Pharmacy - Health Care
Pharmacy - Health Care - BioTech
TMI-Orion data loggers operate with a dedicated software platform for data acquisition, analysis and visualization, compliant with the following directives and standards:plateforme logicielle dédiée, pour la visualisation et la gestion des données,
- FDA 21 CFR Part 11
- ISO 17665 (formerly EN 554)
- EN 13060
- EN 285
- EN 868
- EN ISO 15883
- FDX15-140 : 2024
- IQ/OQ protocol is available as an option
INDUSTRIAL PROCESSES OF MEDICAL
AND PHARMACEUTICAL INDUSTRY
Steam sterilization validation
TMI-Orion Solution
Data loggers
PicoVACQ or NanoVACQ or VACQ xFlat
Software
Qlever software platform
+ Pharma Module (FDA 21 CFR Part 11)
+ Calibration Module
+ LDAP Module: optional
OR
Qlever Software Platform
+Authentication-tracking Module (FDA 21 CFR Part 11)
+ Calibration Module
+ Autoclave validation Module (ISO 17665 / EN 13060 / EN 554 / EN 285 / EN 868): optional
+ LDAP Module: optional
Connectivity
2.4 GHz radio modem or wired interface for NanoVACQ and VACQ,
Wired interface for PicoVACQ.
Steam autoclaves are used to sterilize products inside vials,
bottles, pouches, and most pharmaceutical and medical
equipment.
During the sterilization process, the temperature must
reach a definite temperature for a determined period of
time. TMI-Orion offers solutions to monitor temperature
inside containers and temperature and pressure inside the
autoclaves, with loggers of different sizes and various types
of probes.
Ethylene oxide sterilization validation
Sterilizing with EtO implies low temperature long lasting
cycles. Ethylene Oxide sterilization validation requires
measuring relative humidity and temperature parameters
inside the chambers wih ATEX compliant data loggers, such
as the NanoVACQ HT Ex.
TMI-Orion has a range of ATEX compliant data loggers
marked “II 1G Ex ia IIC T3 Ga” or “II 1G Ex ia IIC T6 Ga” and
compliant with regulations EN 60079-0 and EN 60079-11.
TMI-Orion Solution
Data loggers
NanoVACQ Ex, PicoVACQ Ex
Software
Qlever Software Platform
+ Pharma Module (FDA 21 CFR Part 11)
+ Calibration Module
+ LDAP Module: optional
Connectivity
2.4 GHz radio transceiver or wired interface for
NanoVACQ,
Wired interface for PicoVACQ.
Depyrogenation
Depyrogenation, or dry heat sterilization process, uses hot air to reduce the level of pyrogens in static ovens or in tunnels.
In the process, temperature is measured with platinum or
thermocouple sensors, protected by a thermal shield. Data
loggers and thermal shields are selected according to the
specific needs of the process and the characteristics of the
oven or tunnel.
TMI-Orion Solution
Data loggers
PicoVACQ 1Td ou VACQ xFlat with thermal shield.
Software
Qlever software platform
+ Pharma Module (FDA 21 CFR Part 11)
+ Calibration Module
+ LDAP Module: optional
OR
Qlever Software Platform
+Authentication-tracking Module (FDA 21 CFR Part 11)
+ Calibration Module
+ Autoclave validation Module (ISO 17665 / EN 13060 / EN 554 / EN 285 / EN 868): optional
+ LDAP Module: optional
Connectivity
2.4 GHz radio transceiver or wired interface for VACQ xFlat,
Wired interface for
PicoVACQ
Wired interface for PicoVACQ.
Freeze-drying processes validation
Taking the water out of a product is a way to obtain a more stable product, smaller in volume and weight. This process freezes the product at low temperature, applying vacuum and heat so the ice can evaporate. This process requires measuring the temperature of the chamber and the product.
TMI-Orion provides solutions based on platinum sensors at the end of flexible or semi-rigid probes that can easily fit into small vials through the rubber cap.
TMI-Orion Solution
Data loggers
NanoVACQ 1Tc-2Td or NanoVACQ 1Tc-2Tdi or
PicoVACQ
1Td or PicoVACQ 1Tdi
Software
Qlever software platform
+ Pharma Module (FDA 21 CFR Part 11)
+ Calibration Module
+ LDAP Module: optional
Connectivity
2.4 GHz radio transceiver or wired interface for VACQ
xFlat,
Wired interface for PicoVACQ.
Mapping of climatic and thermostatic chambers, freezers, cold rooms, etc...
Mapping is necessary to ensure all points of the chamber are at the required temperature.
A data logger operating for days at low temperature is recommended.
TMI-Orion Solutions
Data loggers
NanoVACQ Temperature or PicoVACQ ou MiniVACQ ou
VACQ xFlat
Software
Qlever Software Platform
+ Pharma Module (FDA 21 CFR Part 11)
+ Calibration Module
+ LDAP Module : optional
OR
Qlever software platform
+ Authentication-tracking Module (FDA 21 CFR Part 11)
+ Calibration Module
+ Mapping module (FDX15-140 : 2024)
+ LDAP Module: optional
Connectivity
2.4 GHz radio transceiver or wired interface for
NanoVACQ and VACQ xFlat,
Wired interface for PicoVACQ and MiniVACQ.
Aerosol spray
TMI-Orion Solution
Data loggers
PicoVACQ PT Ex
Software
Qlever software platform
+ Pharma Module (FDA 21 CFR Part 11)
+ Calibration Module
+ LDAP Module : optional
OR
Qlever software platform
+ Authentication-tracking Module (FDA 21 CFR Part 11)
+ Calibration Module
+ LDAP Module: optional
Connectivity
Wired interface
In order to acquire process information during hot filling,
crimping, water bath leakage test and transportation of
products in aerosol spray containers, it is possible to insert a
very small data logger directly inside the spray can.
