JP4234373B2

JP4234373B2 - Sterilization management system

Info

Publication number: JP4234373B2
Application number: JP2002238878A
Authority: JP
Inventors: 勝人宮本; 耕二宗
Original assignee: Kawasumi Laboratories Inc
Current assignee: Kawasumi Laboratories Inc
Priority date: 2002-08-20
Filing date: 2002-08-20
Publication date: 2009-03-04
Anticipated expiration: 2022-08-20
Also published as: JP2004073528A

Description

【０００１】
【発明の属する技術分野】
本発明は医療用具等の被滅菌物の滅菌管理システムの改良に関し、滅菌機に封入される滅菌ガス（例えばエチレンオキサイドガス）濃度と滅菌圧力を制御することのできる滅菌管理システムに関する。
【０００２】
【従来の技術及び発明が解決しようとする課題】
図４は従来の滅菌管理システム３１の概略図である。
医療器具等の被滅菌物の滅菌手段としてガス滅菌方法がある。滅菌ガスには例えばエチレンオキサイドガスまたはエチレンオキサイドガスを主成分とする混合ガスがある。前記エチレンオキサイドガス（以下「ＥＯＧ」と略記する）と炭酸ガス等の不活性ガスが任意の濃度比で滅菌ガスボンベ（以下「ボンベ」と略記する）３４に封入されている。前記不活性ガスはボンベ３４内の圧力を高圧にしておく為に封入されている。
ボンベ３４は少なくとも複数本を並列に配置して、気化器３６を介して滅菌機３２に滅菌ガスを加圧封入する。前記複数のボンベ３４の圧力はゲージ３３に表示される。前記ボンベ３４内の重量が減少すると前記ゲージ３３に表示される圧力も低下するので、作業者がゲージ３３の表示を見て一定基準より低下した場合、ボンベ３４を新しいボンベ（図示せず）と交換する。
ところで従来の滅菌管理システム３１では、ボンベ３４内の残量が少なくなると滅菌機３２内に導入される滅菌ガス濃度が低下する（前記炭酸ガス等の不活性ガスが多く滅菌機３２内に導入される）ので、滅菌不良が生じることがある。
このため滅菌不良の判定方法として、例えば化学的インジケーターの色の変色度合と、枯草菌を用いた生物学的インジケーターの枯草菌の死滅による滅菌判定を行い、仮に陽性（滅菌不足）と判定された場合、その都度再滅菌を実施しなければならなかった。
また特公平6-22545号には、「滅菌ガスモニタリングシステム」の発明が開示され、滅菌機内のＥＯＧ濃度を赤外分光分析でモニタリングできる旨が記載されている。
しかしこの発明では、滅菌ガスボンベマニホールドを制御する手段については何ら開示されてないので、滅菌ガスボンベマニホールドの滅菌ガス量が低下した場合、当該該滅菌ガスボンベマニホールの切替えを手動で行わねばならず、操作が煩わしい。
そこで本発明者らは以上の課題を解決するために鋭意検討を重ねた結果次の発明に到達した。
【０００３】
【課題を解決するための手段】
［１］本発明は、上流側に滅菌手段（Ａ）と下流側に滅菌ガス供給手段（Ｂ）を配置することにより構成され、
前記滅菌手段（Ａ）は、滅菌機（２）と、当該滅菌機（２）に第３配管（Ｋ３）を介して接続されるガス濃度測定装置（３）と、滅菌ガス濃度設定装置（１８）と、滅菌ガス圧力制御装置（８）と、前記滅菌機（２）に装着される圧力センサー（１９）と、当該圧力センサー（１９）に接続される圧力モニター（２０）を有し、
前記ガス濃度測定装置（３）は、前記滅菌機（２）内の滅菌ガス濃度を常時または間歇的にモニタリングすると共に、前記滅菌ガス濃度設定装置（１８）で設定した滅菌ガス濃度を感知して、これらの信号を滅菌ガス圧力制御装置（８）に送信するものであり、
前記滅菌ガス供給手段（Ｂ）は、複数本からなる第１系列の滅菌ガスボンベ（４）と、複数本からなる第２系列の滅菌ガスボンベ（４Ａ）と、
前記第１系列の滅菌ガスボンベ（４）の第１重量測定手段（５）と、
前記第２系列の滅菌ガスボンベ（４Ａ）の第２重量測定手段（５Ａ）と、
ボンベ切替え制御装置（９）を有し、
前記第１系列の滅菌ガスボンベ（４）は、第１配管（Ｋ１）を介して、当該第１配管（Ｋ１）の上流に配置された第４配管（Ｋ４）に接続され、
前記第２系列の滅菌ガスボンベ（４Ａ）は、第２配管（Ｋ２）を介して、当該第２配管（Ｋ２）の上流に配置された第４配管（Ｋ４）に接続され、
前記第４配管Ｋ（４）は、当該第４配管（Ｋ４）の上流に配置された第５配管（Ｋ５）に接続され、
当該第５配管（Ｋ５）の上流に前記滅菌機（２）が接続され、
前記第１配管（Ｋ１）の途中に、前記第１系列の滅菌ガスボンベ（４）中の滅菌ガスを滅菌機（２）へ供給／遮断を調節する第１バルブ（Ｖ１）を装着し、
前記２配管（Ｋ２）の途中に、前記第２系列の滅菌ガスボンベ（４Ａ）中の滅菌ガスを滅菌機（２）へ供給／遮断を調節する第２バルブ（Ｖ２）を装着し、
前記４配管（Ｋ４）の途中に、前記各滅菌ガスを滅菌機（２）へ供給／遮断を調節する第４バルブ（Ｖ４）を装着し、
前記ボンベ切替え制御装置（９）は、重量制御部（５Ｂ）を有し、
前記ボンベ切替え制御装置（９）は、前記第１系列の滅菌ガスボンベ（４）の滅菌ガスの供給／遮断を調節する第１バルブ（Ｖ１）及び前記第２系列の滅菌ガスボンベ（４Ａ）滅菌ガスの供給／遮断を調節する第２バルブ（Ｖ２）と連動制御し、
さらに前記ボンベ切替え制御装置（９）は、前記第１系列の滅菌ガスボンベ（４）及び前記第２系列の滅菌ガスボンベ（４Ａ）と連動制御し、
前記ボンベ切替え制御装置（９）は、少なくとも一方の前記第１系列の滅菌ガスボンベ（４）または前記第２系列の滅菌ガスボンベ（４Ａ）の重量が、前記重量制御部（５Ｂ）に入力された初期設定重量を下回った時、前記第１バルブ（Ｖ１）と第２バルブ（Ｖ２）の開閉により、他方の初期設定重量を維持している前記第１系列の滅菌ガスボンベ（４）または前記第２系列の滅菌ガスボンベ（４Ａ）に切り替えることができ、
