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Validation Components
Sampling gaskets are used for thermal mapping during validation. They can also be used to draw samples from the pipeline through 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
The new standard in sampling.
Our engineers at Ultrapharma always try to think out of the box, to make products and processes easier for you. Conventional products may work well, but there is always room for improvement. Like the sampling clamps with the standard 1, 2, 3 and 4 ports, always positioned in the same angles. This makes you very limited in sampling space and a specific clamp is only useful for one configuration.
This is why we introduce the Allport sampling clamp; a half open clamp that can be used for 1, 2, 3, 4 or as many ports as you want. So no need for different clamps, the Allport clamp is useful for all configurations. Combined with new gaskets where we repositioned the ports, which provides more workspace and much easier assembly.
We made sure that in our new configurations the ports are placed in the best position for accessibility and the least obstruction. If you frequently use 3 or 4 ports, you’ll probably recognize the problems of difficult alignment or the wingnut that is obstructing your probe.
The Allport-
Sampling Clamp
Clamps
Gaskets
Assembled
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 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 specially machined clamp.
If one or more of the ports is not used during thermal mapping a hole must be closed with a plug. The maximum pressure for this system is 4 bar. After validation, these Sampling gaskets 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 the 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 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.
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