Moist Heat Terminal Sterilization for Controlled Release Materials

Presentation Overview

– Terminal Sterilization Fundamentals

•  Steam
•  Radiation

– Current Best Practices

• TS processes and approaches that everyone, including regulators can agree on
• Current processes with a modest twist. Those may that create will likely create some angst

– Expected Future Developments

• Thinking outside the current box that might be a part of our future.

Contemporary TS Processes using Moist Heat

Terminal / Non-Porous Loads

• Air over-pressure of the load may be required to maintain containerintegrity.
• Steam quality testing is irrelevant.
• Materials sensitive to excess heat can be processed.
• Minimum and maximum time-temperature or F0 requirements are needed.
• Container-closure interface sterilization can be a concern if components aren’t sterile.

Terminal Sterilization Cycles

• The common autoclave cycles can be used, as well as some others.
• Gravity Displacement
• Single Pre-Vacuum
• Multiple Pre-vacuum
• Steam-Air
• Steam-Water-Air (Raining Water)
• Immersion
• Continuous Sterilizer