JP4164890B2 - Injection pack - Google Patents
Injection pack Download PDFInfo
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- JP4164890B2 JP4164890B2 JP34385297A JP34385297A JP4164890B2 JP 4164890 B2 JP4164890 B2 JP 4164890B2 JP 34385297 A JP34385297 A JP 34385297A JP 34385297 A JP34385297 A JP 34385297A JP 4164890 B2 JP4164890 B2 JP 4164890B2
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- syringe
- medicine
- container body
- container
- injection
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
- A61L2/16—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using chemical substances
- A61L2/20—Gaseous substances, e.g. vapours
- A61L2/208—Hydrogen peroxide
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/002—Packages specially adapted therefor, e.g. for syringes or needles, kits for diabetics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2202/00—Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
- A61L2202/10—Apparatus features
- A61L2202/13—Biocide decomposition means, e.g. catalysts, sorbents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2202/00—Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
- A61L2202/20—Targets to be treated
- A61L2202/24—Medical instruments, e.g. endoscopes, catheters, sharps
Description
【0001】
【発明の属する技術分野】
本発明は、注射剤パックに関するものであり、詳しくは、包装容器に薬剤入り注射器を封入して成る注射剤パックであって、主に滅菌ガスだけを透過する滅菌紙によって封止され、かつ、収容された薬剤入り注射器の滅菌が容易な形態の包装容器を使用した注射剤パックに関するものである。
【0002】
【従来の技術】
薬剤入り注射器は、ディスポーザブル医療機器などと同様に、特定の包装容器によって医療用滅菌包装を施されたいわゆる注射剤パックとして流通される。上記の包装容器は、透明性の樹脂によって一体成形され且つ底面が開放された容器本体と、滅菌ガスを透過可能なシート材から成り且つ容器本体の底面を封止する滅菌紙とから構成される。そして、薬剤入り注射器が封入された包装容器は、例えば、エチレンオキサイドガスに晒されることにより、滅菌紙を透過したガスによって内部が滅菌処理される。なお、斯かる滅菌処理は、処理効率の観点から、通常、多数配列され且つ上下に多数段積み重ねた状態で行われる。
【0003】
【発明が解決しようとする課題】
ところで、注射剤パックを上下に多数段積み重ねた状態で滅菌処理した場合、滅菌紙の表面が上段または下段の包装容器の容器本体で被われるため、滅菌紙における滅菌ガスの透過効率が低下すると言う問題が生じる。また、滅菌処理の後は、残留がない様に滅菌ガスを十分に除去する必要があるが、包装容器の内部に浸透したガスの脱気効率が低いと言う問題もある。
【0004】
本発明は、上記の滅菌処理の効率を一層向上すべくなされたものであり、その目的は、包装容器に薬剤入り注射器を封入して成る注射剤パックであって、滅菌紙によって封止され、かつ、収容された薬剤入り注射器の滅菌が容易な形態の包装容器を使用した注射剤パックを提供することにある。
【0005】
【課題を解決するための手段】
上記の課題を解決するため、本発明の注射剤パックは、包装容器に薬剤入り注射器を封入して成る注射剤パックであって、前記包装容器は、透明性のポリエステル系樹脂によって細長の略器状に一体成形され且つ底面が開放された容器本体と、滅菌用ガスを透過可能なシート材から成り且つ前記容器本体の底面を封止する滅菌紙とから構成され、前記容器本体は、薬剤入り注射器の注射筒の注射針取付部を収容する第1の膨出部と、薬剤入り注射器の略中央部を収容する第2の膨出部と、注射筒のフランジおよびピストンロッドの押し子を収容する第3の膨出部と、これらの膨出部を結合する2つのくびれ部とを備え、かつ、前記第1の膨出部および前記第3の膨出部は、滅菌処理の際の滅菌ガスの貯留用空間を形成しており、前記第2の膨出部は、前記第1の膨出部および前記第3の膨出部よりも低い高さで形成され、前記第3の膨出部は、容器本体の長手側から側面視した場合、中央部が凹没した鞍部状に形成されていることを特徴とする。
