Chinese Journal of Pharmacovigilance ›› 2022, Vol. 19 ›› Issue (11): 1181-1185.
DOI: 10.19803/j.1672-8629.20220395

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Discussion on the experimental scheme of microbial challenge method of sealing of packaging materials

SHI Chunhui1, YIN Xiang1, ZHANG Xiaoning1,*, WANG Wei, YU Jiawei3, YAO Shangchen4#, XU Mingzhe4   

  1. 1Institute of Biosafety Inspection, Heilongjiang Institute of Drug Inspection, Harbin Heilongjiang 150080, China;
    2Harbin Pharmaceutical Group Pharmaceutical General Factory, Harbin Heilongjiang 150000, China;
    3Northeast Forestry University, Harbin Heilongjiang 150040, China;
    4Institute for Drug Control, National Institutes for Food and Drug Control, Beijing 102629, China
  • Received:2022-07-11 Published:2022-11-17

Abstract: Objective To discuss the experimental scheme of microbial challenge method of sealing of packaging materials, so as to provide reference for ensuring the safety of sterile drugs in the whole life cycle. Methods The microbial suspension immersion method was adopted, and the key factors such as different packaging systems, different soaking strains and different soaking conditions were selected for corresponding experiments to explore the specific details of the microbial challenge method. Results This study determined the key parameters such as the preparation of positive samples, the selection of sample quantity, the selection of challenging microorganisms, the invasion concentration and the selection of microbial invasion conditions for the microbial invasion experiment, and selected the appropriate scheme to carry out the microbial challenge experiment on different packaging systems. The results met the corresponding requirements of various laws and regulations. The key pore size of microbial invasion is concentrated in 3-5μm,packaging systems with these apertures have the risk of contamination during daily storage and transportation. Conclusion Pharmaceutical enterprises should combine the actual situation,the physical method and the microbial challenge method should be effectively linked to ensure the sterility of the drug in the whole life cycle

Key words: packaging materials, seal, microbial suspension immersion method, key parameters of microbial invasion

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