Abstract：The selection principle of the number of sampling points for clean plant air-conditioning system confirmation and daily environmental monitoring has always been a topic of discussion in the pharmaceutical industry. In this paper, by comparing the domestic and foreign drug regulatory agencies to confirm and daily environmental monitoring different requirements, which for the confirmation process, the selection of sampling points is relatively clear, the owner can according to the product sales market, comprehensive consideration, in accordance with the most stringent standard selection. However, if there is no clear requirement for environmental monitoring sampling points, assessment and confirmation should be carried out based on the production process, product characteristics and environmental level, and reference suggestions are given in the document. The confirmation and daily environmental monitoring of clean plant and air conditioning system are two independent processes, reflecting the different state of the system respectively and avoiding mutual substitution.
任杏珠. 医药洁净厂房空调系统确认和环境监测取样点选取探讨[J]. 煤炭与化工, 2022, 45(1): 144-150.
Ren Xingzhu. On sampling point selection of HVAC qualificaio discussion n and daily environmental monitoring in pharmaceutical clean room. CCI, 2022, 45(1): 144-150.
