Abstract
Package integrity is a critical factor to ensure that product sterility is maintained over its entire shelf life. An exposure chamber method was developed to determine the integrity of flexible packaging systems, i.e. flexible multilayer linear low‐density polyethylene/nylon pouches with a 100, 50, 25 or 15 µm micro‐channel with 5 mm length defect in the sealing area. Viable cells of Staphylococcus aureus and Escherichia coli have been utilized as model organisms. The aerosol was generated by a nebulizer, about 2.0 × 107 CFU m−3 concentration inside the test chamber. The results demonstrated that defect pouches with a 100, 50 or 25 µm channel leakage exposed to microbiologically challenging conditions could not maintain the sterility of their contents. Micro‐channels with 15 µm diameter can be detected as the critical micro‐channel dimension for bacterial penetration for flexible pouches. Copyright © 2016 John Wiley & Sons, Ltd.
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