FAQ - 制药和生命科学领域粒子监测

问题 During revalidation, is it mandatory to carry out particle monitoring for 3 consequitive days in laminar air flow unit & as well as in area qualification ?: 答案
No. It is required that you certify the area in accordance with ISO 14644-1. You may also chose to perform additional testing to satisfy your monitoring program requirements, but that would be based on a site-by-site issue and not one forced from regulations.

精准质控始自精准监测

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