200901073 九、發明說明 【發明所屬之技術領域】 本發明係有關於，使用包含人或動物等之固 建立關連至檢體的細胞或培養基等生物由來之原 養皿或離心管等谷益或樂品等之資材的原材料， 全操作櫃等無囷操作區域中進彳了細胞調製之際的 管理方法及細胞調製管理系統。更具體而言，是 與原料或資材建立關連而被裝備在該資材之IC 線通訊裝置中所擔持的識別資訊，和被連接成可 資訊之讀取器等無線讀取裝置進行無線通訊的資 置中所預先儲存的與其建立關連的對應之細胞調 訊，會被藉由電腦而發揮機能的前記資訊處理 對，兩者是否一致之結果是被當成核對資訊而輸 調製的操作者，係可一面確認所輸出之前記核對 面在無菌操作區域中依照必要的程序，嚴密地進 製的此種細胞調製管理方法及細胞調製管理系統 【先前技術】 在近年的治療醫學中，將從活體採取到的細 養，以使失去的活體組織再生的醫療、亦即所謂 療之硏究，正如火如荼地進行著。伴隨於此’要 個與檢體相關連的細胞’培養至例如治療所需的 包含因繼代等細胞調製所致之容器的更換’至少 數次細胞調製工程，隨情況不同’會用到100至 有之已被 料、和培 在例如安 細胞調製 有關於， 標籤等無 與讀取該 訊處理裝 製指示資 裝置所比 出，細胞 資訊，一 行細胞調 胞加以培 的再生醫 將至少1 細胞量， 需要進行 3 00左右 200901073 或以上的容器或多種類的複數藥劑等資材。此時，必須要 排除例如容器或室間的交叉污染、防止人爲疏失等，要求 著嚴格的作業程序，這些自不待言（例如，參照專利文獻 1 )。又’細胞調製後的細胞培養以達到必要之細胞量的 工程’係和工業品或食品製造時不同，就管理面而言也需 要經常對每個細胞的履歷做嚴密的監控（例如參照非專利 文獻1 )。因此’培養基更換 '離心分離、繼代等之細胞 調製，通常建議是在依照製藥GMP ( Good Manufacturing Practice )基準的設施中，遵照稱作 SOP ( Standard Operating Procedure )的標準作業程序書來進行（例如參 照非專利文獻2)。 專利文獻1中係記載著，於細胞培養時要增殖到一定 量的細胞數，通常需要進行細胞的繼代培養，而在進行此 種繼代培養時，容器內的培養基之更換、或將細胞再播種 至繼代培養用的新培養基等這類繁雜的細胞調製，必須要 用手作業來進行之。又記載著，伴隨這些繼代培養的細胞 調製，係爲了抑制複數容器間或室間的交叉污染等之發 生，必須視情況而由熟練作業者來進行之，爲了提升其作 業性，在進行培養的容器上備有條碼等識別資訊，一面讀 取該條碼而一面管理進行培養的容器之裝置。非專利文獻 1中係記載著，被關連對應到各個檢體的細胞的成長係不 均勻，在成長後，在製造工程中必須將細胞分成複數群組 而要監視容器更換或培養工程，依情況不同，在製造工程 前後，含有所謂脫逸工程的非流程作業性工程等。又，非 -6 - 200901073 專利文獻2中還記載著，「此種事例的情況下，硬體（細 胞處理設施）當然是基於製藥GMP而計畫、設計、興 建’同時還要實施驗收’但關於軟體（製造管理及品質管 理）則是有義務要作成S OP」。 [專利文獻1]日本特開2004-16194號公報 [專利文獻2]日本專利第3 706 1 2 8號說明書 [非專利文獻1 ]「考慮人類組織培養不均勻性的速度 論評估與生物製程設計」阪大院.基礎工〇（正）紀之岡 正博.（正）田谷正仁（2003年8月12日 化學工學會 秋季大會 硏究發表演講要旨） [非專利文獻2]『空調設備與工廠系統』（ηο.Π 日 _LL工廠技術公報誌 2005.December) 10〜II頁 【發明內容】 [發明所欲解決之課題] 可是’此種細胞調製工程，幾乎都必須要在形成無菌 操作區域的安全操作櫃或細胞調製用作業台等，依照必要 的程序’嚴密地執行各作業階段而實施。因此，至少由數 個工程所成的細胞調製中，每1工程所需要的原料或資材 等原材料’必須要攜帶進無菌操作區域而進行細胞調製， 將原材料分類成在細胞調製後進行保管的有用物和廢棄 物’例如’若需要將有用物予以冷凍保存時，則有用物是 被搬出至配有冷凍庫的保管室等之區域中。另一方面，用 過即丟的廢棄物’則是例如被搬出至設置在無菌操作區域 200901073 附近的廢棄室。然後’再次將必要的原材料攜入至無菌操 作區域’反覆進行下個工程。因此，於至少由數個工程所 成的細胞調製時’被重複攜入至無菌操作區域的包含容器 或藥品等資材的原材料的種類與數量，會達到很龐大的數 目。又’在細胞調製時所使用的容器等資材，基於交叉污 染防止之觀點而多半是用過即丟，如此一來，廢棄資材的 種類或數量也會達到很大數目。 例如’從一位患者採取未分化狀態的數CC的骨髓， 要使其中所含之1 0 7〜1 0 8程度的間葉系幹細胞量，增殖到 1 0 7〜1 0 8程度的細胞量’然後投予給該患者來進行治療的 再生醫療技術’是已經存在（例如參照專利文獻2)。 圖8係此種再生醫療中所使用的本人由來之細胞，進 行培養之際所必須的包含培養皿或離心管等資材之原材料 管理的典型模式圖。若包含使用以培養來進行細胞增殖之 際所使用的自己血清所需之末梢血，來作成培養基的工 程，則每1人所需要的物量爲，例如培養皿3 0 0個以上， 離心管2 5 0根左右，由此可知這是爲數不小的物量。專利 文獻1中所記載的裝置，雖然可藉由確認初代培養及繼代 培養之細胞所被關連到的培養程序或條件等，以對應拿錯 或交叉污染防止等最低限度的需求，但並非設想到要確實 地毫無疏失地管理如此龐大數目的各種資材，其管理上是 有極限存在。再者’細胞調製後’將原材料分類成有用物 與廢棄物的作業亦很繁雜’在有用物與廢棄物很容易發生 錯拿的狀態下’有時可能會導致用過即丟的資材被判斷成 -8- 200901073 有用物而再度使用，此種絕不容許的交叉污染事故恐怕會 發生。 本發明係有鑑於此種情事而硏發，目的在於提供一種 細胞調製管理方法及細胞調製管理系統，可確實無疏失地 管理在無菌操作區域之細胞調製中所被操作的龐大數量的 包含容器或藥劑等資材之原材料，藉此以防患未然地避免 給活體所帶來的危險。 [用以解決課題之手段] 爲了達成前記目的，申請項1中所記載的發明，係一 種在無菌操作區域中使用原材料來進行細胞調製之際的細 胞調製管理方法，其特徵爲，使用包含固有之已被建立關 連至檢體的細胞或培養基等生物由來之原料和培養皿或離 心管等容器或藥品等之資材的原材料，在無菌操作區域中 進行細胞調製之際，至少與用來識別原料的原料識別資 訊、用來識別細胞調製工程的工程識別資訊、用來識別資 材的資材識別資訊等之識別資訊的每一者建立關連的細胞 調製指示資訊，是被預先儲存在藉由電腦而發揮機能的資 訊處理裝置中；被連接成可與該裝置通訊的無線讀取裝 置，將搬入至無菌操作區域的原材料或搬出之原材料上所 著裝的無線通訊裝置中所預先擔持的識別資訊，加以讀 取；資訊處理裝置，係將前記已被讀取之識別資訊、和前 記細胞調製指示資訊所被建立關連之對應的識別資訊，進 行核對，將兩者是否一致的結果，當成核對資訊而加以輸 -9- 200901073 出；藉由細胞調製的操作者，確認到前記核對資訊是一致 時，才繼續進行細胞調製。 申請項2中所記載的發明，係一種方法，係屬於在細 胞調製時所被使用的包含細胞或培養基等生物由來之原料 與培養皿或離心管等容器或藥品等之資材的原材料，是藉 由細胞調製的操作者而被搬入至無菌操作區域的，在無菌 操作區域中使用原材料來進行細胞調製之際的細胞調製管 理方法，其特徵爲，含有：使得前記原材料上所被裝著的 無線通訊裝置中，預先被擔持有用來唯一識別前記原材料 的識別資訊之步驟；和使得藉由電腦而發揮機能的資訊處 理裝置中預先儲存有，至少已被建立關連至前記識別資訊 的細胞調製指示資訊之步驟；和被連接成可與前記資訊處 理裝置通訊的無線讀取裝置，將被搬入無菌操作區域中的 前記原材料之識別資訊，加以讀取之步驟；和前記資訊處 理裝置，係將前記已被讀取之識別資訊、和前記細胞調製 指示資訊所被建立關連之對應的前記識別資訊，進行核 對’將兩者是否一致之判定結果’當成核對資訊而加以輸 出之步驟；當所被輸出之前記核對資訊是表示一致的核對 資訊時，則繼續前記原材料往無菌操作區域的搬入；當所 被輸出之前記核對資訊是表示不一致的核對資訊時，則中 斷前記原材料往無菌操作區域的搬入，並實施錯誤處理。 申請項3中所記載的發明’係在申請項2中所記載的 發明之特徵中’加入以下特徵：在中斷了前記原材料往無 菌操作區域的搬入，並實施錯誤處理後，藉由前記操作者 -10- 200901073 而再度開始前記原材料往無菌操作區域的搬入。 申請項4中所記載的發明，係在申請項2或3中所記 載的發明之特徵中’加入以下特徵：更含有：前記資訊處 理裝置，係將所輸出之前記核對資訊，顯示在被裝備於前 記無菌操作區域的顯示手段上之步驟。 申S靑項5中所記載的發明，係一種方法，係屬於在無 菌操作區域中細胞調製時所被使用的包含細胞或培養基等 生物由來之原料與培養皿或離心管等容器或藥品等之資材 的原材料，是藉由細胞調製的操作者，選別成用過即丟容 器等之廢棄原材料和原料保持狀態之搬送原材料，並從前 記無菌ί架作區域中予以搬出的，在無菌操作區域中使用原 材料來進行細胞調製之際的細胞調製管理方法，其特徵 爲’含有：使得前記原材料上所被裝著的無線通訊裝置 中’預先被擔持有用來唯一識別前記原材料的識別資訊之 步驟；和使得藉由電腦而發揮機能的資訊處理裝置中預先 儲存有’至少已被建立關連至前記識別資訊的、內嵌有用 來識別前記原材料是屬於前記廢棄原材料還是屬於前記搬 送原材料之廢棄原材料資訊的細胞調製指示資訊之步驟； 和被連接成可與前記資訊處理裝置通訊的無線讀取裝置， 在前記原材料被搬入至前記無菌操作區域之際，將前記原 材料的前記識別資訊’加以讀取之步驟；和前記資訊處理 裝置’係將前記已被讀取之識別資訊、和前記細胞調製指 不資訊所被建立關連之對應的前記識別資訊，進行核對， 將兩者是否一致之判定結果，當成核對資訊而加以輸出之 -11 - 200901073 步驟；當所被輸出之前記核對資訊是表示一致的核對資訊 時’則首先將前記原材料搬入至前記無菌操作區域，接著 在細胞調製進行後’從前記無菌操作區域中所搬出的前記 原材料’是被選別成前記廢棄原材料或前記搬送原材料之 任一者；當所被輸出之前記核對資訊是表示不一致的核對 資訊時’則中斷前記原材料往無菌操作區域的搬入，並實 施錯誤處理。 申請項6中所記載的發明，係在申請項5中所記載的 發明之特徵中’加入以下特徵：在中斷了前記原材料往前 記無菌操作區域的搬入’並實施錯誤處理後，藉由前記操 作者而再度開始前記原材料往前記無菌操作區域的搬入。 申請項7中所記載的發明，係在申請項5或6之任一 項中所記載的發明之特徵中，加入以下特徵：在進行了細 胞調製之後’前記原材料被從前記無菌操作區域中搬出之 際’更含有.則|5無線讀取裝置係再度讀取前記識別資訊 之步驟；和則記資訊處理裝置’係將前記已被讀取之識別 資訊、和前記細胞調製指示資訊所被建立關連之對應的前 記識別資訊’進行核對後的判定結果，當成第2核對資訊 而加以輸出之步驟；基於所被輸出之前記第2核對資訊， 藉由前記操作者’將前記原材料選別成前記廢棄原材料或 是前記搬送原材料之任一者。 申請項8中所記載的發明，係在申請項5至7之任~ 項中所記載的發明之特徵中，加入以下特徵：更含有：前 記資訊處理裝置’係將所輸出之前記核對資訊及/或前記 -12- 200901073 第2核對資訊’顯示在被裝備於前記無菌操作區域的顯 手段上之步驟。 申請項9中所記載的發明’係在申請項4中所記載 發明之特徵中’加入以下特徵：前記廢棄原材料被從前 無菌操作區域排出之後，經由被裝備有被連接成可與前 資訊處理裝置通訊之第2無線讀取裝置的傳遞箱而被搬 至廢棄室之際’前記第2無線讀取裝置，係讀取被著裝 前記廢棄原材料的前記無線通訊裝置的前記識別資訊； 記資訊處理裝置，係將前記已被讀取之識別資訊、和內 有前記廢棄指不資訊之前記細胞調製指示資訊所被建立 連之對應的前記識別資訊，進行核對，將兩者是否一致 判定結果’當成第2核對資訊而加以輸出；藉由前記操 者，當所被輸出之前記第2核對資訊是表示一致的核對 訊時，則繼續前記廢棄原材料從前記無菌操作區域往前 廢棄室的搬送；當前記第2核對資訊是表示不一致的核 資訊時，則中斷前記廢棄原材料從前記無菌操作區域往 記廢棄室的搬送，並實施錯誤處理。 申請項1 0中所記載的發明，係在申請項9中所記 的發明之特徵中，加入以下特徵：在中斷了前記原材料 前記無菌操作區域往前記廢棄室的搬送，並實施錯誤處 後，藉由前記操作者而再度開始前記原材料從前記無菌 作區域往前記廢棄室的搬送。 申請項1 1中所記載的發明，係在申請項9或1 0之 一項中所記載的發明之特徵中，加入以下特徵：更含有 示 的 記 記 送 在 二 a- 刖 嵌 關 的 作 資 記 對 刖 載 從 理 操 任 -13- 200901073 前記資訊處理裝置’係將所輸出之前記第2核對資訊，顯 不在被裝備於則記無菌操作區域的顯示手段上之步驟。 申sra項1 2中所g己載的發明，係一種使用細胞調製的 包含細胞或培養基等生物由來之原料與培養皿或離心管等 容器或藥品等之資材的原材料來進行細胞調製之際的細胞 調製管理系統’其特徵爲，含有：無菌操作區域，係有被 著裝有用來唯一識別前記原材料之識別資訊事先予以擔持 之無線通訊裝置的原材料’被搬入其中，而在細胞調製後 被搬出；和藉由電腦而發揮機能的資訊處理裝置，係被預 先儲存有細胞調製指示資訊’其係內嵌有，前記原材料上 所被著裝之前記無線通訊裝置之前記識別資訊所被建立關 連之對應的識別資訊；和被連接成可與前記資訊處理裝置 通訊的無線讀取裝置’係用來讀取前記原材料上所被著裝 之前記無線通訊裝置之前記識別資訊；和輸出手段，係爲 前記資訊處理裝置，將前記已被讀取之識別資訊、和前記 細胞調製指示資訊所被建立關連之對應的前記識別資訊， 進行核對’將兩者是否一致之判定結果，當成核對資訊而 加以輸出；前記資訊處理裝置，係當所被輸出之前記核對 資訊是表示一致的核對資訊時，則藉由前記操作者，繼續 進行前記原材料從前記無菌操作區域的搬出或搬入；當所 被輸出之前記核對資訊是表示不一致的核對資訊時，則中 斷前H5原材料從前記無菌操作區域的搬出或搬入，並實施 錯誤處理。 申i靑項]3中所記載的發明，係在申請項1 2中所記載 -14 - 200901073 的發明之特徵中’力口入以下特徵：在前記資訊處理裝置中 所被預先儲存的前記細胞調製指示資訊內，係內嵌有，用 來識別即記原材料是屬於用完即丟容器等之廢棄原材料或 是原料保持狀態之搬送原材料的廢棄原材料資訊。 申請項1 4中所記載的發明，係在申請項12或丨3之 任一項中所記載的發明之特徵中，加入以下特徵：在前記 無囷操作區域中’裝備有前記資訊處理裝置。 申請項1 5中所記載的發明，係在申請項1 2至1*之 任一項中所記載的發明之特徵中，加入以下特徵：前記資 訊處理裝置’係將用來顯示所輸出之前記核對資訊的顯示 手段’裝備在前記無菌操作區域中。 申請項1 6中所記載的發明，係在申請項1 3或15之 任一項中所記載的發明之特徵中，加入以下特徵：更含有 廢棄室，係Jjy· 目U g己無囷操作區域所排出的前記廢棄原材 料予以廢棄。 申請項1 7中所記載的發明，係在申請項1 6中所記載 的發明之特徵中’加入以下特徵：更含有傳遞箱，係在將 從前記無菌操作區域所排出之前記廢棄原材料，搬送至前 記廢棄室之際，用來讓前記廢棄原材料經由之用。 申請項1 8中所記載的發明，係在申請項1 7中所記載 的發明之特徵中，加入以下特徵：前記傳遞箱，係更具備 被連接成可與前記資訊處理裝置通訊的無線讀取裝置，其 係用來讀取前記廢棄原材料上所被著裝之前記無線通訊裝 置中所被預先擔持的前記識別資訊。 -15- 200901073 可是’本發明中的進行細胞調製之無菌操作區域，係 例如實施例所示般地’含有：安全操作櫃，其係具有讓細 胞調製所用之原材料出入的插入口、和操作已被插入之原 材料的收容部；和操作桌台’其係具備被裝備在該插入口 附近的讀取器等之無線讀取裝置、無線天線、顯示用的觸 控面板等。或者’本發明的無菌操作區域，係可包含被配 置在細胞調製室中的周圍被管理成無菌狀態的細胞調製用 作業台’或將操作桌台配置在外部而以機械手等進行遠端 操作的這類細胞調製室本身。無論如何，被搬出入之原材 料上所被著裝之1C標籤等的無線通訊裝置中，預先擔持 的ID號碼等之識別資訊，係以讀取器等無線讀取裝置加 以讀取’所被讀取到的識別資訊，係與預先儲存之包含例 如指示書等的細胞調製指示資訊所被關連到的識別資訊進 行核對，可確實地執行1個1個之作業的此種無菌操作區 域，較爲理想。再者，在細胞調製指示資訊中，爲了使1 工程之細胞調製完成後，將從無菌操作區域搬出的原材 料，確實地選別處理成應廢棄之原材料與應保管之原材 料，理想上係至少儲存有，與原材料之識別資訊相關連的 廢棄指示資訊。 【實施方式】 圖1係使用本發明所述之細胞調製管理系統來進行細 胞調製之際的程序之槪略及全體系統的槪念圖。 若按照圖8所想定的情形來說明’則身爲細胞調製對 -16- 200901073 象的患者（捐贈者）的檢體，係於醫院中被採取，該檢體 係於所被搬送之符合 GMP標準的細胞處理設施（Ceu P r 〇 c e s s i n g C e n t e r = C P C )中，經過培養收件、細胞調 製、培養、保存及出庫等各個程序而處理，處理好的檢 體’係從細胞處理設施遞送到醫院，然後投予給捐贈患 者。這些程序，理想上係爲依照例如S Ο P爲依據者。圖2 係表示程序進行中的具體手續之一例。圖2所示的例子 中’在細胞調製或培養之前的檢體採取階段中，作成檢體 ID編號；於培養的收件階段中，作成含有檢體ID編號所 被關連到的指示書等的細胞調製指示資訊；於細胞調製培 養階段中’在執行如此作成之指示書時，作成要被擔持 在’包含原料及資材之原材料上所被著裝之1C標籤中的 識別資訊。指示書係如後述，是用來指示細胞調製的每一 工程中所必須之原材料、或該工程中所進行之作業內容的 相關資訊用的資料。 圖3係本發明所述之系統所被實裝之方塊型細胞處理 設施（CPC) 100之一例。圖3中係圖示了，經由穿衣、 脫衣室的人的移動、與經由傳遞箱之原材料的移動、與依 照程序之手續後被廢棄之廢棄物的移動。在細胞處理設施 1 0 0中係設有’在實施程序之際所用到的重要機器（3 0 i〜 3 0 6 )或系統的資訊終端亦即子機（2 0 1〜2 0 3 )所被分別 配備的保管室1 20 '準備室ϊ 30、及細胞調製培養室丨4〇， 和至少配備有管理系統全體的資訊處理裝置亦即母機204 的管理室π 〇。