Sporfix the Biological Indicator holder

The Sporfix® is a new concept used during 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 pipe work. Across the World everyone uses their own method of fixing the biological indicator (BI) of which some likely disappear during the sterilization process. Another aspect of these hand made 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.

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The Sporfix® MINI for 1/2" tubing is now available and is being validated at this moment. 

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The Sporfix® is available in Silicone and EPDM

 

 

 

 

 

The Sporfix® has been developed and validated in cooperation with QV Compliance in Denmark, specialists in validation.

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Sporfix® is a registered trademark of Ultrapharma BV