Shipping Specifications Are NOT Stability Data

     

Pharmaceutical shippers are too cautious. That’s the verdict from regulatory experts and pharmaceutical logistics providers.

The specific problem is the disconnect between stability data and shipping specifications. Company researchers typically have detailed information regarding the stability of products and advanced compounds, but that information may not be transmitted to the logistics department. Instead, logistics personnel are told to ship products within an ideal, temperature range – frequently 2°C to 8°C. That range becomes the shipping specification.

Researchers, however, are beginning to report that products often are stable at a wider range of temperatures than shipping data indicates. Biologicals and vaccines are good examples. Known for their temperature sensitivity, they can become ineffective or even dangerous when stored improperly, so shippers are naturally cautious. To protect such delicate, high value products, the logistics department may try to add some margin for error by specifying a narrower temperature range.

Industry buzz, however, indicates that many products specifying 2° to 8°C are stable for several hours at room temperature. That’s good news for the biopharmaceutical industry. But, if that’s the only temperature specification included with the shipping documents, a temperature excursion could jeopardize the entire shipment. Without the product’s actual stability data, health authorities rely upon the shipping specifications. That small oversight causes millions of still-viable drugs to be destroyed each year. To ensure your temperature-sensitive shipments, include stability data with the shipping specifications, and use a reliable monitoring system to identify temperature excursion as they happen.