Study on sterilization Process of uPright PP-Bag for PacKing infusion
MA Xiao-hong
CHEN Xue-wu
WANG Zhong-bao
HOU Ren-xiu
Abstract：OBjective Todeterminethereliabilityofthesterilizationproceduresandloadingmethodsbyoptimizingthe sterilization process of infusion,and performance verification of infusion bath sterilizer;To determine the effect of sterilization sterilizationprocessbyheatpenetrationandbiologicalindicatortestofthreebatchesoftheproduct.Methods Usingahot water sterilizer,the whole process of sterilization was controlled by programmable automatic control system,and T32 -32 temperature verify system was used for performance verification. On this basis,the use of Bacillus stearothermophilus biologi-calindicatortoverifytheimplementationofthesterilizationprocess,todeterminethesterilizationeffect.Results Sterilized using 121℃ 12 min,F0 values﹥12,sterility assurance level( SAL)≤10-6 . Body bags had no rupture,no deformation,can be placed upright;Preparations tested to meet the quality standard of Chinese Pharmacopoeia 2010 edition. Conclusion Themethodwaspractical,accurateandreliable.
Keywords：Upright PP-bagHot water sterilizerSterilization process
Publication Date：2015-01-01
Online Publishing Date：2025-08-15(First online date of this platform, not the publication date of the document)
Pages：3( 368-370 )