Thermal Validation
Our structured approach to Thermal Validation projects ensures accurate results and seamless execution, from protocol formulation to in-depth reporting and discussion.
As the Life Sciences industry evolves, mastering temperature control and compliance is non-negotiable. Uncover the indispensable role of Thermal Validation services in providing tailored solutions for sterilization and controlled storage processes.
COMPREHENSIVE THERMAL VALIDATION SOLUTIONS
- Sterilization & Disinfection Process Validation
- Cold Rooms, Sites & Storage Area Validation
- Steam Quality Testing EN 285
- Validation for Desinfection of Endoscopes & Dry Cabinets
Sterilization & Disinfection Process 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.
Cold Rooms, Sites & Storage Area Validation
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.
Steam Quality Testing
EN 285
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.
Validation for Desinfection of Endoscopes & Dry Cabinets
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.
PROJECT APPROACH
Our structured approach to Thermal Validation projects ensures accurate results and seamless execution, from protocol formulation to in-depth reporting and discussion.
Customized Protocols & Implementation
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.
In-depth Reporting & Discussion
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.
TAKE YOUR THERMAL VALIDATION TO THE NEXT LEVEL
Do you like our approach? We would love to hear from you!
RELATED SOLUTIONS
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