As Health Care Products become more innovative, the approach in assuring the sterility of the product can also become more complex and might require a combination of methodologies.  The industry continues to recognize the need to provide additional information on a risk-based approach for products that cannot withstand a terminal sterilization process of 10-6 through the release of ISO TS 19930:2017 and update to AAMI ST67:2019 but there is need to continue to drive innovation in practices designed to enhance the assurance of sterility.  

One of the innovative solutions is to better leverage the different technical aspects of Aseptic Processing and Terminal Sterilization. By combining the enhanced microbiological quality controls used in aseptic processing followed an adequate minimal level of sterilization (i.e. adjunct processing) would allow for very low sterilization dose processing and increase the confidence in the overall microbiological quality level (MQL) of the finished product.  This presentation would provide insight into the technical considerations and how this has been applied in a real-world situation.