前記滅菌手段（Ａ）の前記滅菌ガス圧力制御装置（８）と、前記滅菌ガス供給手段（Ｂ）の前記第４バルブ（Ｖ４）とを連動制御し、
前記滅菌手段（Ａ）の前記滅菌ガス圧力制御装置（８）と前記滅菌ガス供給手段（Ｂ）の前記ボンベ切替え制御装置（９）を連動制御し、
前記滅菌機（２）内の滅菌ガス濃度が前記滅菌ガス濃度設定装置（１８）の設定濃度に達すると、その時の滅菌ガス圧力を前記圧力センサー（１９）で検知し、前記圧力モニター（２０）を介して前記滅菌ガス圧力制御装置（８）により、前記第４バルブ（Ｖ４）を閉じて、滅菌ガス圧力を制御、維持することができ、
前記滅菌機（２）内の滅菌ガス圧力が前記滅菌ガス圧力より低下した時、前記滅菌ガス圧力制御装置（８）により前記第４バルブ（Ｖ４）を開いて滅菌ガスを、前記前記第１系列の滅菌ガスボンベ（４）または前記第２系列の滅菌ガスボンベ（４Ａ）より滅菌機（２）内に加圧封入することができる、滅菌管理システム（１）を提供する。
【０００４】
【発明の実施の形態】
図１は本発明の滅菌管理システム１の一例を示す概略図で、図２は当該滅菌管理システム１のブロック図である。
滅菌管理システム１は上流側に滅菌手段Ａと下流側に滅菌ガス供給手段Ｂを配置することにより構成される。
前記滅菌手段Ａは、滅菌機２と、当該滅菌機２のガス濃度測定装置３と滅菌ガス濃度設定装置１８と滅菌ガス圧力制御装置８と圧力センサー１９を有する。
前記滅菌ガス供給手段Ｂは、複数本からなる第１系列の滅菌ガスボンベ４（以下、単に滅菌ガスボンベ４と記載する場合もある）と、複数本からなる第２系列の滅菌ガスボンベ４Ａ（以下、単に滅菌ガスボンベ４Ａと記載する場合もある）と、前記第１系列の滅菌ガスボンベ４の第１重量測定手段５（以下、単に重量測定手段５と記載する場合もある）と、前記第２系列の滅菌ガスボンベ４Ａの第２重量測定手段５Ａ（以下、単に重量測定手段５Ａと記載する場合もある）と、ボンベ切替え制御装置９を有する。
本発明の滅菌管理システム１は、滅菌機２内の滅菌ガス圧力を、同滅菌ガス濃度が、滅菌ガス濃度設定装置１８で設定した濃度に達した時、当該濃度に対応する所定の滅菌ガス圧力を維持し、当該滅菌ガス圧力に達した時点より滅菌を開始し、滅菌終了時までの所定時間、前記滅菌ガス圧力を維持できる。
【０００５】
本発明の滅菌管理システム１は、前記滅菌ガス圧力制御装置８と前記ボンベ切替え制御装置９を連動制御することにより、前記滅菌機２内の滅菌ガス圧力を所定値に維持することができる。
また前記滅菌ガスボンベ４、４Ａと滅菌機２を、第１配管Ｋ１、第２配管Ｋ２、第４配管Ｋ４（以下、単に配管Ｋ１、Ｋ２、Ｋ４と記載する場合もある）を介して連結し、当該配管Ｋ１、Ｋ２、Ｋ４に第１バルブＶ１、第２バルブＶ２、第４バルブＶ４（以下、単にバルブＶ１、Ｖ２、Ｖ４と記載する場合もある）を配置し、当該バルブＶ１、Ｖ２を、前記ボンベ切替え制御装置９と連動制御できるようにしている。さらに前記バルブＶ４と前記滅菌ガス圧力制御装置８を連動制御できるようにしている。
【０００６】
前記ボンベ切替え制御装置９は、重量制御部５Ｂを有し、少なくとも一つの前記滅菌ガスボンベ４、４Ａの重量が、重量制御部５Ｂに入力された初期設定重量を下回った時、前記バルブＶ１、Ｖ２の開閉により、他方の初期設定重量を維持している滅菌ガスボンベ４、４Ａに切り替えることができるようにしている。
前記圧力センサー１９には圧力モニター２０が接続され、前記滅菌機２内の滅菌ガス濃度が前記滅菌ガス濃度設定装置１８の設定濃度に達すると、その時の滅菌ガス圧力を圧力センサー１９で検知し、圧力モニター２０を介して滅菌ガス圧力制御装置８により、バルブＶ４を閉じて、滅菌ガス圧力を制御、維持することができるようにしている。
また前記滅菌機２内の滅菌ガス圧力が前記の滅菌ガス圧力より低下した時、滅菌ガス圧力制御装置８によりバルブ４を開いて滅菌ガスを、前記滅菌ガスボンベ４、４Ａより滅菌機２内に加圧封入することができるようにしている。
【０００７】
なお前記滅菌手段Ａと前記滅菌ガス供給手段Ｂの間に、前記滅菌ガスボンベ４、４Ａ中の滅菌ガスを気化する気化器６を配置し、前記滅菌ボンベ４、４Ａから気化器６を介して滅菌ガスを前記滅菌機２内に供給して、当該滅菌機２内の滅菌ガスの圧力を所定値に維持することができる。気化器６は第５配管Ｋ５（以下、単に配管Ｋ５と記載する場合もある）を介して滅菌機２に接続されている。
さらに詳述すれば、前記各滅菌ガスボンベ４、４Ａ、前記滅菌機２、前記各配管Ｋ１、Ｋ２、Ｋ４、前記各バルブＶ１、Ｖ２、Ｖ４の接続と配置関係は以下のとおりである。
前記第１系列の滅菌ガスボンベ４は、第１配管Ｋ１を介して、当該第１配管Ｋ１の上流に配置された第４配管Ｋ４に接続される。
前記第２系列の滅菌ガスボンベ４Ａは、第２配管Ｋ２を介して、当該第２配管Ｋ２の上流に配置された第４配管Ｋ４に接続される。
前記第４配管Ｋ４は、当該第４配管Ｋ４の上流に配置された第５配管Ｋ５に接続される。当該第５配管Ｋ５の上流に前記滅菌機２が接続される。
前記第１配管Ｋ１の途中に、前記第１系列の滅菌ガスボンベ４中の滅菌ガスを滅菌機２へ供給／遮断を調節する第１バルブＶ１を装着している。
前記第２配管Ｋ２の途中に、前記第２系列の滅菌ガスボンベ４Ａ中の滅菌ガスを滅菌機２へ供給／遮断を調節する第２バルブＶ２を装着している。
前記４配管Ｋ４の途中に、前記各滅菌ガスを滅菌機２へ供給／遮断を調節する第４バルブＶ４を装着している。

【０００８】
以下、滅菌手段Ａについて詳述する。
前記滅菌機２には、当該滅菌機２のガス濃度測定装置３と滅菌ガス濃度設定装置１８と滅菌ガス圧力制御装置８と圧力センサー１９が装着されている。さらに当該滅菌機２には、滅菌条件を入力する操作パネル１５と滅菌時の状況を測定する記録計１７が装着され、当該記録計１７には前記滅菌ガス濃度設定装置１８が隣接されている。
さらに前記滅菌ガス圧力制御装置８には、Ａ／Ｄ変換器７が隣接され、圧力センサー１９で検知された滅菌機２内の圧力信号は、圧力モニター２０を介してＡ／Ｄ変換器７に送信され、滅菌ガス圧力制御装置８を介して前記ボンベ切替え制御装置９に送信される。なお前記圧力信号は滅菌ガス圧力制御装置８から前記記録計１７にも送信され、記録される。
