Eine neue Methode zur Wirksamkeitsprüfung von Sterilgutverpackungen in der Praxis / A New Method for Testing the Effectiveness of the Microbial Barrier Properties of Packaging Materials for Sterile Products

The aim of our study was to develop a practical test for assessing the effectiveness of the microbial barrier of packaging materials for sterile products. The suitability of the test was verified in the exemplary case of double-wrapped sterilized trays. During testing, the bacterial count of the ambient air was 35 and 440 colony-forming units/cubic metre. The test is based on the co-sterilization in the sterile packing of petri dishes containing CASO agar, which at the end of the test were investigated for re-contamination. The petri dishes covered the sterilizing sieves as completely as possible. After sterilization, the packaging was loaded 300 to 900 times at a pressure of 1 kg (5x/min). This was followed by incubation for 48 hours at 37 degrees C, and evaluation (No. of colonies). The ability of the agar to culture colonies of bacteria was preserved unchanged for a period of at least 3 weeks after sterilization. For double-wrapped trays it was shown that re-contamination increases with intensity of mechanical loading and the atmospheric bacterial count. Since the package was breached only for the analysis, confounding factors due to removal of contents for examination, were effectively excluded. This test procedure is characterised by simplicity in handling and high specificity. As a final pack test it effectively closes a gap in the quality assurance chain for sterile materials.