JP6877444B2 - 消毒用組成物 - Google Patents
消毒用組成物 Download PDFInfo
- Publication number
- JP6877444B2 JP6877444B2 JP2018537796A JP2018537796A JP6877444B2 JP 6877444 B2 JP6877444 B2 JP 6877444B2 JP 2018537796 A JP2018537796 A JP 2018537796A JP 2018537796 A JP2018537796 A JP 2018537796A JP 6877444 B2 JP6877444 B2 JP 6877444B2
- Authority
- JP
- Japan
- Prior art keywords
- disinfection
- cleaning
- quat
- enzyme
- bath
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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- 238000000034 method Methods 0.000 claims description 25
- 102000004169 proteins and genes Human genes 0.000 claims description 22
- 108090000623 proteins and genes Proteins 0.000 claims description 22
- 125000000129 anionic group Chemical group 0.000 claims description 21
- QUCDWLYKDRVKMI-UHFFFAOYSA-M sodium;3,4-dimethylbenzenesulfonate Chemical compound [Na+].CC1=CC=C(S([O-])(=O)=O)C=C1C QUCDWLYKDRVKMI-UHFFFAOYSA-M 0.000 claims description 15
- -1 aryl quat compound Chemical class 0.000 claims description 11
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- 150000001639 boron compounds Chemical class 0.000 claims description 5
- 125000001453 quaternary ammonium group Chemical group 0.000 claims description 5
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- UFHFLCQGNIYNRP-UHFFFAOYSA-N Hydrogen Chemical compound [H][H] UFHFLCQGNIYNRP-UHFFFAOYSA-N 0.000 claims description 3
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- QEKATQBVVAZOAY-UHFFFAOYSA-M sodium;4-propan-2-ylbenzenesulfonate Chemical compound [Na+].CC(C)C1=CC=C(S([O-])(=O)=O)C=C1 QEKATQBVVAZOAY-UHFFFAOYSA-M 0.000 claims description 2
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- 125000004432 carbon atom Chemical group C* 0.000 claims 1
- PUAQLLVFLMYYJJ-UHFFFAOYSA-N 2-aminopropiophenone Chemical compound CC(N)C(=O)C1=CC=CC=C1 PUAQLLVFLMYYJJ-UHFFFAOYSA-N 0.000 description 41
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- JBVOQKNLGSOPNZ-UHFFFAOYSA-N 2-propan-2-ylbenzenesulfonic acid Chemical class CC(C)C1=CC=CC=C1S(O)(=O)=O JBVOQKNLGSOPNZ-UHFFFAOYSA-N 0.000 description 1
- 241000158640 Acanthodactylus aureus Species 0.000 description 1
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Classifications
-
- C—CHEMISTRY; METALLURGY
- C11—ANIMAL OR VEGETABLE OILS, FATS, FATTY SUBSTANCES OR WAXES; FATTY ACIDS THEREFROM; DETERGENTS; CANDLES
- C11D—DETERGENT COMPOSITIONS; USE OF SINGLE SUBSTANCES AS DETERGENTS; SOAP OR SOAP-MAKING; RESIN SOAPS; RECOVERY OF GLYCEROL
- C11D3/00—Other compounding ingredients of detergent compositions covered in group C11D1/00
- C11D3/48—Medical, disinfecting agents, disinfecting, antibacterial, germicidal or antimicrobial compositions
-
- A—HUMAN NECESSITIES
- A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
