The US Food & Drug Administration defines extractables as ‘compounds that can be extracted from a container closure system when in the presence of a solvent’ and leachables as ‘compounds that leach into the drug product formulation from the container closure as a result of direct contact with the formulation’. The reason for monitoring and analysing these substances is that they may pose a safety risk to the patient directly, or indirectly, by altering the product’s physico-chemical properties through interactions with the active pharmaceutical ingredient or excipients, thereby adversely affecting product quality.
The safety assessment/qualification of E&L is an important component of the qualification of container closure systems (container selection) and, by correlating extractables to leachables, it is possible to determine extractable limits that can provide safety guidelines on leachables. To comply with safety requirements, it may be necessary to change the nature, composition or manufacturing process of the packaging material or a component of the package or change the formulation of the drug product. Before starting a risk assessment, it is essential to demonstrate that all these factors are under control.
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