本發明就典型上而言，係爲在圖3之細胞 -17 - 200901073 調製培養室1 4 0中所配置的生物危害防制用之安全操作櫃 3 03內所進行的細胞調製管理方法，是爲其所設計的細胞 調製管理系統。 圖4係相當於本發明所述之細胞調製之際所用的圖3 所示之生物危害防制用操作櫃3 03，例如安全操作櫃之一 實施形態的斜視圖。安全操作櫃3 0 3，例如係爲立方體形 狀，其內部爲，細胞調製所用之與捐贈者之檢體相關連的 細胞或培養基等、被收納在原料容器3 2 1中的生物由來之 原料，還有將這些原料，使用培養皿320或離心管322等 容器或藥品3 23等資材來進行細胞調製的收容部3 1 4。 這些原料或資材係總稱爲原材料。 安全操作櫃3 03的前面亦可設置開閉隔門。設置隔門 的情況下，隨著隔門的開閉，就會形成讓原材料出入用的 插入口 3 1 6。圖4係爲已經將細胞調製上所必須之培養皿 或離心管等資材，搬入一部份後的狀況。離心管3 22，係 例如在藉由被配設在圖3之安全操作櫃3 03附近的離心機 3 04來進行純化分離等情況中使用。又，在圖3的細胞調 製培養室1 4 0內，亦可配備有：初代培養及繼代培養時所 用的培養箱306、或裝備有細胞調製後將使用過的原料容 器32 1等廢棄資材予以廢棄之際用以讀取該資材上所被擔 持之I D編號之讀取器的廢棄室或廢棄箱3 0 5。在此種細 胞調製培養室】40內使用安全操作櫃3 03來進行細胞調製 時，細胞調製的操作者3 1 8係一面目視確認收容部3丨4， 一面依照程序來進行必要作業。例如，將必要的原材料攜 -18- 200901073 入至收容部3 1 4時，操作者係將原材料一個一個地，或是 一次複數原材料地，從插入口 3 1 6攜入。各原材料上係著 裝有1C標籤3 24，構成該1C標籤的1C晶片裡，係擔持有 用來識別原材料的ID編號。典型來說，此處所用的安全 操作櫃3 0 3的插入口 316的附近，配置有操作桌台3 27， 其係具備：用來讀取I C標籤中所擔持之ID編號的讀取器 3 2 5、讀取器用之天線3 2 6、顯示用之觸控面板3 2 8等。操 作桌台3 2 7 ’係具有圖3的資訊終端（子機）2 〇 3之機 能’是被連接成可與資訊處理裝置（母機）204通訊。 藉由細胞調製的操作者3 1 8，從插入口 3 1 6被攜入至 安全操作櫃3 0 3之收容部3 1 4內的原材料的每一者，係每 次通過了操作桌台3 27時，原材料上所著裝之1C標籤中 所擔持的ID編號，會被天線3 26確實地測知，而被讀取 至讀取器3 25。讀取器325，係亦可和圖3的資訊終端203 一體化。資訊終端（201〜203 )之每一者，係如上述，是 被連接成可和管理室的資訊處理裝置（母機）204進行通 訊’資訊處理裝置204係藉由電腦而發揮機能。另一方 面，被讀取器3 2 5所讀取到的ID編號，和核對所需之指 示書所被關連到的，含有指示書的細胞調製指示資訊，係 如以下詳細說明般地於事前作成，並預先被儲存在該資訊 處理裝置204中。 細胞處理設施1 00的資訊處理裝置204，係具備：儲 存有應用程式的資料庫伺服器、執行應用程式的應用程式 伺服器、具有通訊機能的w e b伺服器；並透過網路而連接 -19- 200901073 至資訊終端（2 0 1〜2 0 3 )。這些資訊終端（2 0卜 係具有輸出入機能’還具有用來將資料寫入IC 輸入機能。在資料庫中係儲存有：檢體資料；和 資料1對1對應的工程資料；和與該工程資料1 的複數之指示書資料；和與該複數之指示書資料 呈1對多對應的複數之原材料資料。亦即’ 1個 上係被關連到1個工程資料；1個工程資料上係 複數個指示書資料；複數個指示書資料的每一者 連到複數個原材料資料。在資料庫中係還儲存有 用的主資料，例如，人、部屬、職種等之作業者 爲原稿的指示書資訊、身爲工程作成規則的工程 材料資訊、檢查資訊、還有設備機器資訊或安排 需要之假日資訊等。 資料庫所儲存的應用程式，係具有：檢體資 能、工程管理機能、指示書管理機能、原材料管 ID核對機能 '主管理機能。檢體機能，係發行 用來與其他檢體進行區別所需之固有的檢體ID 連同檢體資訊一倂加以管理。在圖2所示的培養 中’會將幾個、何者、哪個檢體要進行何種作業 程。接著’工程管理機能係作成檢體固有的工程 示書資料、原材料資料。這些資料，係因爲與固 ID編號建立關連，因此關於有被賦予ID編號的 料’都可從系統側予以判別。工程管理機能係還 胞調製所需之工程的進度狀況。指示書管理機能 ^ 2 03 )， 標籤用的 與該檢體 對多對應 之每一者 檢體資料 被關連到 上係被關 ，共通使 資訊、身 資訊、原 行程上所 訊管理機 理資訊、 於系統內 編號，並 收件階段 ，加以排 資料、指 有的檢體 所有原材 會管理細 ，係除了 -20- 200901073 指示哪個檢體的哪個作業中具體要做什麼以外，還會記錄 作業結果的適呈與否或實效數量等。原材料管理機能，係 管理哪個檢體的哪個作業中’需要哪個原材料多少程度。 ID核對機能’係將原材料管理機能所指示之預先儲存的 原材料ID編號、和被ID輸入機能所輸入之id編號，進 行核對。主管理機能’係將主資料予以儲存、變更、保 持。 基於圖5的原材料管理之槪念圖及圖6之表示管理及 作業程序的流程圖’說明本發明的一實施形態。 圖5的槪念圖的橫向中所包含的N 〇. 1 (收件）至 N 〇 · 8 (投予）的一連串指示書的組，係爲基於工程作成規 則所作成的工程資料。 工程資料’係針對何時、進行哪個作業，沿著時間軸 而將指示書加以排列’而被作成。被當成工程資料而組合 的指示書，係被儲存在資料庫的主資料中備用；指示書的 組合’係可配合檢體的種類、年齡、性別等，而可選擇各 種組合。依照各個指示書，對每一捐贈者的檢體，具體地 作成在縱向上包含（1 )使用之原材料至（5 )廢棄物的資 訊，並預先儲存在例如資訊處理裝置204的資料庫中。 具體表示內容的指示書例子，指示書No.4係爲圖7。 指示書中係顯示有，安全操作櫃編號、作業日期、操 作者姓名、細胞資訊（細胞的種類、提供者姓名、採取日 等）、作業內容、搬入原材料的ID清單等，此種指示 書，係被顯示在觸控面板3 2 8上。例如，當作業內容是繼 -21 - 200901073 代處理時，則因爲需要將細胞的移轉源的細胞培養完成之 培養皿’從培養箱3 0 6拿到安全操作櫃3 〇 3，因此，特定 之培養皿的ID編號’會被顯示在指示書中。又，在繼代 處理中’對新的空培養皿注入所定之培養液以形成培養 基’然後’例如’從培養細胞的培養皿中取出培養液，使 用藥品等而將培養細胞移換到離心管等，藉由離心機3 〇 4 進行純化分離後，將培養細胞移換至該培養基。爲了進行 這些作業’除了新培養皿或離心管以外，還有移換用的道 具如微量滴管等’是透過傳遞箱，從保管室120而被搬入 至準備室130及細胞調製培養室14〇。因此，在指示書 No.4的搬入原材料清單中也會顯示出，關於這些原料、資 材所被個別賦予的每一ID編號。指示書係還含有，細胞 調製後應被廢棄之廢棄原材料的ID編號清單。含有如此 所作成的一連串之指示書之組合的細胞調製指示資訊，是 被預先儲存在資訊處理裝置。 圖5係想定了’使用被賦予有id編號之原材料來進 行細胞調製的原材料管理之槪念圖。於此圖中若以包括 No·4的縱向部份來說明，則首先（1 )使用的原材料，係 從例如培養箱3 06中取出，攜入至安全操作櫃3 0 3的有被 賦予培養細胞之ID編號的培養皿等。接著（2 )新的資 材’係爲要放進被移換之培養細胞的培養皿等，此階段中 係未賦予ID編號。在培養細胞被移換到新的資材後，例 如與系統之資訊建立關連之狀態下，藉由可輸出標籤的市 售標籤貼紙印表機’將事前準備之（3 )使用標籤，著裝 -22- 200901073 至新資材上，此處，就成爲新資材上有被賦予ID編號之 狀態（（4 )完成的原材料）。該標籤（label )係被著裝 有IC標籤（tag )，藉由被印刷在表面的資訊，就可目視 確認被寫入在IC標籤之資訊者，較爲理想。最後的（$ ) 廢棄物，係經由上記（1 )使用之原材料的培養細胞，是 已被移換到（2)新資材，而變成要被廢棄的使用過之培 養皿等之資材。 細胞調製的操作者3 1 8，係可將如此被著裝在原材料 的1C標籤的ID編號’與已被建立關連至細胞調製指示資 訊的對應之ID編號，一面以觸控面板3 2 8進行確認，— 面確實地實施1個1個的細胞調製之作業。 此處’藉由圖6的流程圖’說明例如安全操作櫃3 〇 3 內的作業程序。 於S4〇0中’含有事前作成之指示書的細胞調製指示 資訊，是被儲存在資訊處理裝置2 04中。 於S410中’操作者318’是按照觸控面板328上所 顯示之細胞調製指示資訊，使必要的原材料，經由操作桌 台3 2 7掃描。 於S420中，操作桌台327的讀取器3 2 5，係將被攜 入至安全操作櫃3 0 3的原材料上所著裝的1C標籤，讀取 ID編號，並發送至資訊處理裝置204。 於S430中，資訊處理裝置204，係將被發送過來的 I D編號’與事先儲存的細胞調製指示資訊所被關連到的 對應之ID編號，進行核對，將兩者是否—致的結果，當 -23- 200901073 成核對資訊而加以輸出，顯示在觸控面板3 2 8上。 操作者3 1 8係確認核對資訊，若其爲表示兩者不一致 之核對資訊時，則於S440中，進行錯誤處理。所謂表示 不一致的核對資訊’係指被攜入的原材料，並非細胞調製 指示資訊中指示的原材料。因此，所謂錯誤處理，係想定 爲例如中斷作業、攜入正確的原材料，或若發生了檢體 ID有異等此種嚴重事態之際，則也可能整個作業都要從 頭來過。 錯誤處理後，於S4 5 0中，操作者3 1 8，係針對攜入 至安全操作櫃303的原材料，再次開始S430。當表示兩 者一致之核對資訊的情況下，於S 4 6 0中，操作者3 1 8係 繼續將原材料攜入至安全操作櫃3 〇 3的作業，根據細胞調 製指示資訊中所含之原材料管理資訊，確認所需要的原材 料是否齊備。 於S 4 7 0中’若仍有必要之原材料尙未齊備時，則操 作者3 1 8係繼續原材料往安全操作櫃3 〇 3的攜入作業。 於S480中，操作者318’係在安全操作櫃303中備 齊必要之原材料的階段時，基於細胞調製指示資訊中所含 之作業資訊，實施細胞調製。 於S4 90中’被攜入的原材料，在細胞調製後，全部 會從安全操作櫃303中搬出。爲了確認是否全部被搬出， 亦可設計成，當原材料從安全操作櫃3〇3排出之際，令其 經由操作桌台3 27、再度被讀取器32S讀取’藉由資訊處 理裝置204而輸出第2核對資訊。 -24- 200901073 於S5 00中，操作者318係基於細胞調製指示資訊中 所含之原材料管理資訊’將搬出的原材料，選別成廢棄原 材料、或要被暫時保管在培養箱3 06或保管室12〇等的搬 送原材料之任一者。 於S510中’若確認到搬出之原材料是屬於搬送原材 料時，則操作者3 1 8係將搬送原材料搬出至目的區域。 於S 5 2 0中，當確認到搬出的原材料是屬於廢棄原材 料時’則操作者3 1 8係將廢棄原材料，例如送進往廢棄室 305的傳遞箱，被裝備在該傳遞箱上的第2讀取器，會讀 取被著裝在廢棄原材料上的1C標籤的id編號，發送至資 訊處理裝置204。接著，資訊處理裝置204，係將被發送 過來的Ϊ D編號’與事先儲存的細胞調製指示資訊所被關 連到的對應之ID編號，進行核對，將兩者是否一致的結 果’當成核對資訊而加以輸出，顯示在觸控面板328上。 於S5 3 0中，操作者318係確認核對資訊，若其爲表 示兩者不一致之核對資訊時，則進行錯誤處理。此時，表 示不一致的核對資訊，係代表被攜入的原材料並非廢棄原 材料之意，因此要確認是否爲搬送原材料，例如使其被搬 送往必要的區域。這就是錯誤處理。 當表示兩者是一致的核對資訊時，則於S 540中，操 作者3〗8係繼續廢棄原材料往廢棄室3 05的廢棄作業，操 作者3 1 8係於S 5 5 0中，確認原材料搬出作業是否全部完 成。 接著，於S5 60中，基於細胞調製指示資訊中所含之 -25- 200901073 原材料管理資訊’確認原材料是否全部被 情況下，則操作者3 1 8係繼續原材料的搬 則操作者3 1 8係結束搬出作業。 如上述，若依據本系統及方法，則如 全操作櫃3 03這種無菌操作區域中所被 料’例如經由被連接成可與資訊處理裝置 器325所被裝備的操作桌台327，讀取器 上著裝之1C標籤中預先儲存的ID編號加 資訊處理裝置2〇4。資訊處理裝置204, iD編號、與該資訊處理裝置2〇4中預先 指示資訊所關連對應的ID編號，進行核 一致的結果當成核對資訊而加以輸出。因 製的操作者3 1 8，係可一面將如此輸出的 控面板3 2 8上一一進行確認，一面確實地 若依據本系統及方法，則可確實防止細胞 胞的錯拿這種攸關人命的事故發生。再者 及方法，則爲了使檢體細胞增殖至必要細 胞調製中所使用的，包含固有之已被建立 胞或培養基等生物由來之原料、和培養皿 或藥品等之資材的排大物量的原材料，或 液或多種類的藥品類做嚴密管理，可毫無 作業。 【圖式簡單說明】 排出。未完成的 出。若非如此， 本實施形態之安 攜入的所有原材 204通訊之讀取 3 2 5係將原材料 以讀取，發送至 係將所讀取到的 儲存之細胞處理 對，將兩者是否 此，負責細胞調 核對資訊，在觸 實施各個作業。 提供者與培養細 ，若依據本系統 胞量所實施的細 關連至檢體的細 或離心管等容器 將所作成的培養 過失地實施各個 -26- 200901073 [圖1 ]本發明所述之細胞調製管理系統的系統運用之 槪念圖。 [圖2]本發明所述之細胞調製管理系統的系統運用中 的各工程之項目例。 [圖3 ]本發明所述之細胞調製管理系統的包含細胞調 製培養室的細胞處理設施之槪略圖。 [圖4 ]本發明所述之細胞調製管理系統的無菌操作區 域中，細胞調製的操作者所做的細胞調製管理狀態的模式 圖。 [圖5 ]本發明所述之細胞調製管理系統的原材料管理 之槪念圖。 [圖6]本發明所述之細胞調製管理系統的作業程序流 程圖。 [圖7]本發明所述之細胞調製管理系統的細胞調製指 示資訊中所含之指示書之一例（指示書Ν〇·4)。 [圖8]本發明所述之細胞調製管理系統中的每1人份 的細胞調製上所必須之原材料的物量例。 【主要元件符號說明】 100 :細胞處理設施 1 1 0 :管理室 1 2 0 :保管室 130 :準備室 140 :細胞調製培養室 -27 - 200901073 20 1〜203 :資訊終端（子機） 204 :資訊處理裝置（母機） 3 〇 3 :生物危害用安全操作櫃 3 04 :離心機 3 〇 5 :廢棄室或廢棄箱 3 0 6 :培養箱（培養器） 3 1 4 :安全操作櫃的收納部 316:安全操作櫃的插入口 3 1 8 :細胞調製的操作者 3 2 0 :新的空培養皿 3 2 1 :收容有原料的培養皿 3 2 2 :離心管 3 2 3 :藥品 3 24 :著裝在培養皿的1C標籤 3 2 5 :讀取器 3 2 6 :天線 3 2 7 :操作桌台 3 2 8 :操作桌台上所裝備的顯示手段等的觸控面板 -28 -。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 。 于 于 于 于 于 于 于 于 于 于 于 于 于 于 于 于 于 于 于 于 于 于 于 于 于 于 于 于 于 于 于 于 于 于 于The raw materials of the materials such as the products, the management method and the cell modulation management system at the time of cell modulation are introduced into the flawless operation area such as the entire operation cabinet. More specifically, it is an identification information that is associated with a raw material or a material and is supported by an IC line communication device equipped with the material, and is wirelessly communicated with a wireless reading device such as a reader that can be connected to the information. The pre-stored corresponding cellular information stored in the resource will be processed by the computer's pre-recorded information. If the two are consistent, the result is the operator who is used as the verification information. This cell modulation management method and cell modulation management system can be confirmed in the aseptic processing area in accordance with the necessary procedures, and the cell modulation management system can be used in the medical treatment in recent years. The medical care that is used to regenerate the lost living tissue, that is, the so-called treatment, is in full swing. Along with this, 'the cells associated with the sample' are cultured to, for example, the replacement of the container required for the treatment of cells by subculture, etc. 