Microbial Testing in Support of aseptic 微生物检验对无菌工艺的影响及帮助.pdf

Microbial Testing in Support of Aseptic Processing Anthony M. Cundell The role of microbial icrobial testing is conducted in the sterile pharma- testing to ensure the ceutical industry in support of sterile product de- sterility of aseptically velopment; for in-process monitoring during asep- tic processing and filling operations; and for testing M filled sterile products finished products. The role that microbial testing plays in pro- is explained, from the moting sterility assurance of aseptically filled sterile products product development will be discussed. phase to in-process monitoring to Product development finished product The objective of the product development process is to take testing. successfully progressing discovery leads from preclinical trials through development with the purpose of defining the formu- lation, delivery system, manufacturing process, and product specifications. The following microbial tests can be used dur-