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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.

Objective.We developed a microbiological test to detect the penetration of airborne microorganisms through the packaging of medical products after sterilization, to meet the requirements of European standard EN 556. We applied this test method to transparent pouches.Design.The microbial-barrier properties of the transparent pouches were determined using the microbial challenge test, in which the package was placed inside an exposure chamber and exposed to a defined aerosol of Saccharomyces cerevisiae. The atmospheric pressure in the chamber was periodically reduced by 0-75 millibars, to simulate weather-dependent pressure changes. Thermoresistant petri dishes filled with nutrient agar were integrated into the transparent pouches before sterilization. The packages were incubated after exposure. They were then opened and examined for colony growth.Results.The number of recontaminated packages per test group (n = 50) depended on the microbial bioload (defined as the number of colony-forming units per plate) to which the packages were exposed and on the size and number of decreases in atmospheric pressure. Results of multiple regression analysis showed a significant increase in the number of recontaminated packages in correlation with the product of the values for microbial bioload and the size and number of decreases in atmospheric pressure. When we analyzed the probability of recontamination of wrapped medical devices after 2 reductions in atmospheric pressure (30 millibars each) and with a surface microbial load of 10 colony-forming units per 64 cm2, we estimated that the frequency of recontamination was 1: 100,000.Conclusion.Multiple regression analysis showed that the proposed microbial challenge test is suitable to determine the probability of package recontamination at the 1: 1,000,000 level.

Outbreaks of Legionnaire's disease present a public health challenge especially because fatal outcomes still remain frequent. The aim of this study was to describe the abundance and epidemiology of Legionellaceae in the human-made environment. Water was sampled from hot- water taps in private and public buildings across the area of Göttingen, Germany, including distant suburbs. Following isolation, we used polymerase chain reaction in order to generate strain specific banding profiles of legionella isolates. In total, 70 buildings were examined. Of these 18 (26%) had the bacterium in at least one water sample. Legionella pneumophila serogroups 1, 4, 5 and 6 could be identified in the water samples. Most of the buildings were colonized solely by one distinct strain, as proven by PCR. In three cases equal patterns were found in separate buildings. There were two buildings in this study where isolates with different serogroups were found at the same time.