【0006】
上記の注射剤パックは、上下に多数段積み重ねた状態で滅菌処理される。その際、容器本体の各くびれ部は、上段または下段の包装容器との間に隙間を形成し、注射剤パックの積層体全体に滅菌ガスを流通させる。そして、薬剤入り注射器の注射筒のフランジおよびピストンロッドの押し子を収容する最も大きな第3の膨出部は、中央部が凹没した鞍部状に形成されているため、上段または下段の包装容器との接触面積が少なく、前記包装容器の滅菌紙における滅菌ガスの接触効率を高める。
【0007】
また、上記の構成の注射剤パックにおいては、積み重ねられた状態で容器本体と他の包装容器の滅菌紙との接触面積を一層低減するため、第2の膨出部の高さは、第1の膨出部および第3の膨出部よりも低く形成されているのが好ましい。
【0008】
【発明の実施の形態】
本発明に係る注射剤パックの一実施形態を図面に基づいて説明する。図1は、注射剤パックにおける包装容器の外形を示す斜視図である。図2は、注射剤パックの包装構造を底面側から示した展開斜視図である。図3は、包装容器の膨出部の形状を示す図であり、容器本体の長手方向に直交する断面図である。図4は、注射剤パックの滅菌処理の態様を示す斜視図である。
【0009】
本発明の注射剤パックは、図1及び図2に符号(P)にて示す様に、包装容器(1)に薬剤入り注射器(4)を収容して構成される。周知の通り、薬剤入り注射器(4)は、注射針を取り付けて直ちに使用できる形態の注射具であり、注射針取付部にキャップ(42)が装着された注射筒(41)と、先端にピストンを有し且つ注射筒(41)に挿入されたピストンロッド(44)と、注射筒(41)に充填された薬剤とから成る。薬剤入り注射器に関する技術は、特開平4−150868号公報などに記載されている。
【0010】
注射剤パック(P)は、滅菌ガスを使用し、加熱することなく容器内部を滅菌処理した医療用滅菌包装の一形態であり、薬剤入り注射器(4)に充填される薬剤としては、加熱に適さない薬剤、典型的には、ヒアルロン酸ナトリウム溶液などが好適である。また、滅菌ガスとしては、処理工程における取扱上の観点から、毒性の低いガスが望ましく、過酸化水素ガスは、エチレンオキサイドガスに比べて殺菌作用が大きく且つ毒性が比較的低いので好適なガスである。
【0011】
図1に示す様に、包装容器(1)は、透明性の樹脂によって細長の略器状に一体成形され且つ底面が開放された容器本体(2)と、滅菌用ガスを透過可能なシート材から成り且つ容器本体(1)の底面を封止する滅菌紙(3)とから構成される。容器本体(2)を構成する樹脂材料としては、細菌を透過させることがなく且つ内容物を目視できる材料であれば適宜の熱可塑性樹脂を使用できるが、ガスバリヤー性および透明性の観点から、容器本体(2)は、ポリエチレンテレフタレート(PET)、ポリブチレンテレフタレート等のポリエステル系樹脂によって構成されているのが好ましい。
【0012】
具体的には、容器本体(2)は、200〜600μmの厚さのポリエチレンテレフタレートフィルムを使用し、ブリスター成形、深絞り成形などの成形法によって作製される。特に、PETフィルムにて構成された容器本体(2)は、廃棄処分の際に塩化ビニルの様に塩素などの毒性ガスの発生がなく、公害防止の観点からも好ましい包装材である。
【0013】
滅菌紙(3)を構成するシート材としては、細菌などの微生物を透過することなく且つ滅菌用ガスや空気などのガスを透過可能な材料、例えば、デュポン社製の商品名「タイベック 1073B」として知られる高密度ポリエチレンのシート材が好適に使用される。斯かる滅菌紙(3)は、容器本体(2)に対し、超音波溶着法または加熱溶着法によって溶着される。
【0014】
本発明の注射剤パック(P)において、容器本体(2)は、薬剤入り注射器(4)の注射筒(41)先端、すなわち、キャップ(42)を装着した注射針取付部を収容する第1の膨出部(21)と、途中まで挿入されたピストンロッド(44)を含む薬剤入り注射器(4)の全長の略中央部を収容する第2の膨出部(22)と、注射筒(41)のフランジ(43)及びピストンロッド(44)の押し子(終端の拡径部)(45)を収容する第3の膨出部(23)と、これらの膨出部を結合する2つのくびれ部(24)、(24)とを備えている。
【0015】
すなわち、容器本体(2)の第1の膨出部(21)及び第3の膨出部(23)は、薬剤入り注射器(4)の両端側に比較的大きな空間を形成し、注射筒(41)とピストンロッド(44)の隙間などの薬剤入り注射器(4)の細部に拡散する滅菌ガスを一時的に貯留する機能を発揮する。そして、中央の第2の膨出部(22)は、包装容器(1)から薬剤入り注射器(4)を容易に且つ衛生的に取り出すための容器本体(2)の折り曲げ支点として機能する。
【0016】