なお本発明の滅菌管理システム１では、滅菌ガス濃度検出装置３で測定した滅菌ガス濃度の履歴を記録計１７に記録することができる。
【０００９】
また前記滅菌ガス濃度測定装置３は第３バルブＶ３（以下、単にバルブＶ３と記載する場合もある）を装着した第３配管Ｋ３（以下、単に配管Ｋ３と記載する場合もある）を介して滅菌機２に接続されている。
前記滅菌ガス濃度測定装置３は、滅菌機２内の滅菌ガス濃度を常時または間歇的にモニタリングすると共に、前記滅菌ガス濃度設定装置１８で設定した滅菌ガス濃度を感知して、滅菌ガス圧力制御装置８に送信する。さらに滅菌ガス濃度測定装置３で測定された滅菌ガス濃度は、（ｍｇ／Ｌ）と重量百分率（％）の二つの信号として記録計１７に送信されて記録されると共に滅菌ガス濃度設定装置１８を介して滅菌ガス圧力制御装置８に送信される。当該滅菌ガス圧力制御装置８よりバルブＶ４の開閉を行うことができる。
本発明で前記滅菌ガス濃度測定装置３とは、例えば赤外線吸光式ガス濃度測定装置やガスクロマトグラフ分析装置等が例示されるが、ＥＯＧ等の滅菌ガスの濃度を測定することができるものであれば、何でも使用することができる。
なお前記滅菌機２には、真空ポンプ２１が接続され、真空ポンプ２１は滅菌ガス圧力制御装置８と連動している。
【００１０】
以下、滅菌ガス供給手段Ｂについて詳述する。
前記滅菌ガスボンベ４、４Ａ中の滅菌ガスは、配管Ｋ１、Ｋ２、Ｋ４を通り気化器６を介して滅菌機２に導入（封入）される。前記配管Ｋ１、Ｋ２、Ｋ４の途中にバルブＶ１、Ｖ２、Ｖ４が配置される。
前記滅菌ガスボンベ４、４Ａ中には、前記［０００２］と同様に滅菌ガスと不活性ガスが封入され、不活性ガスにより、滅菌ガスボンベ４、４Ａ内の圧力は高圧に維持され、バルブＶ１、Ｖ２、Ｖ４を開くことにより、滅菌ガスを滅菌機２内に加圧封入することができる。
前記滅菌ガスボンベ４、４Ａは、それぞれ複数本並列に配置される。当該滅菌ガスボンベ４、４Ａは、そのうち一本または全部を重量測定手段５に載置することができる。
前記ボンベ切替え制御装置９は前記滅菌ガスボンベ４、４Ａの滅菌ガスの供給／遮断を調節するバルブＶ１、Ｖ２と連動し、さらに前記重量測定手段５（５Ａ）及び前記滅菌ガス圧力制御装置８とも連動している。
さらに詳述すれば、ボンベ切替え制御装置９は前記重量制御部５Ｂを介して重量測定手段５、５Ａと連動し、前記滅菌ガスボンベ４または４Ａの滅菌ガスの供給をバルブＶ１またはＶ２の開閉により切り替えることができる。
また、滅菌ガスを気化器６、滅菌機２に供給／遮断を調節するバルブＶ４は前記滅菌ガス圧力制御装置８と連動し、当該滅菌ガス圧力制御装置８によりバルブＶ４の開閉／調整を行うことができる。
【００１１】
それぞれの重量測定手段５、５Ａの信号は、重量制御部５Ｂを介してボンベ切替え制御装置９に送信される。前記ボンベ切替え制御装置９の信号は二つに分かれて送信される。
一方の信号は該ボンベ切替え制御装置９から滅菌ガス圧力制御装置８に送信され、該滅菌ガス圧力制御装置８で処理された信号がバルブＶ４に送られ開閉／調整される。
他方の信号は、前記ボンベ切替え制御装置９を経てそれぞれの配管Ｋ１、Ｋ２の途中に配置されたからバルブＶ１、Ｖ２に送信される。これにより初期設定重量を維持しているボンベ４または４Ａの何れかに切り替わる。
【００１２】
本発明の滅菌管理システム１の使用方法の一例について説明する。
（１）滅菌機２の電源を入れ、予め滅菌条件を滅菌機２の操作パネル１５よりＣＰＵ（中央処理装置、滅菌ガス圧力の制御装置８を含む）に入力する。前記滅菌条件とは例えば滅菌機２の缶内温度、滅菌時間、滅菌機の外筒温度、被滅菌物の温度、エアレーションの回数等で前記温度等は許容範囲を設定することができる。さらに時間条件では開始、終了の設定ができる。
（２）開始ボタンを押して、前記滅菌条件に従って滅菌工程が開始される。滅菌工程は滅菌開始前の準備も含まれており、前記（１）で示した滅菌機２内の缶内温度や被滅菌物の温度が設定温度に達するまで待つ。
（３）前記（２）の滅菌機２内の缶内温度や被滅菌物の温度が設定温度に達した時、滅菌機２内に滅菌ガスが封入され始める。滅菌機２内に封入される滅菌ガスはボンベ４、４Ａから、ボンベ切替え制御装置９の信号により前記ボンベ４または４Ａのいずれか一方が配管Ｋ１、Ｋ２を通り気化器６を介して滅菌機２に封入される。
（４）滅菌機２内の滅菌ガス圧力は、同滅菌ガス濃度が、滅菌ガス濃度設定装置１８に設定した濃度に達した時の滅菌ガス圧力を維持し、当該滅菌ガス圧力に達した時点より滅菌を開始し所定の時間まで前記滅菌ガス圧力を維持していく。
前記滅菌機２内の圧力は圧力センサー１９で検知し、圧力モニター２０、Ａ／Ｄ変換器７、滅菌ガス圧力制御装置８を介してバルブＶ４の開閉により滅菌機２内の圧力が調整される。
例えば前記滅菌機２内の滅菌ガス濃度が前記滅菌ガス濃度設定装置１８の設定濃度に達すると、バルブＶ４を閉じて、滅菌ガス圧力を維持することができる。他方、滅菌機２内の滅菌ガスの圧力が、滅菌ガス圧力制御装置８の設定許容範囲を下回った場合、滅菌ガス圧力の制御装置８によりバルブＶ４が開き再び、前記（２）で使用したボンベ４、４Ａから滅菌ガスを許容範囲の上限まで加圧封入する。
（５）前記（４）の滅菌ガスを所定時間加圧封入した後、作業者が少なくとも滅菌機２内に入って被滅菌物を取り出して作業ができるガス濃度（25ＰＰｍ以下）になるまで滅菌機２内を減圧と常圧を数回繰り返して滅菌ガスを排出させる。
【００１３】
さらに詳述すると、滅菌工程の途中で、例えば重量測定手段５に載置したボンベ４の重量が減少して、予め重量制御部５Ｂに設定しておいたボンベ４の重量（一本または全てのボンベ４の重量）が前記設定値に達した時、ボンベ切替え制御装置９によりバルブＶ１が遮断され、前記ボンベ４からの滅菌ガスの供給が止まり、新たにバルブＶ２が開きボンベ４Ａからの滅菌ガスの供給が始まる。
また逆に重量測定手段５Ａに載置したボンベ４Ａの重量（一本または全てのボンベ４の重量）が減少して、前記重量制御部５Ｂの設定値に達した時、ボンベ切替え制御装置９によりバルブＶ２が遮断されボンベ４Ａの供給が止まり、新たにバルブＶ１が開きボンベ４からの滅菌ガスの供給が始まる。
【００１４】
図３は本発明の滅菌管理システム１の記録計１７の経時変化の一例を示す概略図である。
