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.
Ensuring product purity and process integrity across the pharmaceutical and biopharmaceutical industries.
Validation is a critical part of pharmaceutical manufacturing, ensuring that sterilization processes, thermal mapping and sampling procedures consistently meet regulatory requirements. Ultrapharma’s Validation Components are developed to simplify these activities by providing practical, reliable and innovative solutions that improve accuracy while reducing setup time and complexity.
Our portfolio includes Sampling Gaskets, the versatile Allport Sampling Clamp, the innovative Sporfix® biological indicator holder and a range of accessories designed specifically for qualification and validation studies. Each product is engineered to improve accessibility, increase repeatability and help eliminate the inconsistencies often associated with traditional validation methods.
Manufactured using Ultrapharma’s validated compounds and backed by decades of experience in high-purity sealing solutions, our Validation Components help pharmaceutical and biotechnology manufacturers perform validation studies with greater confidence, efficiency and consistency.
Smarter validation. Reliable results. Designed for pharmaceutical excellence.
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 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.
Sampling gaskets are not available in PTFE
During the sampling process, conventional clamps pose a significant risk to your valuable probes due to the potential for overtightening the wingnut. This frequently leads to the unfortunate outcome of crushed thermocouples, sample tubes, or dataloggers.
Ultrapharma’s Resistor prevents by regulating the tightness with which the ferrules can be compressed, ensuring optimal pressure without the threat of damage. Moreover, it offers users a generously wide point of entry for their probes, enhancing ease of use and minimizing potential mishaps during the sampling process.
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.
Our technical team is ready to help you select the right solution for your application
