JP2015131661A - Sterilization method of vial, sterile vial pack, and assembly method of sterile vial - Google Patents

Abstract

PROBLEM TO BE SOLVED: To attain a colorless and transparent sterilized vial having high bactericidal properties.SOLUTION: A method for sterilizing a vial 5 includes the steps of: placing the vial 5, an elastic lid 6 and a rigid lid 7 each in an inner part 10 of a bag 4 (S1); hermetically closing the bag 4 (S2); and supplying sterile gas to the inner part 10 of the bag 4 to sterilize the vial 5, the elastic lid 6 and the rigid lid 7 (S4). A sterilized vial pack 1 includes: the bag 4; the sterilized vial 5 set in the inner part 10 of the bag 4; the sterilized elastic lid 6 set in the inner part 10 of the bag 4; the sterilized rigid lid 7 set in the inner part 10 of the bag 4; and an enclosure part 11 through which the sterile gas performing sterilization of the vial 5, the elastic lid 6 and the rigid lid 7 can be encapsulated in the inner part 10 of the bag 4.

Description

  The present invention relates to a method for sterilizing a vial enclosing a drug, a sterile vial pack, and a method for assembling a sterile vial.

  In recent years, vials enclosing a drug are required to ensure sterility according to a predetermined standard. For this reason, in the manufacturing process of a vial, a vial is sealed with a lid | cover and sterilized in the said sealing state (for example, refer patent document 1). The sterilization method is generally sterilization by gas or electron beam irradiation.

  As described in Patent Document 1, in the sterilization method by electron beam irradiation, the opening of the vial is sealed with a rubber stopper and a metal cap covering the upper surface thereof, and a low energy electron beam is applied from the outer surface of the cap. Is sterilized on the surface and inside of the vial and the gap between the upper surface of the rubber stopper and the cap.

JP-A-8-266594

  However, in the sterilization method by electron beam irradiation described in Patent Document 1, by irradiating the vial with the electron beam, the color of the glass surface, which is the material of the vial, becomes brown and becomes not transparent. For this reason, when monitoring a vial visually or through an image of a camera, the amount and state of the medicine in the vial may not be confirmed.

  Although sterilization by gas instead of electron beam irradiation is possible, the sterilization method described in Patent Document 1 sterilizes in a sealed state with the vial covered, and thus the sterilization inside the vial cannot be performed. May decrease.

  Accordingly, an object of the present invention is to provide a vial sterilization method, a sterilization vial pack, and a sterilization vial assembling method that can realize a colorless, transparent, and highly sterilized vial.

  In order to solve the above-described problems, a method for sterilizing a vial according to the present invention includes a step of placing a vial and a lid inside a bag, a step of sealing the bag, a gas supplied to the inside of the bag, Sterilizing the lid.

  In the method for sterilizing a vial according to the present invention, since sterilization is performed by supplying gas into the bag, unlike the sterilization by electron beam irradiation, the color of the surface of the vial is not browned and remains colorless and transparent. It can be. Further, since the vial and the lid are respectively arranged inside the bag to which the gas for sterilization is supplied, not only the surface of the vial but also the inside of the vial can be sterilized inside the bag. As described above, a colorless and transparent sterilization vial with high sterility can be realized.

  The vial sterilization method according to the present invention may further include a step of partitioning the vial and the lid before the step of sterilizing the vial and the lid. In this case, since the vial and the lid are separated from each other, the vial and the lid are individually separated, so that the vial and the lid can be prevented from being scattered inside the bag. Moreover, workability | operativity when attaching a vial and a lid | cover inside a bag after sterilization can be improved.

  Further, in the method for sterilizing a vial according to the present invention, the lid has an elastic lid and a rigid lid, and in the step of partitioning the vial and the lid, the vial, the elastic lid, and the rigid lid are partitioned separately. Also good. In this case, since the vial, the elastic lid, and the rigid lid are partitioned separately, each can be prevented from scattering inside the bag. Moreover, it becomes possible to improve workability | operativity when attaching a vial, an elastic cover, and a rigid cover inside a bag after sterilization.

  The sterilization vial pack according to the present invention includes a bag, a sterilized vial provided in the bag, a sterilized lid provided in the bag, and a gas for sterilizing the vial and the lid. And a sealing portion that can be sealed.

