JP2859553B2 - Method for inspecting molding defects of plastic molded articles for medical use - Google Patents
Method for inspecting molding defects of plastic molded articles for medical useInfo
- Publication number
- JP2859553B2 JP2859553B2 JP7039319A JP3931995A JP2859553B2 JP 2859553 B2 JP2859553 B2 JP 2859553B2 JP 7039319 A JP7039319 A JP 7039319A JP 3931995 A JP3931995 A JP 3931995A JP 2859553 B2 JP2859553 B2 JP 2859553B2
- Authority
- JP
- Japan
- Prior art keywords
- plastic molded
- air
- medical
- pressure
- molded article
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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Description
【０００１】[0001]
【産業上の利用分野】本発明は医薬用プラスチック成形
品の成形不良を検査する方法に関する。BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a method for inspecting molding defects of a plastic molded article for medical use.
【０００２】[0002]
【従来の技術】医薬用プラスチック成形品は、成形不良
を皆無にすることを追求して成形される。医薬用プラス
チック成形品の成形不良は、細菌による汚染等の原因と
なるからである。医薬用プラスチック成形品は、密閉構
造で滅菌して細菌の汚染を防止している。ただ、成形不
良によって空気漏れが起こると、気密構造に保持でき
ず、雑菌が侵入して汚染される弊害が発生する。このよ
うな弊害を防止するためには、医薬用プラスチック成形
品が正常に成形されているかどうかを検査する必要があ
る。2. Description of the Related Art Pharmaceutical plastic molded articles are molded in pursuit of eliminating molding defects. This is because molding failure of the plastic molded article for medical use causes bacterial contamination and the like. Pharmaceutical plastic molded articles are sterilized in a closed structure to prevent bacterial contamination. However, if air leakage occurs due to poor molding, the airtight structure cannot be maintained, and there is an adverse effect that bacteria enter and are contaminated. In order to prevent such adverse effects, it is necessary to inspect whether or not the medical plastic molded product is properly molded.
【０００３】医薬用プラスチック成形品を成形後に検査
する従来の方法を図１に示す。この図は、容器の形状に
成形した医薬用プラスチック成形品の検査方法を示して
いる。この検査方法は下記の工程でピンホール等の成形
不良を検査する。[0003] Fig. 1 shows a conventional method for inspecting a medical plastic molded article after molding. This figure shows a method of inspecting a medical plastic molded product molded into the shape of a container. This inspection method inspects molding defects such as pinholes in the following steps.
【０００４】 押圧部材１の空気漏検出面１Ａを医薬
用プラスチック成形品２の開口部に密着し、医薬用プラ
スチック成形品２を検査壁体とする密閉空間３を形成す
る。押圧部材１は、下面の空気漏検出面１Ａを鏡面状と
して、医薬用プラスチック成形品２の開口面に気密に密
着できる形状とし、あるいは、下面の空気漏検出面１Ａ
にゴム状弾性体のパッキンを張設して、医薬用プラスチ
ック成形品２の開口面に気密に密着できる構造としてい
る。[0004] The air leak detection surface 1A of the pressing member 1 is brought into close contact with the opening of the medical plastic molded product 2 to form a closed space 3 having the medical plastic molded product 2 as an inspection wall. The pressing member 1 has a lower surface air leak detection surface 1A having a mirror-like shape and a shape capable of airtightly adhering to the opening surface of the medical plastic molded product 2, or a lower surface air leak detection surface 1A.
A rubber-like elastic gasket is stretched over the rubber molded article 2 so as to be able to hermetically adhere to the opening surface of the plastic molded article 2 for medical use.
【０００５】 押圧部材１に連結している空気弁４を
開いて、医薬用プラスチック成形品２で形成される密閉
空間３に加圧空気を供給し、その後に空気弁４を閉弁す
る。 空気弁４と押圧部材１との間に連結している圧力セ
ンサー５で、密閉空間３の圧力低下を検出する。医薬用
プラスチック成形品２にピンホールがあり、あるいは、
医薬用プラスチック成形品２の開口面に欠損部があっ
て、押圧部材１の空気漏検出面１Ａとの間に隙間ができ
て、密閉空間３から空気が漏れると、圧力センサー５の
検査圧力が変化する。密閉空間３に空気漏れがないと、
圧力センサー５の指示は変化しない。[0005] The air valve 4 connected to the pressing member 1 is opened to supply pressurized air to the closed space 3 formed by the medical plastic molded article 2, and then the air valve 4 is closed. A pressure sensor 5 connected between the air valve 4 and the pressing member 1 detects a pressure drop in the closed space 3. The medical plastic molded article 2 has a pinhole, or
When there is a deficient portion on the opening surface of the medical plastic molded article 2 and a gap is formed between the opening and the air leak detection surface 1A of the pressing member 1 and air leaks from the closed space 3, the inspection pressure of the pressure sensor 5 is reduced. Change. If there is no air leak in the closed space 3,
The indication of the pressure sensor 5 does not change.
【０００６】したがって、この方法は圧力センサー５の
指示を検出して、ピンホール等の成形不良を検査でき
る。Therefore, according to this method, it is possible to detect a molding defect such as a pinhole by detecting an instruction from the pressure sensor 5.
