JPH10234822A - Container for lyophilization - Google Patents
Container for lyophilizationInfo
- Publication number
- JPH10234822A JPH10234822A JP9062047A JP6204797A JPH10234822A JP H10234822 A JPH10234822 A JP H10234822A JP 9062047 A JP9062047 A JP 9062047A JP 6204797 A JP6204797 A JP 6204797A JP H10234822 A JPH10234822 A JP H10234822A
- Authority
- JP
- Japan
- Prior art keywords
- container
- freeze
- drying
- body member
- bottom member
- 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.)
- Pending
Links
Abstract
Description
【０００１】[0001]
【産業上の利用分野】本発明は、凍結乾燥用容器に関す
るものであり、より詳細には、一の室に凍結乾燥物が収
容され、他の室に上記凍結乾燥物の溶解液が収容され、
上記一の室と他の室とが使用時に連結しうる複数の室を
有する医療用容器等の多室容器における上記凍結乾燥物
の必要単位量の凍結乾燥を行い、且つその必要単位量の
凍結乾燥物を塊状のまま上記多室容器内に移し換え可能
とした凍結乾燥用容器に関するものである。BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a lyophilization container, and more particularly, to a lyophilization container in one chamber and a lyophilization solution in another chamber. ,
Freeze-drys the required unit amount of the freeze-dried product in a multi-room container such as a medical container having a plurality of rooms in which the one room and the other room can be connected at the time of use, and freezes the required unit amount The present invention relates to a freeze-drying container capable of transferring a dried product as a lump into the multi-chamber container.
【０００２】[0002]
【従来の技術】一般に抗生物質、蛋白質製剤等の凍結乾
燥物はバイアル、アンプル等に収容されている。凍結乾
燥物は、バイアル内に凍結乾燥用の溶液を除菌フィルタ
を通して無菌的に充填し、これを凍結乾燥装置内で凍結
処理し、バイアルの栓体を半打栓状態にして減圧乾燥し
て乾燥後に完全打栓をして凍結乾燥物入りバイアルを得
る。また、このようなバイアルは輸液容器、透析液容
器、臓器保存液容器等に無菌的に連結され、凍結乾燥物
がこれらの薬液容器に混注されて用いられる。バイアル
と薬液容器とを無菌的に連結させる構造としては、それ
ぞれの口部に刺通する連通針を設けたものが多々提案さ
れている。これは、連結部で連通針を無菌的に保持して
おき、その操作時に連通針を各口部に刺通させてバイア
ル内と薬液容器内とを連通させるものである。そして、
可撓性の薬液容器の壁を圧迫してポンピング操作を行う
ことにより、一部の薬液をバイアル内に注入して混合し
た後、その混合液を戻して混注操作を無菌的に行うもの
である。しかし、かかる連結構造では、連通針で口部を
刺通する操作や薬液容器のポンピング操作等を必要とし
煩雑な面を有している。最近、医療用容器を二つの室に
分け、一の室には薬液を充填し、二の室には凍結乾燥物
を充填したものがある（特開平６−１４９７５号公
報）。医療用容器の各室は剥離可能な隔離シール部で仕
切られ、薬液収容室を外側から圧迫することにより、隔
離シール部が剥離開放されるようになっている。従っ
て、このような薬液容器は容器圧迫のみで簡単に薬剤を
混注することができるようになっている。このため、こ
のような医療用容器が頻用される傾向にある。2. Description of the Related Art Generally, freeze-dried products such as antibiotics and protein preparations are contained in vials, ampules and the like. The lyophilized product is aseptically filled with a solution for lyophilization in a vial through a sterilization filter, freeze-treated in a lyophilization apparatus, and the vial stopper is half-stoppered and dried under reduced pressure. After drying, the vial is completely stoppered to obtain a vial containing a lyophilized product. Such a vial is aseptically connected to an infusion container, a dialysis solution container, an organ preservation solution container, or the like, and a freeze-dried product is used by being co-injected into these drug solution containers. As a structure for aseptically connecting a vial and a drug solution container, there have been proposed many structures provided with a communication needle penetrating each mouth. In this method, a communication needle is aseptically held at a connection portion, and at the time of the operation, the communication needle is pierced into each mouth to communicate between the vial and the chemical solution container. And
By performing a pumping operation by pressing the wall of a flexible medical solution container, a part of the medical solution is injected into the vial and mixed, and then the mixed solution is returned to perform the mixed injection operation aseptically. . However, such a connection structure requires an operation of piercing the mouth with a communication needle, a pumping operation of a drug solution container, and the like, and has a complicated surface. Recently, a medical container is divided into two chambers, one of which is filled with a drug solution and the other of which is filled with a freeze-dried product (Japanese Patent Application Laid-Open No. 6-14975). Each chamber of the medical container is partitioned by a detachable isolation seal portion, and the isolation seal portion is peeled open by pressing the chemical solution storage chamber from the outside. Therefore, in such a drug solution container, a drug can be easily co-injected only by pressing the container. For this reason, such medical containers tend to be frequently used.
