JP2005195496A - Manufacturing method for container containing medical fluid and container for medical fluid - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a manufacturing method for a container containing medical fluid to facilitate the management of a container for medical fluid without lowering the inspection accuracy of foreign matter inspection for the container containing medical fluid. <P>SOLUTION: This manufacturing method is equipped with a first process for manufacturing the container 10 for medical fluid having a transparent container wall 11, forming an identification display 14 on an outer surface of the container wall 10 with fluorescent ink, and storing the manufacture record of the container 10 corresponding to the identification display 14, a second process for housing and sealing the medical fluid in the container 10 with the identification display 14 formed thereon, and a third process for optically performing the foreign matter inspection through the identification display 14 from the outside of the container wall 11. <P>COPYRIGHT: (C)2005,JPO&NCIPI

Description

  The present invention is used in a method for manufacturing a chemical solution container and a method for manufacturing the chemical solution container that optically inspects a foreign substance of the chemical solution from the outside of the transparent container wall after sealing the chemical solution in a chemical solution container having a transparent container wall. The present invention relates to a chemical container.

  2. Description of the Related Art Conventionally, a large number of containers containing various chemical solutions in which chemical solutions are contained in glass or plastic ampoule bottles and vials have been distributed.

  In such chemical containers, strict product management is required, and for all manufactured products, a manufacturing record including the chemical container, the manufacturing date of the chemical, the manufacturer, and various inspection results should be stored. Is required.

  In order to manufacture a container containing such a chemical solution, a chemical solution prepared in advance and clearly recorded in various forms is filled in a pre-formed chemical solution container in an automatic filling line, and after sealing, sterilized as necessary. In addition, all products manufactured in the final stage are irradiated with light from the bottom wall surface or side wall surface of the container, and checked for the presence or absence of foreign matter mixed in the chemical solution by reflected light or transmitted light, using visual or optical machinery. After that, a label is affixed to the container wall, and a product identification number such as a product number is attached to the label, and a manufacturing record of the container containing the chemical solution is stored corresponding to this identification display. It was.

  Here, since the foreign substance inspection performed in the final stage is optically performed through the container wall, there is a possibility that the container wall of the chemical liquid container to be molded in advance may be mixed with the internal chemical liquid or the inside thereof. It is made transparent so that some foreign matter can be optically confirmed, and before the foreign matter inspection, the container wall is not provided with printing or labeling to ensure transparency of the container wall. Thus, the high inspection accuracy of the foreign matter inspection was maintained and the product quality was ensured.

  However, in such a conventional method for manufacturing a container with a chemical solution, for the purpose of maintaining the inspection accuracy of the foreign substance inspection, the chemical solution container itself is not provided with an identification display until the final stage of the manufacturing process of the chemical solution container. The production record of the chemical solution container itself is stored in correspondence with the lot number assigned to the chemical solution container indirectly by attaching a lot number to a case that accommodates a pre-formed chemical solution container. It was. Also, the chemical solution was managed by the rod number indirectly attached to the chemical solution container until the foreign substance inspection was completed after the chemical solution container was filled.

  Therefore, in the unlikely event that a chemical solution container with a different lot number is mixed as a chemical solution container of a predetermined lot number, the chemical solution container must be identified due to minute differences in the chemical solution containers. It is not easy to distinguish afterwards. When stored in a chemical container of another lot number, there is a risk that an accurate manufacturing record cannot be stored. Therefore, conventionally, there has been a problem that handling of the chemical solution container has to be performed strictly, and it takes time and effort for management.

  In particular, when manufacturing chemical liquid containers containing different chemical liquids using the same or similar chemical liquid containers, management of the chemical liquid containers has to be performed strictly.

  Accordingly, an object of the present invention is to provide a method for producing a chemical solution container capable of easily managing the chemical solution container without reducing the inspection accuracy of the foreign substance inspection of the chemical solution container, Another object is to propose a chemical container suitable for the manufacturing method.

  The method for producing a chemical solution container according to claim 1 that solves the above-described problem is to produce a chemical solution container having a transparent container wall, and form an identification display with fluorescent ink on the outer surface of the transparent container wall. A first step of storing a manufacturing record of the chemical solution container in correspondence with the identification display; a second step of storing and sealing the chemical solution in the chemical solution container on which the identification display is formed; and the transparent And a third step of optically inspecting the foreign substance of the chemical liquid through the identification display from the outside of the container wall.

