Since the recommandations for temperature in laboratories are between 20 - 25°C , can we consider that we have a non-conformity only when the temperature exceeds 25,9 °C ?
Generally, laboratory temperature and humidity conditions are governed by the requirements of sophisticated analytical instruments such as FTIR, HPLC, LC-MS/MS, NMR, AAS, and others which are sensitive to the temperature conditions in the surroundings in the laboratory. Therefore, the temperature is usually maintained between 20-25 deg. C in the laboratory.
For the temperature of 25.9 deg C, you may seek advice from the manufacturers of the sophisticated instruments installed in your laboratory, whether this high temperature will be acceptable.
For other areas in the laboratory (such as the wet chemistry laboratory section) the excursion in the temperature up to 25.9 deg. C for a short period should be ok. Please specify these aspects in your internal SOP of Laboratory Management.
Thanks for your answer. So if it last for a long time it can influence on reagents and analysis and even on equipments ?
You are always welcome…!!
Yes, it may affect the quality of reagents and analysis depending upon their Physico-chemical characteristics and stability profile. Sensitive and thermolabile chemicals and reagents should be stored in the refrigerator at 2 to 8 deg. C or even at lower temperatures.
“Good Laboratory Practices” must be followed at all times.
As per FOOD AND DRUG ADMINISTRATION OFFICE OF REGULATORY AFFAIRS ORA Laboratory Manual Volume II
Laboratories are equipped with climate and ventilation control. The temperature and humidity within the laboratory are maintained within limits for the proper performance of each test or analysis and maintained according to the manufacturer’s specifications for the proper operation of instruments. A comfortable working environment is considered 20 to 25° C with relative humidity of 35 to 50% depending on geographical area. In general, the work areas should be free of temperature extremes that are hazardous to health or which interfere with safe operations. Laboratories where toxic materials are handled are under negative pressure to adjoining areas with 8 to 12 air changes per hour. High hazard laboratories, clean rooms/isolators, animal facilities, and Biosafety Level III suites have unique working conditions. Work, storage areas, and restrooms are free of noxious odors. Exhaust ventilation is maintained for 24 hours per day in any area where
chemicals are stored or used. No laboratory air is recycled through the building. The supply vents should not exceed 50 feet per minute (FPM) airflow.
Thanks again for your help. It was very helpful .
Thanks for your clear answer . It is very helpful
You are always welcome.
when a laboratory is temperature controlled 20-25, with telemetry installed in different locations. Is there a need for us to carry out a temperature mapping study as part of our Annual Validation Master Plan?
Could you please provide references aswell of regulatory requirements