Washing-disinfection
TMI-Orion Solution
Data loggers
NanoVACQ or NanoVACQ Flat or MiniVACQ or PicoVACQ
Software
Qlever Software Platform
+ Pharma Module (FDA 21 CFR Part 11)
+ Calibration Module
+ LDAP Module: optional
OR
Qlever Software Platform
+Authentication-tracking Module (FDA 21 CFR Part 11)
+ Calibration Module
+ Washing-disinfection Module (ISO 15883)
+ LDAP Module: optional
Connectivity
2.4 GHz radio transceiver or wired interface for NanoVACQ,
Wired interface for NanoVACQ Flat, PicoVACQ and
MiniVACQ.
Washing-disinfection cycles are performed for disinfection purposes or for cleaning loads prior to steam sterilization as this sterilization process is only efficient on clean surfaces.
After the washing-disinfection cycle, the load is inspected and readied for steam sterilization.
Washer-disinfector machines usually use hot sprayed water.
TMI-Orion offers solutions for setup and detailed analysis
of washing and disinfection cycles. Validation reports are
compliant with the ISO 15883 norm.
TMI-Orion PORTFOLIO FOR MEDICAL AND PHARMACEUTICAL INDUSTRY
You will find a choice of loggers covering temperatures from -90°C to +140°C. A thermal shield is necessary to measure
temperatures up to +1200°C.
Sensors are Pt100, Pt1000 or thermocouples. The probes have various forms and dimensions. Sensors can be internal to the
logger, placed at the end of a rigid probe 10 to 100 mm long, or at the end of a flexible or semi-rigid probe, up to 1 meter long.
Depending on the models, you can chose loggers with 1 to 32 measurement channels.
Data loggers
Temperature measurement in thermal processes from -70°C to +140°C.
The PicoVACQ Temperature is a very small autonomous temperature datalogger (diameter 15 mm). It is equipped with 1 or 2 temperature sensors at the end of rigid, semi-rigid or flexible probes.
PicoVACQ Temperature
PicoVACQ Pressure and temperature
The PicoVACQ PT is a pressure and temperature data logger, from 0°C to +140°C and up to 15 bar.
With its very small dimensions (diameter 16 mm) it can be placed in sprays or very small containers. It is also used in steam sterilization applications.
The NanoVACQ Temperature is an autonomous data logger equipped with 1 to 3 temperature sensors. Some models are watertight under pressure up to 30 bar.
There are many models available, answering most industrial needs. They vary by number and type of probes, temperature operating range and battery capacity.
Its ruggedness allows temperature measurement in harsh environments.
The models NanoVACQ 1Tc-2Td and the disconnectable probe version NanoVACQ 1Tc-2Tdi are very well adapted for freeze drying process.
NanoVACQ Temperature
The NanoVACQ Flat is a single probe temperature data logger. The temperature probe can be internal or have various sizes up to 100 mm. Its small size, diameter 40 mm and height 11 mm, makes it suitable for washing processes or any sterilization process.
NanoVACQ Flat
NanoVACQ PT has one pressure sensor and one or two temperature sensors.
The combination of pressure and temperature measurement is the best way to validate saturated steam sterilization processes.
The standard NanoVACQ Pressure and Temperature models can vary by probe shape or lenght.
NanoVACQ Pressure and Temperature
NanoVACQ HT has one humidity sensor and one or two temperature sensors.
The standard NanoVACQ Pressure and Temperature models can vary by probe shape or lenght.
NanoVACQ Humidity and Temperature
PicoVACQ HT has one humidity sensor and one internal temperature sensor. It is available in Ex version for applications in explosive environment, such as Ethylene oxyde sterilization validation.
PicoVACQ Humidity and temperature
MiniVACQ is adapted to thermal processes from -40°C to +100°C. It is an ideal temperature data logger for washing-desinfection processes.
MiniVACQ Temperature
VACQ xFlat is a thermocouple data logger. It can be used for steam sterilization validation if it is placed outside the autoclave. It can also be used inside depyrogenation process (dry heat) where the data logger is protected by a thermal shield.
VACQ xFlat
VACQ 3000
VACQ 3000 is a pack of 48 thermocouple channels in an easy to store and transport rack for laboratory processes.
The rack can contain a combination of:
- 1 VACQ xFlat 4.8 Radio + 1 VACQ xFlat 2.8 Radio
- or 3 VACQ xFlat 2.8 Radio
The rack is used at room temperature outside the process.
The FullRadio option enables set up and reading of data in real time and wireless, by bi-directional radio transmission. It is then possible to start and stop the data logger while it stays inside the industrial process.
FullRadio is adapted to sterilization process validation .
FullRadio transmission
Qlever software for pharmaceutical and medical industries
For more information, download our guides
TMI-Orion-Flyer-Pharmaceutical industry and medical sector-English
TMI-Orion-Plaquette-Industrie pharmaceutique et secteur médical-Français
TMI-Orion-DS-Qlever software for pharmaceutical industry-English
TMI-Orion-DS-Logiciel Qlever pour l'industrie pharmaceutique et le secteur médical-Français
Miscellaneous
For applications above +140°C, it is necessary to protect the data loggers with a thermal shield.
Thermal shields
The positioning kits help maintain the logger sensor at the cold point inside the process. Depending on the applications, the loggers will be placed inside or outside the container. Usual devices are available, and customization can be studied upon request.
Accessories
