{"id":2122,"date":"2024-11-06T11:41:22","date_gmt":"2024-11-06T03:41:22","guid":{"rendered":"https:\/\/zjbocon.com\/?p=2122"},"modified":"2025-12-05T10:51:11","modified_gmt":"2025-12-05T02:51:11","slug":"production-of-process-challenge-devices-in-eo-sterilization","status":"publish","type":"post","link":"https:\/\/zjbocon.com\/?p=2122","title":{"rendered":"Production of Process Challenge Devices in eo sterilization"},"content":{"rendered":"\n
\"\"<\/figure><\/div>\n\n\n\n

3.4.1.1 プロセスチャレンジデバイス (PCD) の製造<\/h2>\n\n\n\n

プロセス チャレンジ デバイス (PCD) は、選択したプロセス パラメーターの死滅率を評価するために使用される微生物チャレンジ システムです。これは通常、生物学的指標（胞子数が既知のバチルス・アトロファウスの胞子など）を含むデバイスまたはテストパッケージです。滅菌プロセスに対する PCD の耐性は、製品の最も滅菌が難しい領域における自然の微生物負荷の耐性以上である必要があります。 PCD の数量は、GB18279.1-2015 の付録 C の表 C.3 に概説されている要件を満たす必要があります。 PCD は、内部 PCD (IPCD) と外部 PCD (EPCD) に分類されます。<\/p>\n\n\n\n

a) 社内 PCD (IPCD) 生産<\/h3>\n\n\n\n

内部 PCD は通常、製品ファミリーを代表するために企業によって選択された医療機器です。設計と材料構成に基づいて、これらの製品は滅菌が最も難しい製品の一部であると考えられています。バイオロジカルインジケーター (BI) は製品の最も滅菌が難しい位置に配置されており、滅菌プロセスがチャネルをブロックしたり、製品設計を妨げたりしないようにします。<\/p>\n\n\n\n

生物学的インジケーター (BI) を製品の最も滅菌が難しい領域に配置するか、滅菌条件の達成が最も困難な場所に試験微生物 (バチルス・アトロファウスなど) を接種します。BI または試験微生物を最も滅菌が難しい場所に配置できない場合は、代替デバイスを設計して滅菌バリア システム内に配置し、デバイスと同じ耐性を持つようにすることができます。製品の中で最も滅菌が難しい場所。<\/p>\n\n\n\n

一般的な IPCD には以下が含まれますが、これらに限定されません。<\/p>\n\n\n\n

汚染されたキャリアをリング、ピストンヘッド、ワッシャー、シリンジピストンなどのコンポーネントの間に配置します。微生物チャレンジをカテーテル内腔の中央に配置し、接着剤またはコネクタを使用してカテーテルを再封し、製品の完全性を回復します。微生物チャレンジをピストンインターフェースに配置します。<\/p>\n\n\n\n

b)外部PCD（EPCD）生産<\/h3>\n\n\n\n

外部 PCD は、積載される製品の外側に配置されます。 EPCD は通常、ルーチン処理に使用され、処理後にロードから取得されます。滅菌製品の生物学的負荷に対する EPCD の耐性を IPCD の耐性と比較する必要があります。 EPCD は、負荷内で最も滅菌が難しい製品を表す必要もあります。<\/p>\n\n\n\n

EPCD と汚染された製品サンプルの関係を定期的に見直して、滅菌済み製品に変化が生じていないこと、および EPCD が依然として積荷内で最も滅菌が難しい製品であることを確認する必要があります。<\/p>\n\n\n\n