- A01N—PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF; BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES; PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
- A01N63/00—Biocides, pest repellants or attractants, or plant growth regulators containing microorganisms, viruses, microbial fungi, animals or substances produced by, or obtained from, microorganisms, viruses, microbial fungi or animals, e.g. enzymes or fermentates
- A01N63/10—Animals; Substances produced thereby or obtained therefrom
-
- A—HUMAN NECESSITIES
- A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
- A01N—PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF; BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES; PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
- A01N33/00—Biocides, pest repellants or attractants, or plant growth regulators containing organic nitrogen compounds
- A01N33/02—Amines; Quaternary ammonium compounds
- A01N33/12—Quaternary ammonium compounds
-
- A—HUMAN NECESSITIES
- A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
- A01N—PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF; BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES; PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
- A01N63/00—Biocides, pest repellants or attractants, or plant growth regulators containing microorganisms, viruses, microbial fungi, animals or substances produced by, or obtained from, microorganisms, viruses, microbial fungi or animals, e.g. enzymes or fermentates
- A01N63/50—Isolated enzymes; Isolated proteins
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
- A61L2/16—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using chemical substances
- A61L2/18—Liquid substances or solutions comprising solids or dissolved gases
-
- C—CHEMISTRY; METALLURGY
- C11—ANIMAL OR VEGETABLE OILS, FATS, FATTY SUBSTANCES OR WAXES; FATTY ACIDS THEREFROM; DETERGENTS; CANDLES
- C11D—DETERGENT COMPOSITIONS; USE OF SINGLE SUBSTANCES AS DETERGENTS; SOAP OR SOAP-MAKING; RESIN SOAPS; RECOVERY OF GLYCEROL
- C11D1/00—Detergent compositions based essentially on surface-active compounds; Use of these compounds as a detergent
- C11D1/38—Cationic compounds
- C11D1/62—Quaternary ammonium compounds
-
- C—CHEMISTRY; METALLURGY
- C11—ANIMAL OR VEGETABLE OILS, FATS, FATTY SUBSTANCES OR WAXES; FATTY ACIDS THEREFROM; DETERGENTS; CANDLES
- C11D—DETERGENT COMPOSITIONS; USE OF SINGLE SUBSTANCES AS DETERGENTS; SOAP OR SOAP-MAKING; RESIN SOAPS; RECOVERY OF GLYCEROL
- C11D3/00—Other compounding ingredients of detergent compositions covered in group C11D1/00
- C11D3/02—Inorganic compounds ; Elemental compounds
- C11D3/04—Water-soluble compounds
- C11D3/042—Acids
-
- C—CHEMISTRY; METALLURGY
- C11—ANIMAL OR VEGETABLE OILS, FATS, FATTY SUBSTANCES OR WAXES; FATTY ACIDS THEREFROM; DETERGENTS; CANDLES