'At least several cell modulation projects, depending on the situation' will use 100 At most, the regenerative medicine that has been prepared, and cultivated, for example, in the preparation of the cells, the label, etc., is not compared with the device for reading the processing instructions. For the amount of cells, it is necessary to carry out containers such as containers of 200901073 or above or a plurality of materials of various types. At this time, it is necessary to exclude, for example, cross-contamination between containers or rooms, prevention of human error, and the like, and strict operation procedures are required, which are self-evident (for example, refer to Patent Document 1). In addition, the 'engineering of cells after cell preparation to achieve the necessary amount of cells' is different from that of industrial products or foods. In terms of management, it is also necessary to closely monitor the history of each cell (for example, refer to non-patent). Literature 1). Therefore, 'medium exchange' centrifugation, subculture and other cell preparations are usually recommended in a facility based on the Good Manufacturing Practice (GMP) standard, in accordance with standard operating procedures called SOP (Standard Operating Procedure) (eg Refer to Non-Patent Document 2). Patent Document 1 describes that the number of cells to be propagated to a certain amount during cell culture usually requires subculture of cells, and in the case of such subculture, the medium in the container is replaced or the cells are replaced. Such complicated cell preparation, such as re-seeding to a new medium for subculture, must be carried out by hand. In addition, in order to suppress the occurrence of cross-contamination between a plurality of containers or between chambers, it is described that it is necessary to carry out the cultivation of the cells in accordance with these subcultures, and it is necessary to carry out the cultivation in order to improve the workability. The container is provided with identification information such as a barcode, and the device for managing the cultured container is read while reading the barcode. Non-Patent Document 1 describes that the growth of cells that are associated with each sample is uneven, and after growth, it is necessary to divide the cells into plural groups in the manufacturing process, and to monitor the container replacement or culture, depending on the situation. Different, before and after the manufacturing process, non-process work projects including so-called escape projects. In addition, in the case of such an example, in the case of such an example, the hardware (cell processing facility) is of course planned, constructed, and built based on the pharmaceutical GMP, and the acceptance is performed. Regarding software (manufacturing management and quality management), it is obligatory to make an S OP." [Patent Document 1] Japanese Laid-Open Patent Publication No. 2004-16194 [Patent Document 2] Japanese Patent No. 3706 1 2 8 [Non-Patent Document 1] "Speed Theory Evaluation and Biological Process Design Considering Human Tissue Culture Inhomogeneity "Sakasuke University." Basic work (positive) Ji Zhigang Zhengbo. (正) Taniguchi Masaru (August 12, 2003, Institute of Chemical Engineering, Autumn Conference, the keynote of the lecture) [Non-Patent Document 2] "Air Conditioning Equipment and Factory System" (ηο. Π _ LL Factory Technical Bulletin 2005. December) Pages 10 to II [Summary of the Invention] [Problems to be Solved by the Invention] However, in the case of such a cell preparation project, it is necessary to form a safety operation cabinet or a cell preparation work table in an aseptic operation area, etc., as necessary. The program is implemented strictly by performing each work phase. Therefore, in the preparation of cells made up of at least several projects, raw materials such as raw materials and materials required for each project must be carried into the aseptic operation area to perform cell preparation, and the raw materials are classified into useful ones after storage and preparation. When the object and the waste 'for example, if it is necessary to store the useful product in a frozen state, the useful object is carried out in a storage room or the like in which the freezer is stored. On the other hand, the waste that has been used, for example, is carried out to an abandoned room located near the aseptic operation area 200901073. Then, the necessary raw materials are brought into the sterile operation area again, and the next project is repeated. Therefore, the number and amount of raw materials including containers or medicines that are repeatedly carried into the aseptic operation area when the cells are at least composed of a plurality of projects can reach a very large number. Further, materials such as containers used for cell preparation are often used or discarded based on the viewpoint of cross-contamination prevention, and as a result, the number or number of discarded materials will also be large. For example, 'the bone marrow of a number of CCs in an undifferentiated state is taken from a patient, and the amount of mesenchymal stem cells in the range of 1 0 7 to 10 8 is increased to a level of 1 to 7 to 10 8 . 'Regeneration medical technology that is then administered to the patient for treatment' is already present (for example, refer to Patent Document 2). Fig. 8 is a typical schematic diagram of the management of raw materials including materials such as petri dishes or centrifuge tubes, which are necessary for the cells of the present invention to be used in the regenerative medicine. When the culture medium is prepared by using the peripheral blood required for the self serum used for cell proliferation in culture, the amount of material required for each person is, for example, 300 or more petri dishes, and the centrifuge tube 2 About 50 pieces, it can be seen that this is a small amount. In the device described in Patent Document 1, it is possible to cope with the minimum requirements such as mistakes or cross-contamination prevention by confirming the culture procedures or conditions to which the cells of the primary culture and the subculture are related, but it is not There are limits to the management of such a large number of materials that can be managed without any loss of negligence. Furthermore, the operation of classifying raw materials into useful materials and wastes after 'cell preparation' is also very complicated. 'In the state where useful materials and wastes are easily misplaced, it may sometimes result in the use of materials that have been used or lost.