两种灭菌包装材料无菌有效期的研究

Study on sterility validity of two sterile packaging materials

目的为了解两种灭菌包装材料的阻菌效果和无菌有效期。方法采用加速老化法、微生物屏障性能鉴定试验和无菌检验试验,观察两种灭菌包装材料无菌有效期。结果两种灭菌包装材料染色不渗透,在湿性条件下能有效阻隔金黄色葡萄球菌透过,在干性条件下能有效阻隔枯草杆菌黑色变种芽孢透过;该两种灭菌包装材料在温度60℃~65℃、相对湿度80%~85%的条件下7 d后染色不渗透,在湿性条件下能有效阻隔金黄色葡萄球菌透过,在干性条件下能有效阻隔枯草杆菌黑色变种芽孢透过,无菌检查均未检出需氧菌、厌氧菌和真菌。结论该包装材料无菌有效期可达180 d。

Objective To know bacteria resistance and aseptic storage time of two kinds of sterilized packaging materials.Methods The accelerated aging method of pressure steam sterilization after blocking bacteria function of medical packaging materials and bacterial resistance,antiscratch function of medical device packaging materials for microbial barrier performance test and sterility test. Results Two kinds of sterilized of packaging materials cold not penetrate dye,could effectively prvent Staphylococcus aureus through in wet conditions,could effectively prevent Bacillus subtilis through in dry conditions. After stored at a temperature of 60 ℃ to 65 ℃,relative humidity 80%-85% under the condition for 7 d,the two sterilized packing material could not penetrate dye either and could effectively prevent Staphylococcus aureus through in wet conditions,and Bacillus subtilis through in dry conditions. Sterility test were not detected in aerobic bacteria,anaerobic bacteria and fungi. Conclusion The sterilization packaging materials sterile valid is up to 180 d.