Key trends in the life sciences industries are paving the way for Entegris – Jetalon's products in the biopharmaceuticals, biotechnology and healthcare markets, in both laboratory and manufacturing environments. Entegris – Jetalon's products have applications in all wet chemical processing including cleaning process, all liquid process monitoring, quality acceptance/quality control, and sterilization.
The PAT Initiative is an effort to ensure quality by design instead of testing for quality. PAT requires a scientific understanding of chemical and mechanical properties in a proposed drug to identify the variables that affect quality.
Designing efficient manufacturing processes and conducting real-time, continuous quality assurance leads to improved results including reduced cycle times, prevention of reject products and waste, real-time product release, improved energy and material use and increased capacity.
Replacing batch processing, continuous reaction processing requires increased real-time monitoring and control of key liquid chemical properties, especially concentration, flow and temperature. Recalibration becomes difficult without breaks in processing. Biopharmaceutical labs and manufacturing facilities have an incentive to find tools that enable real-time monitoring without interruption to minimize down time, reduce setup time, decrease costly energy and material use and increase throughput.
Vapor Hydron Peroxide (VHP) is the de facto method for sterilization in biopharmaceutical manufacturing (barrier isolators) and healthcare (autoclaves, surgical instruments, hospital rooms). Entegris – Jetalon is fulfilling the market need for monitoring the key properties of VHP during sterilization and decontamination processes.
Entegris – Jetalon's current products by specific application in the biopharmaceuticals, biotechnology and healthcare markets are as follows:
CR-288 and NX-148-BPM: CR-288 is used in clean-inplace skids and chromatography applications in the biopharmaceutical market. Entegris – Jetalon has also produced NX-148-BPM, a Dip Probe concentration monitor based on the operating and engineering principles of CR-288. NX-148-BPM is used in bioreactors to monitor concentrations during reaction processes.
GS-88-VHP: GS-88-VHP is used in any application where VHP is used for sterilization and decontamination. GS-88-VHP simultaneously monitors dew point, VHP concentration, VHP temperature, and the µ-concentration of VHP condensate during sterilization processes.