JP4145400B2

JP4145400B2 - Switching-execution-type solution manufacturing apparatus by replacing units for opening and draining units in use in predetermined order

Info

Publication number: JP4145400B2
Application number: JP24257298A
Authority: JP
Inventors: 田泰治堀
Original assignee: Taisei Kako Co Ltd
Current assignee: Taisei Kako Co Ltd
Priority date: 1998-08-13
Filing date: 1998-08-13
Publication date: 2008-09-03
Anticipated expiration: 2018-08-13
Also published as: JP2000062855A

Description

【０００１】
【発明の属する技術分野】
本発明は２個以上の換装可能ユニット即ち、用時開封ユニット(ユニットＵ1)及び排液ユニット(ユニットＵ2)が所定の順序で液体媒体収容部に冠装されるユニット換装型の製造装置に関する。詳しくは、用時開封ユニットとして、液体媒体収容部に組込用の封止膜穿孔機構、緩衝部及び上段外筒を組合わせたユニットを液体媒体収容部に冠装した先行態様の製造装置及びこの用時開封ユニットを排液ユニット(主としてポンプユニット)に換装した後続態様の製造装置に関する。
【０００２】
【従来の技術】
既に、単筒でその下端域が封止膜で閉塞されて液体媒体を収容し、その封止膜を穿孔又は破壊(本発明では「穿孔」と総称する)することによって開口する液体媒体の用時吐出型容器又は略二重筒構造体の何れかがその下端域で封止膜によって閉塞されて液体を収容すると共に、他方がその封止膜を穿孔する手段と連動した構造の用時開封調製型容器は種々提案されている。
【０００３】
例えば、実開平７−２２９８０号公報(資１)には、略有底単筒型の用時開封型液体収容部と溶質収容部とが同一容器内に区分された容器が記載されている。この区分容器はその内壁中段域に内方向けの環状張出しを備えると共に、その上端開口部周縁に載置された可撓性の部分球面体の中心から下方向けに伸びる棒状の開栓体及びその下端に脱離可能に装着された盆型の栓部が容器内壁中段域の環状張出しの開口に密嵌された形態が示されている。
【０００４】
この容器においては、容器の下半域に溶解液が収容され、上半域に溶解用粉粒体が収容されている点で、従来既知の容器とは異なる。また、一旦開栓体が押込まれた場合には、その下端域に装着されている栓部が脱離して器底に沈み、次に容器を傾けて収容されている液体を注ぎ出す段階においては、容器の内壁中段から突設された環状突条によって栓部が堰き止められて容器の開口へ転落しない。
【０００５】
本発明における開封手段と一見似通った開封手段を備えた従来の容器においては、開栓体と栓部とが当初は相互に連結されているものの、開栓体の押下げに起因して両者間の連結関係が切れ、栓部は容器底に沈下する。この従来の開封手段においては、容器底に沈下した栓部は内容物が用い尽くされるまでは容器内に留まる外は無い。
【０００６】
しかし、脱離した栓部が沈下するか否かは容器内に収容された液体との密度差に負うものであるから、栓部が如何なる場合においても沈下する様に材質等を設定することは容易ではない。それに加えて、沈下を助ける芯材とその外側を取り囲んで芯材と液体との接触を避ける包囲材との親和性等及び包囲材の液体に対する耐久性等においても種々の問題が内在し得る。
【０００７】
しかも、前記の資１においては、容器内において液体が栓部よりも下部に、溶質Ｓが栓部よりも上部に、それぞれ収容されている。処が、この収容方式では、中間を閉塞して両者の接触を阻止している栓部が脱離した場合にも、上部から粉体又は顆粒状等の固形溶質Ｓの全量が下部の液体中へ常に迅速に流下することは期待し難い。即ち、粉体には、その一般に複雑な形状、低い嵩密度(見掛け密度)に加えて、吸湿等に起因する流動性低下等が顕著に現われる。この状況は特に、小粒径の粉体又は流体の場合に、往々にして無視し難い程度に達する。
【０００８】
その結果として、折角開封したに拘わらず、所望の溶液が調製されないという事態も生じ、その原因が主に保管条件に帰せられるとはいえ、実際に如何なる場合でも必要な保管条件を実現することは意外に難しい。
【０００９】
【発明が解決しようとする課題】
本発明の目的は従来の一見類似の開封手段に伴う種々の問題点を解消し、栓部の離脱による開口後には容器内に栓部等の慰留物その他を生じない様に改良すると共に、各段階即ち、開封段階、溶質溶解段階、溶液取出し段階のそれぞれの機能を同一の容器に組付けることに起因する複雑化、作動の確実性低下、大型化、重量増加及びそれらから派生する携帯性低下等を防止又は軽減することにある。
【００１０】
【課題を解決するための手段】
本発明は上記の目的を実現する手段として、上記の開封段階及び溶質溶解段階の機構を組込んだ用時開封調製ユニットを先ず溶質収容部に冠装し、次にこのユニットを溶液排出段階で排液ユニットに換装できる様に構成されている。
すなわち、本発明に係るユニット換装型の溶液等の製造装置は、溶質収容部３に密嵌
された液体媒体収容部１に冠装された用時開封ユニットＵ１がその機能終了後に排液ユニットＵ２に換装されて、その機能が実行される構成のユニット換装型の溶液等の製造装置であって、
前記用時開封ユニットＵ１は、異径管状体の液体媒体収容部１と、棒状の封止膜穿孔部材１２と、前記液体媒体収容部１の外側に着脱自在に装着される上段外筒２と、前記封止膜穿孔部材１２を懸吊するドーム状部１４とを備え、
前記排液ユニットＵ２は、ポンプ機構５と、前記ポンプ機構５を固定するとともに前記液体媒体収容部１の外側に着脱自在に装着される支持筒部６と、ポンプ作動を行う為の押圧頭部５１とを備え、
先行態様として、前記用時開封ユニットＵ１の前記液体媒体収容部１がその下段出口を封止膜１３、３３で封止され、その上端開口を前記ドーム状部１４で密閉され、該ドーム状部１４がその内部に前記封止膜穿孔部材１２を把持及び懸吊し、前記液体媒体収容部１の下段域が異径接続管４の上管部に密嵌され、前記異径接続管４の下管部には封止膜保持部材３２が内嵌されると共に、その環状張出し３２ｂに封止膜３３が保持され、この封止膜保持部材３２が前記溶質収容部３の開口に密嵌されている態様及びそれに次ぐ後続態様として、前記ドーム状部１４、前記封止膜穿孔部材１２及び前記上段外筒２に代えて、前記排液ユニットＵ２の排液機構が異径接続管４の上管部に内嵌されて溶質収容部３に収容された溶液を排出する態様が完成されることを特徴としている。
【００１１】
【発明の実施の形態】
本発明の用時開封ユニット及び排液ユニット換装型の溶液等製造装置(以下、「本発明の製造装置」と称することがある)の形状及び構造を以下に図面に基づいて具体的に説明する。なお、本発明の図面においては、「上下左右前奥表裏」等は説明の便宜上の表現である。
【００１２】
＜ユニットＵ1(用時開封ユニット)＞
図１で統括される態様は本発明の製造装置を構成する先行態様であって、図１(Ａ)は用時開封ユニット(以下、「ユニットＵ1」と略称することがある)が装着された液体媒体収容部１が溶質収容部に装着された状態の模式的縦断面図である。また、図１(Ｂ)は封止膜保持部材３２、封止膜３３、溶質収容部３の上端域及びカシメ部材３５の相互間における位置関係を示す模式的部分切開拡大断面図である。
【００１３】
また、図２で包括される態様は本発明の製造装置を構成する後続態様である排液ユニット(ユニットＵ2)が溶質収容部に接続された状態の模式的縦断面図に示されており、図２(Ａ)は本発明の製造装置において、開封用管状体が封止膜を穿孔した状態を示す模式的縦断面図であり、図２(Ｂ)は図１の製造装置におけるユニットＵ1がユニットＵ2に換装された状態を示す模式的縦断面図である。
【００１４】
＜液体媒体収容部１＞
図１(Ａ)において、１で表わされる異径管状体は溶質を溶解又は分散する液体媒体収容部であって、略円筒状でその下端域が移行域１rで縮径されながら下端開口１mへ到るが、その開口１mは封止膜１３で水密に閉塞されている。該収容部1の下段側壁からは外方へ向けて、突起又は突条(以下、「突部」と総称することがある)１bが突設されており、この突部１bが後述の異径接続管４に内嵌された際に自然には離脱しない様に異径接続管４の上部管４s内壁に備えられた凹陥又は凹溝(以下、「凹部」と総称することがある)４uに係合する。溶解液収容部１の外壁上半部には係合手段として例えば、螺条１sが付設されている。また、液体媒体収容部１が異径接続管４内で回動することを防止する為に、液体媒体収容部１の下段外壁から縦鰭１fが突設されて、異径接続管４の上管部４s内壁から突設された縦鰭４fと係合する。
