PDA TR1（中文） 湿热灭菌验证.pdf

PDA Technical Report No. 1 - Revised 2007 PDA技术报告No. 1 –2007修订版 Validation of Moist Heat Sterilization Processes: Cycle Design, Development, Qualification and Ongoing Control 湿热灭菌工艺验证： 周期设计，开发，验证和持续控制 Contributors作者 James P. Agalloco, Agalloco Associates James E. Akers, Ph.D., Akers Kennedy Associates Wilf Allinson, GlaxoSmithKline Thomas J. Berger, Ph.D., Hospira Frank Bing, Abbott Laboratories (retired) Go¨ran Bringert, GE Kaye Instruments Gary Butler, Steris Corporation Jean-Luc Clavelin, Eli Lilly Co. Peter Cooney, Ph.D., FDA (retired) Phil DeSantis, Schering-Plough Peter Du¨rr, F. Hoffmann-La Roche AG Kristen D. Evans, FDA John G. Grazal, AstraZeneca Nigel Halls, Ph.D., IAGT. Ltd. Paul Hargreaves, MHRA Andrew D. Hopkins, MHRA Martin A. Joyce, Ph.D., GeneraMedix Inc. David Karle, Steris Corporation Bernard Kronenberg, Bakrona Basel AG John W. Levchuk, Ph.D., FDA (retired) Richard V. Levy, Ph.D., PDA Steen Loevtrup, Novo Nordisk A/S Timothy F. Lord, Eli Lilly Co. Genevieve Lovitt-Wood, G.I. Lovitt Associates, Project Manager and Technical Writer Russell E. Madsen, The Williamsburg Group, LLC Vittorio Mascherpa, Ph.D., Fedegari Autoclavi Spa (retired) David W. Maynard, Maynard Associates Robert B. Myers, PDA James E. Owens, Baxter Healthcare (retired) Irving Pflug, Ph.D., University of Minnesota (retired) Dario Pistolesi, Ph.D., Fedegari Autoclavi Spa (retired) Anthony Pochiro, AG Edwards and Sons Jarmo Saari, Leiras OY Michael Sadowski, Baxter Healthcare John T. Shirtz, Baxter Healthcare Keith Shuttleworth, Keith Shuttleworth Associates Ltd. Finlay Skinner, Skinner Pharm-Assist Ian Symonds, GlaxoSmithKline Kevin D. Trupp, Hospira Dieter Witthauer, Ph.D., Novartis Richard T. Wood, Ph.D. (retired) William Young, Baxter Healthcare (retired)