また、容器本体(2)の各くびれ部(24)は、後述する滅菌処理において多数の注射剤パック(P)を積み重ねた際、上段または下段の注射剤パック(P)との間に隙間を形成し、滅菌ガスや空気の流れを良好にする。更に、斯かる観点からは、容器本体(2)の第1の膨出部(21)及び第3の膨出部(23)は、積み重ねる場合の支持点として構成され、第2の膨出部(22)は、第1の膨出部(21)及び第3の膨出部(23)よりも低い高さで形成されているのが好ましい。
【0017】
更に、図3に示す様に、第1の膨出部(21)、第2の膨出部(22)及び第3の膨出部(23)は、注射剤パック(P)を積み重ねた際の滅菌ガスや空気の流れを良好にし且つ上段または下段の注射剤パック(P)の滅菌紙(3)との接触面積を低減するため、角部の曲率半径(R)を5〜20mmの範囲で設定される。
【0018】
本発明の最大の特徴は、上記の容器本体(2)において、第3の膨出部(23)を特定の形状に形成した点にある。すなわち、注射剤パック(P)の滅菌処理における滅菌紙の有効なガス透過面積を十分確保するため、容器本体(2)の第3の膨出部(23)は、容器本体(2)の長手側から側面視した場合、中央部が凹没した鞍部状に形成される。具体的には、図1に示す様に、第3の膨出部(23)は、容器本体(2)の長手方向に沿った前後に突起部分を有し、各突起部分の間に鞍部(25)を有する。
【0019】
注射剤パック(P)は、図2に示す様に、成形された容器本体(2)に薬剤入り注射器(4)を装填した後、容器本体(2)の底面に滅菌紙(3)を溶着することにより、包装容器(1)に薬剤入り注射器(4)を封入して製造される。図2に示す薬剤入り注射器(4)の注射筒(41)のフランジ(43)には、使用時に指を引掛けて薬剤の注入を容易にするアダプター(補助具)(47)が装着されている。アダプター(47)は、隙間を介して2枚の環状の薄板が対向配置された形状を備えている。アダプター(47)は、容器本体(2)に薬剤入り注射器(4)を収容した場合、薬剤入り注射器(4)の揺動を防止する機能も有する。なお、容器本体(2)は、製造効率上、横方向に複数個連続した状態で成形され、複数個の注射剤パック(P)が同時に製造される。
【0020】
滅菌処理は、台車に多数の注射剤パック(P)を積載し且つ台車ごと閉鎖系のチャンバーに装填し、当該チャンバーに過酸化水素ガス等の滅菌ガスを供給して行われる。滅菌処理において、注射剤パック(P)は、図4に示す様に、多数配列され(例示的に1列のみ図示)且つ上下に多数段積み重ねた状態で過酸化水素ガスに晒される。
【0021】
その際、本発明の注射剤パック(P)において、容器本体(2)のくびれ部(24)は、上段または下段の包装容器(1)との間に隙間を形成するため、注射剤パック(P)の積層体全体に過酸化水素ガスを流通させる。そして、薬剤入り注射器(4)の注射筒(41)のフランジ(43)及びピストンロッド(44)の押し子(45)を収容する容器本体(2)の最も大きな第3の膨出部(23)は、中央部が凹没した鞍部状に形成されているため、上段または下段の包装容器(1)との接触面積が少なく、包装容器(1)の滅菌紙(3)における過酸化水素ガスの接触効率を高める。
【0022】
また、滅菌処理した後は、チャンバー内の過酸化水素ガスを排気し、導入した空気に注射剤パック(P)を晒すことにより、包装容器(1)の内部の過酸化水素ガスを脱気する。その際、滅菌処理と同様に、容器本体(2)のくびれ部(24)は、注射剤パック(P)の積層体全体に空気を流通させ、そして、第3の膨出部(23)は、滅菌紙(3)における空気の接触効率を高める。
【0023】
すなわち、本発明の注射剤パック(P)においては、包装容器(1)の容器本体(2)が上述の様な特定の形状を備えており、積み重ねた際に滅菌紙(3)のガス透過面積を十分に確保できるため、滅菌処理において包装容器(1)の内部に短時間で過酸化水素ガスを透過でき、また、包装容器(1)の内部から短時間で過酸化水素ガスを脱気できる。従って、本発明の注射剤パック(P)においては、滅菌処理の効率を一層向上できる。
【0024】
【発明の効果】
以上説明した様に、本発明の注射剤パックによれば、包装容器の容器本体が3つの膨出部とこれらを結合する2つのくびれ部とを備え、かつ、第3の膨出部が中央部を凹没させた鞍部状の形状を備えており、積み重ねた際に滅菌紙のガス透過面積を十分に確保できるため、滅菌処理において包装容器の内部に短時間で滅菌ガスを透過でき、また、包装容器の内部から短時間で滅菌ガスを脱気でき、その結果、滅菌処理の効率を一層向上できる。
【図面の簡単な説明】
【図1】注射剤パックにおける包装容器の外形を示す斜視図
【図2】注射剤パックの包装構造を底面側から示した展開斜視図
【図3】包装容器の膨出部の形状を示す断面図
【図4】注射剤パックの滅菌処理の態様を示す斜視図
【符号の説明】
1 :包装容器
2 :容器本体
21:第1の膨出部
22:第2の膨出部
23:第3の膨出部
24:くびれ部
25:鞍部
3 :滅菌紙
4 :薬剤入り注射器
41:注射筒
43:フランジ
44:ピストンロッド
45:押し子
P :注射剤パック[0001]
BACKGROUND OF THE INVENTION
