|SCOPE OF CALIBRATION AND OQ/PQ QUALIFICATION
|+105 °C to +140 °C
Calibration of temperature and pressure probes alone is not sufficient to determine with certainty what the samples are exposed to in different parts of the space. Therefore, to achieve traceability, it is of great importance to determine the equivalent sterilisation time for different spatial points, temperature fluctuation, difference in dwell time and many other parameters as a part of autoclave calibration.
Recognising the importance of calibration results for such devices, we were among the first laboratories in Europe to offerclients accreditation-based calibration of autoclaves in addition to qualification.
Unlike the temperature and climatic chambers that maintain stable conditions, autoclaves are instruments where a specific dynamic process is carried out with a specific desired outcome. Therefore, we at Metroteka feel that the discussion between our laboratory staff and the client is essential for any qualification and validation process. Together we agree upon the course, scope and method of measurement so as to provide the most accurate information in our report, ensuring a smooth process flow with minimum interference from both the laboratory and the client. In conjunction with the client, we also decide whether to perform the measurements using T-type thermocouples or wireless probes. Depending on the client’s requirements, we are also able to determine the efficiency of heat penetration into the product or an object of sterilisation.
As a standard part of our reports, for all cycles and all points within the autoclave space, during the sterilisation process we determine the effective sterilisation time, along with the mean, minimum and maximum temperatures at a particular point, the deviation from pre-set conditions, differences and fluctuations between and within special points and the extended (k=2) measurement uncertainty for each spatial point as well as for the autoclave as a whole.