成-8- 200901073 Reuse of useful things, this kind of cross-contamination accident that is never allowed will happen. The present invention has been made in view of such circumstances, and aims to provide a cell modulation management method and a cell modulation management system capable of reliably managing a large number of contained containers or cells operated in a cell modulation of an aseptic operation area without any loss. Raw materials such as pharmaceuticals, in order to prevent danger to the living body. [Means for Solving the Problem] The invention described in the first aspect of the invention is a cell modulation management method for performing cell modulation using a raw material in an aseptic operation region, and is characterized in that the use is inherently contained. Raw materials derived from organisms such as cells or culture media that are related to the sample, and materials such as containers or medicines such as petri dishes or centrifuge tubes, which are used for cell preparation in the aseptic processing area, are at least used to identify the raw materials. Each of the identification information of the raw material identification, the engineering identification information for identifying the cell modulation engineering, the identification information for identifying the material identification information of the material, and the like, the related cellular modulation instruction information is pre-stored and played by the computer. In the functional information processing device, the wireless reading device connected to the device can carry the identification information pre-held in the wireless communication device mounted on the raw material of the aseptic operation area or the raw material carried out. Reading; information processing device, which is the identification information that has been read before, and before Recording the corresponding identification information of the cell modulation indication information, and checking the result of whether the two are consistent, and then as the verification information, the information is transmitted as -9-200901073; by the operator of the cell modulation, the pre-check is confirmed. Cell modulation is continued when the information is consistent. The invention described in the application item 2 is a method which is a raw material including a raw material such as a cell or a culture medium, a container such as a petri dish or a centrifuge tube, or a drug, which is used in cell preparation. A cell modulation management method in which a cell-modulated operator is carried into an aseptic operation area and a cell is modulated using a raw material in an aseptic operation area, and is characterized in that it includes: a wireless device mounted on a pre-recorded material The communication device is pre-stored with the identification information for uniquely identifying the pre-recorded raw material; and the information processing device that enables the function by the computer to pre-store, at least, the cell modulation associated with the pre-recorded identification information has been established. a step of instructing information; and a wireless reading device connected to communicate with the pre-recording information processing device, the step of reading the identification information of the pre-recorded raw material in the aseptic operation area; and reading the information processing device The identification information that has been read before, and the pre-recorded cell modulation instruction information are Corresponding pre-recording information of Li Guanlian, check the step of 'consulting whether the two are consistent' as the verification information and outputting it; when the verification information is consistent with the collation information, continue to pre-report the raw materials When moving into the aseptic operation area; when the verification information is an inconsistent verification information before being output, the pre-recording of the raw material into the aseptic operation area is interrupted, and error processing is performed. The invention described in the third aspect of the invention is characterized in that, in the feature of the invention described in the application item 2, the following feature is added: after the pre-recording of the raw material into the aseptic operation area is interrupted, and the error processing is performed, the operator is pre-recorded. -10- 200901073 And before the start of the re-entry, the raw materials are moved into the aseptic operation area. The invention described in claim 4 is characterized in that, in the feature of the invention described in the application 2 or 3, the following feature is added: the pre-recording information processing device further displays the pre-recorded verification information and displays it in the device. The steps in the display means of the aseptic operation area. The invention described in claim 5 is a method comprising a raw material such as a cell or a culture medium used in a cell preparation in an aseptic operation region, a container or a drug such as a culture dish or a centrifuge tube, or the like. The raw materials of the materials are those that are prepared by the cell, and are selected as waste materials such as discarded containers and raw materials, and are transported from the pre-recorded area, in the aseptic operation area. A cell modulation management method for performing cell modulation using a raw material, characterized by the step of: containing: a step of preliminarily holding identification information for uniquely identifying a pre-recorded material in a wireless communication device mounted on a pre-recorded material And the information processing device that enables the function by the computer to pre-store the information of the discarded raw materials embedded in the pre-recorded raw materials or the pre-recorded raw materials. Cell modulation instructions for information; and are connected to In the wireless reading device in which the information processing device communicates, the pre-recording information of the pre-recorded material is read in the pre-recorded aseptic operation area; and the pre-recording information processing device is read. The identification information and the pre-recorded cell modulation refer to the corresponding pre-recorded identification information that is related to the establishment of the non-information, and the verification result is used to check whether the two are consistent and the output is verified as the verification information - -11 - 200901073 When the verification information is output and the matching information is consistent, the first step is to carry the pre-recorded raw material into the pre-surgical operation area, and then the pre-recorded raw material that was removed from the aseptic operation area after the cell preparation is selected. Any one of the discarded raw materials or the pre-recorded raw materials; when the verification information is an inconsistent check-up information before being output, the original material is moved into the aseptic operation area and the error processing is performed. According to the invention of the invention of claim 5, in the feature of the invention described in the application item 5, the following feature is added: after the pre-recording of the pre-recorded material in the aseptic operation area is interrupted and error processing is performed, The operator re-starts the pre-recording of the material in the aseptic operation area. The invention according to claim 7 is characterized in that, in the invention according to any one of the items 5 or 6, the following feature is added: after the cell preparation is performed, the pre-recorded material is taken out from the aseptic operation area. At the time of 'more contains. Then, the |5 wireless reading device reads the pre-recording identification information again; and the information processing device' is the pre-recording identification information corresponding to the identification information that has been read in the pre-recorded and the pre-recorded cell modulation instruction information. 