  According to the sterilization vial pack according to the present invention, since the vial and the lid are sterilized by sealing the gas inside the bag by the sealing portion, the surface color of the vial is different from sterilization by electron beam irradiation. It is not browned and can remain colorless and transparent. Moreover, since the vial and the lid are respectively provided inside the bag and sterilized inside the bag, not only the surface of the vial but also the inside of the vial can be sterilized. As described above, a colorless and transparent sterilization vial with high sterility can be realized.

  In the sterile vial pack according to the present invention, the vial and the lid may be partitioned inside the bag. In this case, since the vial and the lid are separated from each other, the vial and the lid are individually separated, so that the vial and the lid can be prevented from being scattered inside the bag. Moreover, it becomes possible to improve workability | operativity when attaching a vial and a lid | cover inside a bag after sterilization.

  In the sterilization vial pack according to the present invention, the lid has an elastic lid and a rigid lid, and the vial, the elastic lid, and the rigid lid are respectively separated by the first partition and the second partition inside the bag. The vial, the elastic lid, the rigid lid, the first partition, and the second partition are the vial, the first partition, the elastic lid, the second partition, in order from the opposite side of the bag closing portion toward the closing portion, And the rigid lids may be arranged in this order. In this case, it is possible to further improve workability when attaching the vial, the elastic lid, and the rigid lid inside the bag after sterilization.

  The method for assembling a sterilized vial according to the present invention includes a step of preparing a bag in which a vial sterilized by gas and a lid sterilized by gas are respectively provided, and a step of preparing the bag after the step of preparing the bag. The method includes a step of attaching a lid to the vial inside, and a step of opening the bag after the step of attaching the lid to the vial.

  According to the method for assembling a sterilized vial according to the present invention, a bag in which a vial sterilized by gas and a sterilized lid by gas are respectively provided is prepared, and the lid is attached to the vial inside the bag. After that, the bag is opened. Thereby, a sterilized vial is assembled. Since the sterilized vial assembled in this way is sterilized by gas, unlike the sterilized vial by electron beam irradiation, the surface of the vial should not be browned and remain colorless and transparent. Can do. Further, since the sterilized lid of the sterilized vial is provided inside the bag, it is sterilized before being attached. That is, not only the surface of the vial but also the inside of the vial is sterilized, the lid is attached, and then the bag is opened, so that a sterile vial in which sterility within the vial is ensured is assembled. As described above, a colorless and transparent sterilization vial with high sterility can be realized.

  In the method for assembling a sterile vial according to the present invention, in the step of preparing the bag, a bag in which the vial and the lid are partitioned inside the bag may be prepared. In this case, since the vial and the lid are partitioned in the bag prepared in the step of preparing the bag, respectively, the vial and the lid are individually separated, so that the vial and the lid are scattered inside the bag. Therefore, it is possible to improve workability when attaching the vial and the lid in the bag after the step of preparing the bag.

  Further, in the method for assembling a sterile vial according to the present invention, the lid has an elastic lid and a rigid lid, and in the step of preparing the bag, the vial, the elastic lid, and the rigid lid are provided inside the bag. The vial, the elastic lid, the rigid lid, the first partition, and the second partition are respectively separated in order from the opposite side of the bag closing portion toward the closing portion. Preparing a bag arranged in the order of the partition, the elastic lid, the second partition, and the rigid lid, and attaching the lid to the vial inside the bag is to release the first partition and attach the elastic lid to the vial. After the attaching step, the step of attaching the elastic lid to the vial, the step of releasing the second partition and attaching the rigid lid to the vial, and the step of opening the bag may be included. In this case, after the sterilization, the elastic lid is first attached to the vial inside the bag, and after securing the sterility of the inside of the vial, the rigid lid can be attached to the vial. Therefore, since the sterility of the inside of the vial is secured at the stage of attaching the elastic lid to the vial, the work of attaching the rigid lid to the vial and caulking can be performed even after opening the bag.

  ADVANTAGE OF THE INVENTION According to this invention, the sterilization method of a vial which can implement | achieve a colorless and transparent and highly sterilized vial, the sterile vial pack, and the assembly method of a sterile vial can be provided.

