This article discusses how a hygienic temperature probe like the iTHERM TM401/411 from Endress+Hauser helps control complex engineering processes in areas of pharmaceutical industry that include detailed flow, level, and analysis instrumentation.
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Hygienic Temperature Probe Use Case 1
A pharmaceutical company in Germany builds batch systems and plug washing systems for the pharma industry. Since it involves production of drugs, sterile work is of central importance in the production steps to the end product.
In the process, medicines are sterilized, then added to bags, bottles, or vials, and finally sealed in with plugs. The plugs must be pre-sterilized as well so that the medicines are not contaminated. In addition to these plugs, other process steps need sterile caps, needle protectors, aluminium closures, and more for laboratory applications.
What is the challenge?
The products must be sterilized in special plug washing plants called component processing systems. During the treatment of filling material, a succession of different processes is carried out: washing, sterilizing, siliconization, drying, and cooling.
During the course of treatment, the product in the container comes in contact with different media that must be dosed with high accuracy and repeatability. Washing and sterilizing takes place only with high-purity water for injection (WFI) and then with pure steam. This excludes and removes surface germs, particles, and endotoxins.
During siliconization, a fine viscous film is applied to the filling material. This film prevents bonding of the filling material and creates the perfect surface quality for the subsequent application. Siliconization is an optional step.
Finally, the plugs are dried and cooled for further application.
How does the hygienic temperature probe solve the problem?
In the plug washing systems, the iTHERM TM401/TM411 hygienic temperature probe senses temperature in elbow pieces – with QuickNeck for easy tool-free calibration – to monitor the washing and sterilization in cycles.
In pharmaceutical applications, this is the ideal way to use a temperature probe. It occurs in the process with deep immersion in the elbow piece. It also needs a minimum number of wetted welds to test and little heat dissipation by a large process connection.
Hygienic Temperature Probe Use Case 2
Recently, an engineering-procurement-construction company in Pennsylvania won a bid to provide all of the process and clean-in-place (CIP) skids for a new biopharma plant under construction.
What is the challenge?
Here, many bioreactors needed tightly controlled and regulated temperatures. In collaboration with the company’s project manager, Endress+Hauser worked out the right temperature probe for the project.
How did the hygienic temperature probe solve the problem?
The final scope of the project consisted of 1000+ TMR35s (compact temperature probes), 250+ TM411s (hygienic temperature probe) and 150+ TMT125s (temperature transmitter).
TM411 p was selected based on the following criteria:
1) The process had stringent requirements for tight temperature control with wide excursions in range as well as frequent calibration. The design of the TM411, with its QuickNeck and easy in-process calibration, played a large part in its selection. The temperature probes on the bioreactors will be calibrated every six months while less critical points will be calibrated yearly.
2) Endress+Hauser provided all of the necessary documentation to confirm that the equipment met the requirements of the ASME BPE regulations.
3)It also provided Temperature Special Product (TSP) which allowed the customer to use the Quick Disconnect feature of the TM411 with existing thermowells on the piping. A QuickNeck is used because the temperature probe needs to be regularly calibrated.
Hygienic temperature probes like the iTHERM TM411 from Endress+Hauser help the pharmaceutical industry not only abide by regulations but also keep process complexity and costs low. To learn more about this and other temperature probes, please visit Visaya’s temperature products page.
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