【０００７】[0007]
【発明が解決しようとする課題】図１に示す検査方法
は、極めて小さいピンホールを発見して、しかも処理時
間を短くすることができない。小さいピンホールを発見
できることと、処理時間を短くすることは互いに相反す
る特性であって、両方を同時に満足できない。微細なピ
ンホールは空気が少しずつ漏れるので、密閉空間の圧力
が低下するのに時間がかかる。したがって、微細なピン
ホールを発見するためには、加圧空気を圧入した状態
で、圧力低下を検出する時間を長くする必要がある。The inspection method shown in FIG. 1 cannot detect an extremely small pinhole and shorten the processing time. Being able to find small pinholes and shortening the processing time are mutually exclusive properties, and both cannot be satisfied simultaneously. Since the fine pinhole leaks the air little by little, it takes time for the pressure in the closed space to decrease. Therefore, in order to find a fine pinhole, it is necessary to lengthen the time for detecting a pressure drop while pressurized air is being injected.
【０００８】多量生産される医薬用プラスチック成形品
は、ピンホール等の検査時間に制約を受ける。検査時間
が長くなると検査のタクトタイムが長くなるので、生産
のタクトタイムも長くする必要があって、時間当りの生
産数量を少なくする必要がある。このため、医薬用プラ
スチック成形品を能率よく多量生産するためには、検査
時間を短縮する必要がある。しかしながら、検査時間を
短くすると、微細なピンホールの密閉空間では圧力低下
が少なく、確実に検査できなくなる。[0008] The mass production of medical plastic molded products is limited by the inspection time for pinholes and the like. As the inspection time becomes longer, the inspection tact time becomes longer. Therefore, it is necessary to increase the production tact time, and it is necessary to reduce the production quantity per hour. For this reason, it is necessary to shorten the inspection time in order to efficiently produce large quantities of medical plastic molded products. However, when the inspection time is shortened, the pressure drop is small in the closed space of the fine pinhole, and the inspection cannot be performed reliably.
【０００９】この弊害は、密閉空間に高圧の空気を圧入
することで解消できる。高圧空気は、微細なピンホール
からも多量に空気漏れするからである。ただ、実際に医
薬用プラスチック成形品を検査するときに、高圧の空気
を圧入することは極めて難しい。それは、高圧空気を密
閉空間に圧入すると、空気漏検出面１Ａを強く医薬用プ
ラスチック成形品２の開口部に押し付ける必要があり、
さらに、高圧空気で医薬用プラスチック成形品２が変形
したり、あるいは破損する心配があるからである。密閉
空間３に高圧空気を圧入すると、空気漏検出面１Ａは、
圧力と開口面積に比例した力で押圧される。この押圧力
は、密閉空間３を医薬用プラスチック成形品２の開口部
から離そうとするので、空気漏検出面１Ａから空気漏れ
しやすくなってしまう。空気漏検出面１Ａから空気漏れ
が発生しない状態で密着させるために、空気漏検出面１
Ａを強く押圧する必要がある。とくに、開口面積の大き
い医薬用プラスチック成形品２は、面積に比例した押圧
力で押圧する必要があって、相当に強い力で押圧する必
要がある。押圧力を強くすると、医薬用プラスチック成
形品２が変形したり、あるいは破損する弊害が発生す
る。This problem can be solved by injecting high-pressure air into the closed space. This is because a large amount of high-pressure air leaks from fine pinholes. However, it is extremely difficult to inject high-pressure air when actually inspecting a medical plastic molded product. That is, when high-pressure air is pressed into the closed space, it is necessary to strongly press the air leak detection surface 1A against the opening of the medical plastic molded product 2,
Further, there is a concern that the medical plastic molded article 2 is deformed or damaged by high-pressure air. When high-pressure air is press-fitted into the closed space 3, the air leak detection surface 1A
It is pressed with a force proportional to the pressure and the opening area. This pressing force tends to separate the closed space 3 from the opening of the plastic molded article 2 for medical use, so that air leaks easily from the air leak detection surface 1A. In order that the air leak detection surface 1A may be brought into close contact with the air leak detection surface 1A without air leakage, the air leak detection surface 1A may be used.
A must be pressed strongly. In particular, the medical plastic molded article 2 having a large opening area needs to be pressed with a pressing force proportional to the area, and needs to be pressed with a considerably strong force. When the pressing force is increased, the medical plastic molded article 2 is deformed or damaged.