It is a schematic block diagram which shows schematic structure of the sterilization vial pack which concerns on one Embodiment of this invention. It is a figure which shows the enclosure part which can enclose the gas in the sterilization vial pack of FIG. It is a flowchart which shows the method of comprising a sterilization vial pack. It is a flowchart which shows the method of assembling a sterilization vial using a sterilization vial pack. It is a figure which shows the assembly process of the sterilization vial corresponding to the flowchart of FIG. It is a figure shown about the modification regarding the enclosure part of the sterilization vial pack which concerns on one Embodiment.

  The vial sterilization method, sterilization vial pack, and sterilization vial assembly method according to the present invention will be described below with reference to the accompanying drawings. In the description of the drawings, the same elements are denoted by the same reference numerals, and redundant description is omitted.

  First, with reference to FIG.1 and FIG.2, the structure of the sterilization vial pack which concerns on one Embodiment of this invention is demonstrated.

  FIG. 1 is a schematic configuration diagram showing a schematic configuration of a sterile vial pack according to an embodiment of the present invention. As shown in FIG. 1, the sterile vial pack 1 includes a bag 4, a vial 5, an elastic lid 6, and a rigid lid 7. The vial 5, the elastic lid 6, and the rigid lid 7 are disposed inside the bag 4.

  The bag 4 is a sterile bag made of a material that cannot pass bacteria. The bag 4 is a transparent bag made of, for example, a vinyl material, polyethylene terephthalate (PET), polyethylene (PE), or the like. The bag 4 has, for example, a cylindrical shape having a diameter substantially the same as the outer diameter of the main body 5a of the vial 5 or a diameter larger than the outer diameter of the main body 5a. The bag 4 has a cylindrical side portion 4c, a bottom portion 4a that closes one end of the side portion 4c, and a closed portion 4b that faces the bottom portion 4a and closes the other end of the side portion 4c. The interior 10 of the bag 4 is a sealed space by a bottom part 4a, a closing part 4b, and a side part 4c. In the present embodiment, the closing portion 4b of the bag 4 is formed by arranging the vial 5, the elastic lid 6 and the rigid lid 7 in the interior 10 of the bag 4 and then joining the side portion 4c with no gap. The The closed portion 4b is not limited to being formed by joining to the side portion 4c, and may be formed by any method as long as the inside 10 of the bag 4 can be a sealed space.

  The interior 10 of the bag 4 is partitioned into multiple layers by a first partition 8 and a second partition 9. The first partition 8 and the second partition 9 are means for dividing the interior 10 of the bag 4. The first partition 8 and the second partition 9 only need to be able to physically partition the space inside the bag 4, and the vial 5, the elastic lid 6, and the rigid lid 7 may cross each other in the partitioned space. There may be gaps that are not possible, and it is not necessary to have gaps. For example, the first partition 8 and the second partition 9 are formed by fixing the opposing inner side surfaces of the side portion 4 c of the bag 4. Examples of the fixing method include adhesion or welding, anti-twisting of the bag 4 itself, or fixing using another member such as a clip. In the present embodiment, a fixing method by bonding is used, and the inner side surfaces of the side portions 4c of the bag 4 are bonded in a straight line in the direction around the axis of the bag 4 in a dotted manner. In addition, as long as the adhesive strength satisfies the specified condition, it may be solid (fixing method where the adhesive part is continuous within a certain range), or it may be partly dotted and the other part solidified. And may be bonded in combination with solid. The adhesive strength for forming the first partition 8 and the second partition 9 is such that when the first partition 8 and the second partition 9 are released, the bag 4 is released along with the release of the first partition 8 and the second partition 9. Bonded with strength that does not break.

  The interior 10 of the bag 4 includes a first housing portion 10a, a second housing portion 10b, and a third housing portion 10c by the first partition 8 and the second partition 9. The 1st accommodating part 10a, the 2nd accommodating part 10b, and the 3rd accommodating part 10c are the 1st accommodating part 10a, the 2nd accommodating part 10b, and the 3rd accommodating part 10c toward the closed part 4b from the bottom part 4a of the bag 4. It is located in the order.

