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 Plus Wired Thermocouple System
Key Features & Benefits
- A light and compact module with a 10” touch display
- Password protection, Windows authentication, and defining rights to effectively manage riskand user access
- Complies with FDA 21 CFR Part 11 and GAMP guidelines
- Fan-free design for cleanroom compliance
- Quick and easy startup and the ability to set time markers, conduct tests, and change viewsduring studies
- Get all the data you need from a session with 52 measuring points
- View sensor measurements and serial numbers directly on your module with live overview
- Measure a wide range of parameters, including, temperature, pressure & vacuum, relativehumidity, CO2, Digital Inputs/Outputs
- Compatible with all thermocouples 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.
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