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.

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.

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.

About Sporfix

Ensuring product purity and process integrity across the pharmaceutical and biopharmaceutical industries.

European leader in FDA-compliant gaskets and validation components. Ensuring product purity and process integrity across the pharmaceutical and biopharmaceutical industries. Our screen gaskets are not used the same way as conventional filters, although they can be considered a filter.  Conventional filters are built differently and have many layers to prevent particles to pass through, these can reach efficiencies of almost 100%. A particle comes in many different shapes.

For example, a hair has a diameter of Ø 0,1 mm but the length can be centimetres long. If the hair arrives perpendicular to the screen it might pass a 100 mesh screen. With a conventional filter, the second or third layer will prevent the hair to pass. Retention’s of standard screens are calculated according to international standards using perfectly round glass spheres. Our screens are only one layer and therefore they cannot be considered the same as a filter. Each screen gasket has a high-performance gasket made out of one of the validated compounds that we use for our standard Sanitary Gaskets range.

How to use the Sporfix

Available Compounds

  • CMD-1086 Transparent Silicone (platinum)
  • CMD-1073 Black EPDM

The Sporfix Mini

Available Compounds

  • CMD-1086 Transparent Silicone (platinum)
  • CMD-1073 Black EPDM

The Sporfix Mini XS

For even smaller ½” tubing area’s we have developed an extra small (short) Sporfix®. This one is only 46 mm long and can hold a blue envelope Sporestrip which is only 25 mm long. This will open up lots of new opportunities to constantly measure SIP validation sterility tasks.

Available Compounds

  • CMD-1086 Transparent Silicone (platinum)
  • CMD-1073 Black EPDM

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