  FIG. 2 is a view showing an enclosing part capable of enclosing gas in the sterile vial pack 1 of FIG. As shown in FIG. 2, the bag 4 of the sterilization vial pack 1 contains gas (hereinafter simply referred to as “sterilization gas”) for sterilizing the vial 5, the elastic lid 6, and the rigid lid 7 in the interior 10 of the bag 4. An encapsulating portion 11 that can be encapsulated is provided. That is, the sterilization vial pack 1 includes a sealing portion 11. In the present embodiment, the enclosing portion 11 (the portion indicated by the satin surface in FIG. 2) is configured as a part of the side portion 4 c of the bag 4. The enclosure portion 11 extends from the bottom portion 4a of the bag 4 to the closed portion 4b of the bag 4 and has an area that is approximately half the area of the entire side portion 4c of the bag 4.

  The enclosure 11 is means for enclosing a gas for sterilizing the vial 5, the elastic lid 6, and the rigid lid 7 in the interior 10 of the bag 4. The enclosure 11 is made of a material that allows, for example, a sterilizing gas to pass therethrough and cannot pass bacteria. The encapsulating part 11 can use, for example, a medical sterilization packaging material such as a non-woven fabric having a hole of a size that allows sterilization gas to pass through and bacteria cannot pass through. In the sterilization vial pack 1, a sterilization gas is introduced from the outside of the sealed bag 4 into the inside 10 through the enclosure 11. As the sterilizing gas, for example, EOG (ethylene oxide gas) can be used. The introduced sterilizing gas kills the bacteria inside the bag 4. After sterilization, the sterilized gas introduced into the bag 4 passes through the enclosure 11 and is exhausted to the outside of the bag 4. The interior 10 of the bag 4 sterilized in this manner is maintained in a sterilized state for a certain period unless the bag 4 is opened.

  Returning to FIG. 1 again, the configuration of the vial 5, the elastic lid 6, and the rigid lid 7 will be described. The vial 5 is a colorless and transparent container made of glass that contains a medicine in its inside 5c. The vial 5 has a main body 5a and an opening 5b. The vial 5 is sterilized by the sterilizing gas introduced from the sealing portion 11 while being accommodated in the interior 10 of the bag 4. After sterilization, the vial 5 is arranged in the first storage portion 10 a in the interior 10 of the bag 4 by the first partition 8.

  The elastic lid 6 (lid) is a stopper for sealing the opening 5 b of the vial 5. The elastic lid 6 is a lid made of an elastic material, for example, a rubber cap made of an elastic body. The elastic lid 6 has a convex portion 6a that fits into the opening 5b when the opening 5b of the vial 5 is sealed. The elastic lid 6 is disposed in such a direction that the convex portion 6 a is located on the opening 5 b side of the vial 5 disposed in the interior 10 of the bag 4. The elastic lid 6 is sterilized by the sterilization gas introduced from the sealing portion 11 while being accommodated in the interior 10 of the bag 4. After the sterilization, the elastic lid 6 is disposed in the second accommodating portion 10 b in the interior 10 of the bag 4 by the first partition 8 and the second partition 9.

  The rigid lid 7 (lid) is a stopper for further sealing the opening 5 b of the vial 5 from above the elastic lid 6. The rigid lid 7 is a lid made of a substance having rigidity, and is an aluminum cap made of a metal such as aluminum, for example. The rigid lid 7 has a portion 7a that comes into contact with the opening 5b when the opening 5b of the vial is sealed. The rigid lid 7 is arranged in such a direction that a portion 7 a in contact with the opening 5 b is located on the opening 5 b side of the vial 5 arranged in the inside 10 of the bag 4. The rigid lid 7 is sterilized by the sterilizing gas introduced from the enclosing portion 11 while being accommodated in the interior 10 of the bag 4. After the sterilization, the rigid lid 7 is arranged in the third accommodating portion 10 c inside the bag 4 by the second partition 9.

  The vial 5, the elastic lid 6, and the rigid lid 7 are separately partitioned by a first partition 8 and a second partition 9, respectively. Thereby, the vial 5 is provided in the 1st accommodating part 10a, the elastic cover 6 is provided in the 2nd accommodating part 10b, and the rigid cover 7 is provided in the 3rd accommodating part 10c. The vial 5, the elastic lid 6, the rigid lid 7, the first partition 8, and the second partition 9 are arranged in order from the bottom 4 a on the opposite side of the closing portion 4 b of the bag 4 toward the closing portion 4 b. 8, the elastic lid 6, the second partition 9, and the rigid lid 7 are arranged in this order.