【０００３】[0003]
【発明が解決しようとする課題】しかしながら、最近の
二室の医療用容器においては、その凍結乾燥物の充填に
問題がある。複数の室の一の室に凍結乾燥物を充填する
方法としては現在、二つの方法が提案されている。第一
は、タンクで多量の薬剤をまとめて凍結乾燥し、それを
粉砕・整粒した後、医療用容器に必要とされる必要単位
量を秤量して充填・密封する方法ある。しかし、このよ
うな凍結乾燥の充填方法ではその無菌充填操作において
の汚染の危険性を全て解消したとはいえない。充填工程
時に薬剤が湿気を帯びたり異物や細菌が混入するおそれ
がある。また、かかる方法では凍結乾燥品のケーキが必
ずしも薬剤の均一な力価を保持して分布しているとは限
らない。第二は、凍結乾燥用容器で薬剤を医療用容器に
おける必要単位量を凍結乾燥し、次に、凍結乾燥用容器
内の必要単位量の凍結乾燥物を医療用容器にそのまま移
し換えて充填・密封する方法である。そして、かかる方
法に用いる凍結乾燥用容器は、容器本体と栓体とからな
り、容器本体は底部外側が平面状をなして熱伝導性の良
好な形状に形成される。また容器本体の胴部は円筒状で
開口に向けて末広がりのテーパ面状に形成され、その底
部内壁がほぼ半球面状に形成されて、凍結乾燥物の移し
換え時の取り出しが容易になっている。更に、胴部内壁
面が易離型性の被膜処理がなされている。しかし、この
ような凍結乾燥用容器による無菌的充填では、凍結乾燥
用容器の易離型性被膜が機能していれば、凍結乾燥用容
器の転倒で塊状の凍結乾燥物が容易に医療用容器の室内
に投入できるが、かかる容器類は再使用のため洗滌を繰
り返し行うため、容器内壁の易離型性被膜が剥げ落ち、
凍結乾燥用容器の転倒のみで旨く移し換えができなくな
るおそれがある。このため、製造上、歩留まりを悪くす
る。また、アルミニウムや銀等の熱伝導性材を凍結乾燥
用容器とするため、上記容器の外側及び内側の複雑な形
状に合わせて金属加工をするのでコストアップとなる。
従って、本発明は、医療用容器における必要単位量の凍
結乾燥物を塊状のまま医療用容器に移し換えが確実にで
き、また容器自体も簡単に製造できる凍結乾燥用容器を
提供することを目的とする。However, in recent two-chamber medical containers, there is a problem in filling the freeze-dried product. At present, two methods have been proposed as a method of filling a freeze-dried material in one of a plurality of chambers. The first method is to collectively freeze-dry a large amount of drugs in a tank, pulverize and size them, and then weigh and fill and seal a required unit amount required for a medical container. However, such a freeze-drying filling method has not completely eliminated the risk of contamination in the aseptic filling operation. During the filling process, there is a possibility that the medicine may become wet or foreign substances or bacteria may be mixed. In addition, in such a method, the freeze-dried cake is not always distributed while maintaining a uniform titer of the drug. The second is to freeze-dry the required amount of drug in the medical container in the freeze-drying container, and then transfer the required unit amount of the freeze-dried product in the freeze-drying container to the medical container as it is and fill it. It is a method of sealing. The freeze-drying container used in such a method includes a container body and a stopper, and the container body is formed in a shape having good heat conductivity with a bottom outer surface being flat. In addition, the body of the container body is formed in a cylindrical shape with a tapered surface diverging toward the opening, and the bottom inner wall is formed in a substantially hemispherical shape, so that the lyophilized material can be easily taken out at the time of transfer. I have. Further, the inner wall surface of the body is subjected to a coating treatment for easy release. However, in the aseptic filling with such a freeze-drying container, if the easily releasable coating of the freeze-drying container is functioning, the freeze-dried container can easily be turned into a massive freeze-dried product by overturning the freeze-dried container. However, since such containers are repeatedly washed for reuse, the easily releasable coating on the inner wall of the container peels off,
There is a possibility that the transfer cannot be successfully performed only by overturning the freeze-drying container. For this reason, the production yield is deteriorated. In addition, since a thermally conductive material such as aluminum or silver is used as a container for freeze-drying, metal processing is performed according to the complicated shape on the outside and inside of the container, which increases the cost.
Accordingly, an object of the present invention is to provide a freeze-drying container in which a required unit amount of a lyophilized product in a medical container can be reliably transferred to a medical container as a lump and the container itself can be easily manufactured. And
【０００４】[0004]
【課題を解決するための手段】本発明は、一の室に凍結
乾燥物が収容され、他の室に上記凍結乾燥物の溶解液が
収容され、上記一の室と他の室とが使用時に連結しうる
複数の室を有する多室容器における上記凍結乾燥物の必
要単位量の凍結乾燥を行い、且つ該必要単位量の上記凍
結乾燥物を塊状のまま上記多室容器内に移し換え可能と
した凍結乾燥用容器において、筒状胴部材と、該胴部材
内を液密に摺動しうる底部材或いは開口栓体とからな
り、上記筒状胴部材は横断面内形状がほぼ同形状の均一
な筒状に形成されていることを特徴とする凍結乾燥用容
器を提供することにより、上記目的を達成したものであ
る。According to the present invention, a freeze-dried product is contained in one chamber, a solution of the freeze-dried product is contained in another chamber, and the one chamber and the other chamber are used. It is possible to freeze-dry a required unit amount of the lyophilized product in a multi-compartment container having a plurality of chambers that can be sometimes connected, and to transfer the required unit amount of the lyophilized product to the multi-compartment container as a lump. In the freeze-drying container described above, a cylindrical body member and a bottom member or an openable plug that can slide in the body member in a liquid-tight manner, and the cylindrical body member has substantially the same cross-sectional inner shape. The above object has been achieved by providing a freeze-drying container characterized by having a uniform cylindrical shape.
【０００５】上記凍結乾燥物は、溶液を一旦容器内で凍
結させ、凍結後、凍結物から水分を昇華、蒸散させて得
ることのできる乾燥物である。このような凍結乾燥物と
しては、薬剤に多く見られ、抗生物質、生理活性蛋白質
等がその代表として挙げられる。上記凍結乾燥物の溶解
液は、単純な無菌水、生理食塩水等の希釈液、溶解液で
も良く、また、輸液剤、透析液、臓器保存液等の電解質
溶液であっても良い。この場合、多室容器は輸液容器、
透析液容器、臓器保存液容器等の医療用容器となる。
尚、多室容器は少なくとも二以上の室を有する容器で、
且つ上記凍結乾燥物を保存時に乾燥状態で一の室に液密
に収容する容器である。このような容器としては、一般
の樹脂製の医療用バック等である。即ち、多室容器は、
シート及びフィルムから成形したもの、直接ブロー成
形、射出成形したもの等である。容器の樹脂成形壁は単
層に限らず複数の樹脂層からなる多層構造でも、樹脂層
自体が複数の樹脂のブレンド物でも良い。室と室とは同
一の容器で一体形成されていても良く、また別体で形成
されていても良い。また、一の室と他の室とは使用直前
に連通されるが、その連通手段は、破壊開封可能な導
管、隔壁を形成する挟持部材、ピールシール部で形成さ
れた隔離シール部等であっても良い。特に、剥離可能な
ピールシール部或いは弱シール部で室と室との連通手段
を形成することが望ましい。[0005] The above-mentioned freeze-dried product is a dried product which can be obtained by once freezing a solution in a container, freezing, sublimating and evaporating water from the frozen product. Such freeze-dried products are often found in drugs, and include antibiotics, bioactive proteins and the like. The solution of the freeze-dried product may be a simple diluent or solution such as sterile water or physiological saline, or may be an electrolyte solution such as an infusion solution, a dialysate, or an organ preservation solution. In this case, the multi-chamber container is an infusion container,
It becomes a medical container such as a dialysate container or an organ preservation solution container.
The multi-chamber container is a container having at least two or more chambers,
Moreover, it is a container for storing the freeze-dried product in one room in a dry state at the time of storage in a liquid-tight manner. Such a container is a general resin medical bag or the like. That is, a multi-chamber container
Examples include those formed from sheets and films, those obtained by direct blow molding and injection molding. The resin molding wall of the container is not limited to a single layer, and may have a multilayer structure including a plurality of resin layers, or the resin layer itself may be a blend of a plurality of resins. The chamber and the chamber may be integrally formed in the same container, or may be formed separately. Further, one chamber and the other chamber are communicated immediately before use, and the communication means include a conduit that can be broken open, a sandwiching member that forms a partition, and an isolation seal formed by a peel seal. May be. In particular, it is desirable to form the communication means between the chambers with a peelable peel seal portion or a weak seal portion.
