Thermal Validation

Agidens provides tailored solutions for thermal validation studies specified upon sterilization processes (SIP, autoclaves, liquid cycles, waste cycles, table top autoclaves, …) and on disinfection processes (Washer disinfectors in labs, hospitals, pharmaceutical production environment, …).

Our thermal validation services verify the proper functioning of autoclaves and other equipment in line with international regulations and standards (eg. ISO-EN-17665-1, EN-285, ISO-EN-15883,…). We offer:

• Temperature – & pressure measurement
• Analyzing data (eg. Holding time, temperature overshoot, F0 calculations, A0 calculations, min- & maximum temperatures in each phase,… )
• Cycle optimization
• Defining worst-case loading patterns and support in setting up a bracketing approach

We are not limited in the execution of test and can offer broad advise in troubleshooting, setting up VMP’s, FMEA’s, bracketing aproach, and more.

Agidens assists in thermal validation of cold rooms, freezers, refrigerators, and cryogenic tanks. We analyze your systems and areas through temperature mappings and, if applicable, relative humidity mappings to ensure they meet your acceptance criteria.

We assess the temperature distribution within your systems to pinpoint the most representative or worst-case locations for monitoring purposes, ensuring the optimal storage of time and temperature-sensitive pharmaceutical products. Additionally, we can perform open door and power failure tests to gauge the system’s resilience against potential disruptions.

Having your autoclaves and sterilization processes under control is essential, but steam quality plays a significant role too. EN 285 testing offers valuable insights, with the High Council of Public Health recommending annual steam quality testing. Issues like excessive non-condensable gases, inefficient heat transfer, and overheated steam can all lead to suboptimal sterilization results.

Agidens addresses these concerns by analyzing the chemical quality of steam in a qualified laboratory. We ensure your sterilization processes adhere to the highest standards, avoiding problems like decreased steam penetration power, inefficient or incomplete sterilization, and wet loads.

Flexible endoscopes provide numerous technical possibilities, making their cleaning and disinfection increasingly complex. Mechanical cleaning is the preferred method, demanding a well-controlled process.

To comply with JCI or NIAZ-accreditation requirements, it’s essential to demonstrate that all hospital devices involved in disinfection or sterilization processes function properly. Endoscopy department devices, which require a disinfected scope, must be validated. Validation ensures thorough cleaning and disinfection of endoscopes while also confirming proper drying and storage.

A tailored validation program is necessary to evaluate the efficiency of these devices, as endoscopes fundamentally differ from traditional instruments in terms of usage and composition.

Agidens collaborates closely with clients to formulate qualification protocols tailored to their needs. Our protocols outline the guidelines, tests, responsibilities, and materials used in the qualification process.

On of our expert consultants implements the protocols using calibrated and validated material, with temperature measurement systems ranging from -196°C to 1250°C. We also measure other parameters depending on the application, such as pressure, volume, mass, and relative humidity.

Our reports include measured data, an analysis of acceptance criteria per test performed, comments, recommendations, and conclusions. We discuss the report face-to-face to ensure a thorough understanding of the entire process and to address any comments or recommendations.