Research progress in positive control samples in container closure integrity test of aseptic preparations
ZHU Jia-qi
JIA Fei-fei
ZHAO Xia
Abstract：The closure integrity of packaging systems refers to the ability of the packaging systems to prevent the loss of contents,invasion of microorganisms,and entry of gases(oxygen,air,water vapor,etc.)or other substances to ensure that the drug continues to meet the safety and quality requirements.In recent years,the closure integrity testing of packaging systems has received more and more attention.This article discussed the current research status of closure integrity testing technology of packaging systems at home and abroad and introduced the preparation method,calibration method and problems faced by positive control samples which are used in packaging system closure integrity testing.Besides,this article also summarized the main points of domestic research on positive control samples in packaging system closure integrity testing,and prospected its development,in order to provide reference for the research on positive control samples in domestic drug packaging system closure integrity testing.
Keywords：aseptic preparationcontainer closure integrityleakageleakage detection technologypositive control sample
Publication Date：2024-11-30
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：6( 2346-2351 )