- C11D—DETERGENT COMPOSITIONS; USE OF SINGLE SUBSTANCES AS DETERGENTS; SOAP OR SOAP-MAKING; RESIN SOAPS; RECOVERY OF GLYCEROL
- C11D3/00—Other compounding ingredients of detergent compositions covered in group C11D1/00
- C11D3/16—Organic compounds
- C11D3/20—Organic compounds containing oxygen
- C11D3/2003—Alcohols; Phenols
- C11D3/2065—Polyhydric alcohols
-
- C—CHEMISTRY; METALLURGY
- C11—ANIMAL OR VEGETABLE OILS, FATS, FATTY SUBSTANCES OR WAXES; FATTY ACIDS THEREFROM; DETERGENTS; CANDLES
- C11D—DETERGENT COMPOSITIONS; USE OF SINGLE SUBSTANCES AS DETERGENTS; SOAP OR SOAP-MAKING; RESIN SOAPS; RECOVERY OF GLYCEROL
- C11D3/00—Other compounding ingredients of detergent compositions covered in group C11D1/00
- C11D3/16—Organic compounds
- C11D3/34—Organic compounds containing sulfur
- C11D3/3418—Toluene -, xylene -, cumene -, benzene - or naphthalene sulfonates or sulfates
-
- C—CHEMISTRY; METALLURGY
- C11—ANIMAL OR VEGETABLE OILS, FATS, FATTY SUBSTANCES OR WAXES; FATTY ACIDS THEREFROM; DETERGENTS; CANDLES
- C11D—DETERGENT COMPOSITIONS; USE OF SINGLE SUBSTANCES AS DETERGENTS; SOAP OR SOAP-MAKING; RESIN SOAPS; RECOVERY OF GLYCEROL
- C11D3/00—Other compounding ingredients of detergent compositions covered in group C11D1/00
- C11D3/16—Organic compounds
- C11D3/38—Products with no well-defined composition, e.g. natural products
- C11D3/386—Preparations containing enzymes, e.g. protease or amylase
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2202/00—Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
- A61L2202/10—Apparatus features
- A61L2202/17—Combination with washing or cleaning means
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2202/00—Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
- A61L2202/20—Targets to be treated
- A61L2202/24—Medical instruments, e.g. endoscopes, catheters, sharps
-
- C—CHEMISTRY; METALLURGY
- C11—ANIMAL OR VEGETABLE OILS, FATS, FATTY SUBSTANCES OR WAXES; FATTY ACIDS THEREFROM; DETERGENTS; CANDLES
- C11D—DETERGENT COMPOSITIONS; USE OF SINGLE SUBSTANCES AS DETERGENTS; SOAP OR SOAP-MAKING; RESIN SOAPS; RECOVERY OF GLYCEROL
- C11D2111/00—Cleaning compositions characterised by the objects to be cleaned; Cleaning compositions characterised by non-standard cleaning or washing processes
- C11D2111/10—Objects to be cleaned
- C11D2111/14—Hard surfaces
Landscapes
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Engineering & Computer Science (AREA)
- Wood Science & Technology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Organic Chemistry (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Health & Medical Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Zoology (AREA)
- Environmental Sciences (AREA)
- Dentistry (AREA)
- Plant Pathology (AREA)
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Description
