TWI383812B - 適供包裝材料之化學消毒用之水溶液,其製備方法及其用途 - Google Patents
適供包裝材料之化學消毒用之水溶液,其製備方法及其用途 Download PDFInfo
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- 239000007864 aqueous solution Substances 0.000 title claims description 38
- 238000000034 method Methods 0.000 title claims description 32
- 239000005022 packaging material Substances 0.000 title claims description 13
- 239000000126 substance Substances 0.000 title claims description 11
- 238000004659 sterilization and disinfection Methods 0.000 title claims description 10
- 238000002360 preparation method Methods 0.000 title claims description 4
- 230000001954 sterilising effect Effects 0.000 title 1
- MHAJPDPJQMAIIY-UHFFFAOYSA-N hydrogen peroxide Substances OO MHAJPDPJQMAIIY-UHFFFAOYSA-N 0.000 claims description 47
- 239000003381 stabilizer Substances 0.000 claims description 35
- 239000000243 solution Substances 0.000 claims description 21
- 239000007921 spray Substances 0.000 claims description 13
- 238000009455 aseptic packaging Methods 0.000 claims description 9
- OAICVXFJPJFONN-UHFFFAOYSA-N Phosphorus Chemical compound [P] OAICVXFJPJFONN-UHFFFAOYSA-N 0.000 claims description 5
- 229910052698 phosphorus Inorganic materials 0.000 claims description 5
- 239000011574 phosphorus Substances 0.000 claims description 5
- 239000007788 liquid Substances 0.000 claims description 4
- 239000012528 membrane Substances 0.000 claims description 4
- 238000001223 reverse osmosis Methods 0.000 claims description 4
- YDONNITUKPKTIG-UHFFFAOYSA-N [Nitrilotris(methylene)]trisphosphonic acid Chemical group OP(O)(=O)CN(CP(O)(O)=O)CP(O)(O)=O YDONNITUKPKTIG-UHFFFAOYSA-N 0.000 claims description 3
- 238000004448 titration Methods 0.000 claims description 3
- 230000000249 desinfective effect Effects 0.000 claims description 2
- ABLZXFCXXLZCGV-UHFFFAOYSA-N phosphonic acid group Chemical group P(O)(O)=O ABLZXFCXXLZCGV-UHFFFAOYSA-N 0.000 claims description 2
- 238000004806 packaging method and process Methods 0.000 description 4
- BASFCYQUMIYNBI-UHFFFAOYSA-N platinum Chemical compound [Pt] BASFCYQUMIYNBI-UHFFFAOYSA-N 0.000 description 4
- 238000003287 bathing Methods 0.000 description 3
- 230000008901 benefit Effects 0.000 description 3
