Screening and Quantitation of Extractables

Extractables are defined as those chemicals that can be removed from a material with a challenge solvent or other extreme conditions. Leachables are compounds that move from a package or delivery system to the product under normal conditions.

O-rings are used in a wide range of products and can be made from a wide variety of materials depending on their application. They can be used in packaging to seal a container and are also found in medical devices such as syringes, pumps, and other critical components. As such, they are a potential source of extractables/leachables.

Extractable and leachable (E&L) studies are routinely conducted for products such as medical devices, pharmaceuticals, and packaging for these types of products. These studies aim to ensure that the product does not emit anything harmful to the consumer. Harmful compounds can be from the product itself, residuals from manufacturing, or the packaging used for the product.

This document discusses a study using direct thermal extraction to determine extractables from o-rings. Stir bar sorptive extraction (SBSE) and thermal desorption can be used to quantify compounds of interest in various extraction solutions.

This study will utilize the GERSTEL MPS sampler, TD 3.5+ thermal desorber, and CIS 4 inlet for screening and quantifying extractables from rubber o-rings.