Thermal mapping in pharmaceuticals is performed to verify that a controlled environment can maintain the required temperature and RH uniformly throughout the storage area and core area. It helps identify temperature and RH variations, establish suitable locations for routine monitoring, and demonstrate compliance
Purpose of Thermal Mapping in Pharmaceuticals
The purpose of this protocol is to provide the procedure and acceptance criteria for temperature and percentage relative humidity mapping in storage areas wherever applicable of XYZ company. Successful execution of this protocol and successive report compilation shall provide sufficient data to establish that the air handling unit supply the air to the rooms are capable of continuously maintaining desired conditions of temperature and percent relative humidity (performing as intended and are in a state of control) thereby establishing dependability. To identify the worst case (Hot Spot) location for the routine monitoring of the Temperature and % RH.
Read Also => Facility Operation Qualification for Stability – Complete Procedure
Scope of Qualification Activities
Scope of this protocol is limited to Temperature and % RH mapping wherever applicable of the following rooms of storage areas of XYZ Company.
| Room Name | Section | Purpose |
| To find hot spot for temperature monitoring | ||
| To find hot spot for temperature monitoring | ||
| To find hot spot for temperature monitoring |
Roles and Responsibilities during Thermal Mapping in Pharmaceuticals
Responsibilities of different department / personnel involved in different activities related to the Temperature and % Relative Humidity are defined below.
| Department | Responsibility |
| Engineering | Execution of protocol along with the co-ordination of service provider and other departments. Rectification of breakdown, if any, during qualification study. |
| Production | Review of protocol and report. |
| Ware House | Review of protocol and report. |
| Quality Assurance | Preparation and Review of Qualification Protocol Review, approval and certification of the protocol / reports. Review of results of Qualification Report and data evaluation. |
Applicable Reference Documents and Standards
Following documents are referred during preparation of the protocol.
| Document Title | Document Number |
| SOP for HVAC validation and Re-validation | |
| SOP for procedure for Thermal Mapping |
Personnel Training Requirements
Training is to be imparted on approved Qualification Protocol to all personnel involved in the qualification exercise before commencement of the Qualification activity. Training details shall be recorded in training sheet and a copy of training sheet shall be attached along with report.
System/Area Description
Storage area is used to store raw material, in process materials (lubricated blend, compressed tablets, coated tablets etc.). The storage rooms are provided with required utilities in order to maintain desired conditions of temperature and percent relative humidity. Storage areas in hormone & general section and respective conditions of temperature and percent relative humidity are tabulated below:
| Room Name | Section | Area of Room (f) | Limits (NMT) | Catering AHU ID Number | |
| Temperature | % RH | ||||
| 25⁰C | 55 % | ||||
| 25⁰C | 40 % | ||||
| 25⁰C | 40 % | ||||
| 25⁰C | 50 % | ||||
| Test | Number of Run |
| Pre-Requisites | |
| Training Verification | Once |
| Calibration Verification of Test Instruments | Once |
| Qualification Test | |
| Loaded Staging Room Temperature Mapping | 7 Days (168 Hours)/3 days (72 Hours) |
Qualification strategy for Thermal Mapping in Pharmaceuticals
Storage Areas can be affected by seasonal temperature variations, at least three temperature mapping studies may need to be carried out in each area in order to observe the effect of seasonal variation. Typically, one should be carried out during the warmest season; one should be carried out during the rainy season and one during the coldest season because this will represent the worst case scenario. This will establish whether the mapped area is able to maintain stable temperatures throughout the year. The mapping duration of seven days and 72 hours are included representing variations in working days and weekends to simulate the routine operation including door opening and closing.
Qualification test, procedure and acceptance criteria:
Pre-Requisites
Impart training to all personnel involved in the qualification exercise and record the details.
Ensure that all instruments to be used in mapping exercise are in calibrated state, record the details and attach copy of calibration certificates to the report. The instruments shall have valid calibration of at least three points and shall have accuracy of NMT ±1ºC/5.0% RH. Calibration range of the instruments shall be inclusive of acceptance criteria of the storage area.
All recordings shall be on Annexure I only and any raw data generated during the execution shall be attached along with the report.
Loaded Staging Room Thermal Mapping in Pharmaceuticals
Loaded room heat distribution study is to be performed after successful completion of prerequisite. Procedure for Mapping is as follows:
Objective
To perform the temperature / percentage relative humidity mapping wherever applicable in storage areas.
Test Requirements
- Calibrated Data loggers
- Storage Room
Test Procedure
- Configure and locate all pre-calibrated data loggers in the storage areas as per locations mentioned of this protocol.