- 239000000460 chlorine Substances 0.000 description 3
- 238000001816 cooling Methods 0.000 description 3
- 238000001704 evaporation Methods 0.000 description 3
- 238000007254 oxidation reaction Methods 0.000 description 3
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 3
- 239000002253 acid Substances 0.000 description 2
- 238000005516 engineering process Methods 0.000 description 2
- 230000008020 evaporation Effects 0.000 description 2
- 238000012858 packaging process Methods 0.000 description 2
- 229910052697 platinum Inorganic materials 0.000 description 2
- 238000003860 storage Methods 0.000 description 2
- 229910021654 trace metal Inorganic materials 0.000 description 2
- PAWQVTBBRAZDMG-UHFFFAOYSA-N 2-(3-bromo-2-fluorophenyl)acetic acid Chemical compound OC(=O)CC1=CC=CC(Br)=C1F PAWQVTBBRAZDMG-UHFFFAOYSA-N 0.000 description 1
- 101100313097 Caenorhabditis elegans tba-8 gene Proteins 0.000 description 1
- OKTJSMMVPCPJKN-UHFFFAOYSA-N Carbon Chemical compound [C] OKTJSMMVPCPJKN-UHFFFAOYSA-N 0.000 description 1
- ZAMOUSCENKQFHK-UHFFFAOYSA-N Chlorine atom Chemical compound [Cl] ZAMOUSCENKQFHK-UHFFFAOYSA-N 0.000 description 1
- UFHFLCQGNIYNRP-UHFFFAOYSA-N Hydrogen Chemical compound [H][H] UFHFLCQGNIYNRP-UHFFFAOYSA-N 0.000 description 1
- 101150102320 SWC3 gene Proteins 0.000 description 1
- 241000555745 Sciuridae Species 0.000 description 1
- 150000001412 amines Chemical class 0.000 description 1
- QVGXLLKOCUKJST-UHFFFAOYSA-N atomic oxygen Chemical compound [O] QVGXLLKOCUKJST-UHFFFAOYSA-N 0.000 description 1
- 230000015572 biosynthetic process Effects 0.000 description 1
- 229910052799 carbon Inorganic materials 0.000 description 1
- 229910052801 chlorine Inorganic materials 0.000 description 1
- 238000004140 cleaning Methods 0.000 description 1
- 239000012141 concentrate Substances 0.000 description 1
- 239000000356 contaminant Substances 0.000 description 1
- 238000000354 decomposition reaction Methods 0.000 description 1
- -1 described Chemical compound 0.000 description 1
- 230000003670 easy-to-clean Effects 0.000 description 1
- 238000004880 explosion Methods 0.000 description 1
- 239000012467 final product Substances 0.000 description 1
- 239000007789 gas Substances 0.000 description 1
