【正文】 濕熱滅菌程序的驗(yàn)證：滅菌程序的設(shè)計(jì)、開發(fā)、確認(rèn)以及日常控制 目錄 引言 .............................................................................................................................................4 范圍 ......................................................................................................................................4 術(shù)語 .............................................................................................................................................5 滅菌科學(xué) ...................................................................................................................................11 滅菌模式 ...........................................................................................................................12 耐 熱參數(shù)（ DT） .....................................................................................................13 溫度系數(shù)（ z 值） ...................................................................................................15 滅菌率（ Lethal Rate）和累計(jì) 殺滅時間（ lethality， F） ....................................16 滅菌指示劑 ........................................................................................................................20 生物指示劑（ BIs） ................................................................................................20 化學(xué)監(jiān)測器 .............................................................................................................21 熱力學(xué)和蒸汽質(zhì)量 ............................................................................................................22 溫度和熱量 .............................................................................................................22 蒸汽 .........................................................................................................................28 純蒸汽質(zhì)量的測試 .................................................................................................28 滅菌程序的開發(fā) ......................................................................................................................30 設(shè)計(jì)方法 ...........................................................................................................................30 滅菌程序設(shè)計(jì)方法中殘存曲線的應(yīng)用 .................................................................31 裝載類型 ...........................................................................................................................34 多孔 /堅(jiān)硬裝載的定義 ............................................................................................34 液體裝載的定義 .....................................................................................................34 滅菌程序 ...........................................................................................................................35 飽和蒸汽滅菌程序 .................................................................................................35 空氣加壓程序 .........................................................................................................38 滅菌程序的開發(fā) ...............................................................................................................40 多孔 /堅(jiān)硬裝載滅菌程序的開發(fā) ............................................................................40 液體裝載滅菌程序的建立 .....................................................................................45 穩(wěn)定性研究 .......................................................................................................................48 滅菌程序的性能確認(rèn) ..............................................................................................................48 物理確認(rèn) ...........................................................................................................................49 熱分布 .....................................................................................................................49 熱穿透 .....................................................................................................................49 生物指示劑確認(rèn) ..............................................................