- Importance of Sterilization Processes
- Current Best Practices
- Sterilization processes and approaches that everyone, including regulators can agree on.
- Expected Future Developments
- Current processes with a modest twist. These may create some angst.
- Thinking outside the current box that might be a part of our future.
Why is Sterilization Important?
• Many of the patients who receive sterile products may already be seriously ill. Where sterility is compromised patient death may occur
• US LVP failures in 1970’s
• Davenport incident in the UK
• TS production is estimated at more than 1 Billion units per year worldwide.
• Injuries / permanent damage from non-sterile materials has occurred.
• Vision loss from Abtox sterilizer scale-up.
In TS Sterilization is used for
• The product in its container
• Everything in product contact??
• Product Fluid / Powder – sometimes
• Containers / Closures – when filled aseptically
• Product Contact Equipment – aseptic filled
• Everything else that comes close
• Utensils / tools / other materials in the critical zone – usually
• Gowning materials, gloves – always
• Environmental sampling media – always
Current Processes in Use for TS
• Moist Heat
• Widely used, processes vary widely in scale and application.
• Powders, ointments and other non-aqueous products.
• Dry Heat
• A very limited number of non-aqueous products.
The Perfect Sterilization Process
• Destroys all microorganisms rapidly without adverse impact on any of the materials essential properties.
• Isn’t available for anything other than materials with high heatstability. i.e., stainless steel, glass.
• A sterilization process that destroys all microorganisms, but renders the item being sterilized unfit for use is of no value.
• Sterilizing processes are often a compromise between the degradation effect on the materials and destruction of
- author: Agalloco James