JP7161995B2 - 消毒プロセスの有効性を判定する物品及び方法 - Google Patents
消毒プロセスの有効性を判定する物品及び方法 Download PDFInfo
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- JP7161995B2 JP7161995B2 JP2019535254A JP2019535254A JP7161995B2 JP 7161995 B2 JP7161995 B2 JP 7161995B2 JP 2019535254 A JP2019535254 A JP 2019535254A JP 2019535254 A JP2019535254 A JP 2019535254A JP 7161995 B2 JP7161995 B2 JP 7161995B2
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Description
a.10~50重量部のカチオン性窒素含有配位子モノマーと、
b.10~80重量部のアミドモノマーと、
c.10~40重量部のオキシモノマーと、を含み、
a~cの合計は、100重量部である。
R2は(ヘテロ)ヒドロカルビル基、好ましくは1~10個の炭素原子を有する二価アルキレンであり、
各R3は独立して、H又はヒドロカルビル、好ましくはC1~C4アルキルであり、
R14はH、C1~C4アルキル又は-N(R3)2であり、
R15はH又はヒドロカルビル、好ましくはC1~C4アルキル又はアリールであり、
X1は-O-又は-NR3-であり、
oは0又は1であり、かつ
nは1又は2である]。
R3は-H又はC1~C4アルキルであり、
X1は-NR3-又はOであり、
R1はエポキシ官能性又はエーテル官能性(ヘテロ)ヒドロカルビル基である]のものが挙げられる。より詳細には、エーテル官能基は、低級アルキレンオキシアルキル基である。好ましくは、R1基は、オキシラン(エポキシ)基を有する2~30個の炭素原子の直鎖、分枝鎖、環状又は多環式炭化水素に基づいている。より好ましくは、R8基は、グリシジルメタクリレート(GMA)のように、3~10個の炭素を含む。
R7は(ヘテロ)ヒドロカルビル基、好ましくはヒドロカルビル基、より好ましくはC1~C6アルキレンであり、
R3は-H又はC1~C4アルキルであり、
X1は-NR3-又は-O-である]のものである。
R3は-H又はC1~C4アルキルであり、
X1は-NR3-又は-O-であり、
R12は直鎖又は分枝鎖C2~C4アルキレンであり、
R13は直鎖又は分枝鎖C1~C4アルキルである]の低級モノマーエーテルモノマーを含む。好ましくは、R12基及びR13基の炭素原子の合計は、3~10個、好ましくは3~6個である。
R3は-H又はC1~C4アルキルであり、
各R8はH、アルキル又はアリール基であり、
R9及びR10はアルキル基であるか、又は一緒になって5若しくは6員環を形成し得る]の(メタ)アクリルアミド及びN-ビニルアミドを含む。
実施形態Aは、
グラフト化されたコポリマーを有する不織布基材であって、このコポリマーが、共重合した下記のモノマー単位:
第四級アンモニウム含有配位子モノマー及び/又はグアニジニル含有配位子モノマーから選択されるカチオン性窒素含有配位子モノマー、
アミドモノマー、及び
オキシモノマー、を含む、不織布基材と、
基材に接着された乾燥コーティングであって、複数の試験微生物を含む、乾燥コーティングと、
を含む、物品である。
a)10~50重量部のカチオン性窒素含有配位子モノマーと、
b)10~80重量部のアミドモノマーと、
c)10~40重量部のオキシモノマーと、
d)0~30重量部のポリ(アルキレンオキシド)モノマーと、を含み、
a)~d)の合計は、100重量部である、実施形態Aに記載の物品である。
第1の開口部と第1の開口部から間隔があいている第2の開口部とを有する中空チャネルを有する本体と、
中空チャネル内に固定的に配置された、実施形態A~Sのいずれか1つに記載の物品と、を備える、工程試験用具である。
実施形態AAに記載の工程試験用具の中空チャネルを通して有効量の消毒剤を流すことであって、工程試験用具が、検出培地を収容するリザーバを備え、検出培地は、有効量の栄養素及び指示薬化合物を含み、中空チャネルを通して消毒剤を流すことは、物品を消毒剤と接触させることを含む、流すことと、
中空チャネルを通して消毒剤を流している間、及び/又は中空チャネルを通して消毒剤を流した後に、物品を中空チャネル内の消毒剤と既定の温度にて少なくとも所定の最小接触時間で接触させることと、
物品を消毒剤と中空チャネル内において既定の温度にて少なくとも所定の最小接触時間で接触させた後に、物品を消毒剤の抗菌活性を阻害する有効量の中和剤化合物と接触させることと、
