JP2004123235A - Method of filling container for pharmaceuticals such as ampul and vial or the like - Google Patents

Method of filling container for pharmaceuticals such as ampul and vial or the like Download PDF

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JP2004123235A
JP2004123235A JP2003340586A JP2003340586A JP2004123235A JP 2004123235 A JP2004123235 A JP 2004123235A JP 2003340586 A JP2003340586 A JP 2003340586A JP 2003340586 A JP2003340586 A JP 2003340586A JP 2004123235 A JP2004123235 A JP 2004123235A
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container
filling
needle
opening
filling needle
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JP4319883B2 (en
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Wolfgang Szczerba
ヴォルフガング　チェルバ
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Robert Bosch GmbH
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Robert Bosch GmbH
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    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B39/00—Nozzles, funnels or guides for introducing articles or materials into containers or wrappers
    • B65B39/12—Nozzles, funnels or guides for introducing articles or materials into containers or wrappers movable towards or away from container or wrapper during filling or depositing
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B3/00—Packaging plastic material, semiliquids, liquids or mixed solids and liquids, in individual containers or receptacles, e.g. bags, sacks, boxes, cartons, cans, or jars
    • B65B3/003—Filling medical containers such as ampoules, vials, syringes or the like
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B31/00—Packaging articles or materials under special atmospheric or gaseous conditions; Adding propellants to aerosol containers
    • B65B31/02—Filling, closing, or filling and closing, containers or wrappers in chambers maintained under vacuum or superatmospheric pressure or containing a special atmosphere, e.g. of inert gas
    • B65B31/025—Filling, closing, or filling and closing, containers or wrappers in chambers maintained under vacuum or superatmospheric pressure or containing a special atmosphere, e.g. of inert gas specially adapted for rigid or semi-rigid containers
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B39/00—Nozzles, funnels or guides for introducing articles or materials into containers or wrappers
    • B65B39/14—Nozzles, funnels or guides for introducing articles or materials into containers or wrappers movable with a moving container or wrapper during filling or depositing

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  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Chemical & Material Sciences (AREA)
  • Dispersion Chemistry (AREA)
  • Filling Of Jars Or Cans And Processes For Cleaning And Sealing Jars (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Vacuum Packaging (AREA)
  • Basic Packing Technique (AREA)

Abstract

<P>PROBLEM TO BE SOLVED: To ensure the axenic of a filling process by suppressing a turbulent flow or a vortex flow which conventionally occurs from taking place in a method of filling a container for pharmaceuticals. <P>SOLUTION: In the method of filling the container 1 for the pharmaceuticals such as ampul and vial or the like, at least one filling needle 12 is again positioned on a container opening 2 after a filling substance is supplied into the container 1 and is then moved perpendicularly to the transfer direction of the container 1 in at least an almost horizontal direction from the area of the opening 2, thereby the upper area of the opening 2 is opened before the next filling needle 12 starts lowering and an axenic air is flowed around the container 1 perpendicularly to the transfer direction 18 of the container. <P>COPYRIGHT: (C)2004,JPO

Description

　アンプル、バイアル又はこれに類したもののような医薬品用の容器を充填する方法に関する。 に 関 す る A method for filling containers for pharmaceuticals, such as ampules, vials or the like.

　このような方法は、ドイツ連邦共和国特許公開第４３４１９３４号明細書に基づいて公知である。この公知の方法では、容器はタイミング制御されて充填装置の下を搬送される。搬送装置の停止段階において、充填装置の充填ニードルは容器を満たすために該容器内に進入する。充填過程の後で充填ニードルは容器から引き上げられ、そして搬送装置は充填された容器をさらに搬送し、同時に次の容器を充填のために準備する。 方法 Such a method is known from DE 43 41 934 A1. In this known method, containers are conveyed under a filling device in a timed manner. In the stop phase of the transport device, the filling needle of the filling device enters the container to fill it. After the filling process, the filling needle is lifted out of the container, and the transport device transports the filled container further while preparing the next container for filling.

