聚丙烯材质超高速离心管灭菌工艺验证与效果

Validation of effects of sterilization techniques on polypropylene ultra-high speed centrifuge tubes

  • 摘要:
    目的 对比不同灭菌工艺对超高速离心管的灭菌效果及材料物理性能的影响, 为消毒供应中心优化高精密实验耗材的灭菌流程提供依据。
    方法 选取聚丙烯材质超高速离心管, 分别采用高压蒸汽灭菌(134 ℃)、环氧乙烷灭菌及过氧化氢低温灭菌3种方式。通过生物指示剂验证灭菌效果, 结合物理监测和化学指示卡判定灭菌过程安全性。采用游标卡尺测量灭菌前后管体关键部位(管口、螺纹)尺寸变化, 评估形变率;100 000 g超高速离心120 min条件下测试灭菌后离心管抗压强度, 目视检查管体表面完整性(裂纹、透明度变化等)。
    结果 压力蒸汽灭菌与环氧乙烷灭菌的物理、化学及生物监测合格率均为100.00%;过氧化氢低温灭菌的物理监测合格率为(99.60±0.20)%, 化学与生物监测合格率为100.00%。三组灭菌方式在抗压强度不合格率方面比较差异有统计学意义(F=185.640, P<0.001), 其中环氧乙烷灭菌组不合格率最低(0.78±0.30)%。管口直径尺寸形变率在三组间亦差异显著(F=32.170, P<0.001), 压力蒸汽灭菌组形变率最高(2.31±0.50)%。
    结论 高压蒸汽灭菌和过氧化氢灭菌不适用于聚丙烯材质超高速离心管无菌处理, 直接影响材质性能。本研究证实, 环氧乙烷灭菌在保证灭菌效果的同时, 对材料性能和结构稳定性影响最小, 可作为灭菌首选方法。

     

    Abstract:
    OBJECTIVE To compare the effects of different sterilization techniques on ultra-high speed centrifugal tubes and observe the influence on the material physical properties so as to provide bases for optimization of technological process for sterilization of high-precision experimental consumables.
    METHODS The ultra-high speed centrifugal tubes made of polypropylene materials were chosen for the research and were sterilized with high-pressure steam (134 ℃), ethylene oxide and hydrogen peroxide at low temperature, respectively. The sterilization effects were verified by biological indicators, and the safety of sterilization process was determined by combining physical monitoring and chemical indicator cards. Vernier caliper was used to measure the size of key parts (nozzle and thread) of the tube body before and after the sterilization, and the deformation rate was evaluated; the compressive strength of the sterilized centrifuge tube was tested under the condition of 100 000 g ultra-high speed centrifugation for 120 min, and the integrity of the tube body surface (cracks, transparency changes, and so on) was visually inspected.
    RESULTS The qualified rates of physical, chemical and biological monitoring of the pressure steam sterilization method and the ethylene oxide sterilization method were all 100.00%; the qualified rate of physical monitoring of the hydrogen peroxide low-temperature sterilization method was (99.60 ± 0.20)%, and the qualified rates of chemical and biological monitoring were 100.00%. There was significant difference in the unqualified rate of compressive strength among the three groups of sterilization approaches (F=185.640, P < 0.001), and the unqualified rate of the ethylene oxide sterilization group was lowest (0.78±0.30)%. There was significant difference in the deformation rate of diameter of tube orifice among the three groups (F=32.170, P < 0.001), and the deformation rate of the pressure steam sterilization group was highest (2.31±0.50)%.
    CONCLUSIONS The high-pressure steam and hydrogen peroxide are not suitable for the sterilization of ultra-high speed centrifugal tubes made of polypropylene materials, which have direct impact on the material properties. The research proves that the ethylene oxide ensures the sterilization effect and has least impact on the material properties and structural stability, and it should be taken as the preferred approach for sterilization.

     

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