Reducing Nitrosamine Risks in Parenteral Packaging

Packaging components can contaminate drug products through extractables and leachables (E&L), including harmful nitrosamines. These can form from reactions between residual amines and nitrosating agents found in packaging or drug formulations. While nitrocellulose and rubber are key concerns, modern rubber formulations for injectable packaging have significantly reduced these risks.

Dr. Tine Hardeman from Datwyler explains that thanks to advancements in rubber chemistry—such as cleaner crosslinking systems and coatings—most pharmaceutical rubbers today are classified as “ultra-low” in E&L. Early materials like natural rubber and polyisoprene had limitations, prompting a shift to butyl and then halobutyl rubber, which offered improved barrier properties and eliminated harmful accelerators.

The latest innovation is BIMS (brominated polymers), which provide even cleaner profiles, no rubber oligomers, and improved ageing resistance. Coatings further reduce E&L migration, making them ideal for sensitive large-molecule drugs.

Datwyler’s FM457 formulation, based on BIMS, with optional fluoropolymer coatings, offers best-in-class performance for minimizing nitrosamine risks in parenteral packaging.