Extractables and Leachables Testing

Extractables & Leachables testing includes the detection, identification, toxicological evaluation, and monitoring of potentially harmful chemicals that can leach from drug products or medical devices into the patient. The source of these chemicals can be materials used in the construction of primary and secondary packaging, manufacturing equipment, or medical devices. Regulatory agencies such as the FDA and Health Canada require that leachables be evaluated in the drug product or medical device during stability to ensure patient safety. Boston Analytical’s staff has experience evaluating Extractables & Leachables in pharmaceutical packaging, medical devices, drug-delivery/combination products, processing equipment, Single Use Systems, e-cigarettes, and consumer product packaging.

Extractables and Leachables Testing at Boston Analytical

Regulatory Compliance and Expertise

Boston Analytical follows appropriate regulatory guidance and industry best practices including: PQRI best practices, BPOG Protocol, ISO 10993, and USP <661.1>, <661.2>, <1663>, <1664>, <1664.1>. All studies are documented to full cGMP standards, and methods are validated per ICH guidelines. We have experience with all types and forms of products and packaging including: metered dose inhalers, blister packs, pre-filled syringes, drug delivery patches, drug delivery pumps, bottles, caps, single use systems, stents, and process components (filters, bags, tubing).

Product-Safety Based Approach

Boston Analytical’s approach is to provide support that assures patient safety and prompt product approval. Our process includes an initial risk assessment of all primary and secondary contact materials with the drug product. Vendor information is collected and a test plan is devised that addresses risks and ensures testing is not duplicated. This plan can be included with regulatory filings to document the proactive, risk-based approach.

Industry Recognized Experts

The Extractables & Leachables team at Boston Analytical has over 15 years of experience performing plastic and packaging characterization for Extractables & Leachables. Members of our team are active in industry E&L groups including PQRI and USP, and have worked directly with the FDA to ensure compliance. We have experience with drug products and medical devices of all types, as well as packaging systems employing materials of all forms.

Comprehensive Process

We tailor a test protocol that is specific to the drug product, container closure component materials, regulatory needs, and product application. This can include:

  • Controlled Extraction Study
  • Extract Analysis
    • Headspace GC-MS analysis for Volatile Organic Compounds (VOC’s)
    • Liquid injection GC-MS for Semi-Volatile Compounds (SVOC’s)
    • LC-MS analysis for Non-Volatile Compounds (NVOC’s)
    • ICP-MS for Inorganic Compounds and Metals
  • Toxicological Evaluation of Extractables results
  • Leachables Methods Development and Validation
  • Full Validation according to ICH guidelines
  • Product Leachables Screening

Why Use Boston Analytical for your Extractable & Leachable Testing Needs?

At Boston Analytical, we take pride in providing quality testing services, a client-focused service model, and timely results. We offer flexible turn-around times to accommodate our clients’ critical needs and tight schedules. We utilize electronic quality systems such as LabWare Inc.'s™ LIMS/ELN software which allows us to electronically track your samples and document our findings. BASIS, our secure online client data portal, allows instant access to the results from your project and can provide Certificates of Analysis on-demand.