- 239000001307 helium Substances 0.000 description 1
- 229910052734 helium Inorganic materials 0.000 description 1
- SWQJXJOGLNCZEY-UHFFFAOYSA-N helium atom Chemical compound [He] SWQJXJOGLNCZEY-UHFFFAOYSA-N 0.000 description 1
- 239000001257 hydrogen Substances 0.000 description 1
- 229910052739 hydrogen Inorganic materials 0.000 description 1
- 239000012535 impurity Substances 0.000 description 1
- 229910052500 inorganic mineral Inorganic materials 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 239000011707 mineral Substances 0.000 description 1
- 230000003647 oxidation Effects 0.000 description 1
- 239000001301 oxygen Substances 0.000 description 1
- 229910052760 oxygen Inorganic materials 0.000 description 1
- 239000000047 product Substances 0.000 description 1
- 238000000746 purification Methods 0.000 description 1
- 239000012264 purified product Substances 0.000 description 1
- 150000003839 salts Chemical class 0.000 description 1
- 238000005507 spraying Methods 0.000 description 1
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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
- 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
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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
- 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
- A61L2/186—Peroxide solutions
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- A—HUMAN NECESSITIES
- A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
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- A61L12/08—Methods or apparatus for disinfecting or sterilising contact lenses; Accessories therefor using chemical substances
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- B65B55/00—Preserving, protecting or purifying packages or package contents in association with packaging
- B65B55/02—Sterilising, e.g. of complete packages
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Description
本申請案主張2005年9月12日提出申請的歐洲專利申請案第05108331.9號之權益,其以引用方式納入本文。
本發明係關於適供包裝材料之化學消毒用之水溶液,尤其是包含過氧化氫者。本發明也關於一種製備此等水溶液之方法及有關其供包裝材料之化學消毒用之用途。
使用過氧化氫於包裝材料之化學消毒係已知者。已有兩種此等無菌包裝法存在著。第一種為浸浴包裝法,其中係將包裝材料浸入過氧化氫溶液中,諸如在歐洲專利申請案EP 0342485中所述者。此等方法中的消毒常在典型的80℃高溫中操作。為了防止過氧化氫在此高溫下分解,在消毒溶液中必須含有高量的安定劑。