【００１０】さらに、空気漏検出面１Ａにゴム状弾性体
のパッキン（図示せず）を設けているものは、強く押圧
するとゴム状弾性体の変形量が大きくなって、医薬用プ
ラスチック成形品２の開口面にできる成形不良を正確に
発見するのが難しくなる欠点もある。医薬用プラスチッ
ク成形品２は、開口面を極めて高精度な平面状に成形す
る必要のあるものがある。たとえば、図２に示すよう
に、開口面をゴムパッキン１３に押圧して気密に密閉し
て使用する成形品である。この用途に使用される医薬用
プラスチック成形品２は、開口面２Ｃと空気漏検出面の
空気漏れを検査して、成形不良を検査する。開口面の局
部に凹部ができてしまうと、図２に示すように、医薬用
プラスチック成形品２の開口面２Ｃをゴムパッキン１３
に気密に密着できなくなるからである。Further, in the case where a rubber-like elastic body packing (not shown) is provided on the air leak detection surface 1A, when the rubber-like elastic body is strongly pressed, the deformation amount of the rubber-like elastic body increases, and the plastic molded article for medical use 2 There is also a drawback that it is difficult to accurately detect a molding defect formed on the opening surface of the device. Some plastic molded articles for medical use 2 require the opening surface to be formed into an extremely accurate planar shape. For example, as shown in FIG. 2, the molded product is used by hermetically sealing by pressing an opening surface against a rubber packing 13. The molded plastic article 2 for medical use used for this purpose inspects the opening 2C and the air leak detection surface for air leaks to check for molding defects. When a concave portion is formed in a local portion of the opening surface, as shown in FIG.
This is because it is not possible to adhere in a gas-tight manner.
【００１１】空気漏検出面１Ａのゴム状弾性体を、医薬
用プラスチック成形品２の開口面に密着させて、開口面
と空気漏検出面１Ａとの空気漏れを検査する方法は、密
閉空間３の加圧空気を高くして、空気漏検出面１Ａを強
く開口面に押圧すると、ゴム状弾性体の変形量が多くな
って、微細な凹部の検出ができなくなる。ゴム状弾性体
が凹部に沿って変形して、空気漏れが起こらなくなるか
らである。このため、開口面の微細な凹部を検出するた
めには、空気漏検出面１Ａを強く医薬用プラスチック成
形品２の開口面に強く押圧できない。したがって、密閉
空間３に圧入する空気圧を低くする必要がある。ただ、
密閉空間３の空気圧を低くすると、医薬用プラスチック
成形品２の微細なピンホールが発見できなくなってしま
う弊害が発生する。The method of checking the air leak between the opening surface and the air leak detection surface 1A by bringing the rubber-like elastic body of the air leak detection surface 1A into close contact with the opening surface of the medical plastic molded product 2 includes the following steps. When the pressurized air is increased to strongly press the air leak detection surface 1A against the opening surface, the amount of deformation of the rubber-like elastic body increases, and it becomes impossible to detect a fine concave portion. This is because the rubber-like elastic body is deformed along the concave portion so that air leakage does not occur. For this reason, in order to detect a fine concave portion on the opening surface, the air leak detection surface 1A cannot be strongly pressed against the opening surface of the medical plastic molded product 2. Therefore, it is necessary to reduce the air pressure for press-fitting into the closed space 3. However,
When the air pressure in the closed space 3 is reduced, a disadvantage that fine pinholes of the plastic molded article for medical use 2 cannot be found occurs.
【００１２】医薬用プラスチック成形品２の開口部にで
きるかも知れない微細な凹部を確実に検出するために
は、空気漏検出面１Ａを金属製の鏡面とすればよい。た
だ、金属製の空気漏検出面１Ａを開口面に強く押圧する
と、開口部に局部的に強い押圧力が作用して、変形しや
すくなる欠点がある。このため、金属製の空気漏検出面
１Ａも、医薬用プラスチック成形品２の開口面に強く押
圧できない。In order to reliably detect a minute concave portion which may be formed in the opening of the plastic molded article 2 for medical use, the air leak detecting surface 1A may be a metal mirror surface. However, when the metal air leak detection surface 1A is strongly pressed against the opening surface, a strong pressing force acts locally on the opening portion, and there is a disadvantage that the metal air leak detection surface 1A is easily deformed. Therefore, the metal air leak detection surface 1A cannot be strongly pressed against the opening surface of the medical plastic molded product 2.
【００１３】検査の処理時間と、密閉空間３に圧入でき
る空気圧の制限を受けて、現在使用されている検査方法
は、約０．３ｍｍのピンホールを発見できるが、それよ
りも小さいピンホールは発見できない。このため、実際
に医薬用プラスチック成形品２を成形する工程において
約０．３ｍｍよりも小さいピンホールができるとこれを
不良品として識別できない。このため、測定限界をさら
に小さくすることが切望さている。Due to the processing time of the inspection and the limitation of the air pressure that can be pressed into the closed space 3, the inspection method currently used can find a pinhole of about 0.3 mm. I can't find it. For this reason, if a pinhole smaller than about 0.3 mm is formed in the step of actually forming the medical plastic molded product 2, it cannot be identified as a defective product. For this reason, there is an urgent need to further reduce the measurement limit.
【００１４】本発明は、このことを実現することを目的
に開発されたもので、本発明の重要な目的は、処理時間
を短縮できるにもかかわらず、微細なピンホール等の成
形不良を正確に発見できる医薬用プラスチック成形品の
成形不良を検査する方法を提供することにある。The present invention has been developed with the object of realizing this fact. An important object of the present invention is to accurately form molding defects such as fine pinholes despite the fact that the processing time can be reduced. It is an object of the present invention to provide a method for inspecting a molding defect of a plastic molded article for medical use that can be found in Japan.
