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GMP 準拠に不可欠なシステム
バイオ医薬品のクリーンルームエンジニアリングでは、製造環境が GMP 要件を満たしていることを確認するために、消毒および洗浄装置が重要な設備です。以下は 8 つのコア システムとそのアプリケーションです。
1. BIBO (バッグイン/バッグアウト) 封じ込めシステム
BIBO システムは、ISO 14644-1 クリーンルーム規格に準拠した、HEPA フィルター交換用の安全保護装置です。主な特徴:
·汚染の拡大を防ぐ完全密閉操作
·バイオセーフティキャビネットやHVACシステムに最適
·EU GMP Annex 1 の滅菌製品に関する厳しい要件に準拠
2. クリーニングワークステーション
USP <1072> および GMP 要件を満たす、クリーンルーム用器具用に設計された特殊な洗浄システム:
·洗い・すすぎ・乾燥機能を一体化
·最終すすぎ媒体として WFI (注射用水) を使用
·ASTM E3106-18 検証要件に準拠
3. 無菌アイソレーター
ISO 14644-7 および EU GMP Annex 1 に従って設計された密閉システム:
·ISO クラス 5 (クラス 100) の無菌環境を提供
·統合された VHP (過酸化水素蒸気) 滅菌システム
·無菌充填および製品移送作業に最適
4. 滅菌陰圧充填アイソレーター
以下に準拠する特別に設計されたアイソレータ システム:
·米国 FDA の無菌処理ガイダンス (2004)
·負圧を維持して二次汚染を防止します
·統合オンライン粒子監視システム (PMS)
5. VHP HVAC 滅菌システム
蒸発過酸化水素ベースの HVAC 滅菌溶液:
·ISO 14937 滅菌検証規格に準拠
·Geobacillus stearothermophilus の 6 log 減少を達成
·グレードBおよびCのクリーンルーム滅菌に最適
6. VHP フード燻蒸パススルー
クリーンルームフード滅菌用の特殊搬送装置:
·IEST-RP-CC003.4規格に準拠
·滅菌サイクルは 30 分以内に完了します
·統合された生物学的指標検証システム
7. 細胞療法製造アイソレーター
細胞治療製品向けに特別に設計された GMP 生産システム:
·FDA CGT ガイダンス (2020) および EMA ATMP 要件に準拠
·CO₂ インキュベーターと極低温操作モジュールを統合
·21 CFR Part 11 電子記録要件を満たしています
8. GMP調理器具洗濯乾燥機
GMP Annex 1 要件を満たすプロ仕様の洗浄装置:
·ASTM E3106規格に準拠したPQ検証
·追跡可能な清掃記録を提供します
·ステンレス鋼やプラスチック製の器具の洗浄に適しています
関連する国際規格:
·ISO 14644-1:2015 クリーンルームおよび関連する管理された環境
·EU GMP Annex 1:2022 無菌製品の製造
·USP <1072> クリーンルームおよびその他の管理された環境の消毒
·産業用無菌医薬品製品に関する FDA ガイダンス (2004)
·ISO 14937:2009 ヘルスケア製品の滅菌 - 検証の要件
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