【０００６】本発明に係る凍結乾燥用容器は、上記凍結
乾燥物の必要単位量の凍結乾燥を行う。凍結乾燥用容器
は凍結乾燥に用いられる容器であり、凍結乾燥用容器に
は凍結乾燥用溶液が充填される。充填後、凍結乾燥用容
器は凍結乾燥装置内に搬入され、先ず、凍結乾燥用溶液
が容器内で凍結される。次に、凍結乾燥装置内が減圧さ
れ、凍結乾燥用溶液から水分等が昇華、蒸散される。こ
こで、医療用容器における上記凍結乾燥物の必要単位量
とは、凍結乾燥用容器で乾燥された凍結乾燥物をそのま
ま全て医療用容器の室に充填される量を意味し、凍結乾
燥用容器で乾燥された凍結乾燥物を分封して医療用容器
の室に充填する単位量ではない。即ち、上記凍結乾燥用
容器は、上記必要単位量の凍結乾燥物を塊状のまま上記
多室容器内に移し換え可能とするものである。従って、
上記凍結乾燥用容器で凍結乾燥した凍結乾燥物は分封し
て多室容器内に充填するものではない。The freeze-drying container according to the present invention freeze-drys a required unit amount of the freeze-dried product. The freeze-drying container is a container used for freeze-drying, and the freeze-drying container is filled with a freeze-drying solution. After filling, the freeze-drying container is carried into the freeze-drying apparatus, and first, the freeze-drying solution is frozen in the container. Next, the pressure inside the freeze-drying apparatus is reduced, and moisture and the like are sublimated and evaporated from the solution for freeze-drying. Here, the required unit amount of the lyophilized product in the medical container means an amount in which the entire lyophilized product dried in the lyophilizing container is directly filled in the chamber of the medical container, and the lyophilized container It is not a unit amount to pack the lyophilized material dried in the above and fill the room of the medical container. That is, the lyophilization container allows the required unit amount of the lyophilized material to be transferred to the multi-chamber container as a lump. Therefore,
The freeze-dried product freeze-dried in the freeze-drying container is not divided and filled in a multi-chamber container.
【０００７】上記凍結乾燥用容器は、筒状胴部材と、胴
部材内を液密に摺動しうる底部材或いは開口栓体とから
なる。底部材が摺動しうる場合には開口栓体が摺動する
必要はなく、また、開口栓体が摺動する場合は底部材が
胴部材から外れるようになっていれば良い。上記筒状胴
部材はその横断面内形状がほぼ同形状の均一な筒状とな
っている。即ち、胴部材は筒体であり、その断面の内形
状は角形状、円形状、楕円形状でも良いが、胴部材のど
の部分の横断面をとってもその内形状がほぼ同形状であ
る必要があり、開口部が円形状で胴部材の下端開口が楕
円形状であることはない。また、開口部と下端開口部と
の断面内形状が相似形であっても大きさが摺動部材の液
密性及び摺動性を失わない許容範囲以上に異なれば上記
形状を満たしていない。上記開口栓体は、通常、開口を
液密に密封しうる半打栓可能な形状の栓体である。従っ
て、開口栓体は、熱可塑性エラストマー、ゴム等の弾性
材からなり、開口部を挿入する部分は二股形成されてい
る。[0007] The freeze-drying container comprises a cylindrical body member and a bottom member or an openable plug which can slide in the body member in a liquid-tight manner. When the bottom member can slide, the opening plug need not slide, and when the opening plug slides, the bottom member only needs to be detached from the body member. The tubular body member has a uniform tubular shape having substantially the same cross-sectional inner shape. That is, the body member is a cylindrical body, and the internal shape of the cross section may be a square shape, a circular shape, or an oval shape, but the internal shape needs to be substantially the same regardless of the cross section of any part of the body member. The opening is not circular and the lower end opening of the body member is not elliptical. Further, even if the cross-sectional shapes of the opening and the lower end opening are similar to each other, the above-mentioned shape is not satisfied if the sizes are different from the allowable range which does not lose the liquid tightness and the slidability of the sliding member. The opening plug is usually a plug that can be semi-plugged so that the opening can be hermetically sealed. Therefore, the opening plug is made of an elastic material such as a thermoplastic elastomer or rubber, and the portion into which the opening is inserted is formed in two parts.
【０００８】このように構成される凍結乾燥用容器にあ
っては、かかる容器で凍結乾燥した凍結乾燥物は多室容
器に収容する必要単位量をそのまま投入することができ
る。即ち、必要単位量の入った凍結乾燥物の胴部材内に
底部材或いは開口栓体を押し子として摺動させることに
より、確実に多室容器内の室に充填できる。この場合、
胴部材内壁に易離型性被膜が無くてもあっても確実に多
室容器内に充填でき、また、その操作においての無菌的
な移し換えが容易にできる。従って、凍結乾燥後の乾燥
物の粉砕、整粒、秤量等の作業が不要であり、また作業
上、移し換えミス等を生じさせることがない。[0008] In the freeze-drying container thus configured, the required amount of the freeze-dried product freeze-dried in such a container to be stored in a multi-room container can be directly supplied. That is, by sliding the bottom member or the opening plug as a pusher into the body member of the freeze-dried product containing the required unit amount, the chamber in the multi-chamber container can be reliably filled. in this case,
Even if there is no easily releasable coating on the inner wall of the body member, it can be reliably filled in the multi-chamber container, and the aseptic transfer in the operation can be easily performed. Therefore, operations such as pulverization, sizing, and weighing of the dried product after freeze-drying are not required, and there is no occurrence of mistakes in transfer during the operation.