例えば横軸の時間（Ｔ）の経過に対して、縦軸に滅菌機２内の圧力（Ｐ）、滅菌ガス濃度（Ｎ）及び温度等（図示せず）を表示することができる。この他に滅菌機２内の湿度を表示することもできる。前記温度には滅菌機２内の缶内温度や滅菌機２の外筒温度、被滅菌物の温度も表示することができる。
図３において、「Ｔ０」は滅菌工程開始時間（被滅菌物の温度を設定値まで上げるために加温を開始する時間）、「Ｔ１」は滅菌ガス封入開始時間、「Ｔ２」は滅菌開始時間（滅菌ガスの設定濃度と対応する所定圧力により開始）、「Ｔ３」は滅菌終了時間（所定圧力による一定時間の維持が終了）、「Ｓ」は滅菌開始時間、「Ｐ１」は圧力（滅菌機２内）、「Ｎ１」はＥＯＧ（滅菌ガス）設定濃度値、「Ｌ１」はＥＯＧ（滅菌ガス）濃度を示す。
図３に示すように、滅菌機２内の圧力Ｐ１は、前記Ｔ０からＳ、ＳからＴ１、Ｔ１からＴ２、Ｔ２からＴ３までの間（ゲージ圧０ｋｇ／ｃｍ ²から真空ポンプ２１により真空状態にし、その後滅菌ガス封入開始時間Ｔ１より滅菌ガスを封入し始めて、ゲージ圧で１ｋｇ／ｃｍ ²近くまで封入するに至るまで、さらに滅菌開始から滅菌終了に至るまでの間）に経時的に変化する。また滅菌機２内の滅菌ガス濃度Ｌ１も図３の点線に示すようにＴ１からＴ３の間に経時的に変化する。さらに詳述すると「滅菌工程開始時間Ｔ０」とは滅菌を実施するにあたり被滅菌物の品温を一定温度に上昇させる為、滅菌器２内の缶内温度や外筒温度等を設定温度まで上げるために加温を開始する時間である。すなわち滅菌機２本体の作動開始時間を示す。
「滅菌開始時間Ｓ」とは、被滅菌物の品温が設定温度に達し、滅菌ガスを封入させる為に真空ポンプ２１の作動を開始して滅菌が開始する時間である。
【００１５】
次に図３を参照しながら、滅菌工程開始から終了に至るまで経時的に説明する。
（滅菌工程開始時間Ｔ０）滅菌機２内の缶内温度、外筒温度、被滅菌物の品温等を設定温度に上昇させるために加温を開始する。
（滅菌開始時間Ｓ）設定温度に達した後、滅菌機２内の圧力を真空ポンプ２１により陰圧にする。
（滅菌ガス封入開始時間Ｔ１）バルブＶ４を開いて滅菌機２内に滅菌ガスの供給を開始する。
（滅菌開始時間Ｔ２）滅菌機２内の滅菌ガス濃度が設定濃度Ｎ１に達した時に、バルブＶ４を閉じて滅菌ガスの供給を一時止め、滅菌を開始する。前記滅菌ガスの設定濃度Ｎ１に対応する滅菌ガス圧力（Ａ／Ｄ変換器に取り込み続けていた圧力）を滅菌ガス圧力制御装置８に記憶させ、その時の滅菌ガス圧力を圧力センサー１９、圧力モニター２０により設定された許容範囲内で監視、維持する。
前記滅菌ガス圧力が設定値を下回った場合、圧力制御装置８を介してバルブＶ４が開き滅菌ガスが滅菌機２内に再封入される。
（滅菌時間終了時間Ｔ３）加圧封入された滅菌ガスを排気すると共に大気圧に戻し陰圧にして数回のエアレーションを繰り返し滅菌機２内の残留ＥＯＧを排出する。
【００１６】
なお本発明では、滅菌ガス濃度の設定置を、（ｍｇ／Ｌ）、重量百分率（％）で管理し、これに対応する所定の圧力で滅菌を行うため、従来の滅菌管理システムのように圧力のみで滅菌を行う方法と比較して、圧力を低くコントロールすることができ、その圧力差分、コストを低減することができる。
また本発明の滅菌管理システムは、従来の滅菌管理システムのように滅菌終了時になっても滅菌ガス濃度を低下させることなく（不活性ガスを過剰に滅菌機２内に供給することなく）、常に一定濃度の滅菌ガスを滅菌機２内に供給することができる。
【００１７】
【発明の作用効果】
（１）滅菌機２内の滅菌ガス濃度と滅菌ガス圧力を、滅菌ガス濃度検出装置３と滅菌ガス圧力制御装置８で制御し、滅菌機２内が滅菌ガス濃度の設定濃度に達した時の滅菌ガス圧力を許容範囲に維持することにより、終始適切な濃度の滅菌ガスを供給することができ、滅菌不良を防止することができる。
（２）重量測定手段５、５Ａにボンベ４、４Ａを載置して、前記ボンベ４、４Ａの重量が設定した重量を下回った時、初期設定重量を維持しているボンベ４または４Ａのいずれかに切り替えて、滅菌機２内に常に設定濃度の滅菌ガスを一定圧力で常に封入することができるので、滅菌不良を防止することができる。
【図面の簡単な説明】
【図１】本発明の滅菌管理システム１の概略図
【図２】本発明の滅菌管理システム１のブロック図
【図３】滅菌記録の概略図
【図４】従来の滅菌管理システム３１の概略図
【符号の説明】
１、３１滅菌管理システム
２、３２滅菌機
３滅菌ガス濃度測定装置
４第１（列目の）滅菌ガスボンベ（ボンベ）
４Ａ第２（列目の）滅菌ガスボンベ（ボンベ）
３４滅菌ガスボンベ（ボンベ）
５第１重量測定手段
５Ａ第２重量測定手段
５Ｂ重量制御部
６、３６気化器
７Ａ／Ｄ変換器
８滅菌ガス圧力の制御装置
９ボンベ切替え制御装置
１５、３５操作パネル
１７、３７記録計
１８滅菌ガス濃度設定装置
１９圧力センサー
２０圧力モニター
２１真空ポンプ
３３ゲージ（圧力）
Ｋ１第１配管
Ｋ２第２配管
Ｋ３第３配管
Ｋ４第４配管
Ｋ５第５配管
Ｖ１第１バルブ
Ｖ２第２バルブ
Ｖ３第３バルブ
Ｖ４第４バルブ
（Ｔ）時間
（Ｎ）ＥＯＧ（滅菌ガス）濃度
（Ｐ）圧力
Ｔ０滅菌工程開始時間
Ｔ１滅菌ガス封入開始時間
Ｔ２滅菌開始時間
Ｔ３滅菌終了時間
Ｓ滅菌開始時間
Ｐ１圧力表示（滅菌機２内）
Ｎ１ＥＯＧ（滅菌ガス）設定濃度値
Ｌ１ＥＯＧ（滅菌ガス）濃度表示
Ａ滅菌手段
Ｂ滅菌ガス供給手段[0001]
BACKGROUND OF THE INVENTION
The present invention relates to an improvement in a sterilization management system for an object to be sterilized such as a medical device, and relates to a sterilization management system capable of controlling a sterilization gas (for example, ethylene oxide gas) concentration and sterilization pressure enclosed in a sterilizer.
