2Keith Bader, John Hyde, Peter Watler, and Amber Lane. Online Total Organic Carbon (TOC) as a Process Analytical Technology for Cleaning Validation Risk Management. Pharmaceutical Engineering, January/February 2009:8419.
3世界卫生组织GMP、中国《药品生产验证指南》.
4欧洲标准EN554(关于高温蒸汽灭菌设备)Sterilization medical devices Validation and routine control of sterilization by moist heat.
5英国标准HTM2010 Health technical memorandum sterilization.
10Herbert J. Kaiser,Ph. D. & Bruce Ritts,M. S. Validation of Analytical Methods Used in Cleaning Validation [J]. Journal of Validation Technology, 2004,10 ( 3 ): 219.