【０００９】請求項２記載の本発明は、請求項１記載の
凍結乾燥用容器において、上記胴部材がガラス製である
ことを特徴とする。胴部材がガラス製であれば、その胴
部材壁は透明性を維持することができる。また、樹脂製
の透明性材に比べて熱伝導性もある。胴部材壁が透明で
あれば、内部の凍結乾燥用溶液の凍結状態や乾燥状態を
観察、確認することができ、その製造に支障を来すこと
がない。また樹脂素材に比べてガラスの熱伝導性は高
く、凍結処理時に支障を来すことがない。請求項３記載
の本発明は、請求項１又は２記載の凍結乾燥用容器にお
いて、上記底部材が上記胴部材内を摺動し、上記底部材
の中央部が熱伝導性材で上記底部材の周縁が弾性材から
なることを特徴とする。上記底部材が摺動材であれば、
胴部材の内壁に液密に密着して摺動する機能と、凍結乾
燥用溶液の凍結処理のための熱伝導性が十分な材料であ
ることが望ましい。このため、底部材の外周縁を除く、
大部分が熱伝導性材であることが望ましい。熱伝導性材
は、１０Ｗ・ｍ-1／Ｋ-1以上、好ましくは５０Ｗ・ｍ-1
／Ｋ-1以上、特に２００Ｗ・ｍ-1／Ｋ-1以上であること
が望ましい。このような熱伝導性材としては、金、銀、
銅、アルミニウム等である。弾性材はゴム、熱可塑性エ
ラストマー等のシール性のある材料である。According to a second aspect of the present invention, there is provided the freeze-drying container according to the first aspect, wherein the body member is made of glass. If the body member is made of glass, the body member wall can maintain transparency. It also has a higher thermal conductivity than a transparent material made of resin. If the body member wall is transparent, the frozen or dried state of the freeze-drying solution inside can be observed and confirmed, and there is no hindrance to its production. In addition, the thermal conductivity of glass is higher than that of resin material, and there is no problem during freezing. According to a third aspect of the present invention, in the freeze-drying container according to the first or second aspect, the bottom member slides in the body member, and a central portion of the bottom member is made of a heat conductive material. Is made of an elastic material. If the bottom member is a sliding material,
It is desirable that the material be a material having a function of sliding in close contact with the inner wall of the body member in a liquid-tight manner and a sufficient heat conductivity for freezing treatment of the freeze-drying solution. For this reason, except for the outer peripheral edge of the bottom member,
It is desirable that most be a thermally conductive material. The heat conductive material is 10 W · m −1 / K −1 or more, preferably 50 W · m −1.
/ K -1 or more, particularly preferably 200 W · m -1 / K -1 or more. Such thermally conductive materials include gold, silver,
Copper, aluminum and the like. The elastic material is a material having a sealing property, such as rubber and thermoplastic elastomer.
【０００９】請求項４記載の本発明は、請求項１又は２
記載の凍結乾燥用容器において、開口栓体が上記胴部材
内を摺動し、上記底部材は上記胴部材の下端開口から剥
離可能な樹脂シートとからなることを特徴とする。上記
剥離可能な樹脂シートは、上記下端開口を液密に覆う一
方、多室容器への凍結乾燥物の移し換えに際して下端開
口縁から剥離されるものである。樹脂シートは通常下端
開口縁にピールシールされるものである。ピールシール
部は、下端開口の外部との連通を遮断するように樹脂壁
同士が互いに接着されているものである。そして、ピー
ルシール部は剥離開封可能なシール部であり、通常、こ
のようなシール部はピールシール部又は弱シール部と称
される。ピールシール部の形成は、シール温度、シール
時間等を厳しくコントロールして形成することができる
が、より確実で安全に形成するためには内層を異なる軟
化点或いは融点を有する樹脂のブレンド物とすることが
望ましい。融点等が異なる樹脂層では、熱溶着シール強
度と温度条件との一定の関係が得易く、シール強度を容
易にコントロールできるからである。従って、凍結乾燥
物を凍結乾燥用容器から移し換える際には、先ず、樹脂
シートを剥がし、次に開口栓体を押し込むことにより、
胴部材内から多室容器内へと凍結乾燥物を確実に押し込
む。The present invention described in claim 4 is the first or second aspect of the present invention.
In the freeze-drying container described above, the opening plug slides in the body member, and the bottom member is made of a resin sheet that can be peeled from a lower end opening of the body member. The peelable resin sheet covers the lower opening in a liquid-tight manner, and is peeled from the lower opening edge when the freeze-dried product is transferred to the multi-compartment container. The resin sheet is usually peel-sealed at the lower opening edge. In the peel seal portion, resin walls are bonded to each other so as to block communication with the outside of the lower end opening. And the peel seal part is a seal part which can be peeled off and opened, and such a seal part is usually called a peel seal part or a weak seal part. The peel seal portion can be formed by strictly controlling the seal temperature, the seal time, etc., but in order to form it more reliably and safely, the inner layer should be a blend of resins having different softening points or melting points. It is desirable. This is because in a resin layer having a different melting point or the like, a fixed relationship between the heat-sealing seal strength and the temperature condition can be easily obtained, and the seal strength can be easily controlled. Therefore, when transferring the freeze-dried material from the freeze-drying container, first, peel off the resin sheet, and then push in the opening plug,
The freeze-dried material is securely pushed into the multi-chamber container from inside the body member.
【００１０】[0010]
【実施例】以下、本発明に係る凍結乾燥用容器の好まし
い実施例を添付図面を参照しながら詳述する。図１は本
発明に係る凍結乾燥用容器の第一実施例の正断面図であ
る。図２は第一実施例の凍結乾燥用容器から医療用容器
に移し換える際の製造工程を示す医療用容器の正面図で
ある。図３は図２に示す医療用容器の正面図である。図
４は本発明に係る凍結乾燥用容器の第二実施例の正断面
図である。DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Preferred embodiments of a freeze-drying container according to the present invention will be described below in detail with reference to the accompanying drawings. FIG. 1 is a front sectional view of a first embodiment of a freeze-drying container according to the present invention. FIG. 2 is a front view of the medical container showing a manufacturing process when transferring from the freeze-drying container to the medical container of the first embodiment. FIG. 3 is a front view of the medical container shown in FIG. FIG. 4 is a front sectional view of a second embodiment of the freeze-drying container according to the present invention.
【００１１】図１〜図３に示す如く、凍結乾燥用容器２
は、一の室１２に凍結乾燥物４が収容され、他の室１４
に凍結乾燥物４の溶解液１６が収容され、一の室１２と
他の室１４とが使用時に連結しうる複数の室１２、１４
を有する医療用容器１０における凍結乾燥物４の必要単
位量の凍結乾燥を行い、且つ必要単位量の凍結乾燥物４
を塊状のまま医療用容器１０内に移し換え可能としたも
のである。しかして、凍結乾燥用容器２は筒状胴部材６
と、胴部材６内を液密に摺動しうる底部材８と開口栓体
９とからなり、筒状胴部材６は横断面内形状がほぼ同形
状の均一な筒状に形成されている。上記胴部材６がガラ
ス製である。上記底部材８が胴部材６内を摺動し、底部
材８の中央部が熱伝導性材８Ａで底部材８の周縁が弾性
材８Ｂからなる。As shown in FIGS. 1 to 3, a freeze-drying container 2
The lyophilized material 4 is stored in one room 12 and the other room 14
And a plurality of chambers 12, 14 in which one chamber 12 and another chamber 14 can be connected at the time of use.
The required unit amount of the lyophilized product 4 is freeze-dried in the medical container 10 having
Can be transferred into the medical container 10 as a lump. Thus, the freeze-drying container 2 has a cylindrical body member 6.
And a bottom member 8 and an opening plug 9 that can slide in the body member 6 in a liquid-tight manner. The tubular body member 6 is formed in a uniform tubular shape having substantially the same cross-sectional inner shape. . The body member 6 is made of glass. The bottom member 8 slides inside the body member 6, and the center of the bottom member 8 is made of a heat conductive material 8A and the periphery of the bottom member 8 is made of an elastic material 8B.
