摘要
目的:防止生产过程中药品污染和交叉污染的发生,需对生产设备进行清洁验证,尤其是对于同一设备生产多个品种时,选择最难清洗的品种、制定最低的允许残留限度进行清洁验证。方法:通过对头孢类冻干综合线成盐、过滤、超滤、冻干、整粒、振动分装设备清洗灭菌程序的验证,确认冻干生产线成盐至及分装系统按清洗灭菌程序进行清洗灭菌的效果。结果:保证合理有效地将活性物质残留量控制到规定限度,并符合GMP法规的要求。结论:证明清洁的可行性与有效性。
Objective: Cleaning validation must be completed on manufacturing facilities to prevent from contamination and cross-contamination. Especially, to facility used for the multi-variety production,the cleaning validation must be based on the hardest cleaning variety and minimum permitted residue limit. Methods: Cleaning and Sterilizing Procedures validation have been completed to the facilities on freeze-dried Cephalosporin production line(such as salifying,filtering,ultrafiltration,freeze-dried,granulating,and oscillator filling). Results: The results of the above validation proved that the cleaning and sterilizing efficiency is qualified to the whole freeze-dried Cephalosporin production line from salifying to oscillator filling,and the Active Pharmaceutical Ingredient Residues is within the prescriptive limit.All the process are complied with GMP regulatory requirement. Conclusion: It is proved that the Cleaning Process is feasible and effective.
作者
尹大志
Yin Dazhi(Center for Food and Drug Inspection of Heilongjiang Province,Harbin 150001)
出处
《黑龙江医药》
CAS
2019年第3期546-548,共3页
Heilongjiang Medicine journal
关键词
头孢类冻干综合线
多品种
生产设备
清洁验证
Cephalosporium freeze-dried synthetic line
multi-product
equipment
cleaning verification
