Evaluating the impact of distribution, or transport, on finished goods is not a new concept, nor is the process of determining suitable packaging to protect a finished good through its travels from manufacturer to end-user. Almost everybody can relate to receiving a package, only to open it and find the contents damaged. This comes at the cost of time and money for both the manufacturer and consumer.

Perhaps surprisingly, however, evaluating the effects of impacts, compression, vibration, temperature, and high altitude on pharmaceutical and medical device products is something that has only become an expectation from regulatory bodies in recent decades. In addition to straightforward physical damage, these types of products can have unique risks to formulation, product stability, and safety introduced from the distribution process.

In this presentation, CS Analytical will review the general need for distribution testing, unique risks to life science products, current regulatory guidelines and expectations, and industry best practices. International standards by which life science product distribution can be simulated in a laboratory setting will be reviewed (ASTM and ISTA), along with new and pending trends in the unique space of product-package testing using real-world examples.