【００１５】さらに本発明の他の重要な目的は、医薬用
プラスチック成形品を変形し、あるいは破損することな
く、ピンホール等の成形不良を正確に検出できる医薬用
プラスチック成形品の成形不良を検査する方法を提供す
ることにある。Still another important object of the present invention is to inspect a molded plastic article for medical use which can accurately detect a defective molding such as a pinhole without deforming or breaking the molded plastic article for medical use. It is to provide a way to do it.
【００１６】[0016]
【課題を解決するための手段】本発明の医薬用プラスチ
ック成形品の成形不良を検査する方法は、前述の目的を
達成するために下記のようにして検査する。本発明の検
査方法は、筒状で内部に隔壁２Ａを有し、この隔壁２Ａ
には開口周壁２Ｂが設けられている医薬用プラスチック
成形品２の成形不良を検査する方法であって、医薬用プ
ラスチック成形品２の一端に、検査平板１２を密着する
と共に、医薬用プラスチック成形品２の他端には、医薬
用プラスチック成形品２の外側の開口面と、開口周壁２
Ｂの開口面に密着するように、押圧部材１の空気漏検出
面１Ａを密着して、医薬用プラスチック成形品２の内部
に、隔壁２Ａで区画された密閉空間３を形成する。 According to the method of the present invention for inspecting a molding defect of a plastic molded article for medical use, the inspection is carried out as follows in order to achieve the above-mentioned object. The inspection method of the present invention is cylindrical and has a partition 2A inside.
Is a medical plastic provided with an opening peripheral wall 2B
A method for inspecting a molding defect of a molded article 2, comprising:
An inspection plate 12 is adhered to one end of the plastic molded product 2
At the same time, the other end of the medical plastic molded article 2
Opening surface on the outside of the molded plastic article 2 and the peripheral wall 2 of the opening
Air leak detection of the pressing member 1 so as to be in close contact with the opening surface of B.
The surface 1A is brought into close contact with the inside of the plastic molded article 2 for medical use.
Then, a closed space 3 partitioned by the partition 2A is formed.
【００１７】この状態で、隔壁２Ａの両側に形成される
密閉空間３の一方を加圧し、他方を減圧して空気漏れを
検出することを特徴としている。 In this state, it is formed on both sides of the partition 2A.
One of the enclosed spaces 3 is pressurized and the other is depressurized to prevent air leakage.
It is characterized by detecting.
【００１８】[0018]
【実施例】以下、本発明の実施例を図面に基づいて説明
する。ただし、以下に示す実施例は、本発明の技術思想
を具体化するための医薬用プラスチック成形品の成形不
良を検査する方法を例示するものであって、本発明は検
査方法を下記の方法に特定しない。Embodiments of the present invention will be described below with reference to the drawings. However, the following examples illustrate a method for inspecting a molding defect of a medical plastic molded article for embodying the technical idea of the present invention, and the present invention uses the following method for the inspection method. Do not specify.
【００１９】さらに、この明細書は、特許請求の範囲を
理解し易いように、実施例に示される部材に対応する番
号を、「特許請求の範囲の欄」、「作用の欄」、および
「課題を解決するための手段の欄」に示される部材に付
記している。ただ、特許請求の範囲に示される部材を、
実施例の部材に特定するものでは決してない。Further, in this specification, in order to make it easy to understand the claims, the numbers corresponding to the members shown in the embodiments are referred to as "claims", "actions", and "actions". In the column of "Means for solving the problem". However, the members shown in the claims are
It is by no means specific to the members of the embodiment.
【００２０】図３は、筒状で内部に隔壁のある医薬用プ
ラスチック成形品の成形不良を検査する状態を示す。こ
の形状の医薬用プラスチック成形品２は、たとえば、図
４に示すように、薬剤を輸液に混合する容器の外筒７に
使用される。外筒７は、下端に輸液容器８を連結し、上
端に薬剤瓶９を充填している上下筒１０を連結して使用
される。外筒７の内部には、上下に摺動できるように注
入針１１を配設する。注入針１１は外周に鍔を有し、鍔
を外筒７の内面に摺動できるように配設している。この
構造の容器は、上下筒１０を押し下げると、注入針１１
の下端が輸液容器８に、上端が薬剤瓶９のゴム栓に挿通
される。この状態で上下反転させると、輸液が薬剤瓶９
に注入された薬剤に溶解される。その後、さらに容器を
反転させると、薬剤瓶９の輸液が輸液容器８に注入され
る。したがって、この構造の容器を使用すると、外部か
ら遮断して滅菌状態で輸液に薬剤を溶解できる。FIG . 3 shows a state in which a molding defect of a medical plastic molded product having a cylindrical shape and having a partition wall therein is inspected. The medical plastic molded article 2 of this shape is, for example, shown in FIG.