第二種無菌包裝法為噴霧包裝法,其中係用過氧化氫溶液沖洗包裝材料,諸如在例如德國專利申請案DE 19945500中所述者。於此等方法中所用過氧化氫溶液必須具有非常低的乾燥剩餘物以防止蒸發器或噴霧段結垢及避免因此所致之頻繁清潔。該乾燥剩餘物可,與其他一起者,源自H2
O2
溶液中所含安定劑。因此,該噴霧技術需要低量的安定劑。
因此至今為止都不可避免地要使用兩種不同的過氧化氫溶液於兩種方法中。此迫使在現場最常具有兩種程序的包裝機使用者要配置兩種不同的貯存設施而在取用兩種產品中之一者時可能發生錯誤。
在開發可同時用於噴霧及浸浴兩種方法的單一過氧化氫溶液之企圖中,SOLVAY INTEROX GmbH的美國專利申請案US 2004/0247755提出一種新的食料相容性安定劑,亦即,胺基三亞甲基膦酸。此種安定劑可以被低量而有效地使用,尤其是在浸浴法中。不過,此等H2
O2
溶液的乾燥殘餘物在也要適用於噴霧技術中時仍然太高。
本發明的目的包括開發出一種新穎的過氧化氫溶液,其可同時用在浸浴法和噴霧法中的包裝材料之化學消毒,且其具有下列特點:.其係安全者.其可符合藥典標準.其不含有害污染物諸如在過氧化氫製造中自動氧化程序所用的蒽醌.其可使噴霧法設備的加熱器組塊中或浸浴法設備的橡膠滾筒上避免發生結垢或沈積物.其在運送和貯存時具穩定性.其符合食品級品質的法令要求或其他應用法規之要求.其在運作中至少有120小時的穩定期.其包含可溶於水或稀酸中的安定劑,使得包裝機容易清潔和維護。
就此目標而言,本發明係有關一種適供包裝材料之化學消毒用之水溶液,其包含過氧化氫與至少一種食料相容性安定劑,其中在不含該食料相容性安定劑時的該溶液具有以PO4 3 -
表示時為10毫克/仟克之最大磷含量,且呈現出在105℃時最多為10毫克/仟克的乾燥剩餘物。
本發明諸特性點之一在於使用較佳地足夠低量之食料相容性安定劑,配合在添加該食料相容性安定劑之前的溶液中之低雜質含量,以產生低乾燥剩餘物。此種搭配促成可提供可同時用於浸浴法和噴霧法兩種無菌包裝程序中之單一過氧化氫溶液。
本發明水溶液於不含食料相容性安定劑之時具有以PO4 3 -
表示為10毫克/仟克之最大磷含量。此含量常低於或等於8毫克/仟克。於大部份情況中,其係低於或等於5毫克/仟克。其較佳者低於或等於2.5毫克/仟克。通常,其高於或等於0.1毫克/仟克。該磷含量係以熟知的ICP-法測量。
本發明水溶液(包括食料相容性安定劑)通常具有以PO4 3 -
表亦為10毫克/仟克之最大磷含量。此含量較佳者低於或等於8毫克/仟克。於大部份情況中,其高於或等於0.1毫克/仟克。
本發明水溶液具有1毫克/仟克之最大氯含量。此含量常低於或等於0.75毫克/仟克。於大部份情況中,其係低於或等於0.5毫克/仟克。其較佳者係低於或等於0.1毫克/仟克,且最佳者低於或等於0.05毫克/仟克。通常,其係高於或等於0.001毫克/仟克。
本發明水溶液於不含食料相容性安定劑之時在105℃時呈現的乾燥殘餘物為最多10毫克/仟克,通常最多7毫克/仟克,且較佳者最多5毫克/仟克。此乾燥殘餘物常高於或等於0.1毫克/仟克,特別者高於或等於0.5,且於許多情況中至少1毫克/仟克。該乾燥殘餘物係對於添加食料相容性安定劑之前的溶液,根據下述程序以重量法測量:1.將一鉑皿置於900℃蒙浮爐內1小時
2.將該皿置於乾燥器內冷卻,然後秤重到最近於0.0001克;令此重量為B克。
3.將一100毫升燒杯秤重到最接近0.0001克且記錄此重量;於此燒杯中加入:.100克樣品(若H2
O2
濃度為50%或更低者之時).50克樣品(若H2
O2
濃度高於50%之時)
4.將該燒杯再秤重到最接近0.0001克。添加樣品之前與之後的燒杯重量差值為W/克。
5.若使用50克樣品時用去礦質水將樣品稀釋到約100毫升。
6.逐漸地且小心地將樣品轉移到鉑蒸發皿內,用冷水包住。若該皿極為乾燥(其會閃亮),其會結冰。此處必注意者:過氧化氫的分解會伴隨產生實質量的熱及氣體形成;樣品必須在充分冷卻下分小份地小心添加。
7.在蒸汽浴上小心地蒸發該溶液直到乾燥。必須注意者:在蒸發之前若不能使過氧化氫完全分解可能令使樣品濃縮到足以產生爆炸危險。
8.將該皿置於105℃烤箱內至少一小時。
9.置於乾燥器內冷卻30分鐘後,將該皿秤重到最接近0.0001克。令此重量為A,克。
10.使用下面的方程式計算在105℃時之殘量:105℃殘量,其中:.A(單位克)為裝有蒸發殘餘物的皿重.B(單位克)為空皿的重量.W(單位克)為加到皿中的樣品之重量。
本發明水溶液(包含食料相容性安定劑)呈現出,根據上述程序測量,最多為10毫克/仟克,較佳者,最多7毫克/仟克之在105℃時之乾燥殘餘物。此乾燥殘餘物常高於或等於0.1毫克/仟克,且最常者高於或等於0.5毫克/仟克。
本發明水溶液通常呈現出從20至150μS/cm,特別者從50至90μS/cm之導電係數。該導電係數係根據標準DIN IEC 60746-1的方法測量者。該水溶液的導電係數可經由於其中添加鹽,諸如硝酸銨或礦物酸予以調整。
本發明水溶液常呈現出從10至50重量%,特別者從20至45重量%,最佳者從30至40重量%,典型者約35重量%之過氧化氫濃度。過氧化氫濃度係根據ISO標準7157(草稿版本)測量。
本發明水溶液常呈現5毫莫耳/仟克之最大酸度。