【００１５】
図１(Ｂ)においては、封止膜保持部材３２の大径孔３２h中段に位置する環状張出し３２bの頂面には封止膜３３が水密に溶着されて溶質収容部３の内部を外界から遮断している。更に、封止膜３３は環状張出し３２bの頂面に溶着(融着)され、更に封止膜３３の上方からもカシメ部材３５が封止膜３３の周縁域に溶着されると共にそれを押圧して、封止膜３３の剥離を防止している。このカシメ部材３５は断面略コの字型の部材であって、その外輪部３５xが封止膜保持部材３２の外周壁３２xに、その天板部３５tが頂面３２tを及びその内輪部３５iが大径孔３２hの内壁３２iに接触して、封止膜保持部材３２を一連に覆うと共に、その内輪部３５iの下端縁で封止膜３３の上面外周域に融着されている。また、上記の封止膜保持部材３２の中心部を貫通する通液孔３４を閉塞する封止膜３３は使用時(用時)まではその儘で温存されている。
【００１６】
この封止膜３３と封止膜保持部材３２との融着体に要求される性能は通常行なわれる凍結乾燥即ち、溶質を溶解した溶液又は分散した分散液が収容された後に行なわれる高真空印加及びそれに続く低温にも耐えて、封止膜の剥離及び破断等の何れをも生じさせないことである。詳しく説明すれば、凍結乾燥はそれに先だって容器内に強度の減圧(高真空)処理が行なわれるから、仮に容器自体は減圧処理に耐え得ても、封止膜が耐え兼ねて破断、亀裂又は剥離等を生ずれば、凍結乾燥に耐えたことにはならない。
【００１７】
＜溶質収容部３＞
図１において３で表わされる容器は袴部付倒立円錐形の溶質収容部であって、大径の上端開口３hから下方へ向けて通常は中段域まで筒状域に続き、下段域で先細りに形成されると共に、下段域の外側を袴部３xが取囲んで自立性を確保し、その上端開口３hには封止膜保持部材３２が内嵌されている。
【００１８】
この封止膜保持部材３２は略円筒状の短い筒状の栓体であって、その上端域が外側へ張出してフランジ３２fを形成し、封止膜保持部材３２の上方から下方へ向けて穿設された開口から中段までは大径孔３２hに形成され、中段の短区間は稍縮径されて環状張出し３２bが形成され、環状張出し３２bに囲まれた開口３４から下端向けに次第に拡径して錐形孔に形成され、頂面から下端まで一貫した通液路３４が形成されている。
【００１９】
本発明の製造装置の使用態様は溶質収容部３内において凍結乾燥処理が行なわれない態様即ち、溶質収容部内に収容された好ましくは粉体状又は顆粒状の溶質を液体媒体によって溶解又は分散し、調製された溶液又は分散液をユニットＵ1に代わって換装されたユニットＵ2によって、排出する態様をも包含する。
【００２０】
図１の本発明の製造装置を構成するユニットＵ1は上述の封止膜穿孔部材１２tを液体媒体収容部１に装着する為の上段外筒２で主として構成されるが、それに加えてドーム状部１４等が組み付けられている。図１においては、ユニットＵ1をその外壁上段に装着した液体媒体収容部１と溶質収容部３とは異径接続管４によって自然には離脱しない程度に接続されている。
【００２１】
＜異径接続管４＞
図１の異径接続管４は上半部が稍小径管部及び下半部が稍大径管部で形成された構成である。この異径接続管４では、その中段域の内壁から内側へ張出した環状棚４kを境にして上部域を上管部４sと呼び、下部域を下管部４bと呼ぶ。この上管部４sは液体媒体収容部１の外壁下段部を自然には脱離しない様に内嵌収容する為に、その内壁にアンダーカット(凹陥又は凹溝)４uを備えている。他方、下管部４bはその内部に、基本的には溶質収容部３を自然には離脱しない様に収容する。この収容時には、溶質収容部３の開口部３mには既に封止膜保持部材３２が密嵌され、更にその環状張出し部３２bの頂面に封止膜３３の周縁部が溶着(融着)された状態であるから、下管部４bの内壁中段又は下段部には抜出し防止用の突部４fが突起の場合には２ヶ所以上通常４ヶ所以上突設され、突条の場合には弧状に２個以上若しくは全周に亙って突設されている。
【００２２】
＜封止膜穿孔部材１２＞
次に、図１における本発明の製造装置を構成する液体媒体収容部１に接続された溶質収容部３内で実際に収容物を混合して所望の溶液等を調製する為には、液体媒体収容部１内に収容された液体媒体Ｌと、この液体媒体収容部１に接続された溶質収容部３に収容された溶質Ｓとを接触させることが必要である。この接触を行なわせるには、両者を隔てる２枚の封止膜を何れも穿孔して液体流通路を開く手段を要することから、ユニットＵ1は封止膜穿孔部材１２を装備している。
【００２３】
この封止膜穿孔部材１２は上段外筒(後出)２の頂部から上下動可能に懸吊された細長い棒状の幹部１２tの下端域に円板型、角板型等のフランジ部１２fを備え、このフランジ部１２fよりも下端側数ヶ所には、フランジ部１２fと幹部１２tとを連絡する縦鰭１２bが装着されている。
【００２４】
この縦鰭１２bの寸法、形状及び配置は封止膜３の穿孔を容易にすると共に、穿たれた孔の形状を穿孔後に装着される吸上げポンプ(後出)から容器底部まで挿入される溶液吸上げ管(後出)５６の進入を妨げない様に穿孔し得ることが重要である。図１の実施態様では、この縦鰭１２bは幹部１２tの周囲に放射状に４枚設置され、その形状は直角三角形であって、斜辺が幹部１２tの先端からフランジ部１２fの外周へ到る斜線上に一致するものである。
【００２５】
＜上段外筒２＞
図１の上段外筒２は本発明の製造装置を構成するユニットＵ1の主要部を担う部材で、上述の液体媒体収容部１内に上述の封止膜穿孔部材１２を上下動可能に懸吊する手段として、上段外筒２が液体媒体収容部１に着脱可能に外嵌されている。
【００２６】
図１における上段外筒２は略円筒状体であって、その内壁中段域から環状突条２pが突設され、その内壁下段域には螺条２sが付設されている。上段外筒２において環状突条２pよりも上に伸びる部分２gはドーム状部１４が不時の外力印加によって押圧されて、封止膜が穿孔される事態を防止する役割を果たす。
【００２７】
この螺条２sの役割は上述の液体媒体収容部１の上段域外壁に付設された螺条１sと螺合して上段外筒２を液体媒体収容部１から脱離させない様にすることにある。上段外筒２の別異付帯形状としては、上段外筒２の外壁には着脱回動を支援する為のローレット又は細かな縦突条２rが刻設されている。
【００２８】
この上段外筒２の第１の役割はドーム状部１４の脱離を防止する為に、液体媒体収容部１の上端開口縁１eに載置されたドーム状部１４の下端から周囲に張出したフランジ部１４fを環状突条２pの下面で圧下して液体媒体収容部１の上端開口縁１eに密着させることにある。
【００２９】
上段外筒２の第２の役割はそのドーム状部１４tから封止膜穿孔部材１２を懸吊することにある。
<<ドーム状部１４の役割>>
ドーム状部材１４の第１の役割である封止膜穿孔部材１２を懸吊する役割を果たす為にドーム状部１４の内部には下方から上方向けに比較的長い(深い)支承洞１４aが設けられている。この支承洞１４a内には、封止膜穿孔部材１２の稍拡径された頭部１２hが挿入され、その封止膜穿孔部材頭部１２hが支承洞１４aに把持されて封止膜穿孔部材１２の脱離が防止される。
【００３０】
このドーム状部１４は通常はエラストマー製又は熱可塑性エラストマー製の略ドーム状部１４t、その周縁から下方へ伸びるスカート状部１４s、その下端から外側へ張出すフランジ部１４fとで形成されている。
【００３１】
このドーム状部１４の第２の役割は液体媒体収容部１内に収容された液体媒体Ｌのオートクレーブ滅菌(１２１℃×３０min)を行なう際にも、液体媒体Ｌから発生する蒸気による内圧上昇を吸収することによって、それ自身の破裂も封止膜の破裂も生じさせないことにある。この内圧上昇は収容される液体媒体Ｌの種類によって大幅に異なるが、それでもなお、このドーム状部１４には滅菌後に液体媒体収容部１を当初と実質的に同一に保持し得ることが要求される。
【００３２】
＜封止膜１３又は３３＞
本発明の製造装置の先行態様においては、液体媒体収容部１の下端開口１５を閉塞する封止膜１３及びその下面に接触する別異の封止膜として、溶質収容部３の開口３ｍに内嵌された封止膜保持部材３２の上面から下方へ向けて中段まで穿設された大径孔３２hの下端に位置する環状張出し域３２bを通常時(不用時)には閉塞する為に、環状張出し域３２bの頂面に溶着固定された封止膜３３が用いられている。この封止膜３３の周縁域には更に、カシメ部材３５の内輪部３５i下端が溶着されると共に、それによって押圧されて封止膜３３の剥離が二重に防止されている。なお、図１(Ｂ)においては説明の便宜上から、封止膜３３が封止膜保持部材３２の環状張出し部３２b頂面から仮に分離した状態で図示されている。
【００３３】
封止膜１３の装着形態は通常行なわれる樹脂コート層との融着で足りる。この場合に発生する内圧上昇の大部分はドーム状部材１４の膨張によって吸収されるからである。
【００３４】