The present invention relates to an injectable pack, and more particularly, an injectable pack in which a medicine-filled syringe is enclosed in a packaging container, which is sealed with sterilized paper that mainly transmits only sterilized gas, and The present invention relates to an injectable pack using a packaging container in a form that allows easy sterilization of a contained medicine-filled syringe.
[0002]
[Prior art]
Similarly to disposable medical devices, medicine-filled syringes are distributed as so-called injection packs that are sterilized for medical use by a specific packaging container. The packaging container is composed of a container body integrally formed of a transparent resin and having a bottom surface opened, and a sterilized paper made of a sheet material that is permeable to sterilization gas and sealing the bottom surface of the container body. . And the inside of the packaging container in which the syringe containing a medicine is enclosed is sterilized by the gas which permeate | transmitted the sterilization paper by exposing to ethylene oxide gas, for example. In addition, from the viewpoint of processing efficiency, such sterilization processing is usually performed in a state where a large number of sterilization processes are arranged and stacked in a number of stages.
[0003]
[Problems to be solved by the invention]
By the way, when sterilization is performed in a state where many injection packs are stacked one above the other, since the surface of the sterilized paper is covered with the container body of the upper or lower packaging container, the transmission efficiency of the sterilized gas in the sterilized paper is reduced. Problems arise. Further, after the sterilization treatment, it is necessary to sufficiently remove the sterilization gas so that there is no residue, but there is a problem that the deaeration efficiency of the gas that has penetrated into the inside of the packaging container is low.
[0004]
The present invention has been made to further improve the efficiency of the above-described sterilization treatment, and an object thereof is an injection pack in which a medicine-filled syringe is enclosed in a packaging container, which is sealed with sterile paper, And it is providing the injection pack which uses the packaging container of the form with which the sterilization of the accommodated syringe with a medicine is easy.