  The method for producing a chemical solution container according to claim 2 includes a fourth step of providing a chemical solution display on the transparent container wall after the third step in addition to the configuration of claim 1. To do.

  In addition to the structure of Claim 1 or 2, the manufacturing method of the chemical | medical solution container of Claim 3 irradiates predetermined light to the said transparent container wall in the said 2nd process, and confirms the said identification display. And the said chemical | medical solution corresponding to this identification display is accommodated in the said chemical | medical solution container.

  According to a fourth aspect of the present invention, there is provided a method for producing a chemical solution container, wherein, in addition to the configuration according to any one of the first to third aspects, the second and subsequent steps are made to correspond to the identification display of the chemical solution container. The manufacturing record of the chemical solution is stored.

  In addition to the structure according to any one of claims 1 to 4, the manufacturing method of the chemical solution container according to claim 5 forms a cross-sectional shape of the chemical solution container in a circular shape in the first step. In the third step, the foreign matter inspection is performed by rotating the chemical solution container and the chemical solution.

  The chemical solution container according to claim 6 includes an accommodating portion having a transparent container wall and a sealable opening, and the chemical solution is accommodated in the accommodating portion so that optical foreign matter inspection of the chemical solution is performed in the transparent container. A chemical solution container is provided through a wall, and an identification display corresponding to a manufacturing record of the chemical solution container is formed on the transparent container wall with fluorescent ink.

  The chemical solution container according to claim 7 is characterized in that, in addition to the configuration according to claim 6, the entire circumference of the housing portion is formed of the transparent container wall.

  The chemical container according to claim 8 is characterized in that, in addition to the configuration according to claim 6 or 7, the transparent container wall is made of glass.

  According to the method for manufacturing a chemical solution container according to claim 1, the identification display corresponding to the manufacturing record of the chemical solution container is formed on the outer surface of the transparent container wall by the fluorescent ink in the first step. If the identification display of the chemical solution container is managed after the process, it is possible to reliably store the manufacturing record of the correct chemical solution container, and it is easy to manage the chemical solution container, and the identification display on the transparent container wall is fluorescent ink. Therefore, when the foreign substance inspection of the chemical liquid is optically performed from the outside of the transparent container wall in the third step, the optical foreign substance inspection of the chemical liquid can be performed through the identification display, and the detection accuracy Will not get worse. Therefore, it is possible to easily manage the chemical liquid container without reducing the inspection accuracy of the foreign substance inspection of the chemical liquid container.

  According to the method for manufacturing a container with a chemical liquid according to claim 2, even if the chemical liquid display is provided on the transparent container wall after the third step, the identification display is formed by the fluorescent ink. The display is not visually recognized, and the appearance of the chemical solution container is not deteriorated.

  According to the method for producing a chemical solution container according to claim 3, in the second step, the transparent container wall is irradiated with predetermined light to confirm the identification display, and the chemical solution corresponding to the identification display is applied to the chemical solution container. Since it is stored, it is possible to store the predetermined chemical solution in the predetermined chemical solution container more reliably.

  According to the method for producing a chemical solution container according to claim 4, if the production record of the chemical solution is stored in correspondence with the identification display of the chemical solution container, the production record after molding of the chemical solution container is unified. Easy to manage.

  According to the method for producing a chemical solution-containing container according to claim 5, the foreign substance inspection is performed by detecting the rotation of the chemical solution container and the chemical solution using a chemical solution container having a circular cross-sectional shape. When the container is rotated or stopped, the chemical liquid easily flows due to inertial force, and foreign matter inspection is easily performed.

  According to the chemical solution container of claim 6, since the identification display corresponding to the manufacturing record of the chemical solution container is formed on the transparent container wall by the fluorescent ink, the identification display formed on the chemical solution container itself is used. The container for chemical solution can be easily managed, and the identification display on the transparent container wall is made of fluorescent ink. Is possible. Therefore, it is possible to provide a chemical solution container that can be easily managed without reducing the inspection accuracy of the foreign substance inspection.

