{"created":"2023-05-15T14:52:38.171601+00:00","id":71864,"links":{},"metadata":{"_buckets":{"deposit":"64a36cfe-a729-4bcf-8e7d-99b25dad6ccd"},"_deposit":{"created_by":1,"id":"71864","owners":[1],"pid":{"revision_id":0,"type":"depid","value":"71864"},"status":"published"},"_oai":{"id":"oai:repo.qst.go.jp:00071864","sets":["10:28"]},"author_link":["707643","707655","707649","707646","707644","707652","707647","707648","707650","707651","707654","707642","707645","707653","707656","707657"],"item_10005_date_7":{"attribute_name":"発表年月日","attribute_value_mlt":[{"subitem_date_issued_datetime":"2015-11-06","subitem_date_issued_type":"Issued"}]},"item_10005_description_5":{"attribute_name":"抄録","attribute_value_mlt":[{"subitem_description":"学会製造基準では最終バイアルの組み立てや品質検査用検体の抜き取りなどは、最終製剤の無菌性に影響を与える作業であるため、適切に管理されたグレードAのエリアで行うことが定められている。放医研ではこのグレードAを担保する作業エリアとして、無菌アイソレーターを導入した。無菌アイソレーターは外界と隔離された状態で内部作業エリアを過酸化水素ガス滅菌可能にする装置である。滅菌処理後の無菌環境で予め持ち込んだ材料による最終ラインの組み立て、製剤の滅菌、複数の製剤バイアルへの分注、品質検査用検体の採取などの作業に関し、確実な無菌操作を行うことができる。使用条件決定のための滅菌テストとして、アイソレーター内作業エリアの複数のポイントにバイオロジカルインジケーターを設置し、使用する過酸化水素の投入量を変更して滅菌処理能力を確認した。その結果、過酸化水素の投入量を5.0 g/minとし、除染終了時の過酸化水素濃度が1000 ppmとなるとき、設定したすべてのポイントにおいて、運転開始からエアレーションを含み1時間で滅菌が完了した。","subitem_description_type":"Abstract"}]},"item_10005_description_6":{"attribute_name":"会議概要（会議名, 開催地, 会期, 主催者等）","attribute_value_mlt":[{"subitem_description":"第55回日本核医学会学術総会","subitem_description_type":"Other"}]},"item_access_right":{"attribute_name":"アクセス権","attribute_value_mlt":[{"subitem_access_right":"metadata only access","subitem_access_right_uri":"http://purl.org/coar/access_right/c_14cb"}]},"item_creator":{"attribute_name":"著者","attribute_type":"creator","attribute_value_mlt":[{"creatorNames":[{"creatorName":"橋本, 裕輝"}],"nameIdentifiers":[{"nameIdentifier":"707642","nameIdentifierScheme":"WEKO"}]},{"creatorNames":[{"creatorName":"脇, 厚生"}],"nameIdentifiers":[{"nameIdentifier":"707643","nameIdentifierScheme":"WEKO"}]},{"creatorNames":[{"creatorName":"河村, 和紀"}],"nameIdentifiers":[{"nameIdentifier":"707644","nameIdentifierScheme":"WEKO"}]},{"creatorNames":[{"creatorName":"鈴木, 寿"}],"nameIdentifiers":[{"nameIdentifier":"707645","nameIdentifierScheme":"WEKO"}]},{"creatorNames":[{"creatorName":"岩隈, 佳寿子"}],"nameIdentifiers":[{"nameIdentifier":"707646","nameIdentifierScheme":"WEKO"}]},{"creatorNames":[{"creatorName":"金子, いづみ"}],"nameIdentifiers":[{"nameIdentifier":"707647","nameIdentifierScheme":"WEKO"}]},{"creatorNames":[{"creatorName":"藤林, 康久"}],"nameIdentifiers":[{"nameIdentifier":"707648","nameIdentifierScheme":"WEKO"}]},{"creatorNames":[{"creatorName":"張, 明栄"}],"nameIdentifiers":[{"nameIdentifier":"707649","nameIdentifierScheme":"WEKO"}]},{"creatorNames":[{"creatorName":"橋本 裕輝","creatorNameLang":"en"}],"nameIdentifiers":[{"nameIdentifier":"707650","nameIdentifierScheme":"WEKO"}]},{"creatorNames":[{"creatorName":"脇 厚生","creatorNameLang":"en"}],"nameIdentifiers":[{"nameIdentifier":"707651","nameIdentifierScheme":"WEKO"}]},{"creatorNames":[{"creatorName":"河村 和紀","creatorNameLang":"en"}],"nameIdentifiers":[{"nameIdentifier":"707652","nameIdentifierScheme":"WEKO"}]},{"creatorNames":[{"creatorName":"鈴木 寿","creatorNameLang":"en"}],"nameIdentifiers":[{"nameIdentifier":"707653","nameIdentifierScheme":"WEKO"}]},{"creatorNames":[{"creatorName":"岩隈 佳寿子","creatorNameLang":"en"}],"nameIdentifiers":[{"nameIdentifier":"707654","nameIdentifierScheme":"WEKO"}]},{"creatorNames":[{"creatorName":"金子 いづみ","creatorNameLang":"en"}],"nameIdentifiers":[{"nameIdentifier":"707655","nameIdentifierScheme":"WEKO"}]},{"creatorNames":[{"creatorName":"藤林 康久","creatorNameLang":"en"}],"nameIdentifiers":[{"nameIdentifier":"707656","nameIdentifierScheme":"WEKO"}]},{"creatorNames":[{"creatorName":"張 明栄","creatorNameLang":"en"}],"nameIdentifiers":[{"nameIdentifier":"707657","nameIdentifierScheme":"WEKO"}]}]},"item_language":{"attribute_name":"言語","attribute_value_mlt":[{"subitem_language":"jpn"}]},"item_resource_type":{"attribute_name":"資源タイプ","attribute_value_mlt":[{"resourcetype":"conference object","resourceuri":"http://purl.org/coar/resource_type/c_c94f"}]},"item_title":"学会製造基準適合のための無菌アイソレーターの導入について","item_titles":{"attribute_name":"タイトル","attribute_value_mlt":[{"subitem_title":"学会製造基準適合のための無菌アイソレーターの導入について"}]},"item_type_id":"10005","owner":"1","path":["28"],"pubdate":{"attribute_name":"公開日","attribute_value":"2015-11-24"},"publish_date":"2015-11-24","publish_status":"0","recid":"71864","relation_version_is_last":true,"title":["学会製造基準適合のための無菌アイソレーターの導入について"],"weko_creator_id":"1","weko_shared_id":-1},"updated":"2023-05-15T19:46:31.001934+00:00"}