Analysis on background environment cleanliness of class 100 filling zone in pharmaceutical workshops

Analyses the class B specified in European GMP from both production requirement and clean technology. Considers that it is not necessary to set class B to meet the cleanliness of class 100 at static status. As long as the controlled clean zone could reach the cleanliness of class 10 000 at static status, the CFU test results could satisfy the requirements of both ISO 14644 SPC and European GMP, i.e. less than one CFU for four hours in class A zone. Proposes referring the international standard in revising Chinas GMP. And the possible scheme is not to determine the cleanliness at static status in class B zone by just specifying that the operational requirement is the cleanliness of class 10 000 or higher.