Temperature Mapping report template
The mapping report should include the following sections:
a. Introduction: a description of the objectives of the mapping study.
b. Summary: a summary and discussion of the results organized in the sequence set out in the mapping protocol, including a summary of deviations (if any).
c. Conclusions and recommendations: a general conclusion for all verifications and observations indicating the acceptability of the equipment for operation. Recommendations and remarks can be incorporated into this section.
d. Report annexes: The annexes to the report should contain the following:
The site survey shows EDLM locations.
The raw data is presented using the appropriate test data sheet format – see Annex 1.
Spreadsheet data and related temperature graphs for every EDLM used in the mapping exercise.
Raw results of the data analysis, including hot and cold spots.
key documents and notes prepared during the mapping exercise together with any other supporting material.
Deviation reports, including corrective and preventive actions (CAPA) forms, if required: this may include a recommendation for partial or total re-mapping.
Calibration certificates for all EDLMs used.
Conducting the mapping exercise
Conduct the mapping exercise in accordance with the protocol.
Ensure that all relevant personnel in the store are fully briefed so as to avoid inadvertent disruption or deactivation of the EDLMs.
At the end of the study period, collect all the devices, deactivate them, and download the data for analysis.
If the mapping exercise does not include automatic logging of door openings, an access log should be kept during the study so that any temperature excursions caused by personnel movement can easily be identified.
Power outages should similarly be recorded.
Analyzing the data and preparing the mapping report:
The following subsections outline the data analysis process that precedes the writing of the report.
Preliminary analysis
Analyze the overall temperature stability of the study area and identify the variations that occur. Compare the measured temperatures against the acceptance criteria. The analysis of the overall temperature stability should consider factors such as:
the ability of the environmental control systems to maintain temperatures within the acceptance criteria limits (if any).
the overall temperature stability of the area being monitored, and the range in fluctuations it experiences over the study period.
The analysis of temperature variations should consider factors such as:
variations experienced by individual EDLMs.
temperature variations along vertical and horizontal planes, depending on the size of the area, and distribution of EDLMs.
temperature variations in locations close to heating and cooling components, as compared to those farthest away from these units.
Minimum and maximum temperatures and hot and cold spots
A mapping study measures temperature fluctuations. the analyst can identify the minimum and maximum temperatures that occur in the mapped area during the study period.
Minimum temperature refers to the lowest temperature recorded in the mapped space over the study period. maximum temperature refers to the highest value recorded during the same period.
Either or both of these temperatures may be outside the specified acceptance criteria for the store.
A cold spot refers to the lowest temperature(s) recorded in the space over the study period, but these lowest temperature(s) remain within the specified temperature range (e.g. cold spots identified between +15.0 °C and +17.5 °C in a room with a specified temperature range of +15.0 °C to +25.0 °C).
A hot spot refers to the highest temperature(s) recorded in the area studied over the study period, but these highest temperature(s) remain within the specified temperature range (e.g. hot spots identified between +23.0 °C and
+25.0 °C in a room with a specified temperature range of +15.0 °C to +25.0 °C).
The purpose of determining hot and cold spots is to identify the locations where the monitoring system sensors should preferentially be located. Hot and cold spots need to be determined seasonally as they may be significantly different in summer and in winter.
Note:
It is also important to look at the overall high and low trends rather than just the highest and lowest temperatures. Average values can be useful to help confirm true hot and cold spots.
Mean temperatures
Arithmetic means temperatures can be applied to each of the separate areas being monitored over the study period.
These mean temperature measurements can be useful in storage areas where the temperature fluctuates with time in a repetitive pattern (e.g. sinusoidal fluctuation or periodic peak occurrence) and where the temperature also varies depending upon the location of the data logger.
The use of mean temperatures enables the analyst to determine a mean temperature for a given EDLM location over the study period.
These figures can then be compared between all the EDLM locations within the space. This enables
the analyst to identify the locations where the mean temperatures are consistently lower or higher, an outcome that cannot be achieved simply by comparing individual data points.
In Figure 3, the minimum and maximum temperatures have been calculated from the data points for two locations (EDLM-1 and EDLM-2).
The plot shows that the EDLM-2 location is clearly cooler on average, although there are also times when the two locations experience similar low and high temperatures.
Despite the usefulness of mean figures, it is essential not to disregard the actual temperature data because these figures reveal the occurrence.
Interpreting the results and making recommendations:
How to interpret the results, and how to use these results to support the report’s recommendations:
Document the internal temperature variations observed within the space, taking into account the EDLM reading errors specified by the device manufacturer.
Use the data analysis to assess the overall temperature stability of the mapped space in relation to the stated acceptance criteria (if any).
Assess the overall thermal stability of the space during the study period with specific reference to the high and low temperatures experienced.
List the factors that explain the observed temperature variations. For example, the location of the heating and cooling components and doors.
Assess consistent and inconsistent temperature variations and fluctuations within the space in terms of their potential impact on product storage.
Based on the observed temperature fluctuations at the mapped locations within the space, make recommendations about the optimum storage locations for highly sensitive products, and those that are less sensitive.
Based on the observed temperature fluctuations at the mapped locations within the space, make recommendations on the optimum location of the temperature sensor(s) used for routine temperature monitoring and the control sensors used to activate the heating and cooling systems.
Report auditing
The report’s content, including data sheets, results, spreadsheets, and graphs should be audited and peer-reviewed by a competent independent person.
The reviewer should confirm, approve and sign the major reported test and verification results and the recommendations arising from these results. If the report has been prepared by a qualified third party, it should be approved by the person who commissioned the study.
Implementing the mapping report recommendations The final outcome and purpose of a mapping exercise is the implementation of the report recommendations. A detailed discussion of implementation is outside the scope of this document, but it could include any of the following outcomes:
A drawing or diagram showing where TTSPPs can safely be stored in the space that has been mapped: It is possible that there may be some zoning involved. For example, products that are not affected by freezing could be allocated to parts of a cold room where the mapping study has shown some freezing risk.
Allocation of pallet bays to specific categories of TTSPP on the warehouse management system in order to control where stocks are positioned.
Repositioning of temperature monitoring sensors and/or environmental control sensors.
Adjustment of air outlets to reduce temperature stratification and/or minimize cold and hot spots.
Upgrading of mechanical systems to improve temperature control and performance.
A decision to use the space for other purposes because it is unsuitable for the storage of TTSPPs.
Abbreviations
3PL: third-party logistics (provider)
CAPA: corrective and preventive action (procedures)
EDLM: electronic data logging monitor
GMP: good manufacturing practice
IQ :installation qualification
NIST: National Institute of Standards and Technology (US)
SLA: service level agreement
SOP: standard operating procedure
TTSPP: time- and temperature-sensitive pharmaceutical product
Glossary
Component:
Any major piece, part, or assembly of the main equipment or sub-equipment that does not have its own power supply and could not operate as a stand-alone unit (valves, or switches).
Controller:
A device that interprets a mechanical, digital, or analog signal, generated by a sensor, to control an item of equipment or component.
Deviation:
For installation qualification: any discrepancy between the installation specifications and the actual (as found) installation. For operational qualification: any discrepancy between the protocol and the actual performed test, test function methodology, testing equipment, and testing material.
Reference: Temperature mapping of storage areas (WHO Technical Report Series, No. 961, 2011, Annex 9)
