广东省35家保健食品企业厂房空气洁净度检测结果分析

Analysis of results in inspection of air cleanliness in the workshop of 35 health food manufacturing enterprises in Guangdong Province.

目的 为了解广东省保健食品生产企业厂房空气洁净状况 ,促进企业实施《保健食品良好生产规范》(GMP)管理 ,并为GMP评审提供技术资料。 方法 2 0 0 3年 3～ 12月 ,对广东省 3 5家保健食品企业的 2 10间厂房进行空气尘埃粒子数、微生物指标和相关指标现场静态检测。 结果 2 10间厂房设计等级为 10 0 0 0 0级、3 0 0 0 0 0级的厂房分别为 97、113间 ,其空气尘粒数合格率 (符合相应设计洁净度等级 )分别为 93 8%、77 9% ;空气沉降菌合格率分别为84 5 %、73 5 % ;2 10间厂房的静压差、温度、相对湿度等相关指标合格率分别为 71.9%、93 .3 %、75 .2 % ;对 2 10间厂房空气中 0 .5 μm尘粒数、5 μm尘粒数与沉降菌落数进行相关和回归分析 ,认为空气中尘埃粒子数与细菌总数呈正的直线相关关系 (P <0 .0 1) ,决定系数分别为 0 .5 69、0 .3 77;( χ2 =3 6.9,P <0 .0 1)。 结论 本次检测大部分保健食品生产企业厂房空气洁净度符合GMP要求 。

Objective To understand the status of the air cleanliness of the workshops of the health food manufacturing enterprises in Guangdong, promote the implementation of the《Good manufacture practice for health food 》 and provide the basic data for the GMP evaluation. Methods From March to December 2003, the airbome particles, settling microbe and other related parameters including net pressure difference, temperature and relative humidity were measured according to 《Test method for airborne particles in clean rooms (area) of the pharmaceutical industry》, 《Test method for settling microbe in clean room (area) of the pharmaceutical industry》 and 《Standard examination methods for public places》, then evaluated according to 《Code for drug manufacture quality》 . Results In the all of the 210 clean-workshops there were 97 workshops originally designed to reach cleanliness class 100 000 and 113 rooms to reach class 300 000. In the 97 clean-workshops, the qualified rate of the airborne particles and the qualified rate of settling microbe were 93.8% and 84.5% respectively, while in the 113 clean-workshops they were 77.9% and 73.5%. The qualified rates of the net pressure difference, temperature and relative humidity in all of the 210 clean-workshops were 71.9%, 93.3% , 75.2% respectively. By linear correlation analysis it showed that there was linear correlation between airbome particles and settling microbe (P<0.01). There was significant difference (P<0.01) on the cleanliness class among the diffirent kinds of clean-workshops and the cleanliness class of the canning clean- workshops was superior to that of the stuff-handling clean-workshops. Conclusion The cleanliness class of most of the total 210 clean-workshops can reach the stipulation in the 《Good manufacture practice for health food》. Attention should be paid on the comprehensive attainment of criterion of clean-workshops.