[0005]
[Means for Solving the Problems]
In order to solve the above-mentioned problems, the injection pack of the present invention is an injection pack in which a syringe containing a medicine is enclosed in a packaging container, and the packaging container is a long and narrow container made of a transparent polyester resin. And a sterilized paper made of a sheet material that is permeable to sterilizing gas and sealing the bottom surface of the container body. The container body contains a medicine. Accommodates a first bulging portion that accommodates a syringe needle mounting portion of a syringe barrel of a syringe, a second bulging portion that accommodates a substantially central portion of a syringe containing a medicine, and a flange of a syringe barrel and a pusher for a piston rod A third bulging portion and two constricted portions that connect the bulging portions, and the first bulging portion and the third bulging portion are sterilized during sterilization. It forms a storage space of the gas, the second Rise Parts, the formed by the first protruding portion and the third swelled portion lower height than the said third bulging portion, when seen from the side from the longitudinal side of the container body, the central portion It is formed in the shape of a recessed collar.
[0006]
The above-mentioned injection pack is sterilized in a state where a number of layers are stacked in the vertical direction. In that case, each constriction part of a container main body forms a clearance gap between the upper or lower packaging containers, and distributes sterilization gas through the whole laminated body of an injection pack. And since the largest 3rd bulging part which accommodates the flange of the injection cylinder of a syringe with a medicine, and the pusher of a piston rod is formed in the collar part shape in which the center part was dented, the upper or lower packaging container And the contact efficiency of the sterilizing gas in the sterilized paper of the packaging container is increased.
[0007]
In the injection pack having the above-described configuration, the height of the second bulging portion is the first height in order to further reduce the contact area between the container body and the sterilized paper of the other packaging container in the stacked state. It is preferable that the bulge portion and the third bulge portion are formed lower.
[0008]
DETAILED DESCRIPTION OF THE INVENTION
One embodiment of an injection pack according to the present invention will be described with reference to the drawings. FIG. 1 is a perspective view showing an outer shape of a packaging container in an injection pack. FIG. 2 is an exploded perspective view showing the packaging structure of the injection pack from the bottom side. FIG. 3 is a diagram showing the shape of the bulging portion of the packaging container, and is a cross-sectional view orthogonal to the longitudinal direction of the container body. FIG. 4 is a perspective view showing an embodiment of the sterilization treatment of the injection pack.
[0009]
The injection pack of the present invention is configured by accommodating a medicine-filled syringe (4) in a packaging container (1), as indicated by reference numeral (P) in FIGS. As is well known, the medicine-filled syringe (4) is a syringe that can be used immediately after the injection needle is attached. The syringe (41) is provided with a cap (42) attached to the injection needle attachment portion, and a piston is provided at the tip. And a piston rod (44) inserted into the syringe barrel (41) and a medicine filled in the syringe barrel (41). A technique related to a medicine-filled syringe is described in JP-A-4-150868.
[0010]
The injection pack (P) is a form of medical sterilization packaging that uses sterilization gas and sterilizes the inside of the container without heating. As a medicine filled in the medicine-filled syringe (4), heating is used. Unsuitable drugs, typically sodium hyaluronate solution and the like are suitable. Further, as the sterilizing gas, a gas having low toxicity is desirable from the viewpoint of handling in the treatment process, and hydrogen peroxide gas is a suitable gas because it has a sterilizing action and is relatively low in toxicity as compared with ethylene oxide gas. is there.
[0011]
As shown in FIG. 1, the packaging container (1) includes a container body (2) integrally formed into a thin and substantially container shape with a transparent resin and an open bottom surface, and a sheet material that is permeable to sterilization gas. And sterilized paper (3) for sealing the bottom surface of the container body (1). As a resin material constituting the container body (2), an appropriate thermoplastic resin can be used as long as it is a material that does not allow bacteria to permeate and allows the contents to be visually observed. From the viewpoint of gas barrier properties and transparency, The container body (2) is preferably made of a polyester-based resin such as polyethylene terephthalate (PET) or polybutylene terephthalate.
[0012]
Specifically, the container body (2) is manufactured by a molding method such as blister molding or deep drawing using a polyethylene terephthalate film having a thickness of 200 to 600 μm. In particular, the container body (2) made of a PET film does not generate a toxic gas such as chlorine like vinyl chloride at the time of disposal, and is a preferable packaging material from the viewpoint of pollution prevention.
[0013]
As the sheet material constituting the sterilized paper (3), a material that does not permeate microorganisms such as bacteria and is permeable to gas such as sterilization gas or air, for example, a product name “Tyvek 1073B” manufactured by DuPont. A known high density polyethylene sheet material is preferably used. Such sterilized paper (3) is welded to the container body (2) by an ultrasonic welding method or a heat welding method.
