Long-term monitoring of airborne microbial challenge and use of cold atmospheric air plasma technology
Basis for a date-based sterile storage management according to the sterility assurance level of 1:1,000,000*)
Originale
2. Materials and Methods
3. Results
4. Discussion
5. Conclusion
Acknowledgments
Key Words: sterile barrier systems, validation of packaging processes, data-based shelf life calculation, cold atmospheric air plasma technology, airborne microbial challenge, sterilization
Correspondence:
Dr. Hartmut Dunkelberg, In der Lember 4, 37242 Bad Sooden-Allendorf, Germany; e-mail: hdunkel1@gwdg.de
Abstract
Sterile barrier systems must allow access of sterilants (steam, ethylene oxide). They usually have air-permeable components. A data-based method to continuously control the inflow of environmental air into the packaging was developed to estimate the anticipated shelf life. An automated long-term measurement system was developed to calculate the airflow into the packaging caused by weather-dependent air pressure changes. Acceptable shelf (...)