処が、溶質収容部３を外界から遮断する封止膜３３の装着形態は遥かに堅固であることが要求される。即ち、溶質収容部３には凍結乾燥段階で印加される高真空(高減圧)によっても、封止膜３３が破裂又は亀裂等を生じない様に、高真空を吸収してその破壊的作用が封止膜３３に及ばない様にするだけの補償部分が他に設けられていないからである。従って、溶質収容部３においては、封止膜３３の装着は前述の通りに遙かに入念である。
【００３５】
この封止膜３３の材質としては各種のものを採用し得るが、通常は金属箔特にアルミニウム箔又はこの少なくとも片面を樹脂でコートした積層箔が用いられる。本発明においては、封止膜１３及び３３の双方共に好適にはアルミニウム箔に低密度ポリエチレン(LDPE)がコートされた積層箔であるが、封止膜３３の方が厚いことが好ましい。
【００３６】
図２で包括される態様において、図２(Ａ)は本発明の製造装置の使用段階１であって、液体媒体収容部１が溶質収容部３に密装されていると共に、前者にユニットＵ1が外嵌された複合体に対して、上方から押圧力が印加された状態を示す(下向きの白抜き矢印及び英字「ＰＵＳＨ」で表示)模式的縦断面図である。図２(Ｂ)は本発明の使用段階２であって、ユニットＵ1に代えてユニットＵ2即ち、調製された溶液を容器外へ排出する(取出す)為の排液ユニットが液体媒体収容部１に外嵌された状態を示す。
【００３７】
＜発明の作用及び効果＞
本発明の製造装置の使用時における態様について以下に説明する。
図２(Ａ)によれば、使用に際しては本発明の製造装置に外方から押圧力を印加すること及びその結果、上段外筒２の上面に気密に装着されていたドーム状部１４及びそれから懸吊されていた封止膜穿孔部材１２が下方へ移動して２枚の封止膜１３及び３３を穿孔開封した後に、更に溶質収容部３の開口３mに内嵌された封止膜保持部材３２の下段に位置する下側開口部３４へ進入している。
【００３８】
この状態においては、液体媒体Ｌは同一容器３内で溶質Ｓと充分に接触しており、更に溶解度合い又は分散度合いを向上させることが望ましい場合には、本発明の区分容器を左右に振り混ぜる等の措置も有益である。
【００３９】
図２(Ｂ)によれば、当初の溶質収容部３内で調製された所期の溶液を容器外へ排出する(取出す)為に当初(出荷段階で)は装着されていたユニットＵ1即ち、上段外筒２、それに装着されていた封止膜穿孔部材１２及びドーム状部１４からなるユニットＵ1を取外し、それに代えてエアレス型ポンプ機構を主体とするユニットＵ2が冠装されている。
【００４０】
このユニットＵ2は大まかには、上段外筒２と類似形状の支持筒部６の上端にエアレス型ポンプ機構５の幹部５４が固定された構造体である。詳しくは、ユニットＵ2を構成する支持筒部６はその上端に天板部６２を備え、天板部６２の略中央にはポンプ機構５を嵌入させる為の嵌入孔６hが設けられたもので、この嵌入孔６hには、ポンプ機構５の幹部５４の下部である第１幹下部５４d1、その下方に伸びる第２幹下部５４d2及びその下方に伸びる第３幹下部５４d3が嵌入固定されている。
【００４１】
この嵌入固定においては、ポンプ機構５の幹部５４下端から周囲へ張出すフランジ部５４fが支持筒部６の天板部６２の下に位置し、フランジ部５４fの下に下押え板７が位置し、この下押え板７が用時開封型の液体媒体収容部１の上端縁に載置された状態で、フランジ部５４fを挟時する方式が採用されている。
【００４２】
支持筒状側壁部６１はその内壁に係合手段として雌螺条が付設され、その下端では開放されている。この内壁に付設された雌螺条は用時開封型の液体媒体収容部１の外壁に付設された係合手段としての雄螺条と係合して、ユニットＵ1又はＵ2の脱離を阻止すると共に、ユニットを容易に交換できるようにする役割を果たす。更に、支持筒側壁部６１の外壁にはローレット又は多数の低い縦突条６１rが突設されている。その役割はこの支持筒部６の着脱を容易にすることにある。
【００４３】
図２(Ｂ)に例示されたポンプ機構５はエアレス型のスプレーポンプであって、ポンプ幹部５４が支持筒部６の天板６２によって支持され、その内部に可動弁管５３が挿入され、可動弁管５３の上端域にはポンプ作動の為の押圧頭部５１が押圧頭部内筒５１iを介して冠装されている。また、この押圧頭部５１内には管路が形成されており、この管路はスプレーヘッド部５２へ連通する。
【００４４】
押圧頭部５１はその頂面５１tへ押圧力(圧下力)が印加されることによって下降し、その際に可動弁管５３を押し下げる結果、ポンプ機構５内の空気が外部へ排出されて溶質収容部３内の溶液等を吸上げる。この吸上げられた溶液が溶液吸上げ管５６内を上昇してスプレーヘッド５２から噴霧されることになる。
【００４５】
本発明のユニットＵ2に用いられるポンプ機構５は常用のエアレス型機構の中から適宜選択でき、例えばピストンポンプ、プランジャーポンプ又はエアゾール等の吸上げに用いられる吸上げポンプ等の何れでも十分であるが、このポンプ機構５における溶液吸上げ管５６は溶質収容部３の最深部まで到達していることが有用である。
【００４６】
本発明の製造装置にその後続態様として換装されるポンプ機構がエアレス型であることは本発明においては重要である。即ち、溶液等の排出によって溶質収容部３内に生ずる減圧状態を補償する為に外部から空気が取込まれることは各種の汚染をも同伴導入する可能性を生ずる点で好ましくない。
【００４７】
ここで、溶質収容部３の内部下段が略錐形に形成されていることが溶液吸上げ管の最深部到達と相俟って溶質収容部３内で調製された溶液を殆ど残さずに取り出すことに寄与する。
【００４８】
【発明の効果】
本発明の製造装置即ち、用時開封ユニットＵ1が装着された液体媒体収容部１と溶質収容部３とからなる先行態様及びそのユニットＵ1が後続態様へ変更する為にユニットＵ2(排液ユニット)で換装され得る製造装置によれば、下掲の各種効果を奏することができる：
(１)液体媒体Ｌを容器に収容した状態でオートクレーブ滅菌処理に付することができ、封止膜の破断等が生ずる虞も殆ど無い；
(２)溶質Ｓの溶液又は分散液を溶質収容部に収容して減圧下で凍結乾燥後に封止膜で覆われたゴム栓の本打栓を行なう作業をオートクレーブ滅菌処理とは全く独立にしかも並列に実行(並列処理)できる。
(３)液体媒体収容部の開封及び溶液等の調製を行なう場合のユニットＵ1を溶液調製後に、調製された溶液等を容器外へ排出する為のユニットＵ2に容易に換装できる方式を完成した。
【００４９】
【実施例】
以下に、実施例によて本発明の製造装置を更に具体的に説明する。しかし、本発明はこれらの実施例によっては限定されない。
【００５０】
【実施例１】
本発明の液体媒体収容部１をプロピレン結晶性単独重合体製、上段外筒２を同一のプロピレン結晶性単独重合体製、溶質収容部３を非晶質オレフィン共重合体[縮合環構造を繰返し重合単位とする1-オレフィンとの非晶質共重合体]製、異径接続管４をプロピレン結晶性共重合体製、封止膜保持部材３２をブチルゴム[略称:IIR]製、封止膜穿孔部材１２をプロピレン結晶性単独重合体製、ドーム状部１４をブチルゴム製、封止膜１３及び３３をアルミニウム箔の低密度ポリエチエレン(LDPE)コート物並びに、排液ユニットＵ2を構成する機構であるポンプ機構５をプロピレン結晶性単独重合体製及びポンプ機構５の脚部５５をプロピレン結晶性重合体製又は高密度ポリエチエレン(HDPE)製に設定して、本発明の製造装置及びその両機能を担うユニットＵ1及びＵ2を作成した。
【００５１】
上記の中から先行態様を組立てて液体媒体収容部１内には５mlを収容して封止膜で封止したもの、溶質収容部３内には溶質Ｓとして、０.１gを収容して、封止膜付き封止膜保持部材３２を半打栓状態にしたものをそれぞれ用意し、前者をオートクレーブ滅菌(１２１℃;３０min)に供し、それと並行して後者を−４０℃における凍結乾燥に供した後に封止膜付き封止膜保持部材３２で本打栓によって密封した。
【００５２】
処理後の検査においては、オートクレーブ滅菌処理試料にも、凍結乾燥試料にも、封止膜その他に異常が見られず、良好な試料であった。
両試料を常温に戻した後に異径接続管４によって接続し、ドーム状部１４を上方から手の親指で押圧して封止膜穿孔部材１２を下降させることによって、封止膜１３及び３３を穿孔破壊した。液体媒体収容部１に収容された液体媒体Ｌが地溶質収容部３内へ流下した処で溶質収容部を充分に振り混ぜ(振盪し)て、所期の溶液を調製した。
【００５３】
次にユニットＵ1を取外し、それに代えてユニットＵ2を装着した。この際に、溶液吸上げ管５６は溶質収容部３の最深部まで進入させた。ユニットＵ2を構成するポンプ機構５を作動させると、スプレーヘッド５２から調製された溶液が円錐範囲内に噴霧された。
【図面の簡単な説明】
【図１】図１で表わされる態様は本発明の製造装置を構成する先行態様であって、図１(Ａ)は用時開封ユニットＵ1が装着された液体媒体収容部が溶質収容部に接続された状態の模式的縦断面図であって、図１(Ｂ)は上記の接続域におけるる各部材間の相互的位置関係を示す模式的部分切開拡大断面図である。
【図２】図２で包括される態様は本発明の製造装置を構成する後続態様であって、調製された溶液等を収容する溶質収容部にユニットＵ2(排液ユニット)が冠装された態様の模式的縦断面図である。図２(Ａ)は本発明の製造装置の先行態様を使用に供する際の操作を示し、図２(Ｂ)は本発明の製造装置の後続態様であって、先行態様におけるユニットＵ1がＵ2に換装された状態を示す。
