Extractables and Leachables in Medical Devices

Official regulatory bodies require medical device manufacturers to demonstrate that toxic or harmful materials are not present in these devices, in order to prevent migration of such materials from the product to the patient during use. Conducting tests for extractables and leachables is crucial to identifying any extractable toxins that are present, and so helps to ensure product quality and protect consumer safety. When leachables are detected, quantification is necessary to ensure threshold levels are managed and eliminated. This is often achieved through material replacement within regulatory limits.

We provide comprehensive testing for extractables and leachables in medical devices in accordance with ISO 10993-18.

Our testing services

We provide a broad set of tests for chemical characterization of materials, per ISO 10993-18 guidance. Our tests account for the variable environments to which medical devices are subject and could influence the potential for any material to be extractable and potentially cause patient harm. These include placement on or in the body and anticipated duration of use.

For prolonged and long-term contacting devices, we use rigorous regimes – simulated use extraction and exaggerated, or exhaustive extraction – to access substances that are more tightly bound in the device material component matrix.

After we obtain information via chemical characterization, a toxicologist analyzes the data to assess biocompatibility.

Combination products

We also test combination products, which combine medical devices, drugs and biological products. These include products such as sterile injectables marketed in prefilled syringes or in combination with auto injector systems. Medical devices and drug products must meet different standards, and we ensure compliance with all applicable requirements.

What SGS offers

We provide:

Tailored study design for extractables and leachables or chemical characterization, according to medical device standard ISO 10993-18:2020 and pharmaceutical standards (USP<1663>/<1664>, USP <665>/<1665>, PQRI, BPOG, etc.)
Determination of the analytical evaluation threshold (AET), per the corresponding guidelines and most current regulatory expectations
Method development and validation of potential leachables
Identification and structure elucidation of unknowns via our in-house databases, as well as commercially available libraries from NIST, Compound Discoveries, etc.
A variety of studies, including leachables shelf life studies for finished products and simulated use studies for medical devices and combination products
Reporting and evaluation of analytical results according to current guidelines
Toxicological risk assessments

Topographical methods

We use topographical methods and other methods for physical-chemical material characterization and assessment of surface contamination and risk of delamination or surface fracture after stressing. These include:

Thermoanalysis TGA, DSC
X-ray fluorescence analysis (XRF)
Materialography and light microscopy
Electron microscopy (REM, SEM)
Atomic force microscopy (AFM)
X-ray diffraction (XRD, XRT)
Electron probe microanalysis (ESMA)
Photoelectron spectrometry (XPS)
Auger electron spectroscopy (AES)
Spreading resistance profiling (SRP)
Secondary ion mass spectrometry (SIMS-TOF)

Comprehensive extractables and leachables testing for medical devices

With a global network and over 15 years experience in extractables and leachables testing, we have the resources and expertise to ensure that your medical devices are compliant. We provide a complete service for testing extractables in container closure systems, medical devices, single use systems, and leachables in final products. Leachables tests on final products are conducted in cGMP and ISO/IEC 17025 compliant laboratories using technologies that detect ultra trace levels.

To learn more about how we can help with extractables and leachables testing for your medical devices, contact us today.