Pharma industry specifies to carry out temperature mapping study for all vans used for distribution of medicines vaccines etc. It is a mandatory requirement to store all such medicines under controlled temperatures such as 2 to 8 ° Centigrade or 15 to 25 ° Centigrade. If the temperature goes beyond these limits, the medicine loses its therapeutic values. Hence the pharma distributor has to always keep these medicines under the specified temperature.
These medicines are transported in temperature controlled vans. The final stage of the distribution to pharmacies is a very vulnerable phase. In order to prove that these vans always maintain the desired temperature, a temperature mapping study is mandatory.
Guidelines for mapping study of Vans
We are providing hereunder brief guidelines on carrying out a detailed temperature mapping study of vans.
The following are the required tests as part of the complete study:
- Startup test to decide how long it will take to reach the desired temperature once the van is switched on. As an example, we may find out that it requires 40 minutes to stabilize between 2 to 8 ° Centigrade after switching on the vehicle. If so, the client has to write a SOP for their regular operation to indicate the same.
- Testing under an empty condition to prove that the entire area has a uniform temperature for a specified duration.
- Testing under a partially loaded condition (eg. 60%). This is to analyze whether all areas inside the van maintain the temperature within limits during the entire tests.
- Testing under fully loaded condition. This is to prove that the van maintains the correct perform even when the van has a full load.
Guidelines for duration of the mapping study of Vans
We generally recommend the following timelines for the different tests:
- For all loaded tests, we recommend a duration of 12 to 24 hours.
- For startup test, a maximum period of 2 hours will be fine.
- For power failure test, it will require almost 2 hours.
- Door opening tests are required at different durations such as 1 minute, 3 minute, 5 minute etc.
For deciding the type of tests and the duration of tests, we conduct details of applications from the client. All these details will be different based on the usage pattern of each client, country etc.After collecting all the relevant details, a protocol for temperature mapping study of the vans will be written.
Contents of temperature mapping study report
- All the individual readings from all the data loggers.
- Detailed chart analysis of all test data.
- MKT values of each test. This is only for understanding, and not for evaluation of the results.
- Recommendations to include in the Standard operating procedure (SOP) of the client for the vans.
- Hot and cold points for fixing the temperature sensors.
Preparation for mapping study of Vans
The performance of cooling units of vans is always a challenge. We strongly recommend to our clients for proper servicing of the vehicle and the cooling units before carrying out the tests. Also, it is beneficial to have a thorough check of the controller of the cooling unit. Such preparatory checks will reduce chances of failure of the vehicle.
Please see our web page for detailed guidelines on temperature mapping study of various assets for pharmaceutical industry.