{"id":2128,"date":"2024-11-06T13:08:38","date_gmt":"2024-11-06T05:08:38","guid":{"rendered":"https:\/\/zjbocon.com\/?p=2128"},"modified":"2025-12-05T10:49:36","modified_gmt":"2025-12-05T02:49:36","slug":"routine-monitoring-control-and-release-of-ethylene-oxide-sterilization","status":"publish","type":"post","link":"https:\/\/zjbocon.com\/?p=2128","title":{"rendered":"Routine Monitoring, Control, and Release of Ethylene Oxide Sterilization"},"content":{"rendered":"\n
\"Ethylene<\/figure><\/div>\n\n\n\n

日常的な監視と制御<\/h2>\n\n\n\n

EO (エチレンオキシド) 滅菌の日常的な監視と制御の目的は、確認され指定された滅菌プロセスが製品に適用されていることを実証することです。確認された滅菌プロセスの仕様が満たされていることを証明するために、各滅菌サイクルのデータを記録および保持する必要があります。これには少なくとも次のコンテンツが含まれている必要があります。<\/p>\n\n\n\n

a) 前処理 (使用されている場合) に入るときに、製品の環境温度が確認された最低温度に達しているという証拠。これは、指定された最小限の時間、負荷を環境に順応させることで実現できます。保管温度がわかっている場合は、前処理エリアに入る前に製品の温度を決定する必要はありません。輸送中など、製品が極端な温度にさらされた場合、内部の温度と湿度を許容範囲内に安定させるために、前処理の前に製品を一定期間保管する必要がある場合があります。<\/p>\n\n\n\n

b) 指定された場所の前処理エリア (使用されている場合) の温度と湿度の監視と記録。<\/p>\n\n\n\n

c) 各滅菌負荷の前処理の開始時間、および前処理領域 (使用されている場合) から負荷が取り除かれる時間。<\/p>\n\n\n\n

d) 前処理領域 (使用されている場合) から滅菌負荷を除去してから滅菌サイクルの開始までの時間間隔。<\/p>\n\n\n\n

e) ガス曝露段階中のチャンバー内のガス循環システムが適切に動作していることを示す指標 (使用されている場合)。<\/p>\n\n\n\n

f) 滅菌サイクル全体にわたるチャンバー内の温度と圧力。<\/p>\n\n\n\n

g) 処理段階中のチャンバー内の湿度。圧力または直接測定されます。<\/p>\n\n\n\n

h) ガス状 EO が滅菌チャンバーに導入されたことの確認。<\/p>\n\n\n\n

i) 滅菌室内の圧力上昇と使用される EO の量または濃度。<\/p>\n\n\n\n

j) 処理時間。<\/p>\n\n\n\n

k) 露光時間。<\/p>\n\n\n\n

l) Time, temperature, and pressure changes (if applicable) during the aeration phase and\/or venting operations (if used).<\/p>\n\n\n\n

EO滅菌放出<\/h2>\n\n\n\n

a) 生物学的指標法<\/h3>\n\n\n\n

生物学的インジケーター (確認済み EPCD) を使用する場合は、最も滅菌が難しい場所、またはこれらの困難なスポットに関連することがわかっている場所を含む、滅菌負荷全体にそれらを配置する必要があります。前処理を使用する場合、生物学的インジケーターは前処理の前に配置する必要があります。<\/p>\n\n\n\n

生物学的インジケーターは、滅菌サイクル終了後に滅菌負荷から取り外し、できるだけ早く培養して生物学的インジケーターが復活するようにする必要があります。適時に培養されなかった場合は、復活の遅れの間に残留 EO に曝露した影響を評価する必要があります。<\/p>\n\n\n\n

生物学的インジケーターの増殖を分析して、その増殖が物理的プロセス仕様を満たしていないことによるものではないかどうかを判断する必要があり、これには確認プロセスを繰り返す必要があります。<\/p>\n\n\n\n

b) パラメータの解放方法<\/p>\n\n\n\n

パラメータリリースは、すべての物理的プロセスパラメータが生物学的インジケータを使用せずにリリース仕様を満たしていることを証明することに依存します。これは物理的プロセスパラメータの測定と記録のみに基づいており、滅菌プロセスの適切性を十分に宣言するものとして機能します。<\/p>\n\n\n\n