【００１２】第一実施例に係る凍結乾燥用容器２を更に
詳しく説明すると、乾燥用容器２は胴部材６、底部材８
及び開口栓体９からなる。胴部材６はガラス製の円筒体
で、内部も円筒体になっている。胴部材６の上端の開口
部２１には係止鍔（フランジ）６Ａが形成され、係止鍔
６Ａには開口栓体９の大径ヘッド部９Ａが当接される。
胴部材６の下端の開口部２２には内側に向けて係止顎６
Ｂが形成され、係止顎６Ｂには底部材８が当接される。
そして、上端の開口部２１は開口栓体９に液密に閉止さ
れ、下端の開口部２２は底部材８に液密に閉止されると
共に、底部材８は下端の開口部２２から脱抜するのを防
止している。胴部材６の筒内は、その横断面が真円形状
に形成され、上下端にかけて同形状、同径の均一な筒状
になっている。底部材８は、アルミニウム製の熱伝導性
材８Ａと耐寒性のシリコンゴムからなる弾性材８Ｂとか
らなる。アルミニウムは熱伝導性が２００Ｗ・ｍ-1／Ｋ
-1以上であるため、温度差による熱量の移動を迅速にす
る。また、弾性材８Ｂはリング状で底部材８の周縁を成
し、胴部材６の内壁を弾性力により押圧して内壁に密着
している。また、底部材８は胴部材６の下端開口２２か
らの押子等により、胴部材６の内壁を液密に摺動するこ
とができる。開口栓体９は、ゴム製で胴部材６の開口部
２１の挿入部分がスカート状に分かれ、半打栓可能とな
っている。The freeze-drying container 2 according to the first embodiment will be described in more detail. The drying container 2 comprises a body member 6 and a bottom member 8.
And an opening plug 9. The body member 6 is a cylindrical body made of glass, and the inside is also a cylindrical body. A locking flange (flange) 6A is formed in the opening 21 at the upper end of the body member 6, and the large-diameter head portion 9A of the opening plug 9 contacts the locking flange 6A.
An opening 22 at the lower end of the body member 6 has a locking jaw 6 facing inward.
B is formed, and the bottom member 8 abuts on the locking jaw 6B.
The opening 21 at the upper end is liquid-tightly closed by the opening plug 9, the opening 22 at the lower end is liquid-tightly closed by the bottom member 8, and the bottom member 8 is pulled out from the opening 22 at the lower end. Is prevented. The inside of the cylinder of the body member 6 is formed in a perfectly circular cross section, and has a uniform cylindrical shape having the same shape and the same diameter from upper and lower ends. The bottom member 8 includes a heat conductive material 8A made of aluminum and an elastic material 8B made of cold-resistant silicon rubber. Aluminum has a thermal conductivity of 200 W · m -1 / K
Since it is −1 or more, the amount of heat transferred due to the temperature difference is quickly increased. The elastic member 8B has a ring shape and forms a peripheral edge of the bottom member 8, and presses the inner wall of the body member 6 by elastic force to be in close contact with the inner wall. Further, the bottom member 8 can slide on the inner wall of the body member 6 in a liquid-tight manner by a pusher or the like from the lower end opening 22 of the body member 6. The opening plug 9 is made of rubber, and the insertion portion of the opening 21 of the body member 6 is divided into a skirt shape, and can be half-plugged.
【００１３】胴部材６内には凍結乾燥物４が収容され
る。凍結乾燥物４を凍結乾燥用容器２に充填する場合に
は以下の手順で行われる。先ず、胴部材６の上端の開口
部２１から底部材８を胴部材６内に差し込み、下端開口
部の係止顎６Ｂに当接させて完全に設置する。次に、除
菌フィルタに通した凍結乾燥用溶液を胴部材６内に充填
する。凍結乾燥用溶液には、医療用容器１０に充填され
る凍結乾燥物４の必要単位量が電解質溶液等に溶解され
ている。凍結乾燥用溶液の充填後、胴部材６の上端の開
口部２１に開口栓体９に半打栓状態にして取り付ける。
次に、凍結乾燥装置内で胴部材６内の凍結乾燥用溶液を
凍結させる。この場合、底部材８の大部分が熱伝導性材
８Ａからなるため、凍結乾燥用溶液の凍結が製造上、迅
速に行うことができる。また、胴部材６はガラス製で透
明であるため、凍結乾燥用溶液の凍結の程度も確認でき
る。凍結乾燥用溶液の凍結後、次に、凍結乾燥装置内を
減圧にして凍結物中の水分を蒸散、昇華して凍結乾燥物
４を得る。乾燥後、開口栓体９を開口部２１に完全打栓
して凍結乾燥物４を収容した凍結乾燥用容器２を得る。A freeze-dried product 4 is accommodated in the body member 6. When the freeze-dried material 4 is filled in the freeze-drying container 2, the following procedure is performed. First, the bottom member 8 is inserted into the torso member 6 from the opening 21 at the upper end of the torso member 6, and is brought into contact with the locking jaw 6B at the lower end opening to be completely installed. Next, the body member 6 is filled with the freeze-drying solution passed through the sterilization filter. In the freeze-drying solution, a required unit amount of the freeze-dried material 4 to be filled in the medical container 10 is dissolved in an electrolyte solution or the like. After the freeze-drying solution is filled, the opening plug body 9 is attached to the opening 21 at the upper end of the body member 6 in a half-plugged state.
Next, the freeze-drying solution in the body member 6 is frozen in the freeze-drying apparatus. In this case, since most of the bottom member 8 is made of the heat conductive material 8A, the freeze-drying solution can be quickly frozen in manufacturing. In addition, since the body member 6 is made of glass and transparent, the degree of freezing of the freeze-drying solution can be confirmed. After the freeze-drying solution is frozen, the inside of the freeze-drying apparatus is then depressurized to evaporate and sublimate the water in the frozen product to obtain a freeze-dried product 4. After drying, the opener plug 9 is completely plugged into the opening 21 to obtain the freeze-dried container 2 containing the freeze-dried product 4.