物品を中空チャネル内の検出培地と一定期間接触させることと、
物品を中空チャネル内の検出培地と一定期間接触させた後に、中空チャネル内の検出培地を分析して、指示薬化合物が第1の状態から第2の状態に変化したかどうかを判定することと、を含む、方法である。
実施形態AAに記載の工程試験用具の中空チャネルを通して有効量の消毒剤を流すことであって、工程試験用具が、検出培地を収容するリザーバを備え、検出培地は、有効量の栄養素及び指示薬化合物を含み、中空チャネルを通して消毒剤を流すことは、物品を消毒剤と接触させることを含む、流すことと、
中空チャネルを通して消毒剤を流している間、及び/又は中空チャネルを通して消毒剤を流した後に、物品を中空チャネル内の消毒剤と既定の温度にて少なくとも所定の最小接触時間で接触させることと、
物品を消毒剤と中空チャネル内において既定の温度にて少なくとも所定の最小接触時間で接触させた後に、中空チャネルから多量の消毒剤を排除するために、中空チャネルを通してすすぎ溶媒を流すことと、
物品を中空チャネル内の検出培地と一定期間接触させることと、
物品を中空チャネル内の検出培地と一定期間接触させた後に、中空チャネル内の検出培地を分析して、指示薬化合物が第1の状態から第2の状態に変化したかどうかを判定することと、を含む、方法である。
実施形態U~AAのいずれか1つに記載の工程試験用具の中空チャネルを通して有効量の消毒剤を流すことであって、中空チャネルを通して消毒剤を流すことが、物品を消毒剤と接触させることを含む、流すことと、
中空チャネルを通して消毒剤を流している間、及び/又は中空チャネルを通して消毒剤を流した後に、物品を中空チャネル内の消毒剤と既定の温度にて少なくとも所定の最小接触時間で接触させることと、
物品を消毒剤と少なくとも最小接触時間で接触させた後に、物品を消毒剤の抗菌活性を阻害する有効量の中和剤化合物と接触させることと、
物品を検出培地と一定期間接触させることと、
物品を検出培地と一定期間接触させた後に、検出培地を分析して、試験微生物の生物活性を検出することと、を含む、方法である。
実施形態U~AAのいずれか1つに記載の工程試験用具の中空チャネルを通して有効量の消毒剤を流すことであって、中空チャネルを通して消毒剤を流すことが、物品を消毒剤と接触させることを含む、流すことと、
中空チャネルを通して消毒剤を流している間、及び/又は中空チャネルを通して消毒剤を流した後に、物品を中空チャネル内の消毒剤と既定の温度にて少なくとも所定の最小接触時間で接触させることと、
物品を消毒剤と少なくとも最小接触時間で接触させた後に、中空チャネルから多量の消毒剤を排除するために、中空チャネルを通してすすぎ溶媒を流すことと、
物品を検出培地と一定期間接触させることと、
物品を検出培地と一定期間接触させた後に、検出培地を分析して、試験微生物の生物活性を検出することと、を含む、方法である。
実施形態T~AAのいずれか1つに記載の物品をフローストリーム中の消毒剤と少なくとも既定の最小接触時間で接触させることと、
物品を消毒剤と最小接触時間で接触させた後に、物品を、消毒剤の抗菌活性を阻害する有効量の中和剤化合物と接触させることと、
物品を検出培地と一定期間接触させることと、
物品を検出培地と一定期間接触させた後に、検出培地を分析して、試験微生物の生物活性を検出することと、を含む、方法である。
実施形態T~AAのいずれか1つに記載の物品をフローストリーム中の消毒剤と少なくとも既定の最小接触時間で接触させることと、
物品を消毒剤と最小接触時間で接触させた後に、物品を、消毒剤を含まないすすぎ溶媒と接触させることと、
物品をすすぎ溶媒と接触させた後に、物品を検出培地と一定期間接触させることと、
物品を検出培地と一定期間接触させた後に、検出培地を分析して、試験微生物の生物活性を検出することと、を含む、方法である。
実施例1からのディスクを、水浴中にて25℃でインキュベートしたポリスチレン48ウェル培養プレートのウェルに個々に配置した。ディスクを20マイクロリットルの滅菌脱イオン水で予備湿潤させた。400マイクロリットルのオルトフタルアルデヒド(OPA)溶液(Rapicide OPA28高レベル消毒剤、Medivators Company(Minneapolis,MN)から入手可能)を、最低有効濃度で(滅菌脱イオン水を使用して0.35%OPAに希釈)、各ディスク上にピペットで移した。プレートを25℃で5分間維持した後、600マイクロリットルのグリシン(滅菌脱イオン水中6g/L)を各ウェルに添加した。プレートを室温で更に15分間インキュベートした。インキュベーション期間後、滅菌ピンセットを使用して、第2のポリスチレン48ウェル培養プレート内の新しいウェルに各ディスクを移した。第2のプレートの各ウェルに、L-セリン(1mM)及びレザズリンナトリウム塩(0.03mg/mL)を添加した麦芽抽出ブロス(600マイクロリットル、pH7.5)を収容した。プレートをPARAFILM(登録商標)Mプラスチックパラフィンフィルムで密封し、37℃で21日間インキュベートした。
