In the pharmaceutical industry, thorough and accurate documentation is vital when validating measurement systems. Efficiency enhancement and compliance assurance are achieved through comprehensive validation documentation and user support, as provided by Kaye Measurement Systems. This detailed documentation not only ensures regulatory compliance and enables traceability but also forms the basis for continuous improvement processes and the identification of optimization potential within the systems.
Checking the calibration parameters in data loggers is an important part of functional quality management. Especially with temperature data loggers, regular verification of the validity of the calibration data is a recommended practice within risk assessment. Mobile data loggers are exposed to various stresses that can have a lasting negative effect on the calibration offsets stored in the loggers. Documented and regularly conducted checks serve to prevent incorrect measurements and the potentially associated need to repeat an already carried out validation study.
The latest expansion of the Kaye ValProbe RT® product line introduces additional technical and user-oriented features that improve user-friendliness and broaden the application spectrum for GxP compliant validation studies. Thanks to improved hardware and software features, such as the support for up to 50 Kaye ValProbe RT® real-time data loggers per study, application-centric applications such as CO2 incubator qualification are sustainably supported. An additional standard evaluation tool based on AFNOR FDX15-140 also simplifies the qualification of climatic chambers of any type and size.
The pharmaceutical industry constantly faces the challenge of meeting stringent regulatory requirements and high-quality standards. One of the essential tasks is the qualification of critical process equipment. Traditionally, predefined guidelines and standards are followed. However, the increasing focus on quality and safety necessitates more: a comprehensive risk analysis that identifies and evaluates potential sources of hazards. In this paper, we highlight why risk analysis is an indispensable part of the qualification process and how it can be effectively integrated into the qualification plan. The goal is to raise awareness and underscore the importance of risk analysis with subsequent risk evaluation.
In the meticulous environment of pharmaceutical operations, ensuring the integrity and security of data loggers is paramount. The management of Kaye ValProbe (RT) data loggers requires high-quality, robust solutions to simplify transport, storage, and management—key aspects to maintain the accuracy of crucial data.
Everyone who has ever purchased a measuring system knows this. The true quality of the supplier is not only shown in printed words on a data sheet or a favorable offer. It shows itself when it comes to essential after-sales support. Be it the annual calibration, help, and support during commissioning, training for changing operating personnel, or bridging bottlenecks in your own measuring device. Particularly attentive readers of our blog series are certainly looking forward to what Kaye has had to offer in this area from the beginning.
Isn't it familiar? Despite all precautions and a detailed validation plan, it can happen that at the beginning of the validation you realize that one or more measuring systems are outside the calibration interval or are defective. This is annoying as it usually means a delay in qualification and a delay in the planned equipment validation - with all the associated costs. An effective method to avoid such unwanted changes in planning is to secure all Kaye validation and monitoring systems through a fixed and individually tailored maintenance plan. But how can Kaye as a manufacturer assist?
Kaye is more than "just" a supplier of high-precision measuring systems. From the outset, the technical solution has always been viewed in the context of the application. Over the years, an extensive range of useful and labor-saving accessories has been developed. From a variety of different temperature sensors (thermocouples) and special pressure sensors, brackets and feedthroughs, transport boxes or necessary IQ/OQ documents, to specially coordinated calibration units, application-specific complete solutions are offered. In today's blog post, we would like to introduce some of them in more detail.
Enhancing measurement accuracy is crucial in achieving reliable data, and it starts with considering sensor-dependent immersion depth. By calibrating and adjusting the entire measurement chain—including both sensors and data loggers—engineers can ensure precision and consistency in their readings, leading to more trustworthy outcomes in various applications.
Today's edition of our Kaye History Blog Post deals with the impressive development of a small start-up, driven by a Professor for Mechanical Engineering at MIT Boston and some of his visionary students. With an inspiring arsenal of innovative concepts for quick and precise temperature measurement and an unstoppable pioneering spirit, the company has evolved into a global leader in the field of measurement systems and complete solutions.
The real-time data loggers from the Kaye ValProbe RT product family are now available with five sensors and flexible measuring probes. A further optimized electronic system improves the already very good battery life, storing up to 100,000 data points per channel, all without restricting measurement accuracy in a current temperature range from 0-400°C. The proven dual antenna technology ensures continuous data transfer under difficult conditions.
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.