In the context of aseptic Pharmaceutical Manufacturing, the smart asset approach serves a dual role for risk management: 1) it allows for automated, touchless Environmental Monitoring to support sterilization surety during production; and 2) it provides traceability and pedigree data from sterile processing through manufacturing to support FDA regulated facilities so that products can be released to inventory at a higher frequency, and with minimized risk due to contamination.
This is the subject of an article published by Pharmaceutical Manufacturing. Here is an extract:
“By enabling sterilization-proof electronic data to be written directly onto environmental monitoring equipment, and collected digitally at multiple prescribed points throughout the production process, cGMP manufacturers can see dramatic improvement in their productivity, while yielding more accurate and thorough data collection for compliance reporting and recall containment.”
Posted by Dr. Tim Sandle
