Extractables and Leachables Services

To help clients effectively evaluate and mitigate potential product exposure risks, Exponent offers a range of extractables and leachables (E&L) testing services for a variety of product use scenarios and regulatory considerations. Our approach integrates analytical, toxicological, and regulatory expertise with standardized and custom methods to perform comprehensive materials characterization and assess potential health risks from medical devices, drug delivery systems, food and pharmaceutical packaging, and a variety of other consumer products.

In the context of medical devices, the International Organization for Standardization (ISO) defines leachables as “substances that can be released from a medical device or material during clinical use.” They are often considered part of normal use, while extractables are those substances that “can be released from a medical device or material using extraction solvents and/or extraction conditions that are expected to be at least as aggressive as the conditions of clinical use.” Therefore, extractables can represent exaggerated or worst-case scenarios for use. E&L analysis differs from chemical composition testing in that it measures potential user exposure to chemicals and not merely the content of a material, thus eliminating the need for overly conservative assumptions in assessing product risk. 
Exponent consultants work with clients to determine the appropriate testing strategies with tailored approaches. Our consultants are familiar with the relevant regulatory guidance documents and standards (e.g., ISO 10993 Parts 12 and 18, EN 1811 for medical devices) to ensure that your E&L study conforms with the most up-to-date recommendations for testing, depending on the product.

Exponent performs product extractions and prepares leachates in our ISO and ANSI/ASQ accredited laboratory.[1] We leverage the appropriate analytical methods including gas chromatography-mass spectrometry (GC-MS), liquid chromatography-mass spectrometry (LC-MS), and inductively coupled plasma-mass spectrometry (ICP-MS) to capture high-quality data for a broad range of chemicals. Testing can be conducted in accordance with CFR 21 Part 58, U.S. Food and Drug Administration (FDA) Good Laboratory Practices (GLP), as required.

Toxicological Risk Assessments

Exponent toxicologists and risk assessors evaluate extractable and leachable substances and assess potential health risks by estimating user or patient exposures, identifying or deriving health-based exposure limits, and calculating margins of safety to determine whether there are potential human health risks associated with exposure. Exponent toxicologists regularly prepare toxicological risk assessment reports based on E&L data, oftentimes as part of a regulatory submission application to FDA or the European Union (2017/745 Medical Device Regulation [MDR]) for medical devices or in matters related to Proposition 65 for consumer products.

Medical Devices

Exponent has expertise in testing medical devices for chemical characterization according to ISO 10993 standards. Our team of chemists, polymer scientists, and toxicologists collaborates to perform E&L studies (per ISO 10993-18) and provide comprehensive toxicological risk assessments (per ISO 10993-17) as part of a biocompatibility evaluation plan for regulatory submission.

Exponent toxicologists also provide expertise in reviewing E&L testing protocols prepared by third-party laboratories to ensure proper standards and methods are proposed and that an Analytical Evaluation Threshold (AET) has been considered before initiating the study. Additionally, Exponent can assess the resulting data from a third-party laboratory and prepare toxicological risk assessment reports on behalf of the client.

Consumer Products and Product Stewardship

Consumer product E&L testing is an important evaluation tool in any comprehensive product stewardship program. Understanding chemical exposures from consumer products is necessary for regulatory compliance (e.g., Proposition 65) and assessing risk throughout the product’s life cycle. Pre-market E&L testing can be used to identify potential health hazards from typical handling or potential misuse of the product or product components. This feedback can then be used to inform changes in product design or material composition, to support changes based on differences in availability or identified supply chain risks, or to assess supplier practices. Once a product has been introduced, implementing a post-market auditing plan for periodic E&L testing of units ensures that internal quality standards are being met and can enable real-time responses to new or evolving information, such as unforeseen human health risks.

Wearable Electronic Devices

Wearable electronics are intended to function on the body for extended periods during a variety of activities, such as exercising, swimming, or sleeping. These conditions may lead to irritating or sensitizing chemicals being transferred to the skin and increase the likelihood of hazardous dermal effects. Although wearable electronic products are not specifically regulated and industry standards are not fully mature, practices from other industries can be applied to support product development and risk management. Exponent has extensive experience evaluating consumer wearable electronics using a variety of E&L test methods and providing quantitative dermal risk estimates for users of the devices.

[1] Exponent holds a national/international accreditation, ISO 17025, from the ANSI/ASQ National Accreditation Board/ACLASS, and ISO 9001:2015 from BSI/ANAB/ANSI.