'The result of the verification after the verification is output as the second verification information; based on the second verification information before the output is output, the operator pre-records the pre-recorded raw material into the pre-recorded waste material or the pre-recorded transfer material. Either. According to the invention of the present invention, in the invention of the present invention, the feature of the invention described in the claims 5 to 7 is characterized in that: the pre-recording information processing device is configured to / or pre-record -12- 200901073 The second check information 'shows the steps in the means of being equipped in the pre-recorded aseptic operation area. The invention described in claim 9 is characterized in that, in the feature of the invention described in claim 4, the following feature is added: after the waste material is discharged from the prior aseptic operation area, it is equipped to be connected to the pre-information processing device. When the transmission box of the second wireless reading device of the communication is moved to the disposal room, the 'secondary wireless reading device' reads the pre-recording identification information of the pre-recorded wireless communication device that is pre-loaded with the discarded material; , the identification information that has been read in the pre-record, and the pre-recorded identification information corresponding to the establishment of the cell-modulation instruction information before the information is discarded, and whether the two are consistently judged as the first (2) Checking the information and outputting it; if the former reporter remembers that the second verification information is consistent with the verification before the output, the pre-recorded waste material is transferred from the pre-recorded aseptic operation area to the former abandoned room; When the second check information indicates that the nuclear information is inconsistent, the waste material is discarded before the waste operation area from the previous record. Waste transfer chamber in mind, and performs error handling. According to the invention of the invention of claim 9, the feature of the invention described in the application item 9 is characterized in that, after the interruption of the pre-recorded material, the aseptic operation area is forwarded to the waste disposal room, and the error is performed. By the pre-recorder, the pre-recorded material is re-recorded from the pre-recorded aseptic area to the abandoned room. The invention according to claim 1 is characterized in that, in the feature of the invention described in the item of claim 9 or 10, the following feature is added: the note containing the indication is sent to the second a- 刖It is the step of the second verification information before the output of the information processing device is displayed on the display means of the aseptic operation area. In the invention of the sra item 1 2, a cell containing a material such as a cell or a medium prepared by a cell and a material such as a petri dish or a centrifuge tube or a material such as a drug is used for cell preparation. The cell modulation management system is characterized in that it contains an aseptic operation area, and a raw material of a wireless communication device that is previously loaded with identification information for uniquely identifying a pre-recorded material is carried therein, and is carried out after cell modulation. And the information processing device that functions by the computer is pre-stored with the cell modulation instruction information, which is embedded in the system, and the corresponding information is established before the wireless communication device is recorded before the pre-recorded material is worn. The identification information; and the wireless reading device that is connected to communicate with the pre-recording information processing device is used to read the identification information before the wireless communication device is pre-loaded on the pre-recorded material; and the output means is the pre-recording information Processing device, the identification information that has been read before, and the pre-recorded cell modulation instruction The relevant information of the pre-recorded identification information is established, and the result of the verification of whether the two are consistent is output as the verification information; the pre-recording information processing device is a check that the verification information is consistent before being output. In the case of information, the pre-recording operator continues to carry out the pre-recording of the raw materials from the pre-recorded aseptic operation area; when the verification information is an inconsistent verification information before being output, the H5 raw material is interrupted before the aseptic operation area. Move out or move in and implement error handling. In the invention of the invention described in the above-mentioned Item No. 1 - 200901073, the invention is characterized by the following characteristics: a pre-recorded cell pre-stored in the information processing device. In the modulation instruction information, it is embedded in the information of the discarded raw materials for identifying the raw materials that are used as the discarded raw materials such as the discarded containers or the raw materials in the state in which the raw materials are kept. According to the invention of the invention of claim 12, in the feature of the invention of the invention of claim 12, the feature of the invention is characterized in that the pre-recorded information processing device is equipped in the pre-recorded innocent operation area. The invention of claim 1 is characterized in that, in the feature of the invention described in any one of claims 1 to 2, the following feature is added: the pre-recording information processing device is used to display the output before The means of checking the information is 'equipped in the pre-recorded aseptic operation area. The invention according to any one of the first to third aspects of the invention, characterized in that the invention is characterized in that the invention is further characterized in that it contains a disposal room and is operated by Jjy. The pre-recorded waste materials discharged from the area are discarded. According to the invention of the invention of claim 1, the feature of the invention described in the application of the invention is characterized in that the transfer box is further included, and the waste material is transferred before being discharged from the aseptic operation area. At the time of the abandonment of the abandoned room, it is used to pass the waste materials mentioned above. According to the invention of the invention of claim 1, the feature of the invention described in claim 17 is characterized in that the pre-recording transfer box further includes wireless reading that is connected to communicate with the pre-recording information processing device. The device is used to read the pre-recorded identification information previously held in the wireless communication device before being worn on the discarded raw material. -15- 200901073 However, the aseptic operation region for performing cell modulation in the present invention is, for example, as shown in the examples, contains: a safety operation cabinet having an insertion port for allowing raw materials for cell preparation to enter and exit, and an operation having been performed. The accommodating portion of the inserted raw material; and the operation table "there are a wireless reading device such as a reader equipped in the vicinity of the insertion port, a wireless antenna, a touch panel for display, and the like. Or 'the aseptic operation area of the present invention may include a cell preparation work table that is disposed in a sterilized state around the cell preparation chamber' or the operation table is disposed outside and remotely operated by a robot or the like. This type of cell modulates the chamber itself. In any case, in the wireless communication device such as the 1C tag that is loaded on the raw material to be carried in and out, the identification information such as the ID number held in advance is read by a wireless reading device such as a reader. The identification information obtained is checked against the identification information associated with the pre-stored cell modulation instruction information including, for example, a prescription, and the aseptic operation area for one job can be