目的 探究AIM80A型灯检机顶空气体分析（headspace gas analysis，HGA）泄漏检查工位性能，建立北京生物制品研究所有限责任公司（北京公司）冻干疫苗制品HGA泄漏检查标准。方法 通过上机测试标准氧含量小瓶，计算各氧含量水平的相对标准偏差，分析HGA检查的准确性和重复性；再使用标准微孔小瓶(2和5 μm)制备泄漏样品并存放一定时间后测试，记录氧含量值，确认泄漏样品氧含量与放置时间的关系，并根据这一关系制定HGA检查标准。结果 灯检机HGA工位在检查体积分数5%及以上氧含量时具有较好的准确性和重复性。对模拟泄漏产品进行了最长40 d的氧含量测试，根据冻干疫苗泄漏样品氧含量随时间的变化关系曲线，设置北京公司冻干疫苗制品氧含量检查标准为：存放时间应大于2 d，氧含量下限为5%，该标准的检测限为2 μm。结论 成功建立了冻干疫苗泄漏检查标准，该标准结合了泄漏孔径、存放时间等因素，科学合理，为生产过程监控提供了有效手段。

Objective To investigate the performance of headspace gas analysis (HGA) leak detection station of the AIM80A visual inspection machine, and establish the HGA leak detection standards for freeze-dried vaccine products of Beijing Institute of Biological Products Co., Ltd.（Beijing Company）.Methods The accuracy and repeatability of HGA inspection were analyzed by using standard oxygen content vials for detection and calculating the relative standard deviation values among various oxygen content levels. The relationship between oxygen content and storage time of leaked samples was explored by preparing leaked samples using standard microporous vials (2 and 5 μm), testing them after storage, and recording the oxygen content values. The HGA leak detection standard was formulated based on this relationship.Results The HGA station of the lamp inspection machine exhibited good accuracy and repeatability when inspecting oxygen contents （volume fraction）≥ 5%. Oxygen content tests were conducted on simulated leaked products for up to 40 d. According to the relationship curve between oxygen content and time for leaked samples of freeze-dried vaccines, the standard for oxygen content inspection of freeze-dried vaccine products of Beijing Company was set at storage time ＞2 d and 5% lower limit of oxygen content. The detection limit of this standard was 2 μm.Conclusions The leak detection standard of freeze-dried vaccines is successfully established. This standard, which combines factors such as leak pore size and storage time, is scientific and reasonable, providing an effective means for monitoring the production process.