Temperature mapping, also called temperature study or mapping for short, is a study that looks at whether a room, object or means of transportation is suitable for storing and transporting temperature-sensitive products, such as pharmaceuticals and vaccines. In the pharmaceutical industry, it is essential to know whether storage areas and means of transportation can maintain the required temperature standards. A temperature mapping provides insight into temperature trends, hot and cold spots identifies critical control points.
What is temperature mapping?
Gain insight into the temperature history of the space, objects or transport equipment you intend to use to store and transport medicines
The importance of temperature mapping
Performing a temperature mapping is critical to determining whether storage and transportation facilities meet the requirements for temperature-sensitive products. By performing a mapping, you will gain insight into temperature history and determine if the facility is suitable for storing and transporting pharmaceuticals and vaccines.
The steps in the mapping process
A temperature mapping typically consists of four phases:
- Inspection of the space, object or means of transportation:
During the inspection, we review the space, object or means of transportation with the customer. During this process, the acceptance criteria, the guidelines the client must meet, and the client’s specific requirements and wishes are immediately established. This information forms the basis for creating the mapping protocol.
- Drafting the mapping protocol:
The mapping protocol describes the steps and criteria to be followed during the mapping process. It defines the acceptance criteria and methodology so that the entire process is structured and consistent.
- Data collection (implementation):
Mapping loggers are placed according to an established grid to collect temperature data over a period of time.
- Processing data and test results:
The data collected is analyzed and compiled into a report with findings and recommendations. This report includes information on temperature trends, critical control points, and any hot and cold spots.
The mapping protocol
The execution of a temperature mapping is done according to an established protocol, the mapping protocol. This document serves as a guide for the execution and reporting structure and is coordinated and approved in advance by those responsible. The protocol describes acceptance criteria, methodologies used and any additional tests.
Case study
Suppose you want to use a cold room to store drugs that need to be stored between 2°C and 8°C. To determine if this cold room is suitable, you perform a temperature mapping. According to the protocol, mapping loggers are placed at established positions within the cold room. Over a period of usually 72 hours, temperature data is collected and additional tests are performed, such as simulating a refrigeration motor failure or leaving a door open.
Results and follow-up actions
After the testing period, the mapping loggers are removed and the data read out. The results are summarized in a mapping report, which states whether the cold room is suitable, the results of the tests, where the critical control points and hot & cold spots are located, and other points of interest regarding the temperature progression. Based on these outcomes, digital loggers for permanent temperature monitoring can then be placed in the appropriate positions so that the room is ready for use.
By performing temperature mappings according to a structured protocol, you can ensure the adequacy of your storage areas and transportation equipment and ensure safe storage and transportation of temperature-sensitive products such as pharmaceuticals and vaccines.