[0002]
[Prior art and problems to be solved by the invention]
FIG. 4 is a schematic diagram of a conventional sterilization management system 31.
There is a gas sterilization method as a means for sterilizing an object to be sterilized such as a medical instrument. The sterilization gas includes, for example, ethylene oxide gas or a mixed gas mainly composed of ethylene oxide gas. The ethylene oxide gas (hereinafter abbreviated as “EOG”) and an inert gas such as carbon dioxide gas are sealed in a sterilized gas cylinder (hereinafter abbreviated as “cylinder”) 34 at an arbitrary concentration ratio. The inert gas is sealed in order to keep the pressure in the cylinder 34 high.
At least a plurality of cylinders 34 are arranged in parallel, and sterilization gas is pressurized and sealed in the sterilizer 32 via the vaporizer 36. The pressures of the plurality of cylinders 34 are displayed on the gauge 33. When the weight in the cylinder 34 decreases, the pressure displayed on the gauge 33 also decreases. Therefore, when the operator decreases the pressure from a certain standard by looking at the display on the gauge 33, the cylinder 34 is replaced with a new cylinder (not shown). Exchange.
By the way, in the conventional sterilization management system 31, when the remaining amount in the cylinder 34 decreases, the concentration of sterilization gas introduced into the sterilizer 32 decreases (a lot of inert gas such as carbon dioxide is introduced into the sterilizer 32). As a result, poor sterilization may occur.
For this reason, as a method for determining poor sterilization, for example, the degree of discoloration of the chemical indicator and the sterilization determination of the biological indicator using Bacillus subtilis by the killing of Bacillus subtilis were performed. In some cases, re-sterilization had to be performed each time.
Japanese Patent Publication No. 6-22545 discloses an invention of a “sterilization gas monitoring system”, which describes that the EOG concentration in the sterilizer can be monitored by infrared spectroscopic analysis.
However, in the present invention, no means for controlling the sterilization gas cylinder manifold is disclosed, so when the amount of sterilization gas in the sterilization gas cylinder manifold decreases, the sterilization gas cylinder manifold hole must be switched manually, Is bothersome.
Therefore, as a result of intensive studies to solve the above problems, the present inventors have reached the following invention.
[0003]
[Means for Solving the Problems]
[1] The present invention is constituted by arranging a sterilizing unit (A) with a sterile gas supply means to the downstream side to the upstream side (B),
The sterilization means (A) includes a sterilizer (2), a gas concentration measuring device (3) connected to the sterilizer (2) via a third pipe (K3), and a sterilization gas concentration setting device (18). ) , A sterilization gas pressure control device (8) , a pressure sensor (19) attached to the sterilizer (2), and a pressure monitor (20) connected to the pressure sensor (19),
The gas concentration measurement device (3) constantly or intermittently monitors the sterilization gas concentration in the sterilizer (2) and senses the sterilization gas concentration set by the sterilization gas concentration setting device (18). , These signals are transmitted to the sterilization gas pressure control device (8),
The sterilization gas supply means (B) includes a plurality of first sterilization gas cylinders (4), a plurality of second sterilization gas cylinders (4A) ,
First weight measuring means (5) of the first series of sterile gas cylinders (4) ;
Second weight measuring means (5A) of the second series of sterile gas cylinders (4A) ;
A cylinder switching control device (9) ,
The first series sterilization gas cylinder (4) is connected to a fourth pipe (K4) disposed upstream of the first pipe (K1) via the first pipe (K1),
The second sterilization gas cylinder (4A) is connected to a fourth pipe (K4) disposed upstream of the second pipe (K2) through a second pipe (K2).
The fourth pipe K (4) is connected to a fifth pipe (K5) disposed upstream of the fourth pipe (K4).
The sterilizer (2) is connected upstream of the fifth pipe (K5),
In the middle of the first pipe (K1), a first valve (V1) for adjusting supply / blocking of the sterilization gas in the sterilization gas cylinder (4) of the first series to the sterilizer (2) is mounted,
In the middle of the two pipes (K2), a second valve (V2) for adjusting supply / cutoff of the sterilization gas in the second sterilization gas cylinder (4A) to the sterilizer (2) is mounted,
In the middle of the four pipes (K4), a fourth valve (V4) for adjusting supply / cutoff of each sterilization gas to the sterilizer (2) is mounted,
The cylinder switching control device (9) has a weight control unit (5B),
The cylinder switching control device (9) includes a first valve (V1) for adjusting supply / cutoff of the sterilization gas of the first series of sterilization gas cylinders (4) and a sterilization gas of the second series of sterilization gas cylinders (4A). In conjunction with the second valve (V2) that adjusts supply / cutoff,
Further, the cylinder switching control device (9) controls the sterilization gas cylinder (4) of the first series and the sterilization gas cylinder (4A) of the second series in conjunction with each other,
In the cylinder switching control device (9), the weight of at least one of the first-series sterilization gas cylinder (4) or the second-series sterilization gas cylinder (4A) is initially input to the weight control unit (5B). When the first weight (V1) and the second valve (V2) are opened and closed when the weight falls below a set weight, the first series of sterilized gas cylinders (4) or the second series maintaining the other initial set weight. Can be switched to the sterilization gas cylinder (4A)
The sterilization gas pressure control device (8) of the sterilization means (A) and the fourth valve (V4) of the sterilization gas supply means (B) are interlocked and controlled,
The sterilization gas pressure control device (8) of the sterilization means (A) and the cylinder switching control device (9) of the sterilization gas supply means (B) are interlocked and controlled,
When the sterilization gas concentration in the sterilizer (2) reaches the set concentration of the sterilization gas concentration setting device (18), the sterilization gas pressure at that time is detected by the pressure sensor (19), and the pressure monitor (20) The sterilization gas pressure can be controlled and maintained by closing the fourth valve (V4) by the sterilization gas pressure control device (8) via
When the sterilization gas pressure in the sterilizer (2) falls below the sterilization gas pressure, the sterilization gas pressure control device (8) opens the fourth valve (V4) to supply the sterilization gas to the first system. Provided is a sterilization management system (1) that can be pressurized and sealed in a sterilizer (2) from a row of sterilization gas cylinders (4) or the second series of sterilization gas cylinders (4A) .
[0004]
DETAILED DESCRIPTION OF THE INVENTION
FIG. 1 is a schematic view showing an example of the sterilization management system 1 of the present invention, and FIG. 2 is a block diagram of the sterilization management system 1.
Sterile management system 1 is constructed by arranging a sterilizing gas supply unit B to the upstream side in the sterilization unit A and the downstream side.
The sterilization means A includes a sterilizer 2, a gas concentration measuring device 3 of the sterilizer 2, a sterilizing gas concentration setting device 18, a sterilizing gas pressure control device 8, and a pressure sensor 19.
The sterilizing gas supply means B includes a plurality of first sterilization gas cylinders 4 (hereinafter sometimes simply referred to as sterilization gas cylinders 4) and a plurality of second sterilization gas cylinders 4A (hereinafter simply referred to as sterilization gas cylinders 4). Sterilization gas cylinder 4A), first weight measurement means 5 of the first series of sterilization gas cylinders 4 (hereinafter also simply referred to as weight measurement means 5), and second series of sterilization. The gas cylinder 4A includes a second weight measuring unit 5A (hereinafter sometimes simply referred to as a weight measuring unit 5A) and a cylinder switching control device 9.