【符号の説明】
１液体媒体収容部
２上段外筒
３溶質収容部
４異径接続管
５ポンプ機構
６ポンプ機構の支持筒部
７ポンプ機構に対する下押さえ板
１２封止膜穿孔部材
１３液体媒体収容部の下端開口に融着された封止膜
１４ドーム状部
１５液体媒体収容部の下端開口
３２封止膜保持部材
３３封止膜保持部材の環状張出しに載置された封止膜
３４封止膜保持部材の中央域を下方から上方向けに貫通する通液孔(通液路)
３５封止膜保持部材に嵌着されたカシメ部材
５１ポンプ作動のための押圧の頭部
５２スプレーヘッド部
５３可動弁管
５４ポンプ機構の幹部
５５ポンプ機構の脚部
５６溶液等吸上げ管
６１支持筒部の側壁部
６２支持筒部の天板部
６３支持筒状部において天板部よりも上部
１b 液体媒体収容部下段外壁の突部
１e 液体媒体収容部の上端縁(上段開口縁)
１f 液体媒体収容部に突設された回動防止鰭
１r 液体媒体収容部下段の移行域
１s 液体媒体収容部上段外壁の係合手段
２g 上段外筒の環状突部以上の部分
２p 上段外筒の環状突部
２r 上段外筒外周のローレット又は低い縦突条
２s 上段外筒内壁の雌螺条
３m 溶質収容部の開口
３x 溶質収容部の袴部
４b 異径接続管の下管部
４f 異径接続管上管部内壁から突設された縦鰭
４k 異径接続管の上管部と下管部との境界から内方へ張出す環状棚
４s 異径接続管の上管部
４u 異径接続管の上管部内壁に刻設された凹陥又は凹溝
６h 天板部に穿設された嵌入孔
１２b 封止膜穿孔部材の下端域フランジよりも下側の縦鰭
１２f 封止膜穿孔部材の下端域フランジ
１２h 封止膜穿孔部材の上端域に位置する稍大径部
１２t 封止膜穿孔部材の管状部
１４a 緩衝部のドーム状部中心域に下方から上方向けに設けられた支承洞
１４f 緩衝部のドーム状部下端から外方向けに張出したフランジ部
１４t 緩衝部のドーム状部
３２b 封止膜保持部材の大径孔中段に位置する環状張出し
３２h 封止膜保持部材の大径孔
３２i 封止膜保持部材の大径孔内壁
３２t 封止膜保持部材の頂面
３２x 封止膜保持部材の外周壁
３５i 封止膜保持部材に嵌着されたカシメ部材の内輪部
３５m 封止膜保持部材の天板部
３５x 封止膜保持部材に嵌着されたカシメ部材の外輪部
５１i 押圧頭部内筒
５４f 幹部５４の下端から周囲へ張出すフランジ部
５５d ポンプ機構の脚部における下端部
６１r 支持筒状側壁部の外壁から突設されたはローレット又は多数の低い縦突条
５４d1 ポンプ機構の第１幹下部
５４d2 ポンプ機構の第２幹下部
５４d3 ポンプ機構の第３幹下部
Ｌ液体媒体
Ｓ固形溶質[0001]
BACKGROUND OF THE INVENTION
The present invention relates to a unit-replaceable type manufacturing apparatus in which two or more replaceable units, that is, a use opening unit (unit U1) and a drainage unit (unit U2) are crowned in a predetermined order in a liquid medium container. Specifically, as the unsealing unit for use, the manufacturing apparatus according to the preceding aspect in which a unit that combines a sealing film perforating mechanism for incorporation into the liquid medium container, a buffer unit, and an upper outer cylinder is crowned in the liquid medium container, and The present invention relates to a manufacturing apparatus of a subsequent mode in which the opening unit for use is replaced with a drainage unit (mainly a pump unit).
[0002]
[Prior art]
Already a single cylinder whose lower end region is closed with a sealing film to contain a liquid medium, and for the liquid medium to be opened by perforating or breaking the sealing film (collectively referred to as “perforation” in the present invention). Either the time-discharge type container or the substantially double-cylinder structure is closed at the lower end region by the sealing film to contain the liquid, and the other is opened at the time of use in conjunction with the means for perforating the sealing film Various preparation-type containers have been proposed.
[0003]
For example, Japanese Utility Model Laid-Open Publication No. 7-22980 (Appendix 1) describes a container in which a substantially bottomed single cylinder type unsealed liquid storage part for use and a solute storage part are divided into the same container. This section container has an annular projection extending inward in the middle region of the inner wall, and a rod-shaped opening body extending downward from the center of the flexible partial spherical surface placed on the periphery of the upper end opening, and Shown is a form in which a basin-shaped plug portion detachably attached to the lower end is closely fitted to an annular projecting opening in the middle region of the inner wall of the container.
[0004]
This container is different from a conventionally known container in that the dissolution liquid is accommodated in the lower half region of the container and the dissolving powder particles are accommodated in the upper half region. In addition, once the opening body has been pushed in, the stopper attached to its lower end area is detached and sinks to the bottom of the container, and then the container is tilted to pour out the contained liquid. The stopper is dammed up by the annular ridge protruding from the middle stage of the inner wall of the container and does not fall into the opening of the container.
