Track fix/validation

Sporfix® is a new concept used during the qualification and validation of bioreactors and fermenters and other tools. In particular, it can be used to control SIP validation in harsh environments.

The biological spore strips used for this validation work need to be placed inside the piping system and exposed to saturated steam. There is no standard solution to fix the spore strip inside the piping system. All over the world, everyone uses their method to fix the biological indicator (BI) part of which is likely to disappear during the sterilization process. Another aspect of these handmade solutions is that they introduce inconsistencies leading to errors or contamination of the BI.