When the sterilization gas pressure in the sterilizer 2 reaches the concentration set by the sterilization gas concentration setting device 18, the sterilization management system 1 of the present invention has a predetermined sterilization gas pressure corresponding to the concentration. The sterilization is started when the sterilization gas pressure is reached, and the sterilization gas pressure can be maintained for a predetermined time until the end of sterilization.
[0005]
The sterilization management system 1 of the present invention can maintain the sterilization gas pressure in the sterilizer 2 at a predetermined value by interlocking control of the sterilization gas pressure control device 8 and the cylinder switching control device 9.
Further, the sterilization gas cylinders 4, 4A and the sterilizer 2 are connected via a first pipe K1, a second pipe K2, and a fourth pipe K4 (hereinafter sometimes simply referred to as pipes K1, K2, K4) , A first valve V1, a second valve V2, and a fourth valve V4 (hereinafter sometimes simply referred to as valves V1, V2, and V4) are arranged in the pipes K1, K2, and K4, and the valves V1 and V2 are Interlocking control with the cylinder switching control device 9 is possible. Further, the valve V4 and the sterilization gas pressure control device 8 can be controlled in conjunction with each other.
[0006]
The cylinder switching control device 9 has a weight control unit 5B, and when the weight of at least one of the sterilizing gas cylinders 4 and 4A is less than the initial set weight input to the weight control unit 5B, the valves V1 and V2 By opening and closing, it is possible to switch to the sterilization gas cylinder 4, 4A that maintains the other initial set weight.
A pressure monitor 20 is connected to the pressure sensor 19, and when the sterilization gas concentration in the sterilizer 2 reaches the set concentration of the sterilization gas concentration setting device 18, the sterilization gas pressure at that time is detected by the pressure sensor 19, The valve V4 is closed by the sterilization gas pressure control device 8 through the pressure monitor 20, so that the sterilization gas pressure can be controlled and maintained.
When the sterilization gas pressure in the sterilizer 2 is lower than the sterilization gas pressure, the sterilization gas pressure control device 8 opens the valve 4 to add sterilization gas into the sterilization machine 2 from the sterilization gas cylinders 4 and 4A. It can be sealed.
[0007]
A vaporizer 6 for vaporizing the sterilization gas in the sterilization gas cylinders 4 and 4A is disposed between the sterilization means A and the sterilization gas supply means B, and sterilization is performed from the sterilization cylinders 4 and 4A through the vaporizer 6. Gas can be supplied into the sterilizer 2 to maintain the pressure of the sterilization gas in the sterilizer 2 at a predetermined value. The vaporizer 6 is connected to the sterilizer 2 via a fifth pipe K5 (hereinafter sometimes simply referred to as a pipe K5) .
More specifically, the connection and arrangement relationship of the sterilization gas cylinders 4, 4A, the sterilizer 2, the pipes K1, K2, K4, and the valves V1, V2, V4 are as follows.
The first sterilization gas cylinder 4 is connected to a fourth pipe K4 disposed upstream of the first pipe K1 via the first pipe K1.
The second sterilization gas cylinder 4A is connected to a fourth pipe K4 disposed upstream of the second pipe K2 via the second pipe K2.
The fourth pipe K4 is connected to a fifth pipe K5 disposed upstream of the fourth pipe K4. The sterilizer 2 is connected upstream of the fifth pipe K5.
A first valve V1 for adjusting supply / blocking of the sterilization gas in the sterilization gas cylinder 4 of the first series to the sterilizer 2 is mounted in the middle of the first pipe K1 .
A second valve V2 for adjusting supply / blocking of the sterilization gas in the second series of sterilization gas cylinders 4A to the sterilizer 2 is mounted in the middle of the second pipe K2 .
A fourth valve V4 for adjusting supply / interruption of each sterilization gas to the sterilizer 2 is mounted in the middle of the four pipes K4.

[0008]
Hereinafter, the sterilization means A will be described in detail.
The sterilizer 2 is equipped with a gas concentration measuring device 3, a sterilization gas concentration setting device 18, a sterilization gas pressure control device 8, and a pressure sensor 19 of the sterilizer 2. Further, the sterilizer 2 is equipped with an operation panel 15 for inputting sterilization conditions and a recorder 17 for measuring the sterilization condition. The recorder 17 is adjacent to the sterilization gas concentration setting device 18.
Further, an A / D converter 7 is adjacent to the sterilizing gas pressure control device 8, and the pressure signal in the sterilizer 2 detected by the pressure sensor 19 is sent to the A / D converter 7 via the pressure monitor 20. Is transmitted to the cylinder switching control device 9 via the sterilizing gas pressure control device 8. The pressure signal is also transmitted from the sterilization gas pressure control device 8 to the recorder 17 and recorded.
In the sterilization management system 1 of the present invention, the history of the sterilization gas concentration measured by the sterilization gas concentration detector 3 can be recorded in the recorder 17.
[0009]
The sterilization gas concentration measuring device 3 is sterilized via a third pipe K3 (hereinafter also simply referred to as a pipe K3 ) equipped with a third valve V3 (hereinafter also simply referred to as a valve V3 ). Connected to machine 2.
The sterilization gas concentration measuring device 3 constantly or intermittently monitors the sterilization gas concentration in the sterilizer 2 and senses the sterilization gas concentration set by the sterilization gas concentration setting device 18 so as to control the sterilization gas pressure control device. 8 to send. Further, the sterilization gas concentration measured by the sterilization gas concentration measuring device 3 is transmitted to the recorder 17 as two signals (mg / L) and weight percentage (%) and recorded, and the sterilization gas concentration setting device 18 is set. To the sterilization gas pressure control device 8. The sterilization gas pressure control device 8 can open and close the valve V4.
Examples of the sterilizing gas concentration measuring device 3 in the present invention include an infrared absorption gas concentration measuring device and a gas chromatograph analyzing device, but any device capable of measuring the concentration of sterilizing gas such as EOG can be used. Anything can be used.
Note that a vacuum pump 21 is connected to the sterilizer 2, and the vacuum pump 21 is interlocked with the sterilization gas pressure control device 8.
[0010]
Hereinafter, the sterilization gas supply means B will be described in detail.
The sterilization gas in the sterilization gas cylinders 4 and 4A is introduced (enclosed) into the sterilizer 2 via the vaporizer 6 through the pipes K1, K2 and K4. Valves V1, V2, and V4 are arranged in the middle of the pipes K1, K2, and K4.
The sterilization gas cylinders 4 and 4A are filled with a sterilization gas and an inert gas in the same manner as [0002], and the pressure in the sterilization gas cylinders 4 and 4A is maintained at a high pressure by the inert gas. By opening V4, sterilization gas can be pressurized and sealed in the sterilizer 2.
A plurality of the sterilization gas cylinders 4 and 4A are arranged in parallel. One or all of the sterilization gas cylinders 4, 4 </ b> A can be placed on the weight measuring means 5.
The cylinder switching control device 9 is linked with valves V1 and V2 for adjusting the supply / cutoff of the sterilization gas in the sterilization gas cylinders 4 and 4A, and further linked with the weight measuring means 5 (5A) and the sterilization gas pressure control device 8. is doing.
More specifically, the cylinder switching control device 9 is linked to the weight measuring means 5 and 5A via the weight control unit 5B, and switches the supply of the sterilizing gas from the sterilizing gas cylinder 4 or 4A by opening or closing the valve V1 or V2. be able to.