本發明水溶液包含食料相容性安定劑。此安定劑可選自食料相容性膦酸。其一例子為在專利申請案US 2004/0247755中所述的胺基三亞甲基膦酸,該案的內容以引用方式納入本文。安定劑的量通常為至少0.5毫克(100%安定劑)/仟克H2
O2
溶液,特別者至少1毫克/仟克H2
O2
溶液。該量常低於或等於50毫克(100%安定劑)/仟克H2
O2
溶液,尤其是低於或等於10毫克/仟克H2
O2
溶液,且較佳者低於或等於8毫克/仟克H2
O2
溶液。該量為例如約5毫克(100%安定劑)/仟克H2
O2
溶液。該安定劑可用水溶液形式,例如含50重量%安定劑者。
由於安定劑的存在,本發明水溶液中的過氧化氫濃度呈現出高穩定性。其常為使得在96℃下16小時後的相對滴定流失百分比低於或等於起始過氧化氫濃度的5%。此穩定性係根據ISO標準7161(草稿版本)的方法測量者。
本發明水溶液可經由可用來製備過氧化氫水溶液且純化到乾燥殘餘物為諸如上述者的程度之任何恰當方法,及經由於其中添加食料相容性安定劑,其量為低到足以使乾燥殘餘物成為上述者,而製備成。
一種可能的過氧化氫溶液製備法包括熟知的使用蒽醌、氫和氧的自動氧化法,諸如在Kirk-Othmer Encyclopedia of Chemical Technology,1981,3r d
Edition,vol 13,pages 16-21中所載者。
一種可能的純化所得過氧化氫溶液之方法包括使用膜以逆滲透法處理該過氧化氫溶液。其例子可參考專利申請案EP 0930269和WO 2005/033005(為SOLVAY(SocitAnonyme,所有)。
本發明因而也關於一種製備上述水溶液之方法,其中將過氧化氫溶液在加入安定劑之前;使用一膜以逆滲透法予以純化。
本發明水溶液可以有利地用於包裝材料之化學消毒。本發明因而也關於上述水溶液供包裝材料之化學消毒用之用途。
本發明水溶液的諸優點之一在於下述事實:彼溶液可用為浸浴無菌包裝法中的浸浴液體以及在噴霧無菌包裝法中的噴霧液體。
另一項優點在於本發明水溶液的高穩定性,尤其是用於浸浴無菌包裝程序中之時。此穩定性經表成如下:在至少120小時操作中,過氧化氫濃度與起始值的差異於大部份情況中不超過10%。
由於低安定劑含量,在噴霧包裝機的加熱器中發生結垢和堵塞的風險為之減低。
本發明要在下列實施例中藉由示範說明予以進一步描述。
根據自動氧化法製備未經純化的過氧化氫溶液且接著予以蒸餾。最後產物呈現下列特徵:H2
O2
濃度:35%w/w微量金屬:Al <0.1 ppm Cr 0.03 ppm Fe 0.12 ppm Ni 0.02 ppm Cl 0.1 ppm SO4 2 -
0.1 ppm P以PO4 3 -
計 17.3 ppm總有機碳(TOC):50 ppm乾燥殘餘物:25 ppm
然後將此溶液使用SWC3型,由HYDRANAUTICS公司供給的膜,在約28巴的壓力下以逆滲透法純化。最後經純化的產物呈現下列特徵:H2
O2
濃度 35% w/w微量金屬:Al <0.005 ppm Cr <0.002 ppm Fe <0.005 ppm Ni <0.002 ppm Cl <0.005 ppm SO4 2 -
<0.05 ppm P以PO4 3 -
計 <1 ppm TOC:<5 ppm乾燥殘餘物:<2 ppm
之後,加入胺基三亞甲基膦酸,商品名稱CUBLEN AP1(製造商ZSCHIMMER & SCHWARZ,MOHSDORF GmbH & Co KG),其量為10毫克,呈50重量%水溶液每仟克H2
O2
溶液之形式,作為安定劑。
此經安定化的H2
O2
水溶液經依序用於TBA8、TBA9、TBA19和TBA21型之浸浴無菌包裝機中,以及用在COMBIBLOC公司的噴霧無菌包裝機中。兩類型機器都運轉至少120小時而沒有減損其性能。
Claims (13)
- 一種適供包裝材料之化學消毒用之水溶液,其包含:- 過氧化氫,與- 至少一種食料相容性安定劑,其特徵在於,在不含該食料相容性安定劑時的此溶液具有:- 以PO4 3- 表示為10毫克/仟克的最大磷含量,及- 在105℃下最多為10毫克/仟克的乾燥殘餘物。
- 根據申請專利範圍第1項之水溶液,其具有從50至90微西門子/厘米(μS/cm)之導電係數。
- 根據申請專利範圍第1或2項之水溶液,其具有從35至40重量%的過氧化氫濃度。
- 根據申請專利範圍第1或2項之水溶液,其中該過氧化氫濃度呈現以在96℃下16小時後相對滴定流失最大值為5%表示之高穩定性。
- 根據申請專利範圍第1或2項之水溶液,其呈現5毫莫耳/仟克之最大酸度。
- 根據申請專利範圍第1或2項之水溶液,其中該食料相容性安定劑為膦酸。
- 根據申請專利範圍第6項之水溶液,其中該食料相容性安定劑為胺基三亞甲基膦酸。
- 根據申請專利範圍第1或2項之水溶液,其包含從0.5至50毫克/仟克H2 O2 溶液的該食料相容性安定劑。
- 根據申請專利範圍第8項之水溶液,其包含從1至10毫克/仟克H2 O2 溶液的該食料相容性安定劑。
- 一種申請專利範圍第1或2項之水溶液的製備方法,其中過氧化氫溶液,在將安定劑加到其中之前,經使用一膜以逆滲透法予以純化。