As shown in FIG. 4, it is used for an outer cylinder 7 of a container for mixing a drug into an infusion. The outer cylinder 7 is used by connecting an infusion container 8 at a lower end and an upper and lower cylinder 10 filled with a medicine bottle 9 at an upper end. An injection needle 11 is provided inside the outer cylinder 7 so as to be able to slide up and down. The injection needle 11 has a flange on the outer periphery, and the flange is arranged to be slidable on the inner surface of the outer cylinder 7. When the container of this structure is pushed down, the injection needle 11
The lower end is inserted into the infusion container 8 and the upper end is inserted into the rubber stopper of the medicine bottle 9. When the infusion is turned upside down in this state, the infusion is transferred to the medicine bottle 9.
It is dissolved in the injected drug agent. Thereafter, when the container is further inverted, the infusion in the medicine bottle 9 is injected into the infusion container 8. Therefore, when a container having this structure is used, the medicine can be dissolved in the infusion solution in a sterilized state while being shielded from the outside.
【００２１】この用途に使用される外筒７は、隔壁２Ａ
の中心に設けた開口周壁２Ｂの先端面を、輸液容器８の
ゴム栓の上面に気密に密着して、気密室を形成する。し
たがって、この形状の医薬用プラスチック成形品２は、
開口周壁２Ｂの先端を完全な平滑面に成形し、かつ隔壁
２Ａにピンホールがないことが大切である。The outer cylinder 7 used for this purpose has a partition 2A.
Of the opening peripheral wall 2B provided at the center of the infusion container 8 is airtightly adhered to the upper surface of the rubber stopper of the infusion container 8 to form an airtight chamber. Therefore, the medical plastic molded article 2 of this shape is
It is important that the tip of the opening peripheral wall 2B is formed into a completely smooth surface, and that the partition wall 2A has no pinhole.
【００２２】この形状の医薬用プラスチック成形品２
は、図３に示すようにして、下記の工程で、開口周壁２
Ｂの開口面と、隔壁２Ａのピンホールを検査する。 （１） 検査平板１２の上に医薬用プラスチック成形品
２を載せる。検査平板１２は金属製で、医薬用プラスチ
ック成形品２との間で空気漏れが発生しないように、上
面を鏡面状に平面仕上げしている。A medical plastic molded article 2 of this shape
As shown in FIG. 3 , the opening peripheral wall 2
The opening surface of B and the pinhole of the partition 2A are inspected. (1) The medical plastic molded article 2 is placed on the inspection plate 12. The inspection plate 12 is made of metal and has a mirror-finished upper surface so that no air leaks between the inspection plate 12 and the medical plastic molded product 2.
【００２３】（２） 医薬用プラスチック成形品２の外
側の開口面と、開口周壁２Ｂの開口面に密着する押圧部
材１を押圧する。押圧部材１は金属製で、外側の開口面
と、開口周壁２Ｂの開口面に密着する空気漏検出面１Ａ
を鏡面状に平面仕上げしている。この状態で、隔壁２Ａ
の下面の医薬用プラスチック成形品２の内側と、隔壁２
Ａ上面の外側に密閉空間３が形成される。(2) The pressing member 1 which is in close contact with the outer opening surface of the medical plastic molded article 2 and the opening surface of the opening peripheral wall 2B is pressed. The pressing member 1 is made of metal, and has an outer opening surface and an air leak detecting surface 1A which is in close contact with the opening surface of the opening peripheral wall 2B.
Is mirror-finished in a plane. In this state, the partition 2A
Of the medical plastic molded article 2 on the lower surface of the
A closed space 3 is formed outside the upper surface of A.
【００２４】（３） 押圧部材１を貫通して隔壁２Ａの
上方の密閉空間３に加圧空気を圧入し、検査平板１２を
貫通して、隔壁２Ａ下方の密閉空間３の空気を排気して
減圧する。医薬用プラスチック成形品２の隔壁２Ａの上
方の密閉空間３に圧入する空気圧は、たとえば、大気圧
よりも約０．６ｋｇ／ｃｍ ２ 高く設定する。ただ、空気
圧は、医薬用プラスチック成形品２を変形させたり、あ
るいは損傷させいない範囲に設定できる。たとえば、加
圧空気圧は、大気圧よりも０．３〜３ｋｇ／ｃｍ ２ 、好
ましくは、０．３〜２ｋｇ／ｃｍ ２ 、さらに好ましくは
０．３〜１ｋｇ／ｃｍ ２ 高く設定される。さらに、医薬
用プラスチック成形品２の隔壁２Ａ下方の密閉空間３を
減圧する空気圧は、たとえば、大気圧よりも約５００ｍ
ｍＨｇ低く設定される。ただし、減圧する空気圧は、医
薬用プラスチック成形品２に変形等の悪影響のない範囲
で低くするほど、検出感度を高くできる。したがって、
減圧する空気圧は、たとえば、大気圧よりも７３０〜２
００ｍｍＨｇ、好ましくは、６５０〜３５０ｍｍＨｇ、
さらに好ましくは６００〜４００ｍｍＨｇ低く設定され
る。 (3) Pressurized air is injected into the closed space 3 above the partition 2A through the pressing member 1, and the air in the closed space 3 below the partition 2A is evacuated by passing through the test plate 12 through the test plate 12. Reduce pressure. Above partition wall 2A of medical plastic molded article 2
The air pressure for press-fitting into the closed space 3 is, for example, the atmospheric pressure.