[0014]
In the injection pack (P) of the present invention, the container body (2) is a first container that houses the tip of the syringe barrel (41) of the syringe (4) containing a medicine, that is, the syringe needle mounting portion on which the cap (42) is mounted. A second bulging portion (22) for accommodating a substantially central portion of the entire length of the medicine-filled syringe (4) including the piston rod (44) inserted partway, and a syringe barrel ( 41) a flange (43) and a piston rod (44) pusher (terminal enlarged diameter portion) (45), and a third bulge portion (23) for accommodating the bulge portions. Constricted portions (24) and (24) are provided.
[0015]
That is, the first bulging portion (21) and the third bulging portion (23) of the container body (2) form a relatively large space on both ends of the medicine-filled syringe (4), and the syringe barrel ( 41) and a function of temporarily storing sterilizing gas diffusing into the details of the medicine-filled syringe (4) such as a gap between the piston rod (44). The central second bulging portion (22) functions as a bending fulcrum of the container body (2) for easily and hygienically removing the medicine-filled syringe (4) from the packaging container (1).
[0016]
In addition, each constricted portion (24) of the container body (2) has a gap between the upper and lower injection packs (P) when a large number of injection packs (P) are stacked in a sterilization process to be described later. Form and improve the flow of sterilization gas and air. Furthermore, from such a viewpoint, the first bulging portion (21) and the third bulging portion (23) of the container body (2) are configured as support points when stacked, and the second bulging portion (22) is preferably formed at a lower height than the first bulge portion (21) and the third bulge portion (23).
[0017]
Furthermore, as shown in FIG. 3, the first bulging portion (21), the second bulging portion (22), and the third bulging portion (23) are formed when the injection packs (P) are stacked. In order to improve the flow of sterilization gas and air and reduce the contact area of the upper or lower injection pack (P) with the sterilized paper (3), the curvature radius (R) of the corners is in the range of 5 to 20 mm. Set by.
[0018]
The greatest feature of the present invention is that the third bulging portion (23) is formed in a specific shape in the container body (2). That is, in order to secure a sufficient effective gas permeation area of the sterilized paper in the sterilization treatment of the injection pack (P), the third bulging portion (23) of the container body (2) is formed in the longitudinal direction of the container body (2). When viewed from the side, it is formed in the shape of a collar with a recessed central portion. Specifically, as shown in FIG. 1, the third bulging portion (23) has protruding portions on the front and rear along the longitudinal direction of the container body (2), and a collar portion ( 25).
[0019]
As shown in FIG. 2, the injection pack (P) is filled with a syringe (4) containing a medicine in a molded container body (2), and then sterilized paper (3) is welded to the bottom surface of the container body (2). Thus, the medicine-filled syringe (4) is enclosed in the packaging container (1). An adapter (auxiliary tool) (47) is attached to the flange (43) of the syringe barrel (41) of the syringe (4) containing the drug shown in FIG. Yes. The adapter (47) has a shape in which two annular thin plates are opposed to each other through a gap. The adapter (47) also has a function of preventing the medicine-filled syringe (4) from swinging when the medicine-filled syringe (4) is accommodated in the container body (2). In addition, a container main body (2) is shape | molded in the state where several in the horizontal direction was continued on manufacturing efficiency, and several injection pack (P) is manufactured simultaneously.
[0020]
The sterilization process is performed by loading a large number of injection packs (P) on a cart, loading the cart together with a closed system chamber, and supplying a sterilization gas such as hydrogen peroxide gas to the chamber. In the sterilization process, the injection pack (P) is exposed to hydrogen peroxide gas in a state in which a large number of injection packs (P) are arranged (for example, only one row is illustrated) and stacked in a number of stages vertically.
[0021]
At that time, in the injection pack (P) of the present invention, the constricted portion (24) of the container body (2) forms a gap with the upper or lower packaging container (1). Hydrogen peroxide gas is circulated through the entire laminate of P). Then, the largest third bulge portion (23) of the container body (2) that accommodates the flange (43) of the syringe barrel (41) of the medicine-filled syringe (4) and the pusher (45) of the piston rod (44). ) Is formed in the shape of a saddle with a recessed central part, so that the contact area with the upper or lower packaging container (1) is small, and the hydrogen peroxide gas in the sterilized paper (3) of the packaging container (1) Increase contact efficiency.