【００１４】このような凍結乾燥物４を収容した凍結乾
燥用容器２は、クリーンルームに搬入され、図２及び図
３に示す医療用容器１０に以下の如く使用される。先
ず、医療用容器１０について説明する。図２及び図３に
示す如く、医療用容器１０は、点滴用注射針が刺通され
る排出ポート１８を有する輸液バックである。医療用容
器１０は、インフレーション成形した筒状の透明で柔軟
な可撓性樹脂シートから成形する。樹脂シートは肉厚が
２５０μｍで、内層が厚み５０μｍの直鎖状低密度ポリ
エチレンとポリプロピレンとのブレンド物で、外層が厚
み２００μｍの低密度ポリエチレンの二層構造からな
る。直鎖状低密ポリエチレンは融点が１２６℃で、ポリ
プロピレンは融点が１６０℃である。また、内層は直鎖
状低密度ポリエチレンとポリプロピレンとを６５：３５
の割合でブレンドしたものである。医療用容器１０は上
述の樹脂シートの裁断端部１０Ａが完全熱溶着シールさ
れ、完全熱溶着シール部は固着シール部で殆ど剥離せ
ず、剥離しようとするとシートの破断が生じる非剥離シ
ール部となっている。裁断端部１０Ａには熱溶着シール
の際に排出ポート１８が内部と連通して取付られ、排出
ポート１８内には刺通可能な栓体が配されている。医療
用容器１０の中間部には隔離シール部２０が形成され、
隔離シール部２０は容器１０壁の内層同士が剥離可能に
密着シールされている。裁断端部１０Ａ、隔離シール部
２０で囲まれた内部は容器１０の液収容室１４として形
成され、液収容室１４には溶解液１６が所定量収容され
ている。隔離シール部２０は収容室１４を０．２Ｋｇｆ
／ｃｍ2以上で圧迫した時に剥離するようになってい
る。液収容室１４の溶解液１６は電解質溶液であり、医
療用容器１０と共に高圧蒸気滅菌されている。The freeze-drying container 2 containing the freeze-dried material 4 is carried into a clean room and used in the medical container 10 shown in FIGS. 2 and 3 as follows. First, the medical container 10 will be described. As shown in FIGS. 2 and 3, the medical container 10 is an infusion bag having a discharge port 18 through which a drip injection needle is pierced. The medical container 10 is formed from a tubular, transparent and flexible flexible resin sheet formed by inflation. The resin sheet has a thickness of 250 μm, the inner layer is a blend of linear low-density polyethylene having a thickness of 50 μm and polypropylene, and the outer layer has a two-layer structure of a low-density polyethylene having a thickness of 200 μm. Linear low density polyethylene has a melting point of 126 ° C, and polypropylene has a melting point of 160 ° C. The inner layer is a mixture of linear low density polyethylene and polypropylene 65:35.
Is blended at the ratio of In the medical container 10, the cut end portion 10A of the resin sheet is completely heat-sealed and sealed, and the completely heat-sealed seal portion hardly peels off at the fixed seal portion. Has become. A discharge port 18 is attached to the cut end 10A so as to communicate with the inside at the time of heat welding sealing, and a pierceable plug is disposed in the discharge port 18. An isolation seal portion 20 is formed in an intermediate portion of the medical container 10,
The isolation seal portion 20 is tightly sealed so that inner layers of the wall of the container 10 can be separated from each other. The inside surrounded by the cut end 10A and the isolation seal portion 20 is formed as a liquid storage chamber 14 of the container 10, and a predetermined amount of a solution 16 is stored in the liquid storage chamber 14. The isolation seal section 20 divides the accommodation chamber 14 by 0.2 kgf.
/ Cm 2 or more when pressed. The solution 16 in the liquid storage chamber 14 is an electrolyte solution, and is sterilized by high-pressure steam together with the medical container 10.
【００１５】次に、図２に示す如く、クリーンルーム内
で上記凍結乾燥用容器２の開口栓体９が開口部２１から
取り外され、開口部２１は医療用容器２０の他の裁断端
部１０Ｂ内に挿入される。胴部材６の開口部２２には押
子２３が挿入され、押子２３により底部材８が胴部材６
内で移動させられる。この場合、底部材８の周縁におけ
る弾性材８Ｂが胴部材６の内壁を液密に摺動し、凍結乾
燥物４が塊状のまま胴部材６の開口部２２にから医療用
容器２０内に吐き出される。医療用容器１０は裁断端部
１０Ｂが完全熱溶着シールされ、裁断端部１０Ｂ、隔離
シール部２０で囲まれた内部は容器１０の物収容室１２
として形成され、物収容室１２に必要単位量の凍結乾燥
物４が収容されることとなる。医療用容器１０の裁断端
部１０Ａ及び１０Ｂの熱溶着シールはインパルスシール
機で温度１７０℃で５秒間行い、完全熱溶着シール部と
する。一方、隔離シール部２０の熱溶着シールはインパ
ルスシール機で温度１４０℃で１５秒間行い、剥離可能
なシール部とする。図３に示す医療用容器１０を使用す
る際には、液収容部１４を圧迫するだけで、隔離シール
部２０が剥離開封され、この結果、凍結乾燥物４が溶解
液１６に無菌的に且つ簡単に溶解させることができる。
そして、排出口からの点滴投与が可能となる。Next, as shown in FIG. 2, the opening plug 9 of the freeze-drying container 2 is removed from the opening 21 in the clean room, and the opening 21 is inserted into the other cut end portion 10B of the medical container 20. Is inserted into. A pusher 23 is inserted into the opening 22 of the body member 6, and the bottom member 8 is moved by the pusher 23 to the body member 6.
Moved within. In this case, the elastic material 8B at the peripheral edge of the bottom member 8 slides on the inner wall of the body member 6 in a liquid-tight manner, and the freeze-dried product 4 is discharged into the medical container 20 from the opening 22 of the body member 6 in a lump. It is. The medical container 10 is completely heat-sealed at the cut end 10B, and the inside of the medical container 10 surrounded by the cut end 10B and the isolation seal portion 20 is an object storage chamber 12 of the container 10.
The required unit amount of the lyophilized product 4 is stored in the product storage chamber 12. The heat sealing of the cut ends 10A and 10B of the medical container 10 is performed at a temperature of 170 ° C. for 5 seconds using an impulse sealing machine to form a complete heat sealing seal. On the other hand, the heat sealing of the isolation seal portion 20 is performed at a temperature of 140 ° C. for 15 seconds by using an impulse sealing machine to obtain a peelable seal portion. When the medical container 10 shown in FIG. 3 is used, the isolation seal portion 20 is peeled off and opened simply by pressing the liquid storage portion 14, and as a result, the lyophilized product 4 is aseptically and dissolved in the lysis solution 16. Can be easily dissolved.
And the infusion administration from the outlet becomes possible.