  Next, with reference to FIG. 3, a method for constructing the sterile vial pack 1 and sterilizing the vial 5 will be described. FIG. 3 is a flowchart showing a method for constructing the sterile vial pack 1.

  First, the vial 5, the elastic lid 6, and the rigid lid 7 are disposed in the interior 10 of the bag 4 in a state where the bag 4 is opened without the closing part 4b of the bag 4 (step S1). Subsequently, the closing portion 4b is joined to the side portion 4c of the bag 4 without a gap, and the bag 4 is sealed (step S2). This prevents bacteria from entering the interior 10 from the outside of the bag 4.

  Subsequently, the vial 5, the elastic lid 6, and the rigid lid 7 are partitioned separately (step S3). Specifically, from the outside of the bag 4, the inner surfaces of the side portions 4 c of the bag 4 are adhered in a straight line in the direction around the axis of the bag 4, so that the first partition 8 and the second partition are bonded. 9 is formed, and the interior 10 of the bag 4 is divided into a first housing portion 10a, a second housing portion 10b, and a third housing portion 10c. Thereby, the vial 5 is provided in the first housing portion 10 a, the elastic lid 6 is provided in the second housing portion 10 b, and the third housing portion 10 c is provided in the rigid lid 7.

  Subsequently, a sterilization gas is supplied to the inside 10 of the bag 4 through the enclosing unit 11 to sterilize the inside 10 of the bag 4 (step S4). Specifically, this is performed as follows. First, in step S3, the bag 4 in a state where the vial 5, the elastic lid 6, and the rigid lid 7 are partitioned separately is put in a box. In addition, the bag 4 to put may be plural or one. Subsequently, the box containing the bag 4 is placed in the chamber of the sterilizer. Note that a plurality of boxes or one box may be placed in the chamber. At this time, the lid of the box is left open so that the sterilizing gas can flow into the box, or when the lid is closed, the box is opened. Subsequently, a sterilizing gas is introduced into the chamber to sterilize the bag 4 together with the box. At this time, for example, the state in which the chamber is filled with sterilization gas is maintained for 18 hours or more. As a result, the sterilization gas is diffused into the interior 10 of the bag 4, and the vial 5, the elastic lid 6, and the rigid lid 7 disposed in the interior 10 of the bag 4 are sterilized. Since the vial 5 is sterilized in a state where the elastic lid 6 and the rigid lid 7 are not attached, not only the surface of the vial 5 but also the inside 5c of the vial 5 is sterilized.

  As described above, the sterile vial pack 1 is configured, and the vial 5 is sterilized. The sterilization gas in the chamber is forcibly exhausted by continuing the pump exhaust for about 3 days, for example. Further, the sterilized gas remaining in the bag 4 after exhausting by the pump is released by removing the box containing the bag 4 from the chamber and exposing it to the atmosphere.

  Next, with reference to FIGS. 4 and 5, a method for assembling a sterilized vial in which sterility is ensured in the inside 5 c of the vial 5 (hereinafter simply referred to as “sterilized vial”) using the sterilized vial pack 1 will be described. To do. FIG. 4 is a flowchart showing a method of assembling a sterile vial using the sterile vial pack 1. FIG. 5 is a diagram showing an assembly process of a sterile vial corresponding to the flowchart of FIG.

  First, as shown to (a) of FIG. 5, the sterilization vial pack 1 is prepared (process S5). That is, a bag 4 is prepared in which a vial 5 sterilized with sterilization gas, an elastic lid 6 sterilized with sterilization gas, and a rigid lid 7 sterilized with sterilization gas are provided inside 10. Inside the bag 4, the vial 5, the elastic lid 6, and the rigid lid 7 are partitioned by a first partition 8 and a second partition 9.

  Subsequently, as shown in FIG. 5B, the first partition 8 is released (step S6), and the elastic lid 6 is attached to the vial 5 (step S7). In step S <b> 6, the first partition 8 is released by, for example, removing the part that has been adhered by spotting from the outside of the bag 4. In step S7, the elastic lid 6 is attached by fitting the elastic lid 6 into the opening 5b of the vial 5 inside the bag 4 by, for example, grasping the elastic lid 6 through the bag 4 from the outside of the bag 4. Is called. Thereby, the sterility in the inside 5c of the vial 5 is ensured.

