限制进入隔离系统（RABS）和高级无菌工艺(中英文稿).pdfVIP

RABS and Advanced Aseptic Processing 限制进入隔离系统（RABS）和高级无菌工艺 May 1, 2006 By: James P. Agalloco, James E. Akers For at least 20 years, the global parenteral industry has recognized that personnel are the dominant risk relative to microbial contamination in aseptically produced sterile products (1). The contamination source strength of the gowned aseptic processing operator has been estimated in several research studies. Concomitant with this awareness, we have witnessed a series of technological advances that have endeavored to mitigate this contamination risk. These advances can be rou