About 0.6 kg / cm 2 higher than that . Just air
The pressure may deform the plastic molded article 2 for medical use,
Or it can be set in the range that does not damage. For example,
The compressed air pressure is 0.3 to 3 kg / cm 2 , which is better than the atmospheric pressure.
Preferably, 0.3 to 2 kg / cm 2 , more preferably
It is set to be 0.3 to 1 kg / cm 2 higher. Furthermore, medicine
Closed space 3 below partition wall 2A of plastic molded article 2
The air pressure to be reduced is, for example, about 500 m higher than the atmospheric pressure.
mHg is set lower. However, the air pressure to be reduced
Range in which there is no adverse effect such as deformation on the medical plastic molded product 2
, The detection sensitivity can be increased. Therefore,
The air pressure to be reduced is, for example, 730 to 2 below the atmospheric pressure.
00 mmHg, preferably 650-350 mmHg,
More preferably, it is set lower by 600 to 400 mmHg.
You.
【００２５】（４） その後、空気弁４を閉弁して一定
時間経過後に、両密閉空間３の圧力変化を検出する。空
気弁４を閉弁してから圧力変化を検出するまでの時間
は、長くすると検出感度を高くできる。ピンホールから
漏れる空気量が多くなるからである。ただ、この時間を
長くすると、１個の検査時間が長くなって、タクトタイ
ムが長くなる。したがって、空気弁４を閉弁してから、
圧力変化を検出するまでの時間は、検出感度と処理能力
とを考慮して、たとえば、０．５〜５秒、好ましくは
０．７〜３秒、さらに好ましくは０．８〜２秒の範囲に
設定する。閉弁後の内圧と外圧の変化が、設定圧力変化
値よりも大きいと、開口周壁２Ｂの開口面に成形不良が
あり、あるいは、隔壁２Ａにピンホールのある成形不良
品と判定する。成形不良と判定する設定圧力変化値は、
たとえば、医薬用プラスチック成形品２に注入する加圧
空気源を０．６ｋｇ／ｃｍ ２ とする場合、加圧空気圧よ
りも０．１ｋｇ／ｃｍ ２ 低く設定する。また、医薬用プ
ラスチック成形品の減圧部分を、たとえば、大気圧より
も約５００ｍｍＨｇ低く設定するときに、１５０ｍｍＨ
ｇ圧力が変化すると成形不良と判定する。設定圧力変化
値を、加圧空気圧や減圧空気圧に接近させるほど、微細
なピンホールを確実に発見できる。ただ、設定圧力変化
値が加圧空気圧や減圧空気圧に近すぎると、正常品を不
良品と誤って検出する確率が高くなる。したがって、設
定圧力変化値は、微細なピンホールを発見でき、かつ正
常品を不良品と誤判定しない圧力に設定される。 (4) Then, after a certain period of time has passed since the air valve 4 is closed, a pressure change in both the sealed spaces 3 is detected. If the time from when the air valve 4 is closed until the pressure change is detected is increased, the detection sensitivity can be increased. From pinhole
This is because the amount of air leaking increases. Just this time
The longer the inspection time, the longer the inspection time
Longer. Therefore, after closing the air valve 4,
The time until pressure change is detected depends on the detection sensitivity and processing capacity.
In consideration of, for example, 0.5 to 5 seconds, preferably
0.7 to 3 seconds, more preferably 0.8 to 2 seconds
Set. If the change in the internal pressure and the external pressure after the valve is closed is larger than the set pressure change value, it is determined that there is a molding defect in the opening surface of the opening peripheral wall 2B or that the molding is defective with a pinhole in the partition wall 2A. The set pressure change value for determining molding failure is
For example, pressurizing injection into the plastic molded article for medical use 2
When the air source is 0.6 kg / cm 2 ,
And set it 0.1 kg / cm 2 lower. In addition, pharmaceutical
The depressurized part of the plastic molded part is
Is set at about 500 mmHg lower,
If the g pressure changes, it is determined that molding is defective. Set pressure change
The closer the value is to the pressurized or decompressed air pressure, the finer
Pinholes can be found reliably. However, the set pressure change
If the value is too close to pressurized air pressure or decompressed air pressure, normal
The probability of erroneously detecting a good product is increased. Therefore,
The constant pressure change value can detect fine pinholes and
The pressure is set so that the normal product is not erroneously determined to be defective.
【００２６】以上の方法は、隔壁２Ａ上方の密閉空間３
に加圧空気を注入し、隔壁２Ａ下方の密閉空間３を減圧
して空気漏れを検出する。この方法とは反対に、隔壁２
Ａ上方の密閉空間３を減圧し、隔壁２Ａ下方の密閉空間
３を加圧して空気漏れを検出することもできる。The above-described method is applied to the closed space 3 above the partition 2A.
Is pressurized, and the pressure in the closed space 3 below the partition 2A is reduced to detect air leakage. Contrary to this method, partition 2
It is also possible to detect an air leak by depressurizing the closed space 3 above A and pressurizing the closed space 3 below the partition 2A.
