In this blog post, we would like to focus on the addition to the Kaye product line that occurred in the early 2000s: The integration of wireless, battery-powered data loggers, an aspect that was hinted at in our whitepaper on wired vs. wireless validation systems.
Kaye's significant contribution to the development of what we understand today as recognized standards and guidelines in this area becomes particularly clear when looking at the 'PDA Technical Monograph No. 1, Validation of Steam Sterilization Cycles'. This is one of the first globally accepted sets of rules for the validation of sterilization processes. Kaye played a leading role in the development of Chapter 17 - 'Temperature/Pressure Measurement & Calibration'.
In the continued development towards wireless data loggers, the findings previously gained in the field of wired validation systems were consistently implemented and realized with the holistic solutions typical for Kaye.
From Simple Data Logger to Complex, RF-Technology-Based Real-Time Validation System
Admittedly, entering the era of battery-powered data loggers in the field of thermal process validation was somewhat tricky and bumpy. Data loggers, originally designed for other industries such as food, found their way into pharmaceutical applications. However, the demands for accuracy, reliability and seamless data collection posed high challenges that quickly pushed some logger systems to their limits. Technical solutions, such as battery operation over wide temperature ranges up to 140°C, seamless and reliable data recording and storage, as well as permanent use in pressurized, hot sterilization chambers had to be adequately solved to enable use in the demanding GxP environment. Additional requirements, such as water resistance, on-site replaceable batteries, and calibration capability, or at least user verification, also had to be met. Finally, regulations for final data evaluation emerging in the 2000s, such as 21-CFR Part11 (electronic records, electronic signatures), posed another challenge that also had to be addressed with appropriate solutions.
With nearly four decades of experience in developing reliable measuring systems, the Kaye development team rose to this challenge. This eventually led to the technical realization of the first Kaye data logger, the Kaye ValProbe system.
Once again, we aimed at developing more than just a data acquisition system, but a comprehensive, user-oriented solution. It should provide a connection to a traceable temperature standard, offer options for the user to calibrate, and of course, ensure standards-compliant data acquisition and subsequent evaluation. All in keeping with the principle of thermal validation in the GxP environment established by Kaye with the first Digistrip validation systems. In the best Kaye tradition – no compromises and consistent in the implementation.
The introduction of the Kaye ValProbe data logger system marked a significant extension of the product range and now allows users to choose the optimal measuring system depending on the specific application. Both wired data acquisition systems such as the Kaye Validator AVS and the battery-operated product line of Kaye data loggers, Kaye ValProbe, are available.
Of course, the Kaye ValProbe system has continuously adapted to the increasing demands of its users and technical developments such as high-quality Li batteries, temperature-resistant electronic components, and microchips since its introduction.
The range of available temperature sensors has been continuously expanded and now includes rigid sensors of various lengths, flexible or bendable sensors, and sensors for measuring surface temperature. In addition, we have integrated additional variables such as pressure, relative humidity, and CO2. Another innovative step within this product line is the extension of the temperature range, particularly to lower temperatures down to -80°C or the provision of data loggers with up to 5 temperature sensors.
Thanks to the reliable components for transmitters and receivers based on RF technology, available for a few years now, and their implementation in the Kaye ValProbe products, this product line has developed into a currently outstanding, fully qualified, and recognized validation system on the market. The combination of easy handling as well as seamless and reliable data transmission in real-time is a professional alternative and addition to wired recorders such as the Kaye AVS Validator and offers a perfect synergy with the entire Kaye product range.
While the original Kaye ValProbe data loggers and the current Kaye ValProbe RT system carry the same name, the technology and functionality have significantly evolved. In keeping with the long-standing Kaye tradition of combining continuous innovation with tried and trusted methods, the Kaye ValProbe RT system represents a significant advance in technology. Consistent with this tradition, we offer existing users the opportunity to easily and cost-effectively upgrade to the latest product generation, the Kaye ValProbe RT.
Conclusion
We look back on an evolution that began with the introduction of wireless, battery-powered data loggers and has advanced to today's state of technology. As an innovative pioneer in this field, we faced challenges from accuracy and reliability to compliance with regulations like 21-CFR-Part11. Our technology has continuously evolved, both in the accuracy and functionality of the data loggers as well as in the evaluation, transmission, and storage of data.
The integration of RF technology has significantly expanded the development of our product line. Our products, like the Kaye ValProbe RT System, now offer a combination of easy handling, seamless and reliable data transmission in real-time, and are optimally adapted to the specific application. The continuous adaptation and extension of available temperature sensors and measurement variables demonstrate our ambition to provide currently outstanding and complete validation systems.
The Kaye ValProbe RT system represents a significant advance in technology, whereby the improvements address not only technical aspects but also practical ones. In the spirit of our long-standing tradition, we aim for continuous innovation, always with a focus on customer needs. With this commitment and our expertise, we look forward to continually meeting the growing demands of the industry with reliable, efficient, and state-of-the-art solutions.
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