  Subsequently, as shown in FIG. 5C, the second partition 9 is released (step S8), and the rigid lid 7 is attached to the vial 5 (step S9). In step S8, the release of the second partition 9 is performed, for example, by removing a portion that has been adhered by spotting. In step S9, the rigid lid 7 is attached by attaching the rigid lid 7 to the opening 5b of the vial 5 inside the bag 4 by gripping the rigid lid 7 through the bag 4 from the outside of the bag 4, for example. Is called. At this time, the rigid lid 7 is attached so as to cover the elastic lid 6 fitted in the opening 5b of the vial 5, and is further crimped over the bag 4 using a tool or the like. Thereby, the vial 5 is completely sealed. In addition, since the sterility in the inside 5c of the vial 5 is ensured by process S7, you may perform the operation | work which attaches the rigid body cover 7 and crimps after the process of opening the bag 4 mentioned later.

  Subsequently, as shown in FIG. 5D, the bag 4 is opened (step S10). As described above, the sterilized vial 12 in which the sterility in the inside 5c of the vial 5 is maintained is obtained.

  As described above, according to the sterilization method of the vial 5 and the sterilization vial pack 1 according to the present embodiment, the sterilization gas is supplied to the inside 10 of the bag 4 so that the sterilization is performed. The surface color of 5 is not browned and can remain colorless and transparent. Further, since the vial 5, the elastic lid 6, and the rigid lid 7 are arranged in the interior 10 of the bag 4 to which sterilization gas is supplied, not only the surface of the vial 5 but also the vial in the interior 10 of the bag 4. 5 can be sterilized. As described above, a sterilization vial 12 which is colorless and transparent and has high sterility can be realized.

  According to the method for sterilizing the vial 5, before the step S <b> 4 of sterilizing the vial 5, the elastic lid 6, and the rigid lid 7, a step S <b> 3 for partitioning the vial 5, the elastic lid 6, and the rigid lid 7 is included. Moreover, according to the sterilization vial pack 1, the vial 5, the elastic lid 6, and the rigid lid 7 are individually divided by partitioning. Therefore, according to the sterilization method of the vial 5 and the sterilized vial pack 1, the vial 5, the elastic lid 6, and the rigid lid 7 are individually provided in the first accommodating portion 10a, the second accommodating portion 10b, and the third accommodating portion 10c, respectively. As a result, the vial 5, the elastic lid 6, and the rigid lid 7 can be prevented from scattering in the interior 10 of the bag 4. Moreover, workability | operativity when attaching the vial 5, the elastic cover 6, and the rigid cover 7 in the inside 10 of the bag 4 after sterilization can be improved. Furthermore, at the time of sterilization step S4, the vial 5, the elastic lid 6, and the rigid lid 7 can be reliably separated from each other, so that the inside 5c of the vial 5, the outer surface of the elastic lid 6, and the rigid body All of the outer surface of the lid 7 can be reliably sterilized.

  The sterilization vial pack 1 includes a vial 5, an elastic lid 6, a rigid lid 7, a first partition 8, and a second partition 9, in order from the bottom 4 a on the opposite side of the closing portion 4 b of the bag 4 toward the closing portion 4 b. The vial 5, the first partition 8, the elastic lid 6, the second partition 9, and the rigid lid 7 are arranged in this order. Therefore, it is possible to further improve workability when attaching the vial 5, the elastic lid 6, and the rigid lid 7 inside the bag 4 after sterilization.

  According to the method for assembling the sterilization vial 12 according to the present embodiment, a bag in which a vial 5 sterilized by gas, an elastic lid 6 sterilized by gas, and a rigid lid 7 sterilized by gas are provided in the interior 10. 4 is prepared, and after the elastic lid 6 and the rigid lid 7 are attached to the vial 5 inside the bag 4, the bag 4 is opened. Thereby, the sterilized sterile vial 12 is assembled. Since the sterilized vial 12 assembled in this way is sterilized by gas, unlike the sterilized vial by electron beam irradiation, the surface color is not browned and may remain colorless and transparent. it can. In addition, since the sterilized vial 5, the sterilized elastic lid 6, and the sterilized rigid lid are respectively provided in the interior 10 of the bag 4, they are sterilized before being attached. That is, since not only the surface of the vial 5 but also the inside 5c of the vial 5 is sterilized, the elastic lid 6 and the rigid lid 7 are attached and then opened from the bag 4, so that the sterility in the inside 5c of the vial 5 is improved. The secured sterile vial 12 is assembled. As described above, a sterilization vial 12 that is colorless and transparent and highly sterilizable can be realized.