reliably performed. ideal. Further, in the cell preparation instruction information, in order to complete the preparation of the cells of the 1st project, the raw materials which are carried out from the aseptic operation area are reliably selected and processed into raw materials to be discarded and raw materials to be stored, and ideally at least stored , abandonment information related to the identification information of raw materials. [Embodiment] Fig. 1 is a schematic diagram of a program at the time of cell modulation using the cell modulation management system according to the present invention and a concept view of the entire system. According to the situation as illustrated in Figure 8, the sample of the patient (donor) who is a cell-modulated pair of -16-200901073 is taken in a hospital, and the inspection system is in compliance with GMP standards. In the cell processing facility (Ceu P r 〇cessing C enter = CPC ), it is processed through various procedures such as culturing, cell preparation, culture, storage, and delivery, and the processed sample is delivered from the cell processing facility to the hospital. And then to the donor patient. These procedures are ideally based on, for example, S Ο P. Figure 2 shows an example of the specific procedures in the process. In the example shown in FIG. 2, 'the sample ID number is created in the sample taking stage before the cell preparation or culture; in the receiving stage of the culture, the instruction sheet including the sample ID number is connected, etc. The cell modulating instruction information; in the cell modulating and cultivating stage, 'in the execution of the instructions for the preparation, the identification information to be carried in the 1C tag to be mounted on the raw material containing the raw material and the material is prepared. The instruction sheet is used to indicate the raw materials necessary for each process of cell preparation or the related information of the work contents performed in the project, as will be described later. Fig. 3 is a diagram showing an example of a cell type cell processing facility (CPC) 100 mounted in the system of the present invention. Fig. 3 is a view showing the movement of the waste that has been discarded after the person who has passed through the clothes and the clothes drying room, the movement of the material passing through the transfer box, and the procedure according to the procedure. In the cell processing facility 100, there are 'important devices (3 0 i~3 0 6 ) used in the implementation of the program or the information terminal of the system, ie, the slave (2 0 1 to 2 0 3 ) The storage room 1 20 'preparation room 30 and the cell preparation room 丨 4 分别 which are separately provided, and the management room π 母 of the parent machine 204 which is equipped with at least the information processing device of the entire management system. The present invention is, in a typical manner, a cell modulation management method performed in the safety operation cabinet 303 for biohazard control disposed in the cell -17 - 200901073 modulation culture chamber 140 of FIG. A cell modulation management system designed for it. Fig. 4 is a perspective view showing an embodiment of the biohazard control operation cabinet 303 shown in Fig. 3, which is used in the cell preparation according to the present invention, for example, a safety operation cabinet. The safety operation cabinet 300 is, for example, in the shape of a cube, and the inside thereof is a cell or a medium associated with a sample of a donor used for cell preparation, and a raw material derived from a living body contained in the raw material container 31. Further, these raw materials are used in a container such as a petri dish 320 or a centrifuge tube 322 or a material such as a drug 3 23 to perform cell preparation. These raw materials or materials are collectively referred to as raw materials. The front and rear of the safety operation cabinet 3 03 can also be provided with an opening and closing door. In the case where the partition door is provided, as the partition door is opened and closed, the insertion port 3 16 for allowing the raw material to enter and exit is formed. Fig. 4 shows a state in which a material such as a petri dish or a centrifuge tube which has been necessary for modulating a cell has been carried into a part. The centrifuge tube 3 22 is used, for example, in the case of purification separation by a centrifuge 308 disposed in the vicinity of the safety operation cabinet 03 of Fig. 3. Further, in the cell preparation and culture chamber of FIG. 3, the incubator 306 used for primary culture and subculture, or the raw material container 32 1 which is used after cell preparation may be provided. When it is discarded, it is used to read the discarded room or the waste box of the reader with the ID number carried on the material. When the cell is prepared by using the safety operation cabinet 303 in the cell culture chamber 40, the cell preparation operator 318 checks the accommodating portion 3丨4 visually, and performs necessary operations in accordance with the program. For example, when the necessary raw materials are carried into the accommodating section 314-200901073, the operator carries the raw materials one by one, or one of the plurality of raw materials, from the insertion port 3 16 . Each of the raw materials is provided with a 1C label 3 24, and the 1C wafer constituting the 1C label holds an ID number for identifying the raw material. Typically, in the vicinity of the insertion port 316 of the security cabinet 3 0 3 used herein, an operation table 337 is provided, which is provided with a reader for reading the ID number carried in the IC tag. 3 2 5, the antenna for the reader 3 2 6, the touch panel for display 3 2 8 and so on. The operating table 3 2 7 ' has the function of the information terminal (slave) 2 〇 3 of Fig. 3 being connected to communicate with the information processing device (master) 204. Each of the raw materials carried in the accommodating portion 3 1 4 of the safe operation cabinet 3 0 3 from the insertion port 3 16 by the operator of the cell modulation 3 1 8 passes through the operation table 3 each time. At 27 o'clock, the ID number carried in the 1C tag mounted on the raw material is positively detected by the antenna 3 26 and read to the reader 3 25 . The reader 325 can also be integrated with the information terminal 203 of FIG. Each of the information terminals (201 to 203) is connected as an information processing device (parent machine) 204 that can be connected to the management room as described above. The information processing device 204 functions as a computer. On the other hand, the ID number read by the reader 3 2 5 and the cell modulation instruction information containing the instruction book to which the instruction required for verification is related are as described in detail below. It is created and stored in advance in the information processing device 204. The information processing device 204 of the cell processing facility 100 includes: a database server storing an application, an application server executing the application, a web server having a communication function; and connecting through the network -19- 200901073 To the information terminal (2 0 1~2 0 3 ). These information terminals (the input and output functions are also used to write data into the IC input function. The database stores: sample data; and engineering materials corresponding to the data 1 to 1; and The information of the instructions of the plural of the project data; and the raw materials of the plural number corresponding to the information of the multiple of the instructions, that is, '1 upper system is connected to 1 engineering data; 1 engineering data is attached A plurality of instructions