PCD に BI を配置する場合、PCD は製品内の最も滅菌が難しい場所と少なくとも同じ抵抗を備えている必要があります。<\/p>\n\n\n\n

一般的な EPCD には以下が含まれますが、これらに限定されません。<\/p>\n\n\n\n

生物学的インジケーター (BI) を製品パッケージまたはプラスチック袋などの同等品の中に入れ、マニラ封筒の中に入れます。生物学的インジケーターを指定回数折りたたんだ厚いビニール袋に入れます。生物学的インジケーターをピストンワッシャーやピストンヘッドなど、シリンジのさまざまな部分に置きます。追加のパッケージの有無にかかわらず、汚染されたキャリアを含むプラスチックチューブを密閉します。<\/p>\n\n\n\n

上記の方法で製造された PCD は、通常の製造製品と同じ方法で梱包され、製品積載内に均等に分散され、滅菌室内のコールド スポットを覆うように配置されます。<\/p>\n\n\n\n

3.4.1.2 部分サイクル（短サイクル）試験<\/h2>\n\n\n\n

PCD を選択した後、部分サイクルを実行してその適合性を確認します。評価方法は以下の通りです。<\/p>\n\n\n\n

a) 動作評価の結果に基づいて、PCD、テストサンプル、センサーの配置方法を決定します。 PCD の数と分布は十分である必要があります。選択した EPCD が日常的な滅菌プロセスの監視に使用される場合は、計画と手順に従って製品ロードに配置する必要があります。<\/p>\n\n\n\n

b) 生物学的指標の D 値、ST 時間、KT 時間に基づいて、曝露時間を短く設定します。他のパラメータは、日常的な滅菌プロセスパラメータの下限値でテストする必要があります。試験方法は GB18281.2 の付録 A を参照してください。暴露時間が終了したら、微生物培養用の製品、IPCD、および EPCD を取り外し、結果を観察します。<\/p>\n\n\n\n

培養結果は、PCD の抵抗が製品内の最も滅菌が難しい場所の生物学的負荷抵抗以上であることを示す必要があります。<\/p>\n\n\n\n

IPCD と EPCD は部分的に負である必要があります。完全に陰性または完全に陽性の結果は、テストの不合格を示します。IPCD の抵抗は製品より大きく、EPCD の抵抗は IPCD の抵抗以上である必要があります。<\/p>\n\n\n\n

結果が期待どおりでない場合は、原因を調査します。通常、PCD 抵抗または滅菌パラメータの調整が必要であり、結果が期待どおりになるまで再テストが続きます。 3 つすべて (製品、IPCD、および EPCD) で微生物の増殖が見られない場合は、EO 曝露時間を適切に短縮し、再度テストします。すべてに微生物の増殖が見られる場合は、EO 曝露時間を増やして再テストします。<\/p>\n\n\n\n

3.4.1.3 半サイクルテスト<\/h2>\n\n\n\n

ショートサイクルテストが正常に完了したら、一貫した半サイクルテストを 3 回連続して実行して、EO 滅菌プロセスの有効性 (SAL = 10^-6) と再現性を実証します。評価方法は以下の通りです。<\/p>\n\n\n\n

生物学的インジケーターの無菌性を標準として設定し、その他の滅菌プロセスパラメーターを日常の滅菌パラメーターの下限値に設定します (例: 前処理の移送時間が指定範囲内であるなど)。最初の滅菌プロセスの滅菌曝露時間を徐々に半分にし、異なる滅菌時間の後に PCD から生物学的インジケーターを除去します。無菌性が確認されるまで無菌環境で培養します。このようにして決定された最短の滅菌時間 (臨界時間) が半サイクル時間となり、同じ最短時間で少なくとも 2 回以上のテストを実行する必要があります。<\/p>\n\n\n\n

All three test results should show complete inactivation of all biological indicators (initial colony count no less than 1\u00d710^6) to confirm the minimum effective EO exposure time. The exposure time in the routine sterilization process should be at least twice this minimum time.<\/p>\n\n\n\n

生物学的指標の培養結果は、すべての IPCD および EPCD が陰性であることを示すはずです。ショートサイクルテストで EPCD の抵抗が IPCD の抵抗よりも大きいことが示された場合、EPCD は部分的に陽性を示す可能性があります。<\/p>\n\n\n\n