パラメータの解放は、すべてのプロセスパラメータが指定、制御、および直接監視されている場合にのみ許可されます。したがって、パラメータリリースを使用する場合は、滅菌プロセスのパラメータを収集および記録し、滅菌プロセスが仕様に準拠していることを確認するために、チャンバー内の温度と湿度を直接測定し、EO 濃度を直接分析するための装置が必要です。<\/p>\n\n\n\n

滅菌プロセスパラメータが滅菌仕様を満たしていることを証明することに加えて、パラメータリリースでは次の追加データの測定と記録も必要です。<\/p>\n\n\n\n

滅菌サイクル全体を通じて、少なくとも 2 つの場所からチャンバー内の温度を測定します。<\/p>\n\n\n\n

処理段階でチャンバー内の湿度を直接測定します。<\/p>\n\n\n\n

指定された時間間隔で滅菌チャンバーのガスを直接分析して EO 濃度を測定し、曝露期間全体を通じて必要な条件が満たされていることを完全に検証します。<\/p>\n\n\n\n

エチレンオキサイド滅菌について詳しく知りたい場合<\/h2>\n\n\n\n

電話：+8619975258603<\/a><\/p>\n\n\n\n

電子メール:ヘイリー@hzbocon.com<\/a><\/p>\n\n\n\n

ローカルサイト: 中国浙江省杭州市下沙区財通中新1202号室<\/p>\n\n\n\n

Webサイト：hzbocon.com<\/a>zjbocon.com<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

EO (エチレンオキシド) 滅菌の日常的な監視と制御の目的は、確認され指定された滅菌プロセスが製品に適用されていることを実証することです。確認された滅菌プロセスの仕様が満たされていることを証明するために、各滅菌サイクルのデータを記録および保持する必要があります。これには少なくとも次のコンテンツが含まれている必要があります。<\/p>\n","protected":false},"author":234312599,"featured_media":8429,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_uag_custom_page_level_css":"","site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"set","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center 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Ethylene oxide cylinders should be stored separately in a dry, well-ventilated room, with strict prohibition of smoking and open flames. The lighting in the sterilization chamber should be explosion-proof, and any electrical appliances that may cause electric\u2026","rel":"","context":"In "Company News"","block_context":{"text":"Company News","link":"https:\/\/zjbocon.com\/?cat=133125"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/10\/Electrical-Scale.png?resize=350%2C200","width":350,"height":200},"classes":[]},{"id":1950,"url":"https:\/\/zjbocon.com\/?p=1950","url_meta":{"origin":2128,"position":5},"title":"eto sterilization process","author":"Bocon Technical Team","date":"2024-10-23","format":false,"excerpt":"Eto Sterilization is conducted using a eto sterilizer located in a dedicated facility.","rel":"","context":"In "ETO STERILIZER"","block_context":{"text":"ETO STERILIZER","link":"https:\/\/zjbocon.com\/?cat=133124"},"img":{"alt_text":"eto sterilization process","src":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/10\/eto-sterilization-process-e1729654271899.webp?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/10\/eto-sterilization-process-e1729654271899.webp?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/10\/eto-sterilization-process-e1729654271899.webp?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/10\/eto-sterilization-process-e1729654271899.webp?resize=700%2C400&ssl=1 2x"},"classes":[]}],"_links":{"self":[{"href":"https:\/\/zjbocon.com\/index.php?rest_route=\/wp\/v2\/posts\/2128","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/zjbocon.com\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/zjbocon.com\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/zjbocon.com\/index.php?rest_route=\/wp\/v2\/users\/234312599"}],"replies":[{"embeddable":true,"href":"https:\/\/zjbocon.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=2128"}],"version-history":[{"count":4,"href":"https:\/\/zjbocon.com\/index.php?rest_route=\/wp\/v2\/posts\/2128\/revisions"}],"predecessor-version":[{"id":8879,"href":"https:\/\/zjbocon.com\/index.php?rest_route=\/wp\/v2\/posts\/2128\/revisions\/8879"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/zjbocon.com\/index.php?rest_route=\/wp\/v2\/media\/8429"}],"wp:attachment":[{"href":"https:\/\/zjbocon.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=2128"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zjbocon.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=2128"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zjbocon.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=2128"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}