data; each of the plurality of instruction materials is connected to a plurality of raw material materials. In the database, useful master materials are also stored, for example, instructions for the manuscripts of the person, the subordinate, the job type, etc. Information, engineering materials information, inspection information, equipment information, or holiday information required for engineering. The application stored in the database is: physical examination, engineering management, and instructions. Management function, raw material tube ID check function 'main management function. Check function, is the inherent sample ID required to distinguish it from other samples, together with the test body At the same time, in the training shown in Fig. 2, "what kind of work will be performed on which, which, and which sample is to be carried out. Then the project management function is used as the engineering project data and raw material data inherent in the sample. These materials are related to the solid ID number, so the material with the ID number assigned can be judged from the system side. The project management function is the progress status of the project required for the cell modulation. The book management function ^ 2 03 ), each of the sample data corresponding to the sample to be used by the tag is related to the upper system, and the information about the information, the body information, the management mechanism information on the original itinerary, and the number in the system are commonly used. In the receiving stage, the data will be sorted out, and all the raw materials of the sample will be managed. In addition to -20- 200901073, which one of the specimens is to be specified in the operation, the results of the operation will be recorded. No or effective quantity, etc. The raw material management function is the number of which raw materials are required to manage which of the specimens. The ID verification function is a check of the pre-stored raw material ID number indicated by the raw material management function and the id number input by the ID input function. The main management function is to store, change, and maintain the master data. An embodiment of the present invention will be described based on the concept of the management of the raw materials of Fig. 5 and the flowchart of the management and operation procedures of Fig. 6. N 包含 contained in the lateral direction of the mourning diagram of Figure 5. A series of instructions from 1 (received) to N 〇 · 8 (to be cast) are engineering materials based on engineering rules. The project data is created by arranging the instructions along the time axis for which job to perform and which operation to perform. Instructions that are combined as engineering materials are stored in the master data of the database for future use; the combination of the instructions can be selected in accordance with the type, age, sex, etc. of the sample. Each of the donor's specimens is specifically made to contain information on (1) used raw materials to (5) waste in the longitudinal direction, and is stored in advance in, for example, a database of the information processing device 204. An example of a specific indication of the contents, the instruction book No. 4 is the figure 7. In the instruction book, the safety operation cabinet number, the date of the operation, the name of the operator, the cell information (the type of the cell, the name of the supplier, the date of adoption, etc.), the contents of the work, the list of IDs of the materials to be moved, etc., are displayed. It is displayed on the touch panel 32. For example, when the content of the work is processed in the period of -21 - 200901073, the culture dish of the cell culture source from which the cell is transferred is taken from the incubator 306 to the safe operation cabinet 3 〇 3, therefore, the specific The ID number of the dish will be displayed in the instruction book. Further, in the subculture, 'the culture medium is injected into the new empty culture dish to form the medium', and then, for example, the culture solution is taken out from the culture dish of the cultured cells, and the cultured cells are transferred to the centrifuge tube using a drug or the like. After the purification and separation by the centrifuge 3 〇 4, the cultured cells were transferred to the medium. In order to carry out these operations, in addition to the new culture dish or the centrifuge tube, there are also items for transfer, such as a micropipette, etc., which are carried into the preparation chamber 130 and the cell preparation chamber 14 from the storage chamber 120 through the transfer box. . Therefore, in the instruction book No. The list of imported materials in 4 will also show each ID number assigned to each of these materials and materials. The instruction book also contains a list of ID numbers of discarded raw materials that should be discarded after cell preparation. The cell modulation instruction information containing the combination of the series of instructions thus created is pre-stored in the information processing device. Fig. 5 is a conceptual diagram of the management of raw materials using cell materials prepared with an id number. In the figure, if the longitudinal portion including the No. 4 is used, the raw material used in the first (1) is taken out from, for example, the incubator 306, and is carried into the safety operation cabinet 300. Petri dishes with ID numbers of cells, etc. Next, (2) the new material is a petri dish to be placed in the cultured cells to be transferred, and no ID number is given in this stage. After the cultured cells have been transferred to new materials, for example, in connection with the information of the system, the commercially available label sticker printer that can output the label will be pre-prepared (3) using the label, dress -22 - 200901073 On the new materials, here, the new materials are given the ID number ((4) completed raw materials). This label is preferably an IC tag (tag), and it is preferable to visually confirm the information written on the IC tag by the information printed on the surface. The last ($) waste is a cultured cell of the raw material used in the above (1), and it is a material that has been transferred to (2) a new material and becomes a used culture dish to be discarded. The cell-modulating operator 318 can confirm the ID number of the 1C tag thus mounted on the raw material to the corresponding ID number that has been associated with the cell modulation instruction information, and confirm with the touch panel 3 2 8 . , - The surface is surely implemented with one cell modulation operation. Here, for example, the operation program in the safe operation cabinet 3 〇 3 is explained by the flowchart of Fig. 6. The cell modulation instruction information containing the pre-made instruction in S4〇0 is stored in the information processing device 204. In S410, the 'operator 318' scans the necessary raw materials according to the cell modulation instruction information displayed on the touch panel 328 via the operation table 3 27 . In S420, the reader 3 2 5 of the operation table 327 is loaded with the 1C tag loaded on the raw material of the security operation cabinet 303, and the ID number is read and sent to the information processing device 204. In S430, the information processing device 204 checks the ID number of the transmitted ID number and the corresponding ID number to which the previously stored cell modulation instruction information is related, and checks whether the result of the two is - 23- 200901073 The nucleus outputs the information and displays it on the touch panel 32. The operator 3 1 8 confirms the collation information, and if it is the collation information indicating that the two do not