|INSTRUMENTS||SCOPE OF CALIBRATION AND OQ/PQ QUALIFICATION|
|Temperature chambers – freezers, refrigerators, incubators, termostats, drying ovens, sterilisers, furnaces||-160 °C to +1200 °C|
|Drying calibrators||-40 °C to +1200 °C|
|Thermostatic bath||-80 °C to +150 °C|
Due to strictly controlled temperatures, this equipment is critical for ensuring the accuracy and reliability of a number of tests. In order to demonstrate our independence and competence, we were among the first in Europe to offer accredited temperature chamber calibration methods.
Only calibrating temperature probes in incubators, refrigerators or driers is not sufficient to determine with certainty what the samples are exposed todifferent parts of the confinement. Therefore, as a part of the chamber calibration method, we also determine spatial homogeneity, time-related stability and the influence of thermal radiation on temperature and relative humidity in the working environment, without which traceability is not possible to achieve. Determining the vertical and horizontal gradients is of similar importance for calibrating thermostatic baths.
Recognising the importance of calibration results for such devices, we were among the first laboratories in Europe to offer clients accreditation-based calibration of all instruments listed, ensuring the recognition of our calibration certificates in more than 100 countries worldwide.
As a part of OQ and PQ, we determine the distribution and stability of temperature and humidity within the chambers. Being subject to client requirements, we also conduct tests in case of power failure or door openings, which are often of key importance for quality assurance. All chamber qualifications and re-qualifications are performed in accordance with the client’s requirements, needs and protocols, all GMP/ GLP/GDP requirements and, in the GMP area, in particular in accordance with EudraLex, Volume 4, EU Guidelines or Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use, Annex 15: Qualification and Validation.
With each OQ/PQ qualification report, along with other attachments, we also provide clients with accredited calibration certificates for their device.