　バクテリア、菌又はこれに類したものが医薬品の充填時もしくは調量供給時に、医薬品と一緒に容器内に達することを回避するために、予め滅菌された容器の周囲に、充填中並びに場合によっては次いで行われる閉鎖過程中に、無菌空気を流すことが公知である。いわゆる層流と呼ばれるこの流れは、容器の周囲を上から下に向かって、つまり容器のヘッド領域の側から流される。そのために一般的には、空気を容器の下において吸い込み、次いで清浄空気フィルタを介して導く装置が用いられている。このようにして濾過され浄化された空気は次いで再び、ブロワを介して容器に供給される。容器がタイミング制御されて搬送される公知の充填装置では、充填ニードルは位置固定に容器開口に対して整合するように該容器開口の上に配置されているので、容器の周囲を流れる流れは、特に容器の搬送段階中においても邪魔されてしまう。その結果運動する容器と停止している充填ニードルとの間における相対運動によって、層流の邪魔をする乱流もしくは渦流が生ぜしめられる。 To prevent bacteria, fungi or the like from reaching the container with the medicament during filling or metering of the medicament, around the pre-sterilized container, during filling and possibly It is known to flow sterile air during the subsequent closing process. This flow, so-called laminar flow, flows around the container from top to bottom, i.e. from the side of the head region of the container. For this purpose, a device is generally used in which air is sucked under the container and then guided through a clean air filter. The air thus filtered and purified is then again supplied to the container via a blower. In known filling devices in which the container is transported in a timed manner, the flow flowing around the container is such that the filling needle is positioned above the container opening so that it is fixed in position and aligned with the container opening. In particular, it is disturbed even during the transport stage of the container. As a result, the relative movement between the moving container and the stationary filling needle creates turbulence or vortices that hinder laminar flow.

　充填ニードルが容器充填時に容器と同期的に搬送方向において一緒に運動させられるようになっている、連続的に搬送される容器では、充填の後で充填ニードルは容器開口から持ち上げられ、次いで容器の上を搬送方向とは逆方向に戻し行程運動させられる。この場合充填ニードルと容器開口との間における相対速度はなお高速なので、この際に生じる乱流もしくは渦流に基づいて、層流による容器周囲における流れが敏感に邪魔されてしまうことがある。
ドイツ連邦共和国特許公開第４３４１９３４号明細書 In continuously transported containers, in which the filling needle is moved synchronously with the container in the transport direction during filling of the container, after filling, the filling needle is lifted from the container opening and then The upper part is moved back in the direction opposite to the transport direction. In this case, the relative speed between the filling needle and the container opening is still high, so that the turbulence or vortex generated at this time may sensitively obstruct the flow around the container due to laminar flow.
German Offenlegungsschrift 43 41 934

　ゆえに本発明の課題は、アンプル、バイアル又はこれに類したもののような医薬品用の容器を充填する方法において、従来技術において見られたような乱流もしくは渦流の発生を抑えて、充填プロセスの無菌性を保証することである。 It is therefore an object of the present invention to provide a method of filling pharmaceutical containers such as ampoules, vials or the like, which reduces the occurrence of turbulence or vortices as seen in the prior art, and ensures the sterilization of the filling process. It is to guarantee sex.

　この課題を解決するために本発明の構成では、アンプル、バイアル又はこれに類したもののような医薬品用の容器を充填する方法であって、列を成して並べられた容器を、搬送装置を用いて充填装置の領域に搬送し、充填装置に設けられた昇降可能な少なくとも１つの充填ニードルを、調量動作中に容器開口内に進入させ、容器を充填後に再び充填装置の領域からさらに搬送する形式の方法において、少なくとも１つの充填ニードルを、容器への充填物質の供給後に、再び容器開口の上方に位置させ、次いで容器開口の領域から、少なくともほぼ水平方向で容器の搬送方向に対して垂直な方向に移動させ、これによって容器開口の上方領域を、次の充填ニードルの降下の前に解放し、容器の周囲に、該容器の搬送方向に対して垂直な方向で無菌空気を流すようにした。 In order to solve this problem, the configuration of the present invention is a method of filling a container for pharmaceuticals such as an ampoule, a vial or the like, wherein the containers arranged in a row are transferred to a transfer device. The at least one vertically movable filling needle provided in the filling device is transported into the container opening during the dosing operation, and after the container is filled, the container is further conveyed again from the filling device region. In a method of this type, at least one filling needle is again positioned above the container opening after the supply of the filling substance to the container, and then from the region of the container opening at least approximately horizontally with respect to the transport direction of the container. Movement in a vertical direction, whereby the area above the container opening is released before the lowering of the next filling needle, around the container in a direction perpendicular to the direction of transport of the container. It was allowed to flow through the bacterial air.

　このように構成された本発明によるアンプル、バイアル又はこれに類したもののような医薬品用の容器を充填する方法には、公知の方法に対して次のような利点がある。すなわち本発明による方法では、無菌空気による層流の流れが、容器の充填が行われない段階における容器の搬送中に、邪魔されることがない。これによって充填プロセスの無菌性に関する安全性が高められる。 The method of filling a container for medicines, such as an ampoule, a vial or the like, according to the present invention thus configured has the following advantages over known methods. That is, in the method according to the invention, the laminar flow of the sterile air is not disturbed during the transport of the container at the stage when the container is not filled. This increases the safety with respect to the sterility of the filling process.

