对不同材料包扎的生产用容器灭菌效果的比较试验

为了改进长期以来细胞瓶以牛皮纸加无纺布包装后进行灭菌的方式,实验中依据国内外的有关资料和现行GMP的要求,结合生产的实际情况,以15L细胞瓶为对象,用不同材料(牛皮纸加无纺布、铝箔纸、两层无纺布、带砂芯的硅胶塞)包装后进行灭菌效果的比较试验及残留蒸汽冷凝水测量试验,结果显示用带砂芯的硅胶塞包装的细胞瓶在灭菌过程中瓶内实际温度均能达到设定要求,热穿透及微生物标的验证试验也符合《中华人民共和国药典》(三部)2005年版的标准要求,残留蒸汽冷凝水明显少于其它包装方式,有最好的实际应用价值。

Validation test of sterilizing effect to the production-used container wrapped by different materials

In order to renew wrap material such as the kraft paper added the adhesive-bonded cloth and confirm the sterilizing effect to container,the validation test of sterilizing effect was carried out using the Bowin-Dick test.The residual steam condensed water survey test and the micro-organism sign test.The container(15L cell bottle) was wrapped with the kraft paper added the adhesive-bonded cloth.Aluminun foil,two layers of adhesive-bonded cloth and silicon rubber plug with core respectively.The resuts showed that the actual temperature in the cell bottle wrapped with silicon rubber plug with core can achieve the Pharmacopoeia's standard requirement,the Bowin-Dick test and the micro-organism sign test results can also accord with the demands,this kind of wrap material is of the good practical application value.