[0022]
In addition, after sterilization, the hydrogen peroxide gas in the chamber is evacuated, and the injection pack (P) is exposed to the introduced air to degas the hydrogen peroxide gas inside the packaging container (1). . At that time, as in the sterilization process, the constricted portion (24) of the container body (2) allows air to flow through the entire laminate of the injection pack (P), and the third bulging portion (23) Enhance air contact efficiency in sterile paper (3).
[0023]
That is, in the injection pack (P) of the present invention, the container body (2) of the packaging container (1) has the specific shape as described above, and the gas permeation of the sterilized paper (3) when stacked. Since the area can be secured sufficiently, hydrogen peroxide gas can be permeated into the packaging container (1) in a short time during sterilization, and hydrogen peroxide gas can be degassed from the inside of the packaging container (1) in a short time. it can. Therefore, in the injection pack (P) of the present invention, the sterilization efficiency can be further improved.
[0024]
【The invention's effect】
As described above, according to the injection pack of the present invention, the container main body of the packaging container includes the three bulging portions and the two constricted portions that connect them, and the third bulging portion is the center. It has a saddle-like shape with the recessed parts, and it can secure a sufficient gas permeation area of sterilized paper when stacked, so that sterilization gas can permeate into the packaging container in a short time during sterilization, The sterilization gas can be degassed from the inside of the packaging container in a short time, and as a result, the efficiency of the sterilization process can be further improved.
[Brief description of the drawings]
FIG. 1 is a perspective view showing an outer shape of a packaging container in an injection pack. FIG. 2 is a developed perspective view showing a packaging structure of the injection pack from the bottom. FIG. 3 is a cross section showing a shape of a bulging portion of the packaging container. [Fig. 4] Perspective view showing the mode of sterilization of injection pack [Explanation of symbols]
1: packaging container 2: container main body 21: first bulging part 22: second bulging part 23: third bulging part 24: constricted part 25: collar part 3: sterilized paper 4: syringe with medicine 41: Injection cylinder 43: Flange 44: Piston rod 45: Pusher P: Injection pack
Claims (4)
Priority Applications (20)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
JP34385297A JP4164890B2 (en) | 1997-11-28 | 1997-11-28 | Injection pack |
US09/197,614 US6228324B1 (en) | 1997-11-28 | 1998-11-23 | Sterilizing method for medical sterilization packaging and injection pack |
AT98955938T ATE271884T1 (en) | 1997-11-28 | 1998-11-26 | STERILIZATION PROCESS FOR MEDICAL STERILE PACKAGING |
PT98955938T PT971749E (en) | 1997-11-28 | 1998-11-26 | METHOD OF STERILIZATION FOR MEDICAL STERILIZATION PACKAGING AND INJECTION ASSEMBLY |
ZA9810836A ZA9810836B (en) | 1997-11-28 | 1998-11-26 | Sterilizing method for medical sterilization packaging and injection pack. |
NZ336723A NZ336723A (en) | 1997-11-28 | 1998-11-26 | Using hydrogen peroxide to sterilise medicine filled injectors or syringes |
DE29825112U DE29825112U1 (en) | 1997-11-28 | 1998-11-26 | Sterilizing medical injector pre-filled with sodium hyaluronate solution |
RU99118767/12A RU2225226C2 (en) | 1997-11-28 | 1998-11-26 | Method and injection instrument for sterilizing medical packages |
DE69825258T DE69825258T2 (en) | 1997-11-28 | 1998-11-26 | STERILIZATION PROCEDURE FOR MEDICAL-STERILE PACKAGING |
