上海一家企業(yè)參數(shù)放行理念-文庫吧
2025-04-22 01:51 本頁面
【正文】 ? Number of manipulations required 需要大量的人力 ? Number/experience of “Testers” 依賴檢測人員的數(shù)量和經(jīng)驗 ? Environmental factors 受環(huán)境因素影響 ? Unnecessary product rejection 不必要的產(chǎn)品報廢 Why Parametric Release? 為何實行參數(shù)放行？ (Limitations of Sterility Test 無菌檢查的局限性 ) 參數(shù)放行 Parametric Release ? Sterility Test is Costly 無菌檢查消耗成本 ? Multiple product samples from each load 每滅菌鍋取樣量大 ? Clean room validation maintenance 無菌室需驗證及保養(yǎng) ? Specially trained personnel 需特殊培訓(xùn)操作人員 ? Media and equipment preparation 需準(zhǔn)備培養(yǎng)基和設(shè)備 ? High product inventories required 產(chǎn)品庫存量大 Why Parametric Release? 為何實行參數(shù)放行？ (Limitations of Sterility Test 無菌檢查的局限性 ) 參數(shù)放行 Parametric Release Why Parametric Release? 為何實行參數(shù)放行？ （ Process 生產(chǎn)過程） Moist Heat Sterilization Process 濕熱滅菌工藝的特點 ? Nontoxic 無毒 ? Less Expensive 低耗費 ? Universally Recognized 國際普遍認(rèn)可 ? Broad Spectrum Lethality 廣譜殺菌能力 (molds 霉菌 , yeasts 酵母 , bacteria 細(xì)菌 /spores 孢子 , viruses 病毒 ) ? Oldest, Safest, Most Dependable Process 最古老，最安全，最可靠的工藝 ? Easily Controlled and Validated 易于控制和驗證 ? Preferred by Most Regulatory Bodies 被多數(shù)法規(guī)部門推薦使用 參數(shù)放行 Parametric Release Why Parametric Release? 為何實行參數(shù)放行？ （ Moist Heat Sterilization 濕熱滅菌） ? “ Natural” Candidate for Parametric Release 參數(shù)放行是 “ 自然 ” 選擇 ? Minimal Key Parameters 至少應(yīng)有的關(guān)鍵參數(shù) ? Temperature 溫度： 105–135oC ? Exposure Time 暴露時間： 5–200 minutes ? Pressure: Saturated Steam Pressure @121oC = 30 PSIA/15 PSIG 壓力： 121oC的飽和蒸汽壓 = 30 PSIA/15 PSIG 參數(shù)放行 Parametric Release Why Parametric Release？ 為何參數(shù)放行？ ? Baxter is convinced: ? Parametric release is the only way to demonstrate required sterility assurance levels for terminally sterilized products 百特深信： 參數(shù)放行是唯一可以保證最終滅菌產(chǎn)品所要求的無菌保證水平的方法 參數(shù)放行 Parametric Release Parametric Release Requirements 參數(shù)放行的要求 參數(shù)放行 Parametric Release Regions 國家和地區(qū) ? United States 美國 ? Europe 歐洲 ? ICH 國際藥品協(xié)調(diào)會 ? ISO11134 ISO國際標(biāo)準(zhǔn) ? Japan 日本 ? China 中國 參數(shù)放行 Parametric Release FDA Guidance FDA 政策法規(guī)指南 Parametric Release: 參數(shù)放行定義 A sterility release procedure based upon effective control of a validated sterilization process cycle in lieu of release based upon endproduct sterility testing. All parameters within the procedure must be met before the lot is released. 基于對一個經(jīng)過驗證的滅菌循環(huán)過程進行有效的控制，參數(shù)放行可定義為一種替代對最終產(chǎn)品作無菌檢驗的無菌放行程序。一批產(chǎn)品
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