A rationalized, risk-based approach to elastomer selection and qualification is critical for OINDP quality and safety. This is the first of a two-part series of articles on elastomers to be published by Inhalation.
Elastomers have been used in OINDPs for more than 50 years. Constituting an integral part of OINDP container closure systems (CCSs) and/or delivery devices (DDs), they are important to the safety and performance of drug products. The quality of elastomeric components and their construction is essential for ensuring that a CCS/DD functions according to its intended use in the drug product and is not detrimental to a particular product’s quality, safety or efficacy.