Nous sommes heureux d'annoncer un nouveau partenariat stratégique entre Kaye et SOCIETE 2F Service, renforçant ainsi notre engagement à fournir des solutions de pointe aux secteurs pharmaceutique et biotechnologique en Tunisie et en Algérie.
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.
Dans notre Blog intitulé "Importance de la qualité de la vapeur dans la stérilisation par chaleur humide", nous avons déjà évoqué la nécessité de mesurer la température et la pression et leur interdépendance pour obtenir des résultats de stérilisation corrects. Dans le présent article, nous souhaitons approfondir ce sujet.
Les fidèles lecteurs de notre série de billets de blog "Kaye's Time Warp" s'interrogent peut-être sur l'importance de la référence au point de glace de Kaye dans le contexte de la validation des processus thermiques dans l'environnement GxP. Cependant, les connaissances de base que le fondateur de notre société, le Dr Joseph Kaye, a acquises au début des années 1950 dans ce contexte sont cruciales pour le développement de systèmes de validation de haute précision basés sur des thermocouples en tant que capteurs de température.