【００２７】さらに、この図の検査方法は、空気弁４を
閉弁した後に空気圧を検査するのではなく、密閉空間３
に空気を圧入しながら、あるいは排気しながら空気圧を
検出して成形不良を検査することもできる。Furthermore, the inspection method of FIG, instead of checking the air pressure after closing the air valve 4, the closed space 3
It is also possible to detect a molding failure by detecting air pressure while injecting air into or exhausting air.
【００２８】さらにまた、この検査方法は、加圧空気圧
と減圧空気圧の両方を検出し、いずれかの圧力変化が設
定値よりも大きいとき、あるいは、両方の圧力変化が設
定値よりも大きいときに成形不良と判定する必要はな
く、加圧あるいは減圧するいずれか一方の密閉空間３の
空気圧の変化を検出して成形不良を検出することもでき
る。[0028] Furthermore, the inspection method is to detect both the pressurized air pressure vacuum pressure, when either the pressure change is greater than the set value, or when both the pressure change is greater than the set value It is not necessary to determine that the molding is defective, and it is also possible to detect a molding defect by detecting a change in the air pressure of the closed space 3 which is either pressurized or depressurized.
【００２９】[0029]
【発明の効果】本発明の医薬用プラスチック成形品の成
形不良を検査する方法は、独特の方法によって、この種
の用途に大切な極めて優れた下記の特長を実現する。 検査時間を長くすることなく、極めて微細なピンホ
ールを発見できる。それは、本発明の検査方法が、隔壁
の両側に密閉空間を形成し、一方を加圧し、他方を減圧
してピンホールや欠損部からの空気漏れを多くしている
からである。ちなみに、本発明者の実験では、検査時間
を従来の方法と同じにして、０．１５ｍｍのピンホール
を発見することに成功した。実際に医薬用プラスチック
成形品を成形して０．１５ｍｍ以下のピンホールができ
る確率は皆無に近い。ピンホールができるとすれば、こ
れよりも大きくなるからである。したがって、本発明の
医薬用プラスチック成形品の成形不良を検査する方法
は、ピンホール等の成形不良を漏らさず確実に検査でき
る特長がある。Method of inspecting a pharmaceutical plastic moldings molding defects present invention exhibits, by the method of German Patent, to achieve very good following features important for this type of application. An extremely fine pinhole can be found without lengthening the inspection time. It inspection method of the present invention, the partition wall
This is because air is leaked from pinholes and defective portions by increasing the pressure on one side and reducing the pressure on the other side. By the way, in the experiment of the present inventor, the test time was made the same as that of the conventional method, and the pinhole of 0.15 mm was successfully found. Actually, there is almost no probability that a pinhole of 0.15 mm or less is formed by molding a medical plastic molded product. This is because if a pinhole is formed, it becomes larger. Therefore, the method of the present invention for inspecting a molding defect of a plastic molded article for medical use has a feature that a molding defect such as a pinhole can be surely inspected without leaking.
【００３０】 短時間に微細なピンホールを発見し
て、医薬用プラスチック成形品の損傷や変形を防止でき
る。それは、本発明の方法が、密閉空間に圧入する加圧
空気の空気圧を高くすることなく、微細なピンホールを
発見できるからである。加圧空気を低くすることによっ
て、本発明の検査方法は、押圧部材を強く医薬用プラス
チック成形品に押圧する必要がない。[0030] A minute pinhole can be found in a short time to prevent damage or deformation of a medical plastic molded product. This is because the method of the present invention can find fine pinholes without increasing the air pressure of the pressurized air that is pressed into the closed space. By reducing the pressurized air, the inspection method of the present invention does not require the pressing member to be pressed strongly against the medical plastic molded article.
【００３１】 開口面の微細な欠損を正確に検査でき
る。それは、本発明の検査方法が、押圧部材を強く開口
面に押圧する必要がないからである。本発明の検査方法
は、密閉空間の加圧空気圧を高くする必要がないので、
押圧部材を開口面に強く押圧する必要がない。このた
め、空気漏検出面に例えゴム状弾性体のパッキン等を使
用しても、開口面に欠損があると空気漏検出面との間に
空気漏れが発生して成形不良が正確に検出できる。[0031] A minute defect in the opening surface can be accurately inspected. This is because the inspection method of the present invention does not need to strongly press the pressing member against the opening surface. The inspection method of the present invention does not require increasing the pressurized air pressure in the closed space,
There is no need to strongly press the pressing member against the opening surface. Therefore, even if a rubber-like elastic packing or the like is used as the air leak detection surface, if there is a defect in the opening surface, air leakage occurs between the air leak detection surface and the molding defect can be accurately detected. .
【図１】従来の医薬用プラスチック成形品の成形不良を
検査する方法を示す断面図FIG. 1 is a cross-sectional view showing a conventional method for inspecting a molding defect of a plastic molded article for medical use.
【図２】医薬用プラスチック成形品の使用状態を示す断
面図FIG. 2 is a cross-sectional view showing a use state of a plastic molded article for medical use.
【図３】本発明の実施例にかかる方法で医薬用プラスチ
ック成形品の成形不良を検査する状態を示す断面図FIG. 3 is a cross-sectional view showing a state in which a molding defect of a plastic molded article for medical use is inspected by a method according to an embodiment of the present invention.