[0005]
In the conventional container provided with the opening means that looks similar to the opening means in the present invention, the opening body and the plug portion are initially connected to each other, but due to the depression of the opening body, there is a gap between them. The connection is broken and the stopper sinks to the bottom of the container. In this conventional unsealing means, there is no reason that the stopper part that sinks to the bottom of the container stays in the container until the contents are used up.
[0006]
However, since whether or not the detached plug part sinks depends on the density difference from the liquid contained in the container, it is not possible to set the material etc. so that the plug part sinks in any case It's not easy. In addition, various problems may be inherent in the affinity between the core material that helps settling and the surrounding material that surrounds the core material and avoids contact between the core material and the liquid, and the durability of the surrounding material with respect to the liquid.
[0007]
Moreover, in the above-mentioned item 1, the liquid is accommodated in the container below the plug part and the solute S is contained above the plug part. However, in this housing method, even when the plug portion blocking the middle and preventing contact between both parts is detached, the total amount of the solid solute S such as powder or granules from the upper part is contained in the lower liquid. It is hard to expect that it will always flow quickly. That is, in addition to its generally complex shape and low bulk density (apparent density), the powder has a remarkable decrease in fluidity due to moisture absorption and the like. This situation is often difficult to ignore, especially for small particle size powders or fluids.
[0008]
As a result, despite the fact that the desired solution is not prepared despite the fact that it has been opened, the cause can be mainly attributed to the storage conditions, but in practice it is possible to realize the necessary storage conditions in any case. Surprisingly difficult.
[0009]
[Problems to be solved by the invention]
The object of the present invention is to solve various problems associated with conventional seemingly similar opening means, and to improve so as not to generate a confinement product such as a stopper in the container after opening by the removal of the stopper. Complexity, reduced operational reliability, increased size, increased weight, and reduced portability derived from assembly of the functions of the stages, that is, the opening stage, the solute dissolution stage, and the solution removal stage in the same container This is to prevent or reduce the above.
[0010]
[Means for Solving the Problems]
  In the present invention, as a means for realizing the above object, the opening preparation unit incorporating the above-described opening and solute dissolution stage mechanisms is first mounted in the solute container, and this unit is then placed in the solution discharge stage. It is configured to be replaced with a drainage unit.
   That is, the unit replacement type solution manufacturing apparatus according to the present invention,Close fitting in the solute container 3
Unit replacement type solution or the like manufacturing apparatus configured so that the unsealed opening unit U1 crowned in the liquid medium container 1 is replaced with the drainage unit U2 after the function is completed, and the function is executed.Because
  The on-use opening unit U1 includes a liquid medium container 1 having a tubular body with a different diameter, a rod-shaped sealing film perforating member 12, and an upper outer cylinder 2 that is detachably attached to the outside of the liquid medium container 1. A dome-like portion 14 for suspending the sealing membrane perforating member 12;
The drainage unit U2 includes a pump mechanism 5, a support cylinder portion 6 that fixes the pump mechanism 5 and is detachably attached to the outside of the liquid medium storage portion 1, and a pressing head for performing pump operation. 51,
As a preceding aspect, the liquid medium storage unit 1 of the unsealing unit U1 for use is sealed at its lower outlet with sealing films 13 and 33, and its upper end opening is sealed with the dome-shaped portion 14, and the dome-shaped portion 14 grips and suspends the sealing film perforating member 12 therein, and the lower stage region of the liquid medium accommodating portion 1 is tightly fitted to the upper tube portion of the different diameter connection tube 4. A sealing film holding member 32 is fitted in the lower tube portion, and a sealing film 33 is held by the annular protrusion 32b. The sealing film holding member 32 is closely fitted in the opening of the solute accommodating portion 3. As a subsequent aspect and a subsequent aspect, the drainage mechanism of the drainage unit U2 replaces the dome-shaped portion 14, the sealing membrane perforating member 12, and the upper outer cylinder 2 above the different diameter connecting pipe 4. A mode of discharging the solution contained in the solute container 3 by being fitted in the tube part is completed. It is characterized by being.
[0011]
DETAILED DESCRIPTION OF THE INVENTION
The shape and structure of the apparatus for manufacturing solutions etc. (hereinafter sometimes referred to as “manufacturing apparatus of the present invention”) of the unsealing unit and draining unit replacement type of the present invention will be specifically described below with reference to the drawings. . In the drawings of the present invention, “up / down / left / right front / back / front / back” and the like are expressions for convenience of description.
[0012]
<Unit U1 (opening unit for use)>
The mode integrated in FIG. 1 is a preceding mode constituting the manufacturing apparatus of the present invention, and FIG. 1 (A) is equipped with a use opening unit (hereinafter sometimes abbreviated as “unit U1”). 2 is a schematic longitudinal sectional view of a state in which a liquid medium storage unit 1 is mounted on a solute storage unit. FIG. FIG. 1B is a schematic partial cutaway enlarged cross-sectional view showing the positional relationship between the sealing film holding member 32, the sealing film 33, the upper end region of the solute accommodating portion 3, and the caulking member 35.
[0013]
2 is shown in a schematic longitudinal sectional view of a state in which a drainage unit (unit U2), which is a subsequent mode constituting the manufacturing apparatus of the present invention, is connected to a solute container, 2A is a schematic longitudinal sectional view showing a state in which the unsealing tubular body has perforated the sealing film in the manufacturing apparatus of the present invention, and FIG. 2B shows the unit U1 in the manufacturing apparatus of FIG. It is a typical longitudinal section showing the state where it was changed to unit U2.
[0014]
<Liquid medium container 1>
In FIG. 1 (A), a different-diameter tubular body represented by 1 is a liquid medium containing portion for dissolving or dispersing a solute, and is substantially cylindrical, and its lower end region is reduced in diameter in the transition region 1r to the lower end opening 1m. However, the opening 1 m is watertightly closed by the sealing film 13. A protrusion or protrusion (hereinafter sometimes referred to as a “protrusion”) 1b protrudes outward from the lower side wall of the housing part 1, and this protrusion 1b has a different diameter, which will be described later. In a recess or groove (hereinafter sometimes referred to as “concave”) 4u provided on the inner wall of the upper pipe 4s of the different diameter connection pipe 4 so that it does not naturally disengage when fitted into the connection pipe 4. Engage. For example, a thread 1s is attached to the upper half of the outer wall of the solution storage unit 1 as an engaging means. Further, in order to prevent the liquid medium storage unit 1 from rotating in the different diameter connection pipe 4, a vertical rod 1 f is projected from the lower outer wall of the liquid medium storage part 1, It engages with a vertical rod 4f protruding from the inner wall of the pipe portion 4s.
[0015]
In FIG. 1 (B), the sealing film 33 is water-tightly welded to the top surface of the annular overhang 32b located in the middle stage of the large-diameter hole 32h of the sealing film holding member 32 so that the inside of the solute container 3 is exposed from the outside. It is shut off. Further, the sealing film 33 is welded (fused) to the top surface of the annular protrusion 32b, and the caulking member 35 is also welded to the peripheral area of the sealing film 33 from above the sealing film 33 and presses it. Thus, peeling of the sealing film 33 is prevented. This caulking member 35 is a member having a substantially U-shaped cross section, and its outer ring portion 35x is on the outer peripheral wall 32x of the sealing film holding member 32, its top plate portion 35t is the top surface 32t, and its inner ring portion 35i is In contact with the inner wall 32i of the large-diameter hole 32h, the sealing film holding member 32 is covered in series, and is fused to the upper peripheral area of the sealing film 33 at the lower edge of the inner ring portion 35i. Further, the sealing film 33 that closes the liquid passage hole 34 penetrating through the central portion of the sealing film holding member 32 is kept in that state until it is used (used).
[0016]
The performance required for the fusion bonding body of the sealing film 33 and the sealing film holding member 32 is a lyophilization performed normally, that is, a high vacuum application performed after a solution in which a solute is dissolved or a dispersion in which the solute is dispersed is accommodated. In addition, it is resistant to the subsequent low temperature and does not cause any peeling or breakage of the sealing film. In detail, lyophilization is preceded by a strong decompression (high vacuum) process inside the container, so that even if the container itself can withstand the decompression process, the sealing film will endure and break, crack or peel off. If it produces, etc., it does not endure freeze-drying.