- Secure the data loggers properly to avoid any damage because of routine storage operations.
- Ensure that the tips of data logger (if any) are not in contact with any metallic surface / walls.
- Provide sufficient time (Not Less Than 30 minutes) to the data loggers to be conditioned to the temperature / relative humidity of room to be mapped before the mapping exercise begins.
- Perform mapping for at least 24 hours or 72 Hours or 7 days at a logging interval of 30 minutes.
- After completion of the 24 hours or 72 Hours or 7 days Mapping of the respective area. Power failure intervention shall also be performed as per below defined procedure:
- Ensure the completion of the 24 hours or 72 Hours or 7 days Mapping of the respective area.
- Remove the data logger and configure the data logger temperature logging interval of 30 minute.
| Data Logging Interval | 30 Minutes minimum | |||
| Mapping Duration | At least 24 Hours / 72 Hours / 7 Days | |||
| Sr. No. | Room Name | Section | Number of Data Loggers | Rational for number of data logger selection |
- Relocate all reconfigured data loggers in the storage areas at same locations as mentioned of this protocol.
- Provide sufficient time (Not Less Than 30 minutes) to the data loggers to be conditioned to the temperature / relative humidity of room to be mapped before the start the mapping exercise for power failure.
- Switch off the AHU system of the respective area for minimum 10 minutes and then re-start AHU and record the Stop / Start time in respective log book.
- After completion of logging cycle and power failure intervention cycle data logging, collect data loggers and download logged data.
- Attach raw data along with the report and compile qualification report and draw suitable conclusion in the report.
- Details for mapping exercise are tabulated below:
- The summary report shall identify hot spots where routine monitoring shall be carried out.
- Outcomes of the study shall be shared with warehouse / production and identified CAPA, if any, shall be implemented.
Identification of Hot Spot for Thermal Mapping in Pharmaceuticals
The purpose of determining hot spot is to identify the locations where the monitoring system sensors should preferentially be located. Hot spot need to be determined seasonally as they may be significantly different in summer and in winter.
For the areas mentioned in scope of this protocol, determination of Cold Spot is not required as there is no lower limit for any of the parameter i.e. Temperature and % Relative Humidity. Hence, only Hot Spot shall be identified and mentioned in Summary Report.
Analyze the overall temperature stability of the study area and identify the variations that occur during the study period.
Compare the measured temperatures against the acceptance criteria. It should be within the pre define acceptance criteria.
Variation of the individual data logger shall be evaluated.
The data shall be evaluated by the reports printed from the data loggers and hot spot shall be identified based on maximum average of high temperature for given location.
If two or more location is having same number of occurrence for same temperature, the hot spot shall be identified on time duration.
Acceptance Criteria
At all-time points, the recorded temperature shall be within defined range for the particular storage room as defined in section 6.0 of this protocol. Data loggers shall be places in locations as specified in tables below.
Excursion observed, if any, shall be reviewed and suitable action shall be take
Data Logger Locations for Thermal Mapping in Pharmaceuticals
| Name of Area | |||
| S. No. | Location Number | Name of Location | Rationale for location selection |
| 1 | Due to frequent door opening .there is a risk of temperature exchange with the external environment which can result in change in temperature. | ||
Verification Method
Tests outlined in this protocol shall be verified by measuring, by counting, by analyzing, by reading the contents on the parts / tags / HMI. Measurements taken if any shall be by using calibrated reference instrument(s) / devices(s).
Raw data collected on additional data sheets, created on and printed from a computer, or data sheets generated by the system, during execution of this protocol, must be inserted into the protocol. Previously collected data may be used to support execution of the protocol, if applicable. Previously gathered data will be considered adequate for use in documenting the verification and tests outlined in this protocol. This data will be considered valid when the methodology used is traceable; the personnel that executed the procedure(s) were qualified and trained. The data included with the documentation for this protocol or a reference is provided to where they can be found and the tested system remains as it was at the time of testing. Data will be considered acceptable when they meet the requirements of this protocol.
Documentation requirement for Thermal Mapping in Pharmaceuticals
Data sheets created on and printed from a computer or data sheets generated by the system, during execution of the protocol, must be attached with the report at relevant place.
- The report format(s), if any, are ‘Attachment(s)’ to the protocol.
- Report formats give the necessary guidance for final report compilation.
- The report with the data may be created as per the report format(s), arranged as per the requirements of the protocol and the system to be qualified and submitted for review and approval.
- All work is documented using permanent ink only.
- Write or print legibly.
