Sterilisation indicator inks

Chemical Indicator Inks and Sterile Barrier Systems

Chemical Indicator Inks are used in Sterile Barrier Systems to provide visual evidence of exposure to a sterilisation process.  The inks are designed to react to specific sterilisation conditions, irreversibly changing from one colour to a distinctly different colour as a result of this exposure.  A successful result (colour change) does not confirm that the contents were successfully sterilised, however, it does indicate that the Sterile Barrier System was exposed to a proper sterilisation process  If a colour change does not occur, an initial step would be to confirm that the sterilisation system is functioning properly.

By themselves, Chemical Indicator Inks cannot be certified to meet existing standards, such as ISO 11140-1:2014.  It is the entire Sterile Barrier System, including the ink, which may be certified.  The same ink, used in two different systems, may result in one meeting a standard, and the other not.

Using Chemical Indicator Inks

The inks contain specific chemicals called Active Ingredients (AI’s).   AI’s react under the sterilisation conditions to provide the  distinct colour change.  As all Chemical Indicator Inks may behave differently, it is important to contact the ink supplier for guidelines for use.  Although the ink’s themselves are developed for these printing processes, they have characteristics that differ from conventional graphic printing inks; chemical indicator inks may, for example, contain more than 50% solids compared to ~5% for a typical graphic ink.

Selecting a Chemical Indicator Ink

Identifying the appropriate Chemical Indicator Ink requires understanding multiple key items relating to how the Chemical Indicator System will be produced, and how the Sterile Barrier System will be used.