Sterile barrier systems for terminally sterilized medical products must allow access of sterilants (steam, ethylene oxide). They usually have air-permeable components. Airborne bacteria must be removed to maintain sterility up to the point of use.
A data-based method to continuously control the inflow of environmental air into the packaging was developed to estimate the anticipated shelf life by considering the airborne microbial challenge and the barrier performance of the packaging material. An automated long-term measurement system was developed to calculate the airflow into the packaging caused by temperature (...)