Moist Heat Terminal Sterilization for Controlled Release Materials
– Terminal Sterilization Fundamentals
– 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-Water-Air (Raining Water)
• Continuous Sterilizer
- author: Agalloco James