PCT/JP1998/005322 WO1999027971A2 (en) | 1997-11-28 | 1998-11-26 | Sterilizing method for medical sterilization packaging and injection pack |
CA002280941A CA2280941C (en) | 1997-11-28 | 1998-11-26 | Sterilizing method for medical sterilization packaging and injection pack |
AU12605/99A AU752610B2 (en) | 1997-11-28 | 1998-11-26 | Sterilizing method for medical sterilization packaging and injection pack |
ES98955938T ES2224448T3 (en) | 1997-11-28 | 1998-11-26 | STERILIZATION METHOD FOR STERILE MEDICAL PACKAGING. |
DK98955938T DK0971749T3 (en) | 1997-11-28 | 1998-11-26 | Sterilization procedure for medical, sterile packaging |
TW087119662A TW486373B (en) | 1997-11-28 | 1998-11-26 | Sterilizing method for medical sterilization packaging and injection pack |
KR10-1999-7006722A KR100527151B1 (en) | 1997-11-28 | 1998-11-26 | Sterilizing method for medical sterilization packaging and injection pack |
EP98955938A EP0971749B1 (en) | 1997-11-28 | 1998-11-26 | Sterilizing method for medical sterilization packaging |
IS5116A IS2185B (en) | 1997-11-28 | 1999-07-13 | Disinfection method for medical disinfection packaging equipment |
NO19993624A NO312941B1 (en) | 1997-11-28 | 1999-07-26 | Sterilization method for sterilizing a medical package as well as the obtained package |
AT0022605U AT9119U1 (en) | 1997-11-28 | 2005-04-12 | MEDICAL STERILIZATION PACKAGING AND INJECTION PACKAGING |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
JP34385297A JP4164890B2 (en) | 1997-11-28 | 1997-11-28 | Injection pack |
Publications (2)
Publication Number | Publication Date |
---|---|
JPH11155948A JPH11155948A (en) | 1999-06-15 |
JP4164890B2 true JP4164890B2 (en) | 2008-10-15 |
Family
ID=18364743
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP34385297A Expired - Lifetime JP4164890B2 (en) | 1997-11-28 | 1997-11-28 | Injection pack |
Country Status (2)
Country | Link |
---|---|
JP (1) | JP4164890B2 (en) |
ZA (1) | ZA9810836B (en) |
Families Citing this family (13)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JP4098905B2 (en) * | 1997-12-22 | 2008-06-11 | 株式会社資生堂 | Packaging container |
JP4096424B2 (en) * | 1998-11-25 | 2008-06-04 | 株式会社柏木モールド | Packaging container |
KR100390266B1 (en) * | 2000-12-29 | 2003-07-07 | 에이스의료기산업주식회사 | wrapping method of disposable syringe and the wrapped syringe |
JP4671510B2 (en) * | 2001-01-30 | 2011-04-20 | 中外製薬株式会社 | Blister packaging container suitable for automatic loading |
JP2003052819A (en) * | 2001-08-10 | 2003-02-25 | Seikagaku Kogyo Co Ltd | Drug filling syringe package and sterilization or bactericidal method for it |
JP2004035024A (en) * | 2002-07-02 | 2004-02-05 | Nipro Corp | Autoclave sterilizing blister package of improved peelability |
JP2005323740A (en) | 2004-05-13 | 2005-11-24 | Olympus Corp | Syringe holder for balloon catheter, and syringe set for balloon catheter |
JP5362240B2 (en) * | 2008-03-21 | 2013-12-11 | テルモ株式会社 | Packaging body and cover mounting method |
US9333146B2 (en) * | 2010-12-14 | 2016-05-10 | Becton Dickinson France S.A.S. | Compact injection device |
CN108883231B (en) * | 2016-03-31 | 2021-06-04 | 株式会社Gc | Syringe with container |
GB2557655A (en) * | 2016-12-14 | 2018-06-27 | Teva Pharma | Medical injection device packaging |
WO2022202382A1 (en) * | 2021-03-26 | 2022-09-29 | テルモ株式会社 | Method for manufacturing packaged medicine administering tool |
EP4249015A1 (en) * | 2022-03-25 | 2023-09-27 | Stada Arzneimittel Ag | Method for preparing a sterilised drug delivery device |
-
1997
- 1997-11-28 JP JP34385297A patent/JP4164890B2/en not_active Expired - Lifetime
-
1998
- 1998-11-26 ZA ZA9810836A patent/ZA9810836B/en unknown
Also Published As
Publication number | Publication date |
---|---|
ZA9810836B (en) | 2000-05-26 |
JPH11155948A (en) | 1999-06-15 |
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