　請求項１に記載された本発明による方法の別の有利な態様は、請求項２以下に記載されている。 Another advantageous embodiment of the method according to the invention described in claim 1 is described in claim 2 et seq.

　次に図面を参照しながら本発明の実施の形態を説明する。 Next, an embodiment of the present invention will be described with reference to the drawings.

　図１〜図６には、アンプル、バイアル１又はこれに類したもののような医薬品用の容器１に医薬品を充填するための充填装置が、符号１０で示されている。この充填装置１０は充填ヘッド１１を有しており、この充填ヘッド１１には、図示の実施例では８つの充填ニードル１２が保持体１３に固定されている。充填ヘッド１１の下には容器１のための搬送装置１５が配置されている。この搬送装置１５は図示されていない搬送ベルトを有しており、この搬送ベルトに容器保持体１６が固定されている。各容器保持体１６は図示の実施例では、３つの容器１を受容するために働く。搬送装置１５は容器１をエンドレスの列として充填ニードル１２の下において搬送し、この場合容器１相互の水平方向間隔は、充填ニードル１２相互の間隔に相当している。容器１の搬送方向は図示の実施例では矢印１８の方向に延びており、搬送装置１５は連続的に作動する。容器１の搬送中に該容器１に充填を行うことができるようにするために、充填ニードル１２もしくは保持体１３は、容器１の搬送方向に対して垂直な方向で昇降運動可能であるのみならず、保持体１６は充填ニードル１２と共に、容器１の搬送方向に対して平行に水平方向で往復動可能である。 1 to 6 show a filling device 10 for filling a medicine container 1 such as an ampoule, a vial 1 or the like with a medicine. The filling device 10 has a filling head 11 on which eight filling needles 12 are fixed to a holder 13 in the embodiment shown. Below the filling head 11, a transport device 15 for the container 1 is arranged. The transport device 15 has a transport belt (not shown), and the container holder 16 is fixed to the transport belt. Each container holder 16 serves in the embodiment shown to receive three containers 1. The transport device 15 transports the containers 1 as endless rows below the filling needles 12, the horizontal spacing between the containers 1 corresponding to the spacing between the filling needles 12. The conveying direction of the container 1 extends in the illustrated embodiment in the direction of the arrow 18, and the conveying device 15 operates continuously. In order to be able to fill the container 1 during the transport of the container 1, the filling needle 12 or the holder 13 can only be moved up and down in a direction perpendicular to the direction of transport of the container 1. Instead, the holder 16 can reciprocate with the filling needle 12 in the horizontal direction in parallel with the transport direction of the container 1.

　さらに図示されていないが、いわゆる層流（Laminar-Flow）を生ぜしめるための装置が設けられており、この装置は、無菌空気（sterile Luft）を容器１の上方から該容器１の搬送方向に対して垂直に流し、その結果容器１は無菌空気によって取り囲まれる。層流の空気流は流れを示す矢印２１によって示されており、この矢印２１は図面を簡単化するために図１にだけ示されている。もちろん、充填プロセス全体にわたって相応な層流が生ぜしめられるので、容器１の周りには常に無菌空気が流れている。本発明にとって重要なことは、充填ニードル１２を備えた保持体１３が付加的に、容器１の搬送方向に対して垂直でかつ充填ニードル１２の昇降運動に対して垂直な方向な水平方向において可動に構成されていることであり、これは矢印２２，２３（図４及び図６）によって示されている。 Although not shown, a device for generating a so-called laminar flow (Laminar-Flow) is provided, and this device sends sterile air (sterile Luft) from above the container 1 in the transport direction of the container 1. The container 1 is surrounded by sterile air. The laminar air flow is indicated by a flow arrow 21 which is shown only in FIG. 1 for simplicity of the drawing. Of course, a sterile air is constantly flowing around the container 1 since a corresponding laminar flow is produced throughout the filling process. What is important for the invention is that the holder 13 with the filling needle 12 is additionally movable in a horizontal direction perpendicular to the direction of transport of the container 1 and perpendicular to the lifting and lowering movement of the filling needle 12. This is indicated by arrows 22, 23 (FIGS. 4 and 6).

