Validation Components

Sampling gaskets are used for thermal mapping during validation. They can also be used to draw samples from the pipeline by means of a sampling tube. See above animation. A standard sanitary Tri-Clamp flange utilizing the Sampling Thermocouple Gasket obtains the critical thermal mapping information needed during the validation process without interference due to incorrect installation. 

 

The Sampling gaskets can be very useful when performing SIP validation with our new Sporfix concept. Read more about this new product below and at our website www.sporfix.eu

    

Click on the above photo for more details

How to use Sampling Gaskets

The Sampling gasket is 2x the thickness of a standard Tri-Clamp gasket and can therefore hold a probe with a Ø 2,65 mm diameter. This probe can be a thermocouple, a sampling tube, or a wire thermocouple. Insert this probe through one of the holes and securely close the special machined clamp.  

If one or more of the ports is not used during thermal mapping a hole must be closed with a plug. Maximum pressure for this system is 4 bar. After validation these Sampling gasket are replaced with standard gaskets.

  

Available Compounds

CMD-1012  Translucent Silicone 

CMD-1004  Black EPDM

CMD-1010  Black FKM (on request)

Sampling gaskets are not available in PTFE

Click on the above photo for more details

How to use the Sporfix

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.

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.

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.

Available Compounds

CMD-1072  Translucent Silicone (peroxide)

CMD-1086  Transparent Silicone (platinum)

CMD-1073  Black EPDM

New Feature

The Sporfix® can also be used in combination with the Attest Rapid Ampule Biological Indicators. Remove the ampule from the plastic hosing and insert it into the Sporfix®.  Look for the video in the Tutorial section.   

bROCHURE

part numbers

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