新购超低温冰箱的4Q确认

4Q Confirmation of a Newly Purchased Ultra-Low Freezer

对新购超低温-86℃冰箱进行4Q确认,以确认冰箱能满足菌毒种及样本的保藏要求,并指导操作者规范使用和正确维护。根据超低温冰箱确认方案分别实施4Q确认,即设计确认(DQ)、安装确认(IQ)、运行确认(OQ)和性能确认(PQ)。结果表明,超低温冰箱的确认结果都达到确认标准,确认结果符合规定。超低温冰箱的4Q确认结论判为合格,冰箱可用于菌毒种及样本的保藏。

Objective A newly purchased -86℃ Ultra-Low Freezer was confirmed by 4Q to ensure that the equipment could meet the storage requirements of bacterial (viral) strains and specimens, and to guide operators to use it regularly and maintain it correctly. Methods According to the 4Q confirmation scheme of -86℃ Ultra-Low Freezer, design confirmation (DQ), installation confirmation (IQ), operation confirmation (OQ) and performance confirmation (PQ) were implemented respectively. Results All the confirmation results of the -86℃ Ultra-Low Freezer can meet the confirmation standards. Conclusion The 4Q confirmation conclusion of the -86℃ Ultra-Low Freezer was qualified. The freezer can be used for the preservation of bacterial (viral) strains and specimens.