- Fill up complete information in the format provided.
- All documentation work shall be completed concurrently during execution of the qualification study. However the protocol does not define the sequence of the test / documentation to be carried out.
- Do not leave any blank space.
- All data entries are dated and signed or initialed, per the individual Attachment instructions, on the date of entry.
- Correct the wrong entry during execution as per SOP titled ‘Good Documentation Practices’. Explanations are provided when the reason for the correction is not obvious.
- Enter ‘NA’ in the space that is not used to record observation(s) during execution in attachment(s) and signed or initialed with date.
- Each test that fails the acceptance criteria will have a deviation completed and approved, along with reason for the corrective actions performed to rectify the situation.
Deviation and Corrective Action
Any deviation observed during qualification shall be recorded as per QMS and investigated. If the observed deviation does not have any impact on qualification, final conclusion shall be drawn. If the observed deviation has impact on the qualification, intimation is to be given to the concerned department for the corrective action and qualification activity shall be initiated again.
Performance qualification report:
Re-qualification of the Storage areas for Temperature and % RH Mapping shall be performed in one or more of the following cases:
- Any major modification in the area or supplying Air Handling Systems.
- Scheduled Re-Qualification as per re-qualification SOP.
Scheduled Re-Qualification shall be performed at a set frequency of Two (2) Years ± 30 days. During re-qualification, seasonal variation shall also be monitored. To monitor seasonal variation, mapping exercise shall be carried out in alternate seasons as mentioned in table below.
For example, if mapping is performed in season I, it shall be performed in season II in the year when mapping is due. This cycle shall be continued.
| Season | Season Description | Conditions | Season From | Season To |
| Season I | Summer | Maximum Temperatures | April | June |
| Season II | Rainy | Optimum Temperatures, Maximum Humidity | July | August |
| Season III | Winter | Minimum Temperatures | December | February |
Abbreviation and Definition
| Abbreviations | Full Form / Definition |
| Storage Room | An area specified for storage of Material (i.e. Raw Material, Lubricated Blends, Compressed & Coated Tablets and Finished Goods etc.) |
| Data Logger | A data logger is an electronic device that records data over time either with a built in instrument or sensor or via external instruments and sensors. |
| Temperature Mapping | Temperature mapping is the process of monitoring and recording the differences and changes in temperature that occur within a single temperature controlled system due to influences like opening doors, proximity to cooling fans, personnel movement, and the quantity of products being stored at any given time. |
| Excursion | An event in which a Product / Area is exposed to temperatures outside the range(s) prescribed for the storage area. |
| Logging Interval | The period of time over which measurement is taken and logged by a data logger. |
| Logging Cycle | The duration of data logging for a particular study / experiment. |
| °C | Degree Centigrade |
| % RH | Percent Relative Humidity |
| HVAC | Heating, ventilation and Air Conditioning |
| NA | Not Applicable |
Summary report and conclusion:
After completion of protocol execution, qualification report shall be prepared. The report shall contain all the tests and respective observations made during the execution. Conclusion shall be drawn based on the review of observed results. Conclusion shall be a clear statement of compliance or noncompliance with the acceptance criteria defined in the protocol. The summary shall also recommend hot spot to monitor environmental conditions in routine.
Approval of Document
Prepared By:
| Designation | Name | Date | Signature |
| Executive Engineering |
Reviewed By:
| Designation | Name | Date | Signature |
| Head Engineering | |||
| Head Production | |||
| Head Warehouse |
Approved By:
| Designation | Name | Date | Signature |
| Head QA |
Frequently Asked Questions (FAQs) for Thermal Mapping in Pharmaceuticals
Q-1 What is thermal mapping?
Answer: Thermal mapping is a qualification study to check how temperature is distributed throughout a controlled area. It helps confirm that the required temperature is maintained consistently at every location.
Q-2 How long does a thermal mapping study usually last?
Answer: Most thermal mapping studies are carried out for 24 to 72 hours under normal operating conditions and for storage area it shall be carried out for at least 7 days. The actual duration is defined in the qualification protocol and may vary depending on regulatory or company requirements.
Q-3 What are hot spots and cold spots?
Answer: Hot spots are the locations where the highest temperatures are recorded, while cold spots are the areas with the lowest temperatures.
Q-4 When should thermal mapping be performed again?
Answer: Thermal mapping should be repeated after major changes, such as
Equipment relocation,
HVAC modifications
Significant maintenance, or whenever the storage conditions could be affected.
Periodic requalification may also be required as per company requirement or many company’s conducted this at for every 5 years.