  In particular, in the chemical solution container according to claim 7, since the entire periphery of the storage portion is made of a transparent container wall, the entire periphery of the container wall can be used at the time of foreign matter inspection if the identification display is formed of fluorescent ink. It is possible to maintain high inspection accuracy of the foreign matter inspection.

  In the chemical solution container according to claim 8, since the transparent container wall is made of glass, the chemical solution in which the components of the fluorescent ink are stored through the transparent container wall even if the identification display is formed by the fluorescent ink. There is no contamination.

  Embodiments of the present invention will be described below.

  FIG. 1 shows an ampoule bottle as a chemical solution container according to this embodiment.

  The ampoule bin 10 has an opening 12 at the top of the upper part, a storage part 13 having a circular cross-sectional shape for storing a chemical solution in the lower part, and a breakable constricted part 15 at the intermediate part. doing.

  The ampoule bin 10 is made of transparent glass, and the entire periphery of the housing portion 13 is a transparent container wall 11. The transparent container wall 11 is required to have a light transmittance such that a foreign substance that may be mixed with the chemical solution can be visually recognized. For example, the visible light transmittance is preferably 55% or more.

  On the transparent container wall 11, a barcode 14 is formed of fluorescent ink as an identification display that can be distinguished from other ampoule bins with different production records. The bar code 14 is substantially transparent in a normal visible light range, that is, transparent to such an extent that the chemical solution in the container is visible.

  The fluorescent ink is preferably one that is not visible as much as possible with respect to visible light irradiated for foreign substance inspection, and has a transmittance in the range equal to or greater than the visible light transmittance of the transparent container wall 11. Preferably, the visible light transmittance is 70% or more. In the case of the fluorescent ink in such a range, it is difficult to hinder the detection of the foreign matter in the foreign matter inspection described later.

Further, such a fluorescent ink is not visually recognized even when irradiated with visible light, but can be easily visually recognized by irradiating with predetermined light that can obtain fluorescence of the fluorescent ink, such as ultraviolet rays. As the fluorescent ink, for example, _{Zn 2 SiO 4: Mn, ZnS} : Cu, ZnS: and the like can be exemplified those composed of Mn.

  Such an ampoule bin 10 is manufactured by forming a barcode 14 with a fluorescent ink on the surface of the transparent container wall 11 after being formed into a predetermined shape from transparent glass by a normal method.

  The production record of the ampoule bin 10 is stored by making it correspond to the barcode 14. This manufacturing record is, for example, a record indicating the date of manufacture, various inspection results, and the like, and is usually stored after manufacturing separately from the ampoule bin 10.

  Next, a description will be given of a method of manufacturing an ampoule preparation as a container containing a chemical solution by storing the chemical solution using the ampoule bin 10 manufactured as described above and having a production record stored therein.

  First, while preparing a chemical | medical solution previously, as a 1st process, the ampoule bin 10 in which the barcode 14 was formed with the fluorescent ink as mentioned above is manufactured previously.

  Then, as a second step, a predetermined amount of the chemical solution is stored in the storage portion 13 from the opening 12 of the ampoule bin 10 in a filling device (not shown). At this time, since the bar code 14 is formed on the ampoule bin 10, if the bar code 14 is confirmed by irradiating the ampoule bin 10 supplied to the transparent container filling device with predetermined light such as ultraviolet rays, a different manufacture is performed. It is possible to reliably prevent another ampoule bin 10 having a record from being mixed and supplied to the filling device or filling a predetermined chemical solution into the other ampoule bin 10.

  And after filling with a chemical | medical solution in this way, the opening part 12 is fuse | melted and closed, and as shown by the dashed-two dotted line A, the ampule bin 10 is sealed. Thereafter, if necessary, the sealed ampoule bottle 10 is subjected to sterilization such as heat sterilization or ultraviolet sterilization.

  Next, as a third step, the foreign substance inspection of the chemical solution is optically performed from the outside of the ampoule bin 10.

  The foreign matter in the chemical solution is a solid content mixed in the chemical solution at the time of preparation or transfer of the chemical solution, a solid content adhering in the ampoule bottle, an undissolved content of the drug, or the like.

