Label Migration Studies

Label Migration Studies

Chemical safety assessment is an important component of the manufacturing and distribution of drugs. Extractables and leachable testing are important to ensure the safety of the drug product. In the early days of E&L, there was a common misconception that if a container-closure system component did not directly contact the drug product, then extractable from the component would not become drug product leachables. However, this is not always the case, as many of the most commonly used plastic-based primary packaging systems have limited barrier properties.

It is important to recognize printing and labels as leachable sources, as they are often overlooked in the past. Global regulatory organizations are now becoming increasingly aware of the potential risks posed by leachables from printing and labeling, and have increased the requirements for drug product safety assessments.

The composition of the printing ink and label ingredients, as well as the basic packaging barrier properties, are important considerations. Plasticized PVC packaging is particularly susceptible to extractable migration, due to its high plasticizer content. Additionally, contact conditions can also play a role in the migration of extractable. For example, label-package and label-air interfaces can cause extractable to migrate away from the drug product.

It is important to properly assess the potential risks posed by leachables from printing and labeling in order to ensure the safety of the drug product. Understanding the urban myths of chemical safety assessment and evaluating extractable and leachable testing is paramount to the success of the drug product.

Video 01: Extractables and Leachables