胶囊型益生菌保健食品HACCP系统的应用研究

Application of HACCP System to the Production of Probiotic Capsulae

[目的 ]在益生菌保健食品生产领域建立危害分析与关键控制点 (HACCP)系统 ,并验证其可行性和有效性。[方法 ]参照国际食品法典委员会文件《HACCP的原理及其应用准则》推荐的原理和程序及国家保健食品良好操作规范(GMP)法规和药品良好操作规范 (GMP)法规的要求 ,通过对人员、设备、环境、原料、半成品、成品等对象的微生物卫生指标进行一系列检测 ,并对所有原料和加工工艺进行危害分析 ,建立胶囊型益生菌保健食品HACCP体系。 [结果 ]确定了菌种的使用和控制、发酵前灭菌、离心机管道和物料管道的灭菌、充填前的辅料烘料、半成品金属探测为关键控制点 ,制定出一套详细的HACCP计划。经试运行 ,主要危害得到控制。 [结论

To investigate and evaluate the feasibility and validity of HACCP system for its application in production of probiotic capsules. Continuous investigation for microbial indices on personnel,equipments,environments,raw materials,semi-finished goods and final products,as well as the hazard analysis on raw materials and processing technology in a model factory,were carried out under the instruction of 'HACCP system and guideline for its application'(CAC regulation) and the requirements of GMP regulation for medicine manufacture as well as Health Food GMP regulation. Critical control indices on probiotic strains,pipeline sterilization before fermentation and centrifuge,material transportation,etc,were established.The control criterion of both microbiological hygiene and safety/risk assessment for probiotic production were proposed. [Conclusion] HACCP system was established and applied to the production lines of probiotic capsules;its feasibility and validity were proved in model factory.