Tuesday , September 26 2023

Temperature Mapping


To lay down a procedure for temperature mapping in control rooms to determine the hot and cold spots.


This SOP is applicable to Control areas of  Pharmaceutical companies.


Officers and above of respective department shall be responsible for following the procedure..

The engineering department shall be responsible for fixing the data logger in the area.

QA shall be responsible to collect the data and make the report, conclusion, and recommendation.


The QA head is accountable for the compliance of this SOP.


 Not applicable.


Temperature mapping is to record the temperature mapping data for control rooms where the temperature is the key factor due to impact on system, product, or process performance.

The temperature mapping is to collect documentary evidence to ensure the controlling of the minimum requirement of the temperature as per the design HVAC system for the respective area.

The temperature mapping exercise is to record the following information.

  • Identification of hot and cold spots as well as the worst location to affix the temperature monitoring device.
  • Variation of temperature at a single point and across the area.
  • The impact of interventions (Power failures).
  • Length of time of any temperature excursions.
  • To verify the capability of the control system to meet the required temperature at a given set parameter.
  • To verify the mapping data in the hottest months of May or June and the coldest months of December or              January.

The Temperature mapping approach is to identify the worst location of the area during the study and affix the   temperature recording device at the worst point for routine monitoring of temperature as given below:

  • Frequently opened doors affect temperature.
  • Areas near the ceiling or exterior walls (sun-facing walls) may stay warmer or cooler in response to outside temperatures.

Temperature mapping shall be performed in control rooms to find out the hot and cold locations for fixing the hygrometer for routine environmental monitoring.

Temperature mapping should be done at three levels or at one level (in a zig-zag manner) covering the complete area at all storage areas of materials and products.

Identification of a number of data loggers for temperature for the Control Area and Warehouse with rationale (justification).

Identify the location and number of data loggers by considering below points:

  • To map the whole area.
  • Identify the worst location (Hot point) to place the temperature monitoring devices for daily routine use.
  • Try to use the data loggers as much as possible to ensure a good distribution.
  • Make sure, to cover the complete area and all levels, including top to bottom or bottom to top, right to left or left to right, front to rear, or rear to front approach.
  • Considering the locations near doors, walls, and ceilings may be more sensitive to exterior conditions
  • Considering the area include door, window, supply and return grill, sun-facing wall as well as obstruction of air.
  • Distance from one data logger to another data logger should not be more than 6 meters.

The study was long enough to show any possible daily trends, so it is considered not less than 3 days (72 hours). Program the data loggers to acquire data every hour

Temperature mapping shall be performed for the Manufacturing area, Quarantine area, dispensing and sampling room, capsule manufacturing and storage room, ointment manufacturing rooms, Raw Materials, primary packaging materials, secondary packing materials, and Finished Good storage areas of the Warehouse.

Temperature sensors shall be positioned in those locations where the greatest variability in temperature is expected to occur and for it, temperature shall be recorded.

The recording of the temperature and relative Humidity shall be done every hour. This shall be done in the hottest months of May or June and the coldest months of December or January for three consecutive days to assess the hot and cold spots.

The data recorded shall be compiled. The highest and lowest temperature-indicating points shall be determined by temperature mapping.

The HVAC unit of the control area shall be in running condition one hour prior to the execution of the study.

HVAC shall be in running condition up to the end of the study and set the temperature of the HVAC system at the prescribed limit of temperature and Relative Humidity.

Configure the data logger for recording the frequency of every one-hour interval. Place the calibrated sensors of temperature Data Loggers within the room

Start the temperature mapping with one-hour intervals for a total of 72 hours.

At the back of each data logger being used, note down the required details like the data logger Identification number and location where it is to be fixed.

Mark the location in the area where the data logger is to be placed for mapping purposes and mention the location number.

Affix the data logger at the locations identified for temperature mapping and note down the start time and end time.

After the programmed period, stop the data loggers and remove the data loggers from the affixed location, and download / extract the data. Take the printout of the data extracted/downloaded from the data logger.

Attach the extracted/downloaded printed data and graphical representation with the report.

Extract the graphical representation from the data loggers placed in the mapped area for verification of the uniformity of the temperature in the respective area and the same was attached with the report.

If the temperature at a particular point is found to be out of the specified limit, then recommendations will be made not to store materials in such areas.


The significance of the power failure study is to evaluate the intervention of the power failure on the temperature of the room to maintain the temperature within the accepted limit once if power cut exists.

The objective of power failure is to provide documentary evidence to verify the intervention of temperature of the area during the power failure for up to 20 minutes.

A power failure study shall be performed after the completion of the area mapping study. A power failure challenge test shall be performed by closing the respective HVAC system for Warehouse for 20 minutes and starting the Data Logger for recording the temperature during this period. Note down the closing time of the HAVC system.

After 20 minutes start the same HVAC system and note down the time.

After the programmed period, stop the data loggers and remove the data loggers from the affixed location, and download / extract the data. Take the printout of the data extracted/downloaded from the data logger.

The effect shall be accessed and recorded in the report.

 The temperature at all the selected locations should be within range


Temperature mapping of storage areas(Technical supplement to WHO Technical Report Series, No. 961, 2011)


GMP: Good Manufacturing Practices

WHO: World Health Organization


Quality Assurance Department

Production Department




Version Number Effective Date Reason for Revision
00 New SOP

About Pharmaceutical Guidanace

Ms. Abha Maurya is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 18 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

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