For many years, Ellab A/S has been considered one of the leading suppliers of validation solutions for processes within the food, pharmaceutical and medical industry. Where we provide data loggers and thermocouple systems for most applications all around the globe.
As for solutions, Ellab offers a wide range of diverse products and customized fittings in different shapes and sizes that allows users to accurately position sensors and measure the essential parts of a process. The TrackSense® Pro data loggers and E-Val™ Pro thermocouple system can be fitted with sensors that measure additional parameters like pressure, vacuum, CO2, relative humidity and conductivity.
The stainless-steel data loggers are particularly useful, as they can be fully emerged in water, steam and oil, without requiring cables or a feed through system. They can also be placed within most processes due to their highly resistant and small stature.
Validation of food processing equipment such as retorts, pasteurizers and smoke houses, requires that the equipment being used is highly accurate and reliable. Even a systemic error of 1ºC, corresponds to an inaccuracy of 26% in the F0-Value at 120 ºC. Therefore, a large selection of probes, sensors, packing glands and tools have been developed to correctly mount validation equipment in all kinds of containers. New fittings are steadily being developed to improve the heat penetration measurements.
Many different factors can affect the correct temperature measurements in the “cold spot”, so to determine this important “cold spot”, it is necessary to perform heat penetration tests to establish the most suitable temperature/time profile for the product in the container. New tests need to be performed when changing the recipe, container or conditions - for this purpose, a Multipoint sensor can be an especially useful tool. To secure an ongoing accuracy of the measuring chain, it is recommended that probes and sensors are calibrated.
The validation of equipment within the pharmaceutical industry is very challenging, this is due to the pharmaceutical processing equipment, such as moist heat sterilizers, freeze dryers and depyrogenation tunnels, require more than just high accuracy and reliability. They also require detailed documentation and traceability. Furthermore, it is important that the validation system is fully compliant with the relevant requirements and guidelines, such as FDA 21 CFR 11 Part 11 and GAMP4 for the validation of automated Systems in Pharmaceutical Manufacture.
These requirements need to be met before the measuring results can be approved and accepted by FDA/USDA and other regulatory authorities. An important part of the validation, is documentation as well as reporting exactly why the ValSuite™ Pro software facilities play a major role in analysis and execution. The easy and fully automatic execution of validation equipment calibrations are an integrated and essential part of the process, and is therefore embedded in the ValSuite™ software.
The thermal cleaning and disinfection processes of heat-resistant medical devices in Hospitals, are becoming more and more important. This is to ensure that the processed instruments do not pose any health risks towards patients, hospital personnel or any third party due to improper sterilization. Therefore, the validation of medical/hospital equipment, such as EtO or H2O2 sterilizers, ovens and washer disinfectors, require high accuracy and reliability. At the same time, it is important to ensure that all personnel involved, understand how to use the instruments.
Due to this, it is of paramount importance that software as well as hardware is intuitive and easy to use. This can be done through a clear report design with a simple structure, containing the ID of equipment being used, calculations and acceptance criteria, all visualized along with a graph of the entire process. All the setup criteria can be saved and stored in templates for similar/repetitive studies.