Description
Air ventilation systems and air conditioners used in clean rooms should ensure high accuracy of the microclimate parameters and reliable maintenance of the temperature and relative humidity of the air in the room within the specified limits. Depending on the purpose of a clean room, various requirements may be imposed on it not only in terms of purity class, but also in terms of temperature and humidity, and the stability of their maintenance.
How are microclimate parameters measured?
Measurement of temperature and humidity in clean rooms is carried out in order to verify the ability of the ventilation and air conditioning system to maintain the parameters of the microclimate in a certain area within the specified limits during the time agreed by the customer and the contractor.
It is necessary to distinguish between the temperature and humidity control of a clean room, carried out within the framework of the room qualification, and temperature mapping, which is carried out during the qualification of pharmaceutical warehouses.
For the control of temperature and humidity in clean rooms with qualifications used high-precision measuring devices, the control is carried out according to the methods given in GOST R ISO 14644-3-2007 "Clean rooms and associated controlled environments. Part 3. Test methods" and other standards in particular, GOST R 52539-2006 "Air Purity in Medical Institutions. General Requirements" requires that these parameters be measured at the surface level of the operating table (patient's bed) for 1 hour with a frequency of 6 minutes.
Microclimate parameters measurement protocols
The test report for clean rooms includes information on measured values of temperature and relative air humidity and information on compliance or non-compliance of the microclimate of a clean room with the established requirements. If necessary, a report with primary measurement data and a graph showing the dynamics of changes in temperature and humidity in the room during a specified time can be attached.
