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

目的:对我院生产非聚氯乙烯软包装输液时采用的残存概率法灭菌工艺进行验证。方法:主要通过对不同产品进行热穿透试验,以确定在设计的灭菌参数下,装载室中的"最冷点"产品内部标准灭菌时间(F0)值>9min;通过生物指示剂试验,确定产品中固定数量嗜热脂肪芽孢杆菌孢子完全杀灭(生物指示剂为阴性);考察输液袋灭菌适应性及灭菌前、后产品pH,主成分含量和5-羟甲基糠醛量的变化等。结果:采用115℃、30min,8min≤F0<12min的湿热灭菌工艺,热穿透试验中灭菌结束时F0值平均为11.3min;生物指示剂试验中生物指示剂均为阴性;输液袋灭菌适应性良好,产品灭菌后质量符合相关要求。结论:该灭菌工艺可靠。

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℃、30min,8min≤F0〈12min. 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.