Extractables and Leachables

To protect consumer safety, ensure quality and meet the requirements of official bodies, manufacturers of pharmaceuticals and biopharmaceuticals must ensure that toxic substances cannot migrate into their products from packaging or from items used in production, such as filters, tubes and connectors. Therefore, assessment of extractables and leachables is an important step in drug development and materials qualification.

We provide comprehensive testing for extractables in container closure systems and single-use systems and for leachables in final products and combination products.

Our extraction studies are performed under controlled laboratory conditions and use a combination of multiple relevant extraction solvents and appropriate sample preparation techniques, extraction temperatures and extraction durations. Our leachable studies use sensitive, selective, fit for purpose and fully validated analytical methods for assessment during product development and ongoing testing of marketed products.

We also offer extractables and leachables testing for combination products, such as injectables that come in prefilled syringes or are combined with auto injector systems. These products combine medical devices with pharmaceutical or biopharmaceutical products and are subject to standards and guidelines for medical devices as well as drug products.

What SGS offers

Our services include:

• Tailored study design for extractables and leachables or chemical characterization, according to pharmaceutical standards (USP<1663>/<1664>, USP <665>/<1665>, PQRI, BPOG, etc.), and medical device standards (ISO 10993-18:2020) for combination products
• 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 simulated use studies and leachables shelf life studies
• Reporting and evaluation of analytical results according to current guidelines

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, including:

• 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 from an experienced provider

We have 15 years of experience in extractables and leachables testing, with experts operating in cGMP and ISO/IEC 17025 compliant state-of-the-art laboratories around the globe. Our technologies are capable of detecting ultra trace levels.

To learn more about how we can help with extractables and leachables testing for your bio/pharmaceutical products, contact us today.