Tailored extractables and leachables solutions based on solid scientific rationale

Studying the impact of extractable and leachable substances on safety and drug product interaction is of utmost importance to protect the patient and comply with regulations.

Leachable materials may originate from pharmaceutical container closure systems, process equipment, and medical device packaging, and migrate to contaminate products. Extractables and leachables (E/L) studies identify and quantify these substances, ensuring the quality and effectiveness of the drug product. A full-service extractables and leachables testing program also helps you to fulfil the regulatory requirements of your pharmaceuticals and medical devices.

Learn more about our services:
  • Effective pharmaceutical regulation protects public health by ensuring that medicines are of the required quality, safety, and efficacy.

    Regulatory changes
  • The guidelines for pharmaceutical packaging, manufacturing equipment and medical devices are continually progressing. Knowledge of the composition of these components is essential to determine their leachable risk.

    Training services
  • When performing extractables and leachables (E/L) testing it is important that reports are clear, concise, accurate and fully interpretative to demonstrate to the regulatory agencies that a proper risk-based approach was applied.

    Testing reports
  • Designing effective and efficient extractables and leachables studies assists in meeting the risk-based approach and industry regulations.

    Streamlined testing options
  • Available for download, case studies in Leachables from Dry Powder Inhalers (DPI) and Leachables may impact drug efficacy and potency.

    Case studies

Our extractables and leachables services include:

  • Material selection for pharmaceutical container closure systems (CCS) and medical devices
  • Customized E/L study designs developed according to the latest industry best practices
  • Complete method development and validation programs
  • Toxicological safety assessments
  • Development of E/L materials risk assessments and strategy documents suitable for regulatory submission
  • Comprehensive materials characterization and leachables risk evaluation according to ISO-10993 parts 18, 12, and 17
  • On-site training and consulting programs.

We perform extractables and leachables testing on:

  • Container closure systems (CCS), including combination products
  • Single-use manufacturing equipment, including BPOG protocol
  • Implantable medical devices
  • Drug delivery and infusion systems

Exova’s laboratory complies with Good Manufacturing Practice (cGMP) guidelines. Our scientists have been active participants in the working groups that have developed the current extractable and leachable best practices such as PQRI, USP Expert Panels, ELSIE, and BPOG.

Our experience, advanced equipment, and in-depth knowledge of materials and the regulations result in the efficient and successful completion of E/L testing programs for pharmaceutical packaging and manufacturing equipment as well as medical devices.

Meet our experts
  • Mike Shelton

    Mike Shelton - Technical Director

    Specialism - Analytical development and validation of trace impurity quantitation and novel entity assay methods, in particular using hyphenated mass spectroscopy techniques.

    Qualifications - BSc Chemistry, 1982, University of California, Irvine (ACS qualified program)

    Experience

    Extensive experience in developing and validating analytical methods in support of the characterization of pharmaceutical, biological, and consumer product materials, including developing analytical approaches for degradation products, extractables, and leachables from medical devices. Expert in California Proposition 65 compliance and environmental regulations. Radiation Safety and Chemical Hygiene Officer for the laboratory.

    Highlights

    Development and publication of novel methods in unique matrices for the determination of impurities, such as 1,4-dioxane in personal care products, perchlorate in drinking water and foods, nicotine degradation compounds in smoking cessation products, and Polysorbate in buffered protein solutions.

  • Contact Us

    Whatever your query, we'll pass it on to our experts and respond within a very short space of time.
    More details
Pharmaceutical testing facilities

2395 Speakman Dr.,
Mississauga, ON L5K 1B3

Contact: Larissa Hillar - Operations Manager
Tel: +1 905 822 4111 (ext. 10614)

Fax: +1 905 823 1446

Email: americas@exova.com

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1300 First State Blvd, Suite C,
Wilmington, DE 19804

Contact: Waheed Sheikh - President
Tel: +1 302-636-0202

Fax: +1 302-636-0204

Email: americas@exova.com

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9240 Santa Fe Springs Road,
Santa Fe Springs, CA 90670

Contact: Eric Lindsay - General Manager
Tel: +1 562-948-2225

Fax: +1 562-948-5850

Email: americas@exova.com

Sectors
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