Thermal Validation
Autoclave Qualification Process
Qualifying Your Autoclave
To ensure that your process continues to provide safe and sterile results, your autoclave must comply with established standards and norms (EN 285 and ISO 17665)
The requirements for testing your autoclave depends on the country. In Europe, the standardized cycles are 121 °C for 15 minutes or 134 °C for 3 minutes.
Ellab EvalPro Wired Thermocouple System
The E-Val Pro thermocouple system for thermal validation is immensely easy to handle within controlled environments due to its compact size and light weight. The thermocouple system complies with FDA regulations as well and GAMP guidelines and is designed to be the ideal solution for any thermal validation process.
The secure and password protected module can handle up to 40 thermocouples and the large internal memory is capable of holding up to 10 studies at a time. The wired thermocouple system has a built-in 8-hour battery and can be used as a stand-alone unit or be connected to a PC via LAN/USB.
The E-Val Pro is equipped with interchangeable sensor arrays, which can easily be removed for service and calibration. With 4 and 12-channel arrays available, the E-Val Pro can handle all thermocouple types as well as analog and digital inputs.
Ellab Thermal Validation System – Pharmaceutical Application
- Ellab TS Pro Wireless Dataloggers can be used for the Validation of Autoclaves. It can be used for the Heat Distribution as well as Heat Penetration Applications. The needles of the probes are designed to be compatible with different types of containers. We offer fittings and fixtures to any type of containers.
Ellab TrackSense Pro Wireless Data Logger
The TrackSense® wireless data loggers are the most complete validation solution available today. With a wide range of measuring parameters, Ellab’s data loggers are ideal for most applications.
TrackSense® Pro – Wireless Data Logger
- Interchangeable sensor option
- Many types of sensors availble
- Various parameters available
- Real-time data option
- Temperature range from -50 to +150°C
Ellab Wireless Data Logger
The TrackSense® wireless data loggers are the most complete validation solution available today. With a wide range of measuring parameters, Ellab’s data loggers are ideal for most applications.
Eval Flex Thermal Validation System
- E-Val Flex was designed as a single solution for all thermal validation applications. It can be ran as a stand-alone unit or networked with your PC. The software, which handles up to 128 channels, documents and controls each step reducing errors and maintaining guidelines for more complex regulated applications that require tight compliance control. The easy expandability makes this a complete validation solution for a facility with a variety of applications.
The Steam Sterilization Process
Steam Sterilization
Nothing is more important than patient safety!
Validated and controlled manufacturing processes are necessary to ensure that sterility requirements are reached for all products and containers during steam sterilization. View our recommended solutions and learn more about the process and equipment requirements for autoclaves/steam sterilizers.