Improving Quality and Efficacy for Biopharmaceuticals

In-Transit Temperature Monitoring Solutions for the Cold Chain

The continuing growth of pharmaceutical and biological materials that require special handling, including cold chain storage, is expected to grow from an estimated level of US$6.1B in 2011 to US$9.58B by 2016. In addition, by 2016 it is anticipated 8 of the top 10 best-selling global drug products will require 2 to 8 degree C cold chain storage and handling. Monitoring the temperature of biopharmaceuticals from the manufacturer to the health care provider is critical to ensure product efficacy and patient safety, however traditional monitoring methods:

• Do not provide the ability to cost effectively monitor the temperature data in-transit at every stage of the shipping process without opening the shipment and unpacking the contents to access the data on the temperature monitor.
• May not provide an easy to access or comprehensive data record of the product’s temperature history (inside the container) to the recipient.

This white paper describes how new solutions utilizing wireless temperature monitoring technology address these issues and provide the ability to access the temperature data from a tag inside the package in-transit without opening up the packaging. As a result, a consistent record of temperature data can be easily accessed at every step of the cold chain, enabling the health care provider to know with confidence that the product has been properly shipped and will be effective and safe for the patient.