Pharmacy Courses

Temperature Mapping for the Transportation of Pharmaceutical Finished Products


Temperature Mapping, also known as thermal mapping, is an activity performed on temperature-controlled units that record or map out the temperature within the space over a specified period of time.

Temperature mapping in facilities and equipment

The following factors, which may contribute to temperature variability in a facility, should be considered during the process of temperature mapping for storage locations: 

1) Size of the space; 

2) Location of HVAC equipment, space heaters, and air conditioners; 

3) Sun-facing walls; 

4) Low ceilings or roofs; 

5) Geographic location of the area being mapped; 

6) Airflow inside the storage location; 

7) Temperature variability outside the storage location; 

8) Workflow variation and movement of equipment (weekday vs. weekend); 

9) Loading or storage patterns of product; 

10) Equipment capabilities (e.g., defrost mode, cycle mode); and 

11) SOPs. 

The duration of temperature recordings during the thermal mapping of a warehouse or cold room should capture workflow variation that may impact airflow and the resulting temperature fluctuation; for example, this process could last from 1 day to 1 week, depending on the workflow cycle.

Temperature mapping for shipping packaging and vehicles

Pharmaceutical manufacturers should consider primary, secondary, and tertiary packaging that best protects the drug product during storage and distribution. Shipping package performance testing should be documented as part of a QMS. Several standard test procedures are available to evaluate package performance for factors such as shock, vibration, pressure, compression, and other transit events. (See Additional Sources of Information for standards for test methods.)

Packaging at the tertiary level (e.g., outer, external, or shipping package) or thereafter for the distribution of the drug product should be selected and tested to ensure that product quality is maintained and to protect the contents from the rigors of distribution, including environmental or physical damage. Active, passive, or semi-active shippers and transport systems are typically subjected to operation performance qualification by the manufacturers or suppliers of such equipment.

Thermal packaging and vehicles used for transporting the drug product for pharmaceutical manufacturers, wholesalers, and pharmacies should be evaluated based on the labeled storage or transport conditions of the product as well as anticipated environmental conditions. Special consideration should be made for seasonal temperature differences, transportation between hemispheres, and the routes and modes of transport.

Temperature monitors/indicators may include calibrated monitoring or recording devices, real-time monitors such as GPS, and chemical indicators of temperature. Monitoring devices may include an alert mechanism if the preset ranges are breached.

Read also:

Reference: USP

Previous Post Next Post