Impact of Elastomer Extractables in Pharmaceutical/Biomedical Applications - Material Supplier Perspectives

Halobutyl rubber is widely used in pharmaceutical stoppers and seals. The increasingly stringent requirements in pharmaceutical applications have led to a demand for an ever higher cleanliness elastomer with a minimum amount of additives and extractables. In this presentation we report on the level and type of residues and additives in bromobutyl, chlorobutyl, and brominated isobutylene para-methyl styrene terpolymer (BIMSM) destined for pharmaceutical stopper and seal applications. BIMSM is a super-clean elastomer that contains a minimum amount of additive and residue in comparison to halobutyl. Stoppers made using BIMSM elastomer have been demonstrated to provide drug turbidity performance comparable to that of tetrafluoroethene-coated stoppers. The likely mechanism of drug turbidity and how additives or contaminants can lead to drug turbidity formation will be discussed. The importance of elastomer cleanliness is also demonstrated via solvent extraction studies on stoppers made using different type of elastomers. We will compare the extractable level in the various stoppers, including coated ones, tested / studied. As a halobutyl and BIMSM elastomer supplier, ExxonMobil Chemical strives to meet the health care market's rigorous standards and regulations for product cleanliness and additive restriction. During the last few years, changes in our products and manufacturing practices / equipment have been made to meet the increasing product cleanliness and quality performance requirements of our customers. The presentation will include information and example on how we manage product changes to meet the requirements of customers and the highly-regulated pharmaceutical market.