- Blog Post
Why is Measuring Pressure Important in the Validation of a Steam Autoclave?
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.
- Blog Post
Kaye's Time Warp: Ice Point and Cold Junction Compensation
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.
- Blog Post
Importance of Steam Quality in Moist Heat Sterilization
In this blog post, we would like to delve a bit deeper into the importance of steam quality in moist heat sterilization. As usual in our blog posts, we do not lay claim to a highly scientific presentation, but rather focus on imparting basic knowledge. For further in-depth understanding, there's plenty of specialized literature available to interested readers.
- Blog Post
Kaye's Time Warp: The Traceable Temperature Standard
Part 3 of this blog post series deals with another important part of the measurement philosophy that Kaye established early on as a system supplier for measurement systems for the validation of thermal processes. As early as 1972, with the introduction of the first Kaye Validator Digistrip I, it was clear that a data recorder or data logger (Blog Post Part 1) for data acquisition and the calibration furnaces and baths described (Blog Post Part 2) were only part of the journey towards an automated validation system.
- Blog Post
Thermal Validation of Cryo Containers in the GxP Environment
Cryo containers are found in various applications in the pharmaceutical and biotechnology industries. Be it to store biological samples like cells and tissues at extremely low temperatures to preserve them for future studies to use, or even for transportation. Thus, cryo containers are part of the cold chain and therefore must be qualified and validated according to EU GDP (European Union Good Distribution Practice). These guidelines were developed to ensure the quality of pharmaceuticals throughout the entire distribution process from manufacturing to consumption.
- Blog Post
Kaye's Time Warp: From the Bulky Block Calibrator to the Flexible Calibration Unit
The calibration of the systems and sensors currently in use, along with the complete elimination of identified deviations, constitute fundamental components of a qualification. These are essential for the subsequent validation of a critical process within a GxP context.
- Blog Post
Wired Data Recorders vs. Wireless Battery-Powered Data Loggers – A Question of Application
For quite some time, the question of whether to use a wired data recorder or a wireless battery-powered data logger for the validation of thermal processes in the GxP environment has been discussed.
- Blog Post
Kaye’s Time Warp: How It All Began
In today's blog post, we would like to take you on a journey through time to the origins of Kaye and the company's early steps in the field of validating thermal processes in the pharmaceutical and biotechnological industry.
- Blog Post
Efficient Sterilization: Time, Temperature, and Steam Quality per EN285
EN-285 is a European standard that sets guidelines for the sterilization of medical devices in healthcare facilities. When a person is expected to use EN-285 in a regulatory sense, they are required to adhere to the specific procedures and requirements outlined in the standard to ensure the effective sterilization of medical equipment.
- Blog Post
Unlocking the Benefits of a Kaye Service Agreement
When managing the reliability and performance of your equipment, having a solid warranty and service plan in place is key. A Kaye Service Agreement, also known as an EMA (Equipment Maintenance Agreement), is an invaluable resource that offers a multitude of benefits.
- Blog Post
What calibrator is right for you? Points to consider when making your selection
While it might not get as much publicity as validation equipment, your calibration equipment is a critical part of any viable thermal validation system. Having the proper equipment, equipment that you can trust, is essential. There is no place for inconsistent measurements in pharmaceutical and biotech industries, accuracy is key. It is essential to ensure that your validation system provides accurate information, and this is where calibration plays a crucial role in guaranteeing precise measurements. At Kaye, we offer a large variety of calibration equipment, and our goal is to offer everyone a solution that can fit their needs. In this blog post, we are going to look at some of the basic information to consider when selecting calibration equipment.
- Blog Post
Decoding Long-Term Stability: RTD vs. Thermocouple Sensors - Stability lays the foundation for precision
Precision is paramount in the realm of Kaye products, making the choice between Resistance Temperature Detectors (RTDs) and Thermocouples (TCs) is essential for accurate measurements. Let's dive into their long-term stability comparison.