【００１６】次に、本発明に係る凍結乾燥用容器の第二
実施例について説明する。図４は、第二実施例の凍結乾
燥物用容器３０の断面図である。図４に示す凍結乾燥物
容器３０は、一の室に凍結乾燥物が収容され、他の室に
上記凍結乾燥物の溶解液が収容され、上記一の室と他の
室とが使用時に連結しうる複数の室を有する多室容器に
おける上記凍結乾燥物の必要単位量の凍結乾燥を行い、
且つ該必要単位量の上記凍結乾燥物を塊状のまま上記多
室容器内に移し換え可能とした点については第一実施例
の凍結乾燥物用容器２と同様である。また、凍結乾燥用
容器３０の筒状胴部材３２における横断面内形状がほぼ
同形状の均一な筒状に形成されている点も第一実施例の
凍結乾燥物用容器２と同様である。第二実施例の凍結乾
燥用容器３０が第一実施例の凍結乾燥用容器２とことな
る点は以下の点にある。Next, a second embodiment of the freeze-drying container according to the present invention will be described. FIG. 4 is a cross-sectional view of the container for freeze-dried material 30 of the second embodiment. The lyophilized material container 30 shown in FIG. 4 contains a lyophilized material in one room, a lyophilized solution of the lyophilized material in another room, and connects the one room and the other room when used. Perform freeze-drying of the required unit amount of the freeze-dried product in a multi-chamber container having a plurality of chambers,
It is the same as the lyophilized material container 2 of the first embodiment in that the required unit amount of the lyophilized material can be transferred to the multi-compartment container as a lump. Further, the lyophilized product container 2 of the first embodiment is also similar to the lyophilized product container 2 of the first embodiment in that the cylindrical body member 32 of the lyophilization container 30 is formed in a uniform cylindrical shape having a substantially the same cross-sectional inner shape. The difference between the lyophilization container 30 of the second embodiment and the lyophilization container 2 of the first embodiment is as follows.
【００１７】凍結乾燥用容器３０の筒状部材３２はアル
ミニウム製の円筒部材からなり、上端開口部４１及び下
端開口部４２にはリング状の樹脂フィランジ４３、４３
が固着されている。上端開口部４１の開口はゴム製のガ
スケット３４で液密に閉止され、ガスケット３４は筒状
部材３２内での摺動が可能となっている。ガスケット３
４には押子等が装着される螺合穴４４と、半打栓時に蒸
気の排出口となる吐気通路４５が形成されている。下端
開口部４１の開口は底部材用の樹脂シート３６で覆わ
れ、樹脂シート３６はピールシール可能な熱溶着シール
により樹脂フランジ４３に液密に付着されている。樹脂
シート３６は樹脂フランジ４３と同様な樹脂素材からな
り、樹脂素材はポリエチレンである。また、樹脂シート
３６は３００μｍの厚さで、外部と内部との熱量の移動
が十分になされるようになっている。胴部材３２内には
凍結乾燥物４が収容される。凍結乾燥物４を凍結乾燥用
容器３０に充填する場合には以下の手順で行われる。先
ず、胴部材３２の下端開口部４２の樹脂フランジ４３に
樹脂シート３６を熱溶着シールし、下端開口を閉止す
る。次に、除菌フィルタに通した凍結乾燥用溶液を胴部
材３２内に充填する。凍結乾燥用溶液の充填後、胴部材
３２の上端の開口部２１にガスケット３４を半打栓状態
にして取り付ける。The cylindrical member 32 of the freeze-drying container 30 is formed of a cylindrical member made of aluminum, and has ring-shaped resin fillets 43, 43 at the upper end opening 41 and the lower end opening 42.
Is fixed. The opening of the upper end opening 41 is closed in a liquid-tight manner by a rubber gasket 34, and the gasket 34 can slide within the tubular member 32. Gasket 3
4, a screw hole 44 in which a pusher or the like is mounted, and a gas discharge passage 45 serving as a vapor discharge port when the plug is half-plugged are formed. The opening of the lower end opening 41 is covered with a resin sheet 36 for a bottom member, and the resin sheet 36 is liquid-tightly attached to the resin flange 43 by a heat-sealing seal capable of peel sealing. The resin sheet 36 is made of the same resin material as the resin flange 43, and the resin material is polyethylene. Further, the resin sheet 36 has a thickness of 300 μm, so that the amount of heat transfer between the outside and the inside is sufficiently performed. The freeze-dried material 4 is accommodated in the body member 32. When the freeze-dried product 4 is filled in the freeze-drying container 30, the following procedure is performed. First, the resin sheet 36 is heat-sealed and sealed to the resin flange 43 at the lower end opening 42 of the body member 32, and the lower end opening is closed. Next, the body member 32 is filled with the freeze-drying solution passed through the sterilization filter. After filling with the freeze-drying solution, the gasket 34 is attached to the opening 21 at the upper end of the body member 32 in a half-tapped state.
【００１８】次に、凍結乾燥装置内で胴部材３２内の凍
結乾燥用溶液を凍結させる。凍結乾燥用溶液の凍結後、
次に、凍結乾燥装置内を減圧にして凍結物中の水分を蒸
散、昇華して凍結乾燥物４を得る。乾燥後、ガスケット
３４を開口部４１に完全打栓して凍結乾燥物４を収容し
た凍結乾燥用容器３０を得る。このような構成の凍結乾
燥用容器３０にあって、医療用容器内に充填する際に
は、ガスケット３４の螺合穴４４にプランジャ等を取付
け、また、樹脂シート３６を剥離して胴部材３２の下端
開口部４２を開口する。そして、下端開口部４２を医療
用容器内に挿入して移し換えを行う。従って、凍結乾燥
用容器３０は第一実施例の凍結乾燥用容器と同様な作
用、効果を奏する。上記各実施例において、胴部材の内
壁面を胴部材自身の素材を滑面として形成したが、かか
る内壁面に易離型性被膜処理等をして凍結乾燥物４が栓
体或いは底部材の摺動時に完全に取れるようにしても良
い。上記実施例では、医療用容器は複数の室が一体形成
されたものであったが、室ごとに別体容器として形成し
てあっても良い。Next, the freeze-drying solution in the body member 32 is frozen in the freeze-drying apparatus. After freezing the lyophilization solution,
Next, the inside of the freeze-drying apparatus is decompressed to evaporate and sublimate the moisture in the frozen matter to obtain a freeze-dried substance 4. After drying, the gasket 34 is completely plugged into the opening 41 to obtain the lyophilization container 30 containing the lyophilized product 4. In the freeze-drying container 30 having such a configuration, when filling the medical container, a plunger or the like is attached to the screw hole 44 of the gasket 34, and the resin sheet 36 is peeled off to form the trunk member 32. The lower end opening 42 is opened. Then, the lower end opening 42 is inserted into the medical container for transfer. Therefore, the freeze-drying container 30 has the same operation and effect as the freeze-drying container of the first embodiment. In each of the above embodiments, the inner wall surface of the body member is formed as a smooth surface using the material of the body member itself. It may be possible to completely remove it during sliding. In the above embodiment, the medical container has a plurality of chambers formed integrally, but may be formed as separate containers for each chamber.