  In order to inspect whether or not such foreign matter is mixed, the bottom of the ampoule bin 10 is used because the foreign matter reflects visible light or has a refractive index different from that of the chemical even though it is transmitted. It can detect by irradiating visible light from a wall or a side wall. In this foreign matter inspection, the operation of rotating and stopping the ampoule preparation 20 is repeated while irradiating visible light, and the presence or absence of foreign matter is confirmed when the drug solution moves through the container 13 by inertial force.

  If no foreign matter is confirmed by this foreign matter inspection, it is sent to the fourth step as an acceptable product, and is stored in the transparent container wall 11 of the containing portion 13, for example, a product name, a drug name, a component, etc. A label 16 is attached as a chemical display for displaying information on the existing chemical.

  The label 16 can be provided with a code, a symbol, a number, or the like that can be distinguished from other ampoule preparations 20. In this way, the container can be managed even when the barcode 14 is covered with the label 16 and is not visible. At that time, it is preferable to inspect whether or not the barcode 14 and the label 16 are coincident with each other before the label 16 is pasted by irradiating and displaying a predetermined light beam on the transparent container wall 11 in advance.

  And also about the chemical | medical solution accommodated in such an ampoule formulation 20, a manufacture record is preserve | saved corresponding to the display of the label 16, or the barcode 14. FIG. In the case of this embodiment, it is stored corresponding to the barcode 14.

  The manufacturing record of the chemical solution is, for example, a record indicating the manufacturing date, various inspection results, and the like, and is usually stored after manufacturing separately from the chemical solution. Therefore, in such an ampoule preparation 20, the production record of the ampoule bin 10 is preserved as described above, and the production record of the contained chemical solution is preserved, and these production records are stored in the barcode 14 and the label 16. It can be confirmed in response to the description of.

  Accordingly, it is possible to manufacture the ampoule preparation 20 of this embodiment in which each manufacturing record is stored.

  When the ampule formulation 20 is manufactured as described above, the barcode 14 corresponding to the manufacturing record of the ampule bin 10 is formed on the transparent container wall 11 with the fluorescent ink, so that the barcode 14 of the ampule bin 10 can be managed. For example, the manufacturing record of the correct ampoule bin 10 can be reliably stored, and different ampoule bins 10 are not mixed in during the manufacturing process. Therefore, the ampoule bin 10 can be easily managed. At the same time, since the barcode 14 of the transparent container wall 11 is formed of fluorescent ink, when the foreign substance inspection of the chemical liquid is optically performed from the outside of the transparent container wall 11, the identification display is transmitted and the optical liquid of the chemical liquid is transmitted. Foreign matter inspection can be performed, and even if the barcode 14 is provided around the housing portion 13, the detection accuracy does not deteriorate.

  As a result, it is possible to facilitate the management of the ampoule bin 10 without reducing the inspection accuracy of the foreign substance inspection of the ampoule preparation 20.

  Moreover, since it is possible to arrange the label 16 and the barcode 14 at positions where part or all of them overlap, the sizes of the barcode 14 and the label 16 can be freely set. That is, even if a part or all of the barcode 14 is arranged outside the label 16, the barcode 14 is not visually recognized in a normal state, so that the size and position of the label 16 can be freely adjusted. It is possible to make it easier to confirm both.

  Moreover, if the bar code 14 is formed in this way and the label 16 is affixed, even if a label 16 affixing error occurs in the final inspection of the ampoule bin 10 or the label 16 is peeled off, the bar code 14 Confirmation can be performed easily.

  Further, before the label 16 is attached, the transparent container wall 11 of the ampoule bin 10 is irradiated with a predetermined light beam to display the bar code 14 and the inspection corresponding to or corresponding to the label 16 is performed. Management can be performed reliably.

  Moreover, since the manufacturing record of the chemical | medical solution accommodated corresponding to the barcode of the ampoule bin 10 is preserve | saved, the production record after shaping | molding of the ampoule bin 10 can be preserve | saved uniformly and sequentially.

