论文部分内容阅读
近年来我国已在一些制药厂的粉针剂灌封和原药制造等工序中采用了洁净无菌技术,降低了无菌室内空气中的尘粒和菌落数,极大地改善了药品生产的环境质量。表1为某制药厂装设高效空气过滤器的洁净无菌室和无高效空气过滤器的普通无菌室的菌落数统计情况。由表可见,采用洁净技术后,无菌室中的菌落数降低了1倍,测点菌落数的不合格率由42.5％降低到13.6％,这无疑对提高药
In recent years, clean sterilizing technology has been adopted in the process of powder injection and raw drug manufacturing in some pharmaceutical factories, which reduces the number of dust particles and colonies in the sterile room air and greatly improves the environmental quality of drug production. . Table 1 shows the number of colonies in a clean sterile room equipped with a high-efficiency air filter and a normal sterile room without a high-efficiency air filter in a pharmaceutical factory. As can be seen from the table, after using the clean technology, the number of colonies in the aseptic room was reduced by a factor of two, and the rate of failure of the number of colonies at the measuring points was reduced from 42.5% to 13.6%. This is undoubtedly an increase in medicine.