Temperature Mapping SOP

SOP for Temperature Mapping | Temperature Mapping in Pharmaceuticals |

• Temperature Mapping SOP covers below points:
  • What is Temperature Mapping?
  • How to Identify the location for Temperature Mapping?
  • Definition of Temperature Mapping
  • Temperature Mapping procedure

1.0 OBJECTIVE :

• To describe a procedure for Temperature Mapping.

2.0 SCOPE :

• This SOP is applicable for the temperature mapping of storage, testing/incubation, chamber or any closed area.

3.0 RESPONSIBILITY :

• Concerned Departmental Head
• Quality Assurance Head

4.0 ACCOUNTABILITY:

• Quality Assurance Head

5.0 PROCEDURE :

5.1 A validation activity that centers on temperature and for relative humidity of the area is referred as temperature mapping.

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

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

5.4 Temperature Mapping demonstrates that the temperature and /or relative humidity in the area is uniformly distributed and are in the specified limit. This is one time activity for any particular area. Temperature Mapping helps to determine the hottest (worst) location of the area which reflects the specified temperature and relative humidity of the respective area throughout the day.

5.5 Temperature mapping exercise is to record the following information.

• Identification of hot and cold spots as well as 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 control system to meet the required temperature at given set parameter.
• To verify the mapping data in the hottest months of May or June and coldest months of December or January.

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

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

5.7 Temperature mapping is performed in control rooms to find out the hot and cold location for fixing the hygrometer for routine environment monitoring.

5.8 Temperature mapping is done by outside agency using data loggers. (In this SOP)

5.9 Temperature mapping is to be done at three levels or at one level (in a zig zag manner) covering complete area at all storage area of materials and products.

5.10 Workout number of data loggers for temperature for Control Area and Warehouse with rationale (justification).

5.11 Identify the location and number of data loggers while 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 many as possible to ensure a good distribution.
• Make sure, cover 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.

5.12 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 one hour.

5.13 Temperature sensors is positioned in those locations where greatest variability in temperature is expected to occur and that temperature is recorded.

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

5.15 The data recorded shall be compiled. The highest and lowest temperature indicating point shall be determined by temperature mapping.

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

5.17 HVAC shall be in running condition up to the end of study and set the temperature of HVAC system at prescribe limit of temperature and relative humidity.

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

5.19 Start the temperature mapping with one hour interval for the total 72 hours.

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

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

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

5.23 After the programmed period, stop the data loggers and remove the data loggers from the affixed location and download / extract the data. Take the print out of the data extract / downloaded from the data-logger.

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

5.25 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 same was attached with the report.

5.26 If the temperature at a particular point is found to be out of the specified limit, mark suitably that area then recommendations will be made not to store materials/product in such areas.

 6.0 ABBREVIATIONS:

Abbreviation	Expanded form
SOP	Standard Operating Procedure
Q.A.	Quality Assurance
Q.C.	Quality Control
HVAC	Heating Ventilation and Air Conditioning

7.0 ANNEXURES:

Nil

8.0 SOP REFERENCES

• GMP Guidelines

END OF THE SOP

---