Quality Risk Assessment

White Paper – Top 10 considerations when validating an autoclave

Validating an autoclave


Validating an autoclave is a daunting and time-consuming task.

This white paper details the tricks, tips and traps to such a validation project from how to choose your control to which load configuration to use for your validation runs.

The white paper presents very practical steps to validate an autoclave by solving common problems and minimising the inefficiencies associated with test equipment failure, excessive testing or even incorrect testing.


This White Paper is written to assist Validation Specialists in the planning, execution and reporting of autoclave qualification activities.

Autoclaves work on moist heat sterilisation principles and are common in pharmaceutical manufacturing for terminal sterilisation of product or equipment sterilisation in aseptic processes.

The same principles also apply for organisations involved in decontamination processes within physical containment (PC) facilities.

The applicable regulations and guidelines (e.g. FDA, PIC/S etc.) will depend on your application.

The 10 Considerations – Overview

  1. Choosing the right sterilisation cycle to implement
  2. Which load configurations to use?
  3. Choosing the right Control for liquid cycles
  4. Determining which load items are the most difficult to sterilise and which location(s) within the items represents the worst-case conditions
  5. Wired temperature thermocouples are cumbersome and don’t always give accurate data
  6. Determining the acceptance criteria
  7. Adequately documenting the validation test runs
  8. The frequency of thermocouple accuracy verification
  9. Having adequate time and access to the autoclave to complete the validation
  10. Have the right procedural controls in place to ensure ongoing consistency and correct operation


You can download the whitepaper “Top 10 considerations when validating an autoclave” here.

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