(1オーストラリア薬品・医薬品法1989年(Australian Therapeutic Goods Act 1989)の薬品・医薬品規則第54条(Therapeutic Goods Order No 54)に規定された通り(https://www.comlaw.gov.au/Details/F2009C00327)。)
従来技術の例として、内視鏡は、医学診断および治療に使用されることが益々増加している。内視鏡は、指示通りに使用すると、身体の非無菌領域、粘膜、および血液中に存在する微生物で著しく汚れ、極度に汚染される場合がある。したがって、機器は、各使用後に徹底的に洗浄および消毒されなければならない。内視鏡は、物質の組合せで作られている精密機器である。内視鏡は、化学的攻撃に関与する物質に対する感受性を考慮すると洗浄が難しく、アクセス用の細い管腔を有するため、内部表面の洗浄が困難である。
「SCNA guidelines for use of High Level Disinfectants&Sterilants for Reprocessing Flexible Gastrointestinal Endoscopes」に記載されているように、「全ての機器の丹念な手作業での洗浄は、いずれの高水準消毒または殺菌に曝露される前に行わなければならない(Petersenら、2011年;SGNA、2012年)。機器の不適切な洗浄は、可撓性視鏡による感染症の伝染の原因となる1つの要因であることが報告されている(ASGE Standards of Practice Committeeら、2008年;Rutalaら、2008年)。このプロセスは、高水準消毒剤または滅菌剤に対する有機物および微生物の負荷を著しく低減し、生物膜の防止に不可欠なステップである(AlfaおよびHowie、2009年)。内視鏡の詳細な洗浄プロトコールは、SGNAのStandards of Infection Control and Reprocessing of Flexible Gastrointestinal Endoscopes(2012年)に見出される。」2。
(2SCNA guidelines for use of High Level Disinfectants & Sterilants for Reprocessing Flexible Gastrointestinal Endoscopesの9頁。https://www.sgna.org/Portals/0/Issues/PDF/Infection−Prevention/6_HLDGuideline_2013.pdfを参照。)
(3http://jama.jamanetwork.com/article.aspx?articleid=1911326を参照。)
(4SCNA guidelines for use of High Level Disinfectants & Sterilants for Reprocessing Flexible Gastrointestinal Endoscopes。8頁。類似の規格が国際的に適用可能である。)
洗浄用洗浄薬の成分は、滅菌および消毒活性を妨害するため、洗浄ステップと滅菌ステップとの間に、徹底的なすすぎが必要である。第2のステップでは、機器を徹底的にすすいで、洗浄薬、酵素、および他の残留物を除去する。自動内視鏡再処理器(「AER」)で再処理する機器は、このステップでは、典型的には少なくとも3回のすすぎサイクルにかけられる。AERで再処理しない機器は、典型的には、複数回のすすぎが行われる。すすぎには、典型的には、手作業処理では10〜15分間、AERでは6〜10分間かかる。
この10年間で、血液および組織で伝播する可能性のあるもの、例えば、B型肝炎、HIV、および他の感染症等の、非常に深刻で時には致死性である疾患の伝染を回避しようとする関心が特に高まっている。熱感受性機器の場合、高水準消毒は、そのような伝染の回避を確実するための最低限の要件である。例えば、Society of Gastroenterology Nurses and Associates Incによる「Guideline for Use of High Level Disinfectants&Sterilants for Reprocessing Flexible Gastrointestinal Endoscopes」5に記載されているように、消毒ステップは、典型的には、高水準消毒剤を使用することを含み、最も一般的に使用されているものは、過酢酸(「PAA」)、グルタルアルデヒド、オルトフタルアルデヒド(Orthophalaldehyde)(「OPA」)、または高濃度過酸化水素である。
(5https://www.sgna.org/Portals/0/Issues/PDF/Infection−Prevention/6_HLDGuideline_2013.pdf)
(6一般的に使用されているHLDの利点および欠点は、参照文献1の10〜15頁を参照。)
本発明の本質的な特徴は、陰イオン性ヒドロトロープが含まれていることにある。ヒドロトロープは、水溶液中の疎水性化合物を可溶化する化合物である。
望ましくは、「活性保護剤」が存在しており、「活性保護剤」は、(1)酵素安定化化合物および系を含む、液体水溶液中で酵素の安定化に効果的であることが知られている組成物、(2)選択された「ミセル阻害剤」、ならびに(1)および(2)の混合物から選択される。本発明の好ましい実施形態では、「活性保護剤」は、酵素安定化剤であり、より具体的には、好適な濃度のホウ素陰イオンである。本出願では、他の可逆的な酵素阻害剤、例えば、フェニルボロン酸、および欧州特許第0707642号(A1)に記載されている類似化合物が好適であり得る。望ましくは、これらは、ポリオールに溶媒和されており、酵素安定化相乗剤または助剤と組み合わされて、酵素安定化系を形成していてもよい。好ましい「ミセル阻害剤」としては、ミセル形成を修飾ならびに阻害することが知られている種が挙げられ、C1 C6アルカノール、C1 C6ジオール、C2 C24アルキレングリコールエーテル、アルキレングリコールアルキルエーテル、およびそれらの混合物等の水混和性溶媒から選択してもよい。非常に好ましいミセル阻害剤は、ジ−(プロピレングリコール)メチルエーテル(「DPM」)、およびミセル形成を修飾するその類似体である。本発明者により、クワット殺生物剤に付与されている殺生物活性保護を、酵素を不可逆的に変性させずに相乗的に増強することが見出されたDPMと共にホウ酸イオンを使用することを組み合わせることが、特に好ましい。