　容器１を充填するための本発明による方法の作業形式は以下の通りである：
　図１に示されているように、第１段階において充填ニードル１２は容器開口２もしくは容器１内に降下される（矢印１９）。この際に容器１及び充填ニードル１２は矢印１８の方向で連続的に運動させられる。図２に示された充填段階では、充填ニードル１２は既に容器１の容器開口２内に降下しており、調量される液体が充填ニードル１２を介して容器１内に注入される。この場合同時に場合によっては充填ニードル１２の上昇運動が行われてもよく、このようにすると、容器１内の充填レベルに対して充填ニードル１２を常に規定のレベルにおいて位置決めすることができる。図３では、容器１の充填過程は終了しており、充填ニードル１２は既に再び容器１の容器開口２から引き上げられている（矢印２０）。 The mode of operation of the method according to the invention for filling the container 1 is as follows:
As shown in FIG. 1, in a first step the filling needle 12 is lowered into the container opening 2 or into the container 1 (arrow 19). At this time, the container 1 and the filling needle 12 are continuously moved in the direction of the arrow 18. In the filling stage shown in FIG. 2, the filling needle 12 has already descended into the container opening 2 of the container 1, and the liquid to be metered is injected into the container 1 via the filling needle 12. In this case, a lifting movement of the filling needle 12 may also be performed at the same time, so that the filling needle 12 can always be positioned at a prescribed level with respect to the filling level in the container 1. In FIG. 3, the filling process of the container 1 has been completed, and the filling needle 12 has already been pulled up again from the container opening 2 of the container 1 (arrow 20).

　本発明にとって重要なことは次のことである。すなわち図４に示されているように充填ニードル１２を備えた保持体１３は、次の段階において矢印２２の方向で引き戻され、その結果容器１は容器開口２共々、層流によって完全に捉えられることができ、その結果容器１の周囲を無菌空気は邪魔されることなく流れる。次いで図５に示されているように保持体１３は充填ニードル１２と共に再び、次の容器１を充填するための出発ポジションに戻り、つまり戻り行程運動が行われる。従って充填ニードル１２の全戻り行程運動は、容器１のあるカバー領域の外側において行われ、その結果容器１は邪魔されることなく層流によって周囲を貫流される。最後のステップにおいて充填ニードル１２は矢印２３で示されているように、再び、次に充填される容器１の容器開口２と合致させられ、次いで上に述べた動作が相応に繰り返される。 重要 What is important for the present invention is as follows. That is, the holder 13 with the filling needle 12 as shown in FIG. 4 is withdrawn in the next step in the direction of the arrow 22, so that the container 1 with the container opening 2 is completely captured by laminar flow. As a result, sterile air flows around container 1 without interruption. Then, as shown in FIG. 5, the holding body 13 together with the filling needle 12 returns to the starting position for filling the next container 1 again, that is, the return stroke movement is performed. The entire return stroke movement of the filling needle 12 therefore takes place outside a certain cover area of the container 1, so that the container 1 is flowed around without disturbance by laminar flow. In the last step, the filling needle 12 is again aligned with the container opening 2 of the next container 1 to be filled, as indicated by the arrow 23, and the operation described above is then correspondingly repeated.

　付言すると、変化実施例では本発明による方法はもちろん、搬送装置１５のタイミング制御される運転においても使用することが可能である。このような場合には充填ニードル１２は単に昇降運動可能であり、かつ容器１の搬送方向に対して垂直な方向に運動可能である。さらにまた、既に公知でありかつ汎用のように、容器１の充填中に容器１の充填鏡面の上における容器１のヘッド空間にガスを供給し、容器１のヘッド空間における酸素を含んだ空気を押し退けることも可能である。そのためには充填ニードルもしくは充填ヘッドに加えて付加的にガス供給ニードルが設けられる。 Additionally, the modified embodiment can be used not only in the method according to the invention, but also in the time-controlled operation of the transport device 15. In such a case, the filling needle 12 can simply move up and down, and can move in a direction perpendicular to the transport direction of the container 1. Furthermore, as is already known and widely used, gas is supplied to the head space of the container 1 on the filling mirror surface of the container 1 during the filling of the container 1, and oxygen-containing air in the head space of the container 1 is supplied. It is also possible to push away. For this purpose, a gas supply needle is additionally provided in addition to the filling needle or filling head.

　さらにまた、ガス充填装置はいわゆる回転装置もしくは循環コンベヤ（Rundlaeufer）の形で構成されていてもよい。このような場合には充填ニードルは円弧に沿って配置されていて、容器は充填装置の領域において列を成して同様に円弧に沿って搬送される。 Furthermore, the gas filling device may be configured in the form of a so-called rotating device or a circulating conveyor. In such a case, the filling needles are arranged along an arc, and the containers are conveyed in rows in the area of the filling device, likewise along an arc.

