Inspection Guideline for Terminal Sterilisation of Parenterals

We are excited to announce that we have recently added an incredibly useful piece to the Resources section of our website:

Inspection Guideline for Terminal Sterilisation of Parenterals

About the Guideline

This inspection guideline was written for the Chinese FDA back in 2012 when the author (Mark Thompson) was working with and delivering training for the Inspectorate in China.

The Inspection Guideline is focused on the very large water spray terminal sterilisation autoclaves used for LVP. The largest autoclave which was worked on at the time was a 105m3 water spray machine.

Autoclaves of this size pose a significant challenge in terms of monitoring and when combined with the typically low Fo values of LVP terminal sterilisation – this monitoring confidence becomes critical.

The Inspection Guide will also be a useful reference piece for anyone auditing other Terminal Sterilisation Processes as it guides through the requirements for:

  • Pre-sterilisation Bio-burden Control
  • Sterility Assurance Level etc

Click here to visit the Resources section of our website

Click here for a direct link to a pdf download of the document