match, the error processing is performed in S440. The so-called "inconsistent check information" refers to the raw materials that are carried, not the raw materials indicated in the cell modulation instructions. Therefore, the so-called error handling is intended to be, for example, to interrupt the operation, to bring in the correct raw materials, or to have a serious situation in which the sample IDs are different, or the entire operation may have to come from the beginning. After the error processing, in S4500, the operator 318 starts the S430 again for the raw material carried into the safe operation cabinet 303. In the case of the collation information indicating the consistency of the two, in S 4 60, the operator 3 18 continues to carry the raw materials into the safe operation cabinet 3 , 3, according to the raw materials contained in the cell modulation instruction information. Manage information to confirm that the required raw materials are available. In S 4 7 0, if the necessary raw materials are not available, the operator 3 1 8 continues to carry the raw materials into the safe operation cabinet 3 〇 3. In S480, the operator 318' performs cell modulation based on the operation information contained in the cell modulation instruction information when the necessary raw material is prepared in the safe operation cabinet 303. The raw materials carried in the S4 90 are all carried out from the safe operation cabinet 303 after the cells are modulated. In order to confirm whether or not all of them have been carried out, it is also possible to design such that when the raw material is discharged from the safe operation cabinet 3〇3, it is read again by the reader 32S via the operation table 332. Output the second check information. -24- 200901073 In S5 00, the operator 318 selects the raw material to be carried out based on the raw material management information contained in the cell modulation instruction information, and selects it as a waste material or temporarily stores it in the incubator 306 or the storage room 12 Any of the raw materials such as 〇. In S510, when it is confirmed that the raw material to be carried out belongs to the original material to be transported, the operator 318 transports the transported material to the destination area. In S 5 2 0, when it is confirmed that the raw material to be carried out is a waste material, the operator 3 1 8 wastes the raw material, for example, the transfer box to the disposal room 305, and is equipped on the transfer box. The reader reads the id number of the 1C tag mounted on the discarded material and sends it to the information processing device 204. Next, the information processing device 204 checks the ID number associated with the previously stored cell modulation instruction information, and checks whether the two are consistent. The output is displayed on the touch panel 328. In S5300, the operator 318 confirms the collation information, and if it is the collation information indicating that the two are inconsistent, the error processing is performed. In this case, the inconsistent verification information indicates that the raw materials being carried are not intended to be discarded, so it is necessary to confirm whether the raw materials are being transported, for example, to be transported to the necessary areas. This is the error handling. When it is said that the two are the matching check information, in S 540, the operator 3 〗 8 continues to discard the waste material to the disposal of the waste room 3 05, and the operator 3 1 8 is in S 5 50 to confirm the raw materials. Whether the removal operation is completed. Next, in S5 60, based on the -25-200901073 raw material management information contained in the cell-modulation instruction information to confirm whether or not the raw materials are all present, the operator 3 1 8 continues to move the raw materials to the operator 3 1 8 End the move out. As described above, according to the present system and method, the material in the aseptic operation area of the full operation cabinet 303 is read, for example, via an operation table 327 that is connected to be equipped with the information processing device 325. The pre-stored ID number in the 1C tag on the device is added to the information processing device 2〇4. The information processing device 204, the iD number, and the ID number corresponding to the information indicating the information in advance in the information processing device 2〇4, and the results of the matching are output as the collation information. According to the operator 3 181, the control panel 3 2 8 thus output can be confirmed one by one, and it is possible to surely prevent the wrong cell from being taken according to the system and the method. The accident of human life occurred. In addition, in order to proliferate the sample cells to be used in the preparation of the necessary cells, the raw materials including the raw materials such as the cells or the culture medium, and the materials of the culture materials such as the culture dishes or the medicines are contained. , or liquid or a variety of drugs to be strictly managed, no work. [Simple description of the diagram] Discharge. Unfinished out. If this is not the case, all the raw materials 204 carried in this embodiment are read by the communication 3 2 5 system, and the raw materials are read and sent to the stored cell processing pair, whether the two are, Responsible for cell tuning information, and implement various tasks at the touch. Providers and cultures are fine, and if the cells are finely connected to the sample, such as fine or centrifuge tubes, which are carried out according to the amount of the system, the cultures are negligently implemented. -26-200901073 [Fig. 1] The cells of the present invention A concept map of the system management of the modulation management system. Fig. 2 is a view showing an example of each project in the system operation of the cell modulation management system according to the present invention. Fig. 3 is a schematic diagram of a cell processing facility comprising a cell-modulating culture chamber of the cell modulation management system of the present invention. [Fig. 4] A schematic diagram of a cell modulation management state by an operator of cell modulation in the aseptic operation area of the cell modulation management system of the present invention. Fig. 5 is a conceptual diagram of raw material management of the cell modulation management system of the present invention. Fig. 6 is a flow chart showing the operation of the cell modulation management system of the present invention. [Fig. 7] An example of a directive included in the cell modulation instruction information of the cell modulation management system according to the present invention (instruction Ν〇·4). [Fig. 8] An example of the amount of the raw material necessary for the cell preparation per one person in the cell preparation management system according to the present invention. [Description of main component symbols] 100 : Cell processing facility 1 1 0 : Management room 1 2 0 : Storage room 130 : Preparation room 140 : Cell preparation and cultivation room -27 - 200901073 20 1 to 203 : Information terminal (slave) 204 : Information processing device (master machine) 3 〇3 : Safety operation cabinet for biohazard 3 04 : Centrifuge 3 〇 5 : Waste room or waste box 3 0 6 : Incubator (cultivator) 3 1 4 : Storage unit for safety operation cabinet 316: Insertion port of the safety operation cabinet 3 1 8 : Cell-modulated operator 3 2 0 : New empty culture dish 3 2 1 : Petri dish containing raw material 3 2 2 : Centrifuge tube 3 2 3 : Drug 3 24 : 1C label dressing in a Petri dish 3 2 5 : Reader 3 2 6 : Antenna 3 2 7 : Operation table 3 2 8 : Touch panel -28 equipped with display means equipped on the table