We are pleased to announce a new, strategic partnership between Kaye and SOCIETE 2F Service, strengthening our commitment to providing cutting-edge solutions for the pharmaceutical, and biotechnology sectors in Tunisia and Algeria.
It's more clear than ever, especially amid the COVID-19 pandemic, that monitoring and documenting temperature, relative humidity, and other critical parameters are crucial not only during the production of pharmaceuticals but also in their storage, transport, and finally to the consumer through the pharmacy. The storage and distribution of temperature-sensitive vaccines have caught the public's attention through internet and television, making the public more aware of this as a key quality criterion. The importance of maintaining the cold chain was a common topic of public discussion.
Accurate temperature measurement hinges on the proper use of temperature sensors. Among various factors, one aspect holds significant importance that is often overlooked: the correct immersion depth of the sensors. This blog post aims to highlight this frequently overlooked detail – the correct immersion depth of the sensors – and impart a deeper understanding of its importance to the readers.
Looking back on the exciting technological history of the 90s, one can't help but feel a sense of nostalgia for achievements like 3.5" diskettes, Excel spreadsheet calculations, or thermal paper printouts. That decade saw the pharmaceutical industry and regulatory authorities still in their infancy when it came to issues like data security, data integrity or even the ALCOA principles.
Precision and reliability are of the utmost importance in the validation of thermal processes. These requirements demand time-consuming and complex procedures for the validation, calibration, and verification of the instruments used. In this context, the Kaye IRTD, a high-precision traceable temperature standard, plays a noteworthy role. Its application is crucial for the accuracy of Kaye's validation systems, like the Kaye AVS and the Kaye ValProbe, and thus forms an integral part of these verification and calibration processes. However, the use of temperature standards also brings specific challenges and potential risks. This article shows how such risks can be minimized, and the validation and calibration processes can be optimized and have their risks reduced.
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.
There are instances when budgets don't allow for the acquisition of new or supplemental validation systems, or when project requirements unexpectedly change. In these cases, renting additional measurement and validation system capacities can be a practical solution. Our flexible rental models allow the validation equipment to be adapted to meet present validation specifications.
Having delved into the history of the various Kaye measurement systems in previous blog posts, this edition is dedicated to the essential service offerings that go hand-in-hand with Kaye's validation systems. In part 3 of this blog post series, we already addressed the necessity for traceability in calibration. From the very first Kaye validation systems, this traceability was ensured by the Kaye IRTD-400 temperature standard. However, complete traceability in relation to national standards is only ensured by the necessary accreditation. This edition will shed light on what this means in concrete terms.
In our blog post "Importance of Steam Quality in Moist Heat Sterilization," we already discussed the need to measure temperature and pressure and their interrelationship for proper sterilization results. In this post, we would like to delve deeper into this topic.
The loyal readership of our blog post series “Kaye’s Time Warp” might wonder about the significance of the Kaye Ice Point Reference in the context of validating thermal processes in the GxP environment. In fact, Kaye Ice Point references are more likely to be found on aluminum furnaces, in turbine test stands, or in power plant control rooms. However, the basic knowledge that our company founder Dr. Joseph Kaye acquired in the early 1950's in this context is crucial for the development of high-precision validation systems based on thermocouples as temperature sensors.