TMI-Orion presents a full range of high tech data loggers designed for medical and pharmaceutical industries, measuring temperature, pressure and humidity in a variety of processes:
- Steam sterilization,
- ethylene oxide sterilization,
- depyrogenation,
- freeze-drying,
- mapping of climatic and thermostatic chambers, freezers, cold rooms, etc.
- sprays,
- washing-disinfection.
Qlever Software
TMI-Orion data loggers work with Qlever Software for the acquisition, analysis and visualization of measured data. Qlever Software offers specific solutions for the pharmaceutical industry and medical sector.
It allows to define the validation and qualification parameters of the processes (load plan, normative values...) and to generate, verify and approve industry specific reports.
Compliance with directives and norms:
- FDA 21 CFR Part 11
- EN 554
- ISO 17665
- EN 13060
- EN 285
- EN 868
- EN ISO 15883
- FD X15-140/IEC 60068.3.11
- JJF 11-01-2019
- YY/T 0649-2022
- Optional IQ/OQ protocol.
