Changes to sterilisation Facility and its Process and/or Quality Management System

Example

Category (Significant, non-significant)

Change of the sterilisation process, such as:

  • Change from ethylene oxide to gamma radiation sterilization.

Significant
Change that increases the bioburden alert or action levels or that introduces a more difficult to kill organism, such as a change that introduces additional pre-sterilisation transport steps.

Significant

Device design or material change that introduces a more difficult to sterilize feature, such as:

  • The original heat-sealing package barrier found risk of leakage and change to sterile packaging barrier.

Significant
Change from biological indicator to parametric release or change from batch release to parametric release.

Significant
Change in moist heat sterilisation parameters

Significant
Change from a pre-blended sterilant (EtO and CHCs) to EtO post- blended with nitrogen. The ultimate concentration of EtO in the sterilant is the same in both cycles.

Non - Significant
Change from using Air (mixture of 80% Nitrogen and 20% Oxygen) to pure Nitrogen in the aeration process to avoid explosive gas mixtures.

Non - Significant