[0017]
<Solute container 3>
The container represented by 3 in FIG. 1 is an inverted cone-shaped solute container with a collar, and continues downward from the large-diameter upper end opening 3h to the middle region and usually tapers in the lower region. In addition to being formed, the flange 3x surrounds the outside of the lower region to ensure self-supporting property, and a sealing film holding member 32 is fitted into the upper end opening 3h.
[0018]
This sealing film holding member 32 is a short cylindrical plug body having a substantially cylindrical shape, and an upper end region of the sealing film holding member 32 projects outward to form a flange 32f. The sealing film holding member 32 is perforated from above to below the sealing film holding member 32. The large opening 32h is formed from the provided opening to the middle stage, the short section of the middle stage is crimped to form an annular protrusion 32b, and the diameter gradually increases from the opening 34 surrounded by the annular protrusion 32b toward the lower end. A conical hole is formed from the top surface to the lower end.
[0019]
The use mode of the production apparatus of the present invention is a mode in which the lyophilization process is not performed in the solute container 3, that is, preferably a powder or granular solute housed in the solute container is dissolved or dispersed in a liquid medium. Further, an embodiment is also included in which the prepared solution or dispersion is discharged by the unit U2 replaced in place of the unit U1.
[0020]
The unit U1 constituting the manufacturing apparatus of the present invention shown in FIG. 1 is mainly composed of the upper outer cylinder 2 for mounting the sealing film perforating member 12t to the liquid medium container 1, but in addition to that, a dome-shaped portion 14 etc. are assembled. In FIG. 1, the liquid medium container 1 and the solute container 3 having the unit U1 mounted on the upper stage of the outer wall thereof are connected to the extent that they are not naturally separated by the different diameter connecting pipes 4.
[0021]
<Different diameter connection pipe 4>
The different diameter connecting pipe 4 in FIG. 1 has a configuration in which the upper half is formed of a small-diameter pipe and the lower half is formed of a large-diameter pipe. In this different diameter connecting pipe 4, the upper area is called the upper pipe section 4s and the lower area is called the lower pipe section 4b with the annular shelf 4k extending inward from the inner wall of the middle stage area as a boundary. The upper tube portion 4s is provided with an undercut (concave or recessed groove) 4u on the inner wall thereof so as to fit and house the lower step of the outer wall of the liquid medium housing portion 1 so as not to be naturally detached. On the other hand, the lower pipe portion 4b basically accommodates the solute accommodating portion 3 in such a manner as not to be naturally separated. At the time of this accommodation, the sealing film holding member 32 is already tightly fitted into the opening 3m of the solute housing part 3, and the peripheral edge of the sealing film 33 is welded (fused) to the top surface of the annular projecting part 32b. Therefore, if the protrusion 4f for preventing pullout is a protrusion, two or more protrusions are usually provided in the middle or lower part of the inner wall of the lower pipe part 4b. Two or more or projecting over the entire circumference.
[0022]
<Sealing membrane perforating member 12>
Next, in order to prepare a desired solution or the like by actually mixing the contents in the solute container 3 connected to the liquid medium container 1 constituting the manufacturing apparatus of the present invention in FIG. It is necessary to contact the liquid medium L accommodated in the accommodating part 1 and the solute S accommodated in the solute accommodating part 3 connected to the liquid medium accommodating part 1. In order to make this contact, it is necessary to pierce both sealing films separating the two to open the liquid flow path, and therefore the unit U1 is equipped with the sealing film piercing member 12.
[0023]
This sealing membrane perforating member 12 is provided with a flange portion 12f such as a disc type or a square plate type at the lower end region of an elongated rod-like trunk portion 12t suspended from the top of the upper outer cylinder (described later) 2 so as to be movable up and down. A vertical rod 12b that connects the flange portion 12f and the trunk portion 12t is mounted at several locations on the lower end side of the flange portion 12f.
[0024]
  The size, shape and arrangement of the vertical rod 12b facilitate the perforation of the sealing film 3, and the shape of the perforated hole is inserted from the suction pump (described later) attached after the perforation to the bottom of the container.Solution wickingTube (see below) 56It is important to be able to perforate so as not to impede the entry. In the embodiment shown in FIG. 1, the four vertical rods 12b are radially arranged around the trunk 12t, and the shape thereof is a right triangle, and the oblique side extends obliquely from the tip of the trunk 12t to the outer periphery of the flange 12f. Is consistent with
[0025]
<Upper outer cylinder 2>
The upper outer cylinder 2 in FIG. 1 is a member that bears the main part of the unit U1 constituting the manufacturing apparatus of the present invention, and the above-described sealing membrane perforating member 12 is suspended in the above-described liquid medium accommodating portion 1 so as to be movable up and down. As a means for this, the upper outer cylinder 2 is detachably fitted to the liquid medium housing part 1.
[0026]
The upper outer cylinder 2 in FIG. 1 is a substantially cylindrical body, and an annular ridge 2p is projected from the middle area of the inner wall, and a thread 2s is attached to the lower area of the inner wall. A portion 2g extending above the annular protrusion 2p in the upper outer cylinder 2 serves to prevent a situation in which the sealing film is perforated by the dome-shaped portion 14 being pressed by an unexpected external force application.
[0027]
The role of the screw 2s is to prevent the upper outer cylinder 2 from being detached from the liquid medium container 1 by screwing with the screw 1s attached to the outer wall of the upper region of the liquid medium container 1 described above. . As a different accessory shape of the upper outer cylinder 2, a knurling or a fine vertical protrusion 2 r is engraved on the outer wall of the upper outer cylinder 2 to support the rotation.
[0028]
The first role of the upper outer cylinder 2 is to project from the lower end of the dome-like portion 14 placed on the upper end opening edge 1e of the liquid medium accommodating portion 1 to prevent the dome-like portion 14 from being detached. The flange portion 14f is pressed down on the lower surface of the annular ridge 2p to be brought into close contact with the upper end opening edge 1e of the liquid medium accommodating portion 1.
[0029]
The second role of the upper outer cylinder 2 is to suspend the sealing film perforating member 12 from the dome-shaped portion 14t.
<< Role of dome 14 >>
In order to suspend the sealing membrane perforating member 12, which is the first role of the dome-shaped member 14, a relatively long (deep) bearing cave 14a is provided inside the dome-shaped portion 14 from below to above. It has been. A head 12h having an enlarged diameter of the sealing membrane perforating member 12 is inserted into the support cavity 14a, and the sealing membrane perforating member head 12h is gripped by the supporting sinus 14a and the sealing membrane perforating member 12 is inserted. Detachment is prevented.
[0030]
The dome-shaped portion 14 is generally formed of an approximately dome-shaped portion 14t made of an elastomer or a thermoplastic elastomer, a skirt-shaped portion 14s extending downward from the peripheral edge thereof, and a flange portion 14f extending outward from the lower end thereof.
[0031]
The second role of the dome-shaped portion 14 is to increase the internal pressure due to the vapor generated from the liquid medium L even when autoclave sterilization (121 ° C. × 30 min) of the liquid medium L accommodated in the liquid medium accommodating portion 1 is performed. By absorbing, it does not cause rupture of itself or rupture of the sealing film. This increase in internal pressure varies greatly depending on the type of liquid medium L to be accommodated, but nevertheless, the dome-shaped portion 14 is required to be able to hold the liquid medium accommodating portion 1 substantially the same as the original after sterilization. The
[0032]
  <Sealing film 13 or 33>
  In the preceding aspect of the manufacturing apparatus of the present invention, the sealing film 13 that closes the lower end opening 15 of the liquid medium storage unit 1 and the different sealing film that contacts the lower surface of the sealing film 13 are provided in the opening 3m of the solute storage unit 3. In order to close the annular projecting region 32b located at the lower end of the large-diameter hole 32h drilled from the upper surface of the fitted sealing film holding member 32 downward to the middle, A sealing film 33 that is welded and fixed to the top surface of the overhang region 32b is used. Further, the inner ring portion 3 of the caulking member 35 is provided in the peripheral area of the sealing film 33.5i The lower end is welded and pressed to prevent the sealing film 33 from being peeled off. In FIG. 1B, for convenience of explanation, the sealing film 33 is shown as being temporarily separated from the top surface of the annular projecting portion 32b of the sealing film holding member 32.
[0033]
The sealing film 13 may be attached by a fusion with a resin coating layer that is usually performed. This is because most of the increase in internal pressure generated in this case is absorbed by the expansion of the dome-shaped member 14.
