Assessing the Potential Toxicity of Extractables and Leachables From Plastic and Rubber Components Into Drug Products

Assessing the Potential Toxicity of Extractables and Leachables from Plastic and Rubber Components into Drug Products

Allan W. Ader, Ph.D., DABT, Vice President and Principal Toxicologist, SafeBridge Consultants, Inc., Mountain View, CA

The objective of the FDA and other regulatory bodies and the drug, device, or supplier manufacturer is to ensure that those materials identified in extractables and leachables studies (i.e., materials that may get into a product) do not alter the quality of the product or cause toxicity themselves which could result in product recall, consumer or patient illness and/or cause significant business interruption.   A scientific approach is needed which entails use of raw materials that will not be toxic if they end up as leachables into drug product and if they do get into the drug product, a risk assessment of the extractables and leachables is needed that will provide scientific support to the safety of the product.  This presentation will provide approaches on choosing the appropriate raw materials (or what not to choose), assessing analytical data on extractables and leachables, what toxicity data needs to be assessed, and how to conduct an appropriate and scientifically-defensible toxicological risk assessment for extractables and leachables into drug products for health care products.