Determination of the Efficacy of Sterile Barrier Systems Against Microbial Challenges During Transport and Storage

Abstract

Objective.The sterility assurance level of 10−6 is an established standard that defines the quality of sterile products. The aim of the present study was to develop a method that correlated the results from microbial-barrier testing of flexible sterile barrier systems with the estimated microbial challenge that the package encounters during storage and transport.Methods.The effectiveness of microbial-barrier packaging was determined by the use of an exposure chamber test with 20 periodic atmospheric pressure changes of 50 and 70 hPa. Flexible peel pouches were used as sterile barrier systems. The logarithmic reduction value of a sterile barrier system was calculated on the basis of the experimental results and compared with the logarithmic reduction value required for the microbial challenges to maintain sterility during transport and storage.Results.For pouches made of paper and plastic-film material, a logarithmic reduction value of 5.4 was obtained on the basis of 30 of 99 plates becoming nonsterile after being exposed to a 50 hPa difference in periodic atmospheric pressure changes. For pouches made of paper and plastic-film material, a logarithmic reduction value of 5.2 was obtained on the basis of 48 of 100 plates becoming nonsterile after being exposed to a 70 hPa difference in atmospheric pressure. For pouches made of nonwoven and plastic-film material, logarithmic reduction values of 6.38 (ie, 3 of 99 plates became nonsterile after being exposed to a 50 hPa pressure difference) and 6.07 (ie, 3 of the 99 plates became nonsterile after being exposed to a 70 hPa pressure difference) were obtained. Calculating an expected microbial challenge during transport and storage that requires barrier properties corresponding to a logarithmic reduction value of 5.83 and taking the sterility assurance level into account, we found that only the nonwoven pouches fulfilled the European standard EN 556-1.Conclusions.Using the data obtained in a microbial exposure test with a specified flow rate of a bacterial aerosol, we found that the effectiveness of the sterile barrier system against the actual microbial challenge can be examined and evaluated at the sterility assurance level of 10−6.