本発明による容器用の充填装置を充填過程の第１段階において示す斜視図である。1 is a perspective view showing a filling device for a container according to the present invention in a first stage of a filling process. 本発明による容器用の充填装置を充填過程の第２段階において示す斜視図である。FIG. 3 is a perspective view showing the filling device for a container according to the present invention in a second stage of the filling process. 本発明による容器用の充填装置を充填過程の第３段階において示す斜視図である。FIG. 4 is a perspective view showing the filling device for a container according to the present invention in a third stage of the filling process. 本発明による容器用の充填装置を充填過程の第４段階において示す斜視図である。FIG. 4 is a perspective view showing the filling device for a container according to the present invention in a fourth stage of the filling process. 本発明による容器用の充填装置を充填過程の第５段階において示す斜視図である。FIG. 7 is a perspective view showing the filling device for a container according to the present invention in a fifth stage of the filling process. 本発明による容器用の充填装置を充填過程の第６段階において示す斜視図である。FIG. 9 is a perspective view showing the filling device for a container according to the present invention in a sixth stage of the filling process.

符号の説明Explanation of reference numerals

　１　医薬品用の容器、　２　容器開口、　１０　充填装置、　１１　充填ヘッド、　１２　充填ニードル、　１３　保持体、　１５　搬送装置、　１６　容器保持体、　１８，１９，２０，２１，２２，２３　矢印 {1} pharmaceutical container, {2} container opening, {10} filling device, {11} filling head, {12} filling needle, {13} holder, {15} transporter, {16} container holder, {18, 19, 20, 21, 22, 23}

Claims (3)

　アンプル、バイアル又はこれに類したもののような医薬品用の容器（１）を充填する方法であって、列を成して並べられた容器（１）を、搬送装置（１５）を用いて充填装置（１０）の領域に搬送し、充填装置（１０）に設けられた昇降可能な少なくとも１つの充填ニードル（１２）を、調量動作中に容器開口（２）内に進入させ、容器（１）を充填後に再び充填装置（１０）の領域からさらに搬送する形式の方法において、少なくとも１つの充填ニードル（１２）を、容器（１）への充填物質の供給後に、再び容器開口（２）の上方に位置させ、次いで容器開口（２）の領域から、少なくともほぼ水平方向で容器（１）の搬送方向に対して垂直な方向に移動させ、これによって容器開口（２）の上方領域を、次の充填ニードル（１２）の降下の前に解放し、容器（１）の周囲に、該容器の搬送方向（１８）に対して垂直な方向で無菌空気を流すことを特徴とする、医薬品用の容器を充填する方法。 A method for filling containers (1) for pharmaceuticals, such as ampoules, vials or the like, wherein the containers (1) arranged in rows are filled using a transport device (15). The at least one vertically movable filling needle (12) conveyed to the region (10) and provided in the filling device (10) is advanced into the container opening (2) during the metering operation, and the container (1) In the form of a further transfer from the area of the filling device (10) after filling, at least one filling needle (12) is again moved above the container opening (2) after the filling substance has been supplied to the container (1). From the area of the container opening (2) and then at least substantially horizontally in a direction perpendicular to the direction of transport of the container (1), so that the area above the container opening (2) is Of the filling needle (12) The method was released before the bottom, around the container (1), characterized in that the flow of sterile air in a direction perpendicular to the conveying direction of the container (18), filling containers for pharmaceutical products. 　充填時に、充填レベルの上における容器（１）のヘッド空間を保護ガスによって掃気する、請求項１記載の方法。 2. The method according to claim 1, wherein the head space of the container above the filling level is scavenged with a protective gas during filling. 　容器（１）を連続的に搬送し、少なくとも１つの充填ニードル（１２）を充填時に、容器（１）と一緒に運動させ、少なくとも１つの充填ニードル（１２）を、充填後で容器（１）の搬送方向（１８）とは逆向きの戻し行程運動の前に、まず初めに容器（１）の搬送方向（１８）に対して垂直な水平方向において運動させる、請求項１又は２記載の方法。 The container (1) is conveyed continuously and at least one filling needle (12) is moved together with the container (1) during filling, and the at least one filling needle (12) is moved after filling to the container (1). 3. The method according to claim 1, further comprising, before the return stroke movement in the direction opposite to the conveying direction of the container, first of all the movement in a horizontal direction perpendicular to the conveying direction of the container. .
JP2003340586A 2002-10-02 2003-09-30 A method of filling a container for pharmaceuticals such as ampoules, vials or the like Expired - Fee Related JP4319883B2 (en)

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DE10246061B4 (en) 2012-09-06

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