Sporfix ®

The Sporfix® is a new concept used during the qualification and validation of Bioreactors and Fermentors and other utilities. It can especially be used to control SIP validation in harsh environments.

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The biological spore strips that are used for this validation work have to be placed inside the pipework and be exposed to saturated steam. There is no standard solution for fixing the spore strip inside pipework. Across the World, everyone uses their method of fixing the biological indicator (BI) of which some likely disappear during the sterilization process. Another aspect of these handmade solutions is that they introduce inconsistencies leading to failures or contamination of the BI.

 

The placement of the Sporfix® is secured by the solid metal wire. This wire and the thermocouple wire are taped together and brought inside the system through either a valve membrane or a sampling gasket. The distance between the Sporfix® and the outside connection can be any length. The Sporfix® is designed for single use to avoid direct handling of the BI’s after studies.

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When the sterilization cycle has ended the Sporfix® will be removed from the wire by cutting the wire. The biological indicator in the Sporfix® will after the thermal study, only be handled by the laboratory staff during incubation which will reduce the risk of cross-contamination considerably.