Importance and Future Direction of Sterilization Processes

Presentation

• 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.
• Radiation
• 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
microorganisms.