医药工业厂房洁净室确认工作的探讨

对医药工业厂房洁净室周期性确认所进行的测试项目、测试方法和测试周期的关键问题进行了总结和探讨。洁净室周期性确认的测试项目繁多并且彼此相互关联,分别有其重要意义;所采用的测试方法要求精确并有科学性;测试周期必须按照工艺、GMP和相关规范的要求合理进行安排。同时,在进行洁净室确认时,仍然需要一个清洁的测试环境,以保证测试结果的准确性和有效性。

Discussion of Qualification of Cleaning Room in Pharmaceutical Workshop

In this article,the measuring items,methods and period,which are needed to be periodically qualified for the clean-room used in pharmaceutical plant,were discussed and summarized.There are so many measuring items,which has own important role,for periodical qualification of clean-room and there are connections among these items.The measuring methods are required to be precise.The measuring period must be arranged in accordance with the requirements of process,GMP and relevant codes.At the same times,clean measuring environment is still needed to ensure obtaining correct and effect results.