The regulatory requirements concerning the control of Extractables and Leachables (E&L) have become much more onerous in recent years. This course sets out the regulatory and scientific considerations in a logical, stepwise manner and offers practical advice for compliance. The course answers questions such as: “When is an extractable/ leachable study necessary?”, “How do I choose appropriate extraction conditions?” and “How low do I need to go in terms of concentration/amount?”.
Regulators will expect a risk-based approach to compliance, and the steps involved in an E&L risk assessment are described. To facilitate a risk-based approach, typical extractables from various types of plastics will be described, and risk factors for glass erosion will be discussed. In addition, common errors in the design or application of Extractables and Leachables studies will be explained, together with insights into common analytical techniques and analytical errors.
The course includes workshops and interactive discussions.
An exclusive discount of 20% is available for RSC members valid until 25/02/2022
Regulators will expect a risk-based approach to compliance, and the steps involved in an E&L risk assessment are described. To facilitate a risk-based approach, typical extractables from various types of plastics will be described, and risk factors for glass erosion will be discussed. In addition, common errors in the design or application of Extractables and Leachables studies will be explained, together with insights into common analytical techniques and analytical errors.
The course includes workshops and interactive discussions.
An exclusive discount of 20% is available for RSC members valid until 25/02/2022
