 61, 62 ... cylinder, 61a, 62a ... mount,
71, 72 ... pass box, 73 ... carry-in port, 74 ... carry-out port,
73a, 74a ... shutter, 61b, 62b ... telescopic support, 61c, 62c ... fixed claw,
P ... Package, P1 ... Tab, P2 ... Top seal, P3-P6 ... Square part,
P11 ... upper surface, P12 ... lower surface, P13 to P16 ... side surface, θ ... rotation direction, X ... movement direction,
Z: Electron beam irradiation area.

Claims (1)

A method of sterilizing an irradiated object consisting of a hexahedron having an upper surface, a lower surface and four side surfaces by electron beam irradiation,
Utilizing an electron beam irradiation region in which the upper, lower, and one side surfaces of the irradiated object are irradiated surfaces and the irradiation windows of the three electron accelerators are positioned substantially parallel to face the three irradiated surfaces, respectively. And
A first step of clamping the first clamping part of the irradiated object;
The first object is moved in one direction with the irradiation object sandwiched therebetween, and at least a half of the upper surface and the lower surface of the irradiation object and the entire surface of the first side surface pass through the electron beam irradiation region. Two steps,
A third step of rotating 90 ° horizontally while holding the irradiated object;
The object is moved in the opposite direction while holding the object to be irradiated, and at least one half of the upper surface and the lower surface of the object to be irradiated and the entire surface of the second side surface pass through the electron beam irradiation region. 4 steps,
A fifth step of opening the first holding portion of the irradiated object and holding the second holding portion irradiated with the electron beam in the fourth step;
The first object moves in one direction while holding the irradiation object, and at least a half of the upper surface and the lower surface of the irradiation object and the entire surface of the third side surface pass through the electron beam irradiation region. 6 steps,
A seventh step of rotating 90 ° horizontally while sandwiching the irradiated object;
The object is moved in the opposite direction while holding the object to be irradiated, and at least a half of the upper surface and the lower surface of the object to be irradiated and the entire surface of the fourth side surface pass through the electron beam irradiation region. 8 steps,
A ninth step of opening the second clamping part of the irradiated object,
An electron beam sterilization method comprising sterilizing the entire surface of the irradiated object along the first to ninth steps.