1. YOUR TRANSPORT ROUTE IS BEING SCRUTINIZED
The World Health Organization (WHO) recently published guidelines for the storage and transport of time and temperature sensitive pharmaceutical products, and on the transport side, this was something that caught our eye. Qualifying the route your plane, truck, or ship takes is more than just saying,
“This is the most direct route.”
The WHO includes the following qualification parameters: weather data, laboratory tests, equipment tests, and field tests. Maybe most importantly, is the equipment qualification for the transport. If traveling through an especially extreme environment, auditors and regulatory bodies will want to know that your truck, and its cooling system were validated and qualified to hold up in such an environment.
2. THERE IS A TEMPERATURE TASK FORCE
The International Air Transport Association (IATA) is the global trade association for air transportation of goods, and represents over 200 countries. That organization is concerned with the quality of medical and pharmaceutical goods up in the air. So much so, they went ahead and created a task force to deal with temperature sensitive products.
That work group, the Time and Temperature Task Force (TTTF) will now begin creating guidelines for the pharmaceutical industry, and act as a liaison between the IATA and pharmaceutical manufacturers and distributors.
3. 10-MINUTE SAMPLE INTERVALS FOR TRUCKS
The WHO wants you taking and logging the temperature of your road vehicles at a specific interval, or at least no less than six times per hour per sensor position. That’s important, because many, many data loggers have a standard logging time of every 15 minutes. If you have data loggers in your truck, and are transporting pharmaceutical drugs, you need to have many of them, and they need to be taking the temperature of the inside of your truck at least every 10 minutes.
Tags: Healthcare, pharma