  According to the assembling method of the sterilization vial 12, since the vial 5, the elastic lid 6 and the rigid lid 7 are partitioned by the inside 10 of the bag 4 prepared in step S5, each is individually divided. It is possible to prevent the vial 5, the elastic lid 6, and the rigid lid 7 from being scattered inside the bag 10. Therefore, it is possible to improve workability when attaching the vial 5, the elastic lid 6, and the rigid lid 7 inside the bag 4 after the step S <b> 5 of preparing the bag 4. Further, since the elastic lid 6 and the rigid lid 7 are opened for the sterilized vial 12 assembled by such an assembling method for the first time when the user accommodates the medicine in the interior 5c of the vial 5, the sterilization vial 12 immediately before the user uses it. High sterility is maintained. For example, the contamination of bacteria can be greatly reduced as compared with the case where the vial 5 is always exposed to the bacteria from the manufacturing stage of the vial 5 to the stage of storing the medicine in the inside 5c of the vial 5.

  According to the assembling method of the sterilization vial 12, the elastic lid 6 is first attached to the vial 5 in the interior 10 of the bag 4 after sterilization, and the rigid lid 7 is attached to the vial 5 after ensuring sterility in the interior 5 c of the vial 5. Can do. Therefore, since the sterilization in the inside 5c of the vial 5 is secured when the elastic lid 6 is attached to the vial 5, the work of attaching the rigid lid 7 to the vial 5 and caulking can be performed even after the bag 4 is opened. It becomes possible.

  Next, a modified example of the sterile vial pack 1 according to the above embodiment will be described. FIG. 6 is a view showing a modification regarding the enclosure part 11 of the sterile vial pack 1 according to the embodiment.

  As shown in FIG. 2, in the sterilization vial pack 1 according to the above embodiment, the enclosing portion 11 extends from the bottom portion 4 a of the bag 4 to the closing portion 4 b of the bag 4, and has an area of the entire side portion 4 c of the bag 4. The area is approximately half the size. On the other hand, as shown in FIG. 6A, in the modified example, the enclosing portion 13 extends from the bottom 4a of the bag 4 to the closing portion 4b of the bag 4 as in the case of the enclosing portion 11. The area is smaller than the part 11. Further, as shown in FIG. 6B, in the enclosing portion 15 according to another modified example, unlike the enclosing portion 11, it does not extend from the bottom 4a of the bag 4 to the closing portion 4b of the bag 4, The side portion 4c of the bag 4 extends so as to wrap around in the direction around the axis of the bag 4.

  As mentioned above, although preferred embodiment of this invention was described, this invention is not limited to the said embodiment, It changed within the range which does not change the summary described in each claim, or applied to the other thing It may be a thing.

  For example, the first partition 8 and the second partition 9 are not necessarily formed. That is, the method of sterilizing the vial 5 may not include the step S3. In the method of assembling the sterilized vial 12, the vial 5, the elastic lid 6, and the inside of the bag 4 prepared in the step S5. The rigid lid 7 may not be partitioned by the first partition 8 and the second partition 9 and may not include the step S6 for releasing the first partition 8 and the step S8 for releasing the second partition 9. In the case where the bag 4 has a cylindrical shape that is substantially the same diameter as the outer diameter of the body portion 5 a of the vial 5, a large gap is not formed between the bag 4 and the vial 5. Thereby, even if the 1st partition 8 and the 2nd partition 9 are not formed, it can prevent that the vial 5, the elastic cover 6, and the rigid cover 7 are scattered in the inside 10 of the bag 4. FIG.

