Climatic and stability chambers
|INSTRUMENTS||SCOPE OF CALIBRATION AND OQ/PQ QUALIFICATION|
|Climatic and stability chambers||10% RH to 95% RH / +20 °C to +70 °C|
Calibration of chamber temperature probes and relative humidity probes alone is not sufficient to determine with certainty what the samples are exposed to in different parts of the confinement. Therefore, as a part of climatic/stability chamber calibration, we determine the spatial homogeneity, time-related stability and influence of thermal radiation on temperature and relative humidity within the working environment, without which it is not possible to achieve traceability.
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 conduct tests in case of power failure or door openings, whichare 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.