【００１９】[0019]
【発明の効果】以上説明したように本発明に係る凍結乾
燥物用容器は、一の室に凍結乾燥物が収容され、他の室
に上記凍結乾燥物の溶解液が収容され、上記一の室と他
の室とが使用時に連結しうる複数の室を有する多室容器
における上記凍結乾燥物の必要単位量の凍結乾燥を行
い、且つ該必要単位量の上記凍結乾燥物を塊状のまま上
記多室容器内に移し換え可能とした凍結乾燥用容器であ
り、筒状胴部材と、該胴部材内を液密に摺動しうる底部
材或いは開口栓体とからなり、上記筒状胴部材は横断面
内形状がほぼ同形状の均一な筒状に形成されているの
で、医療用容器における必要単位量の凍結乾燥物を塊状
のまま医療用容器に移し換えが確実にでき、また容器自
体も簡単に製造できる。As described above, in the container for freeze-dried material according to the present invention, the freeze-dried material is stored in one chamber, and the solution of the freeze-dried material is stored in the other chamber. Performing freeze-drying of a required unit amount of the lyophilized product in a multi-compartment container having a plurality of chambers in which a room and another chamber can be connected at the time of use, and keeping the lyophilized product in the required unit amount in a lump A freeze-drying container capable of being transferred into a multi-chamber container, comprising: a cylindrical body member; and a bottom member or an opening plug that can slide in the body member in a liquid-tight manner. Is formed in a uniform cylindrical shape with almost the same cross-sectional inner shape, so that the required unit amount of lyophilized material in the medical container can be reliably transferred to the medical container as a lump, and the container itself Can also be easily manufactured.
【図面の簡単な説明】[Brief description of the drawings]
【図１】図１は本発明に係る凍結乾燥用容器の第一実施
例の正断面図である。FIG. 1 is a front sectional view of a first embodiment of a freeze-drying container according to the present invention.
【図２】図２は第一実施例の凍結乾燥用容器から医療用
容器に移し換える際の製造工程を示す医療用容器の正面
図である。FIG. 2 is a front view of the medical container showing a manufacturing process when transferring from the freeze-drying container to the medical container in the first embodiment.
【図３】図３は図２に示す医療用容器の正面図である。FIG. 3 is a front view of the medical container shown in FIG. 2;
【図４】図４は本発明に係る凍結乾燥用容器の第二実施
例の正断面図である。FIG. 4 is a front sectional view of a second embodiment of the freeze-drying container according to the present invention.
２、３０ 凍結乾燥物用容器 ４ 凍結乾燥物 ６ 胴部材 ８ 底部材 ９ 開口栓体 １０ 医療用容器 2, 30 Freeze-dried container 4 Freeze-dried product 6 Body member 8 Bottom member 9 Opening plug 10 Medical container
Claims (4)
に上記凍結乾燥物の溶解液が収容され、上記一の室と他
の室とが使用時に連結しうる複数の室を有する多室容器
における上記凍結乾燥物の必要単位量の凍結乾燥を行
い、且つ該必要単位量の上記凍結乾燥物を塊状のまま上
記多室容器内に移し換え可能とした凍結乾燥用容器にお
いて、筒状胴部材と、該胴部材内を液密に摺動しうる底
部材或いは開口栓体とからなり、上記筒状胴部材は横断
面内形状がほぼ同形状の均一な筒状に形成されているこ
とを特徴とする凍結乾燥用容器。1. A lyophilized product is accommodated in one room, a lyophilized solution of the lyophilized material is housed in another room, and a plurality of chambers that can be connected to one room and another room when used are used. Freeze-drying the required unit amount of the lyophilized product in a multi-compartment container having, and a freeze-drying container capable of transferring the required unit amount of the lyophilized product into the multi-compartment container as a lump, The tubular body member includes a bottom member or an opening plug that can slide in the body member in a liquid-tight manner, and the tubular body member is formed in a uniform tubular shape having substantially the same cross-sectional inner shape. A freeze-drying container characterized in that:
とする請求項１記載の凍結乾燥用容器。2. The freeze-drying container according to claim 1, wherein said body member is made of glass.
記底部材の中央部が熱伝導性材で上記底部材の周縁が弾
性材からなることを特徴とする請求項１又は２記載の凍
結乾燥用容器。3. The bottom member slides in the trunk member, a central portion of the bottom member is made of a heat conductive material, and a peripheral edge of the bottom member is made of an elastic material. The container for lyophilization according to the above.
上記底部材は上記胴部材の下端開口から剥離可能な樹脂
シートとからなることを特徴とする請求項１又は２記載
の凍結乾燥用容器。4. The opening plug body slides in the body member,
The freeze-drying container according to claim 1, wherein the bottom member is formed of a resin sheet that can be peeled from a lower end opening of the body member.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP9062047A JPH10234822A (en) | 1997-02-28 | 1997-02-28 | Container for lyophilization |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP9062047A JPH10234822A (en) | 1997-02-28 | 1997-02-28 | Container for lyophilization |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| JPH10234822A true JPH10234822A (en) | 1998-09-08 |
Family
ID=13188867
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP9062047A Pending JPH10234822A (en) | 1997-02-28 | 1997-02-28 | Container for lyophilization |
Country Status (1)
| Country | Link |
|---|---|
| JP (1) | JPH10234822A (en) |
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2009189492A (en) * | 2008-02-13 | 2009-08-27 | Hosokawa Yoko Co Ltd | Lyophilization container and manufacturing method of lyophilization container |
| US7966746B2 (en) * | 2006-04-24 | 2011-06-28 | Medical Instill Technologies, LLC | Needle penetrable and laser resealable lyophilization method |
| US8272411B2 (en) | 2003-04-28 | 2012-09-25 | Medical Instill Technologies, Inc. | Lyophilization method and device |
| WO2013132891A1 (en) * | 2012-03-08 | 2013-09-12 | ソニー株式会社 | Method for producing microchip for use in nucleic acid amplification reaction |
-
1997
- 1997-02-28 JP JP9062047A patent/JPH10234822A/en active Pending
Cited By (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US8272411B2 (en) | 2003-04-28 | 2012-09-25 | Medical Instill Technologies, Inc. | Lyophilization method and device |
| US7966746B2 (en) * | 2006-04-24 | 2011-06-28 | Medical Instill Technologies, LLC | Needle penetrable and laser resealable lyophilization method |
| US8171652B2 (en) | 2006-04-24 | 2012-05-08 | Medical Instill Technologies, Inc. | Penetrable and resealable lyophilization method |
| US9222728B2 (en) | 2006-04-24 | 2015-12-29 | Medinstill Development Llc | Penetrable and resealable lyophilization device |
| JP2009189492A (en) * | 2008-02-13 | 2009-08-27 | Hosokawa Yoko Co Ltd | Lyophilization container and manufacturing method of lyophilization container |
| WO2013132891A1 (en) * | 2012-03-08 | 2013-09-12 | ソニー株式会社 | Method for producing microchip for use in nucleic acid amplification reaction |
| JPWO2013132891A1 (en) * | 2012-03-08 | 2015-07-30 | ソニー株式会社 | Method for producing microchip for nucleic acid amplification reaction |
| US9545630B2 (en) | 2012-03-08 | 2017-01-17 | Sony Corporation | Method for fabricating microchip for nucleic acid amplification reaction |
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