分别对胶囊剂型保健食品不同时期生产过程中的人员手部、设备表面进行微生物污染调查，监测车间清洁卫生的质量变化，对典型的污染微生物进行分离鉴定，掌握各环节微生物菌群构成，评价企业生产过程微生物控制系统的有效性。结果显示，34份人员手部涂抹样本中大肠菌群、金黄色葡萄球菌的检出值均<10 CFU/手，菌落总数介于10~107 CFU/手；132份设备表面涂抹样本中大肠菌群、金黄色葡萄球菌的检出值均<0.4 CFU/cm2（设备表面），菌落总数介于10~104 CFU/cm2。从样本中分离出46株微生物（其中细菌44株，真菌2株）进行菌种鉴定，优势种群为类芽胞杆菌属（Paenibacillus sp.），占比为60.87%，其次是不动杆菌属（Acinetobacter sp.）、芽胞杆菌属（Bacillus sp.）和短杆菌属（Brevibacterium sp.），占比均为4.35%。基于16S rRNA基因序列和MALDI-TOF蛋白指纹图谱对分离的类芽胞杆菌进行溯源分析发现在人员手部和设备之间存在交叉污染，且该菌长期定殖用于周转物料的容器表面，对产品质量控制存在潜在风险。

Microbiological contamination of human hands and the equipment surfaces in the different production stages of the health food capsule was investigated. The changes in the hygiene and sanitation of the workshop were monitored. The typical contaminating microorganisms were isolated and identified to monitor the composition of microbial flora in each stage and evaluate the effectiveness of the microbial control system in the industrial production process. The results showed that the detection values of coliform and Staphylococcus aureus in 34 smear samples of human hands were < 10 CFU/ hand with the total colony count being 10~107 CFU/hand; in 132 smear samples of equipment surfaces, the detection values of coliform and Staphylococcus aureus were < 0.4 CFU/ cm2 (equipment surface) with the total colony count being 10~104 CFU/cm2; 46 strains of microorganisms (including 44 strains of bacteria and 2 strains of fungi) were isolated from the samples for strain identification. The dominant species was Paenibacillus sp., accounting for 60.87%, followed by Acinetobacter sp., Bacillus sp. and Brevibacterium sp., all accounting for 4.35%. The traceability analysis of the isolated Paenibacillus sp. was performed based on the 16S rRNA gene sequences and MALDI-TOF protein fingerprint revealed cross-contamination of Paenibacillus sp. between the human hands and equipment surfaces. Also, Paenibacillus sp. was colonized on the surfaces of the containers used for turnover materials, which had potential risks to production quality control.

广东省“珠江人才计划”本土创新科研团队（2017BT01S174）；广东省科学院实施创新驱动发展能力建设专项（2019GDASYL-0201001）