How to Include Elastomers in the Nitrosamine Risk Assessment
Putting together a risk assessment for nitrosamines in your final drug product is an extensive undertaking. Many contributing factors need to be considered, such as the drug substance’s manufacturing process, excipients, buffers, water, production equipment and environment, transportation conditions, packaging, and more. Within this scope, primary packaging components, such as elastomeric closures, also could contribute nitrosamines or precursors.
As the generation of nitrosamines depends on several different factors that are tightly bound to migration science, it is crucial to understand the scientific basis. Time and temperature play a role, but also material characteristics and chemical aspects. Not all elastomer components are the same. Given the variety of different formulations and their chemical complexities, and the progress in material development over the past decades, every elastomeric formulation can behave differently.
To address some of these aspects, we invite you to join our webinar given on August 27th 2020 discussing the involvement of elastomers in nitrosamine risk assessment. Please click here to register.