  The second partition 9 is not formed, and only the first partition 8 may be formed. In this case, the elastic lid 6 and the rigid lid 7 are preferably integrated. Since the elastic lid 6 and the rigid lid 7 are integrated, the elastic lid 6 and the rigid lid 7 can be integrally attached to the vial 5 when the sterilization vial 12 is assembled, thereby improving workability. It becomes possible.

  In the above embodiment, the first partition 8 and the second partition 9 are formed by being attached by spotting. However, the present invention is not limited to this, and any method can be used as long as the inside 10 of the bag 4 can be partitioned. May be formed. When the first partition 8 and the second partition 9 are released, the bag 4 may be formed by welding or the like as long as the bag 4 does not break with the release of the first partition 8 and the second partition 9. .

  In the said embodiment, although the enclosure part 11 was comprised as a part of side part 4c of the bag 4, it is not restricted to this, You may be comprised as the whole side part 4c of the bag 4. FIG. Moreover, it may be comprised including the bottom part 4a and the closed part 4b, and may be comprised as the whole bag 4. FIG. The shape of the enclosure portion 11 is not limited to the shape shown in the above embodiment, and may be any shape as long as sterilization gas can be introduced into the interior 10 of the bag 4.

  In the above embodiment, the sterilized vial pack 1 is provided with the elastic lid 6 and the rigid lid 7. However, instead of this, it may be provided with one lid that can seal the vial 5.

  In the said embodiment, although the bag 4 was made into cylindrical shape, a shape is not restricted to this, For example, a flat bag, a square bottom bag, etc. may be sufficient.

  DESCRIPTION OF SYMBOLS 1 ... Sterilization vial pack, 4 ... Bag, 4b ... Closing part, 4a ... Bottom part (opposite side of closing part), 5 ... Vials, 6 ... Elastic lid (lid), 7 ... Rigid lid (lid), 8 ... 1st Partition, 9 ... 2nd partition, 10 ... Inside, 11 ... Enclosing part, S1-S10 ... Process.

Claims (9)

Placing each vial and lid inside the bag;
Sealing the bag;
Supplying gas into the bag to sterilize the vial and the lid;
A method for sterilizing a vial comprising: Further comprising the step of partitioning the vial and the lid before the step of sterilizing the vial and the lid;
The method for sterilizing a vial according to claim 1. The lid has an elastic lid and a rigid lid,
In the step of partitioning the vial and the lid, the vial, the elastic lid, and the rigid lid are separately partitioned,
The method for sterilizing a vial according to claim 2. A bag,
A sterilized vial provided inside the bag;
A sterilized lid provided inside the bag;
An enclosing part capable of enclosing a gas for sterilizing the vial and the lid inside the bag;
Sterile vial pack comprising.   The sterile vial pack according to claim 4, wherein the vial and the lid are partitioned inside the bag. The lid has an elastic lid and a rigid lid,
Inside the bag, the vial, the elastic lid, and the rigid lid are separately partitioned by a first partition and a second partition,
The vial, the elastic lid, the rigid lid, the first partition, and the second partition are arranged in order from the opposite side of the closing portion of the bag toward the closing portion, the vial, the first partition, and the elastic lid. The second partition and the rigid lid are arranged in this order.
The sterile vial pack according to claim 4 or 5. A step of preparing a bag in which a vial sterilized by gas and a lid sterilized by gas are respectively provided;
After the step of preparing the bag, attaching the lid to the vial inside the bag;
After the step of attaching the lid to the vial, opening the bag;
A method for assembling a sterile vial. In the step of preparing the bag, preparing the bag in which the vial and the lid are partitioned inside the bag,
The method for assembling a sterile vial according to claim 7. The lid has an elastic lid and a rigid lid,
In the step of preparing the bag, inside the bag, the vial, the elastic lid, and the rigid lid are separately partitioned by a first partition and a second partition, respectively, the vial, the elastic lid, The rigid lid, the first partition, and the second partition are in order from the opposite side of the bag closing portion toward the closing portion, the vial, the first partition, the elastic lid, the second partition, And preparing the bags arranged in the order of the rigid lids,
The step of attaching the lid to the vial inside the bag includes a step of releasing the first partition and attaching the elastic lid to the vial, and a step of attaching the elastic lid to the vial. Releasing the partition and attaching the rigid lid to the vial; and opening the bag.
The method for assembling a sterile vial according to claim 7 or 8.

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