Pharmaceutical sterilization control - Pharmacy and chemistry

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21 CFR Part 11 compliance

Pharmacy - Biotechnology - Cosmetics - Fine chemistry

TMI-Orion offers a wide range of FDA 21 CFR Part 11 compliant solutions enabling monitoring and qualification of pharmaceutical industry specific processes.

 

 

Software
Results are available through xVACQ-Pharma Software that allows you to comply with FDA CFR 21 Part 11 regulations. Material and software qualification protocol IQ/OQ are available.
The calibration software xETal Temperature enables a calibration of data loggers with appropriate calibration equipment.

 

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Real time data

NanoVACQ with radio option enables temperature, pressure and humidity
real time measurement inside
autoclaves, freeze dryers ...
When using the VACQ 3000 a real time
data reading is possible with the software TQSolutions

Multi-logger interface

pharmaceutical sterilization control PC + NanoVACQ.JPG


NVQ 1TC Ex - NVQHT Ex
pharmaceutical sterilization control NVQ 1Tc EX+NVQ HT EX II.JPG

pharmaceutical sterilization control Pico PT bouchon metal.JPG
PicoVACQ PT

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VACQ 3000

pharmaceutical sterilization control PVQ 1Td chemisé.JPG
PicoVACQ 1Td semi-rigid stainless steel probe

 

 

 

 

Steam pharmaceutical sterilization control

PicoVACQ and NanoVACQ families of data loggers enable operational qualification and
routine control of autoclaves
.
Up to 96 temperature and temperature/pressure data loggers simultaneously.

With VACQ 3000 data logger, it is possible to perform autoclave validation with thermocouples. In this application the data logger is placed outside the autoclave and is permanently connected to a PC.


Ethylene oxide pharmaceutical sterilization control

NanoVACQ Ex is the "low temperature" sterilization processes solution. It measures temperature, humidity/temperature and pressure/temperature. It meets the specifications of the intrinsic security standards Ex.



Freeze-drying processes
NanoVACQ 1Tc-2Td has one sensor at the end of a rigid probe for measuring ambiant temperature inside the freeze-dryer, and two remote sensors at the ends of flexible probes for easily measuring temperature inside small containers. Special fixtures can be designed to hold the vials or other small contained. In some applications the temperature range is -80°C to +130°C. This equipment is also available with radio transmission for real time data.



Sealed aerosol containers
Easily inserted inside a spray, the PicoVACQ PT helps you get process information during hot filling, sealing, water bath and transportation.



Freezer mapping
NanoVACQ can operate for days at -80°C with 0.2°C accuracy. Only by changing the battery type you can work at high temperature.



Depyrogenation
For dry-heat sterilization processes, use TMI-Orion data loggers with thermal shields uo to 400°C. The VACQ Flat is available from 4 to 16 type T thermocouples.


Washing/disinfection
TMI-Orion data loggers enable verification of washing and disinfection.


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Customer log in

last software versions
user's guides ......

>


Distributor log in

you can find the last software versions, the user's guides, the price list and other information.
>



Documents to download :
Pharmacy and chemistry industry brochure

Product ranges related to this page :
PicoVACQ Temperature Humidity data logger
PicoVACQ temperature and pressure data logger
NanoVACQ Temperature Humidity data logger
PicoVACQ temperature data logger
NanoVACQ Temperature Pressure data logger
NanoVACQ / NanoVACQ Flat / XFlat (temperature)
VACQ 3000 temperature data logger
Data processing software



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