One Simple Way to Manage Aseptic Risk Assessments
Aseptic processing presents many risks to sterile product. How can manufacturers address these risks to effectively prevent contamination?
In 2006, I created a sterile risk assessment tool, the Hazard Operability Analysis (HAZOP). This tool proactively identifies microbial contamination risks for aseptically filled sterile products. I have since refined this tool into what I now call the Sterile Product Compliance Risk Assessment (SPCRA).