クワット殺生物剤は、アリールクワット化合物、好ましくはハロゲン化ベンズアルコニウムであることが非常に好ましい。他の殺生物性第四級化合物も使用することができる。
酵素は、保存中、他の酵素の存在下で、ならびに/またはアニオン性界面活性剤、第四級アンモニウム化合物、および洗浄性「ビルダー」等の拮抗性アニオンの存在下で変性する場合があることが周知である。幾つかの酵素安定化系が開発されており、酵素調合物技術分野で周知である。「酵素安定化系」の一例は、過去に単独でまたは選択された他の助剤または相乗剤(例えば、多官能性アミノ化合物、酸化防止剤等)と共に、保存中のおよび種々の製品中のタンパク質分解性等の酵素を保護するために使用されているホウ素化合物(例えば、ホウ酸)である。ホウ素およびカルシウム等の酵素安定化系は、酵素分子をその活性空間配置に保持するように酵素分子を効果的に架橋または留置する分子内結合を形成する。これまで、酵素安定化剤は、クワット殺生物剤の殺生物活性を保護するためには使用されていない。本発明は、少なくとも一部の酵素安定化系が、タンパク質の存在下でのクワット殺生物剤の殺生物活性の保護に効果的であるという驚くべき発見に基づく。
組成物126−8,126−9,126−13,126−14の殺生物効力を、EN1276(殺生物性)およびEN14348(結核菌殺菌性(turbeculocidal))に従って評価した。添付の表6には、これら調合物がHLDを達成するために必要とした処理エンベロープ(濃度、温度、時間)が要約されている。予想通り、ミコバクテリア(TB)は、最も大きな負荷を示した。クワットの濃度を増加させると、殺菌効力が向上した。同時に、水硬度の影響は、当業者が予想するほどクワット活性に有害ではなく、酵素がクワットと共生して、高水準の死滅を達成することができることを示した。
試験生物 Mycobacterium terrae(ATCC15755)
試験温度 40℃、45℃、50℃
接触時間 5分〜30分
製品希釈剤 0ppmおよび300ppm硬水
妨害物質洗浄条件=0.3g/Lのウシ血清アルブミン
汚れ条件=3g/Lのウシ血清アルブミン+3mL/Lの赤血球
対照および検証は全て、基本限度内だった(EN14348)。
添付の表6を参照されたい。
40℃で使用した場合、P126−4は30分以内に殺菌性を示す。
45℃で使用した場合、P126−4は15分以内に殺菌性を示す。
50℃で使用した場合、P126−4は5分以内に殺菌性を示す。
Claims (12)
- タンパク質を含む有機負荷物で汚染された表面を洗浄すると同時に、前記表面の高水準消毒を達成するための方法であって、前記表面が医療機器の表面であり、前記表面を、酵素、殺生物性第四級アンモニウム殺生物剤、陰イオン性ヒドロトロープ、およびホウ素化合物を含む組成物で処理するステップを含む方法。
- ミコバクテリアおよび非エンベロープウイルスに対して少なくとも6対数の減少を達成する、請求項1に記載の方法。
- 前記酵素が、プロテアーゼである、請求項1または2に記載の方法。
- 前記第四級アンモニウム殺生物剤が、アリールクワット化合物である、請求項1〜3のいずれか一項に記載の方法。
- 前記アリールクワット化合物が、ハロゲン化ベンズアルコニウムである、請求項4に記載の方法。
- 前記陰イオン性ヒドロトロープが、アルカリ金属キシレンスルホン酸塩、アルカリ金属クメンスルホン酸塩、他のアルカリ金属アルキルアリールスルホン酸塩、およびそれらの組合せからなる群から選択される、請求項1〜5のいずれか一項に記載の方法。
- 前記陰イオン性ヒドロトロープが、キシレンスルホン酸ナトリウムおよびクメンスルホン酸ナトリウムからなる群から選択される、請求項1〜5のいずれか一項に記載の方法。
- 前記ホウ素化合物が、ホウ酸である、請求項1〜8のいずれか一項に記載の方法。
- 前記組成物が、C1−C6ジオールを含む、請求項1〜9のいずれか一項に記載の方法。
- 前記組成物が、ホウ酸イオンおよびジ−(プロピレングリコール)を含む、請求項10に記載の方法。
- 洗浄および消毒が、単一浴中で実施される、請求項1〜11のいずれか一項に記載の方法。
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US5489531A (en) * | 1990-10-15 | 1996-02-06 | E. R. Squibb And Sons, Inc. | Combined two stage method for cleaning and decontaminating surgical instruments |
DE69425142T2 (de) * | 1993-06-01 | 2001-03-22 | Ecolab Inc., St. Paul | Verdickte reiniger fuer harte oberflaechen |
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US6235692B1 (en) | 1998-08-26 | 2001-05-22 | Cottrell International, Llc | Foaming enzyme spray cleaning composition and method of delivery |
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AU2017210348B2 (en) | 2022-09-08 |
SG11201806124QA (en) | 2018-08-30 |
WO2017124150A1 (en) | 2017-07-27 |
US20210108161A1 (en) | 2021-04-15 |
EP3405218A4 (en) | 2019-08-07 |
CN108834403A (zh) | 2018-11-16 |
EP3405218A1 (en) | 2018-11-28 |
EP3405218B1 (en) | 2023-09-06 |
CN108834403B (zh) | 2022-03-11 |
AU2017210348A1 (en) | 2018-08-02 |
JP2019504077A (ja) | 2019-02-14 |
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