{"created":"2023-05-15T14:47:59.079383+00:00","id":65766,"links":{},"metadata":{"_buckets":{"deposit":"bd4d4161-fc1c-4250-86f3-e48289e3bd46"},"_deposit":{"created_by":1,"id":"65766","owners":[1],"pid":{"revision_id":0,"type":"depid","value":"65766"},"status":"published"},"_oai":{"id":"oai:repo.qst.go.jp:00065766","sets":["10:29"]},"author_link":["647815","647819","647816","647822","647806","647820","647805","647818","647823","647817","647803","647813","647808","647809","647824","647810","647811","647812","647821","647807","647814","647804"],"item_10005_date_7":{"attribute_name":"発表年月日","attribute_value_mlt":[{"subitem_date_issued_datetime":"2014-11-06","subitem_date_issued_type":"Issued"}]},"item_10005_description_5":{"attribute_name":"抄録","attribute_value_mlt":[{"subitem_description":"医薬品製造においては薬物の交差汚染等を防止するために製造設備等の洗浄作業が重要であり、共用している設備等については洗浄バリデーションが必要である。洗浄バリデーションは品質管理や安全性確保の観点からも重要であり、評価法として拭き取り法やリンス法等がある。我々は11C標識薬剤の製造を日本核医学会GMPに適応させるために11C標識自動合成装置の洗浄バリデーションについて検討した。交差汚染が考えられる調剤部品を含めた合成装置、分取HPLCシステムの洗浄手順を確定し、洗浄後のリンス液中の原料と主成分（標品）の残存量についてHPLC分析を行った。合成装置では、アセトン、注射用水、消毒用エタノールで洗浄し、検出限界以下（原料0.003 ppm以下、標品0.016 ppm以下）の残存量であった。分取HPLCシステムでは、70-100%アセトニトリル水溶液（4 mL/min、約1時間）で洗浄し、検出限界以下の残存量であった。洗浄バリデーションにより合成装置と分取ＨＰＬCシステムの交差汚染をなくし、より高い安全性を担保した11C標識薬剤を臨床へ提供している。","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54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":"河村, 和紀"}],"nameIdentifiers":[{"nameIdentifier":"647803","nameIdentifierScheme":"WEKO"}]},{"creatorNames":[{"creatorName":"武井, 誠"}],"nameIdentifiers":[{"nameIdentifier":"647804","nameIdentifierScheme":"WEKO"}]},{"creatorNames":[{"creatorName":"古塚, 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