- 一種用於對包裝材料進行化學消毒之方法,包括使用申請專利範圍第1項之水溶液,此係藉由將該包裝材料浸泡於該水溶液中,或以該水溶液噴霧該包裝材料而進行。
- 根據申請專利範圍第11項之方法,其中彼水溶液係用為浸浴液體以用於浸浴無菌包裝程序中以及用為噴霧液體以用在噴霧無菌包裝程序中。
- 根據申請專利範圍第11或12項之方法,其中該水溶液係用於浸浴無菌包裝程序中且其中該過氧化氫濃度在至少120小時的操作之中,與起始值相差不超過10%。
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DE102011111523B8 (de) * | 2011-08-31 | 2013-03-28 | Sig Technology Ag | Verfahren und Vorrichtung zur Kantenentkeimung von Verpackungsmaterial |
MX343146B (es) | 2011-09-16 | 2016-10-26 | Solvay | Conjunto adaptador y proceso para suministrar un esterilizante a un sistema de envasado para limpiar y llenar envases. |
CA2852185C (en) | 2011-11-10 | 2019-12-03 | Solvay Sa | An adapter assembly and a process for supplying a sterilant to a packaging system for cleaning and filling of packages |
TWI642452B (zh) | 2013-07-18 | 2018-12-01 | 日商三菱瓦斯化學股份有限公司 | 殺菌用過氧化氫水溶液及其製造方法 |
JP6642454B2 (ja) | 2015-01-16 | 2020-02-05 | 三菱瓦斯化学株式会社 | 殺菌剤及びそれを用いた殺菌方法 |
FR3043560B1 (fr) * | 2015-11-18 | 2019-12-27 | Arkema France | Solution aqueuse de peroxyde d'hydrogene comprenant un stabilisant specifique |
WO2018092812A1 (ja) * | 2016-11-16 | 2018-05-24 | 大日本印刷株式会社 | 殺菌剤のガス化装置 |
EP3744182B1 (en) * | 2016-11-16 | 2022-09-14 | Dai Nippon Printing Co., Ltd. | Gasifier for sterilizer |
JP6365645B2 (ja) * | 2016-12-01 | 2018-08-01 | 大日本印刷株式会社 | 殺菌剤のガス化装置 |
KR20230017922A (ko) | 2017-01-31 | 2023-02-06 | 미츠비시 가스 가가쿠 가부시키가이샤 | 살균용 과산화수소 수용액 |
JP6888636B2 (ja) * | 2017-02-20 | 2021-06-16 | 大日本印刷株式会社 | 殺菌剤ガス化装置及び殺菌剤ガス化装置の洗浄方法 |
FR3119327A1 (fr) | 2021-02-01 | 2022-08-05 | Arkema France | Solution pour stérilisation chimique à faible taux de résidu |
KR20230153362A (ko) | 2021-03-08 | 2023-11-06 | 미쯔비시 가스 케미칼 컴파니, 인코포레이티드 | 살균용 과산화수소 수용액 그리고 이것을 이용한 대상물의살균방법 및 살균된 대상물의 제조방법 |
WO2022272257A1 (en) * | 2021-06-23 | 2022-12-29 | Evonik Corporation | A process for sterilization treatment using a residue-free hydrogen peroxide |
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US7776261B2 (en) | 2010-08-17 |
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ATE498410T1 (de) | 2011-03-15 |
AU2006290748B2 (en) | 2012-03-29 |
US20080226497A1 (en) | 2008-09-18 |
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EP1926502B1 (en) | 2011-02-16 |
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