Autoclaves
EFEUMYI.COM
Autoclaves are essential for the Pharma and Biotech Industry. The validation of sterilization cycles are critical in order to meet the requirements of EN 285 and ISO 17665 and to ensure sterility of product, components and instrument.
In order to preform the validation of sterilization cycles on the autoclave, we utilize hardware and software rented from our certified suppliers.
We use thermocouples and wireless dataloggers from Lives International’s XpertLog®, Kaye Instrument or 42Systems to perform IOQs , PQ and revalidation on the autoclaves .
Wireless data loggers optimize the calibration and setup processes and provide Accurate measurements, reliable records and audit-proof reporting. They can also reduce by half the amount of labor needed to execute a validation cycle by cutting out Leak rate test for most autoclave as the chamber integrity remains intact prior to mapping the chamber
These loggers features PT-100 sensors accurate to 0.1°C that significantly reduce the measurement uncertainty and improve the calculation of accumulated lethality, or F-value, over that of thermocouple-based systems.
The software from our vendors, calculates accumulated lethality delivered in a cycle and compares results to acceptance criteria easily configured for our client using the applicable standards such as EN 285 and ISO 17665 to produce a pass or fail result. This reduces human error in the interpretation of results and ensures data integrity.
These loggers features PT-100 sensors accurate to 0.1°C that significantly reduce the measurement uncertainty and improve the calculation of accumulated lethality, or F-value, over that of thermocouple-based systems.
The software from our vendors, calculates accumulated lethality delivered in a cycle and compares results to acceptance criteria easily configured for our client using the applicable standards such as EN 285 and ISO 17665 to produce a pass or fail result. This reduces human error in the interpretation of results and ensures data integrity.
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