Further, the valve V4 for adjusting supply / cutoff of the sterilization gas to the vaporizer 6 and the sterilizer 2 is interlocked with the sterilization gas pressure control device 8, and the sterilization gas pressure control device 8 opens / closes / adjusts the valve V4. Can do.
[0011]
The signals of the respective weight measuring means 5 and 5A are transmitted to the cylinder switching control device 9 via the weight control unit 5B. The signal of the cylinder switching control device 9 is divided into two and transmitted.
One signal is transmitted from the cylinder switching control device 9 to the sterilization gas pressure control device 8, and the signal processed by the sterilization gas pressure control device 8 is sent to the valve V4 to be opened / closed / adjusted.
The other signal is transmitted to the valves V1 and V2 because it is disposed in the middle of the pipes K1 and K2 via the cylinder switching control device 9. Thereby, it switches to either the cylinder 4 or 4A which maintains the initial set weight.
[0012]
An example of how to use the sterilization management system 1 of the present invention will be described.
(1) The sterilizer 2 is turned on, and sterilization conditions are input in advance to the CPU (including the central processing unit and the sterilization gas pressure control device 8) from the operation panel 15 of the sterilizer 2. The sterilization conditions can be set within a permissible range, for example, the temperature in the can of the sterilizer 2, the sterilization time, the outer cylinder temperature of the sterilizer, the temperature of the object to be sterilized, the number of aerations, and the like. Furthermore, start and end can be set under time conditions.
(2) Press the start button to start the sterilization process according to the sterilization conditions. The sterilization process includes preparations before the start of sterilization, and waits until the temperature in the can in the sterilizer 2 and the temperature of the object to be sterilized reach the set temperature shown in (1).
(3) When the temperature in the can in the sterilizer 2 and the temperature of the object to be sterilized reach the set temperature in (2), sterilization gas begins to be sealed in the sterilizer 2. The sterilization gas sealed in the sterilizer 2 is sent from the cylinders 4 and 4A, and either the cylinder 4 or 4A passes through the pipes K1 and K2 through the vaporizer 6 in response to a signal from the cylinder switching control device 9. Enclosed.
(4) The sterilization gas pressure in the sterilizer 2 is maintained at the sterilization gas pressure when the sterilization gas concentration reaches the concentration set in the sterilization gas concentration setting device 18, and from the time when the sterilization gas pressure is reached. Sterilization is started and the sterilization gas pressure is maintained until a predetermined time.
The pressure in the sterilizer 2 is detected by a pressure sensor 19, and the pressure in the sterilizer 2 is adjusted by opening and closing the valve V4 via the pressure monitor 20, the A / D converter 7, and the sterilization gas pressure control device 8. .
For example, when the sterilization gas concentration in the sterilizer 2 reaches the set concentration of the sterilization gas concentration setting device 18, the valve V4 can be closed to maintain the sterilization gas pressure. On the other hand, when the pressure of the sterilization gas in the sterilizer 2 falls below the set allowable range of the sterilization gas pressure control device 8, the valve V4 is opened by the sterilization gas pressure control device 8 and the cylinder used in the above (2) again. 4. Sterile gas is pressurized and sealed from 4 and 4A to the upper limit of the allowable range.
(5) After the sterilization gas of (4) is pressurized and sealed for a predetermined time, the sterilizer is operated until the gas concentration (25 PPm or less) is reached so that the operator can enter the sterilizer 2 and take out the object to be sterilized. The sterilization gas is discharged by repeating the reduced pressure and normal pressure several times in 2.
[0013]
More specifically, during the sterilization process, for example, the weight of the cylinder 4 placed on the weight measuring means 5 decreases, and the weight of the cylinder 4 set in the weight control unit 5B in advance (one or all of the cylinders 4). When the weight of the cylinder 4 reaches the set value, the valve switching control device 9 shuts off the valve V1, the supply of the sterilizing gas from the cylinder 4 is stopped, and the valve V2 is newly opened to sterilize the gas from the cylinder 4A. Supply begins.
Conversely, when the weight of the cylinder 4A placed on the weight measuring means 5A (the weight of one or all cylinders 4) decreases and reaches the set value of the weight control unit 5B, the cylinder switching control device 9 The valve V2 is shut off, the supply of the cylinder 4A is stopped, the valve V1 is newly opened, and the supply of sterilization gas from the cylinder 4 is started.
[0014]
FIG. 3 is a schematic view showing an example of a change over time of the recorder 17 of the sterilization management system 1 of the present invention.
For example, the pressure (P), sterilization gas concentration (N), temperature, etc. (not shown) in the sterilizer 2 can be displayed on the vertical axis with respect to the passage of time (T) on the horizontal axis. In addition, the humidity in the sterilizer 2 can be displayed. In the temperature, the temperature in the can in the sterilizer 2, the outer cylinder temperature of the sterilizer 2, and the temperature of the object to be sterilized can be displayed.
In FIG. 3, “T0” is the sterilization process start time (time for starting heating to raise the temperature of the object to be sterilized to the set value), “T1” is sterilization gas filling start time, and “T2” is sterilization start time (Started with a predetermined pressure corresponding to the set concentration of the sterilization gas), “T3” is the sterilization end time (maintenance of the fixed time by the predetermined pressure is completed), “S” is the sterilization start time, “P1” is the pressure (sterilizer) 2), “N1” indicates an EOG (sterile gas) set concentration value, and “L1” indicates an EOG (sterile gas) concentration.
As shown in FIG. 3, the pressure P1 in the sterilizer 2 is from T0 to S, S to T1, T1 to T2, T2 to T3 (from a gauge pressure of 0 kg / cm ² to a vacuum state by a vacuum pump 21). Then, the sterilization gas starts to be sealed from the start time T1 of the sterilization gas, and is changed over time from the start of the sterilization gas to the close to 1 kg / cm ^{2 and} from the start of the sterilization to the end of the sterilization. Further, the sterilization gas concentration L1 in the sterilizer 2 also changes over time between T1 and T3 as shown by the dotted line in FIG. More specifically, “sterilization process start time T0” means that the temperature inside the sterilizer 2 and the outer cylinder temperature are raised to a set temperature in order to raise the temperature of the sterilized product to a certain temperature when performing sterilization. Therefore, it is time to start heating. That is, the operation start time of the sterilizer 2 main body is shown.
The “sterilization start time S” is the time when the product temperature of the object to be sterilized reaches the set temperature and the operation of the vacuum pump 21 is started to sterilize in order to enclose the sterilization gas.
[0015]
Next, with reference to FIG. 3, a description will be given over time from the start to the end of the sterilization process.
(Sterilization process start time T0) Heating is started in order to raise the temperature inside the can in the sterilizer 2, the temperature of the outer cylinder, the product temperature of the article to be sterilized, etc. to the set temperature.
(Sterilization start time S) After reaching the set temperature, the pressure in the sterilizer 2 is made negative by the vacuum pump 21.
(Sterilization gas filling start time T1) The valve V4 is opened and the supply of sterilization gas into the sterilizer 2 is started.
(Sterilization start time T2) When the sterilization gas concentration in the sterilizer 2 reaches the set concentration N1, the valve V4 is closed to temporarily stop the supply of sterilization gas and start sterilization. The sterilization gas pressure corresponding to the set concentration N1 of the sterilization gas (pressure that has been continuously taken into the A / D converter) is stored in the sterilization gas pressure control device 8, and the sterilization gas pressure at that time is stored in the pressure sensor 19 and the pressure monitor 20. Monitor and maintain within the tolerance set by.
