Study on container closure integrity of packaging system of glycerin fructose sodium chloride injection by mass extraction method
GUO Yan-yan
ZHANG Wan-ying
CHENG Jie
QIU Yi-ting
WANG Xiao-lan
HUANG Wan-sha
HU Min
REN Kun
JIANG Yan
Abstract：Objective:To develop a comprehensive quality extraction method to evaluate the container closure integrity of the packaging system for glycerin fructose sodium chloride injection(specification:500 mL).Methods:By testing negative samples,positive control samples,and large leakage samples,the test parameters of pre-vacuuming,systematic continuous vacuuming,and stable flow were optimized and the methodology was confirmed,and the three batches of samples stored for 0,12,and 24 months were tested.The long-term test conditions were as follows:the temperature was(25±2)℃,and relative humidity was(40±5)％.Results:The detection limit of this method was 5 μm,the detection method was convenient and sensitive,and the tightness of the tested sample met the requirements.Conclusion:The test method can be used to study the sealing property of glycerol fructose and sodium chloride injection in five-layer co-extrusion bag for infusion packaging system.
Keywords：mass extraction methodglycerin fructose sodium chloride injectionfive-layer co-extrusion bag for infusioncontainer closure integrity of packaging system
Publication Date：2025-09-30
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：5( 1997-2001 )