実施例40に記載したものと同一の手順に従ったが、但し、実施例39のコポリマーグラフト化不織布基材からディスクを打ち抜いた。各ディスクに約5×105個の芽胞を付与した。
滅菌脱イオン水中のポリビニルアルコール(PVA)(平均MW96,000、Alfa Aesar Companyから入手可能)の2%溶液を、等量のアスペルギルス・ブラジリエンシス芽胞懸濁液(1×108個/mL)に添加した。希釈工程の後、得られたコーティング懸濁液の最終PVA含有量は、1%であり、芽胞濃度は、約5×107個/mLであった。次いで、実施例38のコポリマーグラフト化不織布基材から打ち抜かれた直径5mm又は7mmのいずれかの円形ディスク上にピペットを使用して、コーティング懸濁液(10マイクロリットル)をスポットした。スポットされた基材を室温で一晩風乾した。各ディスクに約5×105個の芽胞を付与した。
Claims (6)
- グラフト化されたコポリマーを有する不織布基材であって、前記コポリマーが、共重合した下記のモノマー単位:
第四級アンモニウム含有配位子モノマー及び/又はグアニジニル含有配位子モノマーから選択されるカチオン性窒素含有配位子モノマー、
アミドモノマー、及び
オキシモノマー、
を含む、不織布基材と、
前記基材に接着された乾燥コーティングであって、
水溶性又は水分散性ポリマー結合剤と、
芽胞を含む、複数の試験微生物と、を含む、乾燥コーティングと、
を含み、複数の試験微生物の少なくとも一部分が、ポリマー結合剤中に分散されている、消毒または滅菌プロセスの有効性を検証するための物品。 - 前記グラフト化されたコポリマーが、
a.10~50重量部の前記カチオン性窒素含有配位子モノマーと、
b.10~80重量部の前記アミドモノマーと、
c.10~40重量部の前記オキシモノマーと、
を含み、
a)~c)の合計は、100重量部である、請求項1に記載の物品。 - 第1の開口部と前記第1の開口部から間隔があいている第2の開口部とを有する中空チャネルを有する本体と、
前記中空チャネル内に固定的に配置された、請求項1又は2に記載の物品と、を備える、工程試験用具。 - 前記物品が、前記第1の開口部から前記第2の開口部まで前記中空チャネルを通過する流体が前記物品と接触するように、前記中空チャネル内に構成および配置されている、請求項3に記載の工程試験用具。
- 請求項3に記載の工程試験用具の前記中空チャネルを通して消毒剤を流すことであって、前記中空チャネルを通して前記消毒剤を流すことが、前記物品を前記消毒剤と3分から90分の最小接触時間で接触させることを含む、流すことと、
前記中空チャネルを通して前記消毒剤を流している間、及び/又は前記中空チャネルを通して前記消毒剤を流した後に、前記物品を前記中空チャネル内の前記消毒剤と既定の温度にて少なくとも前記最小接触時間で接触させることと、
前記物品を前記消毒剤と少なくとも前記最小接触時間で接触させた後に、前記物品を前記消毒剤の抗菌活性を阻害する有効量の中和剤化合物と接触させることと、
前記物品を検出培地と一定期間接触させることと、
前記物品を前記検出培地と一定期間接触させた後に、前記検出培地を分析して、前記試験微生物の生物活性を検出することと、を含む、方法。 - 請求項1に記載の物品をフローストリーム中の消毒剤と少なくとも3分から90分の最小接触時間で接触させることと、
前記物品を前記消毒剤と少なくとも前記最小接触時間で接触させた後に、前記物品を前記消毒剤の抗菌活性を阻害する有効量の中和剤化合物と接触させることと、
前記物品を検出培地と一定期間接触させることと、
前記物品を前記検出培地と一定期間接触させた後に、前記検出培地を分析して、試験微生物の生物活性を検出することと、を含む、方法。
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WO2018125798A1 (en) | 2018-07-05 |
US20190338335A1 (en) | 2019-11-07 |
EP3562370A4 (en) | 2020-12-16 |
US11629371B2 (en) | 2023-04-18 |
EP3562370A1 (en) | 2019-11-06 |
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