The development of a standard qualification protocol for all climatic and thermostatic chambers according to the requirements of the Good Manufacturing Practices (GMP) and the standards of characterization: NF X 15-140 and NF EN 60068-3.

Abstract

The qualification of climatic and thermostatic chambers is not based on a single standard, but it also requires the control of several standards such as NF X 15-140, NF EN 60068-3 and the requirements of the Good Manufacturing Practices (GMP). So, currently the qualifiers only take into account the standard NF X 15-140 or NF EN 60068-3 to make their qualification, without giving importance to other criteria that must be treated or accurately tested and that are not mentioned in these standards, but they are cited in other references such as GMP (Good Manufacturing Practices). Because with the standards NF X 15-140 or NF EN 60068-3 we can only judge on the conformity of the distribution of temperature and humidity into the chamber. That is to say, in qualification terms, it is the last step of the qualification, which is the PQ (Performance Qualification). While in the GMP, we find the other steps of qualification, which are the IQ (Installation Qualification) and the OQ (Operational Qualification) and even in the GMP, they are not well detailed. Thanks to the use of the characterization standards such as NF X 15-140 and NF EN 60068-3 and the requirements of the Good Manufacturing Practices, we have been able to develop a standard qualification protocol.  Indeed, this protocol could be used for all climatic and thermostatic chambers for the purpose of their qualification. Also, it could allow us to make a judgment on the conformity or not of the chamber to qualify.