关于制药车间百级灌装区背景环境级别设置的分析

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

从工艺和净化两方面分析了欧盟GMP洁净级别划分中B级的设置,认为B级静态条件下洁净度定为百级是没有必要的,静态条件下洁净度万级就可以满足欧盟GMP和ISO14644中A区沉降菌小于1个/(4h)的要求。建议在修订我国GMP时可向国际标准靠拢,即B区静态级别不定,只定动态万级或为高于万级的某级。

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.