联动灌装线的验证研究

Validation of production line combined with vial washing, sterilizing and filling

目前国内对小瓶清洗、干热灭菌、灌封三位一体联动分装线的验证处于起步阶段 ,而国外的某些验证试验方法对于国内大多数制药行业又是不切实际的。依据国内外的有关资料 ,按照现行GMP的要求 ,结合生产的实际情况 ,建立了一套验证试验方法 。

Currently in our country it is a primary stage in validation of production line combined with vial washing, dry heat sterilizing and filling. For the most of pharmaceutical companies in our country, it is not realistic to act upon the overseas experiments of validation. According to the requirements of GMP and our own reality, we have set up a procedure of validation, which is practicable for validation of filling line.