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VALIDATION OF STEAM STERILIZATION
A set of NanoVACQ Temperature and NanoVACQ PT-Tc dataloggers, associated with Qlever software (with the Autoclave Validation Module) compliant with the norm IS0 17665 has been designed for operational qualification. The logger models can be different within a given system. This system allows full compliance with the International norm requirements.
NanoVACQ Temperature NanoVACQ PT-Tc
A multi-logger interface makes programming and downloading possible for up to twelve loggers at the same time.
Multi 6 USB interface Multi 12 USB interface
International norm ISO 17665 and EN554 - Sterilization of medical devices - Validation and routine checking of steam sterilizers - is the reference standard for operational qualification of steam autoclaves.
The norm requires that :
- Temperature be measured at the core of the load
- Saturated steam be checked at base plate level
- Temperature and pressure be maintained constant while on hold pattern
Sterilization temperature while on hold pattern be :
- within specified temperature range, the upper control limit being equal to sterilization temperature plus 3°C,
- with no deviation exceeding 1°C,
- and temperature difference of any 2 points inferior to 2°C.
- Temperature be set within 15s in autoclave whose volume is inferior to 800L, and within 30s in more voluminous ones.
The loggers can be located at the core of loads. They log temperature and pressure versus time.
Examples: Sterilization cycle control inside loads
Qlever system performances meets or exceeds the recommendations of the guide of European standard EN554, published by AFNOR (Reference GA S 98130) and ISO 17665.
- Temperature accuracy better or equal to 0.17°C - NanoVACQ 1Tc: 0.10°C
- Pressure accuracy better or equal to16mbar - NanoVACQ PT-Tc: 10 mbar
Qlever software enables data treatment and presentation in an extensive validation report in compliance with ISO 17665 / EN 13060 / EN 554 / EN 285. (see Qlever data sheet).
ROUTINE CONTROL OF STEAM STERILIZERS
Thanks to an excellent reliability at elevated temperature, the TMI-Orion data loggers are very suitable to the routine control of the autoclaves specifications during sterilization cycles.
ETHYLEN OXIDE STERILIZATION CONTROL
For ethylen oxide low temperature sterilization process the NanoVACQ-Ex data loggers have temperature and humidity/temperature sensors.
These loggers can be programmed and read out with multi-logger interface. They are designed according the Ex norms (explosion proof).
WASHING AND DISINFECTION TEMPERATURE CONTROL
NanoVACQ Flat - MiniVACQ
Two data logger models fit the control of temperature for washing and desinfection processes: NanoVACQ Flat and MiniVACQ. They can easily be placed inside the equipments thanks to their small dimensions.
Qlever software with Washing-disinfection Module is intended for the analysis and validation of washing-disinfection cycles. Data treatment and presentation in an extensive validation report in compliance with ISO 15 883.