  Furthermore, since the ampule bin 10 having a circular cross-sectional shape is used to inspect the foreign matter by rotating the ampule bin 10 and the chemical solution, when the ampule bin 10 is rotated or stopped, there is little disturbance of the chemical solution and the inertial force. Therefore, it is easy to flow and foreign matter inspection is easy.

  Further, since the transparent container wall 11 of the ampoule bin 10 is made of glass, even if the barcode 14 is formed of fluorescent ink, the chemical solution in which the components of the fluorescent ink are stored through the transparent container wall 11. Will not pollute.

  Further, since the bar code 14 is provided on the transparent container wall 11 of the storage portion 13, even if the upper side of the constricted portion 15 is broken due to the use of the ampoule preparation 20, a bar is provided on the storage portion 13 in which the chemical solution is stored. The code 14 can be left, and it is easy to check the production record even after using the medicine.

  In the above embodiment, the example in which the ampoule bin 10 is provided with the linear barcode 14 formed of fluorescent ink has been described. However, the container for storing the chemical and the identification display are not particularly limited. For example, the quick response code 23 can be provided in the vial bin 22 as shown in FIG. 2, or the two-dimensional barcode 27 can be provided in the screw mouth bin 26 as shown in FIG.

  Furthermore, in any of the above-described embodiments, the identification display made of a barcode formed of fluorescent ink on the chemical solution container has been described. However, the present invention is not particularly limited. For example, characters, figures, symbols, These bonds may be used.

  Moreover, although the above demonstrated the example which affixed the label as a chemical | medical solution display to each chemical | medical solution container, for example, it can also form by affixing other members, such as a film which described the information regarding a chemical | medical solution. . Furthermore, as long as it can print on a transparent container wall in the state in which the chemical | medical solution was accommodated, what printed the container directly may be used.

  Furthermore, in the said embodiment, although the identification display was provided in the transparent container wall 11 of the accommodating part 13, the position is not specifically limited, It is also possible to provide in the bottom wall surface etc. of a container.

It is a side view which shows the ampoule bin of embodiment of this invention. It is a side view which shows the modification of embodiment of this invention. It is a side view which shows the other modification of embodiment of this invention.

Explanation of symbols

10 Ampoule bin (chemical solution container)
11 Transparent container wall 12 Opening portion 13 Housing portion 14 Bar code (identification display)
16 Label (medical solution display)
20 ampoule preparation (container with chemicals)
22 vials (medical solution containers)
26 Screw mouth bottle (chemical solution container)

Claims (8)

First, a chemical solution container having a transparent container wall is manufactured, an identification display is formed on the outer surface of the transparent container wall with fluorescent ink, and a manufacturing record of the chemical solution container is stored in correspondence with the identification display. And the process of
A second step of accommodating and sealing the chemical solution in the chemical solution container in which the identification display is formed;
And a third step of optically inspecting the foreign substance of the chemical liquid through the identification display from the outside of the transparent container wall. The method for producing a chemical solution-containing container according to claim 1, further comprising a fourth step of providing a chemical indication on the transparent container wall after the third step. The said 2nd process WHEREIN: Predetermined light is irradiated to the said transparent container wall, the said identification display is confirmed, and the said chemical | medical solution corresponding to this identification display is accommodated in the said chemical | medical solution container. Or the manufacturing method of the chemical | medical solution containing container of 2. The chemical solution container according to any one of claims 1 to 3, wherein after the second step, a manufacturing record of the chemical solution is stored in correspondence with the identification display of the chemical solution container. Production method. 2. The foreign substance inspection is performed by forming a cross-sectional shape of the chemical solution container in a circular shape in the first step and rotating the chemical solution container and the chemical solution in the third step. The manufacturing method of the chemical | medical solution containing container as described in any one of thru | or 4. A container for chemical liquid, comprising a container having a transparent container wall and a sealable opening, in which a chemical liquid is stored in the container, and optical foreign matter inspection of the chemical liquid is performed through the transparent container wall. And
A chemical solution container characterized in that an identification display corresponding to a manufacturing record of the chemical solution container is formed on the transparent container wall with fluorescent ink. The chemical container according to claim 6, wherein the entire periphery of the housing portion is formed of the transparent container wall. The chemical container according to claim 6 or 7, wherein the transparent container wall is made of glass.

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