[0034]
However, the mounting form of the sealing film 33 that blocks the solute container 3 from the outside is required to be much more robust. That is, the solute container 3 absorbs the high vacuum so that the sealing film 33 does not rupture or crack even by high vacuum (high decompression) applied in the freeze-drying stage, and has a destructive action. This is because no other compensation portion is provided so as not to reach the sealing film 33. Therefore, in the solute accommodating portion 3, the sealing film 33 is much more carefully attached as described above.
[0035]
Various materials can be adopted as the material of the sealing film 33, but usually a metal foil, particularly an aluminum foil, or a laminated foil in which at least one surface thereof is coated with a resin is used. In the present invention, both the sealing films 13 and 33 are preferably laminated foils in which low density polyethylene (LDPE) is coated on an aluminum foil, but the sealing film 33 is preferably thicker.
[0036]
2A is a use stage 1 of the manufacturing apparatus of the present invention, in which the liquid medium container 1 is closely packed in the solute container 3, and the former is the unit U1. FIG. 4 is a schematic longitudinal sectional view showing a state in which a pressing force is applied from above to the composite body fitted with (indicated by a downward white arrow and an English letter “PUSH”). FIG. 2 (B) is a use stage 2 of the present invention, and instead of unit U 1, unit U 2, that is, a drain unit for discharging (taking out) the prepared solution out of the container, is provided in liquid medium container 1. The state fitted externally is shown.
[0037]
<Operation and effect of the invention>
The aspect at the time of use of the manufacturing apparatus of this invention is demonstrated below.
According to FIG. 2 (A), in use, a pressing force is applied to the manufacturing apparatus of the present invention from the outside, and as a result, the dome-like portion 14 that is airtightly mounted on the upper surface of the upper outer cylinder 2 and the same. After the suspended sealing membrane perforating member 12 moves downward to perforate and open the two sealing membranes 13 and 33, the sealing membrane holding member is further fitted in the opening 3m of the solute accommodating portion 3. 32 enters the lower opening 34 located at the lower stage.
[0038]
In this state, the liquid medium L is in sufficient contact with the solute S in the same container 3, and when it is desirable to further improve the degree of dissolution or dispersion, the sorting container of the present invention is shaken to the left and right. Such measures are also useful.
[0039]
According to FIG. 2 (B), in order to discharge (take out) the desired solution prepared in the original solute container 3 from the container, the unit U1 that was initially installed (at the shipping stage), that is, A unit U1 consisting of the upper outer cylinder 2, the sealing membrane perforating member 12 and the dome-like portion 14 attached thereto is removed, and a unit U2 mainly composed of an airless pump mechanism is mounted instead.
[0040]
The unit U2 is roughly a structure in which the trunk portion 54 of the airless pump mechanism 5 is fixed to the upper end of a support cylinder portion 6 having a shape similar to that of the upper outer cylinder 2. In detail, the support cylinder part 6 which comprises the unit U2 is provided with the top plate part 62 in the upper end, and the insertion hole 6h for inserting the pump mechanism 5 is provided in the approximate center of the top plate part 62. A first trunk lower part 54d1, which is a lower part of the trunk part 54 of the pump mechanism 5, a second trunk lower part 54d2 extending below the third trunk lower part 54d3 extending below the first trunk lower part 54d3 is fitted and fixed in the insertion hole 6h.
[0041]
In this fitting and fixing, the flange portion 54f extending from the lower end of the trunk portion 54 of the pump mechanism 5 to the periphery is located under the top plate portion 62 of the support cylinder portion 6, and the lower presser plate 7 is located under the flange portion 54f. A method is adopted in which the flange portion 54f is pinched while the lower presser plate 7 is placed on the upper end edge of the unsealed liquid medium container 1 when in use.
[0042]
The supporting cylindrical side wall 61 is provided with a female thread as an engaging means on its inner wall, and is open at its lower end. The female thread attached to the inner wall engages with the male thread as an engaging means attached to the outer wall of the unsealed liquid medium container 1 to prevent the unit U1 or U2 from being detached. At the same time, the unit can be easily exchanged. Further, knurls or a large number of low vertical protrusions 61r are provided on the outer wall of the support cylinder side wall 61. Its role is to facilitate the attachment / detachment of the support cylinder 6.
[0043]
The pump mechanism 5 illustrated in FIG. 2B is an airless type spray pump, in which a pump stem portion 54 is supported by a top plate 62 of a support cylinder portion 6, and a movable valve pipe 53 is inserted therein to be movable. In the upper end region of the valve pipe 53, a pressing head 51 for operating the pump is crowned via a pressing head inner cylinder 51i. Further, a pipe line is formed in the pressing head 51, and this pipe line communicates with the spray head unit 52.
[0044]
The pressing head 51 is lowered by applying a pressing force (reducing force) to the top surface 51t. At this time, the movable valve pipe 53 is pushed down, so that the air in the pump mechanism 5 is discharged to the outside and the solute is accommodated. The solution in the part 3 is sucked up. The sucked solution rises in the solution sucking pipe 56 and is sprayed from the spray head 52.
[0045]
The pump mechanism 5 used in the unit U2 of the present invention can be appropriately selected from ordinary airless mechanisms, and any piston pump, plunger pump, or suction pump used for suctioning an aerosol or the like is sufficient. However, it is useful that the solution suction pipe 56 in the pump mechanism 5 reaches the deepest part of the solute housing part 3.
[0046]
It is important in the present invention that the pump mechanism to be replaced in the manufacturing apparatus of the present invention as a subsequent mode is an airless type. That is, it is not preferable that air is taken in from the outside in order to compensate for the reduced pressure state generated in the solute housing 3 due to the discharge of the solution or the like because it may cause various kinds of contamination.
[0047]
Here, the fact that the inner lower part of the solute housing part 3 is formed in a substantially conical shape is taken out with almost no remaining solution prepared in the solute housing part 3 coupled with reaching the deepest part of the solution suction pipe. It contributes to that.
[0048]
【The invention's effect】
The manufacturing apparatus of the present invention, that is, the preceding mode consisting of the liquid medium storage unit 1 and the solute storage unit 3 to which the unsealing unit U1 is attached and the unit U2 (drainage unit) for changing the unit U1 to the subsequent mode. According to the manufacturing apparatus that can be replaced with, the following various effects can be achieved:
(1) The liquid medium L can be subjected to autoclave sterilization in a state where the liquid medium L is contained in a container, and there is almost no possibility that the sealing film is broken or the like;
(2) The operation of carrying out the final plugging of the rubber plug covered with the sealing film after being lyophilized under reduced pressure after storing the solution or dispersion of the solute S in a solute container is completely independent of the autoclave sterilization process. Can be executed in parallel (parallel processing).
(3) A system has been completed in which the unit U1 for opening the liquid medium container and preparing the solution can be easily replaced with the unit U2 for discharging the prepared solution and the like after the solution is prepared.
[0049]
【Example】
Hereinafter, the production apparatus of the present invention will be described more specifically with reference to examples. However, the present invention is not limited by these examples.
[0050]
[Example 1]
The liquid medium container 1 of the present invention is made of a propylene crystalline homopolymer, the upper outer cylinder 2 is made of the same propylene crystalline homopolymer, and the solute container 3 is an amorphous olefin copolymer [repeating a condensed ring structure] Amorphous copolymer with 1-olefin as a polymerization unit], different diameter connecting tube 4 made of propylene crystalline copolymer, sealing film holding member 32 made of butyl rubber [abbreviation: IIR], sealing film The perforated member 12 is made of a propylene crystalline homopolymer, the dome-shaped portion 14 is made of butyl rubber, the sealing films 13 and 33 are made of a low density polyethylene (LDPE) coated aluminum foil, and a mechanism that constitutes the drainage unit U2. A certain pump mechanism 5 is made of a propylene crystalline homopolymer and a leg 55 of the pump mechanism 5 is made of a propylene crystalline polymer or a high density polyethylene (HDPE), and the production apparatus of the present invention and both functions thereof Unit U1 We have created a beauty U2.
[0051]
Assembling the preceding embodiment from the above, containing 5 ml in the liquid medium container 1 and sealed with a sealing film, 0.1 g as solute S in the solute container 3, Prepare the sealing film holding member 32 with a sealing film in a half-plugged state, and use the former for autoclave sterilization (121 ° C .; 30 min), and the latter for lyophilization at −40 ° C. After that, the sealing film holding member 32 with a sealing film was sealed with this stopper.
[0052]
In the inspection after the treatment, neither the autoclave sterilized sample nor the freeze-dried sample was satisfactory, and no abnormality was observed in the sealing film or the like.