When the sterilization gas pressure is lower than the set value, the valve V4 is opened via the pressure control device 8, and the sterilization gas is re-enclosed in the sterilizer 2.
(Sterilization time end time T3) The sterilized gas sealed in pressure is exhausted, returned to the atmospheric pressure, negative pressure is applied, aeration is repeated several times, and residual EOG in the sterilizer 2 is discharged.
[0016]
In the present invention, the setting of the sterilization gas concentration is managed in (mg / L) and weight percentage (%), and sterilization is performed at a predetermined pressure corresponding to this. Compared with the method of performing sterilization alone, the pressure can be controlled low, and the pressure difference and cost can be reduced.
In addition, the sterilization management system of the present invention does not decrease the concentration of sterilization gas even when sterilization is completed as in the conventional sterilization management system (without supplying excessive inert gas into the sterilizer 2). A constant concentration of sterilization gas can be supplied into the sterilizer 2.
[0017]
[Effects of the invention]
(1) When the sterilization gas concentration and the sterilization gas pressure in the sterilizer 2 are controlled by the sterilization gas concentration detection device 3 and the sterilization gas pressure control device 8, and when the sterilizer 2 reaches the set concentration of the sterilization gas concentration By maintaining the sterilization gas pressure within an allowable range, it is possible to supply a sterilization gas having an appropriate concentration throughout and to prevent sterilization failure.
(2) Either the cylinder 4 or 4A maintaining the initial set weight when the cylinders 4 and 4A are placed on the weight measuring means 5 and 5A and the weight of the cylinders 4 and 4A falls below the set weight. Since the sterilizing gas can be always sealed at a constant pressure in the sterilizer 2, sterilization defects can be prevented.
[Brief description of the drawings]
1 is a schematic diagram of a sterilization management system 1 of the present invention. FIG. 2 is a block diagram of a sterilization management system 1 of the present invention. FIG. 3 is a schematic diagram of a sterilization record. [Explanation of symbols]
1, 31 Sterilization management system 2, 32 Sterilizer 3 Sterilization gas concentration measuring device 4 First (row) sterilization gas cylinder (cylinder)
4A second (row) sterile gas cylinder (cylinder)
34 Sterilization gas cylinder (cylinder)
5 First weight measuring means 5A Second weight measuring means 5B Weight control unit 6, 36 Vaporizer 7 A / D converter 8 Sterilization gas pressure control device 9 Cylinder switching control device 15, 35 Operation panel 17, 37 Recorder 18 Sterilization gas concentration setting device 19 Pressure sensor 20 Pressure monitor 21 Vacuum pump 33 Gauge (pressure)
K1 1st piping
K2 Second piping
K3 3rd piping
K4 4th piping
K5 5th piping
V1 1st valve
V2 Second valve
V3 3rd valve
V4 4th valve (T) Time (N) EOG (sterilization gas) concentration (P) Pressure T0 Sterilization process start time T1 Sterilization gas filling start time T2 Sterilization start time T3 Sterilization end time S Sterilization start time P1 Pressure display (sterilizer) 2)
N1 EOG (sterilization gas) set concentration value L1 EOG (sterilization gas) concentration display A Sterilization means B Sterilization gas supply means

Claims

Upstream and sterilizing means (A) on the downstream side is configured by arranging a sterilizing gas supply unit (B),
The sterilization means (A) includes a sterilizer (2), a gas concentration measuring device (3) connected to the sterilizer (2) via a third pipe (K3), and a sterilization gas concentration setting device (18). ) , A sterilization gas pressure control device (8) , a pressure sensor (19) attached to the sterilizer (2), and a pressure monitor (20) connected to the pressure sensor (19),
The gas concentration measurement device (3) constantly or intermittently monitors the sterilization gas concentration in the sterilizer (2) and senses the sterilization gas concentration set by the sterilization gas concentration setting device (18). , These signals are transmitted to the sterilization gas pressure control device (8),
The sterilization gas supply means (B) includes a plurality of first sterilization gas cylinders (4), a plurality of second sterilization gas cylinders (4A) ,
First weight measuring means (5) of the first series of sterile gas cylinders (4) ;
Second weight measuring means (5A) of the second series of sterile gas cylinders (4A) ;
A cylinder switching control device (9) ,
The first series sterilization gas cylinder (4) is connected to a fourth pipe (K4) disposed upstream of the first pipe (K1) via the first pipe (K1),
The second sterilization gas cylinder (4A) is connected to a fourth pipe (K4) disposed upstream of the second pipe (K2) through a second pipe (K2).
The fourth pipe K (4) is connected to a fifth pipe (K5) disposed upstream of the fourth pipe (K4).
The sterilizer (2) is connected upstream of the fifth pipe (K5),
In the middle of the first pipe (K1), a first valve (V1) for adjusting supply / blocking of the sterilization gas in the sterilization gas cylinder (4) of the first series to the sterilizer (2) is mounted,
In the middle of the two pipes (K2), a second valve (V2) for adjusting supply / cutoff of the sterilization gas in the second sterilization gas cylinder (4A) to the sterilizer (2) is mounted,
In the middle of the four pipes (K4), a fourth valve (V4) for adjusting supply / cutoff of each sterilization gas to the sterilizer (2) is mounted,
The cylinder switching control device (9) has a weight control unit (5B),
The cylinder switching control device (9) includes a first valve (V1) for adjusting supply / cutoff of the sterilization gas of the first series of sterilization gas cylinders (4) and a sterilization gas of the second series of sterilization gas cylinders (4A). In conjunction with the second valve (V2) that adjusts supply / cutoff,
Further, the cylinder switching control device (9) controls the sterilization gas cylinder (4) of the first series and the sterilization gas cylinder (4A) of the second series in conjunction with each other,
In the cylinder switching control device (9), the weight of at least one of the first-series sterilization gas cylinder (4) or the second-series sterilization gas cylinder (4A) is initially input to the weight control unit (5B). When the first weight (V1) and the second valve (V2) are opened and closed when the weight falls below a set weight, the first series of sterilized gas cylinders (4) or the second series maintaining the other initial set weight. Can be switched to the sterilization gas cylinder (4A)
The sterilization gas pressure control device (8) of the sterilization means (A) and the fourth valve (V4) of the sterilization gas supply means (B) are interlocked and controlled,
The sterilization gas pressure control device (8) of the sterilization means (A) and the cylinder switching control device (9) of the sterilization gas supply means (B) are interlocked and controlled,
When the sterilization gas concentration in the sterilizer (2) reaches the set concentration of the sterilization gas concentration setting device (18), the sterilization gas pressure at that time is detected by the pressure sensor (19), and the pressure monitor (20) The sterilization gas pressure can be controlled and maintained by closing the fourth valve (V4) by the sterilization gas pressure control device (8) via
When the sterilization gas pressure in the sterilizer (2) falls below the sterilization gas pressure, the sterilization gas pressure control device (8) opens the fourth valve (V4) to supply the sterilization gas to the first system. The sterilization management system (1), wherein the sterilization machine (2) can be pressurized and sealed into the sterilizer (2) from a row of sterilization gas cylinders (4) or the second series of sterilization gas cylinders (4A).