中国药房2011，Vol.22Issue(37)：3513-3515,3.
非聚氯乙烯软包装输液残存概率法灭菌工艺研究
Bioburden Based Sterilization Process of Non-PVC Soft-packing Transfusion
张强 1严文超 1韩丽萍1
作者信息
- 1. 广州军区广州总医院药剂科,广州市510010
- 折叠
摘要
Abstract
OBJECTIVE: To carry out the bioburden based sterilization process validation for non-PVC soft-packing transfusion. METHODS: Heat penetration tests were carried out among different products so as to make sure Fo value of products at the coldest point was more than 9 min, with certain sterilizing-parameters setting; microbial indicator tests were conducted to prove if the sterilizing techniques can kill all Bacillus stearothermophilus (bioindicator negative); changes of parameters such as pH value, content, 5-hydroxymethylfurfural and temperature-adaptability of non-PVC soft package before and after sterilization were also studied. RESULTS: The sterilizing-parameters were as follows: 115 ℃, 30 min, 8 min≤F0<12 min. In heat penetration tests, F0 was equal to 11.3 averagely at the end of sterilization. In microbial indicator tests, bioindicators were all negative, and temperature adaptability of product was fine. Furthermore, the quality of product was up to the related standards. CONCLUSION: The method is practical and reliable.关键词
非聚氯乙烯软包装/灭菌工艺/验证Key words
Non-PVC soft package/ Sterilization process/ Validation分类
医药卫生引用本文复制引用
张强,严文超,韩丽萍..非聚氯乙烯软包装输液残存概率法灭菌工艺研究[J].中国药房,2011,22(37):3513-3515,3.
