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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。
The key items of the test items, test methods and test cycles periodically confirmed in the clean room of the pharmaceutical industry were summarized and discussed. The periodicity of the clean room tests is numerous and interrelated and has its own significance. The test methods used are accurate and scientific. The test cycle must be properly arranged in accordance with the requirements of the process, GMP and related codes. In the meantime, still need a clean testing environment while confirming in the clean room, in order to guarantee the accuracy and effectiveness of the test result.