FAQ – Temperature Mapping and Monitoring
- What is a temperature mapping service?
The temperature mapping service is the process of installing data loggers that record temperature data for monitoring and analysis, as these items might become harmful or worthless if stored in inclement weather.
- What is temperature mapping?
Temperature mapping is a technique for determining an area’s hot and cold regions so that sensors can be installed for permanent registration. It is an essential procedure for verifying temperature-controlled spaces such as freezers and conditioned storage areas.
- How to perform temperature mapping?
Temperature mapping is used to establish whether a storage space can keep its temperature within certain parameters. Sensors are positioned around the unit/room at predefined areas to ensure that it performs within predefined set points.
- How to do temperature mapping?
Once the overall storage area for temperature mapping has been determined, the number of calibrated devices, such as data loggers, can be determined. In a grid configuration, data loggers should be scattered evenly across the area to be mapped. They are utilized to monitor the area’s corners and should also be positioned in any high-risk areas for heat loss or variation.It is common to utilize two layers of loggers, one near each corner and another in the center. This, however, changes according to the extent of the temperature mapping area. Mapping is only required in areas where merchandise is stored, such as racks, shelves, and other storage facilities.
- What is temperature mapping in the pharmaceutical industry?
The pharmaceutical industry mapping method describes the temperature variances and changes that occur inside a single temperature-controlled system. This is due to factors such as open doors, closeness to cooling fans, personnel movement, and the number of products stored at any particular time.
- What are the ispe guidelines for temperature mapping?
Guidance is offered on the requirements specification (creation of a user requirements document), design, purchase, commissioning (including temperature mapping), qualification, and maintenance of controlled temperature chambers working under cGMPs.
- What are the usp guidelines for temperature mapping?
Temperature mapping should use a sufficient number of thermometers or other temperature recording sensors, according to USP. However, the International Society for Pharmaceutical Engineering (ISPE) recommends using 9 sensors for areas less than 2 m3 in volume.
- What is the purpose of temperature mapping in the pharmaceutical industry?
Temperature mapping is critical in the pharmaceutical sector for assessing the efficacy of temperature-controlled storage systems such as cool rooms, fridges, and warehouses. It is critical for companies that deal with temperature-sensitive items.
- How often should temperature mapping be performed?
Depending on the routine monitoring plan, additional mapping activities may be necessary on a regular basis — for example, every three years – to demonstrate ongoing compliance.
- Why is temperature mapping required?
The temperature mapping service is required to discover hot spots, understand how environmental changes affect internal temperature, and better manage your product’s storage.
- What is the WHO temperature mapping frequency?
Mapping research has no defined time limit. Typically, it should be run for at least seven consecutive days in warehouses and other ambient storage spaces, including five working days and two weekends. For temperature-controlled equipment that is not adversely influenced by diurnal or seasonal changes in ambient temperature (e.g., freezer rooms and cold rooms), the mapping research should be done for 24 to 72 hours, or longer if necessary.
- What is the WHO temperature mapping protocol?
The mapping protocol should contain the following sections:
- Approval page and change control history.
- Acronyms and glossary
- Description and rationale
- Mapping report template.
- Annexes as needed, including templates for the mapping report