【図４】図３に示す方法で検査される医薬用プラスチッ
ク成形品の使用状態を示す断面図4 is a cross-sectional view showing a state of use of pharmaceutical plastic article to be inspected by the method shown in FIG. 3
１…押圧部材 １Ａ…空気漏検出面 ２…医薬用プラスチック成形品 ２Ａ…隔壁
２Ｂ…開口周壁 ２Ｃ…開口面 ３…密閉空間 ４…空気弁 ５…圧力センサー ６…密閉容器 ７…外筒 ８…輸液容器 ９…薬剤瓶 １０…上下筒 １１…注入針 １２…検査平板 １３…ゴムパッキDESCRIPTION OF SYMBOLS 1 ... Pressing member 1A ... Air leak detection surface 2 ... Plastic molded article for medical use 2A ... Partition wall
2B ... Opening peripheral wall 2C ... Opening surface 3 ... Sealed space 4 ... Air valve 5 ... Pressure sensor 6 ... Sealed container 7 ... Outer tube 8 ... Infusion container 9 ... Drug bottle 10 ... Upper and lower tube 11 ... Injection needle 12 ... Test plate 13 ... Rubber packing
Claims (1)
隔壁（２Ａ）には開口周壁（２Ｂ）が設けられてなる医
薬用プラスチック成形品（２）の成形不良を検査する方
法において、 医薬用プラスチック成形品（２）の一端に、検査平板
（１２）を密着すると共に、医薬用プラスチック成形品
（２）の他端には、医薬用プラスチック成形品（２）の
外側の開口面と、開口周壁（２Ｂ）の開口面に密着する
ように、押圧部材（１）の空気漏検出面（１Ａ）を密着
して、医薬用プラスチック成形品（２）の内部に、隔壁
（２Ａ）で区画された密閉空間（３）を形成し、 隔壁（２Ａ）の両側に形成される密閉空間（３）の一方
を加圧し、他方を減圧して空気漏れを検出することを特
徴とする医薬用プラスチック成形品の成形不良を検査す
る方法。 1. A cylindrical shape having a partition wall (2A) inside.
A medical system comprising a partition wall (2A) provided with an opening peripheral wall (2B).
Inspection of molding defects of medicated plastic molded products (2)
In the method, a test plate is attached to one end of a plastic molded article for medical use (2).
(12) Closely adhered and pharmaceutical plastic molded product
At the other end of (2), a plastic molded product for medical use (2)
Close contact with the outer opening surface and the opening surface of the opening peripheral wall (2B)
The air leak detection surface (1A) of the pressing member (1)
And a partition wall inside the plastic molded article for medical use (2)
A closed space (3) partitioned by (2A) is formed, and one of the closed spaces (3) formed on both sides of the partition (2A).
To detect air leaks by increasing the pressure
Inspection of molding defects of medical plastic molded products
Way.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP7039319A JP2859553B2 (en) | 1995-02-02 | 1995-02-02 | Method for inspecting molding defects of plastic molded articles for medical use |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP7039319A JP2859553B2 (en) | 1995-02-02 | 1995-02-02 | Method for inspecting molding defects of plastic molded articles for medical use |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| JPH08210941A JPH08210941A (en) | 1996-08-20 |
| JP2859553B2 true JP2859553B2 (en) | 1999-02-17 |
Family
ID=12549796
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP7039319A Expired - Fee Related JP2859553B2 (en) | 1995-02-02 | 1995-02-02 | Method for inspecting molding defects of plastic molded articles for medical use |
Country Status (1)
| Country | Link |
|---|---|
| JP (1) | JP2859553B2 (en) |
Families Citing this family (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP3303234B2 (en) * | 1997-09-17 | 2002-07-15 | 株式会社吉野工業所 | Inner container leak inspection method for double blow molded bottles |
| DE10025934A1 (en) * | 2000-05-26 | 2001-12-06 | Gea Finnah Gmbh | Leakage control device |
| KR101485888B1 (en) * | 2007-10-29 | 2015-01-26 | 도요세이칸 그룹 홀딩스 가부시키가이샤 | Method and apparatus for inspecting pinhole in synthetic resin bottle |
| JP2012122756A (en) * | 2010-12-06 | 2012-06-28 | Fukuda:Kk | Leakage inspection device |
| JP6653145B2 (en) * | 2014-12-17 | 2020-02-26 | 株式会社エイムテック | Elastic body leakage measurement method and leakage measurement device |
| CN105034606B (en) * | 2015-06-29 | 2017-01-04 | 苏州赛腾精密电子股份有限公司 | Ink-cases of printers side device for detecting leakage |
Family Cites Families (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP3002504B2 (en) * | 1990-06-25 | 2000-01-24 | 株式会社日立製作所 | How to apply internal and external pressure to structures |
| CH685887A5 (en) * | 1992-08-12 | 1995-10-31 | Martin Lehmann | Container leakage testing device |
-
1995
- 1995-02-02 JP JP7039319A patent/JP2859553B2/en not_active Expired - Fee Related
Also Published As
| Publication number | Publication date |
|---|---|
| JPH08210941A (en) | 1996-08-20 |
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