結果が期待を満たさない場合は、原因を調査し、通常は結果が期待と一致するまで再テストする前に滅菌パラメータを調整します。<\/p>\n\n\n\n

例：<\/p>\n\n\n\n

最初の半サイクルの滅菌曝露時間が 4 時間であると仮定します。無菌の場合は、次の検査までの曝露時間を 2 時間に短縮します。微生物の増殖が発生した場合は、4 時間の曝露に基づいて曝露時間を増やしてください。<\/p>\n\n\n\n

2 番目の半サイクルの滅菌曝露時間が 2 時間であると仮定します。無菌の場合は、次の検査までの曝露時間を 1 時間に短縮します。微生物の増殖が発生した場合は、暴露時間を 3 時間に延長してください。<\/p>\n\n\n\n

3 番目の半サイクルの滅菌曝露時間が 3 時間であると仮定します。無菌の場合は、3 時間のテストを 2 回繰り返します。すべての結果が無菌である場合は、最小有効時間として 3 時間を確認します。微生物の増殖が発生した場合は、4 時間曝露してテストを繰り返し、すべての結果が無菌である場合は、最小有効時間として 4 時間を確認します。<\/p>\n\n\n\n

3.4.1.4 フルサイクルテスト<\/h2>\n\n\n\n

フルサイクルテスト中は、EO 曝露時間を半サイクルの最小有効時間の 2 倍に設定し、その他のパラメーターを日常の滅菌パラメーターの上限に設定して、滅菌プロセスの信頼性と再現性を検証します。<\/p>\n\n\n\n

使用する温度および湿度センサーの数は、GB18279.1 の付録 C の要件を満たし、滅菌負荷内で均等に分散する必要があります。温度センサーの配置ポイントには、運用適格性評価 (OQ) 中に滅菌室内のコールド スポットとホット スポットの両方が含まれている必要があります。<\/p>\n\n\n\n

試験後、製品と EPCD の培養結果は完全な無菌性 (すべて陰性) を示すはずです。<\/p>\n\n\n\n

さらに詳しく知りたい場合は<\/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\n\n\n

ISO 11135:2014<\/th>Sterilization of health-care products \u2013 Ethylene oxide \u2013 Requirements for the development, validation and routine control of a sterilization process for medical devices<\/td><\/tr>
ISO 14161:2009<\/th>Sterilization of health care products \u2014 Biological indicators \u2014 Guidance for the selection, use and interpretation of results<\/td><\/tr>
ISO 10993-7:2008<\/th>Biological evaluation of medical devices \u2014 Part 7: Ethylene oxide sterilization residuals<\/td><\/tr>
ISO 11737-1:2018<\/th>Sterilization of health care products \u2014 Microbiological methods \u2013 Part 1: Determination of a population of microorganisms on products<\/td><\/tr>
ISO 11737-2:2009<\/th>Sterilization of medical devices \u2014 Microbiological methods \u2014 Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process<\/td><\/tr>
AAMI TIR16:2017<\/th>エチレンオキシド滅菌の微生物学的側面<\/td><\/tr><\/tbody><\/table><\/figure>\n","protected":false},"excerpt":{"rendered":"

プロセス チャレンジ デバイス (PCD) は、選択したプロセス パラメーターの死滅率を評価するために使用される微生物チャレンジ システムです。これは通常、生物学的指標（胞子数が既知のバチルス・アトロファウスの胞子など）を含むデバイスまたはテストパッケージです。滅菌プロセスに対する PCD の耐性は、製品の最も滅菌が難しい領域における自然の微生物負荷の耐性以上である必要があります。 PCD の数量は、GB18279.1-2015 の付録 C の表 C.3 に概説されている要件を満たす必要があります。 PCD は、内部 PCD (IPCD) と外部 PCD (EPCD) 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