After both samples are returned to room temperature, they are connected by the different diameter connecting pipe 4, and the sealing film punching member 12 is lowered by pressing the dome-shaped portion 14 with the thumb of the hand from above, thereby sealing films 13 and 33. Perforated and destroyed. When the liquid medium L accommodated in the liquid medium accommodating portion 1 flowed into the geosolute accommodating portion 3, the solute accommodating portion was sufficiently shaken (shaken) to prepare an intended solution.
[0053]
Next, the unit U1 was removed and replaced with a unit U2. At this time, the solution suction pipe 56 was advanced to the deepest part of the solute housing part 3. When the pump mechanism 5 constituting the unit U2 was activated, the solution prepared from the spray head 52 was sprayed into the conical area.
[Brief description of the drawings]
FIG. 1 shows a preceding embodiment constituting the manufacturing apparatus of the present invention, and FIG. 1 (A) shows a case where a liquid medium storage portion to which an unsealing unit U1 is attached is connected to a solute storage portion. FIG. 1B is a schematic partial cutaway enlarged cross-sectional view showing the mutual positional relationship between the members in the connection region.
2 is a subsequent mode constituting the manufacturing apparatus of the present invention, in which the unit U2 (drainage unit) is crowned in the solute storage unit for storing the prepared solution and the like. It is a typical longitudinal cross-sectional view of an aspect. FIG. 2 (A) shows the operation when the preceding aspect of the manufacturing apparatus of the present invention is put into use, and FIG. 2 (B) is the subsequent aspect of the manufacturing apparatus of the present invention. Shows the state of being replaced.
[Explanation of symbols]
1 Liquid medium container
2 Upper cylinder
3 Solute housing
4 Different diameter connection pipe
5 Pump mechanism
6 Support cylinder of pump mechanism
7 Lower holding plate for pump mechanism
12 Sealing membrane perforated member
13 Sealing film fused to the lower end opening of the liquid medium container
14 Dome-shaped part
15 Lower end opening of liquid medium container
32 Sealing film holding member
33 Sealing film placed on annular projecting of sealing film holding member
34 Fluid passage hole (fluid passage) penetrating through the central region of the sealing film holding member from below to above
35 Caulking member fitted to sealing film holding member
51 Pressing head for pump operation
52 Spray head
53 Movable valve pipe
54 Executives of the pump mechanism
55 Legs of pump mechanism
56 Suction pipe for solution
61 Side wall of support tube
62 Top plate of the support tube
63 Above the top plate in the support tube
1b Protrusion of the lower outer wall of the liquid medium container
1e Upper edge of the liquid medium container (upper opening edge)
1f Anti-rotation rod protruding from the liquid medium container
1r Transition zone in the lower part of the liquid medium container
1s Engagement means for upper wall of liquid medium container
2g More than the annular protrusion of the upper outer cylinder
2p Annular protrusion of the upper outer cylinder
2r Knurl on the outer circumference of the upper outer cylinder or low vertical ridge
2s Female thread on the inner wall of the upper outer cylinder
3m Solute opening
3x solute containment buttock
4b Lower pipe part of different diameter connection pipe
4f Vertical gutter projecting from the inner wall of the upper pipe part of the different diameter connecting pipe
An annular shelf that protrudes inward from the boundary between the upper and lower pipes of the 4k different diameter connecting pipe
Upper part of 4s different diameter connecting pipe
4u Concave or groove engraved on the inner wall of the upper pipe of the different diameter connecting pipe
6h Insertion hole drilled in the top plate
12b Downspout below the lower end flange of the sealing membrane perforated member
12f Lower end flange of sealing membrane perforated member
12h Large diameter portion located in the upper end region of the sealing membrane perforated member
Tubular part of 12t sealing membrane perforated member
14a A bearing cave provided from the bottom to the top in the central area of the dome of the buffer section
14f Flange projecting outward from the lower end of the dome-shaped part of the buffer part
14t Domed part of buffer part
32b An annular overhang located in the middle stage of the large-diameter hole of the sealing film holding member
32h Large diameter hole of sealing film holding member
32i Large-diameter hole inner wall of sealing film holding member
32t Top surface of sealing film holding member
32x outer peripheral wall of sealing film holding member
35i Inner ring portion of caulking member fitted to sealing film holding member
35m Top plate part of sealing film holding member
35x Outer ring portion of caulking member fitted to sealing film holding member
51i Pressing inner cylinder
54f Flange projecting from the lower end of the trunk 54 to the periphery
55d Lower end of leg of pump mechanism
61r is a knurl or a large number of low vertical ridges protruding from the outer wall of the supporting cylindrical side wall
54d1 Lower first trunk of pump mechanism
54d2 Lower second trunk of pump mechanism
54d3 Lower third trunk of pump mechanism
L Liquid medium
S Solid solute

Claims

溶質収容部（３）に密嵌された液体媒体収容部（１）に冠装された用時開封ユニット（Ｕ１）がその機能終了後に排液ユニット（Ｕ２）に換装されて、その機能が実行される構成のユニット換装型の溶液等の製造装置であって、
前記用時開封ユニット（Ｕ１）は、異径管状体の液体媒体収容部（１）と、棒状の封止膜穿孔部材（１２）と、前記液体媒体収容部（１）の外側に着脱自在に装着される上段外筒（２）と、前記封止膜穿孔部材（１２）を懸吊するドーム状部（１４）とを備え、
前記排液ユニット（Ｕ２）は、ポンプ機構（５）と、前記ポンプ機構（５）を固定するとともに前記液体媒体収容部（１）の外側に着脱自在に装着される支持筒部（６）と、ポンプ作動を行う為の押圧頭部（５１）とを備え、
先行態様として、前記用時開封ユニット（Ｕ１）の前記液体媒体収容部（１）がその下段出口を封止膜（１３）、（３３）で封止され、その上端開口を前記ドーム状部（１４）で密閉され、該ドーム状部（１４）がその内部に前記封止膜穿孔部材（１２）を把持及び懸吊し、前記液体媒体収容部（１）の下段域が異径接続管（４）の上管部に密嵌され、前記異径接続管（４）の下管部には封止膜保持部材（３２）が内嵌されると共に、その環状張出し（３２ｂ）に封止膜（３３）が保持され、この封止膜保持部材（３２）が前記溶質収容部（３）の開口に密嵌されている態様及びそれに次ぐ後続態様として、前記ドーム状部（１４）、前記封止膜穿孔部材（１２）及び前記上段外筒（２）に代えて、前記排液ユニット（Ｕ２）の排液機構が異径接続管（４）の上管部に内嵌されて溶質収容部（３）に収容された溶液を排出する態様が完成されることを特徴とするユニット換装型の溶液等の製造装置。The in-use opening unit (U1) crowned by the liquid medium container (1) tightly fitted in the solute container (3) is replaced with the drainage unit (U2) after the function is completed, and the function is executed. An apparatus for manufacturing a unit-replaceable solution having a structure to be configured ,
The unsealing unit for use (U1) is detachably attached to the outside of the liquid medium container (1) having a tubular body with a different diameter, the rod-shaped sealing film perforating member (12), and the liquid medium container (1). An upper outer cylinder (2) to be mounted; and a dome-shaped portion (14) for suspending the sealing membrane perforating member (12);
The drainage unit (U2) includes a pump mechanism (5), a support cylinder portion (6) that fixes the pump mechanism (5) and is detachably attached to the outside of the liquid medium storage portion (1). And a pressing head (51) for performing the pump operation,
As a preceding aspect, the liquid medium container (1) of the unsealing unit (U1) for use is sealed at its lower outlet with sealing films (13) and (33), and its upper end opening is connected to the dome-shaped part ( 14), the dome-shaped portion (14) grips and suspends the sealing membrane perforating member (12) therein, and the lower region of the liquid medium accommodating portion (1) is a different diameter connecting pipe ( 4) Closely fitted to the upper tube portion, and a sealing film holding member (32) is fitted into the lower tube portion of the different diameter connecting tube (4), and the sealing film is formed on the annular protrusion (32b). (33) is held, and the sealing film holding member (32) is closely fitted in the opening of the solute accommodating portion (3) and the subsequent mode is the following dome-shaped portion (14), the sealing Instead of the perforated membrane perforating member (12) and the upper outer cylinder (2), the drainage mechanism of the drainage unit (U2) is different. Connecting pipe (4) internally fitted has been solute housing portion (3) to be accommodated solution manufacturing device such as a solution of the unit retrofit type, characterized in that the mode is completed to discharge the upper tube portion of.